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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".
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Thoroughly updated and easy-to-follow, Linne & Ringsrud's Clinical Laboratory Science: Concepts, Procedures, and Clinical Applications, 8th Edition offers a fundamental overview of the laboratory skills and techniques you'll need for success in the clinical laboratory. Author Mary Louise Turgeon's simple and straightforward writing clarifies complex concepts, and her unique discipline-by-discipline approach helps you build knowledge and learn to confidently perform routine clinical laboratory tests with accurate, effective results. Topics like safety, measurement techniques, and quality assessment are woven throughout the various skills. The new eighth edition also features updated content including expanded information on viruses and automation. It's the must-have foundation for anyone wanting to pursue a profession in the clinical lab. - Broad content scope provides an ideal introduction to clinical laboratory science at a variety of levels, including CLS/MT, CLT/MLT, and Medical Assisting. - Case studies include critical thinking and multiple-choice questions to challenge readers to apply the content to real-life scenarios. - Expert insight from respected educator Mary Lou Turgeon reflects the full spectrum of clinical lab science. - Detailed procedures guides readers through the exact steps performed in the lab. - Vivid full-color illustrations familiarize readers with what they'll see under the microscope. - Review questions at the end of each chapter help readers assess your understanding and identify areas requiring additional study. - Evolve companion website provides convenient online access to all of the procedures in the text and houses animations, flashcards, and additional review questions not found in the printed text. - Procedure worksheets can be used in the lab and for assignment as homework. - Streamlined approach makes must-know concepts and practices more accessible. - Convenient glossary simplifies the process of looking up definitions without having to search through each chapter. - NEW! Updated content throughout keeps pace with constant changes in clinical lab science. - NEW! Consistent review question format ensures consistency and enables readers to study more efficiently. - NEW! More discussion of automation familiarizes readers with the latest automation technologies and processes increasingly used in the clinical lab to increase productivity and elevate experimental data quality. - NEW! Additional information on viruses keeps readers up to date on this critical area of clinical lab science.
**Selected for Doody's Core Titles® 2024 in Laboratory Technology** Using a discipline-by-discipline approach, Turgeon's Clinical Laboratory Science: Concepts, Procedures, and Clinical Applications, 9th Edition, provides a fundamental overview of the concepts, procedures, and clinical applications essential for working in a clinical laboratory and performing routine clinical lab tests. Coverage includes basic laboratory techniques and key topics such as safety, phlebotomy, quality assessment, automation, and point-of-care testing, as well as discussion of clinical laboratory specialties. Clear, straightforward instructions simplify laboratory procedures and are guided by the latest practices and CLSI (Clinical and Laboratory Standards Institute) standards. Written by well-known CLS educator Mary Louise Turgeon, this edition offers essential guidance and recommendations for today's laboratory testing methods and clinical applications. - Broad scope of coverage makes this text an ideal companion for clinical laboratory science programs at various levels, including CLS/MT, CLT/MLT, medical laboratory assistant, and medical assisting, and reflects the taxonomy levels of the CLS/MT and CLT/MLT exams. - Detailed procedure guides and procedure worksheets on Evolve and in the ebook familiarize you with the exact steps performed in the lab. - Vivid, full-color illustrations depict concepts and applicable images that can be seen under the microscope. - An extensive number of certification-style, multiple-choice review questions are organized and coordinated under major topical headings at the end of each chapter to help you assess your understanding and identify areas requiring additional study. - Case studies include critical thinking group discussion questions, providing the opportunity to apply content to real-life scenarios. - The newest Entry Level Curriculum Updates for workforce entry, published by the American Society for Clinical Laboratory Science (ASCLS) and the American Society for Clinical Pathology (ASCP) Board of Certification Exam Content Outlines, serve as content reference sources. - Convenient glossary makes it easy to look up definitions without having to search through each chapter. - An Evolve companion website provides convenient access to animations, flash card sets, and additional review questions. - Experienced author, speaker, and educator Mary L. Turgeon is well known for providing insight into the rapidly changing field of clinical laboratory science.