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"This inspection examines the characteristics of physician office laboratories (POLs), discusses concerns regarding the quality of testing in POLs, and evaluates State and Federal efforts to regulate them"--I.
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".
Inside, you’ll find a wealth of information on important laboratory terminology and the procedures you’ll need to perform to become an effective member of a physician’s office team. Coverage of the advanced procedures performed outside of the physician’s office explains what happens to the samples you send out. There’s also information on CLIA and other government regulations and how they affect each procedure.
Quality Assurance (QA) is an integral and very important part of laboratory medicine. Pathologists, microbiologists, biochemists and laboratory technicians all need to be proficient in this subject. QA is also mandatory for obtaining accreditation, which ensures a certain level of quality in services being provided. The subject of Quality Assurance (QA), though not new, is a relatively neglected entity and is looked at with some degree of apprehension. This book is addressed to those entrusted with implementing Quality Assurance (QA) in laboratory medicine; generally, these are persons with basic training as pathologists. This handbook is meant as a beginner and handy guide to Quality Assurance; all the basics of Quality Assurance have been incorporated to encourage the beginner to make a start.