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Author: World Health Organization Publisher: ISBN: 9789241548274 Category : Laboratories Languages : en Pages : 0
Book Description
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".
Author: World Health Organization Publisher: ISBN: 9789241548274 Category : Laboratories Languages : en Pages : 0
Book Description
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".
Author: Amitava Dasgupta Publisher: Elsevier ISBN: 0128137770 Category : Science Languages : en Pages : 512
Book Description
Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction, Second Edition, provides a comprehensive review of the factors leading to errors in all areas of clinical laboratory testing. This trusted guide addresses interference issues in all laboratory tests, including patient epigenetics, processes of specimen collection, enzymes and biomarkers. Clinicians and laboratory scientists will both benefit from this reference that applies discussions to both accurate specimen analysis and optimal patient care. Hence, this is the perfect reference for clinical laboratorians, from trainees, to experienced pathologists and directors. - Provides comprehensive coverage across endocrine, oncology, hematology, immunohistochemistry, immunology, serology, microbiology, and molecular testing - Includes new case studies that highlight clinical relevance and errors to avoid - Highlights the best titles published within a variety of medical specialties - Reviewed by medical librarians and content specialists, with key selections compiled in their annual list
Author: Gaffar Zaman Publisher: BoD – Books on Demand ISBN: 1789234123 Category : Business & Economics Languages : en Pages : 160
Book Description
The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.
Author: Philip Carson Publisher: Royal Society of Chemistry ISBN: 1847557724 Category : Science Languages : en Pages : 657
Book Description
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author: Hari Nair Publisher: Academic Press ISBN: 0128009926 Category : Science Languages : en Pages : 306
Book Description
Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in clinical labs. It provides readers with practical examples for assay development, and experimental design for validation to meet CLIA requirements, appropriate interference testing, measuring, validation of ion suppression/matrix effects, and quality control. These tools offer guidance on what type of instrumentation is optimal for each assay, what options are available, and the pros and cons of each. Readers will find a full set of tools that are either directly related to the assay they want to adopt or for an analogous assay they could use as an example. Written by expert users of the most common assays found in a clinical laboratory (clinical chemists, toxicologists, and clinical pathologists practicing mass spectrometry), the book lays out how experts in the field have chosen their mass spectrometers, purchased, installed, validated, and brought them on line for routine testing. The early chapters of the book covers what the practitioners have learned from years of experience, the challenges they have faced, and their recommendations on how to build and validate assays to avoid problems. These chapters also include recommendations for maintaining continuity of quality in testing. The later parts of the book focuses on specific types of assays (therapeutic drugs, Vitamin D, hormones, etc.). Each chapter in this section has been written by an expert practitioner of an assay that is currently running in his or her clinical lab. Provides readers with the keys to choosing, installing, and validating a mass spectrometry platform Offers tools to evaluate, validate, and troubleshoot the most common assays seen in clinical pathology labs Explains validation, ion suppression, interference testing, and quality control design to the detail that is required for implementation in the lab
Author: Judith A. O'Brien Publisher: McGraw-Hill Professional Publishing ISBN: Category : Medical Languages : en Pages : 584
Book Description
-- A valuable look at the clinical challenges and questions that arise. in the everyday operation of the clinical lab -- Focuses on practical solutions to the most common, but not necessarily easy-to-solve, problems. -- Covers procedures and policies, planning continuing education, establishing quality control and quality assurance protocols, tuberculosis control, OSHA, and CLIA-88
Author: J. Jespersen Publisher: Springer Science & Business Media ISBN: 9780792364726 Category : Medical Languages : en Pages : 340
Book Description
The first edition of this manual appeared in 1992 and was entitled ECAT Assay Procedures. This completely revised new edition combines the strengths of the first edition with new and useful features. Laboratory Techniques in Thrombosis - a Manual still gives detailed descriptions of the recommended assays and their alternatives. However, the manual now has a broader scope because it is no longer limited by the frontiers of ECAT. Experts all over the world have contributed to this edition. Furthermore, new assays have been introduced, improvements have been suggested for other assays, while a few others have become redundant or no longer available. The list of manufacturers is fully updated and a list of the recommended nomenclature of quantities in thrombosis and haemostasis is new to this edition, further facilitating the use of this manual. Laboratory Techniques in Thrombosis - a Manual will contribute to furthering the much needed harmonization and standardization of tests within the field and should have a place in all working haemostasis laboratories.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309183618 Category : Medical Languages : en Pages : 261
Book Description
Clinical laboratory tests play an integral role in helping physicians diagnose and treat patients. New developments in laboratory technology offer the prospect of improvements in diagnosis and care, but will place an increased burden on the payment system. Medicare, the federal program providing coverage of health-care services for the elderly and disabled, is the largest payer of clinical laboratory services. Originally designed in the early 1980s, Medicare's payment policy methodology for outpatient laboratory services has not evolved to take into account technology, market, and regulatory changes, and is now outdated. This report examines the current Medicare payment methodology for outpatient clinical laboratory services in the context of environmental and technological trends, evaluates payment policy alternatives, and makes recommendations to improve the system.
Author: World Health Organization
Author: World Health Organization
Author: Paul Valenstein
Author: Amitava Dasgupta
Author: Gaffar Zaman
Author: Philip Carson
Author: Hari Nair
Author: Judith A. O'Brien
Author: Kory M. Ward
Author: J. Jespersen
Author: Institute of Medicine