Laboratory Quality Management System
Laboratory Quality Management System

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

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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".

Accurate Results in the Clinical Laboratory
Accurate Results in the Clinical Laboratory

Author: Amitava Dasgupta

Publisher: Elsevier

Published: 2019-07-20

Total Pages: 512

ISBN-13: 0128137770

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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

Quality Control in Laboratory
Quality Control in Laboratory

Author: Gaffar Zaman

Publisher: BoD – Books on Demand

Published: 2018-08-22

Total Pages: 160

ISBN-13: 1789234123

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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.

Good Clinical, Laboratory and Manufacturing Practices
Good Clinical, Laboratory and Manufacturing Practices

Author: Philip Carson

Publisher: Royal Society of Chemistry

Published: 2007-10-31

Total Pages: 657

ISBN-13: 1847557724

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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.

Quality in Laboratory Hemostasis and Thrombosis
Quality in Laboratory Hemostasis and Thrombosis

Author: Steve Kitchen

Publisher: John Wiley & Sons

Published: 2011-08-24

Total Pages: 325

ISBN-13: 1444360590

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"Over the last decades, major progress has been made in quality assurance of hemostatic laboratory assays. This book will be an indispensable part of every hemostasis laboratory, where, given its hands-on nature, it will rarely sit to get dusty on the shelves." —Frits R. Rosendaal, Leiden University Medical Center The hemostasis laboratory has a vital role in the diagnosis and management of patients with familial and acquired hemorrhagic and thrombotic disorders. Its role in the monitoring traditional anticoagulant therapy as well as therapy using new anticoagulants presents new challenges to the laboratory. Quality in Laboratory Hemostasis and Thrombosis not only addresses these important issues, but also covers international guidelines for testing, the development of international standard materials, management of hemostasis testing from the laboratory to the point of care as well as molecular genetic testing. Designed as a guide for all those working in hemostasis laboratories, this book details a quality program that, when put into place, will help to improve standards in testing. All of the authors are internationally recognised for their work in hemostasis and thrombosis. Using their experience, they provide information on standards, equipment and methods that will guide the development of a quality program to support all activities in the hemostasis laboratory.

Laboratory quality control and patient safety
Laboratory quality control and patient safety

Author: Jeremie M. Gras

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2017-03-06

Total Pages: 105

ISBN-13: 3110384531

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Every clinical laboratory devotes considerable resources to Quality Control. Recently, the advent of concepts such as Analytical Goals, Biological Variation, Six Sigma and Risk Management has generated a renewed interest in the way to perform QC. However, laboratory QC practices remain highly non-standardized and a lot of QC questions are left unanswered. The objective of this book is to propose a roadmap for the application of an integrated QC protocol that ensures the safety of patient results in the everyday lab routine.

Mass Spectrometry for the Clinical Laboratory
Mass Spectrometry for the Clinical Laboratory

Author: Hari Nair

Publisher: Academic Press

Published: 2016-11-02

Total Pages: 306

ISBN-13: 0128009926

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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

Clinical Laboratory Management
Clinical Laboratory Management

Author: Timothy C. Allen

Publisher: John Wiley & Sons

Published: 2024-03-25

Total Pages: 821

ISBN-13: 168367393X

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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.