Quality Management in Clinical Laboratories PDF Download

Author: Paul Valenstein
Publisher:
ISBN: 9780930304881
Category : Diagnosis, Laboratory
Languages : en
Pages : 257

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Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0

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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: Gaffar Zaman
Publisher: BoD – Books on Demand
ISBN: 1789234123
Category : Business & Economics
Languages : en
Pages : 160

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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: Akshay Anand
Publisher: Springer Nature
ISBN: 9811630747
Category : Medical
Languages : en
Pages : 247

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Book Description
This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”

Author: Philip Carson
Publisher: Royal Society of Chemistry
ISBN: 1847557724
Category : Science
Languages : en
Pages : 657

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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: James O. Westgard
Publisher:
ISBN: 9781886958289
Category : Medical
Languages : en
Pages : 286

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Book Description

Author: Timothy C. Allen
Publisher: John Wiley & Sons
ISBN: 168367393X
Category : Medical
Languages : en
Pages : 821

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Book Description
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.

Author: Candis A. Kinkus
Publisher: Demos Medical Publishing
ISBN: 1936287455
Category : Business & Economics
Languages : en
Pages : 121

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Print+CourseSmart

Author: Raouf E. Nakhleh
Publisher:
ISBN: 9780930304867
Category : Autopsy
Languages : en
Pages : 185

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Book Description
Partial Contents: Designing a Quality Improvement Plan; Regulatory Compliance; Strategies for Error Reduction and Prevention in Surgical Pathology; Defining and Handling Errors; Quality Improvement Plan Components and Monitors; Quality Management in Histology, Immunohistochemistry, Cytology, and Autopsy Pathology.

Author: Hari Nair
Publisher: Academic Press
ISBN: 0128009926
Category : Science
Languages : en
Pages : 306

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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