Laboratory Quality Standars And Their Implementation

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Laboratory Quality Management System

Author : World Health Organization
Publisher :
ISBN 13 : 9789241548274
Total Pages : 0 pages
Book Rating : 4.5/5 (482 download)

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Book Synopsis Laboratory Quality Management System by : World Health Organization

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".

Laboratory Quality Standards and Their Implementation

Author : WHO Regional Office for South-East Asia
Publisher : World Health Organization
ISBN 13 : 9789290223979
Total Pages : 0 pages
Book Rating : 4.2/5 (239 download)

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Book Synopsis Laboratory Quality Standards and Their Implementation by : WHO Regional Office for South-East Asia

Download or read book Laboratory Quality Standards and Their Implementation written by WHO Regional Office for South-East Asia and published by World Health Organization. This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Establishing and maintaining laboratory quality standards are essential to generate reliable results to support clinical and public health actions. The Laboratory Quality Standardspresent a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. This book also outlines mechanism to implement them. This book will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requirements set with the ultimate objective to comply with ISO 15189 in a logical and step-by-step manner.

Returning Individual Research Results to Participants

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309475201
Total Pages : 399 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Returning Individual Research Results to Participants by : National Academies of Sciences, Engineering, and Medicine

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-08-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Quality Assurance Implementation in Research Labs

Author : Akshay Anand
Publisher : Springer Nature
ISBN 13 : 9811630747
Total Pages : 247 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Quality Assurance Implementation in Research Labs by : Akshay Anand

Download or read book Quality Assurance Implementation in Research Labs written by Akshay Anand and published by Springer Nature. This book was released on 2021-08-17 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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”

Clinical Laboratory Management

Author : Shakti Kumar Yadav
Publisher : Springer Nature
ISBN 13 : 3031464206
Total Pages : 276 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Clinical Laboratory Management by : Shakti Kumar Yadav

Download or read book Clinical Laboratory Management written by Shakti Kumar Yadav and published by Springer Nature. This book was released on with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Metrology and Instrumentation

Author : Samir Mekid
Publisher : John Wiley & Sons
ISBN 13 : 1119721717
Total Pages : 404 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Metrology and Instrumentation by : Samir Mekid

Download or read book Metrology and Instrumentation written by Samir Mekid and published by John Wiley & Sons. This book was released on 2021-12-02 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metrology and Instrumentation: Practical Applications for Engineering and Manufacturing provides students and professionals with an accessible foundation in the metrology techniques, instruments, and governing standards used in mechanical engineering and manufacturing. The book opens with an overview of metrology units and scale, then moves on to explain topics such as sources of error, calibration systems, uncertainty, and dimensional, mechanical, and thermodynamic measurement systems. A chapter on tolerance stack-ups covers GD&T, ASME Y14.5-2018, and the ISO standard for general tolerances, while a chapter on digital measurements connects metrology to newer, Industry 4.0 applications.

Basic Quality Management Systems

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958289
Total Pages : 286 pages
Book Rating : 4.9/5 (582 download)

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Book Synopsis Basic Quality Management Systems by : James O. Westgard

Download or read book Basic Quality Management Systems written by James O. Westgard and published by . This book was released on 2014-01-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biomedical Product Development: Bench to Bedside

Author : Babak Arjmand
Publisher : Springer Nature
ISBN 13 : 3030356264
Total Pages : 164 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Biomedical Product Development: Bench to Bedside by : Babak Arjmand

Download or read book Biomedical Product Development: Bench to Bedside written by Babak Arjmand and published by Springer Nature. This book was released on 2020-02-05 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

Guidelines for Laboratory Quality Auditing

Author : Doanld C. Singer
Publisher : CRC Press
ISBN 13 : 1498710522
Total Pages : 430 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Guidelines for Laboratory Quality Auditing by : Doanld C. Singer

Download or read book Guidelines for Laboratory Quality Auditing written by Doanld C. Singer and published by CRC Press. This book was released on 2014-07-22 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.

Clinical Laboratory Management

Author : Timothy C. Allen
Publisher : John Wiley & Sons
ISBN 13 : 168367393X
Total Pages : 821 pages
Book Rating : 4.6/5 (836 download)

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Book Synopsis Clinical Laboratory Management by : Timothy C. Allen

Download or read book Clinical Laboratory Management written by Timothy C. Allen and published by John Wiley & Sons. This book was released on 2024-03-25 with total page 821 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Evaluation of Forensic DNA Evidence

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309134404
Total Pages : 270 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Evaluation of Forensic DNA Evidence by : National Research Council

Download or read book The Evaluation of Forensic DNA Evidence written by National Research Council and published by National Academies Press. This book was released on 1996-12-12 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1992 the National Research Council issued DNA Technology in Forensic Science, a book that documented the state of the art in this emerging field. Recently, this volume was brought to worldwide attention in the murder trial of celebrity O. J. Simpson. The Evaluation of Forensic DNA Evidence reports on developments in population genetics and statistics since the original volume was published. The committee comments on statements in the original book that proved controversial or that have been misapplied in the courts. This volume offers recommendations for handling DNA samples, performing calculations, and other aspects of using DNA as a forensic toolâ€"modifying some recommendations presented in the 1992 volume. The update addresses two major areas: Determination of DNA profiles. The committee considers how laboratory errors (particularly false matches) can arise, how errors might be reduced, and how to take into account the fact that the error rate can never be reduced to zero. Interpretation of a finding that the DNA profile of a suspect or victim matches the evidence DNA. The committee addresses controversies in population genetics, exploring the problems that arise from the mixture of groups and subgroups in the American population and how this substructure can be accounted for in calculating frequencies. This volume examines statistical issues in interpreting frequencies as probabilities, including adjustments when a suspect is found through a database search. The committee includes a detailed discussion of what its recommendations would mean in the courtroom, with numerous case citations. By resolving several remaining issues in the evaluation of this increasingly important area of forensic evidence, this technical update will be important to forensic scientists and population geneticistsâ€"and helpful to attorneys, judges, and others who need to understand DNA and the law. Anyone working in laboratories and in the courts or anyone studying this issue should own this book.

Quality Control in Laboratory

Author : Gaffar Zaman
Publisher : BoD – Books on Demand
ISBN 13 : 1789234123
Total Pages : 160 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Quality Control in Laboratory by : Gaffar Zaman

Download or read book Quality Control in Laboratory written by Gaffar Zaman and published by BoD – Books on Demand. This book was released on 2018-08-22 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Laboratory Biosafety Manual

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241546508
Total Pages : 196 pages
Book Rating : 4.5/5 (465 download)

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Book Synopsis Laboratory Biosafety Manual by : World Health Organization

Download or read book Laboratory Biosafety Manual written by World Health Organization and published by World Health Organization. This book was released on 2004-12-28 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the third edition of this manual which contains updated practical guidance on biosafety techniques in laboratories at all levels. It is organised into nine sections and issues covered include: microbiological risk assessment; lab design and facilities; biosecurity concepts; safety equipment; contingency planning; disinfection and sterilisation; the transport of infectious substances; biosafety and the safe use of recombinant DNA technology; chemical, fire and electrical safety aspects; safety organisation and training programmes; and the safety checklist.

How Effectively are State and Federal Agencies Working Together to Implement the Use of New DNA Technologies?

Author : United States. Congress. House. Committee on Government Reform. Subcommittee on Government Efficiency, Financial Management, and Intergovernmental Relations
Publisher :
ISBN 13 :
Total Pages : 140 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis How Effectively are State and Federal Agencies Working Together to Implement the Use of New DNA Technologies? by : United States. Congress. House. Committee on Government Reform. Subcommittee on Government Efficiency, Financial Management, and Intergovernmental Relations

Download or read book How Effectively are State and Federal Agencies Working Together to Implement the Use of New DNA Technologies? written by United States. Congress. House. Committee on Government Reform. Subcommittee on Government Efficiency, Financial Management, and Intergovernmental Relations and published by . This book was released on 2002 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Performance Standards for Antimicrobial Susceptibility Testing

Author : CDC.
Publisher :
ISBN 13 : 9781562388041
Total Pages : 250 pages
Book Rating : 4.3/5 (88 download)

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Book Synopsis Performance Standards for Antimicrobial Susceptibility Testing by : CDC.

Download or read book Performance Standards for Antimicrobial Susceptibility Testing written by CDC. and published by . This book was released on 2017 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This document provides updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards M02-A12, M07-A10, and M11-A8"--Cover.

State Implementation of Federal Standards: The Resource Conservation and Recovery Act

Author : United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Intergovernmental Relations
Publisher :
ISBN 13 :
Total Pages : 176 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis State Implementation of Federal Standards: The Resource Conservation and Recovery Act by : United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Intergovernmental Relations

Download or read book State Implementation of Federal Standards: The Resource Conservation and Recovery Act written by United States. Congress. Senate. Committee on Governmental Affairs. Subcommittee on Intergovernmental Relations and published by . This book was released on 1982 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Global Health and Pathology, An Issue of the Clinics in Laboratory Medicine

Author : Dan Milner
Publisher : Elsevier Health Sciences
ISBN 13 : 0323581595
Total Pages : pages
Book Rating : 4.3/5 (235 download)

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Book Synopsis Global Health and Pathology, An Issue of the Clinics in Laboratory Medicine by : Dan Milner

Download or read book Global Health and Pathology, An Issue of the Clinics in Laboratory Medicine written by Dan Milner and published by Elsevier Health Sciences. This book was released on 2018-02-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This issue of Clinics in Laboratory Medicine, edited by Dr. Dan Milner, will focus on Global Health and Pathology. Topics include, but are not limited to: Clinical Laboratory Volunteerism, Pathologists Overseas; Anatomic Pathology Volunteerism; Funding Strategies in Research and Global Pathology; Diagnostics for Cancer and Health Systems building through pathology laboratories; Training the next pathologists in global health; Maximizing internet resources for improving pathology/lab medicine in LMICs; Pathology-based research in Africa; HIV and Cancer: Role of Pathology in success; Lymphoma and Pathology in Africa: Current approaches and future diagnostics; Laboratory Capacity as a tool for building health systems; Building Cross Country Networks for Laboratory Capacity and improvement; Lab accreditation; Practical success in Telepathology experiences in Africa; Pathology and WHO vision of the future of LMICs; Breast Cancer in LMICs: Why we need pathology and clinical trial capability to solve this challenge; Cytopathology in LMICs: why and how to integrate to capacitate healthcare; and Biorepositories and Data Cores for Research in Global Health.