Author: Donnell R. Christian Jr.
Publisher: CRC Press
ISBN: 1420073052
Category : Business & Economics
Languages : en
Pages : 1434
Book Description
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
Implementing Quality in Laboratory Policies and Processes
Author: Donnell R. Christian Jr.
Publisher: CRC Press
ISBN: 1420073052
Category : Business & Economics
Languages : en
Pages : 1434
Book Description
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
Publisher: CRC Press
ISBN: 1420073052
Category : Business & Economics
Languages : en
Pages : 1434
Book Description
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
Laboratory Quality Management System
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".
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".
Returning Individual Research Results to Participants
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
Book Description
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.
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
Book Description
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.
Clinical Laboratory Management
Author: Timothy C. Allen
Publisher: John Wiley & Sons
ISBN: 168367393X
Category : Medical
Languages : en
Pages : 821
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.
Publisher: John Wiley & Sons
ISBN: 168367393X
Category : Medical
Languages : en
Pages : 821
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.
The Forensic Laboratory Handbook Procedures and Practice
Author: Ashraf Mozayani
Publisher: Springer Science & Business Media
ISBN: 1607618729
Category : Medical
Languages : en
Pages : 604
Book Description
Forensic science has come a long way in the past ten years. It is much more in-depth and much broader in scope, and the information gleaned from any evidence yields so much more information than it had in the past because of incredible advances in analytic instruments and crucial procedures at both the crime scene and in the lab. Many practices have gone digital, a concept not even fathomed ten years ago. And from the first collection of evidence to its lab analysis and interpretation to its final presentation in court, ethics has become an overriding guiding principle. That’s why this new edition of this classic handbook is indispensable. The Forensic Laboratory Handbook Procedures and Practice includes thirteen new chapters written by real-life practitioners who are experts in the field. It covers the tried and true topics of fingerprints, trace evidence, chemistry, biology, explosives and arson, forensic anthropology, forensic pathology, forensic documents, firearms and toolmarks. This text also addresses an array of new topics including accreditation, certification, ethics, and how insects and bugs can assist in determining many facts including a margin of time of death. In the attempt to offer a complete and comprehensive analysis The Forensic Laboratory Handbook Procedures and Practice also includes a chapter discussing the design of a laboratory. In addition, each chapter contains educational requirements needed for the discipline it covers. Complete with questions at the end of each chapter, brief author bios and real crime scene photos, this text has risen to greet the many new challenges and issues that face today’s forensic crime practitioners.
Publisher: Springer Science & Business Media
ISBN: 1607618729
Category : Medical
Languages : en
Pages : 604
Book Description
Forensic science has come a long way in the past ten years. It is much more in-depth and much broader in scope, and the information gleaned from any evidence yields so much more information than it had in the past because of incredible advances in analytic instruments and crucial procedures at both the crime scene and in the lab. Many practices have gone digital, a concept not even fathomed ten years ago. And from the first collection of evidence to its lab analysis and interpretation to its final presentation in court, ethics has become an overriding guiding principle. That’s why this new edition of this classic handbook is indispensable. The Forensic Laboratory Handbook Procedures and Practice includes thirteen new chapters written by real-life practitioners who are experts in the field. It covers the tried and true topics of fingerprints, trace evidence, chemistry, biology, explosives and arson, forensic anthropology, forensic pathology, forensic documents, firearms and toolmarks. This text also addresses an array of new topics including accreditation, certification, ethics, and how insects and bugs can assist in determining many facts including a margin of time of death. In the attempt to offer a complete and comprehensive analysis The Forensic Laboratory Handbook Procedures and Practice also includes a chapter discussing the design of a laboratory. In addition, each chapter contains educational requirements needed for the discipline it covers. Complete with questions at the end of each chapter, brief author bios and real crime scene photos, this text has risen to greet the many new challenges and issues that face today’s forensic crime practitioners.
Laboratory Quality Standards and Their Implementation
Author: WHO Regional Office for South-East Asia
Publisher: World Health Organization
ISBN: 9789290223979
Category : Medical
Languages : en
Pages : 0
Book Description
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.
Publisher: World Health Organization
ISBN: 9789290223979
Category : Medical
Languages : en
Pages : 0
Book Description
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.
Significance of Tests and Properties of Concrete and Concrete-making Materials
Author: Paul Klieger
Publisher: ASTM International
ISBN: 0803120532
Category : Concrete
Languages : en
Pages : 621
Book Description
Publisher: ASTM International
ISBN: 0803120532
Category : Concrete
Languages : en
Pages : 621
Book Description
A Practical Guide to ISO 15189 in Laboratory Medicine
Author: David Burnett (Quality and accreditation systems consultant)
Publisher:
ISBN: 9780902429499
Category : Diagnosis, Laboratory
Languages : en
Pages : 372
Book Description
Publisher:
ISBN: 9780902429499
Category : Diagnosis, Laboratory
Languages : en
Pages : 372
Book Description
Clinical Chemistry - E-Book
Author: Donna Larson
Publisher: Elsevier Health Sciences
ISBN: 0323292534
Category : Medical
Languages : en
Pages : 739
Book Description
Gain a clear understanding of pathophysiology and lab testing! Clinical Chemistry: Fundamentals and Laboratory Techniques prepares you for success as a medical lab technician by simplifying complex chemistry concepts and lab essentials including immunoassays, molecular diagnostics, and quality control. A pathophysiologic approach covers diseases that are commonly diagnosed through chemical tests — broken down by body system and category — such as respiratory, gastrointestinal, and cardiovascular conditions. Written by clinical chemistry educator Donna Larson and a team of expert contributors, this full-color book is ideal for readers who may have minimal knowledge of chemistry and are learning laboratory science for the first time. - Full-color illustrations and design simplify complex concepts and make learning easier by highlighting important material. - Case studies help you apply information to real-life scenarios. - Pathophysiology and Analytes section includes information related to diseases or conditions, such as a biochemistry review, disease mechanisms, clinical correlation, and laboratory analytes and assays. - Evolve companion website includes case studies and animations that reinforce what you've learned from the book. - Laboratory Principles section covers safety, quality assurance, and other fundamentals of laboratory techniques. - Review questions at the end of each chapter are tied to the learning objectives, helping you review and retain the material. - Critical thinking questions and discussion questions help you think about and apply key points and concepts. - Other Aspects of Clinical Chemistry section covers therapeutic drug monitoring, toxicology, transplantation, and emergency preparedness. - Learning objectives in each chapter help you to remember key points or to analyze and synthesize concepts in clinical chemistry. - A list of key words Is provided at the beginning of each chapter, and these are also bolded in the text. - Chapter summaries consist of bulleted lists and tables highlighting the most important points of each chapter. - A glossary at the back of the book provides a quick reference to definitions of all clinical chemistry terms.
Publisher: Elsevier Health Sciences
ISBN: 0323292534
Category : Medical
Languages : en
Pages : 739
Book Description
Gain a clear understanding of pathophysiology and lab testing! Clinical Chemistry: Fundamentals and Laboratory Techniques prepares you for success as a medical lab technician by simplifying complex chemistry concepts and lab essentials including immunoassays, molecular diagnostics, and quality control. A pathophysiologic approach covers diseases that are commonly diagnosed through chemical tests — broken down by body system and category — such as respiratory, gastrointestinal, and cardiovascular conditions. Written by clinical chemistry educator Donna Larson and a team of expert contributors, this full-color book is ideal for readers who may have minimal knowledge of chemistry and are learning laboratory science for the first time. - Full-color illustrations and design simplify complex concepts and make learning easier by highlighting important material. - Case studies help you apply information to real-life scenarios. - Pathophysiology and Analytes section includes information related to diseases or conditions, such as a biochemistry review, disease mechanisms, clinical correlation, and laboratory analytes and assays. - Evolve companion website includes case studies and animations that reinforce what you've learned from the book. - Laboratory Principles section covers safety, quality assurance, and other fundamentals of laboratory techniques. - Review questions at the end of each chapter are tied to the learning objectives, helping you review and retain the material. - Critical thinking questions and discussion questions help you think about and apply key points and concepts. - Other Aspects of Clinical Chemistry section covers therapeutic drug monitoring, toxicology, transplantation, and emergency preparedness. - Learning objectives in each chapter help you to remember key points or to analyze and synthesize concepts in clinical chemistry. - A list of key words Is provided at the beginning of each chapter, and these are also bolded in the text. - Chapter summaries consist of bulleted lists and tables highlighting the most important points of each chapter. - A glossary at the back of the book provides a quick reference to definitions of all clinical chemistry terms.
Implementing ISO/IEC 17025:2017
Author: Bhavan (Bob) Mehta
Publisher: Quality Press
ISBN: 1953079105
Category : Technology & Engineering
Languages : en
Pages : 114
Book Description
The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.
Publisher: Quality Press
ISBN: 1953079105
Category : Technology & Engineering
Languages : en
Pages : 114
Book Description
The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.