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Basic Quality Assurance Practices For Clinical Laboratories
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Book Synopsis Basic Quality Assurance Practices for Clinical Laboratories by : Charles E. Stewart
Download or read book Basic Quality Assurance Practices for Clinical Laboratories written by Charles E. Stewart and published by Lippincott Williams & Wilkins. This book was released on 1987 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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".
Book Synopsis Quality Management in Clinical Laboratories by : Paul Valenstein
Download or read book Quality Management in Clinical Laboratories written by Paul Valenstein and published by . This book was released on 2005-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Good Clinical, Laboratory and Manufacturing Practices by : Philip Carson
Download or read book Good Clinical, Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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”
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.
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:
Book Synopsis Quality Assurance in the Era of Individualized Medicine by : Moumtzoglou, Anastasius S.
Download or read book Quality Assurance in the Era of Individualized Medicine written by Moumtzoglou, Anastasius S. and published by IGI Global. This book was released on 2019-11-29 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a significant deficiency among contemporary medicine practices reflected by experts making medical decisions for a large proportion of the population for which no or minimal data exists. Fortunately, our capacity to procure and apply such information is rapidly rising. As medicine becomes more individualized, the implementation of health IT and data interoperability become essential components to delivering quality healthcare. Quality Assurance in the Era of Individualized Medicine is a collection of innovative research on the methods and utilization of digital readouts to fashion an individualized therapy instead of a mass-population-directed strategy. While highlighting topics including assistive technologies, patient management, and clinical practices, this book is ideally designed for health professionals, doctors, nurses, hospital management, medical administrators, IT specialists, data scientists, researchers, academicians, and students.
Book Synopsis Laboratory Techniques in Thrombosis — a Manual by : J. Jespersen
Download or read book Laboratory Techniques in Thrombosis — a Manual written by J. Jespersen and published by Springer Science & Business Media. This book was released on 2013-12-01 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of this manual appeared in 1992 and was entitled ECAT Assay Procedures. It was the result of a unique cooperation between experts brought together by the European Concerted Action on Thrombosis and Disabilities (ECAT). The Concerted Action was at that time under the auspices of the Commission of the European Union. The second edition, like the first edition, deals with diagnostic tests within the field of thrombosis. However, the second edition has a broader scope because it is no longer limited by the frontiers of ECAT. Experts allover the world, in and outside ECAT, have contributed to this edition. The editors are very grateful for their contributions. The need for a new edition is obvious. Since 1992 new assays have been introduced for research, diagnosis, and therapy of thrombosis; for other assays improvements have been suggested, while a few others became redundant. The editors waived the radioimmunoassays of ~-thrombog1obulin and platelet factor 4 due to the fact that the kits required for these assays are rarely, or no longer, available. Also the PAI-1 activity assay was waived as it is liable to many inconsistencies and to large variations. A list of names and addresses of manufacturers marketing the kits and reagents has been compiled, together with a list of the recommended nomenclature of quantities in thrombosis and haemostasis, in order to facilitate the use of the updated version. These lists have been carefully compiled by Johannes J. Sidelmann, PhD, Department of Clinical Biochemistry in Esbjerg, Denmark.
Book Synopsis Evolution of Translational Omics by : Institute of Medicine
Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.
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)
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.
Book Synopsis Mass Spectrometry for the Clinical Laboratory by : Hari Nair
Download or read book Mass Spectrometry for the Clinical Laboratory written by Hari Nair and published by Academic Press. This book was released on 2016-11-02 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
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)
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.
Book Synopsis Essentials Of Medical Laboratory Practice by : Constance L Lieseke
Download or read book Essentials Of Medical Laboratory Practice written by Constance L Lieseke and published by F.A. Davis. This book was released on 2012-01-31 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inside, you’ll find a wealth of information on important laboratory terminology and the procedures you’ll need to perform to become an effective member of a physician’s office team. Coverage of the advanced procedures performed outside of the physician’s office explains what happens to the samples you send out. There’s also information on CLIA and other government regulations and how they affect each procedure.
Book Synopsis Quality Management in Anatomic Pathology by : Raouf E. Nakhleh
Download or read book Quality Management in Anatomic Pathology written by Raouf E. Nakhleh and published by . This book was released on 2005 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Textbook of Patient Safety and Clinical Risk Management by : Liam Donaldson
Download or read book Textbook of Patient Safety and Clinical Risk Management written by Liam Donaldson and published by Springer Nature. This book was released on 2020-12-14 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementing safety practices in healthcare saves lives and improves the quality of care: it is therefore vital to apply good clinical practices, such as the WHO surgical checklist, to adopt the most appropriate measures for the prevention of assistance-related risks, and to identify the potential ones using tools such as reporting & learning systems. The culture of safety in the care environment and of human factors influencing it should be developed from the beginning of medical studies and in the first years of professional practice, in order to have the maximum impact on clinicians' and nurses' behavior. Medical errors tend to vary with the level of proficiency and experience, and this must be taken into account in adverse events prevention. Human factors assume a decisive importance in resilient organizations, and an understanding of risk control and containment is fundamental for all medical and surgical specialties. This open access book offers recommendations and examples of how to improve patient safety by changing practices, introducing organizational and technological innovations, and creating effective, patient-centered, timely, efficient, and equitable care systems, in order to spread the quality and patient safety culture among the new generation of healthcare professionals, and is intended for residents and young professionals in different clinical specialties.
