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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.
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.
Author: James O. Westgard Publisher: Westgard Quality Corporation ISBN: 9781886958203 Category : Diagnosis, Laboratory Languages : en Pages : 224
Book Description
Together with Dr. Sharon S. Ehrmeyer, PhD, MT(ASCP), Dr. Teresa Darcy, MD, FACP, and with an introduction by Dr. Ronald R. Laessig, PhD, Dr. Westgard has written a new book that explains the practical impact of the new regulations and interpretive guidelines: This new manual provides thorough coverage of the key changes in the CLIA Final Rule, as well as in-depth analysis of the new laboratory responsibilities that the regulations have created. But this manual is more than a compliance guide: * It explains the method validation requirements and details how to organize the statistical studies now required for all new non-waived methods. * It dispels the confusion about waived, non-waived, moderate, and high complexity methods * It defines the new calibration and calibration verification requirements. * It describes the final QC requirements, as well as an overview of a QC Planning and Design process to "Do the Right QC Right" * It provides an authoritative judgment on the new "equivalent QC procedures" * and more...
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".
Author: William B. Coleman Publisher: Springer Science & Business Media ISBN: 1592599281 Category : Medical Languages : en Pages : 593
Book Description
Accompanying CD-ROM contains ... "a companion eBook version of Molecular diagnostics : for the clinical laboratorian, Second edition ... for downloading and use in the reader's PC or PDA."--Page 4 of cover.
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.
Author: Elaine M. Keohane Publisher: Elsevier Health Sciences ISBN: 0323549632 Category : Medical Languages : en Pages : 910
Book Description
**Selected for Doody's Core Titles® 2024 in Laboratory Technology** Make sure you are thoroughly prepared to work in a clinical lab. Rodak's Hematology: Clinical Principles and Applications, 6th Edition uses hundreds of full-color photomicrographs to help you understand the essentials of hematology. This new edition shows how to accurately identify cells, simplifies hemostasis and thrombosis concepts, and covers normal hematopoiesis through diseases of erythroid, myeloid, lymphoid, and megakaryocytic origins. Easy to follow and understand, this book also covers key topics including: working in a hematology lab; complementary testing areas such as flow cytometry, cytogenetics, and molecular diagnostics; the parts and functions of the cell; and laboratory testing of blood cells and body fluid cells. - UPDATED nearly 700 full-color illustrations and photomicrographs make it easier for you to visualize hematology concepts and show what you'll encounter in the lab, with images appearing near their mentions in the text to minimize flipping pages back and forth. - UPDATED content throughout text reflects latest information on hematology. - Instructions for lab procedures include sources of possible errors along with comments. - Hematology instruments are described, compared, and contrasted. - Case studies in each chapter provide opportunities to apply hematology concepts to real-life scenarios. - Hematology/hemostasis reference ranges are listed on the inside front and back covers for quick reference. - A bulleted summary makes it easy for you to review the important points in every chapter. - Learning objectives begin each chapter and indicate what you should achieve, with review questions appearing at the end. - A glossary of key terms makes it easy to find and learn definitions. - NEW! Additional content on cell structure and receptors helps you learn to identify these organisms. - NEW! New chapter on Introduction to Hematology Malignancies provides and overview of diagnostic technology and techniques used in the lab.
Author: National Academies of Sciences, Engineering, and Medicine
Author: National Academies of Sciences, Engineering, and Medicine
Author: James O. Westgard
Author: James O. Westgard
Author: James O. Westgard
Author: Kory M. Ward
Author: World Health Organization
Author: James O. Westgard
Author: William B. Coleman
Author: Timothy C. Allen
Author: Elaine M. Keohane