Clia Final Rules For Quality Systems

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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.

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:

CLIA Final Rules for Quality Systems

Author : James O. Westgard
Publisher : Westgard Quality Corporation
ISBN 13 : 9781886958203
Total Pages : 224 pages
Book Rating : 4.9/5 (582 download)

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Book Synopsis CLIA Final Rules for Quality Systems by : James O. Westgard

Download or read book CLIA Final Rules for Quality Systems written by James O. Westgard and published by Westgard Quality Corporation. This book was released on 2004-01-01 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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...

Basic QC Practices, 4th Edition

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958302
Total Pages : 290 pages
Book Rating : 4.9/5 (583 download)

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Book Synopsis Basic QC Practices, 4th Edition by : James O. Westgard

Download or read book Basic QC Practices, 4th Edition written by James O. Westgard and published by . This book was released on 2016-07 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Basic Method Validation

Author : James O. Westgard
Publisher : Westgard Quality Corporation
ISBN 13 : 9781886958258
Total Pages : 320 pages
Book Rating : 4.9/5 (582 download)

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Book Synopsis Basic Method Validation by : James O. Westgard

Download or read book Basic Method Validation written by James O. Westgard and published by Westgard Quality Corporation. This book was released on 2008-01-01 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Diagnostic Technology

Author : Kory M. Ward
Publisher : Amer. Assoc. for Clinical Chemistry
ISBN 13 : 9781890883898
Total Pages : 206 pages
Book Rating : 4.8/5 (838 download)

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Book Synopsis Clinical Diagnostic Technology by : Kory M. Ward

Download or read book Clinical Diagnostic Technology written by Kory M. Ward and published by Amer. Assoc. for Clinical Chemistry. This book was released on 2003 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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".

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.

Molecular Diagnostics

Author : William B. Coleman
Publisher : Springer Science & Business Media
ISBN 13 : 1592599281
Total Pages : 593 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Molecular Diagnostics by : William B. Coleman

Download or read book Molecular Diagnostics written by William B. Coleman and published by Springer Science & Business Media. This book was released on 2007-10-28 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Six Sigma Quality Design and Control

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958234
Total Pages : 338 pages
Book Rating : 4.9/5 (582 download)

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Book Synopsis Six Sigma Quality Design and Control by : James O. Westgard

Download or read book Six Sigma Quality Design and Control written by James O. Westgard and published by . This book was released on 2006-01-01 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Six Sigma Risk Analysis

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958272
Total Pages : 296 pages
Book Rating : 4.9/5 (582 download)

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Book Synopsis Six Sigma Risk Analysis by : James O. Westgard

Download or read book Six Sigma Risk Analysis written by James O. Westgard and published by . This book was released on 2011 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk Analysis is coming to medical laboratories. But for too many labs, Risk Analysis is a buzzword without meaning, an approach without defined technique. At worst, it threatens to appear like science while being implemented like guesswork. In this book, Dr. Westgard surveys the ISO standards, as well as published CLSI guidelines, and the long-established Joint Commission methodology for Proactive Risk Reduction. After providing an overview of the general Risk Analysis approach, Dr. Westgard explains how to adapt the principles for the medical laboratory, with performance-based tools and practical implementation tips: * Process maps, flowcharts and fishbone diagrams * Risk Acceptability matrices * Assessment of hazards through Failure Mode Effects Analysis (FMEA) * Fault Tree Analysis (FTA) and Failure Reporting, Analysis and Corrective Actions System (FRACAS) * Six Sigma metric integration into Risk Analysis Using Six Sigma metrics, Dr. Westgard shows how Risk Analysis can be converted from qualitative and ephemeral to something more quantitative and concrete. When performance data informs Risk Analysis, the decisions become more relevant to medical laboratories and the patients they serve. Don't settle for arbitrary guesswork in your Risk Analysis. Combine the power of Six Sigma and Risk Analysis tools.

The Medical-Legal Aspects of Acute Care Medicine

Author : James E. Szalados
Publisher : Springer Nature
ISBN 13 : 3030685705
Total Pages : 694 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis The Medical-Legal Aspects of Acute Care Medicine by : James E. Szalados

Download or read book The Medical-Legal Aspects of Acute Care Medicine written by James E. Szalados and published by Springer Nature. This book was released on 2021-04-02 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.

Rodak's Hematology - E-Book

Author : Elaine M. Keohane
Publisher : Elsevier Health Sciences
ISBN 13 : 0323549632
Total Pages : 910 pages
Book Rating : 4.3/5 (235 download)

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Book Synopsis Rodak's Hematology - E-Book by : Elaine M. Keohane

Download or read book Rodak's Hematology - E-Book written by Elaine M. Keohane and published by Elsevier Health Sciences. This book was released on 2019-02-22 with total page 910 pages. Available in PDF, EPUB and Kindle. Book excerpt: **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.

Basic QC Practices

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958074
Total Pages : 352 pages
Book Rating : 4.9/5 (58 download)

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Book Synopsis Basic QC Practices by : James O. Westgard

Download or read book Basic QC Practices written by James O. Westgard and published by . This book was released on 2010-01-01 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Microbiology Procedures Handbook

Author :
Publisher : John Wiley & Sons
ISBN 13 : 1555818811
Total Pages : 2954 pages
Book Rating : 4.5/5 (558 download)

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Book Synopsis Clinical Microbiology Procedures Handbook by :

Download or read book Clinical Microbiology Procedures Handbook written by and published by John Wiley & Sons. This book was released on 2020-08-06 with total page 2954 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the ever-changing needs and responsibilities of the clinical microbiology field, Clinical Microbiology Procedures Handbook, Fourth Edition has been extensively reviewed and updated to present the most prominent procedures in use today. The Clinical Microbiology Procedures Handbook provides step-by-step protocols and descriptions that allow clinical microbiologists and laboratory staff personnel to confidently and accurately perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation.

Whole Slide Imaging

Author : Anil V. Parwani
Publisher : Springer Nature
ISBN 13 : 3030833321
Total Pages : 253 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Whole Slide Imaging by : Anil V. Parwani

Download or read book Whole Slide Imaging written by Anil V. Parwani and published by Springer Nature. This book was released on 2021-10-29 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides up-to-date and practical knowledge in all aspects of whole slide imaging (WSI) by experts in the field. This includes a historical perspective on the evolution of this technology, technical aspects of making a great whole slide image, the various applications of whole slide imaging and future applications using WSI for computer-aided diagnosis The goal is to provide practical knowledge and address knowledge gaps in this emerging field. This book is unique because it addresses an emerging area in pathology for which currently there is only limited information about the practical aspects of deploying this technology. For example, there are no established selection criteria for choosing new scanners and a knowledge base with the key information. The authors of the various chapters have years of real-world experience in selecting and implementing WSI solutions in various aspects of pathology practice. This text also discusses practical tips and pearls to address the selection of a WSI vendor, technology details, implementing this technology and provide an overview of its everyday uses in all areas of pathology. Chapters include important information on how to integrate digital slides with laboratory information system and how to streamline the “digital workflow” with the intent of saving time, saving money, reducing errors, improving efficiency and accuracy, and ultimately benefiting patient outcomes. Whole Slide Imaging: Current Applications and Future Directions is designed to present a comprehensive and state-of the-art approach to WSI within the broad area of digital pathology. It aims to give the readers a look at WSI with a deeper lens and also envision the future of pathology imaging as it pertains to WSI and associated digital innovations.

Direct-to-Consumer Genetic Testing

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309162165
Total Pages : 106 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Direct-to-Consumer Genetic Testing by : National Research Council

Download or read book Direct-to-Consumer Genetic Testing written by National Research Council and published by National Academies Press. This book was released on 2011-01-16 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing. Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson's disease, Alzheimer's disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives. To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.