CLIA Final Rules for Quality Systems

CLIA Final Rules for Quality Systems
Author: James O. Westgard
Publisher: Westgard Quality Corporation
Total Pages: 224
Release: 2004-01-01
Genre: Diagnosis, Laboratory
ISBN: 9781886958203

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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...

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 399
Release: 2018-08-23
Genre: Medical
ISBN: 0309475201

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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

Basic Quality Management Systems
Author: James O. Westgard
Publisher:
Total Pages: 286
Release: 2014-01-01
Genre: Medical
ISBN: 9781886958289

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Clinical Diagnostic Technology

Clinical Diagnostic Technology
Author: Kory M. Ward
Publisher: Amer. Assoc. for Clinical Chemistry
Total Pages: 206
Release: 2003
Genre: Clinical Laboratory Techniques
ISBN: 9781890883898

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Six Sigma Risk Analysis

Six Sigma Risk Analysis
Author: James O. Westgard
Publisher:
Total Pages: 296
Release: 2011
Genre: Medical
ISBN: 9781886958272

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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.

Laboratory Quality Management System

Laboratory Quality Management System
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2011
Genre: Laboratories
ISBN: 9789241548274

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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".

Six Sigma Quality Design and Control

Six Sigma Quality Design and Control
Author: James O. Westgard
Publisher:
Total Pages: 338
Release: 2006-01-01
Genre: Business & Economics
ISBN: 9781886958234

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Rodak's Hematology - E-Book

Rodak's Hematology - E-Book
Author: Elaine M. Keohane
Publisher: Elsevier Health Sciences
Total Pages: 910
Release: 2019-02-22
Genre: Medical
ISBN: 0323549632

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**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 Method Validation

Basic Method Validation
Author: James O. Westgard
Publisher: AACC Press
Total Pages: 292
Release: 2003-01-01
Genre: Business & Economics
ISBN: 9781886958197

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With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.