CLIA Final Rules for Quality Systems - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook CLIA Final Rules for Quality Systems write by James O. Westgard. This book was released on 2004-01-01. CLIA Final Rules for Quality Systems available in PDF, EPUB and Kindle. 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 - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Returning Individual Research Results to Participants write by National Academies of Sciences, Engineering, and Medicine. This book was released on 2018-08-23. Returning Individual Research Results to Participants available in PDF, EPUB and Kindle. 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 - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Basic Quality Management Systems write by James O. Westgard. This book was released on 2014-01-01. Basic Quality Management Systems available in PDF, EPUB and Kindle.
Clinical Diagnostic Technology
Clinical Diagnostic Technology - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Clinical Diagnostic Technology write by Kory M. Ward. This book was released on 2003. Clinical Diagnostic Technology available in PDF, EPUB and Kindle.
Laboratory Quality Management System
Laboratory Quality Management System - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Laboratory Quality Management System write by World Health Organization. This book was released on 2011. Laboratory Quality Management System available in PDF, EPUB and Kindle. 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".
