Basic Method Validation
Basic Method Validation

Author: James O. Westgard

Publisher: AACC Press

Published: 2003-01-01

Total Pages: 292

ISBN-13: 9781886958197

DOWNLOAD EBOOK

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.

Introduction to Statistical Quality Control
Introduction to Statistical Quality Control

Author: Douglas C. Montgomery

Publisher: John Wiley & Sons

Published:

Total Pages: 772

ISBN-13: 1119657075

DOWNLOAD EBOOK

"This book is about the use of modern statistical methods for quality control and improvement. It provides comprehensive coverage of the subject from basic principles to state-of-the-art concepts. and applications. The objective is to give the reader a sound understanding of the principles and the basis for applying them in a variety of situations. Although statistical techniques are emphasized. throughout, the book has a strong engineering and management orientation. Extensive knowledge. of statistics is not a prerequisite for using this book. Readers whose background includes a basic course in statistical methods will find much of the material in this book easily accessible"--

Basic Planning for Quality
Basic Planning for Quality

Author: James O. Westgard

Publisher: Westgard Quality Corporation

Published: 2000-01-01

Total Pages: 272

ISBN-13: 9781886958135

DOWNLOAD EBOOK

A practical introduction to the management and planning of quality control. With the aid of cartoons and more than 60 illustrations, Dr. Westgard dispels the confusion over how to select quality control procedures for laboratory methods. Using a detailed step-by-step planning process, the author shows you how to define the quality needed for a laboratory test, how you can select control rules for tests, and how you can set specifications for allowable bias and CV. CLIA requirements, JCAHO guidelines, CLSI methodologies and QC practice guidelines are discussed, and more than 20 quality-planning examples are graphically demonstrated covering applications for automated chemistry, blood gas, immunoassay, and coagulation tests. Appendices include tables of CLIA quality requirements, European goals for total biologic error, as well as a complete glossary, reference list, online reference list, and a set of self-assessment questions and detailed answers. Basic Planning for Quality is a much-needed primer on the management of quality control in the laboratory. For lab managers and directors, quality specialists, and clinical laboratory scientists who are looking for a saner way to manage quality in their labs, this manual will provide the missing ingredient - an objective way to manage your testing processes to achieve the quality needed for patient care while accounting for the actual performance of the methods in your laboratory. * Establish a practical process for managing quality in your laboratory! * Plan your quality logically, efficiently, and quickly! * Move beyond compliance with JCAHO, CLIA, NCCLS, and other rules! * Optimize your QC to minimize waste and maximize performance! * Select the best control rules for your tests! Basic Planning for Quality makes use of over 65 illustrations, graphs and tables, explains more than two dozen applications in detail, covers CLIA, JCAHO, NCCLS and other requirements, includes appendices on C

Mastering Software Quality Assurance
Mastering Software Quality Assurance

Author: Murali Chemuturi

Publisher: J. Ross Publishing

Published: 2010-09-15

Total Pages: 377

ISBN-13: 1604270322

DOWNLOAD EBOOK

This comprehensive reference on software development quality assurance addresses all four dimensions of quality: specifications, design, construction and conformance. It focuses on quality from both the micro and macro view. From a micro view, it details the aspect of building-in quality at the component level to help ensure that the overall deliverable has ingrained quality. From a macro view, it addresses the organizational level activities that provide an environment conducive to fostering quality in the deliverables as well as developing a culture focused on quality in the organization. Mastering Software Quality Assurance also explores a process driven approach to quality, and provides the information and guidance needed for implementing a process quality model in your organization. It includes best practices and valuable tools and techniques for software developers.Key Features • Provides a comprehensive, inclusive view of software quality • Tackles the four dimensions of quality as applicable to software development organizations • Offers unique insights into achieving quality at the component level • Deals comprehensively with all aspects of measuring software quality • Explores process quality from the standpoint of implementation rather than from the appraiser/assessor point of view • Delivers a bird's eye view of the ISO and CMMI models, and describes necessary steps for attaining conformance to those models

Laboratory Quality Management System
Laboratory Quality Management System

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

DOWNLOAD EBOOK

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".

Crossing the Quality Chasm
Crossing the Quality Chasm

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-07-19

Total Pages: 359

ISBN-13: 0309132967

DOWNLOAD EBOOK

Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.

Quality Assurance of Chemical Measurements
Quality Assurance of Chemical Measurements

Author: John K. Taylor

Publisher: CRC Press

Published: 1987-08-02

Total Pages: 354

ISBN-13: 9780873710978

DOWNLOAD EBOOK

This definitive new book should appeal to everyone who produces, uses, or evaluates scientific data. Ensures accuracy and reliability. Dr. Taylor's book provides guidance for the development and implementation of a credible quality assurance program, plus it also provides chemists and clinical chemists, medical and chemical researchers, and all scientists and managers the ideal means to ensure accurate and reliable work. Chapters are presented in a logical progression, starting with the concept of quality assurance, principles of good measurement, principles of quality assurance, and evaluation of measurement quality. Each chapter has a degree of independence so that it may be consulted separately from the others.