CLIA Final Rules for Quality Systems: Quality Assesment Issues and Answers

CLIA Final Rules for Quality Systems: Quality Assesment Issues and Answers

ISBN: 1886958203

ISBN 13: 9781886958203

Publication Date: January 01, 2004

Publisher: Westgard Quality Corporation

Pages: 224

Format: Paperback

Authors: James O. Westgard, Sharon S. Ehrmeyer, Teresa P. Darcy

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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...

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