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

Westgard, James O.

ISBN 10: 1886958203 / ISBN 13: 9781886958203

Published by WESTGARD QUALITY CORPORATION, 1656

About this Item

The book is in good condition with all pages and cover intact, including the dust jacket if originally issued. The spine may show light wear. Pages may contain some notes or highlighting, and there might be a "From the library of" label. Boxed set packaging, shrink wrap, or included media like CDs may be missing.

Seller Inventory # BSM.101Q9

Bibliographic Details

• Title: CLIA Final Rules for Quality Systems: Quality Assesment Issues and Answers
• Publisher: WESTGARD QUALITY CORPORATION
• Publication Date: 1656
• Language: English
• ISBN 10: 1886958203
• ISBN 13: 9781886958203
• Binding: Soft cover
• Condition: good

About this title

Synopsis

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...