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CLIA Final Rules Manual
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CLIA Final Rules Manual

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2004, 225 pages, 6" x 9" perfect bound
ISBN 1-886958-20-3

With the publication of the CLIA Final Rule and the Interpretive Guidelines in the State Inspector's Manual, the landscape of the healthcare laboratory has once again been profoundly changed. New method validation requirements have altered the responsibilities of laboratories and manufacturers. New guidelines for "equivalent QC procedures" challenge the laboratory to take responsibility for the quality of testing.

With new regulations compounded by new interpretive guidelines, questions remain and confusion reigns.

In this new manual, Dr. James O. Westgard and colleagues will help you identify the impact of the regulations on your laboratory:
  • Navigate the complexities of the new complexity categories: waived, non-waived, moderate, and high complexity testing
  • Identify method validation requirements that apply to new methods in your laboratory
  • Learn how Sigma metrics can ease your decisions on method acceptability
  • Target the issues, guidlines and probes that influence the inspectors
  • Evaluate the implications of "equivalent QC procedures"
  • Understand how to do the right QC right
CLIA Final Rules for Quality Systems is more than a compliance manual. It identifies the specific regulations, then takes the discussion one step further, to the reasoning and logic that shaped CLIA. Readers will gain not only a grasp on the regulatory details, but a broader understanding of the key concepts of quality control, method validation, and even Six Sigma quality management.

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Westgard QC, Inc. copyright 2008