CLIA Final Rules for Quality Systems PDF

New Rules. New Responsibilities. A New Manual to help you handle it all. CLIA Final Rules for Quality Systems is your guide to the new regulatory landscape. 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. James O. Westgard, PhD, FACB, explains the practical impact of the key changes in the new regulations and Interpretive Guidelines:

• new method validation requirements: what new studies must you perform?
• new terms: quality systems, complete analytic process, immediate error detection - what do these mean?
• complexity confusion: waived, non-waived, moderate, high ? how do you handle classifications for both personnel and method validation?
• "equivalent QC procedures": equivalent to what?
• CLIA and Six Sigma: can compliance and excellence coexist?

More than just a compliance guide, CLIA Final Rules for Quality Systems is a critical analysis of the role of regulation and quality control in healthcare laboratories. For those whose job involves or is impacted by CLIA, this book is essential.