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Written by James O. Westgard, Ph.D.
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CLIA Final Rule:
Appropriate QC Procedures
If we realize that "equivalent" qc procedures are not equal... If we want to assure quality rather than comply with regulations... If we want to do the right QC, not the least QC... What is the appropriate QC to do? And how do we determine it? (preview)
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Written by Sharon G. Ehrmeyer, Ph.D. and James O. Westgard, Ph.D. NACB
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CLIA Interpretive Guidelines:
Appendix C of the State Operations Manual
On January 12, 2004, CMS released Appendix C of the State Operations Manual. That happens to be the Interpretive Guidelines for the CLIA Final Rule. And what is contained in those interpretations are some major changes in how laboratories will be regulated, and what kind of QC they will be allowed or required to perform. Get the first look at the true impact of these guidelines with the help of Dr. Sharon Ehrmeyer, Ph.D. and Dr. Westgard
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Written by James O. Westgard, Ph.D.
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CLIA Final Rule:
"Equivalent" Quality Control Practices
In the very near future, CMS will release the Interpretive Guidelines to the Final CLIA Rule. Those guidelines will contain a dangerous new practice called "equivalent quality control procedures." Dr. Westgard explains what this new procedure is, and why it is fatally flawed.
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Written by James O. Westgard, Ph.D.
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Final5 CLIA Rule. Part VI:
Method Validation - Statistical Sense, Sensitivity, and Significance
With new requirements for method validation, laboratories have to become smarter about their use of statistics and experiments. Dr. Westgard examines the best uses and the proper interpretations of statistics and experiments in method validation. (preview)
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Written by James O. Westgard, PhD
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Final5 CLIA Rule. Part V:
Method Validation Process and Procedures
Starting on April 24, 2003, all non-waived laboratory methods must be validated. This includes methods that were previously exempted from validation. In light of these new responsibilities, Dr. Westgard reviews the process and procedures of method validation. Learn what experiments to perform, with how much data, and in what order. (preview)
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