CLIA
Essays on the CLIA Final Rule, State Operators Manual, and other regulations.
James O. Westgard, PhD, FACB
An updated version of this essay appears on the Nothing but the Truth about Quality book.
We've posted a large number of articles about the specifics of the Final CLIA Rule and the accompanying Interpretive Guidelines. But in addition to covering the specifics, we need to look at the big picture. Why did we get the CLIA Final Rule and Interpretive Guidelines the way that we did? Why did it take over ten years to complete? Why did manufacturer's QC clearance go by the wayside? How did we end up with "electronic QC" and "equivalent QC"?
James O. Westgard
The final, final, final, final, final CLIA Rule was published on January 24, 2003. After 15 years, CLIA-88 is finally final. The last rules contain some big changes in terminology, organization, and regulation. It promises to have a huge impact on the "compliance" minimums for QC, on the responsibility for QC in the laboratory, and on the requirements made on manufacturers to provide quality instruments and methods. Read this essay, first of a series, for in-depth and comprehensive coverage of these new rules.
James O. Westgard, PhD, FACB
An updated version of this essay appears on the Nothing but the Truth about Quality book.
For the third time in a row, the CLIA manufacturer clearance requirements for QC clearance have been postponed. What's taking so long? Why can't HCFA and DHSS come to a conclusion? Are the manufacturers exercising some undue influence? Better than answering these questions, Dr. Westgard suggests that we shouldn't wait for more CLIA rules. We have enough rules to go on right now - and here's how to use them to improve QC...