Guest Essay
The 2008 report from the CDC dared to ask the big question: is Proficiency Testing effective? Not only that, it dared to recommend a significant change in the CLIA statutes. Can you guess which law should be changed for better PT?
A recent report from the CDC identified a number of issues with current proficiency testing. Among those problems, the group standard deviation type of quality requirement. What is it? Why is it a problem? What can be done about it?
In 2008, there was a lot of discussion about regulations and the roles of the CDC, CMS, and FDA. In a December 2007 AACC teleconference on "New Developments in CLIA and QC," CMS promoted two new approaches for laboratory quality control, primarily their recommendations for "Equivalent QC" as found in their State Operations Manual, as well as the use of risk analysis for establishing "Alterative QC". The presentation suggested that the FDA might be involved in reviewing manufacturer's recommendations for AQC procedures. This lesson reviews some of the other problems facing the FDA before it can begin a more active role in laboratory qc.
Dr. Freeman and Alison Farr talk more about their 2008 papers on veterinary quality requirements and the Sigma performance metrics they calculated for their laboratory.
What does the word "Quality" mean, anyway? Is it an absolute or relative term? Jerry Ehrmeyer, a frequent speaker at AACC conventions, discusses what "quality" really means, using everyday examples from the quality of wine to the quality of maps.