Guest Essay
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.
Dr. Art Eggert discusses the evolution of clinical laboratory utilization. Do you remember back when laboratories used to be a profit center instead of a cost center? Dr. Eggert traces the history of laboratory testing and its costs, and discusses how to optimize laboratory testing benefits while minimizing the expense.
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.
Dr. R. Neill Carey shows how to derive quality requirements for immunoassays from the proficiency testing criteria. Theophylline, cortisol, thyroxine, and folate examples are illustrated.