Guest Essay
We're delighted to present this guest essay from Dr. Kent Dooley, an astute reader who has done serious thinking about what patient safety implies for quality control. If labs are serious about patient safety, should they be reducing how often they run controls?
Dr. Carmen Ricos and her colleagues have provided us with the fifth edition of their Biological Variation Database. New analytes have been added, figures have been updated and in some cases, corrected. This article summarizes all the changes made to the desirable specifications for total error, bias, and imprecision (derived from biological variation) for hundreds of analytes.
In light of the publication of the fifth edition of the Ricos et al biologic variation database, Sten Westgard contemplates another question: what's the quality of quality requirements? In the parlance of the latest management trend, are quality requirements "Lean"?