posted by Sten Westgard, MS
The Unacceptable IssueThis issue of the Westgard Newsletter is devoted to exploring the rejections, the abnormals, the outliers - in other words, the Unacceptable performance and practices of the laboratory.At the LabQuality Conference in Helsinki, Mark Thelen of SKML made a very trenchant observation: We should not punish laboratories for the failures of the manufacturers. Analytical performance specifications derived from biological variation studies, both old and new, may be too demanding for today's methods.We may use these new biological variation-derived goals to determine when the laboratory is performing unacceptably. But if no labs and no methods are able to achieve this goal, then perhaps we need to realize the manufacturers are the ones performing unacceptably - by failing to engineer methods good enough to meet the necessary goals.We often see conferences, workshops, and meetings that proclaim the reinvention of Quality Control, the revolution, the next-generation, the "2.0" of QC. But more importantly, we may need to redefine what is UNacceptable for today's laboratories.How LabQuality Days tackled the subject of reinventing QCAre today's hemostasis METHODS unacceptable? Or are today's GOALS for hemostasis goals unattainable?