Thoughts on quality-control systems: a laboratorian's perspective.

Abstract

State-of-the-art prospective quality-control systems entail the use of medically relevant, analyte-specific quality control limits. With analyte-specific limits broader than those generally used in the clinical laboratory, there will be fewer false rejections, fewer unnecessary reanalyses, and shorter delays in run reporting. If the analyte-specific limits are narrower than those used in the laboratory, more errors will be detected, but the user is at risk of identifying errors over which s/he and the manufacturer have little control. The use of various patient data quality-control algorithms is described. Conservatism is stressed in adopting manufacturers' guidelines for surrogate, nondestructive quality-control testing. A simple, optimized approach is suggested for the systematic retrospective review of proficiency data. Finally, an approach is presented for converting from older, previously accepted quality control procedures to more efficient analyte-specific quality control.