Performance Standards for Quality Control Systems

Selom Agboyi; Shashi Mehta

doi:10.29074/ascls.118.000299

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Selom Agboyi
Shashi Mehta 1

SHP-Rutgers University

↵* Corresponding author; email: mehtas1{at}shp.rutgers.edu

Abstract

Standard statistical QC has been around since its introduction in 1950 by Levey and Jennings. Today, while most laboratories use standard statistical QC processes, with or without Westgard multi-rules to evaluate quality, few incorporate performance standards in their QC systems. With performance standards, the quality level of each test is determined on a sigma scale. This guides the selection of optimal QC frequency and rules to monitor the analytical system. QC rules are selected based on the sigma score and are specific to each test. While a single rule (13s) is sufficient to efficiently monitor tests with sigma quality at or above 6, a more stringent rule (13s/22s/R4s/41s) is required for those performing at four sigma. The comparison of analytical total error (TE) to the total error allowable (TEa) helps ensure that the system is operating within the defined quality specifications; therefore accurate patient results are produced.