RT Journal Article SR Electronic T1 Performance Standards for Quality Control Systems JF American Society for Clinical Laboratory Science JO Clin Lab Sci FD American Society of Chemistry and Laboratory Science SP ascls.118.000299 DO 10.29074/ascls.118.000299 A1 Selom Agboyi A1 Shashi Mehta YR 2018 UL http://hwmaint.clsjournal.ascls.org/content/early/2018/03/01/ascls.118.000299.abstract AB 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.