Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers.

Background: To minimize patient risk, "bracketed" statistical quality control (SQC) is recommended in the new CLSI guidelines for SQC (C24-Ed4). Bracketed SQC requires that a QC event both precedes and follows (brackets) a group of patient samples. In optimizing a QC schedule, the frequency of QC or run size becomes an important planning consideration to maintain quality and also facilitate responsive reporting of results from continuous operation of high production analytic systems.

Methods: Different plans for optimizing a bracketed SQC schedule were investigated on the basis of Parvin's model for patient risk and CLSI C24-Ed4's recommendations for establishing QC schedules. A Sigma-metric run size nomogram was used to evaluate different QC schedules for processes of different sigma performance.

Results: For high Sigma performance, an effective SQC approach is to employ a multistage QC procedure utilizing a "startup" design at the beginning of production and a "monitor" design periodically throughout production. Example QC schedules are illustrated for applications with measurement procedures having 6-σ, 5-σ, and 4-σ performance.

Conclusions: Continuous production analyzers that demonstrate high σ performance can be effectively controlled with multistage SQC designs that employ a startup QC event followed by periodic monitoring or bracketing QC events. Such designs can be optimized to minimize the risk of harm to patients.