Remote Calibration Verification, Cycle-based Maintenance Schedules and Quality Control Sigmas in the United States Market

• Remote Calibration Verification, Cycle-based Maintenance Schedules and Quality Control Sigmas in the United States Market

AUTHOR(S)

Jennifer Le BREUX^＊１, Emily CEDERLAND^＊２, Steve POSTIMA^＊３ and Ian GILES^＊１

*1 Scientific Affairs, Sysmex America Inc.
*2 Assay Laboratory, Sysmex America Inc.
*3 Service Department, Sysmex America Inc.

SUMMARY

The statistical approaches advocated by James Westgard are applied and valued internationally. The use of clinical goals which are analyte specific is an approach which is highly appropriate for defining and judging measurement performance in biological systems. Analyte specific, and concentration specific performance at clinical decision points can now be reliably and appropriately designed and judged.

Examples of how simple Sigma calculations, OPSpecs Charts and Westgard QC Rules can be applied are described. Specific information relating to the mathematical approaches and tools is available on the website at: www.westgard.com, and is beyond the scope of this article.