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Sigma Metrics misconceptions and limitations
Fudan Univ, Peoples R China.
Linköping University, Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry and Pharmacology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Chemistry.ORCID iD: 0000-0003-0756-7723
Fudan Univ, Peoples R China.
Royal Coll Pathologists Australasia Qual Assurance, Australia.
2025 (English)In: Clinical Chemistry and Laboratory Medicine, ISSN 1434-6621, E-ISSN 1437-4331, Vol. 63, no 6, p. 1080-1083Article in journal (Refereed) Published
Abstract [en]

Objectives This paper further explores the Sigma Metric (SM) and its application in clinical chemistry. It discusses the SM, assay stability, and control failure relationship.Content : SM is not a valid measure of assay stability or the likelihood of failure. When an out-of-control event occurs for an assay with a higher SM value, the same QC rule will have greater power to detect error than assays with a lower SM value. Thus, it is easier to prevent errors from happening for higher SM assays. This rationale encourages using more frequent QC events and more QC samples for a QC scheme of a low SM assay or simply more QC cost for low SM assays. A laboratory can have a high-precision instrument that frequently fails and a low-precision instrument that hardly ever fails. Parvin's patient risk model presumes the bracketed continuous mode (BCM) testing workflow. If overlooked when designing QC schemes, this leads to the common misconception of the SM that one can save the cost of QC since assays with high SM require less frequent QC to ensure patient risk. There is no evidence that an assay's precision is correlated with its failure rate. Schmidt et al., in a series of papers, showed that an assay with a higher Pf or shift in probability will have a higher expected number of unacceptable results. Incorporating Pf into the QC design process presents significant challenges despite the proactive quality control (PQC) methodology.Summary Unfortunately, TEa Six Sigma, as widely practiced in Clinical Chemistry, is not based on classical Six Sigma mathematical statistics. Classical Six Sigma would facilitate comparing results across activities where the principles of Six Sigma are employed.

Place, publisher, year, edition, pages
WALTER DE GRUYTER GMBH , 2025. Vol. 63, no 6, p. 1080-1083
Keywords [en]
quality control; Sigma Metric; analytical error
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:liu:diva-210666DOI: 10.1515/cclm-2024-1380ISI: 001381757800001PubMedID: 39711229Scopus ID: 2-s2.0-85213230785OAI: oai:DiVA.org:liu-210666DiVA, id: diva2:1925440
Available from: 2025-01-08 Created: 2025-01-08 Last updated: 2025-05-15

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