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...
| Publicado en: | Clinical Chemistry Vol. 64; no. 2; pp. 289 - 297 |
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| Autores principales: | , , |
| Formato: | Journal Article |
| Publicado: |
Oxford University Press / USA
2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=129064932&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 129064932 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00099147 10CS jtl: Clinical Chemistry issn: 00099147 maglogo: N pubinfo: dt: 2018 vid: 64 iid: 2 pid: 622 pub: Oxford University Press / USA artinfo: ui: 129064932 10.1373/clinchem.2017.278291 129064932 ppf: 289 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers. aug: au: Westgard, James O. Bayat, Hassan Westgard, Sten A. affil: Department of Pathology and Laboratory Medicine, University of Wisconsin School of Public Health, Madison WI sug: ab: 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 s 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. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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