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Integration of data derived from biological variation into the quality management system

by: Carmen Ricós, Virtudes Alvarez, Fernando Cava, José V García-Lario, Amparo Hernández, Carlos V Jiménez, Joana Minchinela, Carmen Perich, Margarita Simón
Clinica Chimica Acta, Vol. 346, No. 1. (2 August 2004), pp. 13-18.


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Backround: Data on within- and between-subject biological variation are available for around 250 analytes commonly used in medical laboratories. Methods: Integration of this data into the quality system occurs at all three levels of laboratory activity: (a) Preanalytic process: biological variation provides the basis for selecting the most appropriate specimen for analysis, for defining sample stability and for deciding suitable timing between samplings; (b) analytic process: biological variation-derived goals are fundamental for designing internal quality control procedures, and for evaluating laboratory performance; and (c) postanalytic process: delta checks based on within-subject biological variation values are used for validating results and for interpreting serial results from a patient. Conclusion: The biological variation is a pillar for managing quality in laboratory medicine.


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