Integration of data derived from biological variation into the quality management system
Integration of data derived from biological variation into the quality management system
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DOI：
10.1016/j.cccn.2004.03.022
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发表时间：
2004-08-01
影响因子：
5
通讯作者：
Simón, M
中科院分区：
文献类型：
--
作者：
Ricós, C;Alvarez, V;Simón, M
背景：有关医学实验室常用的约 250 种分析物的受试者内和受试者间生物变异的数据可用。方法：将这些数据整合到质量体系中的实验室活动的所有三个层面： (a) 分析前过程：生物变异为选择最合适的分析样本、确定样本稳定性以及决定采样之间的适当时间安排提供了基础； (b) 分析过程：源自生物变异的目标是设计内部质量控制程序和评估实验室绩效的基础； (c) 分析后过程：基于受试者内生物变异值的增量检查用于验证结果并解释来自患者的系列结果。结论：生物学变异是检验医学质量管理的支柱。 (C) 2004 Elsevier B.V. 保留所有权利。
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. (C) 2004 Elsevier B.V. All rights reserved.