Demystifying Reference Sample Quality Control

[摘要] One of the most frequent questions asked by the new clinical chemist is, “How do I set up the quality control for a particular analyzer?” Two new documents described below will readily help both the neophyte and practicing chemist. The practice of quality control in the clinical laboratory has been evolving in fits and starts. Unfortunately, today's laboratory quality control practices are obscured by undeserved complexity which robs the quality control practitioner (primarily the bench medical technologist) of tangible quality control intuition and in Deming's words, also robs her of pride of workmanship (1). In US clinical laboratories, quality control practices are hugely divergent in addition to being costly (2). In a recent review, Kazmierczak stated, “the costs associated with performing quality control testing and the costs associated with evaluating, reviewing and maintaining quality control records are not trivial” (3). He cited a developing nation hospital study that found the costs of quality to be 22% of total direct laboratory expenses, with 89% of the costs for maintaining quality associated with calibration and analysis of quality control material necessary to confirm the accuracy and reliability of test results (4).Simplicity is required in today's quality control practices and in this month's issue of Clinical Chemistry , Yago and Alcover, Spanish clinical chemists, provide highly instructive nomograms that permit the selection of simple quality control rules to yield appropriately low frequencies of defective results in analytic runs of 100 (5). These surprisingly orderly, ready-to-use nomograms provide a welcome contrast to the complex rule sets employed by many practicing clinical chemists and elaborated with or without the aid of quality control selection software. The nomograms of Yago and Alcover yield the number of defective analyses per analytical run of 100 samples. These nomograms visually demonstrate the importance of selecting analyzers with …

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