Internal quality control: planning and implementation strategies

Ann Clin Biochem 2003;40:593-611
© 2003 Association for Clinical Biochemistry


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James O Westgard

University of Wisconsin Medical School, 1300 University Avenue, Madison, WI 53706, USA

The first essential in setting up internal quality control (IQC)of a test procedure in the clinical laboratory is to selectthe proper IQC procedure to implement, i.e. choosing the statisticalcriteria or control rules, and the number of control measurements,according to the quality required for the test and the observedperformance of the method. Then the right IQC procedure mustbe properly implemented. This review focuses on strategies forplanning and implementing IQC procedures in order to improvethe quality of the IQC. A quantitative planning process is describedthat can be implemented with graphical tools such as power functionor critical-error graphs and charts of operating specifications.Finally, a total QC strategy is formulated to minimize costand maximize quality.

A general strategy for IQC implementation is recommended thatemploys a three-stage design in which the first stage provideshigh error detection, the second stage low false rejection andthe third stage prescribes the length of the analytical run,making use of an algorithm involving the average of normal patients’data.

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