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KMID : 1100820230130040255
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Laboratory Medicine Online
2023 Volume.13 No. 4 p.255 ~ p.262
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Application of the Analytical Performance Specification for Quality Management of Clinical Chemistry Tests
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Yim Ji-Sook
Rim John-Hoon
Lim Yong-Kwan
Cho Yong-Geun
Park Yong-Jung
Kim Sol-Lip
Yun Yeo-Min
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Abstract
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In the realm of clinical laboratories, the implementation of a quality management system is vital for the quality management of various test results for patient treatment. Analytical performance specifications (APS) serve as the critical criteria for assessing whether clinical requirements have been fulfilled, and ensuring that these standards are based on appropriate evidence is crucial to effectively estimate the processes and outcomes of the quality management system. Our aim was to define practical APS goals as acceptability criteria for evaluating test quality. This would make it straightforward for laboratories to apply these guidelines. To this end, we examined relevant Clinical and Laboratory Standards Institute guidelines employed in the quality management of clinical laboratories, such as encompassing precision, linearity, comparison between measurement procedures or samples, comparison between reagent lots, delta check of patients’ results, bias evaluation of test methods, among others. Furthermore, after discussion with the Committee on Standardization and Quality Improvement of Korean Society of Clinical Chemistry, we proposed definitions on the evaluation criteria provided in each guideline and the types of APS such as imprecision, bias, and the total allowable error corresponding to them. Setting multiple evidence-based APS goals for each clinical chemistry test would assist in establishing a range of performance levels that clinical laboratories should aim for. We expect the data suggested in this review to facilitate effective quality management for various clinical chemistry tests and simplify the selection and application of APS for the unique circumstances of each laboratory.
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KEYWORD
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Analytical performance specification, Biological variation, Clinical chemistry, Quality management
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