Ali UNCU, Yeliz GÜNEŞ
Çukurova Anestezi ve Cerrahi Bilimler Dergisi - 2026;9(2):328-333
Background: Accurate analytical results are essential for clinical decision -making. The re- vised CLIA 2025 criteria have introduced stricter total allowable error (TEa) limits, requir- ing reassessment of laboratory analytical performance using advanced quality tools. Methods: In this retrospective observational study, internal quality control (IQC) and ex- ternal quality assessment (EQA) data from 2023 were analyzed. Imprecision was evalu- ated using coefficient of variation (CV%), and accuracy was assessed using bias (%). Sigma values were calculated according to updated CLIA 2025 TEa limits. Quality Goal Index (QGI) analysis was performed for tests with low sigma performance. Results: Consider- able variability was observed among analytes. AST demonstrated excellent sigma perfor- mance (>=6), whereas HDL showed good analytical performance within the 3 -6 sigma range. Chloride, BUN, and triglycerides yielded sigma values <3. QGI analysis indic ated that reduced performance was mainly attributable to imprecision. Conclusion: The com- bined use of sigma metrics and QGI provides an effective framework for evaluating la- boratory analytical performance under CLIA 2025 criteria and supports risk -based quality improvement strategies.
