External quality assessment programs of laboratory testresults conducted by the Central Center for Quality Researchin Laboratory Diagnostics in 2022

Abstract

<br><b>Introduction:</b> In 2022, the Central Center for Quality Research in Laboratory Diagnosticsconducted 16 tests as part of seven programs for external assessment of the quality oflaboratory test results. As many as 1,437 medical diagnostic laboratories participated inthe programs. Only the clinical chemistry program was carried out with a frequency offour tests a year, the remaining six programs (in the field of hematology, acid-base balanceparameters and electrolytes ISE, coagulology) and three immunochemistry programs(including basic analytes, extended analytes, and cardiac markers) were conducted witha frequency of two tests a year. External quality assessment programs in the field ofspecialized immunochemistry and glycated hemoglobin HbA1c, by decision of the Ministerof Health, were withdrawn from implementation in 2022. Due to the earlier purchase ofcontrol materials for these programs by the organizer, the Central Center carried out onlyone test for each of them, without issuing annual certificates.</br><br><b>Material and methods:</b> As in the previous year, the Central Center purchased controlmaterials from renowned producers of in vitro diagnostic material devices for the programsbeing implemented. In order to ensure the quick and safe delivery of samples of controlmaterials to laboratories, in 2022 the organizer maintained the five-year-old transportprocedure using courier mail. The methods of assessing control results in the programshave not changed; the same method of calculating reference values, individual assessmentsof participants' control results and annual assessments has been maintained.</br><br><b>Results:</b> The results submitted by program participants in 2022 are presented in aggregateform in tables and figures. The initial tables I-IV contain organizational data of individualprograms, while the next tables V-VI present the collective results of all programs conductedin 2022. Further tables, i.e. VII-XIV, contain detailed data on the correctness of the assessedresults in individual programs and the percentage of correct results according to all criteriafor the assessed analytes.</br><br><b>Conclusions:</b> As compared to 2021, in all programs implemented in 2022, slight differenceswere obtained in the percentage of correct results according to the most favorable criterionfor the participant (from –0.64% to +1.44%); average +0.58%. Also, the annual regularityscores obtained in 2022 are comparable to the results of 2021. The differences range from–0.02 to +0.15 points.</br>