General position of Croatian medical biochemistry laboratories on autovalidation

Abstract

Introduction: Autovalidation (AV) is an algorithm based on predefined rules designed, among others, to automate and standardize the postanalytical phase of laboratory work. The aim of this study was to examine the overall opinion of Croatian medical biochemistry laboratories regarding various aspects of AV. Material and methods: This retrospective study is an analysis of the responses of a survey about AV comprised of 18 questions, as part of Module 10 (“Postanalytical phase of laboratory testing”) of national External Quality Assessment program, administered by the Croatian Centre for Quality Assessment in Laboratory Medicine. Results were reported as percentages of total number of participants in survey or as proportions of observed data if the overall number of data was <100. Results: 121 laboratories responded to the survey, of which 76% do not use AV, while 11% of laboratories use AV in routine laboratory work. 16/29 laboratories implemented semi-automated AV for general biochemistry (7/29), haematology (5/29), and coagulation (4/29) tests. Analytical measurement ranges, critical values, flags from analysers, interference indices and delta check were the most commonly used rules in the algorithm. 12/29 laboratories performed validation of AV with less than 500 samples (8/29). 7/13 laboratories report the percentage of AV being 20-50%, while 10/13 answered that introduction of AV significantly reduced turnaround time (TAT) (for 20 - 25%), especially for biochemistry tests. Conclusions: Despite of its numerous benefits (i.e. shorter TAT, less manual validation, standardization of the postanalytical phase), only a small number of Croatian laboratories use AV.