Abstract: Objective To establish and validate the rules of autoverification of blood analysis in emergency tests to shorten the median turnaround time(TAT)and standardize report review, and improve the quality of emergency laboratory services. Methods With reference to CLSI AUTO 15-ED1 and WS/T 616-2018 methods for autoverification of quantitative test results in clinical laboratories, the autoverification rules for blood analysis were established based on the working characteristics and instrument specifications of our laboratory. A total of 50,007 emergency clinical specimens from October 1 to December 31, 2021 were collected to verify the coverage and accuracy. Among them, microscope examinations were performed on 500 randomly selected specimens for the performance evaluation of false negative, with a requirement of false negative<5%. All 15,320 clinical specimens from January 1 to January 31, 2022 were evaluated for the effects of using autoverification rules, to analysis the autoverification pass rate, the positive rate of rules and the changes in median TAT. Results The laboratorys autoverification rules for blood analysis involved 35 items in 8 categories, including internal quality control rules, specimen quality rules, critical value rules, parameter range and alarm information rules, delta check rules, consistency rules, logical relationship rules, and special patients. Validation results demonstrated that the rules achieved 100% coverage and 100% accuracy, accompanied by a false negative rate of 2.2%, satisfying the performance criteria. After the application of autoverification rules, the median TAT was shortened by 12.6%, and the autoverification rate of 15,320 specimens was 63.56%. Conclusion The establishment and validation of autoverification rules for blood analysis need to be carried out in an orderly manner under the guidance of documents. The autoverifications can be used after the rules are verified which are personalized and standardized according to the characteristics of the instrument's parameters.

Key words: Autoverification, Blood analysis, Performance verification, Quality control, Emergency laboratory testing