PB1154 - Autoverification of Coagulation Test Results: Implementation and Evaluation

Background: Autovefication has a history of several decades, showing good efficiency and high quality for post-analysis. In 2020, following the guide of CLSI auto 10A and auto15A, we established a set of autovefication of coagulation test results in China. During 2021~2022 of the implementation, periodical validation was done to improve the set of autovefication rules. We report our work of the implementation and validation.

Aims: To establish and validation autoverification algorithm of the coagulation test results in order to reduce manual workload and shorten the TAT while assuring the quality.

Methods: A total of 1854 coagulation test results were collected from our hospital, which were splitted into 909 and 945 for rule establishment and validation; 3129 for TAT evaluation in clinical application. TT, PT, APTT, FBG, D-dimer and FDP and related information were retrospected. Manual verification criteria were decided by consultation with clinicians. Method of percentiles was used for preliminary quantitative limits. A set of autoverification rules was determined and optimized. False negative, false positive, pass rate, consistency and TAT were analyzed. Another 9238 coagulation results were collected for periodic verification. Inference testing and biological variation for delta check were optimized.

Results: A total of 33 autoverification rules were established, involving quantitative limits of TT, PT/INR, APTT, FBG, DD, FDP, delta check, instrumental parameters and flag information. The pass rates, the false negative rates, consistency and coincidence rates of the autoverification rules in establishment group and validation group were respectively 68.42% and 60.37%, 0, 98.51% and 97.79%, 98.51% and 97.79%. The average TAT was shortened by 46.16%. In periodic verification, the pass rate, false-negative rate, consistency and coincidence rate were respectively 63.62%, 0, 100%. Biological variation was modified as well as HIL settings.

Conclusion(s): 33 autoverification rules of coagulation test results were established and implemented, which can improve the post-analytical efficiency and assuring test quality.