PB1164 - A clinical study on establishment and evaluation of autoverification rules for coagulation tests

Background: In recent, autoverification of test results has been considered an effective means to improve work efficiency and greatly reduce manual workload. As a branch of clinical laboratory testing, coagulation tests are crucial for the clinical diagnosis and treatment of patients with thrombosis and hemorrhagic diseases. However, due to various factors, there are few reports on autoverification of coagulation tests, involving fewer coagulation items, not diverse rules, and not closely related to clinical practice. In addition, there are still many confusions in the process of scheme design and clinical application.

Aims: Establish autoverification rules for coagulation tests, verify and apply them to clinical laboratories, so as to ensure the accuracy of results and reduce manpower.

Methods: Autoverification rules, including quality control, instrument alarm, sample quality examination, critical value, limit range, delta check, and logical judgment were set up according to the guidelines. Subsequently, we verified the coverage, accuracy and applicability of the rules. The validation was assessed by the autoverification passing rate, the true negative rate, the true positive rate, the false negative rate, the false positive rate and the implementation efficiency was evaluated by the laboratory TAT.

Results: A total of 156,989 historical test reports were collected to establish 39 automatic audit rules involving 7 coagulation test items, and the coverage and accuracy of the rules were 100%. In the clinical application stage from June to October 2022, the autoverification passing rate of 82,310 coagulation test reports was 75.12%, of which the true positive rate was 16.19%, the true negative rate was 75.12%, the false positive rate was 8.69%, and the false negative rate was 0%. The laboratory TAT was shortened by 23 minutes (P < 0.05).

Conclusion(s): The establishment and implementation of autoverification rules can shorten the laboratory TAT, improve the efficiency of coagulation tests and guarantee medical safety while ensuring the test quality.