凝血检验自动审核规则的建立与验证

Establishment and validation of autoverification rules for coagulation tests

目的建立凝血检验的自动审核规则,验证并应用于临床实验室。方法根据指南设置自动审核规则,包含质控、仪器报警、样本质量核查、危急值、限值、Delta check、逻辑判断,进行规则覆盖率、正确率和适用性验证,计算自动审核通过率、真阴性率、真阳性率、假阴性率、假阳性率和实验室内报告周转时间(TAT),评估实施效果。结果根据156989份报告建立了7个凝血项目的39条自动审核规则,规则覆盖率和正确率均为100%。在2022年6—10月临床应用阶段,82310份凝血检验报告的自动审核通过率为75.12%,其中真阳性率16.19%,真阴性率75.12%,假阳性率8.69%,假阴性率0%,实验室TAT缩短了23 min(P<0.05)。结论通过建立和实施自动审核规则,能在保证检验质量的同时缩短实验室TAT,提高凝血检验工作效率,确保医疗安全。

Objective To establish and validate a set of autoverification rules for coagulation tests,and apply them to clinical laboratories for ensuring the accuracy of test results and reducing manpower.Methods Autoverification rules,including quality control,instrument alarm,sample quality checking,critical value,limit range,delta check and logical judgment,were set up according to the guidelines.Subsequently,the coverage,accuracy and applicability of the established rules were verified.The autoverification passing rate,true negative rate,true positive rate,false negative rate,false positive rate,and turn-around time(TAT)in a laboratory were calculated to evaluate the implementation efficiency.Results Thirty-nine autoverification rules for 7 coagulation items were established based on 156989 historical test reports.The coverage and accuracy for the rules were all 100%.In the clinical application stage of the rules between June 2022 and October 2022,the autoverification passing rate of 82310 coagulation test reports was 75.12%,with a true positive rate of 16.19%,a true negative rate of 75.12%,a false positive rate of 8.69%and a false negative rate of 0%.The laboratory TAT was shortened by 23 minutes(P<0.05).Conclusion 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.