中国医学装备2024，Vol.21Issue(1)：135-140,6.DOI:10.3969/j.issn.1672-8270.2024.01.027
常规出凝血检验自动审核规则的建立与验证
Establishment and of preliminary verification of automatic auditing rules for routine coagulation assays
摘要
Abstract
Objective:To establish auto verification rules for the routine coagulation assays,and to provide reference for clinical laboratories to improve the quality and efficiency of results verification.Methods:A total of 24,510 specimens of sodium citrate anticoagulation routine coagulation test from the laboratory departments of eight hospitals including the First Medical Center,Chinese PLA General Hospital during January to March 2020 were collected and randomly divided into a rule establishment group and a rule verification group,with 6,670 specimens in the rule establishment group,including 2,056 Delta checks,and 17,840 specimens in the rule validation group,including 3,210 Delta checks.The activities of prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(Fib),thrombin time(TT),D-dimer(DD)and/or antithrombin(AT)were detected by Stago STA R Max automatic coagulation analyzer and supporting reagents.Taking the manual verification results as the standard,the auto verification and manual false negative rate(invalid verification),false positive rate(invalid interception),pass rate,positive coincidence rate,negative coincidence rate,verification consistency rate and specimen turnaround time(TAT)of the two groups were calculated.Results:The auto verification rules and the application process were preliminarily established,including internal quality control,alarm information,auto verification scope,critical value and deviation value inspection.In the rule establishment group,the single item pass rate was 82.6%-92.4%,and the overall pass rate was 73.8%.The consistency rate between auto verification and manual verification was 98.2%,and the positive coincidence rate and negative coincidence rate were 24.4%and 73.8%,respectively.In the rule verification group,the single item pass rate was 86.4%-91.5%,and the overall review pass rate was 71.5%.By simulating the application of auto verification rules,the average TAT of two hospitals among the eight hospitals was shortened by 1.5 hours and 2.1 hours,respectively.Conclusion:The application of auto verification rules can reduce workload of manual verification,and significantly shorten the TAT,and improve the report efficiency of the laboratory.关键词
诊断试验/血液凝固试验/临床实验室技术/临床实验室信息系统/时间因素Key words
Diagnostic tests/Blood coagulation tests/Clinical laboratory technology/Clinical laboratory information system/Time factors分类
医药卫生引用本文复制引用
邸平,李绵洋,董峰,于雪莹,王梅华,姜威,李月,曹俊,张宏,王伟鑫..常规出凝血检验自动审核规则的建立与验证[J].中国医学装备,2024,21(1):135-140,6.基金项目
国家重点研发计划(SQ2018YFC200022-01) National Key Research and Development Program of China(SQ2018YFC200022-01) （SQ2018YFC200022-01）
