Establishment and validation of an autoverification system for coagulation tests stratified by outpatient and inpatient settings
10.13602/j.cnki.jcls.2025.11.09
- VernacularTitle:基于门诊与住院分层的凝血检验报告自动审核系统的建立与验证
- Author:
Weitao ZHANG
1
;
Huayang ZHANG
1
;
Jie ZHU
1
;
Chong WANG
1
;
Meixiu GU
1
;
Baishen PAN
1
;
Beili WANG
1
;
Wei GUO
1
Author Information
1. 复旦大学附属中山医院检验科,上海 200032
- Publication Type:Journal Article
- Keywords:
coagulation test;
autoverification;
outpatient;
inpatient
- From:
Chinese Journal of Clinical Laboratory Science
2025;43(11):845-850
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish autoverification rules for six routine coagulation assays(PT,APTT,TT,Fib,DD,and FDP)based on the stratification of outpatients and inpatients,in accordance with CLSI AUTO-10A,AUTO-15,and WS/T 616-2018 guide-lines,and to validate the feasibility of this stratified strategy with clinical data while optimizing verification efficiency.Methods A to-tal of 323 451 coagulation test results from Zhongshan Hospital,Fudan University in 2022 were retrospectively analyzed to define auto-verification rules involving critical values,instrument flags,logical rules,historical comparison,and numerical ranges.A stratified au-toverification system was established by applying distinct rules for outpatient and inpatient populations.Subsequently,the rules were op-timized using 87 830 coagulation test results from January to March 2024,and the consistency between autoverification and manual veri-fication was prospectively evaluated using 33 968 consecutive coagulation specimens collected in April 2024.Results A stratified au-toverification system was successfully developed,comprising a total of 53 rules.The pass rate of overall verification was 77.16％(26 210/33 968),with a true-positive rate of 19.64％(6 672/33 968),a false-positive rate of 3.20％(1 086/33 968),a true-nega-tive rate of 77.16％(26 210/33 968),and no false negatives were detected.Conclusion The proposed autoverification system signifi-cantly improved verification efficiency.The stratified design based on outpatient and inpatient populations effectively minimized the risk of false negatives,and may provide a novel approach for the further development and optimization of coagulation test autoverification.
