血细胞分析自动审核规则的验证及应用

doi:10.6040/j.issn.1671-7554.0.2025.0916

摘要/Abstract

摘要： 目的建立和验证急诊检验血细胞分析自动审核规则,缩短实验室内周转时间,规范报告审核,提高急诊检验工作质量。方法参照CLSI AUTO 15-ED1和《WS/T 616-2018临床实验室定量检验结果的自动审核》方法,结合本实验室的工作特点和仪器特点建立血细胞分析自动审核规则。标本分为规则验证组与性能评价组。规则验证组选取2021年10月1日至12月31日急诊检验50 007例临床标本,验证规则覆盖率、通过正确率,并从中随机选取500例自动审核通过的阴性标本进行推片染色后显微镜检查,要求假阴性率<5%。性能评价组选取2022年1月1日至1月31日共15 320例临床标本,分析自动审核通过率、规则阳性率,比较自动审核前后标本量相近的月份血细胞分析实验室内周转时间的变化。结果本实验室血细胞分析自动审核规则涉及室内质控判断、标本质量判断、危急值判断、参数范围和报警信息判断、差值判断、一致性判断、逻辑关系判断、特殊患者8大类35条规则。经验证,规则覆盖率100%、正确率100%、假阴性率为2.2%,性能符合要求。应用自动审核规则前后,实验室内周转时间中位数平均缩短12.6%,自动审核通过率为63.56%。结论血细胞分析自动审核规则的建立和验证需要在文件指导下有序进行,建立合理有效的自动审核规则需要结合本实验室仪器的特点进行个性化规范化设置,验证通过后方可使用。

关键词: 自动审核, 血细胞分析, 性能验证, 质量管理, 急诊检验

Abstract: Objective To establish and validate the rules of autoverification of blood analysis in emergency tests to shorten the median turnaround time(TAT)and standardize report review, and improve the quality of emergency laboratory services. Methods With reference to CLSI AUTO 15-ED1 and WS/T 616-2018 methods for autoverification of quantitative test results in clinical laboratories, the autoverification rules for blood analysis were established based on the working characteristics and instrument specifications of our laboratory. A total of 50,007 emergency clinical specimens from October 1 to December 31, 2021 were collected to verify the coverage and accuracy. Among them, microscope examinations were performed on 500 randomly selected specimens for the performance evaluation of false negative, with a requirement of false negative<5%. All 15,320 clinical specimens from January 1 to January 31, 2022 were evaluated for the effects of using autoverification rules, to analysis the autoverification pass rate, the positive rate of rules and the changes in median TAT. Results The laboratorys autoverification rules for blood analysis involved 35 items in 8 categories, including internal quality control rules, specimen quality rules, critical value rules, parameter range and alarm information rules, delta check rules, consistency rules, logical relationship rules, and special patients. Validation results demonstrated that the rules achieved 100% coverage and 100% accuracy, accompanied by a false negative rate of 2.2%, satisfying the performance criteria. After the application of autoverification rules, the median TAT was shortened by 12.6%, and the autoverification rate of 15,320 specimens was 63.56%. Conclusion The establishment and validation of autoverification rules for blood analysis need to be carried out in an orderly manner under the guidance of documents. The autoverifications can be used after the rules are verified which are personalized and standardized according to the characteristics of the instrument's parameters.

Key words: Autoverification, Blood analysis, Performance verification, Quality control, Emergency laboratory testing

中图分类号:

R446.1

吕金锋,赵汇,秦祥荣,公衍文,毛海婷,孟静. 血细胞分析自动审核规则的验证及应用[J]. 山东大学学报 (医学版), 2026, 64(8): 107-113.

LYU Jinfeng, ZHAO Hui, QIN Xiangrong, GONG Yanwen, MAO Haiting, MENG Jing. Validation and application of autoverification rules for blood analysis[J]. Journal of Shandong University (Health Sciences), 2026, 64(8): 107-113.

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