静脉血标本溶血率质量规范应用分析

An Analysis of the Application of Quality Specifications for Hemolysis Rate of Venous Blood Specimens

目的分析比较不同溶血率质量规范的临床适用性,为实验室制定和应用质量规范提供依据。方法选取2020年全年北京中医药大学东方医院门诊、住院静脉血标本为探索数据,处理后使用VITROS 5600全自动生化免疫分析仪检测溶血指数(hemolysis index,HI)。采用EXCLE 2019和SPSS 26.0分析处理数据;根据溶血指数检测结果计算标本溶血率,分析比较IFCC、NCCL、CMDAL质量规范下的标本可接受性。随后将CMDAL质量规范纳入质量管理,选取2021年全年门诊、住院静脉血标本为验证数据,采用相同的处理及检测方法,比较两年实验室标本溶血率和质量规范等级变化。结果探索数据住院标本HI≥50的溶血率为0.72%,处于IFCC、CMDAL质量规范“适当”等级,低于NCCL质量规范“最低”等级。住院标本HI≥25、HI≥15的溶血率为2.15%和7.03%,分别处于CMDAL质量规范“适当”和“最低”等级。采取质控措施后,验证数据标本溶血率普遍降低(P<0.05),实验室性能等级明显提升。结论CMDAL溶血率质量规范更加简便、真实、客观,符合我国临床实验室实际性能水平,值得推广应用。

Objective To analyze and compare the clinical applicability of different hemolysis rate quality specifications,and to provide a reference basis for the development and application of quality specifications in laboratories.Methods Outpatient and inpatient venous blood specimens from the Dongfang Hospital of Beijing University of Traditional Chinese Medicine were selected as exploratory data for the whole year of 2020,and the hemolysis index(HI)was collected using Vitros 5600 biochemistry analyzer after sample processing step.The data was processed and analyzed using EXCLE 2019 and SPSS 26.0;The hemolysis rate of specimens was calculated based on the hemolysis index test results,and the acceptability of specimens under the IFCC,NCCL and CMDAL quality specifications was analyzed and compared.Subsequently,CMDAL quality specification was incorporated into laboratory quality management,and outpatient and inpatient venous blood specimens were selected as validation data for the whole year of 2021,and the same processing and testing methods were used to compare the hemolysis rate and quality specification grade changes of laboratory specimens for two years.Results In exploratory data,the hemolysis rate of inpatient specimens with HI≥50 was 0.72%,which was at the“appropriate”grade in quality specifications of IFCC and CMDAL,and lower than the“lowest”grade in quality specification of NCCL;The hemolysis rates of hospitalized specimens with HI≥25 and HI≥15 were 2.15%and 7.03%,which were at the“appropriate”and the“lowest”grades in the CMDAL quality specification,respectively.After taking quality control measures,the hemolysis rates of the validated specimens generally decreased(P<0.05),and the laboratory performance level was significantly improved.Conclusion CMDAL quality specification for hemolysis rate is more convenient,realistic and objective,which is in line with the actual performance level of clinical laboratories in China,and is worth promoting and applying.