摘要
目的探讨室内质控(IQC)数据天天比对模式在医学检验实验室的应用效果和价值。方法选取温州市区4家三级甲等医院检验科作为前期试点单位,使用相同版本的实验室质量管理软件(Q-expert)对常规生化检测结果进行天天比对,实现实验室日常IQC管理。结果研究期间共进行6次比对分析,获得185620个IQC数据,6 879份评价结果。以标准差指数(SDI)、变异系数指数(CVI)为衡量测定值正确度的指标,6 879份评价结果中6 444份在SDI允许误差范围,合格率为93.68%;6 567份在CVI允许误差范围,合格率为95.46%。22个项目逐一比对分析,结果显示SDI合格率为85.09%~99.42%,CVI合格率为82.18%~99.07%,室内变异系数合格率为76.76%~100.00%。实验期间共发生12次异常情况,分别采用重复检测该质控品、重新校准仪器后检测质控品、采用新的质控品检测等方法予以改进。4家医院检验科的检验水平均有明显提高,且不同医院之间的差距正逐渐缩小,各检验科的实验室能力比对评分均在合格范围内。结论IQC数据天天比对模式用于实验室IQC数据比对,能客观地评估实验室的正确度和精密度,从而提高实验室检测水平。
Objective To explore the application effect and value of internal quality control(IQC)data daily comparison mode in medical laboratory.Methods The laboratories of 4 class 3A hospitals in Wenzhou urban area were selected as the earlier stage pilots.The same version of the laboratory quality management software(Q-expert)was used to conduct the daily comparison on the results of routine biochemical to achieve daily laboratory IQC management.Results A total of 6 times of comparison analysis were conducted during this study period,185 620 IQC data and 6 879 evaluation results were obtained,which showed that standard deviation index(SDI)and coefficient of variation index(CVI)were the indicators for measuring the accuracy of the measured values.Among 6 879 evaluation results,6 444 results were in the allowable error range of the SDI value with the qualified rate of 93.68%,and 6 567 results were in the CVI value allowable error range,with the qualified rate of 95.46%.Then,the 22 items were analyzed one by one,which showed that the passing rate of SDI was 85.09%-99.42%,the passing rate of CVI was 82.18%-99.07%,and indoor coefficient of variation pass rate was 76.76%-100.00%.In addition,during this experiment,a total of 12 abnormalities occurred,which were resolved by adopting the repeated test of the quality control material,detecting the quality control material after re-calibrating the instrument,and new quality control material.Finally,the test levels of the four hospitals were significantly improved,moreover the gap between different hospitals was gradually shrunk.The proficiency testing(PT)score of various laboratories were within the acceptability range.Conclusion The IQC data daily comparison mode used for laboratory IQC data comparison can objectively evaluate the accuracy and precision of the laboratory,thus improves the laboratory test level.
作者
何卫
徐克
许锴
孔万仲
赵峰
HE Wei;XU Ke;XU Kai;KONG Wanzhong;ZHAO Feng(Department of Clinical Laboratory,Wenzhou Municipal Hospital of Integrated Traditional Chinese and Western Medicine,Wenzhou,Zhejiang 325000,China;Department of Clinical Laboratory,Wenzhou Municipal Central Hospital,Wenzhou,Zhejiang 325000,China;Department of Clinical Laboratory,Wenzhou Municipal People′s Hospital,Wenzhou,Zhejiang 325000,China;Department of Clinical Laboratory,Wenzhou Municipal Hospital of Traditional Chinese Medicine,Wenzhou,Zhejiang 325000,China)
出处
《检验医学与临床》
CAS
2019年第16期2288-2291,2295,共5页
Laboratory Medicine and Clinic
基金
浙江省温州市科技计划项目(2016Y0508,2016Y0513)