应用飞行检查结果分析上海地区临床实验室的检测质量

Analysis on the test quality of clinical laboratories in Shanghai by unannounced inspection results

目的通过对2017年上海市临床检验中心(SCCL)全覆盖飞行检查和室间质量评价(EQA)反馈数据的统计,结合上海地区各临床实验室上报的室内质量控制(IQC)数据,探讨飞行检查对于准确评估临床实验室检测质量的作用。方法收集2017年第1次飞行检查和EQA定量项目的实验室上报数据,计算各项目结果的稳健变异系数(CV)并作分析。结果 770家临床实验室接受了SCCL组织的飞行检查,同时参加了EQA。在飞行检查中,102家实验室有不合格的计划[血脂、血气和酸碱分析、凝血试验、快速C反应蛋白、快速血糖、同型半胱氨酸(Hcy)、肿瘤标志物],其中有85家(83.33%)的实验室在EQA中这些计划的成绩均为合格。相同项目飞行检查与EQA结果CV的差异从0.11%[载脂蛋白B(apo B)]到52.15%[糖类抗原(CA)19-9],平均为6.10%(P=0.014),且飞行检查的CV大于EQA的CV。结论飞行检查能更真实地反映实验室的检测质量,实验室应保存EQA原始数据以保证EQA上报数据的真实性。

Objective To evaluate the role of unannounced inspection for assessing the test quality of clinical laboratories in Shanghai organized by Shanghai Center for Clinical Laboratory(SCCL)in 2017,through analyzing the data of unannounced inspection,external quality assessment(EQA)and internal quality control(IQC).Methods The coefficients of variation(CV)were calculated for the items from the 1st unannounced inspection in 2017 and the quantitative items of EQA.The CV between the 2 programs was evaluated.Results A total of 770 clinical laboratories participated in the programs of unannounced inspection and EQA organized by SCCL.There were 83.33%(85/102)clinical laboratories failed in the unannounced inspection[blood lipid,blood gas and acid-base analysis,blood coagulation,rapid C-reactive protein,rapid blood glucose,homocysteine(Hcy)and tumor markers],but they passed the EQA.The CV were from 0.11%[apolipoprotein B(apo B)]to 52.15%[carbohydrate antigen(CA)19-9],and the average CV was 6.10%,and the CV of unannounced inspection was higher than that of EQA(P=0.014).Conclusions Clinical laboratories should reserve the primary data of EQA to ensure the truth of EQA,and unannounced inspection could be more useful for reflecting the test quality of clinical laboratories than EQA.