血气分析仪智能化质量管理系统临床多中心比对研究  

The multi-center validation of an intelligent blood gas analyzer quality management system

作　　者：高志琪[1] 王清涛[1] 康熙雄[2] 张国军[2] 杨薇[2] 赵晖[2] 胡晓波[3] 陆华[3] 高淑芳[3] 董云[4] 宋孟龙[4] 冯璇璘[4] 周睿[1] Gao Zhiqi;Wang Qingtao;Kang Xixiong;Zhang Guojun;Yang Wei;Zhao Hui;Hu Xiaobo;Lu Hua;Gao Shufang;Dong Yun;Song Menglong;Feng Xuanlin;Zhou Rui(Department of Laboratory, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020 , China)

机构地区：[1]首都医科大学附属北京朝阳医院检验科,100020 [2]首都医科大学附属北京天坛医院检验科 [3]上海中医药大学附属龙华医院检验科 [4]四川省人民医院急诊ICU

出　　处：《中华检验医学杂志》2018年第6期475-480,共6页Chinese Journal of Laboratory Medicine

基　　金：首都卫生发展科研专项项目（2016-1-2031）;国家临床重点专科建设项目;北京市医院管理局市属医院医疗质量管理专题研究项目

摘　　要：目的通过比对智能化质量管理系统（iQM）和传统质量控制的两种质控模式，评估iQM的质控效能以及与传统质控的等效性，保证血气检测结果的准确性。方法本研究选取了首都医科大学附属北京朝阳医院、首都医科大学附属北京天坛医院、上海中医药大学附属上海龙华医院及四川省人民医院4家医疗机构2016年6月至12月患者标本共计3 712份，在常规检测上述标本过程中，同时采用iQM和传统质控模式，分别计算所有血气项目质控的均值，SD, CV（%）及Sigma值，以评价两种质控模式质控效能的差异性。结果4家医疗机构在检测3 712例患者血气标本的过程中，iQM过程控制液（PCS） A、B及C分别运行1 089、7 678及154例质控标本，传统质控模式共运行732例质控标本。对于血气分析中最为敏感的pO2项目，iQM PCS A、B、C液的的质控效能非常卓越（Sigma值均〉8），而传统质控的质控效能表现较差（Sigma值均〈 6）；pCO2、pO2及Na＋项目对于两种质控方案均存在差异有统计学意义（P＝0.004 8，P＝0.000 1，P＝0.004 4，P〈0.01），pH、K＋、Ca＋＋、Glu、Lac和Hct项目对于两种质控方案的差异均无统计学意义（P＝0.250 6，P＝0.062 3，P＝0.034 0，P＝0.346 9，P＝0.186 3，P＝0.823 1，P〉0.01）。iQM检测到错误的标本共22例，其中微小凝块14例，干扰物质8例，如上错误传统质控均未检出。结论血气分析中误差主要源自分析前标本质量。iQM增加的标本检查功能，弥补了传统质控不能监测标本质量的不足，能够实现对每份血气分析标本全过程、全方位实时、动态的监控，具有强大的误差检出能力，自动纠错能力，及自动记录、存储功能。该系统能够有效保证血气检测结果的准确性，符合相关法律法规及相关行业标准对质量的要求，能够满足临床预期用途，为POCT质量管理与改进提供了新思路。Objective To compare and study the two kinds of quality control methodologies related to intelligent quality management system （iQM） and traditional quality control, and the quality control performance of iQM equivalent to traditional quality control were evaluated, ensuring the accuracy of the Results of blood gas testing.Methods Beijing Chaoyang Hospital of Capital Medical University, Beijing Tiantan Hospital of Capital Medical University, Shanghai Longhua Hospital of Shanghai University of Chinese Medicine, and Sichuan Provincial People′s Hospital, these 4 medical institutions were selected to implement this study. During the period from June 2016 to December 2016, in the routine detection of total 3 712 specimen, the iQM and traditional quality control modes were used simultaneously to calculate the mean values of all blood gas parameters quality controls, SD, CV （%） and Sigma values, to evaluate the quality control performance and difference of the two quality control modes.Results During the process of testing blood gas samples from 3 712 specimen in 4 hospitals, iQM process control solution （PCS） A, B, C ran 1 089, 7 678 and 154 quality control samples respectively, and 732 external quality control samples were run by traditional quality control mode. Considering the most sensitive parameters of blood gas testing pO2, iQM PCS A, B, C′s Sigma value are higher than 8, however, the traditional quality control′s Sigma value are less than 6; For parameters pCO2, pO2 and Na＋ , there exists significant difference between two quality control Methods （P=0.004 8, P=0.000 1, P=0.004 4, P〈0.01）, other parameters pH, K＋ , Ca＋ ＋ , Glu, Lac and Hct, there exists no significant difference between two quality control Methods （P=0.250 6, P=0.062 3, P=0.034 0, P=0.346 9, P=0.186 3, P=0.823 1, P〉0.01）. Totally 22 errors detected by iQM, includes 14 micro-clots and 8 interferences samples, which were not detected by traditional quality control .Conclusion sThe error in blood gas analysi

关 键 词：血气分析 床旁检测 质量控制 智能化质量管理系统 

分 类 号：R446.1[医药卫生—诊断学]