巴楚医学

目的:采用6sigma对GEM3500血气分析仪检测项目进行质量评价。方法:收集2018年1月～2018年12月本科室GEM3500血气分析仪质控液QC1、QC2检测数据。各测定项目的不精密度(SD)和偏倚(bias)来源于质控液靶浓度与实测质控液的平均值之差。各测定项目的变异系数(CV)来自各水平质控累计平均值。临床允许分析总误差(TEa)参照美国临床实验室改进修正法案(CLIA'88)能力验证的分析质量要求。根据Westgard的sigma计算方法:sigma=(TEa-|bias|)/CV,计算出各血气指标的sigma值,并对其进行性能评价。结果:低水平和高水平质控物sigma>6有pH、K⁺;sigma>5有pCO2;sigma>4有Na⁺;sigma>3有tHb和Hct;pO2、Ca2⁺两个浓度质控物sigma均<3;Glu低水平时sigma<3,在高水平时sigma>3;Lac低水平时的sigma>6,在高水平时sigma<3。结论:6sigma可用于GEM3500血气分析仪性能评价及指导检验质量改进。

Objective:To evaluate the quality of routine inspection project in GEM3500 blood gas analyzer via application of 6 sigma management.Methods:QC1 and QC2 test data of GEM3500 blood gas analyzer were collected from January 2018 to December 2018.The unprecision(SD)and the bias of each measurement item were derived from the difference between target concentration of the control liquid and the value of the measured control solution.The coefficient of variation(CV)of each measurement item was derived from the cumulative mean of quality control at each level.Allowable total error(TEa)was referred to the American Clinical Laboratory Improvement and Amendment Act(CLIA'88).According to Westgard's sigma calculation method(sigma=(TEa-|bias|)/CV),the sigma value of each blood gas index was calculated to evaluate its performance.Results:In low and high level quality control,the sigma value of pH and K~+were both greater than 6,and pCO2 was greater than 5,and Na~+was greater than 4,while tHb and Hct were greater than 3.The sigma value of pO2 and Ca2~+were both less than 3 in low and high level quality control.The sigma value of Glu was less than 3 in low level quality control,but greater than 3 in high level quality control.The sigma value of Lac was greater than 6 in low level quality control,but less than 3 in high level quality control.Conclusion:6 sigma quality management theory can be used to evaluate the performance of GEM3500 blood gas analyzer and guide the inspection quality improvement.