6σ质量管理在凝血酶原时间室间质量评价与室内质量控制分析应用

Application of 6σTheory on Prothrombin Time Quality Management Through the Data from External Quality Assessment and Internal Quality Control

目的探讨6σ质量管理在持续监控凝血酶原时间(prothrombin time,PT)的室间质量评价(external quality assessment,EQA)和室内质量控制(internal quality control,IQC)中的应用。方法收集灌云县人民医院检验科2017年、2018年PT的省EQA结果和IQC数据,分别获得偏倚(Bias)、差值占允许差值的百分比和半年IQC平均变异系数(coefficient of variation,CV),以允许总误差(total allowable error,TEa),Bias和CV计算σ值:σ=(TEa-|Bias|)/CV,当σ<6时,通过计算质量目标指数(Quality goal index,QGI):QGI=|Bias|/(1.5×CV),分析性能不佳的原因。结果2017(1)EQA五组样本差值占允许差值的百分比平均值为-31.55%,σ水平为4.23,其QGI为1.29;2017(2)EQA五组样本差值占允许差值的百分比平均值为-10.88%,其绝对值低于2017(1),差异具有统计学意义。室内质控CV为2.04%,σ水平为6.55。2018(1)及2018(2)EQA五组样本差值占允许差值的百分比平均值分别为18.57%和11.07%,室内质控CV分别为2.62%和2.82%,σ水平为4.66和4.73,QGI为0.71和0.39。结论应用6σ质量管理综合分析PT连续的EQA结果、IQC数据可达到全面监控和持续改进其检测质量的作用。

Objective To explor the effectiveness of six sigma(6σ)theory on continuous monitoring the external quality assessment(EQA)and internal quality control(IQC)of prothrombin time(PT).Methods Based on data from EQA and IQA of PT between 2017 and 2018,the Bias,the percentage of the difference as the allowable difference and coefficient of variation(CV)in 2017(1),2017(2),2018(1)and 2018(2)were obtained,respectively.Sigma(σ)value was calculated using total allowable error(TEa),Bias,and CV,σ=(TEa-|Bias|)/CV.Whenσ<6,the quality goal index(QGI)was calculated using the formula:QGI=|Bias|/(1.5×CV),by which the factors for poor performance was analyzed.Results In the EQA of 2017(1),the average value of the percentage of the difference in the allowable difference was-31.55%,theσvalue was 4.23,and the QGI was 1.29.In 2017(2),the average value of the percentage of the difference in the allowable difference was-10.88%,which was significantly lower than 2017(1).The CV of IQC was 2.04%,and theσlevel was 6.55.The average value of the percentage of the sample difference in the allowable difference of 2018(1)and 2018(2)was 18.57%and 11.07%,respectively,while the CV of IQC was 2.62%and 2.82%,respectively.Theσvalue was 4.66 and 4.73,and QGI was 0.71 and 0.39,respectively.Conclusion Applying sixσtheory on the management of EQA and IQC in PT could comprehensively monitor and continuously improve its experimental quality.