六西格玛质量管理在全自动血液分析仪质量控制规则选择中的应用

摘要

目的 应用六西格玛(6σ)质量管理来评价全自动血液分析仪各项目检测性能水平,运用操作过程规范图选择合适的质量控制规则,监测仪器检测性能,从而保证检测质量.方法 采用SYSMEX XE-2100D全自动血液分析仪对白细胞(WBC)计数、红细胞(RBC)计数、血红蛋白(Hb)、血细胞比容(HCT)、血小板(PLT)计数、中性粒细胞(NEUT)、淋巴细胞(LYMPH)、单核细胞(MONO)、嗜酸性粒细胞(EOS)与嗜碱性粒细胞(BASO)进行检测.根据各检测项目的不精密度、偏移(BIAS)和允许总误差(TEa),计算西格玛(σ)值,应用操作过程规范图选择合适的质量控制规则.结果 达到6σ的检测项目占80％,达到5σ的检测项目占10％,未达到5σ的检测项目占10％.WBC计数、RBC计数、Hb、HCT、PLT计数、Neut、Lymph和Baso需采用13.5s,N=3,R=1的质量控制规则;Eos需采用13s,N=3,R=1的质量控制规则;Mono需采用12.5s,N=3,R=1的质量控制规则,即能满足90％分析质量要求.结论 临床实验室可根据不同检测项目,选择合适的室内质量控制规则,更好地保证检测质量.%Objective To evaluate the performance of automatic hematological analyzer by six sigma(6σ) quality management,and to choose appropriate quality control rules with OPSpecs charts,monitor analyzer's performance and ensure determination quality. Methods Sigma(σ) values were calculated,according to imprecisions,biases (Bias) and allowable total error (TEa) by SYSMEX XE-2100D automatic hematological analyzer. The parameters included white blood cell (WBC) count,red blood cell (RBC) count,hemoglobin (Hb),hematocrit (HCT),platelet (PLT) count,neutrophil (NEUT),lymphocyte (LYMPH), monocyte (MONO),eosinophil (EOS) and basophil (BASO). Appropriate quality control rules were chosen with OPSpecs charts. Results The parameters achieving 6σ accounted for 80％,those achieving 5σ accounted for 10％,and the other 10％ parameters did not achieve 5σ. For WBC count,RBC count,Hb,HCT,PLT count, Neut,LYMPH and BASO,quality control rule 13.5s, N=3,R=1 should be used. For EOS,quality control rule 13s, N=3,R=1 should be used. For MONO,quality control rule 12.5s, N=3,R=1 should be used. These rules can meet 90％ requirements for ensuring determination quality. Conclusions Clinical laboratories may choose appropriate quality control rules according to different parameters,in order to ensure determination quality.