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
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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-2100 D 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 13.5 s, N=3,R=1 should be used. For EOS,quality control rule 13 s, N=3,R=1 should be used. For MONO,quality control rule 12.5 s, 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.
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-2100 D 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 13.5 s, N=3,R=1 should be used. For EOS,quality control rule 13 s, N=3,R=1 should be used. For MONO,quality control rule 12.5 s, 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.
引文
[1]WESTGARD J O.医学实验室质量控制实践基础[M].杨卫冲,译.3版.上海:上海科学技术出版社,2015:220-236.
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[5]Medicare,medicaid,and CLIA programs:regulations implementing the Clinical Laboratory Improvement Amendments of 1988(CLIA)-HCFA.Final rule with comment period[J].Fed Regist,1992,57(40):7002-7186.
[6]RICOS C,ALVAREZ V,CAVA F,et al.Current databases on biological variation:pros,cons and progress[J].Scand J Clin Lab Invest,1999,59(7):491-500.
[7]FRASER C G.General strategies to set quality specifications for performance characteristics[J].Scand J Clin Lab Invest,1999,59(7):487-490.
[8]WESTGARD J O.OPSpecs manual-expanded edition[M].Ogunquit:Westgard QC,1996:1-10.
[9]XIANG D,YUE J,LAN Y,et al.Evaluation of Mindray BC-5000 hematology analyzer:a new miniature 5-part WBC differential instrument[J].Int JLab Hematol,2015,37(5):597-605.
[10]CEMBROWSKI G S,SMITH B,TUNG D.Rationale for using insensitive quality control rules for today's hematology analyzers[J].Int J Lab Hematol,2010,32(6 Pt 2):606-615.
[2]WESTGARD J O.Charts of operation process specifications("OPSpecs charts")for assessing the precision,accuracy,and quality control needed to satisfy proficiency testing performance criteria[J].Clin Chem,1992,38(7):1226-1233.
[3]WS/T 492-2016临床检验定量测定项目精密度与正确度性能验证[S].2016.
[4]NEVALAINEN D,BERTE L,KRAFT C,et al.Evaluating laboratory performance on quality indicators with the six sigma scale[J].Arch Pathol Lab Med,2000,124(4):516-519.
[5]Medicare,medicaid,and CLIA programs:regulations implementing the Clinical Laboratory Improvement Amendments of 1988(CLIA)-HCFA.Final rule with comment period[J].Fed Regist,1992,57(40):7002-7186.
[6]RICOS C,ALVAREZ V,CAVA F,et al.Current databases on biological variation:pros,cons and progress[J].Scand J Clin Lab Invest,1999,59(7):491-500.
[7]FRASER C G.General strategies to set quality specifications for performance characteristics[J].Scand J Clin Lab Invest,1999,59(7):487-490.
[8]WESTGARD J O.OPSpecs manual-expanded edition[M].Ogunquit:Westgard QC,1996:1-10.
[9]XIANG D,YUE J,LAN Y,et al.Evaluation of Mindray BC-5000 hematology analyzer:a new miniature 5-part WBC differential instrument[J].Int JLab Hematol,2015,37(5):597-605.
[10]CEMBROWSKI G S,SMITH B,TUNG D.Rationale for using insensitive quality control rules for today's hematology analyzers[J].Int J Lab Hematol,2010,32(6 Pt 2):606-615.