6σ质量标准在TMS-1024i全自动生化分析仪上的应用

摘要

Objective Application of 6 sigma quality standard for the evaluation of TMS-1024i automatic biochemical analyzer test item analysis performance,guide the biochemical quality control management,better clinical services. Methods Selected the following 6 items,the urea nitrogen(BUN) , creatinine(Cre) , glucose(Glu) , uric acid(UA) , triglyceride(TG) and cholesterol (TC) , theTMS-1024i automatic biochemical analyzer for precision testing,medical decision level concentrations were 6 sigma quality estimation,using the normalized OPSpecs chart to determine the quality control rules. Results TG, Cre reached 6 sigma quality standards,the quality control method of 13.5s rules,select 2 control measurements(n = 2)to offer a 90% guarantee detection error; UA and Glu relatived to the 6 sigma quality standards of performance in general,UA using 12.5s(n= 4) could only provide 50% guaranteed detection error,Glu using 12.5s(n = 4) could provide 90% guaranteed detection error,and TC,BUN sigma value relative to the 6 sigma quality standard were relatively low, should be used more rules of 13S/22S/R4s/41s/8x (n = 4 ,r = 2). Conclusion The TMS-1024i automatic biochemical analyzer test item analysis performance indicators have reached the united states national committee for clinical laboratory standards(CLSI) standard, the result is reliable, suitable for clinical use. There are some indicators have reached or close to the 6 sigma quality standards,some indicators of the quality level in accordance with the 6 sigma quality standards still need further improvement.%目的 应用6σ质量标准评价TMS-1024i全自动生化分析仪部分检测项目的分析性能,指导生化检验的质量控制管理,更好地为临床服务.方法 选定以下6个项目:尿素氮(BUN)、肌酐(Cre)、葡萄糖(Glu)、尿酸(UA)、三酰甘油(TG)和总胆固醇(TC),对TMS-1024i全自动生化分析仪进行精密度检测,对医学决定水平浓度进行6σ质量估计,用标准化OPSpecs图确定质控规则.结果 TG、Cre基本达到6σ的质量标准可采用质量控制方法13.5s 规则,选择2个控制测定值(n=2),能提供90%的保证检出误差;UA和Glu相对6σ质量标准表现一般,UA采用12.5s规则,选择4个控制测定值(n=4,r=2),只能提供50%的保证检出误差,Glu采用12.5s规则,选择4个控制测定值(n=4,r=2)只能提供90%的保证检出误差,而TC、BUN的σ值相对6σ质量标准较低,应采用多规则13s/22s/R4s/41s/8x,选择4个控制测定值(n=4,r=2).结论 TMS-1024i全自动生化分析仪部分检测项目的分析性能指标达到了美国国家临床实验室标准委员会(CLSI)标准,结果可靠,适合临床使用.有部分指标已达到或接近6σ质量标准,有部分指标的质量水平仍需按照6σ质量标准进一步的改进.