6σ质量标准在血细胞分析中的应用研究

Research of application of 6σ quality management system in clinical blood cell analysis

目的应用6σ质量标准对Beckman-Coulter LH750血细胞分析系统进行分析中质量控制管理，为临床提供更加准确、可靠的分析报告。方法（1）用Beckman-Coulter公司提供的LH750应用试剂、校准物和低、中、高定值质控物对LH750系统进行溯源、校准、系统证实。（2）确定校准物及定值质控物具有可溯源性，系统证实可靠。（3）根据低、中、高定值质控物20d的测定，计算白细胞（WBC）、红细胞（RBC）、血红蛋白（HGB）、红细胞比积（HCT）、血小板（PLT）的均值（x^1）、标准差（SD）以及它们与各自定值的偏差（bias）；根据CLIA’88查找WBC、RBC、HGB、HCT、PLT的最大允许误差（TEn）。（4）根据公式σ=（TEσ-｜bias｜）／SD计算其各参数的σ值。结果各参数σ值除HCT的σ值在4．4～5．2之间外，其余各参数的σ值介于6．1～11．6之间。结论应用6σ质量标准对LH750分析系统的质量管理较科学、有效。

Objective To perfrom quality control management of Beckman-Coulter LH750 blood analysis system by using 6σ quality standardization and to make the report more accurate and reliable for clinic. Methods （1） The trace of origin, calibration and systematic verification of LH750 system were put up by the reagents of LH750,the catibrating materids and the low middle,high criterion liquid offered by Beckman-Coulter company. （2）The trace and reliability of the system were identified. （3） X, SD and the bias of WBC, RBC, HGB, HCT and PLT were calculated; maximum errors expected of WBC, RBC, HGB, HCT and PLT were found according to CLIA＇88. （4）The σ value of each parameter was calculated according to the formula σ= （TEn- ｜ bias ｜ ）/SD. Results The σ value of each parameter was between 6.1-11.6 except that σ value of HCT was between 4.4-5.2. Conclusion It is better to put up the control management of LH750 analysis system by using 6σ quality standardization.