基于六西格玛质量管理方法的血常规项目室内质量控制评价与设计

摘要

Objective To optimize the Westgard internal quality control rules of blood routine test using six sigma (6σ) method,and reduce the probability of false rejection.Methods The out-of-control ratio of eight items (WBC,RBC,Hb,HCT,PLT,MCV,MCH,MCHC) tested by Sysmex XE-5000 automatic blood analyzer in Department of Clinical Laboratory of the First Affiliated Hospital of Xinjiang Medical University from November 2015 to April 2016 were calculated according to the current rules of internal quality control.The detection performance of the above eight inspection items was evaluated according to the health industry standard of the People's Republic of China (WS/T 406-2012).The sigma value of the eight tests were calculated,and personalized internal quality control plan was designed according to quality control rules of different sigma level.The out-of-control ratio from May 2016 to October 2016 was adjusted by using new control rules,and applicability of the new rules of quality control was verified.Results When using 12s,13s,22s and R4s rule,the total number of quality control of eight inspection items (WBC,RBC,Hb,HCT,PLT,MCV,MCH,MCHC) from November 2015 to April 2016 was 2 560,number of out-ofcontrol was 62,and out-of-control ratio was 2.42％.When sigma rule was used to adjust quality control rules of above eight items to 12s,13s rule,the total number of quality control was 2496,the number of out-of-control was 28,and out-of-control ratio reduced to 1.12％.The mean bias before and after using new control rules was 0.38％-1.32％ and 0.46％-3.12％,the CV was 0.6％-1.987％ and 0.679％-2.059％,and the sigma value was 7.17-9.4 and 6-9.02.Conclusion Application of sigma value in designing internal quality control can reduce the false rejection of blood routine test,avoid the waste of resources,and improve the efficiency of quality control system.%目的 应用六西格玛(6d)的方法优化血液常规检验现用的Westgard室内质量控制规则(质控规则),减少假失控.方法 计算新疆医科大学第一附属医院医学检验中心新质控规则使用前(2015年11月-2016年4月)SysmexXE 5000全自动血细胞分析仪对白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血细胞比容(HCT)、血小板(PLT)、红细胞平均体积(MCV)、红细胞平均血红蛋白量(MCH)、红细胞平均血红蛋白浓度(MCHC)8个检测项目的失控率;按照中华人民共和国卫生行业标准(WS/T406-2012)规定的验证方法,对8个检验项目的检测性能进行评价;计算8个项目的σ水平值,并根据每个项目的σ水平值的质控规则,制定个性化的室内质量控制方案;计算新质控规则使用后(2016年5-10月)的失控率,验证新质控规则的适用性.结果 新质控规则使用前为12s、13s、22s、R4s规则,WBC、RBC、Hb、HCT、PLT、MCV、MCH、MCHC 8个项目的检测质控总次数为2 560次,失控总次数为62次,总失控率为2.42％.新质控规则使用后为12s、13s规则,WBC、RBC、Hb、HCT、PLT、MCV、MCH、MCHC 8个项目的质控总次数为2 496次,失控总次数为28次,总失控率为1.12％.新质控规则使用前、后8个项目平均偏倚(Bias)分别为0.38％～1.32％、0.46％～3.12％.新质控规则使用前、后8个项目的变异系数(CV)均在行业标准规定的范围内,平均CV分别为0.6％～1.987％、0.679％～2.059％.新质控规则使用前、后8个项目的σ水平值分别为7.17～9.4、6～9.02.结论 应用σ水平值设计室内质量控制规则,可减少血常规检验项目的假失控,避免资源浪费,提高质控效率.