品管圈在降低急性髓系白血病微小残留病漏检率中的作用

Effect of quality control cycle on reducing the false negative rate of minimal residual disease of flow cytometry in patients with acute myeloid leukemia

目的 研究品管圈（QCC）在降低急性髓系白血病（AML）微小残留病（MRD）漏检率中的作用.方法 采用QCC质量管理方法和操作流程,分析2014年1月至12月具有融合基因异常AML患者流式细胞术（FCM）、实时荧光定量聚合酶链反应（FQ-PCR）法检测MRD的状况,以FQ-PCR结果为参考,分析FCM MRD漏检情况及原因,制订改进措施,在2015年1月至12月实施,判断改进效果.结果 柏拉图显示,2014年度标本稀释或凝固、 分析策略不当以及MRD指标组合不能覆盖三项累计构成比为83.3%（60/72）,是导致FCM MRD漏检的主要因素,也是QCC改善的重点.2015年度,通过降低骨髓穿刺稀释率、优化加样及检测的标准操作流程、加强仪器维护和保养,并重点优化抗体搭配方案和设门分析策略,最终将MRD漏检率从2014年度的14.8%（72/486）降低到2015年度的2.6%（16/620）.结论 通过开展QCC可有效降低FCM检测MRD的漏检率,提高实验室质量管理控制的能力、解决问题的能力,QCC解决问题的模式值得推广.

Objective To analyze the application of quality control cycle （QCC） in reducing the false negative rate of minimal residual disease （MRD） of flow cytometry in patients with acute myeloid leukemia （AML）. Methods In AML patients with abnormal fusion gene detected in hematology laboratory of Changhai Hospital during the year of 2014, the prevalence of AML-MRD detected both by flow cytometry （FCM） and real-time fluorescence quantitative polymerase chain reaction （FQ-PCR） were analyzed retrospectively. The possible causes of false negative rate of flow cytometric MRD referring to PCR were further deeply analyzed, and the improvement measures were adapted from January 2015 to December 2015 and further judged all according to the QCC methods. Results Pareto diagram showed that the dilution and coagulation of the specimen, the improper analysis strategy and the incomplete combination of the MRD index [composition ratio：83.3 % （60/72）] were the main factors leading to the leakage of FCM MRD in 2014. The QCC group devised measures to reduce the dilution probability of bone marrow and develop a standard operating procedures （SOP） for sampling and testing, strengthen the maintenance of the flow instrument and more importantly, focused on optimizing the antibody panels and gated strategies referring to the current two main kinds of MRD detection combination modes on the basis of the latest advances published in 2015. Finally, the undetected rate of AML-MRD was reduced by FCM from 14.8 % （72/486） in 2014 to 2.6 % （16/620） in 2015. Conclusions The QCC can effectively reduce the leakage rate of flow cytometric AML MRD, improve the ability of laboratory quality control and the ability to solve problems. Solving problems with QCC is thus worthy of being popularized.