ISO 15189血细胞分析仪室内质控管理体系的建立

Establishment of internal quality control system for automated hematology analyzer according to ISO15189

目的为提高实验室全血细胞分析结果的准确性和可靠性,根据ISO 15189:2012的相关规定,建立一套适宜的血细胞分析仪室内质控体系。方法使用仪器配套的高、中和低3种水平质控品对全血细胞常规分析22个项目进行检测,绘制Levey-Jennings控制图,每月或每批次对质控数据进行分析与评估。结果建立了一套适宜的室内质控管理体系,包括质量目标的设立、新质控靶值和标准差的设定和质控规则的选择等。新批号质控设定靶值时,MCV、HCT和MCHC应采用至少20个值的均值,而其余项目可以采用10个值的均值;同一项目不同水平和不同品牌以及相同品牌不同仪器之间,某些项目CV值也存在差异,因此应根据不同水平、不同仪器设立相应的质量目标以及新批号的SD值。MCV、HCT和MCHC根据质控品特点,质控图存在漂移现象,因此采用1_(3s)和2_(2s)规则,其余项目则采用1_(3s)、2_(2s)和10x规则。结论在符合ISO15189相关规定的基础上,结合本实验室的实际情况,建立了一套适宜的室内质控管理体系。

Objective To establish a proper internal quality control（QC）system for the automated hematology analyzer according to the corresponding stipulation by ISO15189：2012.Methods The high,normal and low levels of controls offered by the instrument were used to detect 22 items in whole blood cells routine analysis,draw the Levey-Jennings chart,analyze and evaluate the quality control data for each month or each batch.Results A proper QC system was established,including quality goals setting,new QC target value and standard deviation calculating and the QC rules choosing.In setting the target value for new batch of control,MCV,HCT and MCHC should adopt the mean values of at least 20 values,while other items could adopt the mean values of 10values;the difference of CVvalues for some items existed in different QC levels,different brands or different instruments in the same brand.Therefore,the quality goals and standard deviation for new batch should be set according to different levels and different instruments.Due to the QC characteristics and existence of QC chart drift phenomenon,therefore MCV,HCT and MCHC should adopt the 1_（3 s）and 2_（2s）rules.For the other items,the 1_（3 s）,2_（2s）and 10 xrules were adoted.Conclusion Under the corresponding stipulations of ISO15189 and by combining with the laboratory practical situation,a set of applicable internal quality control system is established.