血站血清学实验室质量指标回顾性分析初探

Retrospective analysis of quality indicators in blood bank serological laboratory

目的通过复试/初试阳性率、室内质控失控率、设备故障率等质量指标的分析,对实验室质量管理体系进行持续改进。方法采用2016年4月—2018年3月ELISA试验数据。统计各试剂复试/初试阳性率,对〈50%的试剂进行原因分析;统计室内质控失控率,按失控原因分类统计室内质控失控次数和构成比,利用Pareto图分析失控原因;统计设备故障率,按故障原因分类统计设备的故障次数和构成比,利用Pareto图分析故障原因。结果 12种ELISA检测试剂中有6种试剂复试/初试阳性率〈50%;室内质控失控率为1. 2%,失控的主要原因为设备;设备故障率为0. 58次/1 000标本,故障原因主要为洗板单元。结论阶段性回顾性分析实验室质量指标,可发现实验过程的变化趋势,评价实验室质量管理体系的运行情况,为实验室质量管理体系的持续改进提供有效的依据。

Objective To continuously improve the laboratory quality management system through the analysis of quality indicators such as retest/initial test positive rate,internal quality control out-of-control rate and equipment failure rate.Methods The ELISA experimental data from April 2016 to March 2018 were enrolled in this study. The retest/initial test positive rate of each reagent were acquired and reagents with a rate of less than 50% were further analyzed; The out-of-control rate of the internal quality control was calculated and causes were classified in incident counts and composition ratio. The causes were further analyzed by the Pareto diagram; Classify the number of failures and composition ratio of the statistical equipment according to the cause of the failure,and analyze the cause of the failure by the Pareto diagram. Results Among the 12 ELISA reagents,6 reagents showed a retest/initial test positive rate of less than 50%; Internal quality control loss rate was 1. 2%. The main reason for out-of-control was equipment; equipment failure rate was 0. 58 times/1 000 specimens. The main cause of failure was the rinsing the unit. Conclusion The staged retrospective analysis of laboratory quality indicators can reveal the changing trend of the experimental process,evaluate the operation of the laboratory quality management system,and provide an effective basis for the continuous improvement of the laboratory quality management system.