现场技术审核对PCR实验室质量管理的影响分析

Analysis of the Influence of Field Technical Audit on PCR Laboratory Quality Management

目的总结临床PCR实验室参加室间质量评价活动的PT结果,探讨现场审核与否对室间质评结果的影响,进而分析实验室现场审核对其质量管理的影响。方法统计分析2008~2019年陕西省临床检验中心PCR(HBV-DNA,HCV-RNA)参评实验室室间质评活动结果。结果①2008~2019年累计参评HBV-DNA的实验室次数为617次,其中通过现场审核的实验室累计数450次,合格单位累计数437次,平均能力比对96.4%,合格率97.1%;未通过现场审核的实验室累计数167次,合格单位累计数149次,平均能力比对88.3%,合格率89.2%;②2008~2019年累计参评HCV-RNA的实验室数为526次,其中通过现场审核的实验室累计数425次,合格单位累计数414次,平均能力比对96.6%,合格率97.4%;未通过现场审核的实验室累计数101次,合格单位累计数96次,平均能力比对92.9%,合格率95.0%;③HBV-DNA 2008~2019年累计合格率经χ^2检验,二者比较差异有统计学意义(χ^2=15.888,P<0.001)。结论通过现场审核的PCR实验室能严格进行规范操作,有助于做好室间质评工作,有效提高临床检测的水平和质量。

Objective To analyze the PT results of clinical PCR laboratory participating in the inter room quality evaluation activities,explore the influence of the on-site audit of PCR laboratory on the results of the inter room quality evaluation,and then to analyze the influence of the on-site audit of the laboratory on its quality management.Methods Statistical analysis of the results of EIA activities in the evaluation laboratories of HBV-DNA and HCV-RNA in Shaanxi Clinical Laboratory Center from 2008 to 2019 were carried out.Results①In 2008~2019,the total number of laboratories participating in the evaluation of HBV-DNA was 617,including 450 laboratories passing the on-site audit,437 qualified units,with an average of PT 96.4%,and a qualified rate of 97.1%.167 laboratories failing to pass the on-site audit,149 qualified units,with an average of PT 88.3%,and a qualified rate of 89.2%.②In 2008~2019,there were 526 laboratories participating in the evaluation of HCV-RNA,including 425 laboratories passing the on-site audit,414 qualified laboratories,with an average of PT 96.6%and a qualified rate of 97.4%.101 laboratories failing to pass the on-site audit,with an average of PT 92.9%and a qualified rate of 95.0%.③The cumulative eligibility rate of HBV-DNA in 2008~2019 was 15.888 and P<0.001 byχ^2 test.There was statistical significance between them.Conclusion The PCR laboratory that has passed the on-site audit can strictly carry out the standardized operation,which is helpful to do a good job in the work of inter laboratory quality assessment and effectively improve the level and quality of clinical testing.