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目的通过随机编号样本考核(简称随机编号考核),了解山东省计划生育技术服务机构实验室检测丙氨酸氨基转移酶(alanine aminotransferase,ALT)、葡萄糖(glucose,Glu)、肌酐(creatinine,Cr)项目的真实水平,以有效促进和改进其工作质量。方法 2013年和2014年每年2次由山东省计划生育技术服务检验质量监测指导中心对山东计划生育系统138家从事临床检验工作的实验室,进行生化3项的室间质量评价(external quality assessment,EQA)。在2014年第1次EQA的同时增加1次随机编号考核,即在统一编号发放5个批次常规生化考核样本的同时,还以不同的随机编号发放5个批次考核样本。对各实验室回报的检测结果采用美国1988年临床实验室改进法案(Clinical Laboratory Improvement Amendments of 1988,CLIA’88)的能力验证(proficiency testing,PT)方案的评分方法进行评分,以评价各实验室检测ALT、Glu和Cr合格状况。结果 138家实验室4次常规室间质评实验室ALT的合格率分别为93.4%(132/138)、99.3%(137/138)、97.1%(134/138)、100%;Glu的合格率分别为96.4%(133/138)、97.8%(135/138)、97.8%(135/138)、99.3%(137/138);Cr的合格率分别为84.1%(116/138)、97.1%(134/138)、94.2%(130/138)、98.6%(136/138)。2014年随机编号考核ALT的合格率为95.7%(132/138),Glu的合格率为96.4%(133/138)均低于同批次常规EQA项目合格率,但差异无统计学意义(χ2=0.415和χ2=0.515,P均>0.05)。随机编号考核Cr合格率为86.2%(119/138)低于同时常规质评批次的合格率,差异有统计学意义(χ2=4.105,P<0.05)。结论参评实验室生化3项检测的常规EQA水平有所提高。随机编号考核或许可以帮助EQA组织者了解参评实验室的真实检测水平。
Objective To investigate the detection of alanine aminotransferase (ALT), glucose (Glu), creatinine (Cr) in laboratories of family planning technology service agencies in Shandong Province through the random number sample examination (referred to as random number examination) The true level of the project to effectively promote and improve the quality of its work. Methods Two times per year in 2013 and 2014 were evaluated by the Quality Supervision and Inspection Center of Shandong Province Family Planning Technical Service Inspection Center on 138 laboratories engaged in clinical examination of family planning system in Shandong Province, EQA). In the first EQA in 2014, a random numbering test was added at the same time, that is, five batches of regular biochemical test samples were issued in the unified number, and five batches of test samples were also distributed with different random numbers. The results of laboratory rewards were scored using the scoring methodology of the US Laboratory Clinical Improvement Amendments of 1988 (CLIA’88) proficiency testing (PT) program to evaluate the laboratory ALT, Glu and Cr were tested for eligibility. Results The pass rates of ALT in three routine laboratory evaluation laboratories in 138 laboratories were 93.4% (132/138), 99.3% (137/138), 97.1% (134/138) and 100% respectively in 138 laboratories. The qualified rate of Glu The results showed that the pass rates of Cr were 84.1% (116/138) and 97.1% (97/138) respectively, 97.8% (135/138), 97.8% (135/138) and 99.3% (137/138) % (134/138), 94.2% (130/138), 98.6% (136/138). The qualified rate of randomly assigned ALT was 95.7% (132/138) in 2014, and the pass rate of Glu was 96.4% (133/138), which was lower than the pass rate of routine EQA in the same batch, but the difference was not statistically significant (χ2 = 0.415 and χ2 = 0.515, all P> 0.05). The pass rate of Cr with random number examination was 86.2% (119/138), which was lower than the pass rate of routine quality evaluation batches. The difference was statistically significant (χ2 = 4.105, P <0.05). Conclusion The routine EQA levels in the three tests of laboratory biochemistry showed improvement. Random numbering may help EQA organizers understand the true level of testing in participating laboratories.