卫生行业标准 WS／T403-2012在全国常规化学室间质量评价和室内质控中的应用  

Applications of two analytical specifications in the external quality assessment schemes and the external comparision of internal quality control

作　　者：赵海建[1] 张传宝[1] 王薇[1] 赵彦[1] 马嵘[1] 张天娇[1] 曾洁[1] 王治国[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心生化室,100730

出　　处：《中华检验医学杂志》2014年第11期866-869,共4页Chinese Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划（863计划）（2012AA02A102、2012AA02A116）;“十二五”国家科技支撑计划（2012BAl37801）;北京市自然科学基金（7143182）

摘　　要：目的：探讨卫生行业标准WS／T 403-2012《临床生物化学常规检验项目分析质量指标》在我国常规化学室间质评和室内质控中的适用性。方法质量管理方法研究。收集2013年常规化学室间质量评价第一次活动中23个项目测定结果。依据卫生计生委行业标准WS／T 403-2012和中华人民共和国国家标准GB／T 20470-2006，分别以两个标准来源的总误差评价收集到的数据结果，并计算不同的标准下2013年常规化学室间质评的总及格率；分别以两种不同的变异系数标准评价室内质量控制的变异系数，比较各项目的符合率。结果按照行业标准的总误差标准，各项目第1次室间质评活动中5个批号样本的全部符合的实验室比例范围为55.5％～94.7％；各项目全年及格率范围为73.9％～98.5％。按照GB／T 20470-2006的允许总误差标准，第1次室间质评活动中5个批号样本的全部符合的实验室比例范围为63.0％～99.2％；各项目全年及格率范围为90.0％～99.7％。按照行业标准的变异系数标准，各项目室内质控变异系数的符合率为55.5％～94.7％；按照1／3 TEa标准，室内质控变异系数的符合率为63.0％～99.2％。结论《临床生物化学常规检验项目分析质量指标》作为常规化学室间质量评价总误差和室内质控不精密度的评判标准，能更全面更客观的评价实验室的分析质量，有助于临床实验室发现问题，进行质量改进。Objective To study the applicability of a new analytical specification defined in WS/T 403-2012 in the external quality assessment schemes and the external comparision of internal quality control .Methods It was a quality management method study.Total error allowable criterions listed in WS/T 403-2012 and GB/T 20470-2006 were selected to assess the results of 23 analytes in the 1st challenge of 2013 routine chemistry external quality assessment.The acceptable rate of 23 analytes were calculated with the two specifications.Criterions of imprecision derived from the two standards were applied to assess the coefficient of variation with internal quality control data.Results With the specification based on WS/T 403-2012, the ratio of laboratories that all five samples were passed in the 1st challenge for 23 analytes ranged from 55.5%to 94.7%.The ratio of laboratories with 80%or more samples passed in 2013 EQA ranged from 73.9%to 98.5%.While ratios of two kinds described above evaluated based on GB /T 20470-2006 ranged from 63.0%to 99.2%, and from 90.0% to 99.7%, respectively.The acceptable rate of CV according to the two criterions ranged from 55.5% to 94.7% and 63.0% to 99.2%, respectively.Conclusions As evaluation criterions of external quality assessment allowable total error and internal quality control imprecision in routine chemistry , the specification in WS/T 403-2012 can be used to assess the analytical performance of clinical laboratory more objectively and comprehensively.It can help laboratories to identify the latent problems for further quality improvement.

关 键 词：诊断试验 常规 临床化学试验 实验室 医院 质量控制 

分 类 号：R446[医药卫生—诊断学]