WS/T 403-2012和6σ标准在临床生化检验质量评估中的应用

Application of industry standard WS/T 403-2012 in the quality of clinical biochemistry

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》作为卫生部常规化学室间质评和室内质控判断标准,在提高临床生化检验质量中的作用。方法收集2013-2014年某检验室6次常规化学室间质量评价数据及各项目室内质控数据的累积变异系数(CV%);按照国家标准GB/T 20470-2006和行业标准WS/T 403-2012判断和分析卫生部室间质量评价成绩,并以行业标准WS/T 403-2012规定的允许总误差(TEa),计算已开展的室间质评项目的σ水平,并判断各项目的性能。结果全部23个检测项目,2013年度其中10个项目的σ水平>6σ,14个项目的σ水平>3σ,<2σ的项目有3个。2014年度质评结果 5个项目的σ>6σ,17个项目的σ水平>3σ,其中<2σ的项目1项。结论应用行业标准WS/T 403-2012和6σ标准分析室间质评数据,能更全面更客观地评价实验室的分析质量,有助于临床实验室发现问题,采取措施,提高检验质量。

Objective To discuss the hygiene industry standard WS / T403- 2012'routine test items Analysis of Clinical Biochemistry quality indicators'as the Ministry of Health,conventional chemical EQA and internal quality control criteria and verify the role in improving the quality of biochemical tests. Methods The conventional chemical quality assessment data for six times,the cumulative coefficient of variation( CV%) and various project internal quality control data were collected. In accordance with national standards GB/ T20470- 2006 and industry standard WS / T403- 2012 Quality evaluation results between chamber were judged and analyzed. To allow the total error industry standard WS / T403- 2012 provisions( TEa),the calculation had been carried out in our lab in the σ level of EQA project,meanwhile,the purpose of the performance was determined. Results All 23 test items,the σ level of ten projects > 6σ,14 projects > 3σ,< 2σ project was three. in 2013 the results of our laboratory quality assessment 5 projects σ > 6 σ,σ level 17 items >3σ,where σ project < 2 has one in 2014. Conclusion The industry standard WS / T403- 2012 and 6σ standard analytical EQA data can help us to detect problems and take measures to improve test quality,then the analytic quality can be more comprehensive and objective.