摘要
目的 用6西格玛（σ）管理方法评价脂类检验项目分析性能,用以指导质量改进.方法 质量管理方法研究.选取2012年同时参加脂类正确度验证计划和室内质量控制（IQC）室间比对计划的64家实验室,分别获得各实验室测定胆固醇（TC）、三酰甘油（TG）、高密度胆固醇（HDL-C）、低密度胆固醇（LDL-C）的偏倚（Bias）和变异系数（CV）水平,并依据美国胆固醇教育计划（NCEP）给出的允许总误差（TEa）标准,按照公式σ=（TEa-bias）/CV计算σ值,评价参加实验室的4项脂类检验项目的分析性能;以QGI=Bias/（1.5CV）计算检验项目的质量目标指数（QGI）,查找导致性能不佳的主要原因,便于优先改进.结果 总胆固醇、三酰甘油、高密度胆固醇、低密度胆固醇的分析性能σ≥6的实验室比例分别为21.9％、34.4％、9.38％、18.8％;3≤σ＜6的实验室比例分别为31.3％、29.7％、29.7％、34.4％;σ＜3的实验室比例分别为46.9％、35.9％、60.9％、46.9％,对于σσ＜3的项目,需要优先改进正确度的实验室占91.3％～100％;需要优先改进精密度的实验室占0.00％ ～8.75％;既需要改进正确度又要改进精密度的实验室占0.00％～2.08％.结论 6σ-质量管理是临床实验室质量控制的一项有效管理工具,有助于不断实验室提高临床实验室水平.对实验室脂类检验项目需要进一步加强正确度质量控制的监督管理.
Objective To evaluate the analytical performance of lipid testing with six sigma（a） in order to promote the quality improvement.Methods Sixty-four Laboratories participated in trueness verification program and Internet-Based Interlaboratory Comparison of Internal Quality Control Data program lipid testing in 2012 were included in this study.The CVs and Bias of TC,TG,HDL-C,and LDL-C for each laboratory were evaluated from the reporting data.The sigma metrics based on the Tea from National Cholesterol Education Program according to the formula：σ =（TEa-Bias）/CV for each analyte.Quality goal index （QGI） was also calculated to investigate the reason for dissatisfied performance as follows：QGI =Bias/ （1.5CV）.Results The rates for σ≥6 of TC,TG,HDL-C,and LDL-C were 21.9%,34.4%,9.38%,and 18.8%,respectively.The corresponding rates for 3 ≤ σ 〈 6 were 31.3%,29.7%,29.7%,and 34.4%,while the rates for σ 〈 3 were 46.9%,35.9%,60.9%,and 46.9%,severally.For analytes which σ were less than 3,91.3%-100% of the laboratories should improve the trueness first,0.00%-8.75% of the laboratories should improve the precision,and 0.00%-2.08% should improve both.Conclusions Six sigma is an effective tool for quality control in clinical laboratory,which can help improve the quality level for laboratory testing.The analysis of performance of the lipid testing shows that further effort is acquired to enhance the supervision of the trueness verification.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2014年第4期311-314,共4页
Chinese Journal of Laboratory Medicine
基金
国家高技术研究发展计划资助项目（2011AA02A102,2011AA02A116）
北京市自然科学基金资助项目（7143182）
关键词
全面质量管理
实验室
医院
脂类
质量控制
Total quality management
Laboratories,hospital
Lipids
Quality control
