六西格玛在评价内分泌项目分析性能上的应用

目的探讨六西格玛(6σ)在评价内分泌项目分析性能上的应用价值。 方法收集本实验室2018年10月至2019年3月室内质控(IQC)数据以及2018年第二次和2019年第一次室间质量评价(EQA)数据,应用四个不同来源的性能规范作为质量目标、室内质控长期累计的变异系数作为精密度和室间质评项目的百分差值作为偏倚分别评估内分泌项目的σ水平,分析不同质量目标对内分泌项目的σ值所产生的差异,并制定个性化的室内质控方案。评估σ值<6项目的质量目标指数(QGI),为实验室的质量改进提供实施方案。 结果不同的质量目标,各项目的σ分布存在显著差异,依据国家EQA评价标准、生物学变异导出"适当的"质量规范和美国临床实验室标准化协会(CLSI)推荐的质量规范,σ值≥6项目的比例分布于20.0%~35.4%之间;依据西班牙EQA评价标准,则未见σ值≥6的项目。依据各项目的分析性能,制定个性化的室内质控方案：总三碘甲状腺原氨酸(TT3)、促甲状腺素(TSH)、黄体生成素(LH)和睾酮(T)选择单规则1_3s进行质量控制;催乳素(PRL)选择多规则1_3s/2_2s/R_4s进行质量控制;游离甲状腺素(FT4)选择多规则1_3s/2_2s/R_4s/4_1s进行质量控制;游离三碘甲状腺原氨酸(FT3)、总甲状腺素(TT4)、雌二醇(E2)、卵泡刺激素(FSH)和孕酮(P)选择多规则1_3s/2_2s/R_4s/4_1S/8_X进行质量控制。依据我国EQA评价标准,FT3、FT4、TT4、E2、FSH、P、PRL项目均需优先改进精密度。 结论6σ能够客观评价内分泌项目的分析性能,并促进实验室检测质量的持续改进。

Application of Six Sigma in evaluating the analytical performance of endocrine project

ObjectiveTo investigate the application value of Six Sigma in the evaluation of endocrine project analysis performance. MethodsThe data of internal quality control (IQC) from October 2018 to March 2019 and the data of external quality assessment (EQA) from second time in 2018 and first time in 2019 were collected respectively. Four different sources of performance specifications were used as quality goals, and the long-term cumulative coefficient of variation of IQC were used as precision and the percentage difference of EQA were used as bias to evaluate σlevels of endocrine items and σvalues of endocrine items with different quality objectives. Meanwhile, individualized IQC scheme was formulated. In addition, the quality target index (QGI) of items with σvalue below 6 were evaluated and the plan for laboratory quality improvement was provided. ResultsAccording to the national EQA evaluation standard, biological variation, "appropriate" quality standard and quality standard recommended by CLSI are derived. The proportion of projects with σvalue ≥ 6 is between 20.0% and 35.4%; While, according to the Spanish EQA standard, no analytes with σvalue more than 6 were found. According to the analytical performance of each project, a personalized IQC scheme was developed: total triiodothyronine (TT3), thyroid stimulating hormone (TSH), luteinizing hormone (LH) and testosterone (T) were selected for single rule 1_3s for quality control, prolactin (PRL) was selected multiple rule 1_3s/2_2s/R_4s for quality control, free thyroxine (FT4) was selected multiple rule 1_3s/2_2s/R_4s/4_1s for quality control, free triiodothyronine (FT3), total thyroxine (TT4), estradiol (E2), follicle stimulating hormone (FSH) and progesterone (P) were selected multiple rule 1_3s/2_2s/R_4s/4_1S/8_X for quality control. According to the Chinese EQA standard, the precision of FT3, FT4, TT4, E2, FSH, P and PRL should be improved firstly. ConclusionSix Sigma can reasonably evaluate the analytical performance of the endocrine project and promote the continuous improvement of laboratory test quality.