| 应用 σ度量对深圳市龙华区三家综合医院临床生化检验结果互认的评价研究 |
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| 引用本文： | 陈荣贵,张勇刚,施俊柱,唐曙明,武学成,刘运红,刘爱胜.应用 σ度量对深圳市龙华区三家综合医院临床生化检验结果互认的评价研究[J].现代检验医学杂志,2021,0(1):141-146. |
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| 作者姓名： | 陈荣贵 张勇刚 施俊柱 唐曙明 武学成 刘运红 刘爱胜 |
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| 作者单位： | （1.深圳市龙华区中心医院医学检验科，广东深圳 518110；2.深圳市人民医院龙华分院检验科，广东深圳 518109；3.深圳市龙华区人民医院检验科，广东深圳 518109） |
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| 基金项目： | 深圳市龙华区科技创新局医疗卫生项目(2017103)。 |
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| 摘 要： | 目的 探讨 σ度量在深圳市龙华区三家综合医院临床生化检验结果互认中的应用价值。方法 收集三家医院 2019年广东省临检中心常规化学，特殊蛋白前两次的室间质评（ EQA）样本，经混匀并分割成比对样本送至各评价实验室进行检测；以卫生部临检中心（ NCCL)标准和生物学变异导出的允许总误差（ TEa%）为质量规范，通过加权法计算出各项目 2019年 1～ 6月期间室内质控在控数据的不精密度，以 2018年参加卫生部室间质评（ EQA）数据作为偏倚（ bias%）来源，计算三家医院 29个检验项目的 σ度量值并进行性能评价，利用质量目标指数（ QGI)提出改善方法；将评价项目的 σ度量值与直接比对试验进行比较，通过统计分析确定 σ截断值（ cut-off）。结果 ①三家医院 29个生化项目的性能并不一致，将项目中、高值的 σ值进行配对 t检验，其 t值分别为 2.28，3.01和 0.74，按 α =0.05水准判断得出医院 A与 B，医院 A与 C间的性能差异有统计学意义，医院 B与 C间的性能差异无统计学意义，医院 A项目性能要优于 B，C医院。评估的 87个项目中有 53项 σ平均值 <6，根据 QGI判断，3个项目需优先改善准确度，10个项目需同步改善准确度和精密度，另 40个项目需优先改善精密度。②对医院间项目比对通过率进行配对 χ2检验，其 χ2分别为 5.33，6.25和 2.5，按α=0.05水准判断， B与 A医院比对通过率低于 C与 A医院、 C与 B医院，差异有统计学意义； C与 A医院比对通过率跟 C与 B医院差异无统计学意义。③将 σ度量值与直接比对试验进行比较，经配对 χ2检验，当 σ cut-off值取≥ 2σ， ≥ 3σ，≥ 4σ，≥ 5σ和≥ 6σ时，其 χ2分别为 7.20，0.00，9.09，15.06和 16.06，按 χ20.05，1=3.84，α=0.05水准判断，当σcut-off值取≥ 3σ时，两种比对方法的差异无统计学意义。结论 σ度量值可以单独用于评价医院间生化检验结果的互认，在判断项目是否具有可比性时，可考虑将 σ cut-off值设为≥ 3σ。
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| 关 键 词： | 结果互认 σ度量 总误差 质量目标指数 截断值 |
Evaluation of Mutual Recognition of Biochemical Results in Three Hospitals of Longhua District by σ Metric |
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| CHEN Rong-gui,ZHANG Yong-gang,SHI Jun-zhu,TANG Shu-ming,WU Xue-cheng,LIU Yun-hong,LIU Ai-sheng.Evaluation of Mutual Recognition of Biochemical Results in Three Hospitals of Longhua District by σ Metric[J].Journal of Modern Laboratory Medicine,2021,0(1):141-146. |
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| Authors: | CHEN Rong-gui ZHANG Yong-gang SHI Jun-zhu TANG Shu-ming WU Xue-cheng LIU Yun-hong LIU Ai-sheng |
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| Affiliation: | （1. Department Laboratory Medicine, Longhua District Central Hospital of Shenzhen City，Guangdong Shenzhen 518110，China；2. Department Laboratory Medicine, Longhua Branch of Shenzhen People’s Hospital，Guangdong Shenzhen 518109，China；3.Department Laboratory Medicine, Longhua District People’s Hospital of Shenzhen City， GuangdongShenzhen 518109，China） |
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| Abstract: | Objective To evaluate the mutual recognition of biochemical results of different detection systems in three hospitals of Longhua district byσmetric evaluation.Methods The samples of routine chemistry and special protein from three hospitals in 2019 were collected,and then they were mixed and divided into comparison samples and sent to each evaluation laboratory for testing.The total error(TEa%)derived from NCCL standard and biological variation was used as the quality standard.Through the weighted method,the internal quality control data of each project from January to June in 2019 was calculated.The bias(bias%)was based on the data from the external quality assessment(EQA)of 2018,and theσvalues of 29 test items in three hospitals were calculated and evaluated.The quality goal index(QGI)was used to propose improve quality,the measurement ofσwas compared with the direct comparison test,and found the appropriate cut-off value by statistical analysis.Results①The performance of 29 biochemical projects in three hospitals was not consistent.Paired t-test was carried out for theσvalues of middle and high values of the project,and the t values were 2.28,3.01and 0.74,respectively.According to the level ofα=0.05,the performance difference between A and B,A and C was statistically significant,but the performance difference between B and C was not statistically significant.The project performance of hospital a was better than that of hospital B and C.53 out of 87 projects were<6σ.According to QGI priority should be given to improving the accuracy of 3 projects,simultaneous improvement of accuracy and precision of 10 projects,and priority improvement of precision of 40 projects according to QGI.②The pass rate of inter hospital comparison was tested by pairedχ^2 test,and theχ^2 values were 5.33,6.25 and 2.5,respectively.According to the level ofα=0.05,the pass rate of comparison between hospital B and hospital A was lower than that of hospital C and hospital A,and the difference was statistically significant.There was no significant difference between hospital C and hospital A,and hospital C and hospital B.③The measurement ofσwas compared with the direct comparison test(χ^2 test),and whenσvalue was≥2σ,≥3σ,≥4σ,≥5σand≥6σ,theχ^2 values were 7.20,0.00,9.09,15.06 and 16.06,respectively.According to the level ofα=0.05,whenσcut-off value was≥3σ,and there was no significant difference between the two comparison methods.Conclusion Theσvalue can be used to evaluate the mutual recognition of biochemical test results among hospitals.When judging whether the items are comparable,the cut off value ofσcan be set as≥3σ. |
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| Keywords: | mutual recognition of results σmeasurement total error quality target index cut-off value |
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