患者数据移动均值监控体检样本氯离子检测系统误差的应用评估
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北京协和医院检验科

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R

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首都卫生发展科研专项(首发2020-1-4014)。


Evaluation of Moving Average of Patient Data in Monitoring Systematic Error of Chloride in Physical Examination Samples
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Chinese Academy of Medical Sciences Peking Union Medical College Hospital

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    摘要:

    目的:评估患者数据每日均值对于识别氯离子系统误差的有效性和及时性。方法:计算本实验室2018年罗氏C8000分析仪测定氯离子结果的每日算术均值,以日期为横坐标绘制均值变化图。分析该分析仪的伯乐全球每月室内质控偏倚变化、室间质评、室内不同机型比对结果。比较患者结果均值、室内质控、室间质评、室内比对识别系统误差的有效性与及时性。结果:(1)由移动均值图可见自9月28日起氯离子出现系统性偏低。2017年氯离子结果均值为103.1.±1.0 mmol/L,9月28日到12月17日均值为99.5±0.5mmol/L。(2)与伯乐全球每月室内质控对等组比较:1月~9月氯离子室内质控结果无明显系统性偏倚,10月~12月负偏倚,SDI为-0.97~-1.62。(3)室间质评:6月份CAP室间质评中氯离子偏差为-0.9~+0.2个标准差(-0.9~+0.2SDI),10月份偏差为﹣1.7~﹣2.9SDI。(4)室内仪器间比对:4月份C8000与贝克曼AU5800比对结果无明显差异,10月份C8000结果系统偏低4.0~6.0mmol/L。以上四种方法均可识别出系统误差,患者数据均值法于发生系统偏倚近几日即可观察到变化,全球比对、室间质评或室内比对因受计划时间影响延迟1至2月发现偏差。结论:患者数据均值法识别体检样本氯离子系统偏倚简单有效,时效性优于室间质评和室内比对,可作为当前实验室质量控制的有益补充。

    Abstract:

    Objective:To evaluate the the effectiveness and timeliness of daily averages of patient data in identifying chloride system errors. Method: Calculate the daily arithmetic mean of the chloride ion values determined by Roche C8000 analyzer in 2018, and draw the mean change chart with the date as the abscissa. Analyze the monthly bias of internal quality control of C8000, according to the Bio-Rad Laboratory QC Worldwide Report. Evaluate the external quality assessment results and the bias between different biochemical testing systems.Compare the effectiveness and timeliness of the mean value of patient results, internal quality control, external quality assessment and different testing system comparison to identify system errors. Results: (1)From the moving average map, it can be seen that the chloride ion has been systematically low since September 28.The average value of chloride ion in 2017 was 103.1 ±1.0 mmol/L, while the average value was 99.5 ±0.5mmol/L from September 28 to December 17. (2)Comparison with equivalent group of monthly Bio-Rad Laboratory QC Worldwide Report: There was no obvious systematic bias in the results of chloride internal quality control from January to September, but there was negative bias from Octorber to December, and the standard deviation index ranges from -0.97~-1.69. (3)External quality assessment results: The SDI of chloride ion in CAP external quality assessment in June was- 0.9~+0.2SDI, and the deviation in October was-1.7~-2.9SDI.(4)Comparison in different testing system:There was no significant difference in the chloride ion result between C8000 and Beckman AU5800 in April,while the result of C8000 chloride ion is systematically low 4.0~6.0mmol/L in October. The daily averages of patient data can capture this systematically error in the occurrence of the bias in recent days,and other methods delay the detection of deviation from 1 to 2 months due to the influence of planning time.Conclusion: It is simple and effective to identify the systematic bias of chloride ion by daily averages of patient data, whose timeliness is better than external quality assessment and comparison study. The daily averages of patient data can be used as a useful supplement to the current laboratory quality control.

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高冉,夏良裕,禹松林,高学慧,张瑞丽.患者数据移动均值监控体检样本氯离子检测系统误差的应用评估[J].临床检验杂志,2020,(10):787-789

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  • 收稿日期:2020-08-14
  • 最后修改日期:2020-11-09
  • 录用日期:2020-11-09
  • 在线发布日期: 2021-03-24
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