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移动平均法作为连续分析质量控制工具的实施与应用在24项常规化学检测中得到了验证。

Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays.

作者信息

Rossum Huub H van, Kemperman Hans

机构信息

.

出版信息

Clin Chem Lab Med. 2017 Jul 26;55(8):1142-1151. doi: 10.1515/cclm-2016-0696.

Abstract

BACKGROUND

General application of a moving average (MA) as continuous analytical quality control (QC) for routine chemistry assays has failed due to lack of a simple method that allows optimization of MAs. A new method was applied to optimize the MA for routine chemistry and was evaluated in daily practice as continuous analytical QC instrument.

METHODS

MA procedures were optimized using an MA bias detection simulation procedure. Optimization was graphically supported by bias detection curves. Next, all optimal MA procedures that contributed to the quality assurance were run for 100 consecutive days and MA alarms generated during working hours were investigated.

RESULTS

Optimized MA procedures were applied for 24 chemistry assays. During this evaluation, 303,871 MA values and 76 MA alarms were generated. Of all alarms, 54 (71%) were generated during office hours. Of these, 41 were further investigated and were caused by ion selective electrode (ISE) failure (1), calibration failure not detected by QC due to improper QC settings (1), possible bias (significant difference with the other analyzer) (10), non-human materials analyzed (2), extreme result(s) of a single patient (2), pre-analytical error (1), no cause identified (20), and no conclusion possible (4).

CONCLUSIONS

MA was implemented in daily practice as a continuous QC instrument for 24 routine chemistry assays. In our setup when an MA alarm required follow-up, a manageable number of MA alarms was generated that resulted in valuable MA alarms. For the management of MA alarms, several applications/requirements in the MA management software will simplify the use of MA procedures.

摘要

背景

由于缺乏一种能实现移动平均(MA)优化的简单方法,将其作为常规化学分析的连续分析质量控制(QC)的普遍应用失败了。一种新方法被用于优化常规化学分析的MA,并在日常实践中作为连续分析QC仪器进行评估。

方法

使用MA偏差检测模拟程序对MA程序进行优化。偏差检测曲线以图形方式支持优化过程。接下来,对所有有助于质量保证的最佳MA程序连续运行100天,并调查工作时间内产生的MA警报。

结果

优化后的MA程序应用于24种化学分析。在此次评估期间,产生了303,871个MA值和76次MA警报。在所有警报中,54次(71%)是在办公时间产生的。其中,41次被进一步调查,原因包括离子选择性电极(ISE)故障(1次)、由于质量控制设置不当导致质量控制未检测到的校准故障(1次)、可能的偏差(与其他分析仪有显著差异)(10次)、分析的非人类材料(2次)、单个患者的极端结果(2次)、分析前误差(1次)、未确定原因(20次)以及无法得出结论(4次)。

结论

MA在日常实践中作为24种常规化学分析的连续质量控制仪器得以实施。在我们的设置中,当MA警报需要跟进时,产生的可管理数量的MA警报产生了有价值的MA警报。对于MA警报的管理,MA管理软件中的几个应用程序/要求将简化MA程序的使用。

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