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移动平均法作为实时分析质量控制的附加工具:在小体积医学实验室中的实施挑战和机遇。

Moving average procedures as an additional tool for real-time analytical quality control: challenges and opportunities of implementation in small-volume medical laboratories.

机构信息

Department of Laboratory Diagnostics, Railway Healthcare Institute, Belgrade, Serbia.

Department of Medical Biochemistry, University of Belgrade, Faculty of Pharmacy, Belgrade, Serbia.

出版信息

Biochem Med (Zagreb). 2022 Feb 15;32(1):010705. doi: 10.11613/BM.2022.010705. Epub 2021 Dec 15.

DOI:10.11613/BM.2022.010705
PMID:34955673
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8672389/
Abstract

INTRODUCTION

Moving average (MA) is one possible way to use patient results for analytical quality control in medical laboratories. The aims of this study were to: (1) implement previously optimized MA procedures for 10 clinical chemistry analytes into the laboratory information system (LIS); (2) monitor their performance as a real-time quality control tool, and (3) define an algorithm for MA alarm management in a small-volume laboratory to suit the specific laboratory.

MATERIALS AND METHODS

Moving average alarms were monitored and analysed over a period of 6 months on all patient results (total of 73,059) obtained for 10 clinical chemistry parameters. The optimal MA procedures were selected previously using an already described technique called the bias detection simulation method, considering the ability of bias detection the size of total allowable error as the key parameter for optimization.

RESULTS

During 6 months, 17 MA alarms were registered, which is 0.023% of the total number of generated MA values. In 65% of cases, their cause was of pre-analytical origin, in 12% of analytical origin, and in 23% the cause was not found. The highest alarm rate was determined on sodium (0.10%), and the lowest on calcium and chloride.

CONCLUSIONS

This paper showed that even in a small-volume laboratory, previously optimized MA procedures could be successfully implemented in the LIS and used for continuous quality control. Review of patient results, re-analysis of samples from the stable period, analysis of internal quality control samples and assessment of the analyser malfunctions and maintenance log have been proposed for the algorithm for managing MA alarms.

摘要

简介

移动平均值(MA)是一种在医学实验室中使用患者结果进行分析质量控制的方法。本研究的目的是:(1)将之前针对 10 项临床化学分析物优化的 MA 程序实施到实验室信息系统(LIS)中;(2)将其作为实时质量控制工具进行监测;(3)为小型实验室定义适合特定实验室的 MA 报警管理算法。

材料与方法

在 6 个月的时间内,对所有 10 项临床化学参数的患者结果(共 73059 个)进行了 MA 报警的监测和分析。之前使用一种称为偏差检测模拟方法的已有技术选择了最佳 MA 程序,将偏差检测能力和总允许误差大小作为优化的关键参数进行考虑。

结果

在 6 个月期间,共记录到 17 个 MA 报警,占生成 MA 值总数的 0.023%。在 65%的情况下,其原因是分析前的,在 12%的情况下是分析的,在 23%的情况下未找到原因。钠的报警率最高(0.10%),钙和氯的报警率最低。

结论

即使在小型实验室中,之前优化的 MA 程序也可以成功地在 LIS 中实施,并用于连续质量控制。建议使用患者结果复查、稳定期样本的重新分析、内部质量控制样本分析以及评估分析仪故障和维护记录来管理 MA 报警的算法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8713/8672389/3715b2b4cc38/bm-32-1-010705-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8713/8672389/867dfb35a74c/bm-32-1-010705-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8713/8672389/3715b2b4cc38/bm-32-1-010705-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8713/8672389/867dfb35a74c/bm-32-1-010705-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8713/8672389/3715b2b4cc38/bm-32-1-010705-f2.jpg

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Assessment of patient-based real-time quality control algorithm performance on different types of analytical error.
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How to Implement Patient-Based Quality Control: Trial and Error.如何实施基于患者的质量控制:反复试验。
J Appl Lab Med. 2020 Nov 1;5(6):1153-1155. doi: 10.1093/jalm/jfaa132.
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