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在一家多地点兽医实验室中,对 Sysmex XT-2000iV 血液分析仪进行重复患者测试的质量控制与商业质控品的比较。

Repeat patient testing-quality control compared to commercial quality control material for the Sysmex XT-2000iV hematology analyzer in a multi-site veterinary laboratory.

机构信息

Veterinary Pathology Group, Brushville House, Dosco Business Park, Cork, Ireland.

School of Veterinary Medicine and Science, University of Nottingham, Leicestershire, UK.

出版信息

Vet Clin Pathol. 2024 Feb;53 Suppl 1:48-59. doi: 10.1111/vcp.13332. Epub 2024 Feb 14.

Abstract

BACKGROUND

Quality control material (QCM) for hematology in veterinary laboratories is limited, and repeat patient testing quality control (RPT-QC) is an alternative method using excess matrix-specific samples.

OBJECTIVES

This study aimed to determine if median differences between RPT-QC analyses for each time interval for RBC, HGB, HCT, and WBC were the same, determine if unified RPT-QC limits can be applied to a network of veterinary laboratories, compare the performance of RPT-QC to commercial QCM for the reference analyzer and evaluate the experience over a 4 month period and design, improve and implement an automated spreadsheet for RPT-QC data management.

METHODS

The potential to unify individual analyzer RPT-QC limits for red blood cells (RBC), hematocrit (HCT), hemoglobin (HGB), and white blood cells (WBC) on multi-site Sysmex XT-2000-iV analyzers was explored by a difference of means test and confidence interval determination for the median difference for each network analyzer in comparison to the network reference analyzer. User experience of an automated RPT-QC data management Excel spreadsheet was collected by user feedback during monthly meetings. Numbers of out-of-control results and the root causes for these for RPT-QC were compared against those of a commercial QCM over a 4-month period.

RESULTS

Differences between individual analyzer RPT-QC limits were too large to allow for unification of network limits. The automated spreadsheet successfully highlighted out-of-control events for RPT-QC. Trends or shifts were more frequent for commercial QCM based on observed performance and a 1-2.5 s QC rule than for RPT-QC. Following routine troubleshooting, RPT-QC out-of-control events were resolved with an alternative RPT-QC sample indicating random error associated with excessive deterioration. Use of an automated spreadsheet for recording RPT-QC, documentation and troubleshooting of out-of-control events, and collating monthly summary calculations were considered an asset in laboratory quality management.

CONCLUSIONS

RPT-QC can be successfully implemented and integrated into a multi-site veterinary laboratory. Individual analyzer RPT-QC limit generation is recommended. The deterioration of commercial QCM caused shifts or trends in QC results, which initiated more repeat analyses and investigations than did RPT-QC.

摘要

背景

兽医实验室的血液学质量控制材料(QCM)有限,而使用多余的基质特异性样本进行重复患者检测质量控制(RPT-QC)是一种替代方法。

目的

本研究旨在确定 RBC、HGB、HCT 和 WBC 的每个时间间隔的 RPT-QC 分析之间的中位数差异是否相同,确定是否可以将统一的 RPT-QC 限制应用于兽医实验室网络,比较 RPT-QC 与参考分析仪的商业 QCM 的性能,并在 4 个月的时间内评估经验,设计、改进和实施用于 RPT-QC 数据管理的自动化电子表格。

方法

通过均值差异检验和置信区间确定,探讨了在多站点 Sysmex XT-2000-iV 分析仪上对红细胞(RBC)、红细胞压积(HCT)、血红蛋白(HGB)和白细胞(WBC)的单个分析仪 RPT-QC 限制进行统一的可能性,以比较网络参考分析仪的每个网络分析仪的中位数差异。通过每月会议期间的用户反馈收集用户对自动化 RPT-QC 数据管理 Excel 电子表格的使用体验。在 4 个月的时间内,比较 RPT-QC 和商业 QCM 的失控结果数量及其根本原因。

结果

个体分析仪 RPT-QC 限制之间的差异太大,无法实现网络限制的统一。自动化电子表格成功突出了 RPT-QC 的失控事件。基于观察到的性能和 1-2.5sQC 规则,商业 QCM 的趋势或偏移更为频繁,而 RPT-QC 则较少。经过常规故障排除后,使用替代 RPT-QC 样本解决了 RPT-QC 的失控事件,表明与过度劣化相关的随机误差。使用用于记录 RPT-QC、失控事件的文档记录和故障排除以及汇总每月汇总计算的自动化电子表格被认为是实验室质量管理的一项资产。

结论

可以成功实施和整合 RPT-QC 到多站点兽医实验室。建议生成单个分析仪 RPT-QC 限制。商业 QCM 的劣化导致 QC 结果发生偏移或趋势,这比 RPT-QC 导致更多的重复分析和调查。

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