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南非一家学术医院参与澳大利亚皇家病理学家学院项目的外部质量保证经验。

External quality assurance experience with Royal College of Pathologists of Australasia Program at an academic hospital in South Africa.

作者信息

Mokoka Ngwanatala Sophia, Schapkaitz Elise, Louw Susan

机构信息

Department of Molecular Medicine and Hematology, Faculty of Health Sciences, University of Witwatersrand Medical School, Johannesburg, South Africa.

出版信息

Lab Med. 2025 Jan 6;56(1):70-80. doi: 10.1093/labmed/lmae069.

Abstract

INTRODUCTION

Laboratories use their performance in external quality assurance (EQA) to establish quality planning strategies and to assess whether testing processes require improvement.

METHODS

The EQA performance of the hematology and coagulation test parameters on the Royal College of Pathologists of Australasia EQA program was evaluated over a 4-year cycle at an academic hospital in Johannesburg, South Africa. The test performance was determined from analytical quality specification (APS) and/or z-scores. Bias and imprecision were used to calculate sigma (σ) metric scores. Specifications from European Federation of Laboratory Medicine and/or biological variation were applied.

RESULTS

The laboratory achieved a mean testing score of 98.7 ± 4.0%. There were 103 (10.7%) unacceptable results. On investigation, root causes included: presurvey issues (83%), transcription errors (9%), random errors (6%), and test performance errors (3%). All test parameters evaluated achieved an acceptable median APS during the study period. The mean z-scores, however, were >2 and unacceptable for mean cell hemoglobin concentration and hematocrit. On investigation, this was attributed to significant delay in transport and storage of full blood count samples. White cell count and d-dimer achieved a σ ≥ 6.

CONCLUSION

EQA participation assisted the laboratory in maintaining a quality system. Close monitoring is necessary for international laboratories to avoid sample delays that can affect result quality.

摘要

引言

实验室利用其在外部质量保证(EQA)中的表现来制定质量规划策略,并评估检测过程是否需要改进。

方法

在南非约翰内斯堡的一家学术医院,对澳大利亚皇家病理学家学院EQA计划中血液学和凝血检测参数的EQA表现进行了为期4年的评估。检测性能由分析质量规范(APS)和/或z分数确定。偏差和不精密度用于计算西格玛(σ)指标分数。采用了欧洲实验室医学联合会的规范和/或生物学变异。

结果

该实验室的平均检测得分为98.7±4.0%。有103个(10.7%)结果不可接受。经调查,根本原因包括:预调查问题(83%)、转录错误(9%)、随机误差(6%)和检测性能误差(3%)。在研究期间,所有评估的检测参数均达到可接受的中位数APS。然而,平均红细胞血红蛋白浓度和血细胞比容的平均z分数>2且不可接受。经调查,这归因于全血细胞计数样本运输和储存的显著延迟。白细胞计数和D-二聚体的σ≥6。

结论

参与EQA有助于实验室维持质量体系。国际实验室有必要密切监测,以避免可能影响结果质量的样本延迟。

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