Evaluation of performance in preanalytical phase EQA: can laboratories mitigate common pitfalls?

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Clinical chemistry and laboratory medicine Pub Date : 2024-12-16 Print Date: 2025-04-28 DOI:10.1515/cclm-2024-0990
Anna Linko-Parvinen, Jonna Pelanti, Tanja Vanhelo, Pia Eloranta, Hanna-Mari Pallari
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引用次数: 0

Abstract

Objectives: Preanalytical phase is an elemental part of laboratory diagnostics, but is prone to humane errors. The aim of this study was to evaluate performance in preanalytical phase external quality assessment (EQA) cases. We also suggest preventive actions for risk mitigation.

Methods: We included 12 EQA rounds (Labquality Ltd.) with three patient cases (36 cases, 54-111 participants, 7-15 countries) published in 2018-2023. We graded performance according to percentage of correct responses in each case as ≥900 % excellent, 70-89 % good, 50-69 % satisfactory, 30-49 % fair and <30 % poor. Performance was simultaneously failed with ≥10 % of responses leading to harmful events.

Results: Overall performance was excellent in 7, good in 12, satisfactory in 10, fair in 4 and poor in 3 cases. Additionally, 7 cases showed failed performance. Routine requests with incorrect sample tubes or incorrect sample handling were detected with good performance. Lower performance was seen with sudden abnormal results, with rare requests, with false patient identification (never-events) and with incorrect test requests. Information technology (IT) solutions (preanalytical checklists, autoverification rules and patient specific notifications) could have prevented 33 of 36 preanalytical errors.

Conclusions: While most common errors were detected with good performance, samples with rare requests or those requiring individualised consideration are vulnerable to human misinterpretation. In many instances, samples with preanalytical errors should have been identified and rejected before reaching the laboratory or being directed to analysis. Optimising IT solutions to effectively detect these preanalytical errors allows for focus on infrequent events demanding accessible professional consultation. EQA preanalytical cases may help in education of correct actions in these occasions.

分析前阶段EQA的绩效评价:实验室能否减少常见的缺陷?
目的:分析前阶段是实验室诊断的基本组成部分,但容易出现人为错误。本研究的目的是评估分析前阶段外部质量评估(EQA)案例的表现。我们还建议采取预防措施减轻风险。方法:我们纳入了2018-2023年发表的12轮EQA (Labquality Ltd.) 3例患者(36例,54-111名受试者,7-15个国家)。我们根据每个病例的正确回答百分比对表现进行评分:≥900 %优秀,70-89 %良好,50-69 %满意,30-49 %一般。结果:总体表现为优秀7例,良好12例,满意10例,一般4例,差3例。另有7例表现不佳。使用错误的样管或错误的样品处理的常规要求被检测出良好的性能。突然的异常结果、罕见的请求、错误的患者识别(从未发生过的事件)和不正确的测试请求会导致较低的表现。信息技术(IT)解决方案(分析前检查清单、自动验证规则和患者特定通知)可以防止36个分析前错误中的33个。结论:虽然大多数常见的错误被检测出具有良好的性能,但具有罕见请求或需要个性化考虑的样本容易受到人为误解的影响。在许多情况下,有分析前误差的样品应该在到达实验室或用于分析之前被识别和拒绝。优化IT解决方案以有效地检测这些分析前错误,可以将重点放在需要专业咨询的不常见事件上。EQA分析前案例可能有助于在这些情况下教育正确的行动。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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