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

Anna Linko-Parvinen; Jonna Pelanti; Tanja Vanhelo; Pia Eloranta; Hanna-Mari Pallari

doi:10.1515/cclm-2024-0990

Article

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

Anna Linko-Parvinen , Jonna Pelanti , Tanja Vanhelo , Pia Eloranta and Hanna-Mari Pallari

Published/Copyright: December 16, 2024

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 5

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.

Keywords: preanalytical phase; external quality assessment; laboratory diagnostics

Corresponding author: Anna Linko-Parvinen, PhD, MD, Tyks Laboratories, Clinical Chemistry, Turku University Hospital, Kiinamyllynkatu 10, 20520, Turku, Finland; and Department of Clinical Chemistry, University of Turku, Kiinamyllynkatu 10, 20520, Turku, Finland, E-mail: anna.linko-parvinen@tyks.fi

Research ethics: Not applicable.
Informed consent: Not applicable.
Author contributions: Anna Linko-Parvinen designed and produced the original study case contents, and wrote the primary draft of the manuscript including the data synthesis. Anna Linko-Parvinen and Hanna-Mari Pallari were resposible for case evaluation. Jonna Pelanti was responsible for gathering the data for all the study cases included in the study and provided detailed information regarding case responses. Tanja Vanhelo and Pia Eloranta were responsible for gathering the data in individual study cases. Hanna-Mari Pallari had significant contribution in data synthesis and manuscript draft writing. All authors participated in the manuscript drafting. The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Use of Large Language Models, AI and Machine Learning Tools: None declared.
Conflict of interests: Anna Linko-Parvinen has received rewards for the EQA rounds from Labquality (creation and review). She has not received any rewards regarding this publication. This publication is an independent retrospective study with a scientific purpose only. Jonna Pelanti, Tanja Vanhelo and Pia Eloranta are employees at Labquality. They have not received any rewards regarding this publication. This publication is an independent study with a scientific purpose only. Hanna-Mari Pallari states no conflict of interest.
Research funding: None declared.
Data availability: EQA case descriptions are provided as Supplementary Material. Raw data, including response distribution and classificaation, is available upon request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0990).

Received: 2024-08-25

Accepted: 2024-12-02

Published Online: 2024-12-16

Published in Print: 2025-04-28

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Supplementary Material

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Keywords for this article

preanalytical phase; external quality assessment; laboratory diagnostics