The Significance of External Quality Assessment Schemes for Molecular Testing in Clinical Laboratories

Abstract

External quality assessment (EQA) schemes are a tool for clinical laboratories to evaluate and manage the quality of laboratory practice with the support of an independent party (i.e., an EQA provider). Depending on the context, there are different types of EQA schemes available, as well as various EQA providers, each with its own field of expertise. In this review, an overview of the general requirements for EQA schemes and EQA providers based on international guidelines is provided. The clinical and scientific value of these kinds of schemes for clinical laboratories, clinicians and patients are highlighted, in addition to the support EQA can provide to other types of laboratories, e.g., laboratories affiliated to biotech companies. Finally, recent developments and challenges in laboratory medicine and quality management, for example, the introduction of artificial intelligence in the laboratory and the shift to a more individual-approach instead of a laboratory-focused approach, are discussed. EQA schemes should represent current laboratory practice as much as possible, which poses the need for EQA providers to introduce latest laboratory innovations in their schemes and to apply up-to-date guidelines. By incorporating these state-of-the-art techniques, EQA aims to contribute to continuous learning.

The imperative for quality control programs in Monkeypox virus DNA testing by PCR: CIBERINFEC quality control

“…External QC initiatives, as demonstrated in this study, play a critical role in addressing these challenges 12 . As in other QC programs, 8,13 the control samples distributed to the participating centers enabled the identification and rectification of diagnostic inaccuracies, leading to improved overall diagnostic accuracy.…”

“…External QC initiatives, as demonstrated in this study, play a critical role in addressing these challenges. 12 As in other QC programs, 8,13…”

Quality Assurance in Histopathology Laboratories

“…Similarly, other ancillary technique results (e.g., FISH results) should be incorporated in the final report as per relevant/current guidelines/protocols. [44][45][46][47][48][49] External quality assessment schemes…”

Longitudinal analysis of 20 Years of external quality assurance schemes for PCR/NAAT-based bacterial genome detection in diagnostic testing

“…Over the past decades, huge efforts have been made in standardizing assay reagents, creating diagnostic workflows, and incorporating internal controls with the aim of achieving results with the highest level of accuracy and reliability. External quality assessment (EQA) schemes are a crucial component in the reliable performance of routine diagnostic assays for pathogens or genetically encoded pathogenicity factors in medical microbiology and infectious diseases ( Laudus et al, 2022 ). The value of regular participation is beyond dispute and hence mandatory in the official guidelines and regulations of most countries worldwide ( De la Salle et al, 2017 ).…”