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Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic
Lien Tembuyser1, Elisabeth M C Dequeker2
1Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, KU Leuven - University of Leuven, Herestraat 49, box 602, 3000, Leuven, Belgium.
Abstract:
Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.
Insights
Ensuring quality assurance in molecular diagnostics is crucial for patient safety. This review covers best practices and risks, advocating for a holistic approach and an international association for quality improvement.
Area of Science:
- Medical laboratory science
- Molecular diagnostics
- Quality management
Background:
- Patient safety in molecular diagnostic laboratories relies heavily on robust quality assurance (QA).
- Risks to high-quality procedures span the entire workflow, from sample collection to result reporting and external quality assessment (EQA).
- A multidisciplinary approach is essential for safeguarding quality at all levels.
Purpose of the Study:
- To provide an overview of good quality assurance practices in molecular diagnostics.
- To identify and discuss risks that can compromise quality in diagnostic laboratories and EQA schemes.
- To offer recommendations for promoting and improving QA in molecular pathology.
Main Methods:
- Literature review of current quality assurance practices.
- Analysis of potential risks in molecular diagnostic workflows.
- Discussion of strategies for enhancing quality management and EQA.
Main Results:
- Effective QA requires a holistic, multidisciplinary approach across all laboratory processes.
- Emerging molecular targets and technologies present new challenges for clinical implementation and EQA.
- The growing complexity necessitates improved QA frameworks and international collaboration.
Conclusions:
- Continuous improvement of quality assurance is vital for molecular diagnostic laboratories.
- There is a need for enhanced EQA schemes to keep pace with technological advancements.
- Formation of an international association is recommended to advance quality assurance in molecular pathology.
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