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Observations from a national sample exchange program for molecular haematology testing.

Clare Gould¹, Michelle McBean¹, Ella Thompson¹

¹Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Vic, Australia.

|February 27, 2024

Summary

External quality assessment programs (EQAP) for molecular haematology show high analytical concordance but reveal significant post-analytical discordances in reporting. Improving these post-analytical aspects is crucial for accurate clinical decision-making in complex molecular diagnostics.

Keywords:

Molecular haematology inter-laboratory comparison quality assurance

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Area of Science:

Clinical Diagnostics
Molecular Haematology
Laboratory Medicine

Background:

External quality assessment programs (EQAP) traditionally focus on the analytical phase of laboratory testing.
Molecular haematology diagnostics are increasingly complex, necessitating robust evaluation of all testing phases.
Limited evaluation of post-analytical components in current EQAPs may impact clinical interpretation.

Purpose of the Study:

To integrate comprehensive post-analytical evaluation into an existing molecular haematology EQAP.
To analyze four years of longitudinal data on laboratory reporting in molecular haematology.
To identify key areas for improvement in inter-laboratory concordance for molecular haematology testing.

Main Methods:

Eighteen laboratories participated in an annual reciprocal sample exchange program from 2019-2022.
Conventional and next-generation sequencing (NGS) assays were covered.
Laboratory reports were centrally reviewed against consensus values and reporting standards.

Main Results:

High analytical concordance was observed (0.9% incorrect variant detection).
Post-analytical concordance was significantly lower, with discordances in 28.9-57.6% (conventional) and 33.3-100% (NGS) of reports.
Frequent discordances included missing technical information, non-standard nomenclature, and issues with variant classification/interpretation in NGS reports.

Conclusions:

Inter-laboratory concordance in molecular haematology is high analytically but shows room for improvement post-analytically.
Comprehensive EQAPs evaluating both analytical and post-analytical phases are essential.
Harmonizing reporting and supporting accurate interpretation are critical for clinical decision-making.