Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience.

Fiche publication


Date publication

décembre 2021

Journal

HemaSphere

Auteurs

Membres identifiés du Cancéropôle Est :
Dr CORNILLET-LEFEBVRE Pascale


Tous les auteurs :
Alary AS, Maute C, Kosmider O, Sujobert P, Gauthier A, Macintyre E, Preudhomme C, Hayette S, Luque-Paz D, Baran-Marszak F, Davi F, Lippert E, Cornillet-Lefebvre P, Delfau-Larue MH, Cassinat B, Cayuela JM, Flandrin-Gresta P

Résumé

Molecular tests have become an indispensable tool for the diagnosis and prognosis of hematological malignancies and are subject to accreditation according to the International Standard ISO 15189. National standardization of these techniques is essential to ensure that patients throughout France benefit from the same care. We report here on the experience of the GBMHM (). By organizing External Evaluation of Quality (EEQ) programs and training meetings, the GBMHM has contributed to improvement and standardization of molecular tests in 64 French laboratories. A retrospective analysis of the quality-control results of 11 national campaigns spanning 10 years was performed for the 3 most frequently prescribed tests: , V617F, and lymphoid clonality. For each test, particular attention was placed on comparing methodologies and their evolution throughout the period. The establishment of the , V617F, and lymphoid clonality EEQ programs and the associated training meetings have initiated a process of collective standardization concerning the methods of implementation ( V617F) and the interpretation and formulation of results (lymphoid clonality). In addition, it resulted in objective improvement in technical performance (). Our evaluation of the impact of these EEQ programs demonstrates that it is possible to obtain reproducible values across different laboratories in France by applying national recommendations. To our knowledge, this is the first publication that evaluates the impact of a national quality assurance program on improving molecular results in hematology.

Référence

Hemasphere. 2021 Dec;5(12):e658