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

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 bene...

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Autores principales:	Anne Sophie Alary, Carole Maute, Olivier Kosmider, Pierre Sujobert, Audrey Gauthier, Elizabeth Macintyre, Claude Preudhomme, Sandrine Hayette, Damien Luque-Paz, Fanny Baran-Marszak, Frederic Davi, Eric Lippert, Pascale Cornillet-Lefebvre, Marie Helene Delfau-Larue, Bruno Cassinat, Jean Michel Cayuela, Pascale Flandrin-Gresta
Formato:	article
Lenguaje:	EN
Publicado:	Wolters Kluwer 2021
Materias:	Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/b7b260158f644af0afccc9a2a97d7551
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spelling	oai:doaj.org-article:b7b260158f644af0afccc9a2a97d75512021-11-25T07:58:36ZImprovement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience2572-924110.1097/HS9.0000000000000658https://doaj.org/article/b7b260158f644af0afccc9a2a97d75512021-12-01T00:00:00Zhttp://journals.lww.com/10.1097/HS9.0000000000000658https://doaj.org/toc/2572-9241Molecular 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 (Groupe des Biologistes Moléculaires des Hémopathies Malignes). 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: BCR-ABL1, JAK2 V617F, and lymphoid clonality. For each test, particular attention was placed on comparing methodologies and their evolution throughout the period. The establishment of the BCR-ABL1, JAK2 V617F, and lymphoid clonality EEQ programs and the associated training meetings have initiated a process of collective standardization concerning the methods of implementation (JAK2 V617F) and the interpretation and formulation of results (lymphoid clonality). In addition, it resulted in objective improvement in technical performance (BCR-ABL1). 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.Anne Sophie AlaryCarole MauteOlivier KosmiderPierre SujobertAudrey GauthierElizabeth MacintyreClaude PreudhommeSandrine HayetteDamien Luque-PazFanny Baran-MarszakFrederic DaviEric LippertPascale Cornillet-LefebvreMarie Helene Delfau-LarueBruno CassinatJean Michel CayuelaPascale Flandrin-GrestaWolters KluwerarticleDiseases of the blood and blood-forming organsRC633-647.5ENHemaSphere, Vol 5, Iss 12, p e658 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Diseases of the blood and blood-forming organs RC633-647.5 Anne Sophie Alary Carole Maute Olivier Kosmider Pierre Sujobert Audrey Gauthier Elizabeth Macintyre Claude Preudhomme Sandrine Hayette Damien Luque-Paz Fanny Baran-Marszak Frederic Davi Eric Lippert Pascale Cornillet-Lefebvre Marie Helene Delfau-Larue Bruno Cassinat Jean Michel Cayuela Pascale Flandrin-Gresta Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
description	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 (Groupe des Biologistes Moléculaires des Hémopathies Malignes). 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: BCR-ABL1, JAK2 V617F, and lymphoid clonality. For each test, particular attention was placed on comparing methodologies and their evolution throughout the period. The establishment of the BCR-ABL1, JAK2 V617F, and lymphoid clonality EEQ programs and the associated training meetings have initiated a process of collective standardization concerning the methods of implementation (JAK2 V617F) and the interpretation and formulation of results (lymphoid clonality). In addition, it resulted in objective improvement in technical performance (BCR-ABL1). 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.
format	article
author	Anne Sophie Alary Carole Maute Olivier Kosmider Pierre Sujobert Audrey Gauthier Elizabeth Macintyre Claude Preudhomme Sandrine Hayette Damien Luque-Paz Fanny Baran-Marszak Frederic Davi Eric Lippert Pascale Cornillet-Lefebvre Marie Helene Delfau-Larue Bruno Cassinat Jean Michel Cayuela Pascale Flandrin-Gresta
author_facet	Anne Sophie Alary Carole Maute Olivier Kosmider Pierre Sujobert Audrey Gauthier Elizabeth Macintyre Claude Preudhomme Sandrine Hayette Damien Luque-Paz Fanny Baran-Marszak Frederic Davi Eric Lippert Pascale Cornillet-Lefebvre Marie Helene Delfau-Larue Bruno Cassinat Jean Michel Cayuela Pascale Flandrin-Gresta
author_sort	Anne Sophie Alary
title	Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
title_short	Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
title_full	Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
title_fullStr	Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
title_full_unstemmed	Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience
title_sort	improvement of standardization of molecular analyses in hematology: the 10-year gbmhm french experience
publisher	Wolters Kluwer
publishDate	2021
url	https://doaj.org/article/b7b260158f644af0afccc9a2a97d7551
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Improvement of Standardization of Molecular Analyses in Hematology: The 10-year GBMHM French Experience

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