Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.
Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.
Laboratoire d'hématologie, Hôpital Nord, CHU Saint-Étienne, Saint-Étienne, France.
Pascale
P
Flandrin-Gresta
Laboratoire d'hématologie, Reims, France.
Pascale
P
Cornillet
Laboratoire d'hématologie, Lyon, France.
Sandrine
S
Hayette
Laboratoire d'hématologie, Limoges, France.
Nathalie
N
Gachard
Laboratoire d'hématologie, Montpellier, France.
Sylvie
S
Tondeur
Laboratoire d'hématologie, Paris, France.
Carole
C
Mauté
Laboratoire d'hématologie, Paris, France.
Jean-Michel
JM
Cayuela
D000068:Accreditation / Q000592:standards*; D005602:France; D019337:Hematologic Neoplasms / Q000473:pathology*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D059232:Laboratory Personnel / Q000193:education / Q000592:standards; D008967:Molecular Biology / Q000592:standards*; D011785:Quality Assurance, Health Care; D011786:Quality Control; D015203:Reproducibility of Results
accreditation; hematological malignancy; molecular biology