Quality assurance

CNR Toxoplasmosis

All the member laboratories of the CNR Toxoplasmosis seek quality assurance and all of them drafted their procedures according to the GBEA (French programme that has drafted Good Practices Guide for Medical Biology Analyses). Their accreditation process is currently underway according to ISO standard 15189 for molecular biology and serology.

The Coordinating Laboratory and the three Associate Laboratories are in the active phases of accreditation and have obtained quality guidelines under the responsibility of a Department Manager and a Quality Manager; they must undergo external quality evaluations, particularly for serological diagnosis of toxoplasmosis: CQN ANSM and European control (QCMD) for the molecular biological diagnosis of toxoplasmosis.

All of the CNR member laboratories participate in the national quality control for molecular biological diagnosis of toxoplasmosis (Molecular Biology Pole).

Biological Resource Centre Toxoplasma

Certification according to standard CRB NF S96900, obtained in January 2010 for the CRB Toxoplasma, associated with the CNR (Coordinating laboratory, Reims and associated Strains Pole, Limoges) was maintained in a follow-up audit in 2011.

Dr Foudrinier (PH, Reims Coordinating Laboratory) is in charge of the quality assurance for the CRB Toxoplasma that has two locations (Reims and Limoges/Strains Pole). The CRB Toxoplasma was certified on 12 January 2010 according to reference AFNOR NF 96-900 (after obtaining an ANR programme for the certification of CRBs in France obtained in 2006, I Villena). The dual locations of the Reims and Limoges bank reinforces the safety of sample preservation, reception of samples, and their placement in the cryobank, which are the object of written standard operating procedures according to AFNOR standards.

Transporting samples is ensured by an accredited carrier. This certification process was overseen by a Quality Engineer appointed by INSERM.

The CRB Toxoplasma also joined the European network of CRB (BBMRI) and benefits from the IBiSA label. With the close collaboration between the CRB Toxoplasma and the Strains Pole of the CNR Toxoplasmosis, the CRB’s quality process has a direct effect on the quality level of the CNR.