Quality and Accreditation

Laboratory Accreditation

The LDGA includes several disciplines with a laboratory-wide quality assurance system based on the international standard ISO 15189. The LDGA (registration number M007) has been accredited by the RvA since October 2006.

Scope M007: List of activities LDGA

Laboratory accreditation history

Molecular Genetics has been accredited by the RvA since 1998 on the basis of ISO 17025 (and including ISO 9001).

Cytogenetics received accreditation in 2000 from both the CCKL (Foundation for the promotion of quality in laboratory research and for the accreditation of healthcare laboratories) and the RvA. Both laboratories were the first to receive accreditation in their field. The CCKL accreditation was voluntarily terminated on January 1, 2008, because the CCKL, unlike the RvA, cannot provide an internationally recognized accreditation.

The Haemoglobinopathy Laboratory has been accredited by the RvA since 2006. Please see the list of accredited LDGA activities.

Quality assurance in practice within the LDGA

Quality assurance within the laboratories focuses on preventing of sample mix-ups, and on the production of reliable and reproducible results. All methods and techniques are validated and recorded.
Basic protocols have, where possible, checks built in to prevent sample interchange. The detailed description of workflows and the extensive internal training of employees are the two main pillars of diagnostics.

Cytogenetic quality assurance depends on high-quality chromosome preparations and the expert technicians who detect and recognize the potential chromosomal abnormalities.

For molecular analyses, two tubes of blood from the same patient are separately processed to yield two duplicate DNA samples, each with its own sample code. Any mutation analysis finding is confirmed in this second sample before the results are released. The inclusion of positive and negative controls and documented internal training ensures the reproducibility of the results.

In addition, the laboratory participates in several collaborative studies at the European level and the laboratory organizes collaborative studies for two common hereditary disorders.

Quality and patient care outpatient clinics Clinical Genetics