As its name indicates, the Healthcare division is responsible, within Cofrac, for the accreditation of everything related to health and the medical sector, and in particular biomedical laboratories.
At the end of 2020, 755 entities were accredited.
- 451 assessments carried out in 2020
- 46 employees
Our Healthcare division is the most recent division of Cofrac. It was created in 2009 to fulfil the requirement to accredit all biomedical laboratories in France. Since then, our Healthcare division has also accredited forensic biology laboratories and anatomy and cytopathology (ACP) structures.
The division has four units:
- the Support & Assessors unit
- the three accreditation units : East, West and Paris area & Island territories. See the distribution of the biomedical laboratories and anatomy and cytopathology testing structures on a map.
What are the specific characteristics of laboratory accreditations ?
Our Healthcare division covers all examination activities carried out by biochemistry, genetics, haematology, immunology, reproductive biology and microbiology laboratories.
Biomedical laboratories are subject to standard ISO 15189, recognised as a standard of excellency worldwide. It is complemented by standard ISO 22870 for point-of-care testing. In accordance with the international regulations, the accreditation of biomedical laboratories is founded on a peer assessment of practices, with the support of quality assessors. Its objective is to guarantee the reliability of the examinations and the quality of the services offered by the laboratories, in the interests of patients.
Forensic biology laboratories.
Unlike biomedical laboratories, you are not required to have your activities accredited. However, accreditation is vital for guaranteeing the competence and reliability of the examinations you carry out in the framework of criminal procedures (genetic analyses for human identification, etc.) or civil procedures (paternity, maternity tests, etc.). Its scope covers biology-biochemistry, molecular genetics, toxicology, human doping tests, hematocytology and forensic entomology. The applicable standard is ISO/IEC 17025.
Other areas and prospects for development
Our Healthcare division at Cofrac also handles the accreditation (non-mandatory) of your anatomy and cytopathology (ACP) and human biology structures. Its field of action may be extended in time to new technical medical procedures such as medical imaging.
Reform of accreditation for biomedical laboratories
Since the medical analysis activity has such a major impact on public health, the French Public Healthcare Code (article L 6221-1) made accreditation of biomedical laboratories mandatory in 2009. This reform concerns both private and hospital biomedical labs.
31 December 2017 was the first deadline. By this date, biomedical laboratories had to fulfil two criteria: being accredited for each of the three families of examinations practised (biochemistry-genetics, immunology-haematology-reproductive biology, microbiology) and for at least 50% of their activity. The next deadline will cover all of the biomedical activity carried out by the LBM in accordance with the terms specified by the order of July 16, 2020 defining the framework for the accreditation mentioned in article L. 6221-1 of the Public Healthcare Code. LBMs now have until May 1, 2021 to submit an accreditation request to cover all of their skills (all scope lines corresponding to the examinations carried out).