PRIORITY business intelligence

A new law reforming clinical laboratories in France was published in the official journal of the French Republic. This legislation modernises the legal framework for medical laboratories, to take into account medical and scientific innovations, which have occurred in the discipline. It provides a uniform framework for the practice of the profession, and sets out to improve the quality of service through compulsory ISO 15189 accreditation for all laboratories, no later than the end of 2016.

Some key areas covered include:

• Harmonisation of operating rules between the public and private sector.
• Encouraging inspection on the basis of reference systems.
• Setting up of a compulsory accreditation scheme for all medical laboratories with
• a deadline of 1st November 2016 to be in place and 1st November 2013 for laboratories to have made attempts to obtain accreditation.
• External quality assurance is to be in place for all tests.
• Details of inspections to be carried out and the associated disciplinary and criminal penalties.