Accreditation process in European countries - an EFLM survey

Area of Science:

• Medical Laboratory Science
• Quality Management Systems
• International Standards

Background:

• Accreditation is crucial for medical laboratories, with many European labs adopting quality systems based on ISO 15189.
• Data on the extent of laboratory accreditation across Europe remains limited.
• The European Federation of Laboratory Medicine (EFLM) Working Group surveyed the accreditation landscape.

Purpose of the Study:

• To review the current status of medical laboratory accreditation in European countries.
• To assess the adoption of ISO 15189 standards and related practices.
• To investigate the inclusion of point-of-care testing (POCT) in accreditation.

Main Methods:

• An online questionnaire was distributed to delegates of 39 EFLM scientific societies in March 2014.
• One response per country was collected, covering mandatory status, number of accredited labs, flexible scope, and medical fields.
• The survey also examined the status of point-of-care testing (POCT) accreditation.

Main Results:

• 29 responses (74% participation) were received, indicating widespread engagement in accreditation.
• All surveyed countries have initiated accreditation processes, with National Accreditation Bodies (NABs) offering or developing ISO 15189 accreditation.
• Accreditation typically covers all examination phases and various medical fields, with 69% of countries including POCT, often referencing ISO 15189 and ISO 22870.

Conclusions:

• ISO 15189 accreditation is broadly embraced across European medical laboratories, despite diverse implementation approaches.
• The adoption of a unified standard and collaborative efforts among scientific societies, EFLM, and accreditation bodies promote consistent accreditation practices.
• This cooperation facilitates the uniform implementation of laboratory accreditation concepts throughout Europe.