INAB provides laboratory accreditation for medical laboratories to ISO 15189 since its publication in 2003. ISO 15189 “Medical Laboratories – Requirements for Quality and Competence” is closely based on the general laboratory accreditation standard ISO 17025, but incorporates essential elements for medical laboratories, in particular focusing on patient needs and on clinical personnel needs. It addresses additional issues which include the provision of advisory services to clinicians, collection of patient samples, provision of testing in a medical emergency and the contribution of medical laboratory service to patient care.
For the medical laboratory programme INAB uses a combination of technical experts and medically qualified assessors from other EA Accreditation Bodies who have significant experience in medical laboratory accreditation. INAB has also trained a number of Irish technical experts in ISO 15189.
Legislation (SI No 360 of 2005) published in 2005 requires blood bank laboratories to operate to ISO 15189 by November 2008. These laboratories must also comply with additional requirements relating to blood traceability and haemovigilance (notification of serious adverse reactions and events).
The general accreditation process involves a documentation review of an applicant laboratory’s quality system and processes, an on-site pre-assessment visit to identify possible gaps to be addressed prior to assessment, and an on-site assessment visit with the full INAB assessment team to verify the technical competence of the laboratory and its compliance with ISO 15189 and INAB criteria. When all issues have been satisfactorily addressed a detailed report with the supporting recommendation is presented to the Board of INAB for decision on award of accreditation. Accreditation is awarded for a 5 year period and is reconfirmed through annual on-site surveillance visits.