Ms Marie Culliton:

In terms of standards, in 2004, 2005 and 2006, there was no agreed or funded accreditation of medical testing laboratories in Ireland. There was some funding and a requirement for accreditation of food laboratories but not for clinical diagnostic laboratories. Many of the Irish laboratories undertook, of their own volition, to be accredited using the clinical pathology accreditation from the UK. That was a set of standards, which looked, as all laboratory accreditation does, at the pre-analytical variables, the analytical part, which is what happens in the laboratory, and the post-analytical parts.

In 2005, on foot of the EU blood directive, there was a statutory instrument looking for blood transfusion laboratories to be accredited to the ISO 15189 standard, which is the international standard for medical testing laboratories. That was mandated for blood transfusion laboratories and that was to be achieved by November 2008. Specific funding was made available in terms of staffing and allocation of resources for the accreditation of blood transfusion laboratories but those alone. At that time the Irish National Accreditation Board, INAB, which provides accreditation to the ISO 15189 standards, was not resourced or scoped up to accredit all the laboratories in Ireland and it was working towards the blood transfusion laboratories. At the same time there was a European co-operation for accreditation, EA, regulation in Europe which provided that accreditation services were not a matter for competition and must be provided by the national accreditation agency.

That stalled the accreditation process for Irish laboratories, as many people who had been preparing to go with the UK CPA accreditation had to realign themselves with the ISO 15189 standard, given that the CPA was, after a certain time, no longer allowed to provide accreditation services in Ireland.

Although the laboratories were not accredited, they were all working in a quality management system and most - the cytology laboratories certainly had - had applied for accreditation in anticipation of this tender. It was similar to the situation with hospital accreditation, where people were working to a standard and self-assessing but had not been inspected by the hospital accreditation system.