Training on accreditation of medical laboratories for POCT (Point-of-care-testing)

Particular relevant in the context of the Covid-19 pandemic, a 2-day virtual training focusing on accreditation of medical laboratories for POCT (Point-of-care-testing) was held on 12-13 November 2020.

The training was provided by 2 experts, Aliki Stathopoulou and Ioannis Sitaras from the Hellenic Accreditation System and was moderated by Rózsa Ring. This area of accreditation, particularly relevant in the context of the COVID-19 pandemic, is new for the accreditation bodies of the SEE region. None of them has yet received application for accreditation for POCT. Therefore, it was especially important for them to have a training for their personnel (e.g. internal staff, technical committee members, technical assessors and experts) to be involved in accreditation in this area. 

During the training, the detailed requirements of the relevant international standards (ISO 15189 and ISO 22870) and the guideline of the European co-operation for Accreditation (EA-4/20) have been presented. Several case studies made the requirements more understandable and the Greek experiences were shared. The trainers, having been involved in the technical work of EA in the field of medical laboratories, provided information on the latest developments at European level. The participants could also learn about the main areas where POCT are usually applied. In addition, a specific session was reserved for POCT applied for SARS-CoV-2 diagnostics.

31 participants from the SEE accreditation bodies attended the virtual training. The staff members of the national accreditation bodies raised several questions related to the training and competence of the assessment teams, to the assessment against specific requirements (e.g. information management, external quality assurance) and to selection of witnessing. The external experts of the national accreditation bodies, mainly representing medical institutions/laboratories, presented their challenges related to the organisation/structure and responsibilities for POCT, staff training, internal quality control and external quality assurance, information management and connectivity. There was a fruitful discussion on the tests currently used for SARS-CoV-2 diagnostics in the SEE counties and Greece.

The feedback of the participants to this virtual training was positive, they found the virtual training very informative and useful for supporting the national accreditation bodies to establish or to extend their accreditation services for POCT.