A meeting of the EA WG in the Health Care Sector Laboratory Medicine was held in Oslo (Norway) in the period between 29th and 30th November 2011.
The meeting was attended by the representatives of accreditation bodies from a large number of countries and representatives of professional organisations and interested parties. Rolf Straub (SAS) chaired the meeting.
The following items were discussed at the meeting:
Anne Graendsen (NORSK) presented the procedure used in case of the accreditation of medical laboratories in Norway. Accreditation of medical laboratories is voluntary in Norway, and it is performed as per ISO 15189 and ISO/IEC 17025 (mainly in case of forensic laboratories). About 50 % of medical laboratories have flexible scopes.
- Research as regards the estimate of uncertainty of measurement in medical laboratories (FINAS, Tuija Sinervo)
Results of the research pertaining to the mode of estimate and use of uncertainty of measurement showed that most of the laboratories estimated the uncertainty of measurement on the basis of the results of the internal quality control, while two laboratories estimated the uncertainty of measurement as per GUM JCGM 100:2008. The results are not usually presented with the uncertainty of measurement.
- Application of IVD and MD directives in medical laboratories
In 2011, the mandatory document governing medical matters entitled “IAF Mandatory Document for the Application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO 13485)” was published, while its application would commence on 15th July 2012. This document specifies the requirements for accreditation bodies assessing and accrediting conformity assessment bodies performing certification activities in line with ISO 13485, and other requirements laid down in ISO/IEC 17011.
- Status of documents of importance to accreditation of medical laboratories:
After ISO 15189 has been revised, it will be recommended to distribute the new version of ISO 15189 (Medical laboratories-Particular requirements for quality and competence) to ISO members to vote on it.
Revision of ISO 15195 (Laboratory medicine - Requirements for reference measurement laboratories) is on-going and it aims at incorporate certain requirements of ISO/IEC 17025 therein.
The Guide for the Implementation of Uncertainty of Measurement in Routine Medical Laboratories is being prepared.
The document pertaining to supply and transfer of samples “Procurement and transfer of specimens” is currently in preparation.
- Cooperation with the EA (European co-operation for Accreditation) /EFI (European Federation for Immunogenetics)
Given the intent to cooperate in the process of accreditation performed by EFI and EA (on the basis of the Procedure for collaboration between EA and EFI 2008), Andrea Harmer, Chair of the EFI Accreditation Committee, presented the accreditation programme performed by this organisation in the field of immunogenetics.
EFI has been performing accreditation in the field of immunogenetics since 1994, and it established cooperation with EUROTRANSPLANT (organ distribution) and JACIE (stem cell transplantation)
The main objectives of the EFI are as follows:
- assistance in developing immunogenetics which includes transplantation of organs and chematopoetic stem cells;
- establishment of the accreditation criteria, standardisation of techniques and quality control.
The new Directive 2010/45/EU governs the introduction of quality and safety standards when dealing with human organs to be transplanted. The risk is related to the characterisation of organs and cells of donors and recipients, and to transmissive diseases.
- Accreditation of multi-site medical laboratories.
The procedure used in case of the accreditation of multi-site medical laboratories in Switzerland (Simon Herren) and in Finland (Tuija Sinervo) was presented at the meeting.
The procedures of the said countries share the following elements:
-all units belonging to a laboratory are part of the uniform quality management system,
-all criteria defined at the central laboratory level are used by the laboratories at different locations.
Ljubinka Gligić PhD attended the meeting of the EA WG in the Health Care Laboratory Medicine on behalf of the Accreditation Body of Serbia.