Meeting Report on the WG in the Health Care Sector Laboratory Medicine

International activities

In the period between 4th and 5th December 2012 a meeting of the EA WG in the Health Care Sector Laboratory Medicine was held in Zagreb (Croatia). The meeting was organised and chaired by Rolf Straub (SAS).

Biserka Bajzek Brezak MSc, Director of the Croatian Accreditation Agency (HAA), welcomed the members of the Working Group when she pointed to the situation with accreditation of medical laboratories in Croatia.

Members of the working group presented the following:

a)    system of accreditation of medical laboratories in Croatia was presented (Dragica Križanec, HAA),

b)    accreditation of Clinical Pathology Accreditation (CPA) is in the process of transition to  accreditation to ISO 15189 by UKAS. UKAS developed the accreditation scheme for PT providers in the field of physiological diagnostics.

One of the news related to the merging of EC4 and EFCC into EFLM (European Federation of Clinical Chemistry and Laboratory Medicine). This organisation is responsible for the quality and regulations, standards, accreditation and IVD (In Vitro Medical Devices) directive. Working Group for the IVD directive is currently working on the implementation of the new regulations.

Furthermore, a collaboration between EA and Joint Research Centre - Institute for Health and Consumer Protection (JRC-IHCP) was established to develop EA / ECN project related to the EU programme for the establishment of an accreditation Breast Cancer Services (BCSS) scheme. These two organisations are harmonising the approach to BCU accreditation/certification.

Cooperation with the European Federation for Immunogenetics (EFI) has been established, whereas EFI basic objectives are as follows:

- assistance in developing immunogenetics includes organ transplantation and haematopoietic stem cells;

- establishment of criteria for accreditation, standardization techniques, quality control.

Standardization in the field of immunogenetics is necessary given that this is a high level risk field of medicine, while transplantation is carried out at international level. New Directive No 2010/45/EU lays down implementation of standards of quality and safety when handling human organs needed for transplantation. The risk is related to the characterisation of organs and cells of donors and recipients, as well as to transmissive diseases.

The Accreditation Committee has a number of following tasks: development of strategy and policy, review and update of documents, delivery of training, and maintenance of competence of inspectors, development and application of standards.

Brief information about the EA and IAF/ILAC meeting conclusions pertaining to the field of laboratory medicine

The General Assembly agreed to:
- support the project “closer relationship between the Russian Federation and the European Union accreditation’s systems”;
- continue developing the project for the accreditation of European Breast Cancer Services Accreditation;
- accreditation of reference material producers (RMP) will be carried out only as per ISO Guide 34:2009;
- a closer cooperation with the EDQM (European Directorate for the Quality of Medicines;
- WADA published the new technical documentation relating to the boundaries of measurement uncertainty.

New edition of ISO 15189:2012 (Laboratory medicine - Requirements for reference measurement laboratories) was published on 5th November 2012. The transition period for the new edition of ISO 15189:2012 must end by 1st March 2016.

 A new working group was established as part of the WG EA in the HC Sector Laboratory Medicine to determine the differences between the previous and new edition.
The following ILAC published documents are of importance to this field:

- ILAC-G26:07/2012 Guidance for the Implementation of a Medical Laboratory Accreditation System using ISO 15189;
- Brochure  ISO 15189 Medical Laboratory Accreditation.

Working Group EA WGHC presented the draft guideline POCT - Guidance document that pointed out different aspects of POCT testing and facilitated the conclusion making process based on standards.

W. Huisman, stakeholder representative, presented the preliminary results of a research conducted using the Questionnaire for Training and Qualification of Lead and Technical Assessors.