A meeting of the EA Working Group Healthcare, Laboratory Medicine, was held on 4th and 5th December in London (Sunningdale, Ascot). The United Kingdom Accreditation Service (UKAS) hosted the meeting.
The meeting was attended by the representatives of accreditation bodies from different European countries. The representatives of the interested parties joined the meting at a later stage (Clinical Pathology Accreditation and European Societies for Clinical Chemistry). The meeting was chaired by Dr Andreas Steinhorst.
After a usual introduction of the meeting participants, adoption of the agenda and the previous EA LC WG Healthcare minutes of the meeting that was held in Lisbon in July 2008, the meeting participants were informed about the conclusions from the previous meetings of the EA/LC and ILAC/AIC and ISO/TC 212/WG1.
The task of the Working Group is to harmonise the accreditation process in Europe, while problems relating to certain professional and technical aspects of accreditation of medical testing laboratories were tackled at the meeting and those can be put across succinctly in the form of the following items:
1. A need for the revision of ISO 15189 was officially confirmed. However, it is not expected that the revised document would be published soon.
2. EA LC WG Healthcare drafted the final version of the document on the description the scope of accreditation of medical laboratories entitled “Guidance for the description of scopes for medical laboratories” that was subject to all phases of discussion and decision-making process. It will be a category 3 document and therefore mandatory and it will be published as EA- 4/17. For each field of medicine to be mentioned in the scope of accreditation, a medical laboratory must ensure a full service including activities prior to testing, during testing and after testing (interpretation of results of the testing was carried out). The scope of accreditation must define fields of medical testing, whereas the definition of fields of medical testing in each of the countries will be taken into consideration. The second level of mandatory information from the scope of accreditation is the type of testing, i.e. fields of technical testing.
This guide will describe the scope of accreditation as a fixed or flexible one. In a few countries the flexible scope of accreditation was put in place in some areas of testing (e.g. UKAS).
In order to harmonise the accreditation process in the filed of clinical laboratories in Europe, and provide help to accredited bodies to implement ISO 15189 the EA Working Group Healthcare intend to produce a guide containing a harmonised stand for certain requirements and a training programme for assessors determining technical competence. The same objective led to a discussion on conformity process, laboratory equipment, testing reports, provision of testing quality, validation of microbiological methods, review of the need to validate methods requiring the use of kits, frequency of PT for certain parameters, situation in other countries as regards participation in PT schemes, etc. The conclusions of these discussions will be a part of the FAQ Section.
3. A special attention was paid to the importance of In Vitro Diagnostic Medical Devices Directive (98/79/EC) in the process of accreditation of medical laboratories. The objective of the In Vitro Diagnostic Medical Devices Directive (98/79/EC) is primarily to regulate the requirements specific to the safety of In Vitro medical devices. Transitional period was set to be from the entry into force of the EU Directive to December 2003 when no IVDs (In Vitro Medical Devices) could be placed on the market if they did not meet the requirements of this Directive. It was suggested that there was a difference between the IVDs and medical devices used solely to obtain information.
These are some of the information about the status of the documents and novelties that were tackled:
• Standards for EQAS ISO 14136 and amendments for ISO 15189 genetic testing are no longer valid.
• Standard ISO 22870 (Point-of-Care Testing/Requirements for Quality and Competence) will be reviewed and it may be used only when combined with ISO 15189. POCT parameters will be given as an Annex to accreditation certificate.
• Accreditation of reference laboratories will be carried out only when combined with ISO 15189 and ISO /IEC 17025.
• Traceability in medical laboratories is of great importance and therefore two working groups were formed JCTLM-WG1 (for reference materials and procedures) and JCTLM-WG2 (reference laboratories).
During the meeting, representatives of the accreditation bodies reported on the novelties as regards accreditation of medical laboratories in their countries.
Ljubinka Gligić, PhD, Senior Adviser with the Accreditation Board of Serbia, attended the meeting of the EA Working Group Healthcare, Laboratory Medicine, in London.