A meeting of the EA WG in the Health Care Sector Laboratory Medicine was held in Dublin, Ireland, in the period between 15th and 16th June 2011. The meeting was attended by the representatives of national accreditation bodies and technical organisations. Dr Rolf Straub (SAS) chaired the meeting.
Here are some pieces of information presented at the meeting:
• status of accreditation of medical laboratories
Early in 2011, the Spanish Accreditation Body (ENAC) conducted a research entitled “Accreditation of medical laboratories within EA” with the aim of reviewing the status of accreditation of medical laboratories in some of the countries. The research results (there were 19 countries that participated therein) showed, among other things, the following:
- in most of the countries accreditation of medical laboratories is performed solely as per ISO 15189, while in a smaller number of countries both standards are used, i.e. ISO 15189 and ISO/IEC 17025;
- number of accredited laboratories when compared with the total number of laboratories varies in different countries;
- accreditation of medical laboratories in most of the countries is not mandatory, except in France and Lithuania (in France accreditation is mandatory in case of all medical laboratories, while in Lithuania it is mandatory for those that are integral parts of hospitals);
- in some of the countries there is a legal obligation to accredit certain areas of medical examinations such as examinations performed in cell banks in Norway and Holland, paternity tests (Holland), etc.
• Accreditation of Point of Care Testing (POCT)
POCT accreditation is performed in several countries in Europe (UK, Finland, Germany, etc.). POCT accreditation guideline is being prepared and it will include questions pertaining to roles and responsibilities assumed during POCT testing (QMS, document and records control, personnel competence, equipment, quality assurance), and competence of POCT providers and other critical issues.
• Preparation of the training for technical assessors assessing medical laboratories
Preparation of the training for technical assessors is a task of the EA WG HC that is chaired by Wim Huisman (EFCC). Thus training for technical assessors will be harmonised in Europe and worldwide. Training elements were presented at the meeting:
- information about the EA guidelines pertaining to types and content of training sessions
- a need to have a defined procedure for the selection of assessors (mode of assessing expertise of assessors and their competence, participation in national professional associations in the selection of assessors) and maintenance of assessor competence
• OMCL Network Guidelines (European Directorate for the Quality of Medicines & Health Care-EDQM)
OMCL Network Guidelines (EDQM) can be useful for the validation of computer systems or equipment qualification, and they contain description of process planning, delivery and recording.
OMCL Guideline on Qualification of Automatic Titrators (Annex 5)
OMCL Guideline on Qualification of piston pipettes (Annex 6)
• In Vitro Diagnostic Medical Devices Directive- 98/79/EC
Given that medical laboratories are end users of diagnostic tools, it is necessary to draft the guideline for the assessment of IVD influence on the services provided by medical laboratories. This document will be drafted in cooperation with the EA WG Health Care and EDMA (European Diagnostic Manufactures Association).
Harmonised application of ISO /IEC 17011 in case of certification bodies performing certification as per ISO 13485 was a reason for the revision of the document entitled Application of ISO/IEC 17011 in Medical Device Quality Management Systems.
• Accreditation and conformity assessment in the field of prevention and treatment of breast cancer (Breast Cancer Units; EUABR)
Tuija Sinervo (FINAS) presented a short report on the activities performed as part of the said project.
Accreditation as per ISO 15189 and ISO/IEC 17025 will cover disease screening and diagnostic tests, while surgery, therapy, treatment and recovery will be covered by certification.
• Cooperation with EFI (European Federation for Immunogenetics)
After the Procedure for collaboration between EA and EFI 2008 has been drafted there was a need to establish the joint accreditation system of EA and EFI (European Federation of Immunogenetics).
The EFI has been performing accreditation in the field of immune genetics since 1994, and it established the cooperation with EUROTRANSPLANT (organ distribution) and JACIE (stem cell). The EFI has accredited 255 laboratories worldwide. EFI established good cooperation with accreditation bodies of Sweden and Germany.
• How to describe the scope of accreditation in case of medical laboratories
Given that the guide entitled EA-4/17 (EA Position Paper on the description of scopes of accreditation of medical laboratories) contains a recommendation on how to describe the flexible scope of accreditation in case of medical examination, current experiences from Switzerland and France were presented at the meeting.
SAS (Swiss Accreditation Service) accredits fixed, partly flexible and flexible scopes of accreditation. The scopes were harmonised with EA-2/15 (EA Requirements for the Accreditation of Flexible Scope) and EA-4/17. On the basis of assessed competence laboratories shall be allocated certain level of flexibility in terms of possible modification or introduction of new methods for the area they were accredited and it will not require the approval of an accreditation body. COFRAC (France) accredits only those with flexible scopes of accreditation.
• External quality control for EA MLA signatories
Rolf Straub reminded the EA ILC WG organises PT schemes in order to assess accredited laboratories of the EA MLA signatories. In this year an assessment in the field of microbiology was organised - HIV1 RNA quantification Scheme organised by UK NEQAS (www.ukneqas.org.uk).