Meeting of the EA WG HCLMInternational activities
In the period between 2nd and 3rd December 2010 an EA WG HCLM meeting (Health Care Laboratory Medicine) was held in Paris at the premises of the French Accreditation Body (COFRAC). The meeting was attended by the representatives of the national ABs and interested parties, while the meeting was chaired by Dr Rolf Straub (SAS).
The following topics were discussed during the meeting:
- Accreditation of medical laboratories in France
Helene Mehay (COFRAC) shortly presented the accreditation programme for medical laboratories that would be implemented in France. Pursuant to this Programme, accreditation is mandatory. Implementation of this accreditation programme is very complex given that the number of medical laboratories is large (about 1,000). The accreditation programme envisages that all medical laboratories in France should be accredited by the end of 2016.
- EDMA (European Diagnostic Manufactures Association)
Establishment of the cooperation between the European Diagnostic Manufactures Association (EDMA) and European Federation of Clinical Chemistry and Laboratory Medicine (EFCC) is of special importance given that medical laboratories are end users of medical equipment, while clinicians and patients are users of test results. Until recently, it was considered that In Vitro Diagnostic Directive 98/79/EC (IVD) was related solely to manufacturers of medical equipment. Additionally, users of medical equipment did not have enough information until now about the IVD Directive and CE product marking, while on the other hand the IVD manufacturers did not have in mind the requirements of ISO 15189.
- Classification of laboratories supporting cell banks
The issue of adequacy of accreditation standards in case of laboratories supporting cell banks, e.g. for stem cells or for the needs of IVF (In Vitro Fertilization) was discussed at the meeting.
- Accreditation of laboratories performing human molecular genetics testing
In order to introduce quality system in laboratories performing human molecular genetics testing researches were conducted in the previous period to involve accreditation of laboratories performing human molecular genetics testing under the name of EUROGENTEST.
- Specific areas in medicine and accreditation
The establishment of the ECN (European cancer network) and EA project pertaining to conformity assessment in the field of breast cancer (EUABR) is in progress. The aim of the project is to build a system promoting quality in the field of breast cancer research that is based on accreditation and certification.
- Accreditation of multi site laboratories
There are different approaches to multi site laboratory accreditation procedure and those sites can be sampling and/or testing points. Accreditation can be granted only to a multi site laboratory that is a legal entity having locations with the same status. Special attention must be paid to the mode of communication (transport of samples and information) between the sample and/or test location with the central laboratory.
- EA and ILAC short news
ILAC AIC WG6 made a draft version of the guidelines for the accreditation of medical laboratories that would help ABs having less experience in this field. The aim is to promote ISO 15189.
ILAC AIC WG6 was involved in the development of ISO/DTS 25680 (Medical laboratories - calculation and expression of measurement uncertainty).
ILAC AIC WG10 prepared a draft forensic testing document that contains elements of ISO/IEC 17025 and ISO/IEC 17020.
Ljubinka Gligić PhD attended the EA WGHCLM meeting in Paris on behalf of the ATS.