With the recent rapid increase of innovation in genetic testing and a boom in for-sale services, particularly through the Internet, European Union policy makers have agreed upon a need for an established regime of standards and practices across the continent. To ensure that Europeans remain well informed of the growing market and to facilitate the development of a pan-European standard for genetic testing, the EU has funded the Network of Excellence (NoE) EuroGentest. EuroGentest held its first expert workshop recently in Leuven, Belgium. The workshop, considered a success by both organisers and participants, focused on quality management and accreditation for European genetic testing laboratories.
The recent expert workshop was organised by Prof Els Dequeker
from Leuven; Dr Michael Morris from Geneva, Management Consulting
and Research (MCR), a spin-off of the Catholic University of
Leuven and the Unit 1 team of the project. Through small group
sessions, it focused on ISO and related national standards,
document management, non-conformities, auditing, training and
aims to harmonise disparate testing standards.
Participants included lab directors, scientists, technicians and quality managers from accredited and non-accredited laboratories across Europe.
Victoria Aldridge, a researcher from the Regional Molecular
Genetics Laboratory in London noted that even though her organisation
is already accredited the workshops were beneficial because
they allowed her the opportunity to learn from others'
experiences, in addition to serving as a good networking opportunity.
“Although we had a good idea of the elements of a quality
system, the workshop highlighted areas in which we could improve
and gave a good overview of all aspects of Quality Management,
not just document control. We found the group discussion sessions
very worthwhile and it was interesting to hear other peoples'
views on, amongst other things, laboratory practice and reporting
procedures,” she said.
Kadri Raudsepp from Tartu University Clinics, a leading centre for hospitals in Estonia, represented the non-accredited portion of the sector and discussed the importance of accreditation for her laboratory.
“My lab started quite recently implementing a quality
system. Perhaps next year we are going to apply accreditation
from the Estonian Accreditation Board for our laboratory as
a whole, but for HLA (human leukocyte antigen) typing we have
to apply accreditation from the European Federation for Immunogenetics
(EFI) because our clinic is collaborating with Nordic Stem Cell
Bank and they do not accept our HLA results without EFI accreditation.”
Due in part to the successes of the recent workshop in Leuven, a second expert workshop is planned for Athens in April 2007.
"We were delighted with the enthusiasm of the participants and the way in which they took on board the quality message. We now look forward to Athens and the next workshops," said Prof. Dequeker, co-organiser of the Leuven event.