The first workshop providing practical hands on advice about how to successfully gain and maintain accreditation and open to all genetic testing laboratories was held recently in Leuven
Both the demand for genetic testing and the number of laboratories involved continues to grow in the enlarged EU.
To ensure patients maintain confidence in the service and results being provided, EuroGentest, an EU-funded network of excellence, is promoting the increased uptake and harmonisation of quality management schemes across Europe through a range of activities, including expert workshops.
The first providing practical hands on advice about how to successfully gain and maintain accreditation and open to all genetic testing laboratories was held recently in Leuven.
Organised by Els Dequeker from Leuven, Michael Morris from Geneva, Management Consulting and Research (MCR), a spin-off from the Catholic University of Leuven and the Unit 1 team, the workshop featured expert-led interactive sessions in small groups.
Discussions covered every aspect on quality management and accreditation: ISO and related national standards, document management, non-conformities, auditing, training and IT support.
Both organisers and most importantly participants judged the workshop a great success and a second workshop will be held 12-13 April 2007 in Athens.
Participants included lab directors, scientists, technicians and quality managers from both already accredited and non-accredited laboratories across Europe.
Typical of accredited participants were Victoria Aldridge and Tony Young from the Regional Molecular Genetics Laboratory in London's famous Great Ormond Street Hospital which along with Clinical Genetics and Cytogenetics, forms a strategic genetics unit and also constitutes the North East Thames regional genetics service that serves a population of approximately five million.
They explained their reasons for attending: "The laboratory achieved accreditation with Clinical Pathology Accreditation (UK) in July 2003 and we are currently working towards accreditation review later next year.
"Accreditation status has become an important part of any laboratory within the UK, particularly in reference to receiving samples from other centres as part of the UK genetic testing network.
"We found the workshop very enjoyable and worthwhile.
"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, among other things, laboratory practice and reporting procedures.
"We would definitely recommend the workshop, particularly to laboratories that are yet to start the accreditation process, as a lot of useful and pragmatic information could be gained before undertaking such a process.
"Additionally, although we have been accredited for a few years ourselves we still gained knowledge and some useful ideas on how we could improve our current system".
Kadri Raudsepp from Tartu University Clinics, a leading centre for hospitals in Estonia, represented the non-accredited sector: "I am responsible for one small lab in the department of immunoanalyses, called simply the PCR lab, since we are dealing with many different analyses: qualitative and quantitative analyses of HIV, hepatitis viruses, CMV, EBV; HLA typing; leukemic chromosomal translocations etc.
"As to the question why accredit at all, I would answer perhaps to be competitive in the market, but first of all to ensure yourself that everything is working properly and our results are credible.
"Many of our departments are already accredited, in our department some groups of tests have been accredited.
"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 typing we have to apply accreditation from EFI, because our clinic is collaborating with Nordic Stem Cell Bank and they do not accept our HLA results without EFI accreditation.
"I enjoyed the workshop very much, because I have dealt with quality management for a very short time and during the workshop I received a general overview of it, which I did not have before.
"When we started our quality system I (and technicians even more) were quite resistant against it, because it just seemed to be boring paperwork and we felt that it impedes our everyday work.
"Nobody gave us the whole picture or explained to us the aim and purpose of the process.
"In the workshop we also worked through all the stages of implementing QSM and I got a lot of advice and hints.
"I also got valuable information about software systems for quality management.
"I will definitely recommend the EuroGentest workshops to others.
"First I thought that those labs, who are still moving towards accreditation gained more, but later I realised that there is still much to improve and develop for those labs, who have already been accredited for a long time.
"I was surprised that so many lab managers seemed to be afraid of computers and new software.
"Estonians are very keen on computers - most of the public services are available via the internet and we always want the most up-to-date instruments".
Professor Els Dequeker and Dr Michael Morris were both satisfied with the workshop: "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."
