First Open Genetic Testing Accreditation Workshop Proves A Major Success - Parti

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First Open Genetic Testing Accreditation Workshop Proves A Major

Success - Participants From Across Europe Welcome Initiative

http://www.medicalnewstoday.com/medicalnews.php?newsid=57786

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 Prof

Els Dequeker from Leuven, Dr from Geneva, Management

Cousulting 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 12th-

13th April 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

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

5 million.

They explained their reasons for attending:

" The laboratory achieved accreditation with Clinical Pathology

Accreditation (UK) Ltd 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,

amongst 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 center 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 realized 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 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. "

EuroGentest is an EU-funded project (10 million Euro for 5 years)

that aims to establish an NoE (Network of Excellence) in genetic

testing. Started in January 2005 the project is coordinated by

Professor Jean-Jacques Cassiman, an acknowledge world expert in CF

testing who holds the Arthur Bax and Vanluffelen chair of Human

Genetics at the Center for Human Genetics in Leuven, Belgium. The

project is divided into 6 units each with a number of working

parties.

http://www.eurogentest.org

Facts and figures

-- 1,000 testing centres in Europe

-- Over 1,000 conditions tested

-- 100% - 300% Annual growth in testing

-- Number of people in the EU suffering from genetic disease > 30

million

-- Cost to EU health sector - EUROS 500 million

University of Leuven - Campus UZ Gasthuisberg

Center for Human Genetics

Herestraat 49 - Box 602

3000 Leuven, Belgium

http://www.med.kuleuven.ac.be