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Clinical Laboratory Geneticists

Statement from the EBMG on certifying excellence in Clinical Laboratory Geneticists

The EBMG has developed a set of standards and a curriculum for clinical laboratory geneticists undertaking analysis of genetic material. These standards reflect consensus amongst experts in this field from a wide range of European countries and apply to professionals trained in either clinical science or medicine who are working in clinical genetic laboratory settings.

To ensure patient safety, the EBMG recommends very strongly that clinical laboratory geneticists engaged in genetic testing for clinical purposes should undergo training and education (normally with a duration of 5 years) that includes all those topics in the European curriculum. In addition, they should be able to demonstrate competence in the areas defined by the EBMG standards.

The EBMG makes clear that these standards and curriculum do not fulfil the requirements for those medical professionals trained in clinical genetics and genomics, the needs of which must cover the full breadth of clinical diagnosis, familiarity with laboratory techniques, interpretation of data, and genetic counselling.

N.B.: EBMG is mainly there to check and certify your expertise as a CLG; presently we do not organize CLG education.

 

 

News / Good to know

--> The SOPs of the CLG-branch board can be found here.

--> Criteria how CLG-branch board is set up - see here

 

- EBMG is a non-profit-organization - i.e. all members of the board are not paid for the work.

- There are ~430 registered ErCLGs now: see here.

- ErCLGs (without Dutch CLG title) can authorize laboratory reports in the Netherlands.

Members of the (Er)CLG-board

Chair
Thomas Liehr - Germany - present term until 12/2026
Co-Chair
Isabel Carreira - Portugal - present term until 12/2026


Secretary
Martina Rincic - Croatia - present term until 12/2026

Members
Zsofia Balogh - France - present term until 12/2026
Zanda Daneberga - Latvia - present term until 12/2026
Malgorzata Drozniewska - Poland - present term until 12/2026
Karen Heath - Spain - present term until 12/2026
Florentia Fostira - Greece - present term until 12/2026
Amina Kozaric - Bosnia and Herzegovina - present term until 12/2026
(terms may be prolonged)

Working group - previous board members

Since 2023 there is a working group supporting the actual board of CLG branch as listed above

  • Domenico A Coviello (Italy)
  • Elena Dominguez Garrido (Spain)
  • Lina Florentin (Greece)
  • Hans Scheffer (Netherlands)
  • Aniko Ujfalusi (Hungary)

 

Their possible tasks are

-  Support the work of the corresponding 10 actual CLG-branch board members
-  Be available on request to supervise/organize in place exams of group 3 country applicants
-  Be available on request for Zoom meetings to assist oral part of exams of group 3 country applicants
-  Submit suggestions to the Board what could/should be done for our branch development
-  Support ongoing work
-  Giving advice and expertise in order to promote the international situation/recognition of CLGs
-  Serve as highly appreciated 'backup information' on things decided in the past.

 

 

Basics

In accordance with the goals of the EBMG our Professional Branch Board has opened the possibility for recognition of practitioners / non-Medical Doctors working in Human Genetics diagnostics laboratories to be recognized as European registered Clinical Laboratory Geneticists (ErCLG).

A core curriculum for the ErCLG was established in 2012 and was slightly revised in 2015 and 2022.

For the history of the Board see here.

All our actions will hopefully be EU-recognized in future based on the now approved EU Directive 2005/36/EC - policy developments  and Proposal for modernising the Professional Qualifications Directive = EU Directive 2013/55/EU. The latter was implemented on 16th January 2016. 
The request to EU has obviously to go to “Recognition Committee for Professional Qualification" from a EU memberstate national health ministry.

Interestingly there is also an OECD guideline for quality assurance in molecular genetic testing from 2007 in which following has been stated and requested - this document was approved by most if not all EU memberstates:

  • E.3    Existing  specialist  education  and  training  programmes  relevant  to  molecular genetic testing that meet recognised standards should be formally adopted by governments, regulatory and/or professional bodies.
  • E5.          Relevant  government  or  professional  authorities  should  recognise  medical  genetics  as  a  discipline  comprising  both  a  clinical  and  a  laboratory  specialty.
  • E.ii           Appropriate    specialist    qualifications,    education    and    training    standards for individuals directing molecular genetics laboratories should be established. (...) Educational   requirements   should   include   formal   training   in   molecular  genetics   and   where   available,   certification   in   the   specialty   of   clinical   laboratory molecular genetics, or another relevant discipline. 
  • E.vi    Comparison  of  specialist  education  and  training  systems  between  jurisdictions should be facilitated as a means to establish equivalence.
  • 2. These   Guidelines   offer   principles   and   best   practices   for   quality   assurance  in  molecular  genetic  testing  for  clinical  purposes.  They  are  addressed to all those involved in the regulation and provision of molecular genetic  testing.  The  Guidelines  are  intended  to  assist  both  OECD  and  non-OECD  governments  in  the  development  and  introduction  of  their  standards  for  quality  assurance  systems  and  molecular  genetic  testing  laboratory  practices.  The  Guidelines  recognise  the  existence  of  regional,  national  and  international  quality  assurance  frameworks  and  seek  to  facilitate  their  mutual recognition.
  • 24.  Principle  B2  refers  to  the  concept  of  “equivalent  recognition”.  This  should  include  assessment  of  competence  in  services  provided,  including  technical  competence  and  relevant  specialist  education  and  training;  and  also  compliance  with  relevant  legal,  professional  and  quality  management  standards. (B2)

Publications in the field

Here you can download the paper: Liehr et al. European registration process for Clinical Laboratory Geneticists in genetic healthcare. Eur J Hum Genet. 2017;25:515-519.

Here you can download the paper: Liehr T. Expert knowledge on human genetic counselling and chromosomics are necessary for sound genetic laboratory diagnostics. Mol Exp Biol Med 2017;1:1-3.

Here you can download the paper: Liehr et al. Regarding the rights and duties of Clinical Laboratory Geneticists in genetic healthcare systems; results of a survey in over 50 countries. Eur J Hum Genet. 2019; 27:1168-1174.

 

(c) European Board of Medical Genetics Contact: EBMG c/o Vienna Medical Academy, Alser Strasse 4, 1090 Vienna, Austria - office(at)ebmg.eu - T: +43 1 405 13 83 41 - F: +43 1 407 82 74