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 there to check and certify your expertise as a CLG; we do not organize CLG education.
Members
Chair
Thomas Liehr - Germany - present term until 12/2022
Co-Chair
Isabel Carreira - Portugal - present term until 12/2022
Secretary
Martina Rincic - Croatia - present term until 12/2022
Members
Zsofia Balogh - France - present term until 12/2022
Domenico Coviello - Italy - present term until 12/2022
Zanda Daneberga - Latvia - present term until 12/2022
Lina Florentin - Greece - present term until 12/2022
Elena Dominguez Garrido - Spain - present term until 12/2022
Anikó Ujfalusi - Hungary - present term until 12/2022
Irmgard Verdorfer - Austria - present term until 12/2022
(terms may be prolonged)
N.B. EBMG is a non-profit-organization - i.e. all members of the board are not paid for the work done in connection with the EBMG and ErCLG certification.
There are >400 registered ErCLGs now!
Latest news: ErCLGs (without Dutch CLG title) can now authorize laboratory reports in the Netherlands - link.
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.
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)
Download
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.
When to apply?
Submissions are accepted only between July 15th and October 15th each year.
Submission procedure is explained here.
Subtypes of ErCLG already?
During the application procedure, applicants may request one of the five different subtypes of ErCLG titles:
- European registered Clinical Laboratory Geneticists (general)
- European registered Clinical Laboratory Geneticists (focus on Clinical Genetics)
- European registered Clinical Laboratory Geneticists (focus on Molecular Genetics)
- European registered Clinical Laboratory Geneticists (focus on Biochemical Genetics)
- European registered Clinical Laboratory Geneticists (focus on Tumorgenetics)
However, the Board reserves the right to make the final decision in agreement with the applicant, which ErCLG certificate is finally issued.
Explanations for these subtypes:
Core competence for all subtypes of ErCLG titles:
- understanding and interpretation of basic mechanisms in human genetics
- knowledge of patterns and modes of inheritance
- basic knowledge on metabolic disorders
- knowledge of common international nomenclature systems
- completely independent in use of basic as well as modern cytogenetic and molecular cytogenetic techniques to provide a best possible diagnostic results in their own work field
- knowledge of medical ethical issues in diagnostics and research
- basic knowledge about prenatal genetic tests including risks and limitations
There is no difference between the 5 ErCLG titles in terms of one being more valuable/ above the other. They just shall help to show exactly in which fields the holder of the title has core competences. In case e.g. an “ErCLG with focus on Tumorgenetics” changed during the last 3 years field and does now only pre- and postnatal diagnostics he/ she may go either for “ErCLG focus on Clinical Genetics”.
- European registered Clinical Laboratory Geneticists (general)
This title confirms expertise in cytogenetics and molecular genetics (i.e. prenatal, postnatal and molecular genetics, or tumorcytogenetics and molecular genetics in oncology; knowledge on Biochemical Genetics is optional). Title confirms to have knowledge of how to organize/establish and lead a cytogenetic and molecular genetic laboratory.
- European registered Clinical Laboratory Geneticists (focus on Clinical Genetics)
This title confirms expertise in cytogenetics and/or molecular genetics in prenatal and or postnatal settings. Title confirms to have knowledge of how to organize/establish and lead a cytogenetic and molecular (cytogenetic) laboratory.
- European registered Clinical Laboratory Geneticists (focus on Molecular Genetics)
This title confirms expertise in molecular genetics in prenatal and/or postnatal diagnostics; tumorgenetics may be included. Title confirms to have knowledge of how to organize/establish and lead a molecular genetic laboratory. Bioinformaticians with sufficient background knowledge as outlines in the core curriculum may go for this title, as well.
- European registered Clinical Laboratory Geneticists (focus on Biochemical Genetics)
This title confirms expertise in biochemical genetics as applied e.g. in metabolic disorders or mitochondriopathies. Title confirms to have knowledge of how to organize/establish and lead a laboratory specialized in biochemical genetics.
- European registered Clinical Laboratory Geneticists (focus on Tumorgenetics)
This title confirms expertise in cytogenetics and/or molecular genetics in oncological field. Title confirms to have knowledge of how to organize/establish and lead a cytogenetic and molecular (cytogenetic) laboratory.
How to apply?
The prerequisites for registration are based on the core curriculum for the ErCLG. As every country has different national education schemes the latter were aligned with nation-specific representatives (link).
According to that European and non-European countries were divided into 3 groups.
Group 1: countries with national CLG education scheme which is in accordance with the core curriculum for the ErCLG.
Group 2: countries with national CLG education scheme which is not in (complete) accordance with the core curriculum for the ErCLG. .
Group 3: countries without national CLG education scheme at all.
To check if the country where you come from and/or hold a national CLG certificate can be found here.
In case your country is not listed yet, please contact Dr. Thomas Liehr Thomas.Liehr(at)med.uni-jena.de to learn how to proceed further. In principle practitioners / non-Medical Doctors working in Human Genetics diagnostics laboratories worldwide may apply for the ErCLG title.
Since 2016/2017 round we accept also applicants worldwide. Such applicants being eligible for the ErCLG title but not working in Europe can obtain the title 'affiliated ErCLG'.
Since 2017/2018 round we also accept applicantions of MDs which exclusively lead a clinical laboratory and see no patients from group 1, 2 and 3 countries, following application way of group 3-country-applicants. Also we now accept applications of Non-MDs from group 1 and group 2 countries, who have no chance to obtain the corresponding national title. However, each such applicant has a) to outline why it is never possible to obtain the national title and b) follow rules of group 3-country-applicants.
Who holds an ErCLG already?
All actual holders of a ErCLG-certificate can be found here.