Until now , there has been no simple or reliable way to identify, for a particular diagnostic test, a laboratory with a quality system, nor conversely to determine for a given laboratory what is included in its QAu system. For example, does a laboratory participate in external quality assessment (EQA) schemes or is it accredited?
Being able to obtain this information is important:
- for consumers (patients, doctors, laboratories, etc.), to facilitate an informed choice of a laboratory partner for performing genetic tests which cannot be performed locally;
- for the general public and politicians, to educate them about the importance given to quality issues by our profession;
- for the laboratories themselves, to valorize and provide recognition of their effort and investment in quality assurance.
To respond to this need, EuroGentest has developed the European QAu database in close collaboration with Orphanet
. We believe this QAu database is an essential resource for geneticists and other health-care professionals worldwide, as well as for patients and families. The QAu data will be updated in collaboration with Orphanet.
The data is also being used (anonymously) as a research tool, to follow the development of quality assurance in European genetic services over the years.
We are aiming to create a resource that is useful to everybody involved in genetics diagnosis; consequently, we would be very pleased to receive your comments for improvements in future versions of the database. Please send your suggestions to .
The database wants to represent all laboratories offering any form of genetic testing (molecular, cytogenetic, biochemical) and will be continuously updated. If you would like to add your coordinates and data in the QAu database, please go to http://www.eurogentest.org/QAuDatabase.
The EuroGentest QAu database team
Dr Michael Morris
Dr Elisabeth Dequeker
Dr Anniek Corveleyn
Nick Nagels: Technical development and support
Lieve Desmet: administrator
Collaborators and partners
Orphanet , AEDP, BVDH, CDC, CF Network, DEKS, EMQN, EQUALIS, ERNDIM, GEDNAP, Hamburg, IEQA-ISS, INSTAND, IRTIQAS, OQUASTA, SISN, UKNEQAS, UKSH, WEQAS
National Genetics Societies of Czech Republic, Germany, Italy, Switzerland, Spain and Serbia & Montenegro
Many EuroGentest collaborators (Sarah Berwouts, Jean-Jacques Cassiman, ...)
1. Identification of potential genetic diagnostic laboratories
- Information was compiled from many sources (Orphanet, EQA providers, national databases, personal contacts) in order to create the most comprehensive possible database of contact persons (not unique laboratories) potentially working in diagnostic laboratories.
- After eliminating duplicate email addresses, the initial EUGT contact database contained approximately 2300 unique contact persons.
2. Survey development
- The Quality Assurance (QAu) survey contains two parts:
(a) laboratory coordinates and contact details, and
(b) quality management data, containing information about the quality manager, EQA participation (but not success/failure, which we regard as confidential information) and accreditation, certification, and licensing status.
- The web-based questionnaire was sent to all contacts in the database; the replies were recorded directly into a database.
3. Collection of results from the QAu survey
- The questionnaire was sent by email to approximately 2300 contacts on December 1st 2005
- The email invitation contained a specific URL that linked the respondent to the website hosting the survey. Embedded within the URL was a unique identifier to ensure security and confidentiality and that permitted tracking of responses
- After submission of the data, respondents received a confirmation email including a summary of their answers to the survey
- Laboratory information was shared with Orphanet.
4. Validation of data
- Individual laboratories were identified (by address and contact persons) and assigned a "EUGT number"
- The EUGT number assigned to a laboratory is number assigned by Orphanet to the labs in the Orphanet database and used by the EuroGentest QAu database to link the quality assurance data of the labs to their data in the Orphanet database. The aim is to use this number as a unique identifier for a lab across different databases.
- The QAu data is validated by EUGT :
(a) quality manager
(b) EQA participation and
(c) accreditation/certification
- The laboratory coordinates and contact details are checked by Orphanet
- Data is regularly exchanged between the EUGT and Orphanet databases, to ensure that labs are not contacted unnecessarily.
5. Final approval from laboratories
- After validation of the QAu data, a copy of the final validated data is sent to all participants, for verification and authorization before publishing (labs also had the possibility of participating in the survey, but requesting that their data were not made public)
- The data are released to the final QAu database and are publicly available via the EUGT website and shortly via Orphanet
- A public search engine permits the laboratories to transparently search combined data from EUGT and Orphanet, for example for particular tests, performed by labs which are accredited or participate in EQA.
6. Update of QAu data
- After release of the QAu database in July 2007, an informatics tool was developed which permits laboratories to update their data online.
- In March 2008, the QAu data already in the QAu database will be updated using the new online form. Orphanet sends out an update form for laboratory and contact data as well as data about testing activities, later in 2008.
The evaluation/validation of the QAu data is done in three parts:
- the quality managers,
- EQA participation and
- accreditation, certification and licensing.
- EUGT sent all quality managers (identified by the laboratories or from accreditation scopes) a mail and reminders if necessary, asking for a reply and a confirmation of his/her function, name and email address. The name and contact data will appear in the EuroGentest QAu database
- To validate EQA participation , EUGT compares participation data provided by the laboratory with the participant's database of the appropriate EQA provider. For some providers, the laboratories have to give formal permission to the EQA provider for reasons of confidentiality. In the cases where the providers do not cooperate, the laboratories have the option of sending us their participation certificate.
No data concerning success or failure in EQA were requested or collected by EUGT. EUGT considers participation in EQA as a positive and essential element of QAu regardless of the result, which we regard as confidential.
For logistical reasons, we do not include informal ring trials and interlaboratory exchanges.
The OECD Guidelines For Quality Assurance In Molecular Genetic Testing (2007) state that "Laboratories should make the fact that they participate in proficiency testing publicly known". The QAu database gives the labs a simple solution to this recommendation.
- Accreditation and licensing are validated according to the definitions available here . Examples of standards or other requirements for these categories included:
-
- Accreditation: international standards ISO 15189 or 17025; national standards such as CPA or CCKL.
- Licensing: agrément (France), KB 1987 (Belgium), Gentechnikgesetz (Austria).
- Accreditation is validated with the scopes from the web sites of the accreditation organizations and/or that a laboratory sends us.
The status of laboratories that are preparing for accreditation ("underway") is not validated; in the future, labs that declare this status for several years running will be asked for more precise information.
- Licensing: EUGT validates the agrément for the French laboratories according to the lists from the Ministry of Health in France (we were not able to confirm some agréments for preimplantation diagnosis).
The remaining licensing status of labs was not validated, because of the great diversity of agencies.
Find out more about the search engine for the EuroGentest European Quality Assurance Database
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