The European Federation for Immunogenetics (EFI) awards the EFI certificate to laboratories that meet the quality requirements set by EFI (Standards). EFI is a European organisation that focuses on immunogenetics, tissue typing and transplantation. The EFI certificate is required by a number of organisations operating in the field of stem cell and solid organ transplantation including JACIE, NMDP and the Eurotransplant foundation.
The EFI Accreditation Programme provides an internationally recognised accreditation scheme for laboratories providing Histocompatibility & Immunogenetics (H&I) testing services in support of solid organ and haematopoietic stem cell transplantation, blood transfusion, disease diagnosis and drug hypersensitivity reactions.
The Accreditation Committee (AC) is responsible for achieving the Accreditation programme's mission and goals and is in charge of its administration:The AC takes decisions relating to accreditation, including the granting, maintaining, extending, reducing, suspending and withdrawing of accreditation. It develops policies and supervises the implement and procedures related to the accreditation of H&I laboratories. Takes and reviews decisions on accreditation and works together with other accrediation bodies. It meets at least twice a year to evaluate the accreditation programme, disucss cases, review the programme's policies and take decisions relevant for the accreditation programme. Click here to read more about the Accrediation Committee.
For the EFI certificate, requirements apply in different categories:
- qualification of staff: including level of education of director, technical manager and quality manager;
- quality assurance: including available facilities and manuals for all laboratory procedures;
- techniques and test protocols with regard to organ and tissue transplants: such as the terminology, instruments and techniques used;
- specific requirements for kidney and / or pancreas transplants, transplants from other organs and blood stem cell transplants and blood transfusion.
In the HLA Journal an article 'Accreditation of histocompatibility and immunogenetics laboratories: Achievements and future prospects from the European Federation for Immunogenetics Accreditation Programme' by Harmer et al was published, the reference of the article is HLA. 2018;92:67–73. All EFI Members have access to the article through the link on the EFI Homepage.
In order to ensure that individual laboratories are not adversely impacted by the choice of inspectors performing their inspection it was agreed that a flat fee should be introduced so that every laboratory pays the same amount to cover the costs of their accreditation inspections. Click here to read the letter about the new annual accrediation fee.
For the current EFI Standards we kindly refer to the Standards Committee page.
Continuously, EFI evaluates what standards should be applicable to laboratories performing tests in Histocompatibility and Immunogenetics. Remarks on standards arise most frequently during inspections or on completing application packets. If you feel that any of the EFI standards need a change, complete the post inspection questionnaire form that will be evaluated by the EFI Standards Committee.
Part of the ongoing education of an EFI Inspector is to take part in an Inspectors’ Workshop at least once every two years. These workshops will preferably take place in the context of the annual EFI meetings.
A new EFI Inspector will be invited to attend a dedicated Inspector’s Training Day before performing his/her first inspection as a Trainee together with two regular Inspectors. The Trainee has to be familiar with the EFI standards and inspection forms.