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.
EFI Accreditation update!
On-site inspections for EFI accreditation are currently not being performed due to the restrictions in place because of the covid-19 pandemic. The accreditation cycle for all currently accredited laboratories has been extended with all annual renewals in 2020 now being carried out by document submission and self-inspection. Scheduled inspections will restart in 2021. The Directors of all accredited laboratories have been directly contacted with details of the new application and inspection schedule. This will ensure that all currently accredited labs are able to maintain their accreditation during this period.
Applications by new laboratories will be accepted but there will be a delay in processing these as the process of accrediting a new laboratory cannot be completed without an on-site inspection. The situation is being kept under review by the Accreditation Committee and inspections for new applicants will be scheduled when travel and other restrictions permit. Laboratories should contact Sonja Geelhoed S.H.H.Geelhoed@lumc.nl from the EFI Accreditation Office if they have any questions about a new application already in progress or if they wish to start the process of applying for accreditation.
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.