Quality assurance in immunogenetics and histocompatibility: experience with EFI Accreditation |
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Authors: | G Mertens Maria Gielis Denise De Smet Gert Van Cleynenbreugel |
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Institution: | (1) Bloedtransfusiecentrum Antwerpen, Wilrijkstraat 8, 2650 Edegem, Belgium Tel.: +32-3-829 00 00 Fax: +32-3-829 01 61, BE |
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Abstract: | The European Federation for Immunogenetics (EFI) has its own standards for histocompatibility testing. Compared with EN 45001
and ISO Standards, EFI Standards are more detailed, actually stating "what to do" in the laboratory. The decision of Eurotransplant
that all its organ transplantation programmes must be EFI-accredited by the year 2000, illustrates the importance of the these
standards. It took us 11 months to prepare the EFI questionnaire, describing the main features of our laboratory and how they
complied with EFI Standards. After approval of this file, inspection was performed by a team of two peers who routinely worked
in an EFI-accredited tissue typing laboratory. The pre-analytical, analytical and post-analytical phases were inspected during
a one day visit. Furthermore, a checklist was reviewed against the laboratory's documentation system. Within 1 month of reception
of the inspection report, we were expected to send a reply listing the corrective actions taken. Upon acknowledgement of the
latter, EFI Accreditation was granted, for 1 year. We feel that detailed standards, specifically designed for a certain type
of laboratory, offer many advantages.
Received: 15 April 2000 · Accepted: 15 April 2000 |
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Keywords: | Accreditation EFI Eurotransplant Immunogenetics Histocompatibility standardization |
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