EURO­GTP Euro GTP Guidance European Union Project in the framework of the Public Health Program Agreement number: 2007 207 Coordinator: Transplant Services Foundation 1 List of Authors ‐ Euro GTP Project Coordinator TSF ▪ Transplant Services Foundation | Spain Project Partners BISLIFE | Netherlands BTV ▪ Banca Tessuti della Regione Veneto | Italy CBC ▪ Hornhautbank Berlin Charite Universitatsmedizin | Germany EHB ▪ European Homograft Bank | Belgium ESB ▪ Euro Skin Bank | Netherlands HBM ▪ Hornhautbank München Gemeinnutzige | Germany ISS‐CNT ▪ Istituto Superiore di Sanita Centro Nazionale Trapianti | Italy KCBTiK ▪ Krajowe Centrum Bankowania Tkanek I Komórek | Poland QAMH ▪ Queen Astrid Military Hospital | Belgium REGEA ▪ Tampere Yliopisto. University of Tampere | Finland i Table of Contents PURPOSE AND SCOPE ................................................................................................................................................1 SECTION A: GENERAL REQUIREMENTS .......................................................................................................................3 A.1. PERSONNEL ............................................................................................................................................................... 3 A.2. FACILITIES AND EQUIPMENT ..................................................................................................................................... 8 A.2.1. FACILITIES, EQUIPMENT AND MATERIALS FOR RECOVERY................................................................................ 8 A.2.1.1. Facilities .........................................................................................................................................................................8 A.2.1.1.1. General...................................................................................................................................................................8 A.2.1.1.2. Operating room......................................................................................................................................................8 A.2.1.1.3. Unusual place of recovery......................................................................................................................................9 A.2.1.1.4. Ancillary areas........................................................................................................................................................9 A.2.1.2. Equipment......................................................................................................................................................................9 A.2.1.3. Materials......................................................................................................................................................................11 A.2.1.4. Safety and Environment...............................................................................................................................................11 A.2.2. FACILITIES, EQUIPMENT AND MATERIALS FOR PROCESSING .......................................................................... 12 A.2.2.1. Facilities .......................................................................................................................................................................12 A.2.2.1.1. General.................................................................................................................................................................12 A.2.2.1.2. Processing area ....................................................................................................................................................13 A.2.2.1.3. Environmental airborne control...........................................................................................................................15 A.2.2.1.4. Environmental microbiological control ................................................................................................................18 A.2.2.1.5. Sanitation .............................................................................................................................................................19 A.2.2.1.6. Isolator technology ..............................................................................................................................................19 A.2.2.1.7. Ancillary areas......................................................................................................................................................20 A.2.2.2. Equipment....................................................................................................................................................................21 A.2.2.3. Materials......................................................................................................................................................................22 A.2.2.3.1. General.................................................................................................................................................................22 A.2.2.3.2. Material requirements .........................................................................................................................................23 A.2.2.4. Safety and Environment...............................................................................................................................................23 A.2.3. FACILITIES, EQUIPMENT AND MATERIALS FOR STORING ................................................................................ 24 A.3. DONOR SCREENING................................................................................................................................................. 24 A.3.1. ACTIVITIES........................................................................................................................................................ 24 A.3.1.1. Donor detection...........................................................................................................................................................24 A.3.1.1.1. Determination of death........................................................................................................................................25 A.3.1.1.2. Donor identification .............................................................................................................................................25 A.3.1.1.3. Post Morten donor maintenance.........................................................................................................................26 A.3.1.2. Donor consent; judicial and familiar ............................................................................................................................27 A.3.1.2.1. Deceased donor ...................................................................................................................................................29 A.3.1.2.2. Living donor..........................................................................................................................................................30 A.3.1.3. Data protection and confidentiality.............................................................................................................................31 A.3.1.4. Advertising ...................................................................................................................................................................32 A.3.1.5. Prohibition of financial compensation for donors .......................................................................................................32 A.3.1.6. Donor evaluation; medical, social and physical ...........................................................................................................33 A.3.1.6.1. General.................................................................................................................................................................33 A.3.1.6.2. Medical and social evaluation..............................................................................................................................35 A.3.1.6.3. Physical evaluation of cadaveric donors ..............................................................................................................38 A.3.1.6.4. Exclusion criteria ..................................................................................................................................................40 A.3.1.6.5.1. Deceased donor ...........................................................................................................................................40 A.3.1.6.5.2. Additional exclusion criteria for dead children donors ................................................................................42 A.3.1.6.5.3. Living donors ................................................................................................................................................42 ii A.3.1.6.5.3.1. Allogeneic use donation.................................................................................................................................42 A.3.1.6.5.3.2. Autologous use donation ...............................................................................................................................43 A.3.1.6.6. Autopsy.....................................................................................................................................................................43