1 TISSUES AND CELLS TRACEABILITY Documentation on donor selection and recovery. Key factor for tissue request and follow up Dr. Maria Jesús Félix. ([email protected]) Medical Coordinator of Tissues and Cells Catalan Transplant Organization on behalf of Catalan Health Services. Health Department. Government of Catalonia

2 To guarantee quality and security of tissue and cells from human origin used with therapeutic purposes Aim of the European legislation: DC 2004/23, 2006/17 and 2006/86 How can legislation guarantee safety of donated tissue ?? - Establishing quality rules of mandatory application in all procedures and processes required to obtain viable tissue for transplantation

3 - Donation /Procurement - Tissue Bank (TE ) - Transplantation Legislation tools to guarantee safety of tissues and cells Codify all processes Standardized Protocols SOP’s Quality Control Program in TE GTP’s Reporting back to TE Recipient follow up Final Quality Control tools :  Traceability  Bio Vigilance Final Quality Control tools :  Traceability  Bio Vigilance

4 Traceability. Definition (I) Traceability : Ensuring donor /recipient trace  Ability to locate, track and identify cells and tissues at any step of process from the donation, procurement, processing, testing, storage and distribution for transplantation into a recipient or to be dismissed and / or destroyed

5 Traceability: Also includes the ability to identify the donor, TE and the facility in which receives, processes and stores the tissues or cells, as well as the ability to identify the transplanted recipient/s. And also covers the ability to locate and identify any relevant products and materials they will be in direct contact with tissue/cells and can affect the quality and safety of these Traceability. Definition (II)

6 Fulfilling Traceability. Support tools  Codifying processes and procedures  Establishing a standardized system of Information for every level (Consensus with professionals)  Establish regular channels of communication and information among professionals of different levels  Agreeing which information should be shared between levels

7 Donation Transplant Coordinator Procurement/explantation Team/Professional Responsible Tissue Bank TB Director Transplantation Professional Responsible Traçeability Traceability- Levels and Responsible

8 What do surgeons wish when they ask for a cornea for Transplantation? A very good cornea from a young donor The best cornea quality and with a high number of cells adapted to patient needs To receive it as soon as possible to perform the transplant To make a successful transplant …. And get another good cornea for next transplantation Key factors for tissue request and follow up. Transplantation. Information needed by Surgeon

9 Key factors for tissue request and follow up Tissue for transplantation. Information needed by EB What does the EB need to know to satisfy the request? D ata center and surgeon identity Data recipient and outstanding data (age, specific characteristics, some analytical results…) Diagnosis indication for transplantation. Scheduled date for transplantation. Data of responsible person who will collect tissue in transplant center The outcome of transplantation and confirm true data of recipient And…to know the follow up of transplant recipient

10  Transplantation. Information needed by Surgeon Key factors for tissue request and follow up When both sides fulfill their needs and work together is very easy to keep the traceability  Tissue for transplantation. Information needed by EB Standardized application form with transplantation results and identity of true recipient have to be sent to EB. Standardized Tissue information form have to be send to the surgeon. Fulfilling required technical data Standardized application form asking for tissue have to be sent to EB. Fulfilling required EB data

11 If Traceability is fulfilled with a methodological control, it’s possible and easy to establish a system of Bio vigilance. Make institutional and regular checks to verify the compliance of Traceability Traceability. How to check and verify it ? It’s advisable that the Custodian of traceability data should be at the tissue bank It’s advisable that the Custodian of traceability data should be at the tissue bank

12 Annex III Fitxa tècnica per a la sol·licitud de teixit corneal per a trasplantament Segons les recomanacions de la Comissió Assessora de Trasplantament de Còrnia del Servei Català de la Salut, DOGC núm. 2337 Dades de l’hospital o centre sol·licitant Metge sol·licitant:............. Hospital:...................... Metge trasplantador:....................... Adreça de l’hospital:........................ Telèfon:.........................Fax:............... Data de l’intervenció:......../.................../.......... Dades del receptor Edat:............. Grup sanguini:............ Rh:............. Nom i cognoms:......................... Consentiment informat: Sí No Serologia VIH: Sí No INDICACIÓ DEL TRASPLANTAMENT DE CÒRNIA : Sol·licitud urgent: Sí No 1. Edema corneal a. Postcirurgia de cataractes b. Postcirurgia d’altre tipus (especifiqueu-les) c. Edema no postquirúrgic 2. Distròfies corneals a. Endotelials b. Estromals c. Ectàstiques 3. Opacificacions congènites 4. Infeccions víriques 5. Infeccions microbianes (bactèries, protozous, clamidies i espiroquetes) Observacions: --------------------------------- 6. Queratitis ulcerativa no infecciosa 7. Degeneracions corneals 8. Traumes. Corrosions per càustics 9. Retrasplantament per rebuig immunològic 10. Retrasplantament per altres motius (especifiqueu-les) 11. Alteració secundaria a cirurgia refractiva 12. Altres motius (especifiqueu-los) Accepto el compromís d’aportar informació al banc emissor del teixit, sobre les incidències relacionades amb el trasplantament i la seva evolució. Data / / Signatura i número de col·legiat del metge trasplantador:

13 Annex IV Fitxa tècnica de viabilitat del teixit corneal Segons les recomanacions de la Comissió Assessora de Trasplantament de Còrnia del Servei Català de la Salut, DOGC núm. 2337 Dades del donant Edat:....... Grup sanguini:.......Rh:.....Codi del teixit:...... Causa de la mort:....................................................................................... Malalties associades:.................................................... Serologies:. IgG anti-[VIH-1]:.... IgG anti-[VHI-2]:... Ag Austràlia (VHB):..... Ac anti-VHC:... Lues (RPR):...............................Observacions:............................. Exitus (asistòlia): Hora...../....Data... /..... /... Enucleació: Hora... /... Data.../... /...... Dissecció corona: Hora....... /.......... Data....... /.......... /... Valoració de paràmetres del teixit cornial Biomicroscòpia:....................................................... Microscòpia endotelial:................................................. Densitat cel·lular mitjana:................................................. Morfologia cel·lular mitjana:............................................... Pleomorfisme:.......................................................... Caducitat:............................................................ Observacions:......................................................... Mitjà de conservació:................Temperatura:...... Dia/hora:.......... Validació efectuada:Hora......./..........Data....... /.......... /...... Responsable de la validació: Dr........................................... Destinació del teixit Teixit corneal destinat a (centre):...........Hora...... /.... Data... /.. /.... Al metge: Dr............................................................ El responsable del banc:.................................................

14 Annex V Fitxa tècnica de reinformació al banc. Evolució del trasplantament de còrnia Segons les recomanacions de la Comissió Assessora de Trasplantament de Còrnia del Servei Català de la Salut, DOGC núm. 2337 (Per trametre al banc per fax en rebre el teixit i de nou a les tres setmanes de la intervenció) Teixit corneal destinat a l’hospital:.......................................... Al metge: Dr............................ Fax:............. Tel.:........... El responsable del banc:................................................. Dades del receptor del teixit corneal Teixit:.................. Rebut:.............. Hora:...... del dia:......... Banc de procedència:.................................................... Núm. de registre del teixit:........................ Codi:................... Trasplantat el dia:............................... Hora:................... Avaluació de resultats al cap de tres setmanes de la intervenció:................................... S’informa al banc emissor del teixit......................................... Responsable de la reinformació: Dr......................................... Hora....... Data....... /....... /.......... Fax del banc:................. Nom i cognoms:........................................................ Edat:............ Grup sanguini:.......... Rh:.............. Codi:........ Consentiment informat: Sí No VIH previ intervenció: Sí No Diagnòstic:............................................................ Observacions:.......................................................... Metge trasplantador:.....................................................

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18 Hvala vam za vašu pažnju Thank for you attention Grazie per la vostra attenzione Muchas gracias