Ines Alvarez - Uruguay - Monday 28 - Donation and Transplantation Registries and Traceability of Organs, Tissues and Cells
11 th Congress of the International Society for Organ Donation and Procurement 2 nd Congress of the Iberoamerican Society of Transplant Coordinators 27-30 November 2011 Buenos Aires, Argentina 2011 ORGAN DONATION CONGRESS
Prof. Dra. Inés Álvarez DONASUR: Mercosur Donation and Transplantation Registry National Institute of Donation and Transplant ation (INDT) URUGUAY Pro Tempore Presidency Uruguay
MERCOSUR HEALTH (03/95) <ul><li>Integration for the benefit of population health </li></ul>COUNCIL OF THE COMMON MARKET HEALTH MINISTERS MEETING OF MERCOSUR (RMS) PLANS PROGRAMS STRATEGY GUIDELINES WORKING SUBGROUP OF HEALTH (SGT-11) COMMON MARKET GROUP REGULATIONS INTERGUBERNAMENTAL COMISSIONS I.N.D.T.
Comisión Intergubernamental “Sist. de Información y Com. en Salud” (CISCIS) Comisión Intergubernamental “Política de Medicamentos (CIPM) Comisión Intergubernamental “Control de Dengue” (CICD) Comisión Intergubernamental “Sist. de Información y Com. en Salud” (CISCIS) Comisión Intergubernamental “VIH / SIDA” (CIVIH) Comisión Intergubernamental “Control de Tabaco” (CICT) Comisión Intergubernamental “Salud Sexual y Reproductiva” (CISCIS) Comisión Intergubernamental “Salud y Desarrollo” (CISD) Comisión Intergubernamental “Gestión de Riesgo y Reducción de Vulnerabilidad” (CIGRRV) Comisión Intergubernamental “Salud Ambiental y del Trabajador” (CISAT) Comisión Intergubernamental “Implementación del Regl. Sanitario Internacional” (CIRSI) Intergubernamental Commission of “Donation and Transplantation” (CIDT) INTERGUBERNAMENTAL COMISSIONS I.N.D.T.
MERCOSUR Action of Health Ministers (RMS) Accord Nº 03/06 Constitution of the Intergubernamental Commission of Donation and Transplantation (CIDT) in the MERCOSUR Part and Associated Countries environment I.N.D.T.
Action of the Intergubernamental Commission of Donation and Transplantation (CIDT) MERCOSUR (created by Accord No. 03/06 of RMS 29/06/2006) 2. Propose recommendations on regulatory standards related to: Stem Cell research, cryopreservation of cells and new technologies that require regulatory standards. 1. Promote policies to harmonize legal framework that regulate the process of donation and transplantation of organs, tissues and cells. 3. Develop and propose common strategies for the rational use and optimization of medication costs, resources of the donation and transplantation process and mainly immunosuppressive therapy. 4. Implement the exchange and technical cooperation for the development of adequate management and registration systems of donation data in countries. I.N.D.T.
7. Promote integration and joint availability of a regional registry of volunteer donors of Hematopoietic Stem Cells (HSC). 9. Train Human Resources in Donation and Transplantation of organs, tissues and cells. 8. Establish cooperation mechanisms to obtain organ and tissue transplants aimed to generate the conditions that allow agreements for the exchange of organs and tissues respecting the legal and regulatory standards in each country. 10. Proposal for Living Donor Follow-up. 6. Develop a common regional coding system for traceability of tissues and cells to facilitate future exchanges of tissues and cells between countries. 5. Promote cooperation and exchange of experiences to strengthen strategies of promotion for donation of organs, tissues and cells in the Part and Associated Countries of MERCOSUR. I.N.D.T.
MERCOSUR/RMS ACCORD Nº 11/10 Instructions for CIDT to elaborate an instrument of Harmonized Registry of Activitiy, Surveillance and Trazability in donation and transplantation of organs, tissues and cells in the Part and Associated Countries of MERCOSUR I.N.D.T.
CIDT <ul><li>10/2010: Accord: 02/10 </li></ul><ul><li>Proposal of Donation and Transplantation Project: MERCOSUR Registry </li></ul><ul><li>Author: INCUCAI - ARGENTINA </li></ul><ul><li>Referent: Mariano Soratti </li></ul><ul><li>20/05/2011: Minutes of Consitution of the Project “Mercosur Registry of Donation </li></ul><ul><li>and Transplatation” </li></ul><ul><li>c) 18/08/2011: Propose of Project of Accord RMS </li></ul><ul><li>Proposal of Directive Commission F unctioning </li></ul><ul><li>Author: INDT - URUGUAY </li></ul><ul><li>Referent: Dra. Inés Álvarez </li></ul>I.N.D.T.
RMS/ACCORD Nº 09/11 Approval of the Constitution of the Mercosur Donation and Transplantation Registry Project I.N.D.T.
7/11 – DONASUR REGISTRY Constitution of Directive Commission of Mercosur Registry with Focal Points of CIDT: Argentina: Carlos Soratti Brasil: Heder Murari Paraguay: Hugo Espinosa Uruguay: Inés Álvarez Director of Project: Mariano Soratti I.N.D.T.
14/10/2011 <ul><li>Approval of Statute of the Directive Commission Functioning of DONASUR Registry </li></ul><ul><li>Beginning of the Executive Project: Donasur Registry </li></ul><ul><li>Parts and Associated Countries: </li></ul>Argentina Brasil Paraguay Uruguay Bolivia Venezuela Ecuador Management Plan: Ing. Mariano Soratti I.N.D.T.
Concerning the Directive Commission: I.N.D.T. Chapter I Regarding the members of the Directive Commission of the Mercosur Registry of Donation and Transplantation Article 1: The Executive Committee of Mercosur Donation and Transplantation Registry DONASUR is specifically integrated by representatives of the Intergubernamental Commission of Donation and Transplantation (CIDT) of MERCOSUR Part States and the Director of the Project. It can also be integrated by representatives of the Associated States of Mercosur which have expressed their willingness to be part of the Commission. The Directive Commission of Mercosur Donation and Transplantation Registry DONASUR will be managed by a President, who will represent the Pro Tempore Presidency Country of MERCOSUR at the Intergubernamental Commission of Donation and Transplantation. All the members, including the President, shall have an alternate. The titular and the alternate members will occupy the position until the representation be formally revoked by the Minister of Health.
1. Manage adhesion or decommissioning of member countries. 2. Define the specific objectives and scope of the registry. 3. Define the rights, responsibilities and restrictions of the member countries. 4. Define the variables, scope, visibility, validation, and format. 5. Define reports and indicators published by de registry, visibility, level of data exploitation and the flexibility and depth of information analysis. 6. Create and maintain a common terminology dictionary that includes definitions for a single language interpreted by all countries and that allows proper analysis of the information contained in the registry. 7. Disseminate and ensure the growth and expansion of the registry. RESPONSIBILITIES: I.N.D.T.
- C reat ion of a group of technical referents composed by one representative of each country designated by the country's representative o f the Directive Commission . - The director of the project is responsible for establishing the rules of communication and forms of intervention of the group for the development of the project. RESPONSIBILITIES AND FUNCTIONS: - Speaker and communicator between the project and the Organism of the represented country regarding the work situation, progress state, plans and strategies, etc. - Principal local trainer in relation to the use of the registry . - Responsible for manag e and complet the technical tasks established in the project plan for the development of the record. - Responsible for manag ement of the data update in the registry at the beginig of the functioning. About the Technical Referents: I.N.D.T.
Management Plan of Human Resources Project Organizational Chart I.N.D.T. Directive Commission Project Management Development Team Permanent Technical Secretariat Platform and Services Administration Database Management Assistance and Technical Support Technical Referents
Scope of work General components that will integrate the Registration System I.N.D.T. Available for every country Available for every country Management component Collection component Support component Access component (portal) Available for Member countries Available for Member countries
STAGES OF IMPLEMENTATION <ul><li>Stage 1: Initial Data Collection (Record v1.0) </li></ul><ul><li>Stage 2: Official Publication </li></ul><ul><li>Stage 3: Update of the Registry </li></ul>I.N.D.T.
STAGES OF IMPLEMENTATION I.N.D.T. Project Stage 1 Stage 2 Stage 3 1.1 Definitions 2.1 Definitions 3.1 Definitions 1.2 TIC 2.2 Development 3.2 Development 1.3 Development 2.3 Implementation 3.3 Implementation 1.4 Implementation
Deliverables of Directive Commission I.N.D.T. Stage 1 1.1 Definitions 1.1.1 Act of Constitution of the Project 1.1.2 Constitution of the Directive Com . 1.1.3 Name of the Registry 1.1.4 Information of the country 1.1.5 Glossary v1.0 1.1.6 Registry of donation v1.0 1.1.7 Registry of transplantation v1.0 1.1.8 Regional List of Emergency v1.0 1.1.9 Regional Data 1.1.10 Definition of the period of beginning of the Registry 1.1.1 2 Obligations and rights of the countries 1.1.11 Authors identification
Management Plan Project Project Schedule of the Project States I.N.D.T.