in Organ Donation - ODEQUS

1 Organ Donation European Quality SystemQ ODEQUSQ uality Criteria &Quality Indicatorsin Organ Donation cobertes Quality_Maquetaci n 1 17/12/13 17:42 P gina 1 Organ Donation European Quality SystemQ ODEQUSQ uality Criteria &Quality Indicatorsin Organ Donation PortugalInstituto Portugu s do Sangue e daTransplanta o - IPST Ana Fran a, Rui Maio, Catarina BolotinhaRomaniaFundatia Pentru Transplant - FPT Victor Zota, Rosana Turcu SpainFundaci Bosch i Gimpera - FBG Sandra Mart nSpainDonation and Transplantation Institute - DTI Maria Paula Gomez, Gloria Paez, Luciana TeixeiraSpainFundaci n Investigaci n Biom dica HospitalGregorio Mara n - FIBHGM Jos Luis Escalante SwedenKarolinska Institutet - KI Bo-Goran Ericzon.

2 Ystein JyngeUKNHS Blood and Transplant Directorate of OrganDonation and Transplantation - NHSBTSue Falvey Consortium AustriaMedizinische Universitaet Wien - MUW Ferdinand M lbacher, Georg Gy riCroatiaMinistry of Health and Social Welfare Republic ofCroatia - MHSW Mirela Busic, eljka Gavranovi FranceAgence de la Biomedecine - ABM Marie Thuong, Julien Charpentier GermanyDeutsche Stiftung Organtransplantation - DSO Franz Schaub, Werner LauchartItalyFondazione per l Incremento dei Trapiantid Organo e Tessuti - FITOT Francesco ProcaccioPolandCentrum Organizacyjno Koordynacyjne - POLTRANSPLANT Jaroslaw Czerwinski External consultants and expertsSpainFundaci Avedis Donabedian - FAD Rosa Maria Saura ODEQUS Project AuthorsCoordinator SpainUniversitat de Barcelona - UB Mart ManyalichSpainHospital de la Plana - VillarrealXavier Guasch TABLE OF CONTENTSINTRODUCTION.

3 6 QUALITY CRITERIA ..7 LIVING Donation ..81. Legal Framework ..92. Organization: Protocols ..93. Living Donor Coordinator and Team Requirements ..94. Documentation and Registries ..95. Donor Identification ..96. Donor Evaluation ..107. Follow-Up of Living Donor and Recipient ..108. Research ..109. Quality Evaluation and Outcomes ..1010. Donor Protection ..10 DECEASED Donation .. Framework .. Organisation .. Donation Person (KDP) and Donation Team (DT) and Registries .. Identification and Referral .. Evaluation .. Treatment / Maintenance .. of Brain Death / Diagnosis of Death.

4 Support .. Sharing .. Retrieval .. of Organs (in-hospital, inter-hospital) and Logistics .. and Packaging .. Services .. and Education .. Training and Research .. Evaluation and Outcomes ..234 ODEQUSQ uality Criteria & Quality IndicatorsQUALITY INDICATORS ..25 LIVING Donation .. for Living Donation from a council .. of the centre in living donors registry .. of potential kidney living donors .. follow-up of living donors .. of potential living donors ..31 DECEASED Donation .. process procedures .. Donors Identification Protocol .. team full-time availability .. team members with ICU background.

5 Dedicated by the Key Donation Person (KDP) ..396a. Documentation of key points of the Donation process ..406b. Documentation of cause of no Donation .. consent .. of all possible donors in the ICU .. in-hospital DCD donor identification .. DCD donor identification .. of controlled DCD Donation protocols .. of possible DBD donors .. organs documented .. of Brain-Dead donors .. management .. cardiac arrest .. Organ donor preservation .. on Organ Donation .. of evaluation of potential donors .. identification .. rate in DBD donors .. rate in uncontrolled DCD donors .. rate in controlled DCD donors.

6 Transplanted from uncontrolled DCD donors .. transplanted from controlled DCD donors ..6oGLOSSARY ..61 ODEQUSQ uality Criteria & Quality Indicators5 INTRODUCTIONO rgan transplantation is the most cost-effective treatment for end-stage renal failure and the only oneavailable for some other Organ failure; unfortunately Organ shortages is the major limiting factor fortransplantation and as result waiting lists continue grow worldwide. Different Strategies to face this problem have been implemented by European Countries but until now bigdifferences continue to exist in Donation rate among different EU Members.

7 The Action Plan on OrganDonation and Transplantation from CEC promote the creation of Quality Improvement Program in allhospitals where there is a potential donor with the aim of establish a quality procedures in Organ donationand then increase the number and quality of Organ for transplant. ODEQUS is a Quality System for Organ Donation Process with Quality Criteria of best practices and QualityIndicators for Donation after Brain Death (DBD), Donation after Cardiac Death (DCD) and Living Donation (LD). Organ Donation European Quality System project ( ODEQUS ) was co-financed by the Executive Agencyfor Health and Consumers, agreement 20091108, coordinated by the University of Barcelona, Spain fromOctober 2010 to December 2013 and count with the participation of fourteen different nationalorganisations and hospitals from eleven European quality system created by ODEQUS is based on the principles of good practices, ensuring that thequality and safety of the organs and services are provided and maintained.

8 Moreover than identify bestpractices in three types of Organ Donation DBD, DCD and LD, this Manual also covers all 3 aspects ofdonation services: structure, procedures and outcomes. After applying ODEQUS quality system at hospital level, it will be possible to homogenize the organdonation process creating a methodology to evaluate the Organ procurement performance and definingimprovement strategies enhancing the efficiency of transplant systems in Europe. 6 ODEQUSQ uality Criteria & Quality IndicatorsQuality Criteria LIVING DONATIONT otalLiving Donation8 ODEQUSQ uality Criteria & Quality Indicatorsnumber of criteria1 Legal Framework (Legal Requirements)2 Organisation.

9 Protocols3 Living Donor Coordinator and Team Requirements4 Documentation and Registries5 Donor Identification6 Donor Evaluation7 Follow-Up of Living Donor and Recipient8 Research9 Quality Evaluation and Outcomes10 Donor Protection321223211320 ODEQUSQ uality Criteria & Quality Framework (Legal Requirements)LD All Institutions where living Donation procurement and transplantation is processed should All living donors should obtain approval for Donation by a specific group, in accordance withnational legislation. Their judgement should conform to the guiding principles laid down by acommittee assigned to each transplant centre, which will evaluate the ethical, technical andpsycho-social aspects of the Donation All living Organ donations should be based on an informed consent, including donor s rights, inaccordance with national rules, policies, current practices, medical complications and coverageof Donation -related.

10 ProtocolsLD Hospital activity in the area of living Donation and transplantation should be provided accordingto the state of the art, written medical protocols, guidelines and recommendations accepted All hospitals involved in living Donation should have the capacity to ensure proper follow-up ofthe donors and be responsible for such Donor Coordinator and Team RequirementsLD All potential Living Donors should always be evaluated by a trained and competent and RegistriesLD All hospitals involved in living Donation should supply data (including follow-up data) to anational or supranational LD A complete medical record should be maintained in all investigations for a possible livingdonation, including the basis for decisions on approval or IdentificationLD All recipients accepted for kidney transplantation should be investigated regarding potential Identification of potential living donors should be recommended by healthcare professionalsinvolved in Donation and transplantation.