1. Tasks and responsibilities of the German organ procurement organization DSO Technical Assistance for Alignment in Organ Donation 1st International Symposium Crowne Plaza İstanbul, 29 of May 2014 Axel Rahmel MD th

2. Legal Framework 2 2 The German Procurement Organisation (DSO) 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1 Contents Finances in Organ Donation and Transplantation

3. Legal Framework 2 2 The German Procurement Organisation (DSO 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1

4. The legal basis German Transplantation Act ( adopted in 1997 ) Regulates organ donation, allocation and transplantation from deceased and living donors Informed consent (opt-in) Brain death: complete and irreversible loss of all brain function No donation after cardiac death (DCD)! First amendment on 4th September 2007 Second amendment on 1st August 2012

5. Transplantation act – shared responsibilities Transplant-Centers Waiting list Organ donation procedure Transplantation Allocation Stiftung Eurotransplant Leiden / Niederlande OPO Deutsche Stiftung Organtransplantation since June 2000 Eurotransplant DSO Transplant-centers

6. Stakeholder in Organ Donation Process TT-Labs Transplant Centers Hospitals Eurotransplant (NL)

7. Legal Framework 2 2 The German Procurement Organisation (DSO 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1

8. The German Procurement Organisation (DSO) The DSO has the responsibility to organise organ procurement in every German hospital (regulated by German Transplant Act) is the national organ procurement organisation

9. Germany Residents: 82,4 mill. Federal States: 16 DSO 7 regions 80 coordinators (nurses / physicians) Hospitals with ICU: 1.346 Transplant Centers: 47

10. Cooperation with hospitals Appropriate communication path - Donor referral (suitability of donor/support) Support in determination of brain death Examinations / therapy regarding - organ function - diagnosis of infection - tumor diagnosis - immunological parameters Data transfer to allocation authority Organization of - transport of organs/teams On the spot support during organ donation process Any time (365 days / 24 hours) Process time ≤ 12 h

11. Contracts 693 contracts with procurement surgeons 181 contracts with consultants for brain death diagnosis 45 contracts with transplantation-centres Pathology / Immunology 12 contracts for HLA-typing

12. Legal Framework 2 2 The German Procurement Organisation (DSO 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1

13. Organization of the organ donation process in Germany

14. The Organ Donation Process Primary or secondary brain injury

15. Causes of Death of Organ Donors 84 % Atraumatic causes of death

16. Killed in road traffic 2010: 3657 Verkehrstote

17. Reduced mortality after stroke

18. Organ Donation in Germany (Age of Organ Donors)

19. Primary or secondary brain injury Diagnosis of brain death The Organ Donation Process

20. Detection of brain death and confirmation

21. Brain death protocol According to the guidelines of the federal medical counsil 2 qualified doctors not involved in transplantation have to confirm independently brain death

22. Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) The Organ Donation Process

23. Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) Family discussion The Organ Donation Process

24. Written wish to donate

25. Next of kin

26. To accompany the decision means: Competent partner with time, goal, kowledge and emotion Ask helpful and prudent open question, build bridges Reflect together Provide information and guarantees Avoid after decision-dissonance! Therapy Grieving Process Death (Brain death) Decision Accompany the Decision Process

27. Reasons for Refusal (%) Next of kin discordant Death not accepted Religious reason Others Unknown Negative attitude towards organ donation known Deceased person´s attitude not known Damage to bodily integrity % % % % % % % n = 2520

28. Reasons for Consent (%) Desire to make sence of the sudden death of a loved one Knowing someone who needs a transplant or benefied from a organ donation Other reason Unknown Positive attitude towards organ donation known Altruistic motives (compassion) % % % % n = 4669 44,8 %

29. Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) Family discussion Medical examination of the deceased patient The Organ Donation Process

30. Medical and behavioural history Standardised questionnaires should be used to obtain the following information:  clinical history and pre-existing diseases  behavioral risk and previous medical treatment  history of chemical and/or radiation exposure, previous and current medication  travel history or overseas/out-of-country residency  recent history of any immunization with live vaccines  risk of transmitting prion disease  information about congenital or inherited disorders  other relevant family medical history

31. Standardized medical history

32. www.edqm.eu

33. Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) Family discussion Medical examination of the deceased patient Data transfer to Eurotransplant for organ allocation The Organ Donation Process

34. Report & Update Procurement Allocation & XMRequestTransplant Medical history Admission Procurement Orders Transports Notification DIAG LABICDOPS MNT MED med. Evaluation HTD Attorne y Relative s Legal prerequisite Processing donor- & organinformation ET-Interface

35. Key Features  Different userprofiles  Documentation according to the process  Standardized diagnostics and procedures  Timerelated information  Calculator for laboratory values  Modification history  Validation and businessrules  Interfaces for medical and administative information  Data-Warehouse retrieval and reporting  New attributes easy to add - parameter model

36. Medical examination of the deceased patient Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) Family discussion Data transfer to Eurotransplant for organ allocation Organ harvesting The Organ Donation Process

37. Organization of the organ procurement Organisational framework Number of participating teams Transport routes and times Scheduling Weather conditions Experience of the teams Coordination between the teams Waiting time at the OT

38. Primary or secondary brain injury Diagnosis of brain death Reporting of potential donor to OPO (DSO) Family discussion Medical examination of the deceased patient Data transfer to Eurotransplant for organ allocation Organ harvesting Organ transport The Organ Donation Process

39. Establishing an air transport network responsible for the organisation of all national and international transports of organ retrieval teams and organs. DSO : Air transport - extrarenal organs Main goals and principles:  quality, safety and economic efficiency  medical necessities, CIT  consideration of transport distance  avoiding „empty“ flights  rare use of cost-intensive jets trustworthy und competent partners

40. Organ harvesting Organ transport Transplantation Data transfer to Eurotransplant for organ allocation Medical examination of the deceased patient Family discussion Reporting of potential donor to OPO (DSO) Diagnosis of brain death Primary or secondary brain injury The Organ Donation Process

41. Legal Framework 2 2 The German Procurement Organisation (DSO 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1

42. SOP (Standard Operation Procedure) 5 4 1 2 3 Development and Implemantation of Standard Operating Procedures (SOP) together with DSO Coordinators and inclusion of contact persons from the hospital

43. Information materials for professionals CD-ROM Guidelines www.dso.de Manuals Annual reports

44. Legal Framework 2 2 The German Procurement Organisation (DSO 3 3 The Organ Donation Process 4 4 Tasks of hospitals 5 5 Finances in Organ Donation and Transplantation 1 1

45. Health insurance company of the organ- recipient Lump sum per Tx registration -lump sum organ removal (DSO) § 11 TPG organ removal (DSO) § 11 TPG DRGs donor-hospital organ allocation (ET) § 12 TPG organ allocation (ET) § 12 TPG refund organ transplantation (TPZ) § 10 TPG organ transplantation (TPZ) § 10 TPG

46. Organisational flat rate DSO does not recieve an entire budget sum but recieves a lump- compensation for every transplanted organ, negotiated yearly. In the year 2013, the organisational flat rate is 8.460 € per transplanted organ. 4.000 transplantations are assumed. DSO covers all costs theat occur during the donation process as well as structural costs with this flat. DSO has contracts with organ retrieval surgeons, neurologists, labs beside the own staff. Exeptions: refund of costs to the donor hospitals and flight costs for non- renal organs. Compensation mechanisms if the fixed number of cases is not reached or exeeded. DSO: Budgeting systematics

47. Example: Allowances Surgeons Special cases: Kidneys en bloc: 820,00 € Split liver, if both splits are transplanted: 1.640,00 € 1 organ (individual kidney, liver or pancreas)€ 820,00 2 organs€ 1.640,00 3 organs€ 2.460,00 4 organs€ 3.280,00 5 organs€ 4.100,00 If no organ has eventually been transplanted€ 290,00 Allowance for abdominal retrieval teams

48. DSO : Air transport - extrarenal organs Air transport of extrarenal organs In 2013, the lump sum for an air transport of an extrarenal organ is 7.652 € per transplanted organ for which a separate flight is carried out. Unsuccessful operations are included in the lump sum and will noch be refunded separately. The lump sum is based on the assumption that 880 air transports will be carried out in 2013. If the number of 880 flights is exeeded 50 % of the additional proceeds will be refunded to payers. If the number of flights is lower than 880 flights 50 % of the lacking revenues will be refunded by the payers.

49. Thank you for your attention!