1. 1 Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation Living Donor Committee Fall 2015

2.  Define therapeutic donor as an individual whose organ is removed as treatment for a medical problem and whose organ is suitable for transplant into another individual.  Delineate the subset of existing policies that are necessary to protect the therapeutic donor and the recipient. Most living donor policies are not appropriate or applicable for therapeutic donors.  Limit policy requirements to avoid potential impediments that might prevent a therapeutic donor organ from being transplanted What is the goal of the proposal? 2

3. A member contacted the OPTN concerning the inappropriate aspects and burdens of current living donor policy with regard to domino donation and transplantation Upon investigating this potential problem by consulting other members as well as regional representatives, the Committee understood that there is an additional population of living donors, therapeutic non- domino donors, who are not addressed in current policy. Background for the proposal 3

4. Living Donors include Therapeutic and Domino Donors 4 Domino Donor - an individual undergoing organ transplantation whose native organ is suitable for transplant to another transplant candidate Therapeutic Donor - an individual who has an organ removed as a component of their treatment for a medical problem, and their organ is suitable for transplant into a transplant candidate Living Donor- an individual from whom at least one organ is recovered for transplant

5. Living Donors Therapeutic Donors (Non-Domino) Therapeutic Donors (Domino) Currently defined in OPTN Policy YesNo Currently referenced in OPTN Policy YesNoYes Has an organ removed as a component of their treatment for a medical problem NoYes Donates an organYes Receives an organ transplantNo Yes Compare and Contrast Living, Therapeutic and Domino Donors 5

6. Living DonorsTherapeutic Donors (includes Domino Donors) Provide ILDAPolicy 14.2No Informed Consent Policy 14.3 Limited to 4 elements from Policy 14.3 – confidentiality, valuable consideration, reporting some health information Psychosocial Evaluation Policy 14.1 Limited to one element from Policy 14.1 – evaluate for disease transmission as defined by US PHS Guideline Medical Evaluation Policy 14.4 Limited to 3 elements from Policy 14.4 – evaluate for transmissible disease, exclusion criteria and blood type Peri-operative Reporting Policy 18.1 Limited to submitting the Living Donor Feedback (LDF) and Living Donor Registration (LDR) forms (proposed Table 14.9) Reporting Disease Transmission Policy 15.4 Yes, but limited to Policy 15.4.A – reporting potential or proven disease transmission It is not a requirement to have an approved living donor program component to recover or transplant therapeutic donor organs. Current and Proposed Policy Requirements 6

7.  Since 2006, no domino heart donor transplants have been reported to the OPTN  8 to 12 domino liver donor transplants performed in each of the past 4 years  The OPTN does not currently collect data on other types of therapeutic organ donors (i.e. patients treated for renal cell carcinoma or ureteral trauma), so the number of therapeutic donors is not known. Supporting Evidence 7

8.  Transplant hospitals: follow new informed consent, medical evaluation, and data submission requirements specific to therapeutic donors  Could be considered by the OPTN/UNOS Board in Dec. 2015. If approved, effective date is March 1, 2016.  Proposed policies will not be evaluated during routine site surveys. Members are expected to comply with the requirements and must provide documentation if requested.  Does not require additional data collection How will members implement this proposal? 8

9. Supports:By: Goal 1 – Increase the number of transplants Establishing minimum requirements for the evaluation of therapeutic donors could lead to an increase in the number of transplants Goal 4 - Promote living donor and transplant recipient safety Establishing minimum requirements for the informed consent, psychosocial and medical evaluation, and follow-up of therapeutic donors promotes donor and recipient safety How does this proposal support the OPTN Strategic Plan? 9

10. Mary Amanda Dew, PhD Committee Chair dewma@upmc.edu Regional representative name (RA will complete) Region X Representative email address Lee Bolton Committee Liaison Lee.Bolton@unos.org Questions? 10

11. Non-domino therapeutic donors do exist, are used and have been described in the literature Transplantation. 2006 Nov 15;82(9):1241-2.Transplantation. The symptomatic pelvic kidney: a new source of organs for living donor kidney transplantation? Li JLi J, Nadalin S, Paul A, Sotiropoulos GC, Broelsch CE, Kranz B, Vester U, Schaffer R, Philipp T, Otto T.Nadalin SPaul ASotiropoulos GCBroelsch CEKranz BVester USchaffer RPhilipp TOtto T PMID: 17102780 Transpl Int. 2015 Sep;28(9):1126-30. doi: 10.1111/tri.12594. Epub 2015 May 7.Transpl Int. Living donor renal transplantation with incidental renal cell carcinoma from donor allograft. Lugo-Baruqui JA Lugo-Baruqui JA 1,2, Guerra G 1,3, Chen L 1,2, Burke GW 1,2, Gaite JA 1, Ciancio G 1,2.Guerra GChen LBurke GWGaite JACiancio G Evidence for Non-Domino Therapeutic Donation 11