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Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation

Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation. Living Donor Committee Fall 2015. What is the goal of the proposal?.

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Proposal to Establish and Clarify Policy Requirements for Therapeutic Organ Donation

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

  2. What is the goal of the proposal? • 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

  3. Background for the proposal 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.

  4. Living Donors include Therapeutic and Domino Donors

  5. Compare and Contrast Living, Therapeutic and Domino Donors

  6. Current and Proposed Policy Requirements

  7. Supporting Evidence • 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.

  8. How will members implement this proposal? • 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

  9. How does this proposal support the OPTN Strategic Plan?

  10. Questions? 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

  11. Evidence for Non-Domino Therapeutic Donation Non-domino therapeutic donors do exist, are used and have been described in the literature   Transplantation. 2006 Nov 15;82(9):1241-2. The symptomatic pelvic kidney: a new source of organs for living donor kidney transplantation? Li J, Nadalin S, Paul A, Sotiropoulos GC, Broelsch CE, Kranz B, Vester U, Schaffer R, Philipp T, Otto T. PMID: 17102780 Transpl Int. 2015 Sep;28(9):1126-30. doi: 10.1111/tri.12594. Epub 2015 May 7. Living donor renal transplantation with incidental renal cell carcinoma from donor allograft. Lugo-Baruqui JA1,2, Guerra G1,3, Chen L1,2, Burke GW1,2, Gaite JA1, Ciancio G1,2.

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