1. 800-DONORS-7 core.org Living Organ Donation in a Life Support Withdrawal Patient who was not a DCD Candidate “An Opportunity Lost-A time for Change” Kurt Shutterly, COO

2. 800-DONORS-7 core.org DEATH: AN EVERYDAY AFFAIR There is an Estimated 4,000 Deaths in the United States each day where there’s a Conscious Decision to Limit Treatment in some way. About 1,400 ICU deaths per day –One in five Americans die using Intensive Care Services –Approximately 90% of these deaths following decision to withdraw life support.

3. 800-DONORS-7 core.org ROBERT and KATHY OSTERRIEDER

4. 800-DONORS-7 core.org CASE REVIEW 52 year old Caucasian male Admitted to UPMC Presbyterian on 5/11/2012 Complaint of blurry vision and frontal headache. History of Factor V Leiden Mutation Prolonged hospital stay related to shunt failure and new stroke in Left Lateral Medulla.

5. 800-DONORS-7 core.org CLINICAL PICTURE 5/16/2012 Neurological Assessment: –Intermittently following commands on vent –Progressive deterioration in neurologic status secondary to Intracranial HTN following Thrombolysis and Embolization of Fistulae. Labs: –ABO O –Bun 8, Creatinine 0.7 –LFT: Normal –Urine, Blood and CSF Cultures Negative Plan of Care: continue Heparin gtt and Full Support

6. 800-DONORS-7 core.org FIRST REFERRAL 5/16/12 Initiated because of imminent death Family considering withdrawal of support In-hospital coordinator reviewed chart –Patient on minimal ventilator support –Care team hopeful to wean off ventilator Family decides to pursue Skilled Nursing Facility and against withdrawal of support Patient removed from Pending list No interaction between family and OPO

7. 800-DONORS-7 core.org SECOND REFERRAL 10/2/12 (Almost 5 Months from Initial Admission) Social Worker contacts CORE Patient in and out of hospital since May and now family considering limiting treatment. Wife knows her husband wishes to donate and inquiring about next steps to fulfill his wishes. Organ Procurement Coordinator dispatched to hospital to discuss donation options.

8. 800-DONORS-7 core.org CLINICAL PICTURE 10/2/2012 Patient on aerosol tracheostomy mask Limited neurological function secondary to multiple cerebral emboli Labs: –Bun 2, Creatinine 0.4 –LFT: Normal –WBC 12.3 Patient on Antibiotics –Blood Cultures Positive for Coagulase Negative Staph

9. 800-DONORS-7 core.org DISCUSSIONS WITH FAMILY & HEALTH CARE TEAM Discussion with family and decision to no longer treat aggressively. Patient has donor designation on his license. Family very strong proponent of donation, –asking if patient was ventilated Family provided option of tissue and eye donation. – antibiotics continued with negative blood culture results.

10. 800-DONORS-7 core.org HONORING THE DONOR’S WISHES Dr. Joseph Darby CCM meets with family to discuss comfort measures only (CMO). Family disappointed that they could not donate organs as this was the patient’s wish. Discussion with family regarding the donation of one kidney and the lobe of the liver prior to initiating CMO.

11. 800-DONORS-7 core.org HONORING THE DONOR’S WISHES President/CEO of CORE states –“lets honor the donor and family’s wishes and make this happen”. Family fills out medical social questionnaire with OPO coordinator Meetings scheduled to define processes

12. 800-DONORS-7 core.org HOSPITAL ACTIONS Multi-Disciplinary Meeting with and approval from: –Hospital Ethics –Unit Director –Risk Management –Hospital Legal Council –Patient Attending Physician –Hospital Administration

13. 800-DONORS-7 core.org OPO ACTIONS Serology and Tissue Typing Completed Assist with setting up hospital meetings Contacted UNOS Administrator to discuss proper allocation –Unable to run deceased donor list as patient will be a living donor –Must use Hospital Living Donor Program List ran and recipient identified

14. 800-DONORS-7 core.org DISCUSSION WITH LOCAL TRANSPLANT CENTERS Local transplant center 1: –Declined due to quality and did not think their surgeons would recover due to living donor. Local transplant center 2: –Declined due to Altruistic Donor without patient’s actual authorization. Local transplant center 3: –Declined for same reasons and also felt the OPO may be pushing the limit and worried about negative media.

15. 800-DONORS-7 core.org DISCUSSION WITH ADDITIONAL OPOs AND TRANSPLANT CENTERS Ohio Transplant Center: –Director declined for the same reasons and also stated that this will be the topic at their next ethics meeting. Three other OPO’s contacted for assistance to find a surgeon who would recover organs on this patient without success.

16. 800-DONORS-7 core.org OUTCOME OF ORGAN PLACEMENT Notified Dr. Darby –Transplant centers would not recover due to the patient unable to give his own authorization to donate while he was still living. Dr. Darby met with family to discuss the outcome –patient was made CMO on 10/7/12. Patient CTB on 10/09/12 at 1315 –was medically unsuitable to be a tissue or cornea donor due to infection.

17. 800-DONORS-7 core.org REFLECTIONS FROM DR. DARBY “In light of the events transpiring over the last several days as it regards to the patient and his family’s determined efforts to honor his wishes to become an organ donor at the end of his life, I am now determined to make every effort possible to change our organ donation policy to allow for organ donation to take place in the future in circumstances that are determined to be appropriate.

18. 800-DONORS-7 core.org REFLECTIONS FROM DR. DARBY I want to do this to honor him, his family and more importantly for those patients who might benefit from such a policy here and at other institutions well into the future. This missed opportunity should not be left squandered. I know he was a good man, father and husband. His legacy should also reflect the conversation that led to important change in the world of organ donation and transplantation.”

19. 800-DONORS-7 core.org DR. DARBY’S COMMENTS “I do not believe that patients should be denied the opportunity to altruistically donate their organs at the end of their natural life as was the case here. I fully understand all of the issues surrounding the dead donor rule but it’s time to change that and help others understand that as well. I do appreciate all the efforts that our institution and administration made on behalf of the family and patient and applaud those individuals who were supportive.”

20. 800-DONORS-7 core.org THE PRECEDENT HAS ALREADY BEEN SET o A 20 year old suffered catastrophic ICH. o Following decision to withdraw life support, family raised the issue of organ donation for a related patient with kidney failure. o Ethics committee approved the procedure arguing surrogate decision maker was ethically acceptable. o Living related donation carried out. o Patient subsequently died after withdrawal of life support. Surrogate Consent for Living Related Organ Donation. JAMA 2004; 291 (6): 728-731

21. 800-DONORS-7 core.org POSSIBILITIES Waiting list as of 01/11/2013 at 3:22 pm: –117,271 Candidates –Approximately 80% are in need of a kidney There is an Estimated 4,000 Deaths each day where there’s a Conscious Decision to Limit Treatment in some way. About 1,400 ICU deaths per day –Approximately 90% of these deaths following decision to withdraw life support.

22. 800-DONORS-7 core.org POSSIBILITIES About 1,400 ICU deaths per day –Approximately 90% of these deaths following decision to withdraw life support. –If 5-10% donated one transplantable kidney this would result in 2,555 to 5,110 kidneys per year Still would take 18 to 36 years to reduce the Kidney list to zero It would help to decrease the kidney waiting list

23. 800-DONORS-7 core.org ISSUES: WHAT DO WE CALL THESE DONORS? Deceased Donors –Brain Dead –DCD Donors Living Donors –Living Related –Living: Altruistic –Living Donation Prior to Natural Death Altruistic Living Donation Prior to Death Withdrawal of Life Support Donors (WLS) DPD: Donation Prior to Death

24. 800-DONORS-7 core.org ADDITIONAL OBSTACLES: No Provision for these Donors in OPTN/UNOS Informed Consent: First Person VS Surrogate Consent Potential Donor Pool: Is it worth the effort? Costs: Who pays for Procedures and Care? Risks: Donor Operation Only– No long term concerns OPTN/UNOS Policy Changes Required

25. 800-DONORS-7 core.org FAMILY COMMENTS

26. 800-DONORS-7 core.org “REQUEST FOR ACTION” Every OPO start the discussion with your staff, donor hospitals and Boards Consider holding a summit and asking multiple disciplines to attend Create a white paper Organized approach for Legislation Collaborative Policy Development “Near-end-of-life Altruistic Donation

27. 800-DONORS-7 core.org QUESTIONS