Deceased Organ Donation Basics Thursday, October 6, 2016 R. Patrick Wood, M.D. F.A.C.S. Chief Medical Officer, LifeGift

DISCLOSURES

GOALS AND OBJECTIVES ◦Understand the function of Organ Procurement Organizations (OPOs) and how OPOs interact with donor hospitals and transplant centers ◦Understand the rules and regulations regarding organ donation ◦Become familiar with the three types of donors ◦Present data on the number of Hispanics on the National and Region 4 waiting lists ◦Review the transplant rates for Hispanic patients in Region 4 ◦Emphasize the dignity and respect afforded to all donors throughout the entire donation process

ORGAN PROCUREMENT ORGANIZATIONS (OPOs) ◦58 federally-designated, non-profit organ procurement organizations (OPOs) in the U.S. ◦Authorized by CMS to procure organs and tissues for transplantation and research ◦OPOs are the link between the organ donor, the transplant centers and their recipients ◦OPOs operate in designated service areas (DSA)

MANY ROLES OF OPOs ◦Support grieving families. ◦Advocate for those awaiting a life-saving transplant. ◦Offer hope to families through the opportunity of organ and tissue donation. ◦Inform the families of registered donors of their loved ones’ wishes to donate. ◦Coordinate the organ and tissue recovery process with surgeons, transplant centers, and donor hospitals. ◦Partner with hospitals to continually develop effective donation systems to increase the number of donated organs available for transplant. ◦Help hospitals to develop policies and procedures in keeping with federal and state laws regarding the donation process. ◦Educate the public about the need for organ and tissue donation. ◦Continue to support and maintain contact with donor families following the donation process. ◦Facilitate communication between recipients and donor families, if both parties desire.

COMMUNICATION BETWEEN RECIPIENTS AND DONOR FAMILIES Roy Irwin Heck III loved baseball and fishing – and loved his family and friends with all his being. Once, he modestly told his mom, Shannon Lenox, he wouldn’t mind if she donated his organs and tissues if anything happened to him. Two weeks later, Roy was in a car accident. Roy’s family waited in the ICU for three days before the doctors confirmed his brain death. His organs saved four people. But that was just the beginning. Remembering how cold it was in the ICU, Shannon started the It’s a “Heck” of a Blanket Ministry, embroidering fleece blankets with encouraging words for other donor families, patients waiting for transplants or anyone else who has experienced any type of loss. “Love people today,” she said. “We are not guaranteed tomorrow.” The recipient is Michael Nall. Michael Nall is a father and grandfather and lives in Cypress, Texas. He is also a die-hard Aggie fan.

LIFEGIFT ◦Texas is served by 3 OPOs: – LifeGift – Southwest Transplant Alliance (STA) in Dallas – Texas Organ Sharing Alliance (TOSA) in San Antonio ◦By population served, LifeGift is the 5 th largest of 58 OPOs in U.S. ◦One of the top 4 OPOs nationally for saving lives through organ donation ◦Oklahoma is served by 1 OPO – LifeShare Transplant Donor Services of Oklahoma ◦Together Texas and Oklahoma make up Region 4

UNOS REGIONS

UNOS (NATIONAL) WATING LIST (AS OF 8/12/2016) *Totals may be less than the sums due to patients included in multiple categories

NATIONAL WAITING LIST BY ETHNICITY % of Waiting List All Organs KidneyLiverPancreas Kidney/ Pancreas HeartLung Heart/ Lung Intestine All Ethnicities 100%131,027107,26514, ,9294,1341, White 42%55,17539,35310, ,0732,5551, Black 30%38,97035,8871, , Hispanic 19%24,27020,7882, Asian 8%9,9088, American Indian/Alaska Native 1%1,2181, Pacific Islander 0.4% Multiracial 1%

HISPANIC PATIENTS REGION 4 WAITING LIST Organ Procurement Organization (OPO) % of Waiting List All OrgansKidneyLiverHeartLungPancreasKP TOSA52%2,6332, LifeGift27%1,4211, STA27%1, LifeShare7.3% Region 4 has 21.2 % of total Hispanics population listed nationally as potential recipients

NATIONAL HEALTH CRISIS

NEED FOR DONATION ◦In 2015: – 25,771 transplants performed nationwide – 15,068 donors nationwide ◦9,080 Deceased Donors – 7,586 DBD – 1,494 DCDD ◦5,988 Living Donors (23.2% of all donors) – 5,628 Kidney – 359 Liver ◦Average of 22 people die each day while waiting for a transplant

“PART OF THE SOLUTION!”

THREE TYPES OF DECEASED DONORS Organ Donor Tissue Donor Brain Dead Donor (BDD)Donation After Circulatory Death Determination (DCDD) Any Hospital Death Irreversible, non-survivable brain injury Patient currently maintained on a ventilator Tests performed to confirm brain death (e.g. clinical exam, apnea test) First Person/Next of Kin provides authorization for donation Pt maintained in ICU while donation evaluation/work up completed To OR for organ recovery Organ donors may also donate tissue and corneas Irreversible, non-survivable brain injury Patient currently maintained on a ventilator Any ventilator-dependent patient where plans are to withdraw support Patient has not progressed to brain death Family decided to take patient off ventilator Family wants organ donation to occur First Person/Next of Kin provides authorization for donation Patient extubated, cardiac standstill w/in 90 minutes, rapid recovery of organs in OR Organ donors may also donate tissue and corneas Patient may or may not have sustained a brain injury Patient is not currently on a ventilator No Cardiac or respiratory activity First Person/Next of Kin provides authorization for donation May donate tissue and corneas (bone, heart, valves, skin, etc.)

DONATION POTENTIAL 1. EYES/CORNEAS 2. LUNGS 3. HEART/HEART VALVES 4. LIVER 5. PANCREAS 6. BONE 7. VEINS 8. KIDNEYS 9. SMALL INTESTINE 10. FASCIA 11. SKIN 12. CARTILAGE

WHY DO DONOR HOSPITALS HAVE TO COOPERATE? ◦Federal Regulations – CMS ◦State Laws – Texas Anatomical Gift Act 2009 – Registries

KEY POINTS OF THE TEXAS ANATOMICAL GIFT ACT ◦Donate Life Texas Registry: – Affirms First Person Authorization – Family cannot overturn donor designation of adults – Individuals less than 18 years of age can register without parental consent ◦Makes appropriate timing of donation first mention even more critical ◦Must not give NOK the impression they have decision to make if the adult patient is registered ◦Parental authorization is still required for individuals less than 18 years of age even if registered

ABOUT THE REGISTRY ◦Established in 2006 by Glenda P. Dawson, Texas legislator and kidney recipient ◦Allows Texans the opportunity to designate themselves as donors – Legally binding – Family cannot override

ABOUT THE REGISTRY ◦A Texas resident can register three ways: – Department of Public Safety (largest source of donors with 90 percent coming through the doors of DPS offices) – Online at – Through the Department of Motor Vehicles (DMV) when updating vehicle tags

WHERE DO WE STAND NATIONALLY? ◦Fastest growing; behind due to late start, now managed by the three Texas OPOs ◦Looking at percentage of adult population:

THE GLENDA DAWSON DONATE LIFE TEXAS REGISTRY ◦As of 8/18/16, there are 8,716,035 registered donors – With the addition of registering on social media sites like Facebook and Twitter, along with DPS and Donate Life Texas website, the number of registered donors have increased dramatically

WHY DO DONOR HOSPITALS HAVE TO COOPERATE? ◦Hospital Policies ◦American College of Surgeons policies

CLINICAL TRIGGERS FOR REFFERAL POTENTIAL BRAIN DEAD ORGAN DONOR CLINICAL TRIGGERS Refer all ventilated patients with a neurological injury with either 1.Loss of one or more brainstem reflexes (pupils, gag, cough, etc.) OR 2.GCS less than or equal to 5 POTENTIAL DONATION AFTER CIRCULATORY DEATH DETERMINATION DONOR CLINICAL TRIGGER When family initiates discussion of withdraw of life-support POTENTIAL TISSUE DONOR CLINICAL TRIGGER Any Death in Hospital

WHY SHOULD DONOR HOSPITALS “WANT TO” COOPERATE? ◦To support grieving families ◦To honor the registered donor’s wishes ◦To save lives

NUMBERS TO REMEMBER ◦52% of adults in the United States are on a donor registry ◦75% of families say yes when offered the option of organ donation ◦35% of families say yes when offered the option of tissue donation

GENERAL REFERRAL PROCESS - ORGAN DONOR ◦Patient meets clinical triggers ◦LifeGift NOTIFIED ◦Coordinator dispatched to hospital ◦Registry accessed to see if patient is on donor registry ◦Coordinator evaluates potential organ donor – Huddle with ICU Team (good communication is the key) – Review medical record ◦Case reviewed with LifeGift Administrator on Call and the Chief Medical Officer ◦Potential donor ruled either suitable or unsuitable to donate

SUITABLE BRAIN DEAD ORGAN DONOR ◦Donor declared brain dead by ICU team ◦Family informed of donor registry status or approached for authorization for donation ◦Donor discharged and readmitted to LifeGift

DONOR MANAGEMENT ◦LifeGift assumes management of brain dead organ donor (BDD) and works with intensive care unit (ICU) team and the LifeGift chief medical officer to manage the donor ◦Team works to improve organ function to maximize the gift ◦Time in the ICU varies from 24 to over 72 hours depending on the clinical situation

ORGAN ALLOCATION ◦When sufficient data is available, the UNOS waiting lists of potential recipients are generated for each suitable organ ◦Organ offers made to transplant centers in sequential order of the potential recipients on the waiting list ◦In general, the offers go first to the local patients, then to the regional patients, and finally to the national patients but broader sharing is increasingly common

TEXAS ORGAN SHARING ALLIANCE (TOSA): ORGAN TRANSPLANTS BY ETHNICITY 2015 No. of Tx% of Tx All Ethnicities698100% White % Black547.7% Hispanic % Asian121.7% American Indian/Alaska Native3.43% Pacific Islander00% Multiracial1.14%

2015 No. of Tx% of Tx All Ethnicities1,095100% White % Black % Hispanic % Asian454.1% American Indian/Alaska Native00% Pacific Islander1.09% Multiracial9.82% LIFEGIFT: ORGAN TRANSPLANTS BY ETHNICITY

SOUTHWEST TRANSPLANT ALLIANCE (STA): ORGAN TRANSPLANTS BY ETHNICITY 2015 No. of Tx% of Tx All Ethnicities1,009100% White % Black % Hispanic % Asian383.8% American Indian/Alaska Native20.2% Pacific Islander20.2% Multiracial30.3%

LIFESHARE: ORGAN TRANSPLANTS BY ETHNICITY 2015 No. of Tx% of Tx All Ethnicities319100% White % Black4714.7% Hispanic237.2% Asian82.5% American Indian/Alaska Native309.4% Pacific Islander41.3% Multiracial21.0%

THE ORGAN RECOVERY PROCEDURE ◦Discuss scheduling case in operating room in the donor hospital ◦Arrival of recovery team coordinated by LifeGift ◦Organ recovery surgery takes 1 to 4 hours ◦Organs preserved, cooled, removed, and packaged ◦Recovery teams return to the recipient hospital

RESPECT FOR THE DIGNITY OF THE DONOR ◦THIS IS THE SINGLE MOST IMPORTANT PART OF DONATION PROCESS ◦Highlighted by – Moment of Honor in intensive care unit – Moment of Silence in operating room

DONOR FAMILY FOLLOW-UP ◦Phone call to family following OR with recovery information (by CCD or Organ Team) ◦A memory box is sent to the family within 6 weeks following the donation. The memory box includes a letter with recovery information, bereavement/resource materials and information on how to reach out to recipients. ◦A remembrance/bereavement card is sent on the 6 month and 1 year anniversary of the death, as well as during the birthday month of the donor. ◦Invitation to create a quilt square in honor of the donor is sent to the family with the 6 month bereavement card ◦An invitation to our annual Celebration of Life ceremony in which the family is presented a donor medal of honor. ◦An invitation to participate in our 2nd Chance Run ◦Holiday grief support guide sent in November ◦Family Satisfaction Survey

DONOR HOSPITAL FOLLOW-UP ◦Donation System Specialist (DSS), creates a “Donor Flyer” within 4 to 5 business days of the donation. ◦ “Donor Flyers”, report the organs recovered and the transplant outcome ◦Flyers are shared with our partners at the donor hospital

WE PROVIDE HOPE Tragedy of 1 patient’s death = Up to 8 lives saved

FUTURE DIRECTIONS IN ORGAN DONATION ◦Increase the Number of Lives Saved ◦First Person Authorization ◦Expand the Pool of Donors (Living, BDD, DCDD) ◦Machine Preservation

FIRST LIVING RELATED LIVER TRANSPLANT IN THE TMC IN 1992

HMH – FIRST LIVER PERFUSION DEVICE

QUESTIONS