Elaine R. Berg President & CEO

WHAT WE WILL COVER TODAY: 1. National picture: Supply vs. Demand 2. How the donation & allocation system works 3. Regulatory oversight of the donation & allocation system 4. “ Where do donors come from? ”

THE NEED

THE ESSENTIAL ISSUE Need for Organ Donation in U.S. 91,532 as of

THE NEED More than 93,000 men, women & children currently await life-saving transplants The need for organs is expected to increase in the coming years (Hep C, aging population …) Every 13 minutes another name is added to the national transplant waiting list 17 people die each day on average from the lack of available organs for transplant – That’s 6,000 each year

Total Persons Waiting: 93,000 THE NEED IN THE UNITED STATES ,751 2,507 3,090 3,008 17,257 66,116 Intestine Heart / Lung Pancreas Kidney/Pancreas Lung Heart Liver Kidney Source: UNOS, April 3, 2006 Data subject to change due to future data submission or correction.

DONOR AVAILABILITY Only 1.5% of all people who die in hospitals are eligible to be organ donors In the NYODN region, there are approximately 56,000 hospital deaths per year Only 650 of those are eligible to be donors Only 300 families consent to donation

RESPONSES TO THE SHORTAGE

DECEASED & LIVING DONORS 1996 – 2005

Source: UNOS/OPTN DECEASED & LIVING ORGAN DONORS NEW YORK STATE, 1992 –

DONATION AFTER CARDIAC DEATH OPTN data from UNOS Yearly Number of DCD

THE OUTCOMES OF TRANSPLANTATION

ONE-YEAR, FIVE-YEAR GRAFT SURVIVAL Percent Graft Survival From US OPTN 2003 Annual Report

TRANSPLANT TIMELINE 1668 First successful bone graft (dog to man – repair cranium) 1868 First skin graft (by Swiss surgeon Jacques Louis Reverdin) 1906 First corneal transplant 1954 First kidney transplant (brother to brother, performed by Dr. Murray at Peter Bent Brigham Hospital in Boston) 1963 First liver transplant (by Dr. Starzl in Denver) 1964 First lung transplant (by Dr. James Hardy, Univ. of Mississippi in Jackson, MS) 1964 First heart transplant (by Dr. Christian Barnard, Groote Schur Hospital, Cape Town, South Africa) 1968 First pancreas transplant (by Dr. Lillche, Univ. of Minnesota, Minneapolis)

1968 First definition of brain death based on neurological criteria 1969 First legislative proposal addressing organ donation, the Uniform Anatomical Gift Act (UAGA); Established legal mechanism to donate organs 1978 Introduction of Cyclosporin as a major immunosuppressant 1978 Kidney transplants included under Medicare coverage 1979 NCCUSL recommends Uniform Determination of Death Act for adoption by all 50 states TRANSPLANT TIMELINE, cont.

1980 Presidential Commission establishes neurologic criteria for determination of death, expanding on Harvard Criteria National Organ Transplant Act ► Prohibited buying & selling of organs ► Established OPTN & Scientific Registry 1980’s L iving-Related liver transplants 1987 UAGA – Legal & uniform framework for organ donation; amends 1969 version 1990’s Living-Related lung transplants 1998 Routine Referral Legislation 2000 HHS implemented a Final Rule establishing a regulatory framework for the structure & operations of the OPTN. Under the terms of the Final Rule, policies intended to be binding upon OPTN members are developed through the OPTN committees & Board of Directors & then submitted to the Secretary of HHS for final approval.

FEDERAL OVERSIGHT

U.S. DONATION / TRANSPLANT SYSTEM OVERSIGHT

U.S. DONATION / TRANSPLANT SYSTEM MANAGEMENT

REGULATORY OVERSIGHT OF HOSPITALS

  New York State Dept of Health   JCAHO   CMS – 1998 Hospital Conditions of Participation REGULATORY OVERSIGHT OF HOSPITALS

  Hospitals required to notify OPO of ALL deaths AND IMMINENT DEATHS in a timely manner   Maintain patient viability to evaluate for brain death   Request for organ / tissue donation will be made only by trained requestors CMS - HOSPITALS CONDITIONS OF PARTICIPATION Effective: August 1998 Enforcement: August 1999

HOW THE SYSTEM WORKS

NATIONAL ORGAN TRANSPLANT ACT of 1984 (NOTA)   Single nationwide network (OPTN)   Private & non-profit under Federal contract (UNOS)   Transplant Centers & OPO’s must be members of OPTN to receive Medicare reimbursement   OPO’s required to be non-profit

OPTN CONFIGURATION Transplant Centers – 254 OPO’s – 58 Histocompatibility Labs – 152 Voluntary Health Organizations – 8 Professional /Scientific Organizations – 27 Consortium Members – 3 General Public Members – 12

OPTN RESPONSIBILITIES  Organ match & placement  Policies / procedures for recovery, distribution & transportation  Collect / manage scientific data  Provide data to stakeholders  Professional / public education  Created by National Organ Transplantation Act of 1984 (NOTA)  Management of waiting list  Oversight of transplant centers  Oversight of OPO’s (currently 58 in U.S.) (range from 1 million population to 16 million)

ORGAN PROCUREMENT ORGANIZATION SERVICE AREAS 1. New England Organ Bank21. LifeCenter Northwest Donor Network41. Arkansas Regional Organ Recovery Agency 2. LifeChoice Donor Services 22. Carolina Donor Services42. Louisiana Organ Procurement Agency 3. NJ Organ and Tissue Sharing Network23. Pacific Northwest Transplant Bank43. New Mexico Donor Services 4. Center for Donation and Transplant24. Life Alliance Organ Recovery Agency44. LifeShare Transplant Donor Services of OK 5. Upstate NY Transplant Services25. Organ Donor Center of Hawaii 45. Southwest Transplant Alliance 6. NY Organ Donor Network26. Mid-South Transplant Foundation46. Texas Organ Sharing Alliance 7. Finger Lakes Donor Recovery Network27. LifeLink of Georgia47. LifeGift Organ Donation Center 8. LifeLink of Puerto Rico28. Kentucky Organ Donor Affiliates48. Iowa Donor Network 9. Center for Organ Recovery and Education29. Tennessee Donor Services49. Mid-America Transplant Services 10. Washington Regional Transplant Consortium30. LifePoint50. Midwest Transplant Network 11. Transplant Resource Center of Maryland31. Gift of Hope Organ and Tissue Donor Network51. Nebraska Organ Recovery System 12. Gift of Life Donor Program 32. Indiana Organ Procurement Organization52. Donor Alliance 13. Nevada Donor Network33. Gift of Life Michigan53. Intermountain Donor Services 14. LifeNet34. LifeSource, Upper Midwest OPO 54. Donor Network of Arizona 15. Alabama Organ Center35. LifeCenter Organ Donor Network 55. OneLegacy 16. LifeQuest Organ Recovery Services36. LifeBanc56. Golden State Donor Services 17. LifeShare of the Carolinas37. Lifeline of Ohio57. Lifesharing Community Organ & Tissue Donation 18. Mississippi Organ Recovery Agency38. Life Connection of Ohio58. California Transplant Donor Network 19. TransLife39. University of Wisconsin Hospital & Clinics OPO 20. LifeLink of Florida 40. Wisconsin Donor Network

THE MATCHING PROCESS RECIPIENT HOSPITAL OPO DONOR UNOS ( MATCH ) OPO TRANSPLANT CENTER UNOS OPO ( MATCH )

ORGAN MATCHING CRITERIA Medical urgency Tissue match Blood type Waiting time on list (for kidneys) Organ size Immune status Geographic distance Done by national computer list at UNOS

HOW LONG CAN AN ORGAN REMAIN VIABLE ONCE RECOVERED? Heart4 hours Liver hours Lungs 4 hours Pancreas hours Kidneys hours Intestines8 hours

HOW OPO’S MAKE DONATION HAPPEN Handle all organ & tissue donor referrals Donor evaluation, donor management Family counseling, consent process Surgical recovery of organs & tissues Matching of organs to recipients Transportation of organs to transplant centers Hospital development & professional education Public education Donor family aftercare Public policy Data entry, management & dissemination

BARRIERS TO DONATION

PSYCHOSOCIAL BARRIERS   Acceptance of personal mortality   Acceptance of brain death / confusion with “coma”   Distrust in the medical community / poor experience with hospital   Death & burial rituals   Skepticism about fair allocation / where are these organs going?   Lack of knowledge

MYTHS, MISCONCEPTIONS, & THE MEDIA   “They’ll take out my organs before I’m dead.”   “It’s impossible to have a regular funeral service following organ donation.”   “Only famous people get transplanted.”   “Organ donation costs money.”

“DONATION IS AGAINST MY RELIGION”

POTENTIAL DONOR IS NO LONGER A YOUNG MALE MVA DEATH! IN THE NYODN REGION:   Trauma patients are only 22% of organ donors (39% nationally)   54% of donors are over 50 (35% nationally)   21 % of donors are over 65 (10% nationally)

DONATION HELPS DONOR FAMILIES! Studies show that: Studies show that: – 98% of families who consented to donation felt it had a positive impact during their time of grief 2. All respondents had no regrets regarding their decision to donate Batten HL, Prottas JM. Kind strangers: The families of organ donors. Health Aff 1987: 37: Bartucci MR. Organ Donation: A study of the donor family perspective. J Neurosci Nurs 1987: 19(6): Savaria DT, Rovelli MA, Schweizer RT. Donor family surveys provide useful information for organ procurement. Transplant Proc 1990: 22(2):

38 Intestines Lungs Kidneys Pancreas Corneas Liver Bone Skin Femoral Veins Saphenous Veins Tendons Heart & Heart Valves ORGANS & TISSUES THAT CAN BE TRANSPLANTED

A WORD ABOUT TISSUE

TISSUES RECOVERED (CARDIAC DEATH)   Eyes   Skin   Bone   Vascular

USES FOR TISSUE   Heart Valve Replacement   Orthopedics: Spine, Joint   Dental: Bone Replacement   Corneal Transplant   Skin for Burns

RESPONSES TO THE SHORTAGE Living donation Expanded donor pools Donation after cardiac death State & National registries HRSA Breakthrough Collaborative

PUBLIC POLICY QUESTIONS Presumed consent Non-financial incentives (preferred status, points for donors, etc.) Internet matching Organ markets / payment for organs Specific registries (Lifesharers…) Public solicitation

HOW TO BECOME A DONOR SIGN your driver’s license (some states require witness) SIGN your HOD donation card ENROLL in the New York State Donor Registry TALK to your family about end of life decisions, including donation

  More than 93,000 men, women & children currently await life-saving transplants   Every 13 minutes another name is added to the national transplant waiting list   17 people die each day on average from the lack of available organs for transplant   In 2004, there were 7,150 deceased organ donors & 7,004 living organ donors, resulting in 27,035 organ transplants   Over 46,000 cornea transplants were performed in 2003   Over 900,000 tissue transplants were performed in 2003 SOURCES: COALITION ON DONATION & OPTN FINAL THOUGHTS

THE GIFT OF LIFE Donating a loved one’s organs can give solace to a family experiencing the grief & pain of a sudden & tragic loss. Transplantation is not a stopgap. Recipients live full & useful lives for decades after transplant. FINAL THOUGHTS