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Elaine R. Berg President & CEO

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.

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Elaine R. Berg President & CEO

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  1. Elaine R. BergPresident & CEO

  2. 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?”

  3. THE NEED

  4. THE ESSENTIAL ISSUE Need for Organ Donation in U.S. 91,532 as of 4-7-06

  5. 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

  6. THE NEED IN THE UNITED STATES 66,116 Kidney Liver 17,257 Heart 3,008 Total Persons Waiting: 93,000 Lung 3,090 Kidney/Pancreas 2,507 Pancreas 1,751 Heart / Lung 150 Intestine 193 Source: UNOS, April 3, 2006 Data subject to change due to future data submission or correction.

  7. 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

  8. RESPONSES TO THE SHORTAGE

  9. DECEASED & LIVING DONORS 1996 – 2005

  10. DECEASED & LIVING ORGAN DONORS NEW YORK STATE, 1992 – 2005 1994 1998 2002 2004 Source: UNOS/OPTN

  11. DONATION AFTER CARDIAC DEATH 556 389 264 Yearly Number of DCD 190 165 112 82 62 OPTN data from UNOS

  12. THE OUTCOMES OF TRANSPLANTATION

  13. ONE-YEAR, FIVE-YEAR GRAFT SURVIVAL PercentGraftSurvival From US OPTN 2003 Annual Report

  14. TRANSPLANT TIMELINE 1668First successful bone graft(dog to man – repair cranium) 1868First skin graft(by Swiss surgeon Jacques Louis Reverdin) 1906First corneal transplant 1954First kidney transplant(brother to brother, performed by Dr. Murray at Peter Bent Brigham Hospital in Boston) 1963First 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) 1968First pancreas transplant(by Dr. Lillche, Univ. of Minnesota, Minneapolis)

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

  16. TRANSPLANT TIMELINE, cont. 1980Presidential Commission establishes neurologic criteria for determination of death, expanding on Harvard Criteria. 1984National Organ Transplant Act ►Prohibited buying & selling of organs ► Established OPTN & Scientific Registry 1980’s Living-Related liver transplants 1987UAGA – Legal & uniform framework for organ donation; amends 1969 version 1990’sLiving-Related lung transplants 1998 Routine Referral Legislation 2000HHS 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.

  17. FEDERAL OVERSIGHT

  18. U.S. DONATION / TRANSPLANTSYSTEM OVERSIGHT

  19. U.S. DONATION / TRANSPLANTSYSTEM MANAGEMENT

  20. REGULATORY OVERSIGHT OF HOSPITALS

  21. REGULATORY OVERSIGHTOF HOSPITALS New York State Dept of Health JCAHO CMS – 1998 Hospital Conditions of Participation

  22. CMS - HOSPITALSCONDITIONS OF PARTICIPATION Effective: August 1998 Enforcement: August 1999 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

  23. HOW THE SYSTEM WORKS

  24. NATIONAL ORGAN TRANSPLANT ACTof 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

  25. 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

  26. 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)

  27. ORGAN PROCUREMENT ORGANIZATION SERVICE AREAS 1. New England Organ Bank 21. LifeCenter Northwest Donor Network 41. Arkansas Regional Organ Recovery Agency 2. LifeChoice Donor Services 22. Carolina Donor Services 42. Louisiana Organ Procurement Agency 3. NJ Organ and Tissue Sharing Network 23. Pacific Northwest Transplant Bank 43. New Mexico Donor Services 4. Center for Donation and Transplant 24. Life Alliance Organ Recovery Agency 44. LifeShare Transplant Donor Services of OK 5. Upstate NY Transplant Services 25. Organ Donor Center of Hawaii 45. Southwest Transplant Alliance 6. NY Organ Donor Network 26. Mid-South Transplant Foundation 46. Texas Organ Sharing Alliance 7. Finger Lakes Donor Recovery Network 27. LifeLink of Georgia 47. LifeGift Organ Donation Center 8. LifeLink of Puerto Rico 28. Kentucky Organ Donor Affiliates 48. Iowa Donor Network 9. Center for Organ Recovery and Education 29. Tennessee Donor Services 49. Mid-America Transplant Services 10. Washington Regional Transplant Consortium 30. LifePoint 50. Midwest Transplant Network 11. Transplant Resource Center of Maryland 31. Gift of Hope Organ and Tissue Donor Network 51. Nebraska Organ Recovery System 12. Gift of Life Donor Program 32. Indiana Organ Procurement Organization 52. Donor Alliance 13. Nevada Donor Network 33. Gift of Life Michigan 53. Intermountain Donor Services 14. LifeNet 34. LifeSource, Upper Midwest OPO 54. Donor Network of Arizona 15. Alabama Organ Center 35. LifeCenter Organ Donor Network 55. OneLegacy 16. LifeQuest Organ Recovery Services 36. LifeBanc 56. Golden State Donor Services 17. LifeShare of the Carolinas 37. Lifeline of Ohio 57. Lifesharing Community Organ & Tissue Donation 18. Mississippi Organ Recovery Agency 38. Life Connection of Ohio 58. California Transplant Donor Network 19. TransLife 39. University of Wisconsin Hospital & Clinics OPO 20. LifeLink of Florida 40. Wisconsin Donor Network

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

  29. 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

  30. Heart 4hours Liver 12 - 18hours Lungs 4hours Pancreas 8 - 12hours Kidneys 24 - 48hours Intestines 8 hours HOW LONG CAN AN ORGAN REMAIN VIABLE ONCE RECOVERED?

  31. 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 HOW OPO’S MAKE DONATION HAPPEN

  32. BARRIERS TO DONATION

  33. 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

  34. 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.”

  35. “DONATION IS AGAINST MY RELIGION”

  36. 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)

  37. DONATION HELPS DONOR FAMILIES! Studies show that:1.85 – 98% of families who consented to donation felt it had a positive impact during their time of grief2.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: 35-47. Bartucci MR. Organ Donation: A study of the donor family perspective. J Neurosci Nurs 1987: 19(6): 305-309. Savaria DT, Rovelli MA, Schweizer RT. Donor family surveys provide useful information for organ procurement. Transplant Proc 1990: 22(2): 316-317.

  38. ORGANS & TISSUES THAT CAN BE TRANSPLANTED Corneas Lungs Heart & Heart Valves Liver Kidneys Pancreas Intestines FemoralVeins SaphenousVeins Skin Bone Tendons

  39. A WORD ABOUT TISSUE

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

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

  42. RESPONSESTO THE SHORTAGE • Living donation • Expanded donor pools • Donation after cardiac death • State & National registries • HRSA Breakthrough Collaborative

  43. 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

  44. 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

  45. FINAL THOUGHTS 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 http://www.shareyourlife.org/facts_stats.html&OPTN http://www.optn.org/latestData

  46. 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.

  47. QUESTIONS ???

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