Elaine R. Berg President

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Elaine R. BergPresident CEO
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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?

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THE NEED
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THE ESSENTIAL ISSUE
Need for Organ Donation in U.S.
91,532 as of 4-7-06
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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
  Thats 6,000 each year

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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
1,751
Pancreas
150
Heart / Lung
193
Intestine
Source UNOS, April 3, 2006 Data subject to
change due to future data submission or
correction.
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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

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RESPONSES TO THE SHORTAGE
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DECEASED LIVING DONORS 1996 2005
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DECEASED LIVING ORGAN DONORS NEW YORK
STATE, 1992 2005
1994
1998
2002
2004
Source UNOS/OPTN
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DONATION AFTER CARDIAC DEATH
556
389
264
Yearly Number of DCD
190
165
112
82
62
OPTN data from UNOS
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THE OUTCOMES OF TRANSPLANTATION
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ONE-YEAR, FIVE-YEAR GRAFT SURVIVAL
Percent Graft Survival
From US OPTN 2003 Annual Report
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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)

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TRANSPLANT TIMELINE, cont.

• 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

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TRANSPLANT TIMELINE, cont.

• 1980 Presidential Commission establishes
  neurologic criteria for determination of
  death, expanding on Harvard Criteria.
• 1984 National Organ Transplant Act
• ? Prohibited buying selling of organs
• ? Established OPTN Scientific Registry
• 1980s Living-Related liver transplants
• 1987 UAGA Legal uniform framework for
  organ donation amends 1969 version
• 1990s 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.

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FEDERAL OVERSIGHT
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U.S. DONATION / TRANSPLANTSYSTEM OVERSIGHT
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U.S. DONATION / TRANSPLANTSYSTEM MANAGEMENT
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REGULATORY OVERSIGHT OF HOSPITALS
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REGULATORY OVERSIGHTOF HOSPITALS
? New York State Dept of Health ?
JCAHO ? CMS 1998 Hospital Conditions
of Participation
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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

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HOW THE SYSTEM WORKS
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NATIONAL ORGAN TRANSPLANT ACTof 1984 (NOTA)

• ? Single nationwide network (OPTN)
• ? Private non-profit under Federal
  contract (UNOS)
• ? Transplant Centers OPOs must be
  members of OPTN to receive Medicare
  reimbursement
• ? OPOs required to be non-profit

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OPTN CONFIGURATION

• Transplant Centers 254
• OPOs 58
• Histocompatibility Labs 152
• Voluntary Health Organizations 8
• Professional /Scientific Organizations 27
• Consortium Members 3
• General Public Members 12

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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 OPOs (currently 58 in
  U.S.)(range from 1 million population to 16
  million)

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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

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

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HOW LONG CAN AN ORGAN REMAIN VIABLE ONCE
RECOVERED?

• Heart 4 hours
• Liver 12 - 18 hours
• Lungs 4 hours
• Pancreas 8 - 12 hours
• Kidneys 24 - 48 hours
• Intestines 8 hours

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HOW OPOS 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

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BARRIERS TO DONATION
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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

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MYTHS, MISCONCEPTIONS, THE MEDIA
? Theyll take out my organs before Im
dead. ? Its impossible to have a regular
funeral service following organ donation.
? Only famous people get transplanted. ?
Organ donation costs money.
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DONATION IS AGAINST MY RELIGION
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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)
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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
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
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.
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ORGANS TISSUES THAT CAN BE TRANSPLANTED
Corneas
Lungs
Heart Heart Valves
Liver
Kidneys
Pancreas
Intestines
Femoral Veins
Saphenous Veins
Skin
Bone
Tendons
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A WORD ABOUT TISSUE
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TISSUES RECOVERED(CARDIAC DEATH)
? Eyes ? Skin ? Bone ? Vascular
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USES FOR TISSUE

• ? Heart Valve Replacement
• ? Orthopedics Spine, Joint
• ? Dental Bone Replacement
• ? Corneal Transplant
• ? Skin for Burns

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RESPONSESTO THE SHORTAGE

• Living donation
• Expanded donor pools
• Donation after cardiac death
• State National registries
• HRSA Breakthrough Collaborative

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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

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HOW TO BECOME A DONOR

• SIGN your drivers 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

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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

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FINAL THOUGHTS
THE GIFT OF LIFE Donating a loved ones
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.
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QUESTIONS ???