1. Management and Organizational Models
for Donation and Transplantation: A
Challenge for Healthcare Systems –
North America
Presented by:
Howard M. Nathan
President and CEO
Gift of Life Donor Program
Philadelphia, PA, USA

2. Gift of Life Donor Program
Philadelphia, USA

3. Gift of Life Donor Program
Philadelphia, Pennsylvania USA
• Non-Profit OPO/Tissue Recovery/Eye Bank
• Established in 1974
• Federally designated OPO (by Medicare) for
eastern PA, Southern NJ & Delaware
- 130 Acute Care Hospitals
- 15 Transplant Centers, 43 Programs
- 10.3 Million Population
• 2011* Projected Data:
- 440 Organ Donors / 43 Donors/MM
- 1,236 Bone Donors and 2,551 Cornea Donors
• Over 32,000 organs for transplantation and
over 375,000 tissue allografts
• Accredited by: Association of Organ Procurement
Organizations (AOPO); American Assoc. of
Tissue Banks (AATB) & Eye Bank Assoc. of
America (EBAA); UNOS/OPTN member OPO
*Source: Gift of Life data. 2011 Projection Based on YTD performance through 11/15/2011

4. The U.S. Federal Government’s Role
in Donation and Transplantation
Department of Health and Human
Services (DHHS)
Advisory Committee on
Transplantation (ACOT)
Centers for Medicare &
Other Agencies Health Resources and Services Medicaid Services
Administration (HRSA) (CMS)
Healthcare Systems
Bureau (HSB)
Division of
Transplantation
(DOT)
OPTN Contractor
SR Contractor CWBYCTP
(UNOS)
Slide Courtesy of Charlie Alexander, UNOS

5. Organ Procurement and
Transplantation Network (OPTN)
• Federal law mandates that all U.S. transplant centers
and organ procurement organizations (OPOs) be
members of the Organ Procurement and
Transplantation Network (OPTN) to receive any funds
through Medicare
• United Network for Organ Sharing (UNOS), based in
Richmond, Virginia, administers the OPTN under
contract with the Health Resources and Services
Administration (HRSA) of the U.S. Department of
Health and Human Services (HHS)

6. U.S. Organ Donation &
Transplantation Structure
• 58 Organ Procurement Organizations (OPOs)
• 252 Transplant Centers (Hospitals)
– 800+ organ programs (kidney, heart, liver, lung, pancreas, intestine)
• United Network for Organ Sharing (UNOS) – OPTN Contractor
• U.S. Donation & Transplantation Statistics (2010):
– Deceased Organ Donors = 7,943 (DCD Donors = 941)
– Living Organ Donors = 6,559
– U.S. Total Transplants Performed – 31,160
• Deceased Donor Transplants = 24,601
• Living Donor Transplants = 6,559
Source:UNOS

7. Board of Directors:
41 elected members with no more
than 50% transplant professionals;
meets quarterly.
United Network 16+ committees (e.g. organ
specific, ethics, patients, OPO, etc.)
For Organ Each of 11 regions represented
By Councilor
Sharing All allocation policies
developed by UNOS are
subject to final approval
by the Secretary of DHHS.
In 1987, the DHHS (federal government) contracted with UNOS
to operate the OPTN (organ procurement and transplantation network)

8. What UNOS Does
• Oversees national database of clinical transplant information
and operates computerized organ sharing system since 1986
• Manages Wait List - establishes candidate wait list criteria
• Facilitates organ matching
– Matches donated organs to patients via 24-hour Organ Center
• Establishes allocation policies for all deceased donor organs
• Establishes criteria for transplant centers and approvals
• Maintains data on all donors and transplants (LIVING &
DECEASED) and audits OPOs and Transplant Centers
• Supports OPOs by assisting in educating national healthcare
associations and societies

9. UNOS Regional Map
Organ allocation policies are “local” (OPO), then regional
then national – and are patient specific (not transplant center)

10. U.S. National Data
Waiting List vs. Transplant Recipients
130,000 WAITING TRANSPLANTED
120,000 110.225
110,000
100,000
90,000
80,000
70,000
60,000 37,291
50,000
40,000
30,000
20,000
15,208 24,601
10,000
4
5
6
7
8
9
0
1
2
3
4
5
6
7
8
9
0
199
199
199
199
199
199
200
200
200
200
200
200
200
200
200
200
201
Source: Based on OPTN data as of March 11, 2011 with transplant data available through December 31, 2010 .
Waiting list data as of December 31, 2010. Count is based upon registrations.

11. United States Waiting List
Total Candidates
November 2011*
90,368 Kidney
16,264 Liver
3,171 Heart
1,733 Lung
2,118 Kidney/Pancreas
1,345 Pancreas
72 Heart/Lung
263 Intestine
112, 674 TOTAL WAITING
Source: UNOS as of November 23, 2011

12. U. S. National Trends in Organ Donation
Living vs. Deceased Organ Donors
2010 1995 – 2010
8,500
Deceased 8,024 8,085 7,990 8,021
8,000
Organ Donors 7,593 7,943
7,500 7,153
7,943 7,000 6,895
6,618 6,814 6,965
6,731
6,610
6,560
6,500 6,559
5,873 6,455 6,313 6,218
Living 6,000
5,985
6,080
6,187
5,794 5,824
Organ Donors 5,500
5,362 5,416 5,478 5,001
5,000
6,559 4,557
4,500
4,052
4,000 3,781
Waiting List 3,500
3,488
Deaths 3,000
6,176 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Living Donors Deceased Donors
Source: Based on OPTN data as of March 11, 2011 with donor / wait list removal data available through December 31, 2010.
Count based on candidates. Candidates - A patient who is waiting at more than one center, or for multiple organs, is counted as only
one candidate. Totals may be less than the sums due to patients included in multiple categories.

13. U.S. National Organ Donor Experience
1995 – 2010
Total Donors = 201,001
LD (n=93,340) BD (n=101,443) DCDs (n=6,218)
564 644 920
14,000 393 791 848 941
168 189 268
13,000
NUMBER OF ORGAN DONORS
12,000 117
11,000 87
75 6,757 7,029 7,375
10,000 6,189 7,294 7,102 7,002
71 78 5,912 6,001 7,142
64
9,000 5,868
8,000 5,737
5,718
7,000 5,401
5,347
6,000 5,299
5,000
4,000
6,619 6,630 6,828 7,004 6,902 6,732 6,609 6,559
3,000 5,945 6,315 6,218
4,570 5,045
2,000 3,496 3,802 4,066
1,000
0
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
YEAR
*Source: Based on OPTN data as of March 17, 2001 with data through December 31, 2010.

14. US Deceased Organ Donation Summary
1 Jan 2010 – 31 December 2010
Population (Millions) Donors Per Mill Population Transplants Per Million Population
400
350 307
300
250
200
150 83.1
100
26.6
50
0 POPULATION DONORS /MM TRANSPLANTS /MM
(MILLIONS)

15. Organ Donation In the U.S.
• Each OPO has geographical service area designated by
the Federal Government for recovering organs in all
hospitals in that region
• OPO designation carried out by the Centers for Medicare
and Medicaid Services (CMS), based on organ recoveries
and organ transplants performed
• OPOs required to be a member of the national Organ
Procurement and Transplantation Network (OPTN)

16. 58 OPO Donation Service Areas in the U.S.
307 million people – 7,944 deceased donors (2010)
OPO Data
Population Bases from 1.2 Million to 18.9 Million
Deceased Donors Recovered ranged from 32 to 439 Donors
Donors per million (dpm) ranged from 17 to 44 DPM: 26.5 mean

17. A Donate Life Organization

18. Pennsylvania Act 102 - 1994
State Routine Referral Law
Hospital Requirements
• Routine Referral of all patient
deaths to OPO
• Consent requests restricted to
OPO staff or “designated
requestors”
• Medical record reviews to monitor compliance
• $ 500 fine for each instance of non-compliance

19. Revised Hospital
Conditions of Participation
For Hospitals
Receiving Medicare Funding
Guidelines published:
June 22, 1998
Effective date:
August 21, 1998

20. U.S. Secretary of Health Challenges
Community to Increase Donation
and Transplantation
• Increase the number of deceased
organ donors (2003)
GOAL: 75% conversion rate
• Increase the average number of U.S. Department of Health
organs transplanted per deceased and Human Services
Secretary Tommy Thompson
donor (2004) announced in April 2003
GOAL: 3.75 organs/donor
• Increase DCDs to 10 % of all

21. U.S. Hospital and OPO Requirements
and Collaborative Goals
• Routine Referral of All Deaths
• Conversion Rate = 75%
• Organs Transplanted per Donor
= 3.75
• Implementation of Donation
After Cardiac Death (DCD)
Policy

22. Where the Rubber
Meets the Road….
Conversion Rate
Total number of organ donors
divided by the total number of
potential (eligible) donors,
shown as a percent

23. Understanding Perspectives
OPO Interest Care Team Perspective
Organ referral Failure & loss
On-site; early linkage Family betrayal
Optimize organ function Caring for dead patient
Brain death pronouncement Time, resources: futile care
Collaborative request Loss of control
Compliance Dictated practice

24. Organ Transplantation
Breakthrough Collaborative,
identified “breakthrough”
best practices that are associated
with increases in transplantation.

25. OPOs
Effective
Relationships &
Best Practices
Donor Transplant
Hospitals Centers

26. 90,000
80,000
70,000
Number of Registrations
60,000
50,000
40,000
30,000
20,000
10,000
0
3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0
199 199 199 199 199 199 199 200 200 200 200 200 200 200 200 200 200 201
Kidney Liver
Source: Based on OPTN data as of May 23, 2011 with data through December 31, 2010. Count based upon candidates.
Candidates - A patient who is waiting at more than one center, or for multiple organs, would be counted as only one candidate.

27. 5,000
Number of Candidates
4,000
3,000
2,000
1,000
0
93
94
95
96
97
98
99
00
01
02
03
04
05
06
07
08
09
10
19
19
19
19
19
19
19
20
20
20
20
20
20
20
20
20
20
20
Heart Lung Pancreas Heart-Lung Kidney-Pancreas
Source: Based on OPTN data as of May 23, 2011 with data through December 31, 2010. Count based upon candidates.
Candidates - A patient who is waiting at more than one center, or for multiple organs, would be counted as only one candidate.

28. US Deceased Donors by Donor Type:
1996-2009
9000
8000
7000
6000
5000 DCD
4000 ECD
3000 SCD
Increase in Donors 1996 -2009:
2000
SCD 17%, ECD 102%, DCD 1196%
1000
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Source: UNOS, based on OPTN data as of July 23, 2010

29. Kidney Transplants in the U.S.
(Living & Deceased Donors)
1999 – 2010
11,500
10,622
10,661 10,591
10,500 10,553 10,442
9,913
9,500 9,359
8,539 8,668
8,500
8,126 8,234
8,044
7,500
6,647 6,570
6,500 6,434 6,387
6,470
6,240 6,043 5,968 6,277
6,042
5,500
5,495
4,721
4,500
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Deceased Donor Tx (113,752) Living Donor Tx (73,294)
Source: Based on OPTN data as of November 23, 2011 with data through December 31, 2010.

30. Liver Transplants in the U.S.
(Living & Deceased Donors)
1999 – 2010
7,000
6,363
6,228 6,101
6,000 5,848 6,121 6,070 6,009
5,351
5,000 4,969
4,595 4,671
4,499
4,000
3,000
2,000
1,000 524
406 363 323 323
322 288 219 282
257 266 249
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Deceased Donor Tx (66,825) Living Donor Tx (3,822)
Source: Based on OPTN data as of November 23, 2011 with data through December 31, 2010.

31. Organ Transplants in the U.S.
1999 – 2010
1,000 941
915 903 924
891 906
871 881 864 854 828
837
603
555 542
500 504
473 466 468
439 436
378
359 350
198 185 180
178 175
152 151
113 107 116
73 82
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Kidney Pancreas Pancreas Intestine
Source: Based on OPTN data as of November 23, 2011 with data through December 31, 2010.

32. Organ Transplants in the U.S.
1999 – 2010
2,500
2,333
2,199 2,202 2,211
2,188 2,155 2,125 2,193 2,209
2,057 2,163
2,015
2,000
1,770
1,660
1,500 1,478
1,468
1,406 1,405
1,172
1,085
1,000 1,059 1,042
959
893
500
51 48 31 31 27
33 29 40 35 30 41
27
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Heart Lung Heart/Lung
Source: Based on OPTN data as of November 23, 2011 with data through December 31, 2010.

33. Push and Pull in Organ Donation and
Transplantation - Challenges
OPO Push Transplant Center Pull
Recover as many organs CMS quality review
as possible means actual vs. expected
increased: outcomes
ECDs if lower than expected
DCDs - center cited
Higher Kidney Discards Results in Conservative
Organ Allocation policy organ selection
limitations (no older Increase living donation
donors for older recipts) with paired donation

34. Population (million inhabitants): 34.1
Deceased Organ Donors, incl 495 (14.5)
DCD (pmp)
Deceased Donor Kidney TX (pmp) 749 (22.0)
Living Kidney TX (pmp) 485 (14.2)
Liver TX (pmp) 451 (13.2)
Heart TX -incl Ht-Lu TX - (pmp) 170 (5.0)
Heart-Lung TX (pmp) 2 (0.1)
Lung TX (pmp) 180 (5.3)
Pancreas TX (pmp) 73 (2.1)
Small Bowel TX (pmp) 1 (0.0)
Source: Newsletter Transplant , Volume 16, No 1; September 2011.

35. ORGAN AND TISSUE DONATION
AND TRANSPLANTATION SYSTEM
• Principles of the Canada Health Act:
– Public administration, comprehensiveness, universality
portability and accessibility
• The Canada Health Act establishes the criteria and conditions
related to insured health care services - the national standards -
that the provinces and territories must meet in order to receive the
full federal cash transfer contribution. (Government of
Canada, 2007, www.hc-sc.gc.ca)
• The provinces of Canada are constitutionally responsible for the
administration and delivery of health care services.
• In June 2005, the Supreme Court struck down a Quebec law that
prohibited people from buying private health insurance to cover
procedures already offered by the public system.

36. ORGAN PROCUREMENT PROGRAMS
10 Provincial OPO’s

37. TRANSPLANT PROGRAMS
2009 Statistics*
2,155 organs transplanted
• 1,208 kidneys
• 458 livers
• 168 hearts
• 184 lungs
3,796 on waitlists
• 316 withdrew from lists
• 249 died while waiting
487 deceased organ donors
*CORR e-statistics

38. Transplants, Canada, 1996-2009 (pmp)
80.0
70.0 68.3
64.9 63.9
61.3 61.5
60.0 56.8 57.5 57.0 56.9 58.5
53.8 53.8 55.5
52.8
50.0
40.0
30.0
20.0
10.0
0.0
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Source: Canadian Organ Replacement Register, Canadian Institute for Health Information (2010)

39. Deceased Donor Kidney Transplant Rates in Canada
Provincial Comparisons (2007-2009)
Kidney Transplants (Deceased Donor only) PMP
35.0
30.0
25.0
20.0
15.0
10.0
5.0
0.0
Canada BC AB SK MB ON QC ATL
2007 2008 2009 Source: Canada: CORR e-statistics
Note: not possible to compare for other organs as not every province transplants all organs

40. Canada 2010:Total-468 DCD-44 (9.4%)
Slide courtesy of Frank Markel, Trillium Gift of Life Network

41. All Organ Recipients from DCD Donors
Trillium Gift of Life, Ontario
June 2006 – Dec 31, 2010
123 donors, 36(22%) no donation
ORGAN NUMBER
Kidney left 116
Kidney right 109
Kidney both 1
Liver 50
Lung left 5
Lung right 2
Lung Bilateral 18
Pancreas 2
Islets 1
Total # Transplants 304
Slide courtesy of Frank Markel, Trillium Gift of Life Network

42. Lessons Learned RE: DCD
• DCD has been the single largest driver of kidney transplant
activity in Ontario (17% for the last 3 years), 226 additional
kidney txps in 4 1/2 years
• While there is potential for improvement in NDD, both
demographics and critical care management will reduce
potential eligible NDD donors
• In Ontario we are being more conservative regarding
acceptance of DCD donors ( reduce age from 70 to 65yrs) and
some programs are even more limited
Slide courtesy of Frank Markel, Trillium Gift of Life Network

43. CBS MANDATE
In April 2008, the FPT governments (except Québec) gave Canadian Blood
Services a mandate for organ and tissue donation and transplantation:
Activities of the former Canadian Council for Donation and Transplantation (CCDT),
including advice to FPT Ministers of Health on matters related to OTDT;
• Development of leading practices, public awareness and professional
education;
• System performance;
• Patient Registries: Living Donor Paired Exchange, National Organ Waitlist,
Highly-Sensitized Patients, and other related databases; and,
• Development of a coordinated strategic plan for OTDT
45

44. ORGAN DONATION AND TRANSPLANTATION
SYSTEM TRANSFORMATION
TODAY FUTURE SYSTEM
A professional option, limited A professional obligation, routine
Organ Donation in
accountability for performance, and end-of-life care and support for
Canadian Hospitals
unrealized donation potential 50% more transplants
Wide variation in referral criteria, waitlist Canadians with Consistent policies and
management, allocation rules and wait End-Stage Organ standards, transparent allocation rules
times Failure and fairer access to transplantation
No consistent approach to Mandatory reporting and
accountability; few if any Accountability transparency of compliance
consequences for poor performance and performance
Lack of sustained, systematic efforts Dedicated, evidence-based,
Performance
to improve overall Canadian methodology-driven performance and
Management
performance strategy management
Single waitlist with automated matching
Limited, high-level data integration to
Information and offer management; integrated data
support analysis; manual offer
Systems and Data management and analytics to support
management and urgent status wait list
performance management

45. THE SYSTEM IS READY FOR CHANGE…
The organ and tissue communities are ready — there is the
will, the capacity and the commitment—the momentum is
there now
Canadian Blood Services is ready — for the first time, the
organ and tissue communities have identified a leader to
facilitate change
Breakthrough performance is possible — with collaboration
and shared accountability between provinces, programs and
institutions
47

46. Thank You!
Andrea Reynolds, Gift of Life
Charlie Alexander, UNOS Past President
Kim Young, Canadian Blood Services
Correspondence: hnathan@donors1.org

47. Gracias!