Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
Variation in Organ Donation 
Among Transplant Centers 
JANET REHNQUIST 
INSPECTOR GENERAL 
May 2003 
OEI-01-02-00210  O I G
FFICE OF  NSPECTOR  ENERAL

http://www.oig.hhs.gov/ 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, 
is to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as 
the health and welfare of beneficiaries served by those programs.  This statutory mission is carried out 
through a nationwide network of audits, investigations, and inspections conducted by the following 
operating components: 
Office of Audit Services 
The OIG's Office of Audit Services (OAS) provides all auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits examine the 
performance of HHS programs and/or its grantees and contractors in carrying out their respective 
responsibilities and are intended to provide independent assessments of HHS programs and operations in 
order to reduce waste, abuse, and mismanagement and to promote economy and efficiency throughout the 
Department. 
Office of Evaluation and Inspections 
The OIG's Office of Evaluation and Inspections (OEI) conducts short-term management and program 
evaluations (called inspections) that focus on issues of concern to the Department, the Congress, and the 
public.  The findings and recommendations contained in the inspections reports generate rapid, accurate, 
and up-to-date information on the efficiency, vulnerability, and effectiveness of departmental programs. 
Office of Investigations 
The OIG's Office of Investigations (OI) conducts criminal, civil, and administrative investigations of 
allegations of wrongdoing in HHS programs or to HHS beneficiaries and of unjust enrichment by 
providers.  The investigative efforts of OI lead to criminal convictions, administrative sanctions, or civil 
monetary penalties.  The OI also oversees State Medicaid fraud control units which investigate and 
prosecute fraud and patient abuse in the Medicaid program. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 
advice and opinions on HHS programs and operations and providing all legal support in OIGs internal 
operations.  The OCIG imposes program exclusions and civil monetary penalties on health care providers 
and litigates those actions within the Department.  The OCIG also represents OIG in the global settlement 
of cases arising under the Civil False Claims Act, develops and monitors corporate integrity agreements, 
develops model compliance plans, renders advisory opinions on OIG sanctions to the health care 
community, and issues fraud alerts and other industry guidance.  OBJECTIVE 
The objective of this report is to describe variation in organ donation among transplant 
centers. 
We analyzed data for 190 of the nations 255 transplant centers on patients who were 
medically eligible to be organ donors and the number of donors for whom consent was 
given to donate.  We found that the rate of consent for donation (the consent rate) varies 
widely among transplant centers at the national level, as well as within geographic regions 
and at the organ procurement organization (OPO) service area level.  We found a slightly 
higher consent rate in hospitals with a larger number of transplant programs and 
operations. 
However, of 190 transplant centers in our analysis, 18 had a consent rate below 30 percent, 
compared to a national average of 51 percent.  Had these 18 transplant centers obtained 
consent at the average rate of the other 172 centers (54 percent), they would have realized 
130 more donors beyond their current performance, resulting in an estimated additional 
450 life saving organs. 
BACKGROUND 
More than 80,000 Americans are currently awaiting organ transplants, yet fewer than 
25,000 people received a transplant in 2002.  During that same year more than 6,400 
people died while waiting for a transplant.1  It is estimated that 12,000 to 15,000 deaths 
annually could yield organs for transplantation; however, fewer than half of those deaths 
led to such an outcome in 2002.2 
Medicare requires that all hospitals receiving Medicare or Medicaid funding have an 
agreement with an OPO to coordinate organ donation efforts. Every hospital participating 
in Medicare and Medicaid must contact its OPO in a timely manner about patients whose 
deaths are imminent or who die while in the hospital.3 
No specific requirements govern organ donation at hospitals that perform organ 
transplants.  Hospitals that receive Medicare reimbursement for heart, liver, and heart-lung 
transplants must demonstrate adequate plans for organ procurement meeting legal and 
ethical criteria, as well as yielding viable transplantable organs in reasonable numbers.4 
Although this criterion lays out a general expectation for transplant center performance in 
donation, it does not specify a minimum level of donation that a transplant center should 
achieve, and it applies only to heart, liver, and heart-lung transplant centers. 
This analysis focuses on transplant centers because they are in a key position to take a 
leadership role in donation.  Their staff are familiar with the life-saving benefits of organ 
transplantation. Operating a transplant program brings significant prestige in the medical 
community.  These hospitals are at the forefront of implementing sophisticated medical 
procedures. 
Organ Donation in Transplant Centers  OEI-01-02-00210  The Health Resources and Services Administration (HRSA) oversees the nations organ 
procurement and transplantation system.  Among its other responsibilities, HRSA funds 
the Organ Procurement and Transplantation Network (OPTN). 5  All transplant programs 
are members of the OPTN.  The OPTN is charged with operating and monitoring an 
equitable system for allocating organs, maintaining a waiting list of potential recipients, 
matching potential recipients with donors, and increasing organ donation. 
Since 1999, HRSA has funded demonstration and research projects to test and replicate 
interventions designed to increase organ donation.  OPOs, hospitals (including transplant 
centers), and other organizations receive these grants.  In the most recent round of grant 
projects, funded in September 2002, the agency funded 16 grants that test medical 
strategies and outreach efforts intended to increase the number of donors. 
The Centers for Medicare & Medicaid Services (CMS) specifies organ procurement 
service areas, establishes conditions of coverage for the nations 59 OPOs, and certifies 
those organizations for participation in Medicare.  CMS also establishes the conditions that 
a transplant center must meet in order to receive Medicare reimbursement for organ 
transplants. 
OBJECTIVE, SCOPE, AND METHODOLOGY 
The objective of this analysis is to present data on variation in organ donation among 
transplant centers.  This data presentation is part of our continuing work toward helping to 
increase organ donation.  Documenting variation among transplant centers can help 
identify centers with potential for increasing the number of donors, as one step in closing 
the gap between the need for and the availability of organs. 
Our analysis uses hospital-specific data that OPOs submit to the OPTN.  The OPTN 
provides these data to HRSAs Division of Transplantation.  The requirement for 
submission of these data is HRSAs response to OIGs 2000 recommendation that it 
require OPOs to submit hospital-specific data on referrals and on organ recovery to help 
the Department assess the effectiveness of efforts to increase organ donation. (Office of 
Inspector General, Medicare Conditions of Participation for Organ Donation:  An Early 
Assessment of the New Donation Rule, OEI-01-99-00020, August 2000.) 
The data report the number of eligible donors and the number for whom consent to donate 
was given, from August 2001 through November 2002.  An eligible donor is defined as a 
patient aged 70 or younger whose death is determined by neurological criteria (brain death) 
and who does not have clinical conditions, such as tuberculosis, HIV, or hepatitis.6  From 
this data set, which covers all hospitals in the United States, we created a subset of data for 
transplant centers by using the OPTN list of hospitals that were operating a transplant 
program in February 2003.  The total number of transplant centers is 255. 
We then narrowed the data set to include only those transplant centers for which data were 
reported for at least 14 of the 16 months from August 2001 through November 2002.  We 
also chose to include only those transplant centers with a minimum of 4 eligible donors 
Organ Donation in Transplant Centers  2  OEI-01-02-00210  during this 16-month period.  We made this decision to avoid skewing the rates with 
extreme percentages for hospitals that saw few eligible donors.  We also excluded data 
from one OPO that identified reporting errors in its initial data submission. 
All told, our analysis includes 190 of the 255 transplant centers (approximately 75 
percent), and 51 of the 59 OPOs (approximately 86 percent).  For these hospitals and 
OPOs we calculated the consent rate as the number of eligible donors for whom consent 
was given divided by the number of eligible donors. 
We identified three limitations to these data.  First, although OPOs use uniform definitions 
for identifying potential donors, the data are self-reported by the OPO. OPOs could vary 
in how they apply these definitions, although we would expect consistency within each 
OPO. 
Second, these data have not been independently verified.  Although each OPO has 
validated its own submission, neither we at OIG, nor HRSA or the OPTN has 
independently audited these data for accuracy. 
Finally, as noted above, some gaps in reporting exist among 8 of the countrys 59 OPOs. 
Seven OPOs did not provide data for at least 14 of the 16 months in the reporting period, 
and 1 OPO discovered errors during its validation process.  We excluded these eight OPOs 
from our analysis.  As these OPOs submit data, our analysis can be easily updated for the 
additional transplant centers involved. 
Our analysis is based on the consent rate at each transplant center.  The consent rate is the 
number of patients for whom consent to donate organs was given, as a percentage of all 
patients at the hospital who were medically eligible to donate organs.  A medically eligible 
donor is defined as a patient aged 70 or younger whose death is determined by 
neurological criteria (brain death) and who lacks certain clinical conditions, such as 
cancers, tuberculosis, HIV, or hepatitis, among other diseases.  Our analysis covers a 16-
month period, from August 2001 through November 2002. 
FINDINGS 
National Variation in Donation Rates at Transplant Centers 
Table 1 shows the variation in consent rates among transplant centers.  Nationally, these 
190 transplant centers obtained consent from a mean of 51 percent of potential donors, 
with a median of 52 percent.  Thirty centers (16 percent) had consent rates of 70 percent or 
higher. 
However, at 18 of the 190 centers the consent rate fell below 30 percent.  These centers 
averaged 22 eligible donors during this 16-month period.  Ten of the 18 centers had at least 
1 eligible donor per month; in some centers, the number was considerably higher.  Yet they 
still had a low consent rate, despite multiple opportunities for donation. 
Organ Donation in Transplant Centers  3  OEI-01-02-00210  Table 1 
National Variation in Consent Rate 
Among Transplant Centers (8/01-11/02) 
Number of 
Consent Rate  Percentage of Total 
Centers 
0 -9.9%  2  1.1% 
10% -19.9%  4  2.1% 
20% -29.9%  12  6.3% 
30% -39.9%  22  11.6% 
40% -49.9%  35  18.4% 
50% -59.9%  45  23.7% 
60% -69.9%  40  21.1% 
70% -79.9%  17  8.9% 
80% -89.9%  8  4.2% 
90% -100%  5  2.6% 
Total  190  100.0% 
source: OIG analysis of OPO data submitted to OPTN and HRSA 
Although Medicare and the OPTN have no minimum requirement for consent rates, this 
level presents substantial opportunity for improvement.  For example, had these 18 
transplant centers achieved a consent rate of 40 percent, they would have realized 75 
additional donors, resulting in about 260 more organs for transplantation.  Omitting these 
18 centers, the national mean consent rate was 54 percent.  Had these 18 centers achieved 
that 54 percent rate, they would have obtained consent for 130 more donors beyond their 
current performance, resulting in an additional 450 life saving organs. 
Figure 1 shows the geographic distribution of those transplant centers with a consent rate 
of less than 30 percent.  The 18 transplant centers that fell below 30 percent consent rates 
are distributed among 12 OPO service areas. 
Undoubtedly, there are factors in addition to being a transplant center that can explain 
some portion of this variation.  For example, many of the centers with lower consent rates 
are located in urban areas that traditionally have had difficulty in obtaining donors.  It is 
important to note that overall, transplant centers have a slightly higher consent rate than do 
other hospitals.  For the service areas in this analysis, the consent rate for transplant centers 
averages 51 percent, versus 47 percent for other hospitals. 
The OPO service areas contain 1 to 11 transplant centers.  For the 51 OPO service areas 
included in this analysis, variation is widest in those service areas with the largest numbers 
of transplant centers. 
Organ Donation in Transplant Centers  4  OEI-01-02-00210  Figure 1. 
Location of Transplant Centers with Consent Rates Below 30 Percent 
1 transplant center  more than 1 transplant center 
Variation by Number of Transplant Programs at a Center 
Transplant centers can operate between one and eight transplant programs.  Almost all 
transplant centers (243 of 255) perform kidney transplants, while fewer centers have other 
programs.7  Table 2 displays consent rates by number of transplant programs that a 
transplant center operates.  Larger programs show slightly higher consent rates.  For 
example, the 21 centers that operate either 7 or 8 transplant programs had a combined 
consent rate of 55 percent.  The 87 centers operating either 1 or 2 programs had a 
combined rate of 48 percent. 
Among the 18 transplant centers with consent rates below 30 percent, 5 had only one 
transplant program, but 6 had 4 or more transplant programs. 
Organ Donation in Transplant Centers  5  OEI-01-02-00210  Table 2 
Consent Rate By Number Of Transplant Programs (8/01-11/02) 
Transplant Center Consent 
Rates 
(eligible donors / consents) 
Number of  Number of  Eligible 
Consents  Mean  High  Low 
Programs  Hospitals  Donors 
8  7  215  139  64.7%  95%  28% 
7  14  513  261  50.9%  76%  21% 
6  25  800  425  53.1%  73%  35% 
5  20  487  271  55.6%  93%  13% 
4  20  359  207  57.7%  89%  38% 
3  17  526  259  49.2%  80%  0 % 
2  36  788  372  47.2%  90%  0% 
1  51  1,391  671  48.2%  100%  28% 
Total/ Mean  190  5,079  2,605  51.3% 
source: OIG analysis of OPO data submitted to OPTN and HRSA 
Variation by Number of Transplant Operations Performed 
We ranked centers by the number of transplant operations they had performed between 
1987 and 2001.  The volume of transplant operations is highly concentrated into a few 
centers.  Ten of the 190 centers in our analysis had performed 25 percent of all the 
transplants, and 30 had performed 50 percent of the transplants. 
As with the number of transplant programs in a hospital, these data show that the large 
programs exhibit a somewhat higher mean consent rate.  At the same time, however, the 
variance around that mean is quite large, for all sizes of programs. 
Table 3 
Consent Rate by Number of Transplant Operations (8/01-11/02) 
Transplant Center 
Number of 
Number of  Eligible  Consent Rates 
Quartile  Transplants  Consents 
Hospitals  Donors  (eligible donors / consents) 
(1987-2001) 
Mean  High  Low 
0-25%  10  40,488  347  202  58%  95%  21% 
26-50%  20  41,259  670  396  59%  93%  32% 
51-75%  34  39,211  1,162  593  51%  82%  0% 
76-100%  126  40,388  2,900  1,414  49%  100%  0% 
Totals  190  161,346  5,079  2,605  51% 
source: OIG analysis of OPO data submitted to OPTN and HRSA 
Organ Donation in Transplant Centers  6  OEI-01-02-00210  Among the 18 transplant centers with consent rates below 30 percent, one was included in 
the quartile of the 10 largest hospitals that perform 25 percent of all transplants. 
SUMMARY 
Our objective was to describe va riation among transplant centers, which, because of their 
role in organ transplantation, can be potential national leaders in donation. 
These data illustrate the wide variation among transplant centers in procuring organ 
donors.  In documenting this variation, our analysis highlights the existing potential to 
increase the number of organ donors. 
Undoubtedly, there are factors in addition to being a transplant center that can explain 
some share of this variation.  For example, many of the centers with lo w consent rates are 
located in urban areas that traditionally have had difficulty in obtaining donors.  Our aim 
here is not to explain these differences, but rather to identify areas in which there is broad 
opportunity for increasing organ donation. 
We recognize the limitations to these data.  They are self-reported and we have not 
independently verified them.  The data do not cover 8 of the 59 OPOs; they also exclude 
65 of the 255 transplant centers.  Nevertheless, even with these limitations, the data 
highlight the variation among transplant centers in donor consent rates.  As additional data 
are submitted, this analysis could be replicated to determine whether more comprehensive 
data reveal any changes in consent rates. 
No specific criteria exist either in Medicare or in the OPTN governing organ donation and 
consent rate expectations at transplant centers.  However, if those transplant centers with 
lower consent rates can rise toward the mean, many more transplantable organs will 
become available, and the gap between the need for organs and their availability will begin 
to close.  With the shortage of transplantable organs growing, any steps that can help 
reduce that gap should be examined. 
HRSA, in its ongoing oversight of the OPTN, can work with the transplant center 
community to increase consent rates.  HRSA could encourage the OPTN to focus on 
transplant centers with lower consent rates, where substantial unmet potential exists.  All 
centers are members of the OPTN, giving that organization access to and particular 
credibility in the transplant community. 
HRSA funds grant programs that focus on clinical interventions and social/ behavioral 
strategies to increase organ donation.  Recipients of these grant funds include OPOs, 
hospitals, and other organizations.  HRSA might choose to give special attention to project 
proposals that focus on transplant centers with lower consent rates. 
HRSA might also choose to make hospital-specific data on donation publicly available. 
We previously had recommended that CMS make such data public, and the agency agreed 
that this idea has merit and should be considered.8  In that report, we also recommended 
Organ Donation in Transplant Centers  7  OEI-01-02-00210  that HRSA require OPOs to submit hospital-specific data on referrals of potential donors 
and on organ recovery.  The agency concurred with our recommendation; in its contract 
with the OPTN, HRSA required the submission of those data and it began collecting them. 
As a result, HRSA appears to be the more appropriate agency to make the data public.  In 
fact, HRSA plans to make these data publicly available in the summer of 2003. 
As more data become available, HRSA may also wish to examine trends in for those 
centers with low consent rates to assess whether they have made improvements. 
CMS is reexamining the conditions of coverage for OPOs and is also considering new 
conditions for participation for transplant centers.  Both of these efforts provide an 
opportunity to implement more specific criteria governing organ donation.  The data 
presented here give CMS a base line, which it might use in considering whether and how 
to incorporate criteria governing donation in transplant centers in these new conditions. 
Organ Donation in Transplant Centers  8  OEI-01-02-00210  APPENDIX

Table A-1 
Variation in Consent Rate Among 
Transplant Centers Across OPTN Regions (8/01-11/02) 
Number of  Organ 
OPTN 
Transplant  Procurement 
Transplant Center Consent Rates 
Region 
Centers  Organizations 
Mean  High  Low 
Region 01  13  2  66.7%  90.0%  34.3% 
Region 02  18  4  43.2%  67.0%  0.0% 
Region 03  23  9  48.1%  93.0%  25.0% 
Region 04  17  3  54.1%  80.2%  13.3% 
Region 05  23  6  49.2%  100.0%  23.8% 
Region 06  5  2  62.7%  75.0%  54.5% 
Region 07  19  4  62.8%  90.0%  25.0% 
Region 08  18  5  70.6%  88.9%  25.0% 
Region 09  15  4  44.9%  61.5%  0.0% 
Region 10  19  5  50.6%  85.7%  14.3% 
Region 11  20  7  46.4%  73.3%  27.6% 
Total / 
mean  190  51  51.3%  100.0%  0.0% 
source: OIG analysis of OPO data submitted to OPTN and HRSA 
Organ Donation in Transplant Centers  9  OEI-01-02-00210  Figure A-1

Regional Variation in Donation at Transplant Centers

Variation in Consent Rate

Among Transplant Centers by OPTN Region (8/01-11/02)

Region 1 
Region 7 
Region 9 
Region 6 
Region 10 
Region 2 
Region 8 
Region 5 
Region 11 
Region 4 
Region 3 
Key: 
< 50 percent  50-59 percent  60 > percent 
source:  OIG analysis of OPO data submitted to OPTN and HRSA 
Organ Donation in Transplant Centers  10  OEI-01-02-00210  Endnotes 
1 According to the United Network for Organ Sharing, which holds the federal contract for the 
Organ Procurement and Transplantation Network, as of April 4, 2003, there are 80,953 candidates 
on the waiting list for an organ transplant.  24,866 people received a transplant in 2002; 6,608 of 
these transplants were from living donors (kidneys and livers), and 18,258 were from cadaveric 
donors.  There were 6,184 cadaveric donors in 2002, and 6,818 living donors. 
(http://www.unos.org/data/default.asp?displayType=usData, accessed April 4, 2002) 
2 Steven Gortmaker, Carol Beasely, et al., Organ Donor Potential and Performance: Size and 
Nature of the Organ Donor Shortfall, Critical Care Medicine, 24: 432-439. 
3 42 C.F.R., 283.45 was added at 63 Fed. Reg. 33,875, June 22, 1998, effective August 21, 1998. 
4 These criteria for coverage were established for heart transplants at 52 Fed. Reg. 10,935, April 6, 
1987; for liver transplants at 56 Fed. Reg. 15,006, April 12, 1991; and for lung and heart-lung 
transplants at 60 Fed. Reg. 6,537, February 2, 1995.  Medicare does not restrict which hospitals or 
physicians may perform pancreas transplants.  Medicare bases certification of intestinal transplant 
centers on volume and survival criteria only.  Medicare certification of kidney transplant centers, 
which dates to 1976, does not address donation. 
5  The OPTN contract is held by the United Network for Organ Sharing, based in Richmond, 
Virginia. 
6 Eligible donors are defined as any patient who is aged 70 or younger meeting death by 
neurological criteria, based on the American Academy of Neurology Practice parameters for 
determining brain death, who does not have the following: 
 Tuberculosis 
 Human Immunodeficiency Virus Infection with Special Conditions 
 Creutzfeldt-Jacob Disease 
 Herpetic Septicemia 
 Rabies 
 Reactive Hepatitis B Surface Antigen 
 Any Retro virus infection 
 Active malignant Neoplasms, except Primary CNS tumors and skin cancers 
 Hodgkins Disease, Multiple Myeloma, Leukemia 
 Miscellaneous Carcinomas 
 Aplastic Anemia 
 Agranulocytosis 
 Fungal and Viral Meningitis 
 Viral Encephalitis 
 Gangrene of Bowel 
 Extreme Immaturity 
 Positive Serological or Viral Culture Findings for HIV 
7 In addition to kidney transplants (243 hospitals), hospitals can perform transplants for hearts (139 
hospitals), livers (120), lungs (72), heart-lung blocs (74), pancreata (136), pancreas islets (36), and 
intestines (39).  In the 191 hospitals in this sample, the totals are: Kidneys-184; 109 hearts-109; 
Organ Donation in Transplant Centers  11  OEI-01-02-00210  livers-90; lungs-59; heart-lung blocks-58; pancreata-99; pancreas islets-26; and intestines-33. 
8 Office of Inspector General, Medicare Conditions of Participation for Organ Donation:  An Early 
Assessment of the New Donation Rule, OEI-01-99-00020, August 2000. 
Organ Donation in Transplant Centers  12  OEI-01-02-00210  ACKNOWLEDGEMENTS 
This report was prepared under the direction of Mark R. Yessian, Ph.D., Regional 
Inspector General for Evaluation and Inspections in Boston and Joyce M. Greenleaf, 
M.B.A., Assistant Regional Inspector General.  Other principal Office of Evaluation and 
Inspections staff who contributed include: 
Russell W. Hereford, Ph.D., Project Leader  Alan Levine, Program Specialist 
Ivan E. Troy, M.P.A., Program Analyst