Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JANET REHNQUIST 

INSPECTOR GENERAL 

May 2003 

OEI-01-02-00210 

Variation in Organ Donation 

Among Transplant Centers 
OFFICE OF INSPECTOR GENERAL

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 OIG’s 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 nation’s 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 nation’s 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 nation’s 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 HRSA’s Division of Transplantation. The requirement for 

submission of these data is HRSA’s response to OIG’s 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 country’s 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) 

Consent Rate Number of 

Centers Percentage of Total 

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 

Programs 

Number of 

Hospitals 

Eligible 

Donors Consents Mean High Low 

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) 

Quartile Number of 

Hospitals 

Number of 

Transplants 

(1987-2001) 

Eligible 

Donors Consents 

Transplant Center 

Consent Rates 

(eligible donors / consents) 

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) 

OPTN 

Region 

Number of 

Transplant 

Centers 

Organ 

Procurement 

Organizations Transplant Center Consent Rates 

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 6 

Region 5 

Region 8 

Region 7 

Region 4 

Region 3 

Region 11 

Region 10 

Region 2 

Region 9 

Region 1 

Key: 

< 50 percent 50-59 percent 

source: OIG analysis of OPO data submitted to OPTN and HRSA 

60 > percent 

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 

• Hodgkin’s 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