United States General Accounting Office
GAO Report to the Ranking Minority Member,
Committee on Labor and Human
Resources, U.S. Senate
November 1997
ORGAN PROCUREMENT
ORGANIZATIONS
Alternatives Being
Developed to More
Accurately Assess
Performance
GAO/HEHS-98-26
United States
GAO General Accounting Office
Washington, D.C. 20548
Health, Education, and
Human Services Division
B-276948
November 26, 1997
The Honorable Edward M. Kennedy
Ranking Minority Member
Committee on Labor and Human Resources
United States Senate
Dear Senator Kennedy:
Advancements in organ transplant technology have increased the number
of patients who could benefit from an organ transplant. At the end of 1996,
people on the waiting list for a transplant numbered 50,047. The supply of
organs, however, has not kept pace with the increasing number of
transplant candidates, continuing to widen the gap between transplant
demand and organ supply. With the passage in 1984 of the National Organ
Transplant Act, the Congress sought to increase the organ supply. The
number of cadaveric1 organ donors increased 33 percent between 1988
and 1996—from 4,083 to 5,416 annually, although not enough to meet the
demand. More dramatically, the number of organs transplanted from
cadaveric donors rose from 10,964 to 16,802 in the same time period.
Organ procurement organizations (OPO) play a crucial role in procuring
and allocating organs.2 OPOs provide all the services necessary in a
geographical region for coordinating the identification of potential donors,
requests for donation, and recovery and transport of organs. OPOs work
with the medical community and the public through professional
education and public awareness efforts to encourage cooperation in and
acceptance of organ donation. Although they have similar responsibilities,
OPOs vary widely in the geographic size and demographic composition of
their service areas as well as in number of hospitals, transplant centers,
and patients served. The Health Care Financing Administration (HCFA)
administers section 1138 of the Social Security Act,3 which requires,
among other things, that (1) the Secretary of the Department of Health and
Human Services (HHS) designate one OPO per service area and (2) OPOs
meet standards and qualifications to receive payment from Medicare and
Medicaid. Section 371(b)(3)(B) of the Public Health Service Act4 provides
1
Some patients receive organs, particularly kidneys, from living donors. In 1995, 3,180 people donated
organs.
2
OPOs are nonprofit, private entities that facilitate the acquisition and distribution of organs.
3
42 U.S.C. 1320b-8.
4
42 U.S.C. 273(b)(3)(B).
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that an OPO should “conduct and participate in systematic efforts,
including professional education, to acquire all usable organs from
potential donors.”
HCFA regulations set performance standards for OPOs. These standards
assess OPOs according to their achieving numerical goals in five categories
based on 1 million population in the OPO service area. The five categories
include number of (1) organ donors; (2) kidneys recovered; (3) kidneys
transplanted; (4) extrarenal organs, that is, hearts, livers, pancreata, and
lungs recovered; and (5) extrarenal organs transplanted. HCFA assesses
OPOs’ adherence to the standards and qualifications every 2 years. Each
OPO must meet numerical goals in four of the five categories to be
recertified by HCFA as the OPO for a particular area and to receive Medicare
and Medicaid payment.5,6 Without HCFA certification, an OPO cannot
continue to operate. In 1996, HCFA assessed OPOs for the first time using the
population-based standard with 1994 and 1995 procurement and transplant
data.
You raised concerns about whether the HCFA population-based standard
appropriately measures the extent to which OPOs are maximizing their
ability to identify, procure, and transplant organs and tissue. This report
responds to your request that we (1) determine the strengths and
weaknesses of the current standard and (2) identify and assess
alternatives to the current standard.
To conduct this study, we interviewed HCFA headquarters and regional
officials and an official with the Health Resources and Services
Administration (HRSA) Division of Transplantation.7 We also interviewed
representatives of the Association of Organ Procurement Organizations
(AOPO) and the American Congress for Organ Recovery and Donation. We
met with representatives of several OPOs and the Partnership for Organ
Donation. We reviewed and analyzed relevant documents and data and
identified alternative measures that we used to rank OPO performance
using 1994 and 1995 data. We conducted our work between March and
October 1997 in accordance with generally accepted government auditing
5
During the 1996 designation period only, HCFA redesignated OPOs that met numerical goals in three
of the five categories and submitted an acceptable corrective action plan.
6
According to HCFA regulations, certification or recertification refers to HCFA’s determination that an
entity meets the standards for a qualified OPO; designation or redesignation refers to HCFA’s approval
of an OPO to receive Medicare and Medicaid payments. These terms are usually used interchangeably.
7
HRSA is the designated HHS unit that administers the National Organ Transplant Act.
Page 2 GAO/HEHS-98-26 OPO Performance Standards
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standards. (App. I further describes the scope and methodology for this
report.)
HCFA chose a population-based standard to assess OPO performance after
Results in Brief considering the availability and cost to the OPOs of obtaining and analyzing
various types of data. When HCFA first applied this standard in 1996, five
OPOs were subject to action for failing to meet the standard. This resulted
in two OPOs’ service areas being taken over by adjacent OPOs, a portion of
one OPO’s service being taken over by an adjacent OPO, and the merger of
one OPO with another. The fifth OPO that failed the standard was
determined to be a new entity and not subject to meeting the performance
standard.
HCFA’s current population-based standard, however, is not an accurate
measure for assessing OPO performance because OPO service areas consist
of varying populations. Although potential organ donors share certain
characteristics, including causes of death, absence of certain diseases, and
being in a certain age group, OPO service area populations can differ
greatly in these characteristics.
For example, motor vehicle accidents, the cause of death for about
one-quarter of organ donors in 1994 and 1995, ranged from about 4.4 to
about 17.9 per 100,000 population among the states and the District of
Columbia. In addition, the rates of acquired immunodeficiency syndrome
(AIDS), a disease that eliminates someone for consideration as an organ
donor, differ among the states and the District of Columbia—from 2.8 to
246.9 cases per 100,000 people in 1994. Furthermore, although most organ
donors were between 18 and 64 years of age in 1994 and 1995, this age
group constitutes from 56 to 66 percent of the population. Thus, the
number of potential organ donors may vary greatly for OPOs serving
equally sized populations.
In developing its current OPO performance standard, HCFA considered using
the number of service area deaths as the basis for assessing performance.
It also considered using an adjusted measure of deaths for the
performance standard. Both measures have drawbacks that limit their
usefulness, however, including lack of timely data and inability to identify
those deaths suitable for use in organ donation. We ranked the OPOs, using
1994-95 OPO procurement and transplant data, according to these three
measures—population, number of deaths, and adjusted deaths. Although
three OPOs would not qualify for recertification under any of these
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measures, according to our review, the number of and which OPOs would
not qualify vary depending on the measure used.
HCFA did not consider two alternative measures—medical records reviews
and modeling—that show promise for determining OPOs’ ability to acquire
all usable organs. Consistently applied and uniform reviews of hospital
medical records with verifiable results may accurately assess the number
of OPOs’ potential donors. Such reviews, however, are labor intensive and
therefore expensive. But, because most OPOs already conduct some
records review, any added expense and increase to the cost of organs may
be negligible. The cost of producing independently verified estimates of
the number of each OPO’s potential donors may be substantial, however,
and the expense and impact on OPOs and cost of organs must be
considered. Though not yet fully developed, a modeling approach using
substitute measures to determine the number of potential donors may be
less expensive and easier to execute.
As we have reported in the past, unless OPO performance is measured
according to the number of potential donors, HCFA cannot determine OPOs’
effectiveness in acquiring organs.8 The measures we have identified
provide alternatives for HCFA to pursue to more accurately assess OPO
performance.
Although the number of donors is not growing as quickly as the demand
Background for organs, the number of donors has steadily increased since 1988. The
major reason for this increase is because many more older people are
becoming organ donors than in the past. Nearly two-thirds of cadaveric
donors were between the ages of 18 and 49 in 1988, but, by 1996, only
about one-half of donors were in this age group. The proportion of donors
aged 50 and older doubled from about 12 percent in 1988 to about
26 percent in 1996. Another reason for the increase in donors is because
more minorities are consenting to donate organs. Between 1988 and 1996,
the percentage of organ donors who belonged to racial and ethnic minority
groups increased from about 16 to 23 percent.
The organ donation process usually begins at a hospital when a patient is
identified as a potential organ donor. Only those patients pronounced
8
Organ Transplants: Increased Effort Needed to Boost Supply and Ensure Equitable Distribution of
Organs (GAO/HRD-93-56, Apr. 22, 1993).
Page 4 GAO/HEHS-98-26 OPO Performance Standards
B-276948
brain dead are considered for organ donation.9,10 Most organ donors either
die from nonaccidental injuries, such as a brain hemorrhage, or accidental
injuries, such as a motor vehicle accident. Other causes of death
appropriate for organ donation are drowning, gunshot or stab wound, or
asphyxiation.
Once a potential organ donor has been identified, a staff member of either
the hospital or the OPO typically contacts the deceased’s family, which then
has the opportunity to donate the organs. If the family consents to
donation, OPO staff coordinate the rest of the organ procurement activities,
including recovering and preserving the organs and arranging for their
transport to the hospital where the transplant will be performed.
One donor may provide organs to several different patients. Each
cadaveric donor provides an average of three organs. In 1996, OPOs
procured kidneys from 93 percent of organ donors and livers from
82 percent of them; other organs were procured at lower rates (see fig. 1).
9
States set the legal standard for determining death. “Brain death” is defined as the irreversible
cessation of all functions of the entire brain, including the brain stem.
10
Organs are recovered from a small number of donors declared dead by traditional cardiac death
criteria. Some have termed these donors as “non-heartbeating.”
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Figure 1: Total Number of Cadaveric
Organ Donors by Type of Organ Number
Donated, 1996 5500
5000
4500
4000
3500
3000
2500
2000
1500
1000
500
0
s
ey
er
art
s
ng
or
rea
Liv
dn
Lu
He
on
nc
Ki
lD
Pa
Al
Source: United Network for Organ Sharing (UNOS) Organ Procurement and Transplantation
Network (OPTN) data as of Sept. 20, 1997.
Role of OPOs The national system of 63 OPOs currently in operation coordinates the
retrieval, preservation, transportation, and placement of organs. For
Medicare and Medicaid payment purposes, HCFA certifies that an OPO meets
certain criteria and designates it as the only OPO for a particular geographic
area. OPOs must meet service area and other requirements. As of January 1,
1996, each OPO must meet at least one of the following service area
requirements:
1. Include an entire state or official U.S. territory.
2. Either procure organs from an average of at least 24 donors per
calendar year in the 2 years before the year of redesignation or request and
receive an exception to this requirement.
3. If it operates exclusively in a noncontiguous U.S. state, territory, or
commonwealth, procure organs at the rate of 50 percent of the national
Page 6 GAO/HEHS-98-26 OPO Performance Standards
B-276948
average of all OPOs for both kidneys procured and transplanted per million
population.
4. If it is a new entity, demonstrate that it can procure organs from at least
50 potential donors per calendar year.
In addition, each OPO must have a board of directors or an advisory board
with the authority to recommend policies on donating, procuring, and
distributing organs. The board must have a transplant surgeon from each
transplant center in the OPO’s service area and representation from
hospital administrations, tissue banks, voluntary health associations, and
either intensive care or emergency room personnel, the public, and
physicians or people skilled in human histocompatibility and neurology.
OPOs must also meet other requirements. Among these, an OPO must be a
nonprofit entity and have accounting and other procedures to ensure its
fiscal stability. It must also have the appropriate staff and equipment to
obtain organs from donors in its service area and have working
relationships with at least 75 percent of the hospitals in its service area
that participate in Medicare and Medicaid. OPOs must also conduct
systematic efforts to acquire all usable organs from potential donors.
Furthermore, OPOs must have arrangements to cooperate with tissue banks
to ensure that they obtain all usable tissues from donors.
To ensure the fair distribution and safety of organs, OPOs must have a
system to equitably allocate organs to transplant patients. OPOs must also
arrange for appropriate tissue typing of organs and ensure that donor
screening and testing for infectious diseases, including human
immunodeficiency virus (HIV), are performed.
OPOs use a variety of methods for increasing donation such as raising
public awareness of organ donation and developing relationships with
hospitals. The goal of public education is to promote the consent process,
giving people the information they need to make decisions about organ
and tissue donation and encouraging them to share their decisions with
their families. Such public education campaigns include mass media
advertising; presentations to schools, churches, civic organizations, and
businesses; and informational displays in motor vehicle offices, city and
town halls, public libraries, pharmacies, and physician and attorney
offices.
Page 7 GAO/HEHS-98-26 OPO Performance Standards
B-276948
The racial and ethnic makeup of an OPO’s service area can affect its ability
to procure organs because minority families often do not consent to organ
donation. One study found that African American families’ refusal rate for
organ donation was 60 percent compared with 29 percent for white
families. Organ donation among minority populations, however, has
increased over time. For example, African Americans accounted for
8.9 percent of organ donors in 1988 and 12 percent in 1996. The OPOs
realize the need to emphasize organ donation by minorities and are
focusing on increasing donation by minority populations. To help increase
minority donation, OPOs have staff sensitive to the needs of and accepted
by the minority population to conduct outreach and request donations and
have established ethnic task forces. These efforts have increased the
number of minority organ donors. (See fig. 2.)
Figure 2: Percentage of Cadaveric
Donors by Race/Ethnicity, 1988 and 100 Percentage
1996
90
80
70
60
50
40
30
20
10
0
White African Hispanic Asian/Other
American
1988
1996
Source: UNOS 1996 Annual Report: The U.S. Scientific Registry of Transplant Recipients and The
Organ Transplantation Network and UNOS OPTN data as of Sept. 20, 1997.
Page 8 GAO/HEHS-98-26 OPO Performance Standards
B-276948
In addition, education efforts help hospital staff clarify organ and tissue
recovery policies to ensure that potential donors are consistently
recognized and referred. Such activities as educating staff both in
seminars and informally and featuring hospital newsletter articles about
organ donation help OPOs educate hospital staff.
OPOs also conduct hospital development activities to build strong
relationships with service area hospitals to promote organ donation. OPOs
try to have representatives at their larger hospitals so that they can
facilitate donation when a potential donor becomes available. In addition,
OPOs encourage hospital staff to get involved in the organ donation process
through such activities as post-donor recovery conferences to brief staff
on the results of transplantations, inform them of recipients’ status, and
discuss the strengths and weaknesses of the organ recovery process. Most
OPOs, as part of their hospital development activities, conduct medical
records reviews to determine their procurement process’ strengths and
weaknesses and to share data on missed potential donors and donation
consent rates with donor hospitals.
Many Identified Potential Many potential donors referred to OPOs do not meet OPO acceptance
Donors Do Not Become criteria; for others, the donors’ families do not consent to donation. In
Organ Donors addition, sometimes after donation consent is obtained, doctors find that
potential donors have diseases or physical conditions that make their
organs unusable. As figure 3 shows, a high proportion of potential donors
do not become organ donors. These data, from an AOPO annual survey of
member OPOs, indicate that in 1995 about two-thirds of patients identified
as potential donors were eliminated either because the family refused
consent or because the donor was ultimately judged to be unsuitable for
such reasons as HIV or hepatitis infection or poor condition of the organs
upon inspection.
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Figure 3: Reasons Referred Potential
Donors Are Eliminated During the Consented but Unsuitable
Donation Process
• 11%
30% • Donors
36%
•
23% • Consent Refused
Unsuitable
Note: Data based on responses from 49 of 66 OPOs operating in 1995, which reported a total of
14,453 donor referrals.
Source: 1995 Annual AOPO Survey Results, May 1996.
HCFA’s OPO Oversight HCFA’s regional offices oversee the entire OPO certification process.11
Role Regional offices handle the OPO application process, conduct on-site
reviews of OPOs, redesignate or terminate OPOs, and settle OPO territory
disputes. HCFA headquarters provides the regional offices with advice and
technical assistance, reviews corrective action plans submitted by OPOs
that did not fully qualify for recertification, and calculates the results of
the performance assessments.
During our review, four HCFA headquarters staff oversaw OPO performance
as part of their duties in the End Stage Renal Disease Program. HCFA has
recently reorganized the headquarters staff, however, and assigned
11
HCFA regional offices are located in Boston, New York, Philadelphia, Atlanta, Chicago, Dallas,
Kansas City, Denver, San Francisco, and Seattle. However, HCFA regional offices are forming
consortia to consolidate expertise in certain areas, including OPO surveying. For the 1996 assessment,
the New York regional office was the only one to form a consortium for OPO survey purposes. The
New York office surveyed the OPOs for the New York, Philadelphia, and Boston regional offices. For
1998, more regional offices may form consortia for OPO surveying, although it is still unclear how
many or which ones.
Page 10 GAO/HEHS-98-26 OPO Performance Standards
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overseeing OPO performance to the Division of Integrated Delivery Systems
within the Center for Health Plans and Providers and the Clinical
Standards Group in the Office of Clinical Standards and Quality. Regional
office staff are involved only during the few months every 2 years when
OPO recertification takes place.
HCFA Has Established a HCFA has developed a standard for assessing OPO performance. Starting on
Population-Based January 1, 1996, OPOs were required to achieve at least 75 percent of the
Performance Standard for national mean in four of the five performance categories averaged over the
2 calendar years before the year of redesignation. During the 1996
OPOs transition period, OPOs meeting numerical goals in three of the five
categories were recertified if they submitted an acceptable corrective
action plan to increase organ donation. Recertification was granted to five
OPOs that met numerical goals in three categories and submitted corrective
action plans. In addition, five OPOs met goals in fewer than three
categories, failing the performance standard. Of these OPOs, adjacent OPOs
took over the service areas of two and a portion of the third’s. The fourth
OPO merged operations with another OPO, and the fifth, determined to be a
new entity, was exempt from meeting the performance standard. Recent
legislation allows HCFA to change the cycle time from 2 to 4 years for OPOs
meeting the standard during the previous cycle. The five performance
categories for which OPOs must achieve numerical goals based on 1 million
population in the OPO service area are number of
• actual organ donors;
• kidneys recovered;
• kidneys transplanted;
• extrarenal organs (heart, liver, lung, and pancreas) recovered; and
• extrarenal organs transplanted.
HCFA may grant exceptions from its performance standard for OPOs
operating exclusively outside the contiguous United States such as in a
U.S. territory or commonwealth. Because distance from the U.S. mainland
can make transporting organs difficult, the procurement rate for such
areas tends to be lower. OPOs typically do not recover organs unless they
can identify suitable recipients. OPOs in these areas must, however, meet a
standard of 50 percent of the national average of all OPOs for kidneys
recovered and transplanted per 1 million population.
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We Have Reported on OPO In the Transplant Amendments Act of 1990, the Congress mandated that
Performance Measures in we study and report on the effectiveness of the national organ
the Past procurement and allocation system. As part of that study, we reported on
the effectiveness of OPOs in procuring organs and the extent of HHS’
monitoring of OPOs’ procurement efforts.12 We reported that donor
procurement rates—consisting of the number of donors procured per
1 million population in a geographic area—varied by OPO. We questioned
the usefulness of this procurement effectiveness measure, however,
because it overlooked the number of potential organ donors. HCFA
nevertheless chose population as its basis for assessing OPO organ
procurement performance.
HCFA’s current standard does not accurately measure OPOs’ performance in
HCFA’s Current procuring organs usable for transplantation for several reasons. Although
Standard Is Not the HCFA identified several advantages of using population data, measuring
Best Measure of OPO performance according to population has many inherent weaknesses. For
example, in the last assessment cycle, HCFA used population data that were
Performance not current. Furthermore, the standard does not account for variations in
demographics and other factors that can affect the organ donation rates of
OPOs, including causes of death and nonresident donors. In addition, for
the initial round of recertification, HCFA did not account for the total U.S.
population.
HCFA Noted Several HCFA chose a population-based measure because the data are readily
Advantages of Using a available. Collected by the Bureau of the Census, population data for an
OPO service area can be developed on the basis of the county-level data the
Population-Based Measure
census provides. Furthermore, the population data can be adjusted to
account for hospitals that deal with OPOs outside the designated OPO
service area. Another reason HCFA chose population data is that OPOs pay
little if anything for these data and they are relatively easy to obtain. HCFA
officials also said that the organ procurement industry, mainly AOPO,
agreed with using a population-based standard.13
In addition, HCFA officials said that population, unlike other measures,
such as number of deaths, would not pose a disadvantage for OPOs serving
urban areas. Although urban areas may be more likely to have more
violent deaths than other areas, the higher incidence of HIV and other
12
GAO/HRD-93-56, Apr. 22, 1993.
13
In its June 1996 comments on the HCFA rules, AOPO said, “AOPO recommends that population data,
while clearly flawed, continue to be used pending identification or development of alternatives.”
Page 12 GAO/HEHS-98-26 OPO Performance Standards
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diseases would limit the number of donors. In comparing the use of
population data with other alternatives, HCFA officials believe that OPOs
failing to meet a population-based standard would likely fail to meet other
standards such as ones based on the number of service area deaths.
Population Data Were Not In the last performance cycle, HCFA allowed OPOs to use either 1990 or 1992
Timely census data to count their service area populations. All OPOs chose to use
1990 data. In the next performance cycle covering 1996-97, HCFA plans to
require that OPOs use more current population data—for 1995.
Assessing OPO 1994-95 procurement and transplantation performance
using 1990 population data fails to account for population changes from
1990 to 1994. The nation’s population grew during the period from about
249 million to about 260 million, a 4.7-percent increase, with regional
increases varying. The northeast and midwest states’ population increased
by 1.2 and 2.9 percent, while the southern and western states’ population
increased by about 6.1 and 7.7 percent, respectively. Any OPO whose
service area population had increased would have had an advantage by
using the 1990 data.
Population Demographics A problem with using population as the basis for the standard is that it
Vary by Region does not account for variation in population demographics that affect
organ donation potential. Age and disease, for example, influence the
acceptability of individuals as organ donors. These characteristics vary by
region and by OPO and can pose advantages or disadvantages to an OPO’s
ability to procure donors.
About 72 percent of cadaveric organ donors in 1994 and 1995 were
between the ages of 18 and 64. Although this age group constitutes
61 percent of the nation’s overall population, among the states and the
District of Columbia, this group constitutes from about 56 to 66 percent.
Not considering other demographic factors, OPO service areas with
proportionately fewer individuals between the ages of 18 and 64 may have
a disadvantage in procuring organs. Conversely, OPOs with a greater
proportion of individuals in this age group may have an advantage in
procuring organs over other OPOs because a greater proportion of their
population would be eligible to become organ donors.
The rate of diseases, such as HIV, also varies by region, and HIV-infected
individuals are not acceptable as organ donors. Annual rates of AIDS ranged
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from a low of 2.8 cases per 100,000 population in South Dakota to a high of
246.9 cases per 100,000 population in the District of Columbia in 1994.
During 1995, the prevalence of AIDS ranged from 2.6 cases to 185.7 cases
per 100,000 population in those same jurisdictions. Such factors could
clearly limit the eligible donor pool in some OPO service areas.
Causes of Death That Yield In addition, a standard relying on population fails to account for regional
Organ Donors Also Vary variations in causes of death. Organ donors typically die from head trauma
Geographically and accidental injuries, the rates for which vary geographically. For
example, motor vehicle accidents caused the death of about 25 percent of
organ donors in 1994 and 1995. The rates of these accidents in an OPO’s
service area can pose an advantage or a disadvantage to an OPO’s ability to
procure donors. Data from the Centers for Disease Control and Prevention
show that in 1991 the number of drivers fatally injured ranged from 4.44
per 100,000 population in the District of Columbia to 17.87 per 100,000
population in Mississippi.
Some Donors Do Not Live Some OPOs may draw donors from a much larger area than their service
in the Procuring OPO’s areas. They may serve high tourist areas or have trauma centers to which
Service Area patients from outside their area are transferred. This affects the validity of
the population-based standard because nonresident donors are not
counted in the procuring OPO’s service area population. For seven OPOs
whose service areas constituted an entire state, a limited analysis of
United Network for Organ Sharing (UNOS) data shows that, from about 2 to
17 percent of the donors reported by these OPOs for 1994-95 lived outside
these OPOs’ service areas.14,15 Table 1 shows the number and percentage of
donors who lived outside the procuring OPOs’ service areas.
14
UNOS, under contract with HRSA, operates the OPTN authorized in the National Organ Transplant
Act. The OPTN contractor establishes organ transplantation policy, helps OPOs allocate organs, and
conducts efforts to increase the organ supply.
15
Data did not allow for an analysis of all 66 OPOs operating in 1994-95, most of whose service areas
cross state lines or represent a part of a state.
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Table 1: Donors Living Outside
Procuring OPOs’ Service Areas, Percentage of
1994-95 Donors from donors from
Total donors outside the outside the
OPO 1994-95 service area service area
Donor Network of Arizona 144 16 11.1
Organ Donor Center of
Hawaii 24 3 12.5
Louisiana Organ
Procurement Agency 211 25 11.8
Transplantation Society of
Michigan 355 9 2.5
Nevada Donor Organ
Referral Service 41 7 17.1
New Mexico Donor
Program 81 7 8.6
Oklahoma Organ Sharing
Network 154 7 4.5
Source: HCFA was the source for the number of total donors. The number of donors outside the
service area was provided by UNOS using data from the UNOS Cadaver Donor Registration/
Referral Form.
These data, however, may underestimate the number of donors living
outside the procuring OPOs’ service areas. OPO coordinators collect the data
used to perform this analysis when a potential donor becomes available.
They collect the data on a UNOS form and submit it to UNOS. UNOS does not
verify the data’s accuracy, and one OPO representative said that the UNOS
forms often do not capture donors’ actual residences. The coordinator
may record the donor’s residence as the donor hospital’s city, state, and
ZIP code when residency information is lacking.
HCFA Did Not Account for The population data used in assessing performance for some OPOs in 1996
Total U.S. Population but varied from the population data of the states and counties that comprise
OPOs’ service areas as defined by HCFA. The differing population data occur
Plans to in the Next Cycle
because OPOs may adjust their service area populations to account for
donor hospitals that affiliate with OPOs outside their service areas.
The law requires hospitals to have an agreement for notification of
potential organ donation only with the OPO designated for the area in
which a hospital is located.16 The law does provide, however, for the
Secretary of HHS to waive this requirement so that hospitals can refer
16
42 U.S.C. 1320b-8(a)(1)(A)(iii) and (C).
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potential donors to OPOs outside the service area.17 The Secretary must
approve such a request if she determines that it (1) is expected to increase
organ donation and (2) will ensure equitable treatment of patients waiting
for transplant within the affected OPOs’ service areas. As of October 6,
1997, HCFA had approved 173 waivers; 11 others were pending final action.
When hospitals affiliate with other OPOs, these OPOs adjust their
populations to accurately reflect their service area populations. The
affected OPOs agree upon and make the population adjustments, according
to HCFA officials. HCFA has not prescribed a method for adjusting
population data. The 1990 populations for the HCFA-defined service areas
and the populations adjusted by the OPOs appear in appendix II.
In addition, for the 1996 recertification cycle, we found, using HCFA’s OPO
service area definitions, that 39 counties with a total population of about
1.4 million people had not been assigned to an OPO. The accuracy of the
OPO definitions HCFA used for that cycle raises concerns because three of
the unassigned counties had sizable populations of about 100,000 people
or more. One of these counties headquartered an OPO. (App. III lists the
unassigned counties.) According to a HCFA official, for the next
recertification cycle, all counties will be assigned to OPOs. Table 2 shows
the 1990 U.S. population, including Puerto Rico, the total population
assigned to the OPOs, and the population of the unassigned counties.
Table 2: OPOs Adjusted 1990
Population Data to More Accurately Population
Reflect Service Area Populations (in
Population group thousands)
U.S. including Puerto Rico 252,240
Assigned to OPOs 248,734
39 unassigned counties 1,386
Not unaccounted for by OPO adjustments and unassigned counties 2,120
Because of adjustments to OPO populations and the unassigned counties,
about 3.5 million people were not assigned to any OPO. Although the
affected OPOs are to consider their total populations and agree on
population adjustments, OPOs did not account for about 2.1 million people
in their population data. The unassigned counties, according to a HCFA
official, generally did not have a hospital in their service areas. For the
next recertification cycle, HCFA regional offices are to reconcile the OPO
populations to account for the total U.S. population.
17
42 U.S.C. 1320b-8(a)(2).
Page 16 GAO/HEHS-98-26 OPO Performance Standards
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HCFA considered but rejected using the number of deaths as a basis for its
An Alternative standard. Assessing OPO procurement and transplantation performance
Standard Based on the according to the number of deaths is slightly more suitable than using
Number of OPO population as a standard because it limits comparisons to the portion of
the population eligible for organ donation. It has several disadvantages,
Service Area Deaths Is however, including lack of timely data and of adjustments for factors
Slightly More surrounding an organ donor’s death, such as whether it was an in-hospital
death, cause of death, declaration of brain death, and age, among others,
Accurate but Still a that do not allow for accurately assessing the number of potential donors.
Gross Measure of
Performance
HCFA Considered but HCFA reasoned that because states collect vital statistics data, such as
Rejected a Standard Using mortality data, such data may be inconsistent among the states. HCFA also
Number of Deaths had concerns about OPOs’ cost in obtaining death data and its timeliness.
When HCFA was developing its population-based performance standard and
considering alternatives, the National Center for Health Statistics (NCHS)
had public use tapes of mortality statistics available. HCFA did not want
OPOs to incur expenses by having to purchase the tapes and certain
computer resources and staff to analyze the data. In addition, NCHS’
mortality statistics have an approximately 2-year delay in availability.
Number of OPO Service Although some organs, typically kidneys, are obtained from living donors,
Area Deaths Rather Than OPOs recover organs from cadaveric donors. Therefore, the number of
Population More deaths in their service areas more accurately reflects the number of OPOs’
potential donors. In 1994, the United States had about 2.3 million deaths
Accurately Reflects out of a population of about 260 million. Although using total deaths fails
Number of Potential to consider other factors about and characteristics of potential donors, it
Donors would eliminate considering a portion of the population that an OPO clearly
could not consider for organ donation.
National Mortality Data Because collecting vital statistics is typically a state function, NCHS obtains
Are Not Complete or mortality statistics from the states, the District of Columbia, and
Timely Enough for OPO territories. Some territories, such as Puerto Rico, do not submit data to
NCHS. In addition, the availability of data lags by 2 years. For example,
Assessment Purposes mortality data for 1995 were not available until mid-1997. Because of this,
using NCHS mortality data to assess OPO performance would result in a
problem similar to that of using 1990 population data for the 1994-95
assessment cycle: namely, comparing the number of deaths for
incomparable time periods. The degree to which death rates vary over
Page 17 GAO/HEHS-98-26 OPO Performance Standards
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time is not clear; comparing data from different time periods, however,
may skew the results of this type of analysis. This situation may become
less problematic when HCFA moves to a 4-year recertification cycle
because data would then be available for at least part of the period under
review.
Small Portion of Those Because only a fraction of those who die make acceptable organ donors,
Who Die May Become using number of deaths as a standard provides only a gross measure of the
Organ Donors number of potential donors. The United States had about 2.3 million
deaths in 1994; however, national estimates of potential donors vary
widely—totaling 5,000 to 29,000. Organ donors’ characteristics account for
the small number of acceptable organ donors compared with the number
of deaths.
Many older people are not considered potential donors upon their death
because they are less likely than younger people to yield organs suitable
for transplantation. People 65 years of age or older accounted for
73 percent of U.S. deaths in 1994. This age group accounted for less than
5 percent of the organ donors in 1994 and 1995. In addition, organ donors
are admitted to a hospital before death, most to an intensive care unit.
Furthermore, certain causes of death are more likely to result in the
declaration of brain death than others. The vast majority of organ donors
in 1994 and 1995 died from head trauma, such as that occurring from
motor vehicle accidents or violent injuries; intracranial hemorrhage or
stroke; or anoxia (insufficient amount of oxygen reaching the tissues of
the body) caused, for example, by drowning or asphyxiation.
Some other causes of death make organ donation unacceptable because of
disease that compromises the viability of organs for transplant. These
diseases include HIV infection, hepatitis B, certain cancers, and
tuberculosis, among others. Cancer, the second leading cause of death in
1996, accounted for 24 percent of the deaths that year.
Because of these factors, a standard based on the number of donors and
organs procured and organs transplanted per 100,000 deaths may be little
better than one based on population in assessing OPOs’ performance in
procuring organs from potential donors.
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HCFA also considered and rejected using adjusted death data to assess OPO
An Alternative performance. Adjusting for cause of death and age would more accurately
Standard Using estimate the number of potential organ donors than do either population
Number of Deaths or total death statistics. Considering only those causes of death that most
often result in organ donation is an indicator of the number of potential
Adjusted for Cause of donors. In addition, because older people generally do not become organ
Death and Age Would donors, limiting consideration to certain age groups would better reflect
the number of likely donors.
More Accurately
Measure the Number Unfortunately, incomplete and untimely data would make adjusting for
of Potential Donors cause of death and age problematic as it does using total number of
deaths. The coding of causes of death may not sufficiently identify suitable
but Still Be donors, and methods for adjusting for causes of death are not standard
Approximate and require special staff and equipment capabilities. These drawbacks
hinder the usefulness of an adjusted cause of death and age standard for
assessing OPO performance.
HCFA Considered Using When HCFA was developing its performance standard, the agency
Number of In-Hospital suggested that the number of in-hospital deaths provided a more targeted
Deaths as a Standard measure of the number of an OPO’s potential donors. However, the agency
had concerns that such data would be unavailable or incomplete.
Adjusting for Cause of Measuring OPO performance according to the number of service area
Death and Age More deaths adjusted for cause of death and age more accurately reflects the
Accurately Estimates number of potential donors than measuring performance according to the
number of all service area deaths. The number of service area deaths
Number of Potential adjusted for cause of death and age better estimates the number of
Donors Than Number of potential donors because it accounts for the small subset of the deceased
Deaths Alone that may be suitable organ donation candidates. Adjusting for cause of
death and limiting consideration to deaths of those under age 75, we found
that in 1994 about 147,000, or 6 percent, of the 2.3 million U.S. deaths
involved these causes of death or were from this age group. This estimate,
however, is much larger than the estimates some have made of a national
donor pool of from 5,000 to 29,000 people per year.
Adjusted Cause of Death Adjusted cause of death data are a subset of the NCHS mortality statistics.
Data Are Incomplete or As noted, these data have completeness and timeliness limitations.
Not Timely Enough for Depending on the variables used for adjusting, it may not be possible to
make these adjustments to analyze these data for all OPOs. For example,
OPO Assessment Purposes
Page 19 GAO/HEHS-98-26 OPO Performance Standards
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Oklahoma does not distinguish whether the death occurred in or out of
hospital. Just as for total number of deaths, adjusted death data have a
2-year lag in availability. Again, this may be less problematic when HCFA
moves to a 4-year recertification cycle.
Coding Cause of Death State offices of vital statistics report mortality statistics using the
Data May Not Sufficiently International Classification of Diseases 9th Revision Clinical Modification
Identify Suitable Donors (ICD-9-CM) codes to classify deaths by cause and circumstances. Medical
staff apply these codes at the time of death. An NCHS official stated that
state offices of vital statistics accurately apply these codes, and studies
have shown that only 3 percent of cases have coding discrepancies.
Whether physicians are appropriately diagnosing cause of death and
recording it accurately on the death certificate is unknown.
ICD-9-CM codes have limitations for estimating the number of potential
donors in the absence of more detailed information. For example, the
codes may not allow for determining the site of a cerebrovascular accident
(CVA). CVA was the cause of death in about 40 percent of donors in 1994 and
1995. The lesion’s site in a CVA determines whether brain death will occur,
so knowing the site is important for determining donation potential for
assessing organ procurement performance.
Methods for Adjusting for We did not identify an agreed-upon set of variables for indicating the
Cause of Death Not subset of deaths that would yield suitable organ donors. We consulted
Standard and Require experts to identify ICD-9-CM codes most frequently associated with organ
donors; however, the measure we used does not fully account for the
Certain Resources characteristics of potential donors. For example, our definition of adjusted
deaths does not include in-hospital deaths, a requisite for organ donation.
In addition, data, such as from NCHS, do not reveal enough information to
accurately identify deaths with organ donation potential because data on a
patient’s social history and medical conditions ruling out organ donation
are missing.
Another drawback of using adjusted death data is the resources needed to
perform the analyses. As HCFA noted in rejecting this alternative, OPOs
would need to have certain computer and staff resources to compute the
number of adjusted deaths in their service areas.
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As stated, using the number of deaths and adjusted deaths may be an
More OPOs Would incremental improvement over using population data because OPOs are
Have Been Subject to assessed according to subsets of the population that can become organ
Termination Under donors. However, like population data, these measures do not accurately
reflect organ procurement performance. Our analysis determined whether
Alternative Measures OPOs identified as poor performers under the current standard would fare
differently under alternative measures.
To assess the OPOs using these alternative measures, we used the 1994-95
OPO data on the categories HCFA used to assess performance. (See app. I for
more information on our methodology.) As shown in table 3, some but not
all OPOs would have fared differently depending on the standard used to
assess performance. Five OPOs would have been subject to termination for
failing to meet at least 75 percent of the national average for at least three
of the five performance categories using HCFA’s population-based standard;
three of these five OPOs would also have failed using a standard based on
the number of deaths or adjusted deaths. The two other OPOs subject to
termination under the current population standard would also have failed
to meet the adjusted deaths standard. An additional 10 OPOs would have
been subject to termination under one or the other (or in one case, both)
of the two alternative standards.
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Table 3: OPOs Not Meeting 75 Percent
of the Average for at Least Three of the Performance standard based on
Five Performance Categories Using Adjusted
Various Measures OPO Population Deaths deaths
Long Island Transplant Program X X X
Mississippi Organ Recovery X X X
Agency
Medical College of Georgia X X X
Northwest Organ Procurement X X
Agency
Regional Organ Procurement X X
Agency of Southern California
Arkansas Regional Organ X X
Recovery Agency
New England Organ Bank X
OPO of Albany Medical College X
Upstate New York Transplant X
Services, Inc.
Carolina Life Care X
Donor Network of Arizona X
Mid-South Transplant Foundation X
South Carolina Organ Procurement X
Agency
South Texas Organ Bank X
Southern California Organ X
Procurement Center
Note: We did not include the OPOs for Hawaii and Puerto Rico in our analysis because (1) the
OPOs are in a noncontiguous state and territory and therefore have to meet different criteria and
(2) mortality data were not available for Puerto Rico.
More OPOs would have been subject to termination under a standard based
on the number of deaths and adjusted deaths, 7 and 12 respectively, than
under a standard based on population. Thus, although population does not
accurately assess OPO performance, it may mean fewer OPOs are being
assessed as poor performers. Although additional OPOs are identified as
poor performers under the alternative standards, this does not necessarily
indicate that action against them would have been warranted but may
indicate flaws in these alternate measures.
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A standard using the number of donors and the number of organs
An Alternative recovered and transplanted compared with the number of potential organ
Standard Using donors would more accurately assess OPO performance. A retrospective
Medical Records review of death records from hospitals in an OPO’s service area could be
used to estimate the number of potential donors. In developing its
Reviews Would More standards, HCFA did not consider using medical records reviews to
Accurately Determine estimate the number of potential donors for assessing OPOs’ performance.
Most OPOs are conducting some form of medical records review to gain
the Number of OPOs’ information on the strengths and weaknesses of their organizations’ organ
Potential Donors but procurement policies and practices. AOPO has started a medical records
May Be Costly review project to determine the feasibility of using medical records
reviews to estimate the number of potential donors. Using medical records
reviews for assessing performance depends on several considerations:
consistency of OPOs’ reviews, their independent and valid results, the cost
of the reviews, and the cooperation of donor hospitals in giving access to
medical records. HCFA is considering rules that would require hospital
cooperation in medical records reviews.
Medical Records Reviews Systematically reviewing donor hospital medical records can help to
Can Accurately Estimate accurately estimate the number of an OPO’s potential donors. A medical
the Number of an OPO’s records review involves reviewing all deaths at a hospital, with an in-depth
examination of those meeting certain criteria. Reviewing the charts for
Potential Donors these patients reveals the patients’ suitability for organ donation based on
several factors, including cause of death, evidence of brain death, and
contraindications for donation such as age and disease. Such reviews can
identify that subset of deaths in which patients could have become organ
donors—the true number of potential donors for an OPO service area.
Most OPOs Conduct Some A survey of 68 OPOs that we conducted in 1992 showed that 60 conducted
Form of Medical Records some form of medical records review.18 The reviews varied from a yearly
Review review of all major hospitals to a review of a sample of cases at some
major hospitals. A more recent survey, AOPO’s 1995 annual survey of its
member OPOs, showed that 43 of the 49 OPOs participating in the survey
conducted records reviews, mainly in donor-producing hospitals. The
surveyed OPOs, however, are increasingly reviewing records in hospitals
that have not provided organ donors to determine if these hospitals have
the potential for donors.
18
GAO/HRD-93-56, Apr. 22, 1993.
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In addition, OPOs use these reviews as a management tool. They track
indicators such as the rate at which hospitals identify and refer potential
donors to the OPO, rates of requesting donation, and rates of consent to
donation. Staff at the OPOs we visited stated that this information allows
them to determine where they need to focus their efforts to increase organ
donation.
Of the OPOs we visited, all were conducting some form of medical records
review. This included one OPO that had instituted a voluntary system in
which hospitals in its service area agreed to notify the OPO of all in-hospital
deaths.19 About 75 percent of the hospitals in the service area participate.
Even with this system, the OPO still found it valuable to conduct medical
records reviews to determine the completeness and accuracy of the
information reported by the participating hospitals. The OPO conducts
more complete records reviews at hospitals not participating in the
system.20
AOPO Is Conducting a AOPO is conducting a medical records review project partially funded by
Medical Records Review HRSA involving 33 participating OPOs. The project’s goal is to develop a
Project method for consistently collecting information to determine the potential
donor population. The OPOs are conducting the reviews for 18 months. To
ensure consistent reviews, AOPO has developed a manual for and trained
staff of the participating OPOs.
AOPO estimates that the project’s conclusions will be available by mid-1998.
Preliminary results of the project, however, were presented at the AOPO
annual meeting in June 1997. Data were presented on, among other things,
the number of potential donors identified, the number referred to the OPOs,
consent rates, and the number of organ donors. Preliminary results of the
project raised some concerns, including the varying levels of cooperation
by donor hospitals, consistency in record reviewers’ interpretation of data,
and the cost and time needed to validate self-reported data. As part of this
project, AOPO plans to develop hospital demographics data collection
forms to produce a model for estimating donor potential. This will reduce
the effort needed to conduct medical records reviews.
19
This system allows the OPO to assess the information and screen for potential donors rather than
rely on the hospital staff to identify likely donors.
20
A Pennsylvania state law requires that hospitals notify the OPOs of deaths for the OPOs to determine
the suitability of donors for organ donation. One OPO we contacted in the state said that it conducts
medical records reviews to, among other things, check on hospital compliance with the death
notification requirement.
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Donor Acceptability Differences in donor acceptance criteria by OPO may make it difficult to
Criteria Vary by OPO consistently identify potential donors. Some OPOs are accepting organs
from older donors and those with diseases such as hepatitis C,
hypertension, and certain cancers. Organs from these donors can be more
costly to procure, and recipient survival rates can be lower. Using such
donors can increase the donor pool, however, and benefit patients who
otherwise would not receive a transplant.
If HCFA were to assess OPOs’ performance according to their number of
potential donors, OPOs that use liberal donor acceptance criteria for
estimating purposes would not fare as well as those with more
conservative donor acceptance criteria. Potential donors who are older or
have compromising health conditions are less likely to become donors and
may yield fewer organs than younger and healthier donors.
To illustrate, one OPO we visited is participating in the AOPO medical
records review project and provides data to AOPO using the AOPO potential
donor criteria. The OPO, however, for its own purposes, uses more liberal
criteria than AOPO’s to identify potential donors. As a result, 28 percent of
the potential donors the OPO identified using its own acceptance criteria
did not meet the AOPO criteria. OPO officials conceded that most of the
28 percent of potential donors would not have been acceptable, but to
maximize its number of organ donors, counted these patients as potential
donors. OPOs told us that an important factor in allowing them to use
liberal donor criteria is the willingness of the transplant centers in their
service area to use organs from these donors. Because most organs go to
the transplant centers in an OPO’s service area, the OPO’s criteria will reflect
the practice styles of those transplant centers. Where a transplant center is
willing to transplant organs from older or less healthy donors, the OPO will
expand its criteria to recover organs from older donors and those with
certain diseases and medical conditions; where transplant centers are not
likely to use these organs, an OPO will not recover such organs if it does
not believe it can place them.
For medical records reviews to be used for identifying the number of an
OPO’s potential donors and assessing OPO performance according to its
donor potential, consideration must be given to OPOs’ varying donor
acceptance criteria. For OPOs that have liberal donor acceptance criteria,
adjustments must be made for the lower organ yield per donor these OPOs
may have.
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Cost of Medical Records Although medical records reviews are a valuable tool for determining the
Reviews Must Be number of potential donors, they can be expensive for an OPO. Many OPOs,
Considered however, that are conducting comprehensive records reviews are already
bearing the cost of the reviews. In addition, the degree to which added
expense will be incurred to conduct the reviews and analyze the results is
not clear. The OPOs we visited use different approaches to conduct these
reviews. Some OPOs have separate staff to conduct hospital development
tasks, which include records reviews, while other OPOs rely on their
procurement coordinators to conduct the reviews at their assigned
hospitals. We asked the OPOs to provide information on the resources
needed and the costs associated with conducting medical records reviews.
One OPO reported the cost as a few thousand dollars; another OPO reported
the cost as $250,000. We did not determine what these costs comprised.
The OPO with the highest records review costs increased its staff from 35
full-time equivalent positions in 1993 to 63.2 in 1997, an 81-percent
increase. The additional staff were hired to perform organ procurement
and hospital development as well as support services. During this same
period, the OPO increased its number of organ donors by 51 percent. The
increase in organ procurement and hospital development staff was critical
to increasing the number of organ donors, according to OPO officials. OPO
officials also noted that the growth in organ donation in the 5-year period
allowed them to hold organ acquisition fees relatively constant even with
the increased investment in personnel.
Medical Records Reviews For medical records reviews to be used to accurately estimate the number
Are Not Consistent by OPO of potential donors as part of HCFA’s recertification standards, they must
yield consistent and valid results. The OPOs that conduct medical records
reviews, however, do so to determine their operations’ weaknesses and
what practices they should emphasize to increase organ donation. These
OPOs design their reviews to meet their needs and available resources.
In addition, OPOs conducting records reviews generally use different
methodologies for their reviews. As the AOPO project revealed, consistent
records reviews would require standard collection forms, manuals, and
reviewer training. As AOPO found, validating results can be costly and time
consuming. To use records reviews for assessing OPO performance, HCFA
would have to validate the results somehow. One way to validate results
would be to include a sample validation component when inspecting OPOs.
Furthermore, a minority of OPOs do not conduct medical records reviews.
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These OPOs lack the experience of some other OPOs because they have not
been working with hospitals to allow them access to records.
Some donor hospitals’ lack of cooperation is a major concern to OPOs. The
OPOs we visited cited hospitals in their service areas that refused to
cooperate with records reviews. One reason for this is the hospital’s
concern for patient confidentiality. Currently, OPOs have no leverage to
make hospitals cooperate in the reviews. We also learned that the degree
of cooperation varies among participating hospitals: Some hospitals will
provide lists of hospital deaths and facilitate access to records; at other
hospitals, the reviewers have to take additional steps to locate appropriate
records for review.
HCFA is considering changing requirements for hospitals participating in
Medicare regarding organ donation. The agency may propose changes
requiring hospitals to cooperate with OPOs in reviewing death records.
Other possible changes would provide OPOs with more control over
identifying potential donors, requesting donations, educating hospital
staff, and managing donors while testing and placement take place.
A team of researchers from the Partnership for Organ Donation, the
An Alternative Harvard Medical School, and the Harvard School of Public Health has
Standard Based on developed a modeling method using information about hospitals to predict
Modeling Might Be the number of potential donors. The goal of this effort is to design an
estimating procedure that will be relatively simple to execute, inexpensive,
Used to Estimate the and valid. The scope of their study includes three OPOs and a random
Number of Potential stratified sample of 88 hospitals in the OPOs’ service areas.
Donors The team identified variables that are statistically significant predictors of
the number of potential donors. It collected medical records review data
for calendar years 1993 and 1992 in the smallest hospitals in the sample.
Using the number of potential donors from the medical records review as
the dependent variable, the team tested the variables in a series of
regressions to identify those that best predicted the number of potential
donors.21 Variables included total number of deaths, total staffed beds,
Medicare case mix, medical school affiliation, and trauma center
certification.
Death data were not readily available at all sample hospitals. For example,
data on the numbers of deaths were not available at 6 hospitals, and only
21
The team used a series of hierarchical Poissan regressions.
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partial death data were available at 12 hospitals. Because of this, the team
identified proxy variables for death. These variables included total staffed
beds. In addition, the team found case mix to be a strong predictor of the
number of potential donors. Case mix is the type of patients, based on
diagnosis, that are in the hospital.
Research results have shown that the estimated numbers of potential
donors are reasonably close to the numbers estimated from the medical
records reviews. This modeling method shows promise for accurately
estimating the number of potential donors and involves fewer resources
than medical records reviews. If this research effort realizes its goal, this
method could be a reasonable alternative to medical records reviews for
assessing OPO performance.
Because of the gap between the supply of organs and the demand for
Conclusions organ transplants, OPOs are legislatively required to conduct and
participate in systematic efforts to acquire all usable organs from potential
donors. HCFA’s current population-based performance standard cannot
accurately assess OPOs’ ability to meet the goal of acquiring all usable
organs because it does not identify the number of potential donors within
the OPOs’ service areas.
We identified performance measures as alternatives to the current
population-based standard. Two of these alternatives—organ procurement
and transplantation compared with the number of deaths or deaths
adjusted for cause of death and age—would more accurately estimate the
number of potential organ donors but have drawbacks. These drawbacks
include lack of timely data and inability to identify the subset of causes of
death suitable for organ donation. HCFA considered and rejected each of
these alternatives when it established the current standard.
Two other alternative measures that HCFA did not consider—medical
records reviews and modeling—show more promise for accurately
identifying the number of potential donors. Reviewing hospital medical
records is the most accurate method of estimating the number of potential
donors in an OPO’s service area. Most OPOs do conduct medical records
reviews but at varying levels of sophistication. For such a measure to be
usable, the reviews would have to be conducted consistently among OPOs
and the results would need to be available for validation. The AOPO records
review project has raised questions about consistency in conducting the
reviews and the independent verification of their results. Although most
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OPOs are conducting some form of medical records reviews and therefore
incurring the costs of these reviews, HCFA must consider its own and the
OPOs’ additional expense involved in standardizing such reviews. Other
considerations include the extent to which the reviews would add to the
cost of organs and whether these costs would outweigh the benefit of
more accurately measuring the number of potential donors.
Another alternative, modeling, shows promise and would be less
expensive than medical records reviews. At least one group is developing
a modeling method using substitute measures to provide a valid measure
for estimating the number of potential donors. Using existing data would
make this alternative less costly than medical records reviews; however,
the accuracy of such a model has yet to be established. If the number of
potential donors for an OPO can be reasonably predicted using a set of
variables, this could eliminate concerns about the cost of implementing
medical records reviews.
HCFA believes its current standard identifies OPOs that are “poor
performers.” In its final rule, however, the agency stated that it was
interested in any empirical research that would merit consideration for
further refining its standard. The approaches we have identified merit
HCFA’s consideration.
To better ensure that HCFA accurately assesses OPOs’ organ procurement
Recommendations performance and that OPOs are maximizing the number of organs procured
and transplanted, we recommend that the Secretary of Health and Human
Services direct HCFA to evaluate the ongoing development of methods for
determining the number of potential donors for an OPO. These methods
include medical records reviews and a model to estimate the number of
potential donors. If HCFA determines that one or both of these methods can
accurately estimate the number of potential donors at a reasonable cost, it
should choose one and begin assessing OPO performance accordingly.
HCFA was given a draft of this report but could not provide written
Agency Comments comments in time for their inclusion in this report. We met with HCFA
headquarters officials responsible for the OPO certification process, and
they concurred with our recommendation.
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We are sending copies of this report to the Secretary of Health and Human
Services, the Administrator of the Health Care Financing Administration,
and the Administrator of the Health Resources and Services
Administration, and other interested parties. We will also make copies
available to others upon request.
Please contact me at (202) 512-7119 if you or your staff have any questions.
Major contributors to this report include Marcia Crosse, Roy Hogberg,
Andrea Rozner, Joan Vogel, and Craig Winslow.
Sincerely yours,
Bernice Steinhardt
Director, Health Services Quality
and Public Health Issues
Page 30 GAO/HEHS-98-26 OPO Performance Standards
Page 31 GAO/HEHS-98-26 OPO Performance Standards
Contents
Letter 1
Appendix I 34
Scope and
Methodology
Appendix II 37
Difference in the 1990
OPO Service Area
Population and the
Population HCFA
Used for Assessment
Purposes
Appendix III 40
Counties Not
Assigned to Any OPO
for the 1996
Recertification Cycle
Tables Table 1: Donors Living Outside Procuring OPOs’ Service Areas, 15
1994-95
Table 2: OPOs Adjusted 1990 Population Data to More Accurately 16
Reflect Service Area Populations
Table 3: OPOs Not Meeting 75 Percent of the Average for at Least 22
Three of the Five Performance Categories Using Various
Measures
Table I.1: ICD-9-CM Codes Used to Adjust for Cause of Death 36
Figures Figure 1: Total Number of Cadaveric Organ Donors by Type of 6
Organ Donated, 1996
Figure 2: Percentage of Cadaveric Donors by Race/Ethnicity, 1988 8
and 1996
Figure 3: Reasons Referred Potential Donors Are Eliminated 10
During the Donation Process
Page 32 GAO/HEHS-98-26 OPO Performance Standards
Contents
Abbreviations
AIDS acquired immunodeficiency syndrome
AOPO Association of Organ Procurement Organizations
CVA cerebrovascular accident
HCFA Health Care Financing Administration
HHS Department of Health and Human Services
HIV human immunodeficiency virus
HRSA Health Resources and Services Administration
NCHS National Center for Health Statistics
OPO organ procurement organization
OPTN Organ Procurement and Transplantation Network
UNOS United Network for Organ Sharing
Page 33 GAO/HEHS-98-26 OPO Performance Standards
Appendix I
Scope and Methodology
To learn about organ procurement issues and organ procurement
organization (OPO) operations and develop information on alternative
performance measures, we conducted a literature review and interviewed
a number of federal officials and representatives of organizations and
OPOs. We interviewed officials and obtained documentation from the
Health Care Financing Administration (HCFA) and the Health Resources
and Services Administration’s Division of Transplantation. We met with
and obtained documentation from representatives of the Association of
Organ Procurement Organizations, American Congress for Organ
Donation, Partnership for Organ Donation, United Network on Organ
Sharing, and selected OPOs.
We also met with and received data from representatives of seven OPOs,
including the
• Regional Organ Procurement Agency of Southern California, Los Angeles,
California;
• Southern California Organ Procurement Center, Los Angeles, California;
• Regional Organ Bank of Illinois, Chicago, Illinois;
• New England Organ Bank, Newton, Massachusetts;
• LifeGift Organ Donation Center, Houston, Texas;
• Southwest Transplant Alliance, Dallas, Texas; and
• Washington Regional Transplant Consortium, Falls Church, Virginia.
We selected these OPOs because they were reviewing medical records and
because they represented different geographic locations and a range of
performance rankings under the current performance standards.
To rank OPOs’ performance using standards other than HCFA’s population-
based standard, we obtained 1994 county-level mortality data from the
Centers for Disease Control and Prevention’s National Center for Health
Statistics (NCHS). Using these data, we determined the total number of
deaths and the number of deaths adjusted for the cause of death and age
for 65 OPOs during 1994. (NCHS could not provide mortality data for Puerto
Rico.) Although we wanted to use mortality statistics for 1994 and 1995,
the most recent year for which we could obtain data was 1994.
After developing the number of deaths and adjusted deaths for each OPO,
we modified them to account for adjustments OPOs made in their
population data, which HCFA used to assess their performance. If an OPO
adjusted its population data upwards, we increased the numbers of deaths
and adjusted deaths proportionately. Likewise, if an OPO adjusted its
Page 34 GAO/HEHS-98-26 OPO Performance Standards
Appendix I
Scope and Methodology
population data downwards for assessment purposes, we decreased the
number of deaths proportionately.
To determine the number of deaths adjusted for cause of death, we
developed a list of causes of death that could reasonably result in brain
death and from which organ donation might therefore be possible. The list
was limited to deaths occurring under the age of 75 because almost no
organ donors exceed this age. To develop data on deaths associated with
brain death, we (1) used the Partnership for Organ Donation’s medical
records review form, which identifies causes of death most likely to
produce potential organ donors; (2) reviewed the ICD-9-CM, Fourth
Edition to identify the codes for these causes of death; and (3) sent a list of
the codes we selected to NCHS’ Mortality Branch for review and revision to
ensure that we had chosen the most appropriate codes. Table I.1 lists and
describes the codes we used in our search.
Page 35 GAO/HEHS-98-26 OPO Performance Standards
Appendix I
Scope and Methodology
Table I.1: ICD-9-CM Codes Used to
Adjust for Cause of Death ICD-9-CM Code Description
430 - 438 Cerebrovascular disease
798.0 Sudden infant death syndrome
E810 - E825a Motor vehicle accident
E830 Accident of watercraft causing submersion
E832 Other accidental submersion or drowning in water
transport accident
E850 - E858 Accidental poisoning by drugs, medicinal substances,
and biologicals
E910 - E913 Accidental submersion, suffocation, and other foreign
bodies
E920 Accidents caused by cutting and piercing instruments or
objects
E922 Accident caused by firearm missile
E930 - E950.5 Drugs, medicinal and biological substances causing
adverse effects in therapeutic use, suicidal and
self-inflicted poisoning by solid or liquid substances
E953 - E955.4, E956, E958.5 Suicide
E962.0 Assault by poisoning
E963 Assault by hanging and strangulation
E964 Assault by drowning
E965 - E965.4 Assault by firearms and explosives
E966 Assault by cutting and piercing instrument
E970 Injury due to legal intervention by firearms
E974 Injury due to legal intervention by cutting and piercing
instrument
E980.0 - E980.5 Poisoning, undetermined whether accidentally or
purposely inflicted
E983 Hanging, strangulation, or suffocation, undetermined
whether accidentally or purposely inflicted
E984 Drowning, undetermined whether accidentally or
purposely inflicted
E985 - E985.4 Injury by firearms, undetermined whether accidentally or
purposely inflicted
E986 Injury by cutting, piercing instruments, undetermined
whether accidentally or purposely inflicted
a
“E” codes permit the classification of environmental events, circumstances, and conditions as the
cause of injury, poisoning, and other adverse effects.
Page 36 GAO/HEHS-98-26 OPO Performance Standards
Appendix II
Difference in the 1990 OPO Service Area
Population and the Population HCFA Used
for Assessment Purposes
OPO 1990
population using 1990 OPO
HCFA definition adjusted Population
OPO of service area population difference
Alabama Organ Center 4,236,799 4,200,000 –36,799
Donor Network of Arizona 3,665,228 3,665,000 –228
Arkansas Regional Organ
Recovery Agency 1,947,665 1,947,665 0
California Transplant
Donor Network 9,593,175 9,979,519 386,344
Golden State Transplant
Services 1,712,294 1,712,294 0
Organ and Tissue
Acquisition Center of
Southern California 2,607,319 2,607,319 0
Regional Organ
Procurement Agency of
Southern California 12,312,344 9,800,935 –2,511,409
Southern California Organ
Procurement Center 3,444,191 5,643,679 2,199,488
Colorado Organ Recovery
Systems, Inc. 3,672,986 3,672,986 0
Northeast OPO and Tissue
Bank 1,297,770 1,552,727 254,957
Washington Regional
Transplant Consortium 3,923,574 3,709,499 –214,075
LifeLink of Florida 2,541,773 2,541,773 0
LifeLink of Southwest
Florida 978,935 1,014,415 35,480
The OPO at University of
Florida 2,671,905 2,499,702 –172,203
TransLife 2,143,078 2,145,883 2,805
University of Miami OPO 4,418,559 4,537,294 118,735
LifeLink of Georgia 4,150,032 4,144,358 –5,674
Medical College of
Georgia 1,967,617 1,960,631 –6,986
Organ Donor Center of
Hawaii 1,108,229 1,108,229 0
Regional Organ Bank of
Illinois 10,975,331 10,254,251 –721,080
Indiana Organ
Procurement
Organization, Inc. 4,740,780 4,740,780 0
Iowa Statewide Organ
Procurement Organization 2,793,497 2,776,755 –16,742
(continued)
Page 37 GAO/HEHS-98-26 OPO Performance Standards
Appendix II
Difference in the 1990 OPO Service Area
Population and the Population HCFA Used
for Assessment Purposes
OPO 1990
population using 1990 OPO
HCFA definition adjusted Population
OPO of service area population difference
Midwest Organ Bank 4,982,841 4,456,332 –526,509
Kentucky Organ Donor
Affiliates 3,289,825 3,743,335 453,510
Louisiana Organ
Procurement Agency 4,219,973 4,219,973 0
Transplant Resource
Center of Maryland 2,947,789 3,194,019 246,230
New England Organ Bank 11,873,328 10,329,684 –1,543,644
Organ Procurement
Agency of Michigan 9,295,297 9,295,297 0
Upper Midwest Organ
Procurement
Organization, Inc. 5,801,912 5,801,912 0
Mississippi Organ
Recovery Agency, Inc. 2,505,306 2,505,306 0
Mid-America Transplant
Association 3,839,119 4,100,000 260,881
Nebraska Organ Retrieval
System, Inc. 1,547,215 1,578,385 31,170
Nevada Donor Network 1,201,833 741,459 –460,374
New Jersey Organ and
Tissue Sharing Network 5,987,846 6,187,749 199,903
New Mexico Donor
Program 1,515,069 1,515,069 0
Long Island Transplant
Program 2,609,212 2,109,212 –500,000
New York Regional
Transplant Program 9,113,955 9,613,955 500,000
OPO of Albany Medical
College 2,140,126 2,145,405 5,279
University of Rochester
Organ Procurement
Program 2,363,371 2,363,371 0
Upstate New York
Transplant Services, Inc. 1,568,454 1,568,454 0
Carolina Life Care 1,786,468 1,786,568 100
Carolina Organ
Procurement Agency 3,241,147 3,180,550 –60,597
Life Share of the Carolinas 1,734,300 1,716,874 –17,426
Life Connection of Ohio 2,406,986 2,472,522 65,536
LifeBanc 4,161,380 4,241,536 80,156
Lifeline of Ohio 2,823,495 2,800,000 –23,495
(continued)
Page 38 GAO/HEHS-98-26 OPO Performance Standards
Appendix II
Difference in the 1990 OPO Service Area
Population and the Population HCFA Used
for Assessment Purposes
OPO 1990
population using 1990 OPO
HCFA definition adjusted Population
OPO of service area population difference
Ohio Valley Life Center 1,839,876 1,839,876 0
Oklahoma Organ Sharing
Network, Inc. 3,145,585 3,145,585 0
Pacific Northwest
Transplant Bank 3,551,900 3,551,900 0
Center for Organ
Recovery and Education 5,452,392 5,636,618 184,226
Delaware Valley
Transplant Program 10,145,168 9,982,214 –162,954
Lifelink of Puerto Rico 3,522,037 3,522,037 0
South Carolina Organ
Procurement Agency 3,148,739 3,215,891 67,152
Life Resources Donor
Center 635,668 635,668 0
Mid-South Transplant
Foundation 1,343,807 1,300,000 –43,807
Tennessee Donor Services 3,456,887 3,373,477 –83,410
LifeGift Organ Donation
Center 6,437,243 6,461,472 24,229
South Texas Organ Bank 3,824,020 3,824,020 0
Southwest Organ Bank 6,515,753 6,783,713 267,960
Intermountain Organ
Recovery Systems 2,169,595 2,277,953 108,358
Life Net 3,074,738 2,800,000 –274,738
Virginia Organ
Procurement Agency 1,798,580 1,567,415 –231,165
Northwest Organ
Procurement Agency 5,081,913 5,081,913 0
Sacred Heart Organ
Procurement Agency 959,996 959,996 0
University of Wisconsin
OPO 2,630,297 2,722,306 92,009
Wisconsin Donor Network 2,169,463 2,169,463 0
Total 250,762,985 248,734,178 –2,028,807
Page 39 GAO/HEHS-98-26 OPO Performance Standards
Appendix III
Counties Not Assigned to Any OPO for the
1996 Recertification Cycle
State County Population
Arkansas Miller 38,467
California Colusa 16,275
Glenn 24,798
Tehama 49,625
Florida Collier 152,099
Sumter 31,577
Georgia Richmond 189,719
Idaho Adams 3,254
Blaine 13,552
Boise 3,509
Butte 2,918
Camas 727
Custer 4,133
Elmore 21,205
Gooding 11,633
Idaho 13,783
Lemhi 6,899
Lincoln 3,308
Teton 3,439
Valley 6,109
Indiana Clark 87,777
Harrison 29,890
Scott 20,991
Kentucky Christian 68,941
New York Clinton 85,969
Greene 44,739
Hamilton 5,279
Ohio Perry 31,557
Texas Anderson 48,024
Cherokee 41,049
Jim Wells 37,679
Virginia Buckingham 12,873
Danville 53,056
Floyd 12,005
Franklin 39,549
Smyth 32,370
West Virginia Cabell 96,827
Hancock 35,233
(continued)
Page 40 GAO/HEHS-98-26 OPO Performance Standards
Appendix III
Counties Not Assigned to Any OPO for the
1996 Recertification Cycle
State County Population
Wyoming Sublette 4,843
Total 1,385,680
(108315) Page 41 GAO/HEHS-98-26 OPO Performance Standards
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Address Correction Requested
Organ Procurement Organizations: Alternatives Being Developed to More Accurately Assess Performance
Published by the Government Accountability Office on 1997-11-26.
Below is a raw (and likely hideous) rendition of the original report. (PDF)