oversight

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)

                 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
                   B-276948




                   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



                   Page 3                                GAO/HEHS-98-26 OPO Performance Standards
             B-276948




             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
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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.”


Page 5                                               GAO/HEHS-98-26 OPO Performance Standards
                                      B-276948




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
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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
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                                     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
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                            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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                                       B-276948




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.



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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



                           Page 13                               GAO/HEHS-98-26 OPO Performance Standards
                             B-276948




                             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).



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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



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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


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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.



                       Page 27                                             GAO/HEHS-98-26 OPO Performance Standards
              B-276948




              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



              Page 28                                GAO/HEHS-98-26 OPO Performance Standards
                  B-276948




                  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.




                  Page 29                               GAO/HEHS-98-26 OPO Performance Standards
B-276948




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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