Organ Procurement Organizations: Alternatives Being Developed To More
Accurately Assess Performance (Letter Report, 11/26/97, GAO/HEHS-98-26).

Pursuant to a congressional request, GAO reviewed whether the Health
Care Financing Administration's (HCFA) population-based standard
appropriately measures the extent to which organ procurement
organizations (OPO) are maximizing their ability to identify, procure,
and transplant organs and tissue, focusing on: (1) the strengths and
weaknesses of the current standard; and (2) alternatives to the current
standard.

GAO noted that: (1) HCFA chose a population-based standard to assess OPO
performance after considering the availability and cost to the OPOs of
obtaining and analyzing various types of data; (2) when HCFA first
applied this standard in 1996, five OPOs were subject to action for
failing to meet the standard; (3) 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; (4) the fifth OPO that failed the standard was determined to be
a new entity and not subject to meeting the performance standard; (5)
HCFA's current population-based standard, however, is not an accurate
measure for assessing OPO performance because OPO service areas consist
of varying populations; (6) 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
have generally differing characteristics; (7) thus, the number of
potential organ donors may vary greatly for OPOs serving equally sized
populations; (8) GAO ranked the OPOs, using 1994-95 OPO procurement and
transplant data, according to three measures--population, number of
deaths, and adjusted deaths; (9) although three OPOs would not qualify
for recertification under any of these measures, the number of and which
OPOs would not qualify vary depending on the measure used; (10) HCFA did
not consider two alternative measures--medical records reviews and
modeling--that show promise for determining OPOs' ability to acquire all
usable organs; (11) consistently applied and uniform reviews of hospital
medical records with verifiable results may accurately assess the number
of OPOs' potential donors; (12) because most OPOs already conduct some
records review, any added expense and increase to the cost of organs may
be negligible; (13) 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 organ cost
must be considered; (14) 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; (15) unless OPO
performance is measured according to the number of potential donors,
HCFA cannot determine OPOs' effectiveness in acquiring organs; and (16)
the measures GAO has identified provide alternatives for HCFA to pursue
to more accurately assess OPO performance.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-98-26
     TITLE:  Organ Procurement Organizations: Alternatives Being 
             Developed To More Accurately Assess Performance
      DATE:  11/26/97
   SUBJECT:  Institution accreditation
             Health care programs
             Health resources utilization
             Productivity
             Standards evaluation
             Non-profit organizations
             Statistical methods
             Population statistics
             Medical records

             
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Cover
================================================================ COVER


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

OPO Performance Standards

(108315)


Abbreviations
=============================================================== ABBREV

  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

Letter
=============================================================== LETTER


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 cadaveric\1 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 Act\4 provides 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 standards.  (App.  I further describes
the scope and methodology for this report.)


--------------------
\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). 

\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. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

HCFA chose a population-based standard to assess OPO performance
after 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 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. 


--------------------
\8 Organ Transplants:  Increased Effort Needed to Boost Supply and
Ensure Equitable Distribution of Organs (GAO/HRD-93-56, Apr.  22,
1993). 


   BACKGROUND
------------------------------------------------------------ Letter :2

Although the number of donors is not growing as quickly as the demand
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 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). 

   Figure 1:  Total Number of
   Cadaveric Organ Donors by Type
   of Organ Donated, 1996

   (See figure in printed
   edition.)

Source:  United Network for Organ Sharing (UNOS) Organ Procurement
and Transplantation Network (OPTN) data as of Sept.  20, 1997. 


--------------------
\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."


      ROLE OF OPOS
---------------------------------------------------------- Letter :2.1

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 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. 

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 1996

   (See figure in printed
   edition.)

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. 

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
      DONORS DO NOT BECOME ORGAN
      DONORS
---------------------------------------------------------- Letter :2.2

Many potential donors referred to OPOs do not meet OPO acceptance
criteria; for others, the donors' families do not consent to
donation.  In 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. 

   Figure 3:  Reasons Referred
   Potential Donors Are Eliminated
   During the Donation Process

   (See figure in printed
   edition.)

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 ROLE
---------------------------------------------------------- Letter :2.3

HCFA's regional offices oversee the entire OPO certification
process.\11 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 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. 


--------------------
\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. 


      HCFA HAS ESTABLISHED A
      POPULATION-BASED PERFORMANCE
      STANDARD FOR OPOS
---------------------------------------------------------- Letter :2.4

HCFA has developed a standard for assessing OPO performance. 
Starting on January 1, 1996, OPOs were required to achieve at least
75 percent of the national mean in four of the five performance
categories averaged over the 2 calendar years before the year of
redesignation.  During the 1996 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. 


      WE HAVE REPORTED ON OPO
      PERFORMANCE MEASURES IN THE
      PAST
---------------------------------------------------------- Letter :2.5

In the Transplant Amendments Act of 1990, the Congress mandated that
we study and report on the effectiveness of the national organ
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. 


--------------------
\12 GAO/HRD-93-56, Apr.  22, 1993. 


   HCFA'S CURRENT STANDARD IS NOT
   THE BEST MEASURE OF OPO
   PERFORMANCE
------------------------------------------------------------ Letter :3

HCFA's current standard does not accurately measure OPOs' performance
in procuring organs usable for transplantation for several reasons. 
Although HCFA identified several advantages of using population data,
measuring performance according to population has many inherent
weaknesses.  For example, in the last assessment cycle, HCFA used
population data that were 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
      ADVANTAGES OF USING A
      POPULATION-BASED MEASURE
---------------------------------------------------------- Letter :3.1

HCFA chose a population-based measure because the data are readily
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 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 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. 


--------------------
\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."


      POPULATION DATA WERE NOT
      TIMELY
---------------------------------------------------------- Letter :3.2

In the last performance cycle, HCFA allowed OPOs to use either 1990
or 1992 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 VARY
      BY REGION
---------------------------------------------------------- Letter :3.3

A problem with using population as the basis for the standard is that
it 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 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
      ORGAN DONORS ALSO VARY
      GEOGRAPHICALLY
---------------------------------------------------------- Letter :3.4

In addition, a standard relying on population fails to account for
regional variations in causes of death.  Organ donors typically die
from head trauma 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 IN
      THE PROCURING OPO'S SERVICE
      AREA
---------------------------------------------------------- Letter :3.5

Some OPOs may draw donors from a much larger area than their service
areas.  They may serve high tourist areas or have trauma centers to
which 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. 



                          Table 1
          
           Donors Living Outside Procuring OPOs'
                   Service Areas, 1994-95

                                                Percentage
                                                 of donors
                                 Donors from  from outside
                  Total donors   outside the   the service
OPO                    1994-95  service area          area
----------------  ------------  ------------  ------------
Donor Network of           144            16          11.1
 Arizona
Organ Donor                 24             3          12.5
 Center of
 Hawaii
Louisiana Organ            211            25          11.8
 Procurement
 Agency
Transplantation            355             9           2.5
 Society of
 Michigan
Nevada Donor                41             7          17.1
 Organ Referral
 Service
New Mexico Donor            81             7           8.6
 Program
Oklahoma Organ             154             7           4.5
 Sharing Network
----------------------------------------------------------
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. 


--------------------
\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. 


      HCFA DID NOT ACCOUNT FOR
      TOTAL U.S.  POPULATION BUT
      PLANS TO IN THE NEXT CYCLE
---------------------------------------------------------- Letter :3.6

The population data used in assessing performance for some OPOs in
1996 varied from the population data of the states and counties that
comprise OPOs' service areas as defined by HCFA.  The differing
population data occur 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 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 Reflect Service Area
                              Populations

                                                                Popula
                                                                  tion
                                                                   (in
                                                                thousa
Population group                                                  nds)
--------------------------------------------------------------  ------
U.S. including Puerto Rico                                      252,24
                                                                     0
Assigned to OPOs                                                248,73
                                                                     4
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. 


--------------------
\16 42 U.S.C.  1320b-8(a)(1)(A)(iii) and (C). 

\17 42 U.S.C.  1320b-8(a)(2). 


   AN ALTERNATIVE STANDARD BASED
   ON THE NUMBER OF OPO SERVICE
   AREA DEATHS IS SLIGHTLY MORE
   ACCURATE BUT STILL A GROSS
   MEASURE OF PERFORMANCE
------------------------------------------------------------ Letter :4

HCFA considered but rejected using the number of deaths as a basis
for its standard.  Assessing OPO procurement and transplantation
performance according to the number of deaths is slightly more
suitable than using population as a standard because it limits
comparisons to the portion of the population eligible for organ
donation.  It has several disadvantages, however, including lack of
timely data and of adjustments for factors 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, that do not
allow for accurately assessing the number of potential donors. 


      HCFA CONSIDERED BUT REJECTED
      A STANDARD USING NUMBER OF
      DEATHS
---------------------------------------------------------- Letter :4.1

HCFA reasoned that because states collect vital statistics data, such
as mortality data, such data may be inconsistent among the states. 
HCFA also 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 AREA
      DEATHS RATHER THAN
      POPULATION MORE ACCURATELY
      REFLECTS NUMBER OF POTENTIAL
      DONORS
---------------------------------------------------------- Letter :4.2

Although some organs, typically kidneys, are obtained from living
donors, OPOs recover organs from cadaveric donors.  Therefore, the
number of 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 out of a population of about 260 million. 
Although using total deaths fails to consider other factors about and
characteristics of potential donors, it would eliminate considering a
portion of the population that an OPO clearly could not consider for
organ donation. 


      NATIONAL MORTALITY DATA ARE
      NOT COMPLETE OR TIMELY
      ENOUGH FOR OPO ASSESSMENT
      PURPOSES
---------------------------------------------------------- Letter :4.3

Because collecting vital statistics is typically a state function,
NCHS obtains mortality statistics from the states, the District of
Columbia, and 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, 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 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 WHO
      DIE MAY BECOME ORGAN DONORS
---------------------------------------------------------- Letter :4.4

Because only a fraction of those who die make acceptable organ
donors, using number of deaths as a standard provides only a gross
measure of the 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. 


   AN ALTERNATIVE STANDARD USING
   NUMBER OF DEATHS ADJUSTED FOR
   CAUSE OF DEATH AND AGE WOULD
   MORE ACCURATELY MEASURE THE
   NUMBER OF POTENTIAL DONORS BUT
   STILL BE APPROXIMATE
------------------------------------------------------------ Letter :5

HCFA also considered and rejected using adjusted death data to assess
OPO performance.  Adjusting for cause of death and age would more
accurately estimate the number of potential organ donors than do
either population 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 donors.  In addition, because
older people generally do not become organ donors, limiting
consideration to certain age groups would better reflect the number
of likely donors. 

Unfortunately, incomplete and untimely data would make adjusting for
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 donors, and methods for adjusting for causes of death are
not standard 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 NUMBER
      OF IN-HOSPITAL DEATHS AS A
      STANDARD
---------------------------------------------------------- Letter :5.1

When HCFA was developing its performance standard, the agency
suggested that the number of in-hospital deaths provided a more
targeted 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 DEATH
      AND AGE MORE ACCURATELY
      ESTIMATES NUMBER OF
      POTENTIAL DONORS THAN NUMBER
      OF DEATHS ALONE
---------------------------------------------------------- Letter :5.2

Measuring OPO performance according to the number of service area
deaths adjusted for cause of death and age more accurately reflects
the number of potential donors than measuring performance according
to the number of all service area deaths.  The number of service area
deaths adjusted for cause of death and age better estimates the
number of potential donors because it accounts for the small subset
of the deceased 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 DATA
      ARE INCOMPLETE OR NOT TIMELY
      ENOUGH FOR OPO ASSESSMENT
      PURPOSES
---------------------------------------------------------- Letter :5.3

Adjusted cause of death data are a subset of the NCHS mortality
statistics.  As noted, these data have completeness and timeliness
limitations.  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, 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 DATA
      MAY NOT SUFFICIENTLY
      IDENTIFY SUITABLE DONORS
---------------------------------------------------------- Letter :5.4

State offices of vital statistics report mortality statistics using
the International Classification of Diseases 9th Revision Clinical
Modification (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
      CAUSE OF DEATH NOT STANDARD
      AND REQUIRE CERTAIN
      RESOURCES
---------------------------------------------------------- Letter :5.5

We did not identify an agreed-upon set of variables for indicating
the subset of deaths that would yield suitable organ donors.  We
consulted experts to identify ICD-9-CM codes most frequently
associated with organ donors; however, the measure we used does not
fully account for the 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. 


   MORE OPOS WOULD HAVE BEEN
   SUBJECT TO TERMINATION UNDER
   ALTERNATIVE MEASURES
------------------------------------------------------------ Letter :6

As stated, using the number of deaths and adjusted deaths may be an
incremental improvement over using population data because OPOs are
assessed according to subsets of the population that can become organ
donors.  However, like population data, these measures do not
accurately reflect organ procurement performance.  Our analysis
determined whether 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. 



                                Table 3
                
                   OPOs Not Meeting 75 Percent of the
                 Average for at Least Three of the Five
                  Performance Categories Using Various
                                Measures

                                  Performance standard based on
                            ------------------------------------------
                                                        Adjusted
OPO                         Population    Deaths        deaths
--------------------------  ------------  ------------  --------------
Long Island Transplant      X             X             X
Program

Mississippi Organ Recovery  X             X             X
Agency

Medical College of Georgia  X             X             X

Northwest Organ             X                           X
Procurement 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                     X
College

Upstate New York                          X
Transplant Services, Inc.

Carolina Life Care                                      X

Donor Network of Arizona                                X

Mid-South Transplant                                    X
Foundation

South Carolina Organ                                    X
Procurement 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. 


   AN ALTERNATIVE STANDARD USING
   MEDICAL RECORDS REVIEWS WOULD
   MORE ACCURATELY DETERMINE THE
   NUMBER OF OPOS' POTENTIAL
   DONORS BUT MAY BE COSTLY
------------------------------------------------------------ Letter :7

A standard using the number of donors and the number of organs
recovered and transplanted compared with the number of potential
organ donors would more accurately assess OPO performance.  A
retrospective 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 standards, HCFA did not consider using
medical records reviews to estimate the number of potential donors
for assessing OPOs' performance.  Most OPOs are conducting some form
of medical records review to gain information on the strengths and
weaknesses of their organizations' organ procurement policies and
practices.  AOPO has started a medical records 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 CAN
      ACCURATELY ESTIMATE THE
      NUMBER OF AN OPO'S POTENTIAL
      DONORS
---------------------------------------------------------- Letter :7.1

Systematically reviewing donor hospital medical records can help to
accurately estimate the number of an OPO's potential donors.  A
medical records review involves reviewing all deaths at a hospital,
with an in-depth examination of those meeting certain criteria. 
Reviewing the charts for 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 FORM
      OF MEDICAL RECORDS REVIEW
---------------------------------------------------------- Letter :7.2

A survey of 68 OPOs that we conducted in 1992 showed that 60
conducted some form of medical records review.\18 The reviews varied
from a yearly 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. 

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


--------------------
\18 GAO/HRD-93-56, Apr.  22, 1993. 

\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. 


      AOPO IS CONDUCTING A MEDICAL
      RECORDS REVIEW PROJECT
---------------------------------------------------------- Letter :7.3

AOPO is conducting a medical records review project partially funded
by HRSA involving 33 participating OPOs.  The project's goal is to
develop a 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. 


      DONOR ACCEPTABILITY CRITERIA
      VARY BY OPO
---------------------------------------------------------- Letter :7.4

Differences in donor acceptance criteria by OPO may make it difficult
to 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. 


      COST OF MEDICAL RECORDS
      REVIEWS MUST BE CONSIDERED
---------------------------------------------------------- Letter :7.5

Although medical records reviews are a valuable tool for determining
the number of potential donors, they can be expensive for an OPO. 
Many OPOs, 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 ARE
      NOT CONSISTENT BY OPO
---------------------------------------------------------- Letter :7.6

For medical records reviews to be used to accurately estimate the
number 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.  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. 


   AN ALTERNATIVE STANDARD BASED
   ON MODELING MIGHT BE USED TO
   ESTIMATE THE NUMBER OF
   POTENTIAL DONORS
------------------------------------------------------------ Letter :8

A team of researchers from the Partnership for Organ Donation, the
Harvard Medical School, and the Harvard School of Public Health has
developed a modeling method using information about hospitals to
predict the number of potential donors.  The goal of this effort is
to design an estimating procedure that will be relatively simple to
execute, inexpensive, and valid.  The scope of their study includes
three OPOs and a random stratified sample of 88 hospitals in the
OPOs' service areas. 

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 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. 


--------------------
\21 The team used a series of hierarchical Poissan regressions. 


   CONCLUSIONS
------------------------------------------------------------ Letter :9

Because of the gap between the supply of organs and the demand for
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 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. 


   RECOMMENDATIONS
----------------------------------------------------------- Letter :10

To better ensure that HCFA accurately assesses OPOs' organ
procurement 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. 


   AGENCY COMMENTS
----------------------------------------------------------- Letter :11

HCFA was given a draft of this report but could not provide written
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. 


--------------------------------------------------------- Letter :11.1

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


SCOPE AND METHODOLOGY
=========================================================== Appendix I

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 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. 



                               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 -E825\a            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,     Suicide
E958.5

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. 


DIFFERENCE IN THE 1990 OPO SERVICE
AREA POPULATION AND THE POPULATION
HCFA USED FOR ASSESSMENT PURPOSES
========================================================== Appendix II

                      OPO 1990
                    population
                    using HCFA
                    definition      1990 OPO
                    of service      adjusted    Population
OPO                       area    population    difference
----------------  ------------  ------------  ------------
Alabama Organ        4,236,799     4,200,000       -36,799
 Center
Donor Network of     3,665,228     3,665,000          -228
 Arizona
Arkansas             1,947,665     1,947,665             0
 Regional Organ
 Recovery Agency
California           9,593,175     9,979,519       386,344
 Transplant
 Donor Network
Golden State         1,712,294     1,712,294             0
 Transplant
 Services
Organ and Tissue     2,607,319     2,607,319             0
 Acquisition
 Center of
 Southern
 California
Regional Organ      12,312,344     9,800,935    -2,511,409
 Procurement
 Agency of
 Southern
 California
Southern             3,444,191     5,643,679     2,199,488
 California
 Organ
 Procurement
 Center
Colorado Organ       3,672,986     3,672,986             0
 Recovery
 Systems, Inc.
Northeast OPO        1,297,770     1,552,727       254,957
 and Tissue Bank
Washington           3,923,574     3,709,499      -214,075
 Regional
 Transplant
 Consortium
LifeLink of          2,541,773     2,541,773             0
 Florida
LifeLink of            978,935     1,014,415        35,480
 Southwest
 Florida
The OPO at           2,671,905     2,499,702      -172,203
 University of
 Florida
TransLife            2,143,078     2,145,883         2,805
University of        4,418,559     4,537,294       118,735
 Miami OPO
LifeLink of          4,150,032     4,144,358        -5,674
 Georgia
Medical College      1,967,617     1,960,631        -6,986
 of Georgia
Organ Donor          1,108,229     1,108,229             0
 Center of
 Hawaii
Regional Organ      10,975,331    10,254,251      -721,080
 Bank of
 Illinois
Indiana Organ        4,740,780     4,740,780             0
 Procurement
 Organization,
 Inc.
Iowa Statewide       2,793,497     2,776,755       -16,742
 Organ
 Procurement
 Organization
Midwest Organ        4,982,841     4,456,332      -526,509
 Bank
Kentucky Organ       3,289,825     3,743,335       453,510
 Donor
 Affiliates
Louisiana Organ      4,219,973     4,219,973             0
 Procurement
 Agency
Transplant           2,947,789     3,194,019       246,230
 Resource Center
 of Maryland
New England         11,873,328    10,329,684    -1,543,644
 Organ Bank
Organ                9,295,297     9,295,297             0
 Procurement
 Agency of
 Michigan
Upper Midwest        5,801,912     5,801,912             0
 Organ
 Procurement
 Organization,
 Inc.
Mississippi          2,505,306     2,505,306             0
 Organ Recovery
 Agency, Inc.
Mid-America          3,839,119     4,100,000       260,881
 Transplant
 Association
Nebraska Organ       1,547,215     1,578,385        31,170
 Retrieval
 System, Inc.
Nevada Donor         1,201,833       741,459      -460,374
 Network
New Jersey Organ     5,987,846     6,187,749       199,903
 and Tissue
 Sharing Network
New Mexico Donor     1,515,069     1,515,069             0
 Program
Long Island          2,609,212     2,109,212      -500,000
 Transplant
 Program
New York             9,113,955     9,613,955       500,000
 Regional
 Transplant
 Program
OPO of Albany        2,140,126     2,145,405         5,279
 Medical College
University of        2,363,371     2,363,371             0
 Rochester Organ
 Procurement
 Program
Upstate New York     1,568,454     1,568,454             0
 Transplant
 Services, Inc.
Carolina Life        1,786,468     1,786,568           100
 Care
Carolina Organ       3,241,147     3,180,550       -60,597
 Procurement
 Agency
Life Share of        1,734,300     1,716,874       -17,426
 the Carolinas
Life Connection      2,406,986     2,472,522        65,536
 of Ohio
LifeBanc             4,161,380     4,241,536        80,156
Lifeline of Ohio     2,823,495     2,800,000       -23,495
Ohio Valley Life     1,839,876     1,839,876             0
 Center
Oklahoma Organ       3,145,585     3,145,585             0
 Sharing
 Network, Inc.
Pacific              3,551,900     3,551,900             0
 Northwest
 Transplant Bank
Center for Organ     5,452,392     5,636,618       184,226
 Recovery and
 Education
Delaware Valley     10,145,168     9,982,214      -162,954
 Transplant
 Program
Lifelink of          3,522,037     3,522,037             0
 Puerto Rico
South Carolina       3,148,739     3,215,891        67,152
 Organ
 Procurement
 Agency
Life Resources         635,668       635,668             0
 Donor Center
Mid-South            1,343,807     1,300,000       -43,807
 Transplant
 Foundation
Tennessee Donor      3,456,887     3,373,477       -83,410
 Services
LifeGift Organ       6,437,243     6,461,472        24,229
 Donation Center
South Texas          3,824,020     3,824,020             0
 Organ Bank
Southwest Organ      6,515,753     6,783,713       267,960
 Bank
Intermountain        2,169,595     2,277,953       108,358
 Organ Recovery
 Systems
Life Net             3,074,738     2,800,000      -274,738
Virginia Organ       1,798,580     1,567,415      -231,165
 Procurement
 Agency
Northwest Organ      5,081,913     5,081,913             0
 Procurement
 Agency
Sacred Heart           959,996       959,996             0
 Organ
 Procurement
 Agency
University of        2,630,297     2,722,306        92,009
 Wisconsin OPO
Wisconsin Donor      2,169,463     2,169,463             0
 Network
==========================================================
Total              250,762,985   248,734,178    -2,028,807
----------------------------------------------------------

COUNTIES NOT ASSIGNED TO ANY OPO
FOR THE 1996 RECERTIFICATION CYCLE
========================================================= Appendix III

                                        Popula
State               County                tion
------------------  ------------------  ------
Arkansas            Miller              38,467
California          Colusa              16,275
                    Glenn               24,798
                    Tehama              49,625
Florida             Collier             152,09
                                             9
                    Sumter              31,577
Georgia             Richmond            189,71
                                             9
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
Wyoming             Sublette             4,843
==============================================
Total                                   1,385,
                                           680
----------------------------------------------

*** End of document. ***