Organ Donation: Assessing Performance of Organ Procurement Organizations
(Statement/Record, 04/08/98, GAO/T-HEHS-98-131).

GAO discussed: (1) whether the current standard for assessing the local
organ procurement organizations' (OPO) effectiveness appropriately
measures the extent to which OPOs are maximizing their ability to
identify, procure, and transplant organs and tissue; and (2)
alternatives to the current standard that could be more effective.

GAO noted that: (1) the Health Care Financing Administration's (HCFA)
current performance standard does not accurately assess OPO's ability to
meet the goal of acquiring usable organs because it is based on the
total population, not the number of potential donors within the OPOs'
Service areas; (2) GAO identified two alternative performance measures
that would better estimate the number of potential organ
donors--measuring the rates of organ procurement and transplantation
compared with either the number of deaths or the number of deaths
adjusted for cause of death and age; (3) both these approaches have
limitations, however, in data availability and accuracy; (4) two other
methods for assessing OPO performance--medical records reviews and
modeling--show promise because they could more accurately determine the
number of potential donors; and (5) because OPOs must meet performance
goals to continue to operate, approaches that more accurately
differentiate between OPOs that achieve greater or lesser proportions of
all possible donations in their service areas can help increase
donations.

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

 REPORTNUM:  T-HEHS-98-131
     TITLE:  Organ Donation: Assessing Performance of Organ Procurement 
             Organizations
      DATE:  04/08/98
   SUBJECT:  Statistical methods
             Surgery
             Population statistics
             Health resources utilization
             Health care planning
             Program evaluation
             Medical records
IDENTIFIER:  Medicare Program
             Medicaid Program
             
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Cover
================================================================ COVER


Before the Subcommittee on Human Resources, Committee on Government
Reform and Oversight, House of Representatives

For Release on Delivery
Expected at 11:00 a.m.
Wednesday, April 8, 1998

ORGAN DONATION - ASSESSING
PERFORMANCE OF ORGAN PROCUREMENT
ORGANIZATIONS

Statement for the Record by Bernice Steinhardt, Director
Health Services Quality and Public Health Issues
Health, Education, and Human Services Division

GAO/T-HEHS-98-131

GAO/HEHS-98-131T


(108368)


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

  HCFA - ABC
  HHS - ABC
  OPO - ABC

ORGAN DONATION:  ASSESSING
PERFORMANCE OF ORGAN PROCUREMENT
ORGANIZATIONS
============================================================ Chapter 0

Mr.  Chairman and Members of the Subcommittee: 

We are pleased to contribute this statement for the record as part of
the Subcommittee's review of issues concerning organ donation.  Our
comments will focus on the current standard for assessing the
effectiveness of organ procurement organizations and alternatives to
this standard. 

Advancements in organ transplant technology have increased the number
of patients who could benefit from such transplants.  The supply of
organs, however, has not kept pace with the growing 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.  To some extent, this has succeeded:  the number of
cadaveric\1 organ donors increased 33 percent between 1988 and
1996--from 4,083 to 5,416--and the number of organs transplanted from
cadaveric donors rose from 10,964 to 16,802 in the same period. 
Nevertheless, the organ supply has not kept pace with demand, and
over 54,000 patients are now on the waiting list for a transplant. 

The Department of Health and Human Services (HHS) has just published
a new regulation to change the allocation of organs from what is now
a largely regional approach to a more national approach.\2 Under
current policies, matching organs are usually made available to all
listed patients in a local organ procurement area before they are
made available to other patients.  Today we will discuss a key
element of the current system, the local organ procurement
organizations (OPO), rather than the impact of the change in policy. 

To help the Congress better understand the operation of the organ
allocation and procurement system, we have issued several reports
over the last few years examining the equity of organ allocation
decisions, variations in patient waiting times, and the lack of
adequate measures to assess organ procurement effectiveness.\3 Most
recently, in November 1997, we reported on our examination of the
approaches for assessing the effectiveness of OPOs in increasing the
organ supply.\4 Our statement will focus on this most recent work, in
which we examined (1) whether the current standard for assessing
OPOs' effectiveness appropriately measures the extent to which OPOs
are maximizing their ability to identify, procure, and transplant
organs and tissue and (2) alternatives to the current standard that
could be more effective. 

OPOs play a crucial role in procuring and allocating organs.\5 They
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,\6 which requires, among other things, that the Secretary of HHS
designate one OPO per service area and that OPOs meet standards and
qualifications to receive payment from Medicare and Medicaid. 
Section 371(b)(3)(B) of the Public Health Service Act\7 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.\8 These
standards assess OPOs according to their achieving numerical goals
per million population in their service areas in five categories: 
(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 payments.\9 \10 Without HCFA
certification, an OPO may not 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. 

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 was the subject of our
recent report.  We determined the strengths and weaknesses of the
current standard and identified and assessed alternatives to that
standard. 

In brief, HCFA's current performance standard does not accurately
assess OPOs' ability to meet the goal of acquiring all usable organs
because it is based on the total population, not the number of
potential donors, within the OPOs' service areas.  We identified two
alternative performance measures that would better estimate the
number of potential organ donors:  measuring the rates of organ
procurement and transplantation compared with either the number of
deaths or the number of deaths adjusted for cause of death and age. 
Both these approaches have limitations, however, in data availability
and accuracy.  Two other methods for assessing OPO
performance--medical records reviews and modeling--
show promise because they could more accurately determine the number
of potential donors.  Because OPOs must meet the performance goals to
continue to operate, approaches that more accurately differentiate
between OPOs that achieve greater or lesser proportions of all
possible donations in their service areas can help increase
donations. 


--------------------
\1 Some patients receive organs, particularly kidneys, from living
donors.  In 1996, 3,524 people donated organs. 

\2 63 Federal Register 16296 et seq., Apr.  2, 1998 (to be codified
at 42 CFR Part 121). 

\3 Organ Transplants:  Increased Effort Needed to Boost Supply and
Ensure Equitable Distribution of Organs (GAO/HRD-93-56, Apr.  22,
1993) and Impact of Organ Allocation Variances (GAO/HEHS-95-203R,
July 31, 1995). 

\4 Organ Procurement Organizations:  Alternatives Being Developed to
More Accurately Assess Performance (GAO/HEHS-98-26, Nov.  26, 1997). 

\5 OPOs are nonprofit private entities that facilitate the
acquisition and distribution of organs. 

\6 42 U.S.C.  1320b-8. 

\7 42 U.S.C.  273(b)(3)(B). 

\8 42 CFR Part 486, Subpart G. 

\9 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. 

\10 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. 


   BACKGROUND
---------------------------------------------------------- Chapter 0:1

Although the number of donors is growing more slowly than 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.\11
\12 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 that can result in organ donation
include 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. 


--------------------
\11 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. 

\12 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
-------------------------------------------------------- Chapter 0:1.1

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 had to meet at least
one of the following service area requirements: 

1.  It must include an entire state or official U.S.  territory. 

2.  It must either procure organs from an average of at least 24
donors per calendar year in the 2 years before the year of
redesignation, or it must request and receive an exception to this
requirement. 

3.  If it operates exclusively in a noncontiguous U.S.  state,
territory, or commonwealth, the OPO must 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, the OPO must demonstrate that it can
procure organs from at least 50 potential donors per calendar year. 

In addition, an OPO must be a nonprofit entity and meet other
requirements for the composition of its board, its accounting, its
staff, and its procedures.  To ensure the fair distribution and
safety of organs, OPOs must have a system to equitably allocate
organs to transplant patients.  In addition, OPOs must arrange for
appropriate tissue typing of organs and ensure that donor screening
and testing for infectious diseases, including the human
immunodeficiency virus, 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. 

In addition, education efforts help hospital staff clarify organ and
tissue recovery policies to ensure that potential donors are
consistently recognized and referred.  OPOs also conduct hospital
development activities to build strong relationships with service
area hospitals to promote organ donation. 


   PROBLEMS WITH THE CURRENT
   STANDARD
---------------------------------------------------------- Chapter 0:2

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 area
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. 

A population-based standard, however, does not accurately assess 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, 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 in different states.  Thus, the number
of potential organ donors can vary greatly for OPOs serving equally
sized populations. 


   ALTERNATIVE STANDARDS COULD
   MORE ACCURATELY ASSESS OPO
   PERFORMANCE
---------------------------------------------------------- Chapter 0:3

We identified several performance measures as alternatives to the
current population-based standard.  The alternatives we examined
included measuring organ procurement and transplantation compared
with (1) the number of deaths, (2) the number of deaths adjusted for
cause of death and age, (3) the number of potential donors based on
medical records reviews, and (4) the number of potential donors based
on modeling estimates in an OPO service area. 

In developing its current OPO performance standard, HCFA considered
using the number of service area deaths as the basis for assessing
performance.  Although some organs, typically kidneys, are obtained
from living donors, OPOs recover organs from cadaveric donors. 
Therefore, the number of deaths in an OPO's service area more
accurately reflects the number of an OPO's 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. 

HCFA also considered using an adjusted measure of deaths for the
performance standard.  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 of people in 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. 

We found that both the death and adjusted-death 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 the current population-based
measure and these two alternative measures--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.  More OPOs would have been subject to termination under
either of these alternative measures. 

HCFA did not consider two other methods for determining the number of
potential donors--medical records reviews and modeling--that show
promise for determining OPOs' ability to acquire all usable organs. 
Reviewing hospital medical records is the most accurate method of
estimating the number of potential donors in an OPO's service area. 
A medical records review involves reviewing all deaths at a hospital
with an in-depth examination of those meeting certain criteria. 
Reviewing the records of 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 do conduct medical records reviews but at varying levels of
sophistication.  For records reviews to be useful for assessing OPO
performance, the reviews would have to be conducted consistently
among OPOs and the results would need to be available for validation. 
Such reviews, however, are labor intensive and therefore expensive. 
Although most OPOs are conducting some form of medical records
reviews and therefore already 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.  The
goal of this effort is to design an estimating procedure that will be
relatively simple to execute, inexpensive, and valid.  This approach
uses information from hospitals in the OPO's service area on
variables, such as total number of deaths, total staffed beds,
Medicare case mix, medical school affiliation, and trauma center
certification, to predict 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. 


   RECOMMENDED FUTURE STEPS
---------------------------------------------------------- Chapter 0:4

HCFA believes its current standard identifies OPOs that are poor
performers.  When publishing 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 identified in our report merit HCFA's consideration. 

More specifically, our report recommended that to better ensure that
HCFA accurately assesses OPOs' organ procurement performance and that
OPOs are maximizing the number of organs procured and transplanted,
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 has concurred with our recommendation.  It has indicated that
when the ongoing research on medical records reviews and modeling are
complete and it receives the studies, it will review the results to
determine if it can support a better performance standard. 

HCFA's continuous monitoring of the developments in approaches to
identifying potential organ donors is important.  Because the demand
for organs surpasses the supply, OPOs are required by law to conduct
and participate in systematic efforts to acquire all usable organs
from potential donors.  As we have reported, unless HCFA measures OPO
performance according to the number of potential donors, the agency
cannot determine OPOs' effectiveness in acquiring organs. 


*** End of document. ***