I . 
Department of Health and Human Services 
OFFICE 
INSPECTOR GENERAL 
THE  OF ORGANS 
DISTRIBUTION 
FOR 
TRANSPLANTATION: 
EXPECTATIONS AND PRACTICES 
f.lwJcrs. 
Richard P. Kusserow 
INSPECTOR GENERAL 
'0  ""d3'a 
GEl -01-89-00550
Jy-l"  EXECUTIVE  SUMMARY

PURPOSE 
The piIrposes of this study are to: (1) clarfy expectations governing organ distrbution practices 
in the United States, (2) detennine the extent to which actual practices are in accord with 
expectations, and (3) offer recommendations that facilitate close accord between expectations 
and practices. 
BACKGROUND 
In April 1990, 20, 171 people in the United States were awaiting an organ transplant. This 
number has risen sharly in recent years as the demand for transplants has grown much faster 
than the supply of available organs.

In this repon, we focus on the distrbution of cadaver organs from the point of procurement to 
the point of transplantation. Although the repon addresses all organs, we pay particular attention 
to the distrbution of kidneys because they account for about 75 percent of organ transplants and 
about 84 percent of those awaiting a transplant. 
The repon is based primarly on an analysis of a data base consisting of the 17,556 individuals in 
the United States who were waiting for or received a first kidney trsplant between October 1 
1987 and March 31, 1989. In addition, it draws on an on-site review of the operations of organ 
procurement organizations in California, Florida, Wisconsin, and Pennsylvania; on interviews 
on a review of 
with many individuals involved with the field of organ trnsplantation; and 
pertnent literature and documents. 
EXPECTATIONS 
Congress and professional leaders envision the development of organ distribution practices 
that are equitable to those in need, carried out in accord with a national system, and based on 
the cooperation of transplant professionals. More specifcally, they expect: 
each person on a transplant waiting list to have an equal opponunity to receive a 
medical criteria; 
trnsplant, subject to established 
organ distrbution to occur in accord with a national system adhering to unifonn policies 
and standards; and 
transplant surgeons and other transplant professionals to work together cooperatively in 
the best interest of all patients waiting for transplants.  FINDINGS 
While there has been progress, current organ distribution practices fall short of congressional 
and professional expectations in each of the three areas. 
Equity 
The access of patients to donated organs remains unequal in some important respects. 
Blacks on kidney waiting lists wait almost twice as long as whites for a first 
transplant, 13.9 months compared with 7.6. Such a differential remains even when 
bloo type, age, immunological, and locational factors are taken into account. 
Patients at some transplant centers wait much longer than those at others. At 15 of 
the 202 trnsplant centers reviewed, the waiting time for a first kidney transplant was 
18 months or over, at 79 it was less than 6 months. 
those whose immune system makes it difficult for them 
Highly sensitized patients-
to receive organs-wait almost 4 times as long for a kidney trnsplant as all other 
patients , 32.4 months vs. 8. 
National System 
There has been considerable progress in establishing a national system grounded in 
unifonn policies and standards for the distrbution of organs. However, organ distrbution 
the individual transplant centers and confined primarily 
. remains heavily controlled by 
within the individual service areas of 72 Organ Procurement Organizations (OPOs). 
Cooperation 
The development of the Organ Procurement and Transplantation Network (OPTN) is a 
significant cooperative achievement of transplant professionals and others. Yet at the 
transplant center and OPO levels, the sense of local ownership that some transplant 
professionals have towards organs they have procured impedes the development of an 
equitable and national system forthe distrbution of organs.  RECOMMENDATIONS 
The Public Health Service (PHS) 
The PHS, in collaboration with the OPTN, should issue regulations to require that each OPO (1) 
establish a single, unified list of patients awaiting trnsplantation and (2) distrbute donated 
organs to those patients on a first come first served basis, subject to established medical criteria. 
The PHS, in collaboration with the OPTN, should issue regulations to require that each 
donor hospital in an OPO service area adhere to the centralized organ 
transplant center and-
distribution policies of the OPO governing that area. 
The PHS, in collaboration with the OPTN, should support the development of medical practice 
guidelines addressing organ transplantation. . 

The PHS should fund a demonstrtion effort incorporating the following two features: (1) the 
establishment of a single, unified waiting list including all patients awaiting an organ transPlant 
in a number of OPO service aras and (2) the mandatory distrbution of donated organs to those 
patients on a first come first served basis, subject to established medical criteria. 
The Health Care Financing Administration (HCFA) and the Public Health Senice 
The HCFA and the PHS should support research efforts that could help reduce racial disparities 
in organ allocation. 
, in collaboration with PHS, should 
Before granting Medicare recertification to an OPO, HCFA
assure that the OPO is distrbuting organs equitably among patients, according to established 
medical criteria. 
recertification to an OPO, HCFA, in collaboration with PHS, should 
Before grnting Medicare 
assure that the OPO is conducting a rigorous, soundly based organ procurement effort. 
The American Society of Transplant Surgeons (ASTS) and the American Society of 
Transplant Physicians (ASTP) 
The ASTS and the ASTP should conduct their own inquiries of the factors leading to longer 
median waiting times for blacks than whites awaiting a kidney transplant and of any actions their 
associations should take to help reduce this disparty. 
111  COMMENTS 
Within the Department of Health and Human Services, we received comments from PHS, HCFA 
and ASPE. The PHS and HCFA agreed with the recommendations directed to them. The ASPE 
raised a number of concerns about the recommendations. 
Outside the Department, we received comments from the ASTS and ASTP and nUmerous other 
organizations, including the United Network for Organ Sharng, the American Society for 
Histocompatibilty and Immunogenetics, the Association of Organ Procurement Organizations, 
the North American Transplant Coordinators Organization, the New England Organ Bank, and 
the South-Eastern Organ Procurement Foundation. 
In response to our recommendation directed to ASTS and ASTP, the ASTP indicated that it 
recently completed a study addressing the differential access of blacks and whites to organ 
ASTS noted its readiness to (a) define medical indices of patient suitabilty 
trnsplantation. The 
for being placed on transplant waiting lists, (b) develop an allocation scheme that addresses all 
(racial included) factors that affect organ transplantation, and (c) delineate standards to assess 
OPO activity and perfonnance. 
In appendix D, we present the detailed comments of each of the organizations and our responses 
to them.  ............................,........... ............. .................. ............ ...... ........... ....................... ... .... ................. .. ...........,. ............................... .............. . ....
TABLE OF CONTENTS

EXECUTIVE SUMMARY

INTR 0 D UCTIO N..............................................................................

FINDINGS .............................................. .......  ..................................... 8

RECOMMENDATIONS 

COMMENTS ON THE DRAFT REPORT ...........................................................

APPENDIX A 
Statistical Methodology And Notes ...................... ............................... .......... A-
APPENDIX B

Tables Derived From The Organ Procurement And Transplantation 
Network Data Base.... .......... 
APPENDIX C 
.....,................................................................................. C
Endnotes................... 
APPENDIX D

Detailed Comments On The Draft Report

And GIG Response To The Comments........................................................... D-
 INTRODUCTION
In this report, we focus on the distrbution of organs to the more than 20,000 people who have 
been detennined to be medically suitable candidates for an organ transplant and are now 
1 We examne the distrbution 
awaiting a donated organ.  procss, from the point that an organ is 
2 We pay parcular 
procured to the point that it is transplanted. attention to the expectations and 
practices governing the actual selection of the individuals who wil receive an organ transplant. 3 
Throughout the report, we emphasize the distrbution of kidneys. We do that because kidney 
transplants account for about 75 percent of all organ transplants and because about 84 percent of 
the individuals on transplant waiting lists are awaitig a kidney transplant. 
At the same time, we believe that most of th  basic issues addrssed in the report are of equal 
significance to the distrbution for transplantation of hears, livers, and other organs. In large 
measure kidney procurement and distrbution practices have provided and wil continue to 
provide the fraework for practices governing these other organs. 
The basic purposes of our study are threefold: (1) to clarfy expectations governing organ 
distrbution practices in the United States, (2) to determe the extent to which actual practices 
are in accord with expectations, and (3) to offer recommendations that faciltate close accord 
between expectations and practices. 
inquir: 
Our methodology is based on four major lines of 
A statistical analysis of a data base consisting of the 17,556 individuals in the United 
States who were waiting for or received their fIrst kidney transplant between October 1 
6 The analysis focuses on demographic and other factors 
1987 and March 31, 1989.
associated with the length of time waiting tor kidney trnsplantation (see appendix A for a 
detailed description of data used in the analysis); 
case studies of four large organ procurement organizations and affiliated transplant centers 
in California, Florida, Wisconsin, and Pennsylvania; 7
interviews with representatives of national organizations involved with the field of organ 
transplantation, government policymakers, public and private researchers, and transplant 
8 and 
professionals;
a review of pertinent literature and documents concerning organ procurement, distrbution 
and transplantation.  . BACKGROUND 
In 1984, after congressional hearngs which addrssed the inadequate supply of organs being 
made available for transplantation and the often unfai systems for distributing those that did 
become available, 1O Congrss passed the National Organ Trasplant Act. Among other things 
the legislation prohibited the buying or sellng of organs and called for the Deparment of Health 
and Human Services (HS) to provide by contract for the establishment and operation of an 
Organ Procurement and Transplantation Network (OPTN) and to establish a Task Force on 
Organ Transplantation (hereafter referred to as the Task Force). 
Congress mandated that the Task Force be composed of 25 members and stipulated the 
Secreta. In addition to 4 ex-officio 
categories of members to be appointed by the HHS 
members representing varous par of HHS, it specified that there were to be 12 from the organ 
trnsplantation field (9 of whom must be physicians or scientists); 4 who as a group had 
backgrounds in law, ethics, health car financing, and the social and behavioral sciences; 3 from 
the general public; and 2 from the health insurance field. Congress instructed the members to 
develop recoinmendations on how to achieve more effective, effcient, and equitable systems for 
organ procurement, distrbution, and trnsplantation. 
In April 1986, the Task Force issued its report to Congress. The recommendations set forth in 
the report provided the stimulus for subs  uent legislation in 1986 and for the initiation of the 
1984 legislation. 12 
OPTN called fodn the 
In September 1986, the Public Health Service (PHS) contrcted with the United Network for 
13 to develop the OPTN. 
Organ Sharng (UNOS)  One year later, PHS and UNOS agreed to a 
year contract for UNOS to operate the OPTN. The contrct calls for the OPTN to: 
improve the effectiveness of cadaver organ procurement and distrbution; 
trnsplant; 
improve and increase the access to an optimal organ 
improve the system for sharng renal and extrenal organs so as to: (1) facilitate 
matching; (2) improve the access to transplantation of patients whose immune system 
makes it difficult for them to receive an organ; (3) improve the outcomes of organ 
transplantation; and (4) decrease the wastage of organs; 
assure quality control by the collection, ana  sis, and publication of data on organ 
donation, procurement, and transplantation; 4 
maintain and improve professional skills of those involved in organ procurement and 
transplantation; and 
members. 
maintain an OPTN governance entity or board elected by a majority vote of all OPTN The OPTN board, much like the prior Task Force s membership, is a diverse one, but one in
which transplant professionals are heavily represented. Among the 34 members of the board, 
are physicians, and 15 of the physicians ar trsplant surgeons.
In 1986, Congress passed legislation that had far reaching impact on organ procurement and
distrbution practices throughout the countr. On the basis of this legislation:
HHS had to delineate organ procurement service areas throughout the country and
designate a single organ procurement organization responsible for each area (previously,
in many areas of the countr OPOs were competing with one Clother for the procurement
of organs);
OPOs had to be members of and abide by the rules and requirements of the OPTN;
OPOs had to adhere to perfonnance standards established by HHS;
hospitals with transplant centers, as a Medcare condition of participation, had to be
members of the OPTN and abide by the rules and regulations of the OPTN; and
all hospitals, as a Medicare condition of parcipation, had to develop 
written  rotocols for
identifying potential organ donors and for notify ng an OPO of such donors. 
In the midst of this legislative activity, there were continued advances in transplantation
. technology and immunosuppression therapies, resulting in improved patient outcomes. As
transplantation became an increasingly accepted treatment for organ failure, third pary coverage

for the costs of the procedure became increasingly common. At the Federal level, the Medicare
program had long covered the costs of kidney transplantation as par of the near universal
16 However
coverage accorded to individuals with end stage renal disease (ESRD). , in 1987 it
17 and in March 
made hear trnsplantation a covere service for Medcare beneficiares  1990
issued a draft re  coverage of liver transplants in adults under certain
fulation proposing;

circumstances. 1

developments has been a steady incrase in the number of transplantation
Paraleling the above 
programs. By April 1990, there were 250 medcal institutions in the United States operating
19 There were 72 HHS designated OPOs that in 
organ transplantation progrms. varous ways

and to varing degrs were involved in the procurement and distrbution of organs to be
transplanted in these institutions.
From the perspective of patients awaiting an organ transplant, these developments are of
profound importance. They present the opportunity for a medical intervention that can
significantly improve their physical well-being or, indeed, save their life. Yet, because the
demand for trnsplants has risen much faster than the available supply of organs, the opportunity
is one that wil be long delayed or never achieved by may of these patients. While there has
always been a gap between the supply and demand, it widened appreciatively between 1986 and
1988 (figure 1), and on the basis of preliminar data, it appears that trend continued in 1989. ' - - -*- - - - - . - -. .  -. ...:._..-,.  .-.. .-_......'- .-.. .-_.*..."..  ---.-.. .-..-  -- -- - -- - -* - - - - - -- -- - - - - *
FIGURE 1 
Growth In Kidney Transplants And In The Number Waiting For Transplants 
1983 - 1988 
13.282 
916 8.967 8.
932 
I- 8  695-
96 -
112 . 
1983  1984  1985  1986  1987  1988 
YEAR 
Source: ESRD Facilty Survey. HCFA. BDMS 
In the pages that follow, we address the expectations and practices governing how donated 
22 are made available to the more than 20,
cadaver organs 000 people now awaiting them. We 
fundamental expectations which Congress and professionalleaders 
star by identifying the 
have set fonh. Then, in our fmdings section, we indicate the extent to which these expectations 
are reflected in practice. In so doing, we find some disturbing discrepancies. We close by 
offering a number of recommendations on how these discrepancies might by eliminated or at 
least narwed. 
EXPECTATIONS 
ell vision the development of orgall distributioll practices 
COllgress and professional leaders 
equitable to those in need  carried out in accord with a natiollal system, and (3) 
that are  (1)  (2) 
based on the cooperation of transplant professionals. 
From statutes and supporting documents, HHS and OPfN policies, the final report and other 
documents of the Task Force on Organ Transplantation, and our own extensive interviews, we 
found extensive and clearly stated support for the three above-noted expectations. We found that  .. 
the realization of each of these expectations was widely regarded as essential to the underlying
24 Each is briefly explained
legitimacy and continued advancement of organ trnsplantation.
below.
Congress and professional leaders expect each person on a transplant waiting list to
have an equal opportunity to receive a transplant subject to established medical criteria.
There is a clear trail of authoritative congressional and professional expressions that provide the
Transplant Act
underpinning of the above expectation. The trail begins with the National Organ 
of 1984. In that legislation, Congress specified that an OPO must "have a system to allocate
donated o  2ans am6ong trnsplant centers and patients according to established medical
criteria.  In an accompanying report, the Senate Labor and Human Resources Committee
added the following: "An equitable policy and system is necessar so that individuals
throughout our countr can have access to or-gan trsplantation when appropriate and
necessar. ,,
Two years later, the Task Force reinforced Congress' expectation governing the equitable
allocation of organs and defined it more specifically. In its final report, it stated the following:
The Task Force recommends that selection of patients bothfor waiting lists and for
allocation of organs be based on medical criteria that are publicly stated and fairly
1st.rec omm end that the criteria be developed by a broadly
applied. The Task Force also 
representative group that wil take into account both need and probability for success.
qualifed should be based on length of time on
Selection of patients otherwise medically 
ng 
t e walt
It amended the
Then, in 1988, Congress once again addressed the matter of organ distrbution. 
1984 legislation to clarfy that in allocating organs according to established medical criteria an
OPO must act "equitably" and must focus strctly on the allocation among patients, not
28 In a report accompanying the amendment, the House Committee on Energy
trnsplant centers.
in a position to show
and Commerce noted that concerns had been raised about OPOs being "
favoritism to patients of a parcular transplant facilty." Whe the commttee indicated it had no
knowledge of any parcular instace of such favoritism, it added that it expected "the Secretar
to monitor the allocation of organs closely.
Thus, the clear intent of Congrss is that organs be distrbuted faily without regard to such
factors as a trnsplant candidate s income, sex, race, or residence and without regard to the
transplant center at which that candidate expects to receive a trsplant. In one way or another
nearly all the individuals we interviewed in the course of this study supported this congressional
intent.
In expressing its expectations on how an organ distrbution system should function, Congress, in
the 1984 legislation, singled out one group that it felt needed special attention if it were to
receive a fair opportunity for a transplant. Specifically, in callng for the OPTN to develop "
national list of individuals who nee organs" and a "national system... to match organs and
individuals on the list," it indicated that paricular attention should be given to "individuals , "
whose immune system makes it diffcult for them to receive organs.  30 -In so doing, it 
31 individuals, the opportunity to receive a medically 
recognized that for these highly sensitized
suitable organ increases as the size of the available pool of donors increases.
Yet, Congress did not accord the highly sensitize with an actual preference, nor 
professionals in the transplantation field agree on how much, if any, preference they should
receive in distrbuting organs.
Congress and professional leaders expect organ distribution to occur in accord with a
national system adhering to uniform policies and standards.
The 1984 legislation was a response to the infonnal and fragmented practices then characterizing
32 It recognized that it was in the public 
the distrbution of organs in many parts of the countr.
interest to develop more fonnalized and systematic mechanisms guiding organ procurement, 
throughout the countr. In this regard, the legislation enjoyed 
distrbution, and transplantation 
widespread support among the organ transplant community. 
Thus, as already noted, the legislation called for the OPTN to establish one nationwide list of
individuals awaiting transplantation and "a national system" that would allow for donated organs
to be quickly matched with medically suitable candidates on that list. Congress called for the
OPTN to develop this capabilty through the use of computers and in accord with established
medical criteria. 
In callng for a national system, Congress essentially sought two outcomes: (1) the development
of some common rules to which all OPTN members were bound and (2) the development of the
technical capability to distrbute organs nationally, expeditiously, and in accord with explicitly
stated criteria. Yet it did not mandate any such national distrbution, and. it specifically stated 
that a national list and a national system could be established in regional centers instead of in one
central location. 
The Task Force reinforced the importce of developing a national system and urged the 
33 Such policies and 
adoption of "unifonn policies and standards by which all wil abide. ,,
of an organ for 
standads, it indicated, should address matters such as the acceptabilty 
trnsplantation, the acceptable length of organ preservation time, andthe desirable degree of 
tissue matching between donor and recipient. The Task Force noted that while diverse practices 
. and protocols were to be expected during the pioneerig year of trsplantation  at this point in 
the evolution of organ transplantation, sufficient data have been developed to allow for the
establishment of certain standards of practice. ,, 
Congress and professional leaders expect transplant surgeons and other professionals to 
work together cooperatively in the best interests of all patients waiting for transplants. 
Such an expectation is one that would apply to any complex human endeavor. Yet, it is an 
imponant one to include here because it is so integral a par of the framework of expectations 
characterizing not only organ distrbution, but also organ procurement and transplantation.  From the earliest efforts to enlist the support of potential donors. and donor hospitals to the post 
transplant efforts to improve patient outcomes, successful perfonnance requires the cooperative 
efforts, often under very strct time pressures, of a wide range of professionals. These include 
trsplant 
but are by no means limited to  coordinators, nurses, social workers, neurologists, 
nephrologists, transplant surgeons, immunologists, and OPO administrators. While each of these 
participants have their own paricular interests, they must work together effectively as trustees of 
organs for all the persons awaiting a transplant 
It was in recognition of the complex nature of this collaborative effort that Congress called for 
the unusual approach. of a private body, the OPTN, having a strong role in shaping the national 
system. Congrss and professional leaders saw the OPTN and, to a lesser degree, the OPOs 
themselves as forums for developing policies and protocols buttressed by broadly based 
consensus.  FINDINGS
organ distribution practices fall short of congressional
While there has been progress, current 
alld professiollal expectatiolls ill each of the three areas.
Almost every individual with whom we conversed, whether in highly structured telephone
interviews or in the halls outside of operating rooms, regarded the establishment of the OPTN as
a substantial accomplishment. In varous ways, they indicated that it provided a foundation for
the development of an equitable national system rooted in cooperative professional relationships.
Yet, upon questioning, these same individuals were quick to point out that such a system has not
yet been achieved. Our review of the OPTN data reinforced this conclusion.
The three more specific findings that follow indicate how current practices fall short of each of
the three sets of expectations addressed earlier.
EQUITY
The access of patiellts to donated organs remains unequal in some important respects.
Our primar patient data base, as indicated earlier, concerns the 17 556 individuals in the United 
States who between October 1 , 1987 and March 31, 1989 were waiting for or actually received a 
first kidney transplant. In analyzing the data, we found that in three respects there were 
significant disparities in the access that these individuals had to kidney transplants. The 
s race, transplant center, and level of sensitization. 
disparties related to an individual'
First, with respect to race, we found that blacks were waiting almost twice as long as 
Race: 
whites for their first kidney trsplant. In paricular, we found that the median waiting time for 
blacks was 13.9 months, compared with 7.6 months for whites (see appendix B, table B-3). 
In seeking to explain this  we were informed by professionals in the 
substatial difference, 
trsplantation field that medcal considerations involving bloo type, level of sensitization 
and/or age might account for some or all of the gap. However, we found that these 
considerations accounted for little of the difference. For each blood type, blacks who are not 
35 and are between 18 and 64 years of a
highly sensitize e waite significantly longer than 
whites for their first kidney trnsplant. For all blood types combined, the median waiting time 
for non-highly sensitize blacks 18 to 64 years old was still nearly twice that of comparable 
whites, 12.6 months compard with 6.9 (figure 2). Not surprisin 
6' therefore, blacks have been
receiving only about 23 percent of all cadaver kidney transplants, while they represent about 
30 percent of those on kidney transplant waiting lists.  ..",.--_. 
FIGURE 2 
Estimated Median Waiting Times To First Kidney Transplant 
By Race And Blood Type 
1987 - March 31, 1989 
October  1, 
17. 
_"'H.__._.-..,,"-....._m... 
t- 10

All Blood Types 
BLOOD TYPE

Black (N=3 797) I2 White (N=8,360) 
18- Not Highly Senstized (i. =75) 
Note: Ages  64,  e., PRA 
Data Source: OPTN Contractor 
Data Anlysis: OIG/OEI 
38 wherein 
Thus, on the basis of the above-noted analysis and of a proportonal hazds analysis
we examined the independent effect of race, holding age and blood type constant, we are unable 
bloo 
to explain the longer waiting time of blacks on the basis of  type, level of sensitization, 
and/or age.

In seeking other possible explanations, we considered that there might be some kind of 
locational effect. We sought to determne if the longer median waiting time of blacks existed 
throughout the countr or if it were concentrated at certin centers and/or certain parts of the 
countr. 
In this regard, we conducted two additional analyses. Both involved a calculation of the mean 
ratio of black reipients ' median waiting time to that of white recipients for each transplant 
registration center. With this approach, a ratio greater than 1 iRdicates that blacks waited longer  on the average, than whites. (See appendix A for further elaboration on the calculation and the
analyses summarzed below. 
In the first analysis, we calculated the average ratio for registration centers in each of 10 regions 
of the countr. We found that in two regions (New England and the Plains States), the ratios 
were considerably lower than in the others and that the median waiting time for blacks and 
74. 
whites was about the same. In the other regions, blacks waited longer, with the ratios ranging 
from 1.25 to 2.
In the second analysis, instead of pars of the countr, we focused on the percent of blacks on 
waiting lists. More s  ecifically, we perfonned a regression analysis of the percent of blacks on a 
waiting list against the ratio. We found that the ratio of blacks' median 
registration center ' 
waiting time for a first transplant to that of whites was not affected by the percent of blacks on 
the waiting list of a center. 
Once again, therefore, we are unable to explain the substantially longer median waiting time for 
blacks. Our analyses indicate that although there are some locational varances, the longer
median waiting time for blacks is widespread, not confined to a few parts of the country or to a
few transplant centers or .organ procureme,:1t organizations.
There are numerous other factors that we were not able to analyze that might help account for 
the disparty. What would appear to be the most consequential of these is that typically organ 
40 In 
allocation systems are at least parially based on human leukocyte antigen (HLA) matching.
response to our draft repon (see appendix D), the American Society for Transplant Surgeons 
explained as follows how this practice might disadvantage blacks: "Since most donors are 
white, whites are more likely to have better HLA matche  than blacks with a given donor; thus, 
among potential recipients the proportion of whites first offered a kidney could be greater than
the proportion of whites waiting, because of the increased probability of a good match.
Another possibly, important factor is the economic status of the candidates. Although nearly all
kidney transplant candidates are Medcare covered individuals, those who are not can be subject 
to financial costs which in some way inhibit their access to a transplanted kidney. Furter, even 
for Medcar covere individuals the Medicar program does not cover the cost of 
immunosuppressive drgs for more than one year after the transplant and does impose certain 
coinsurance and deductible requirements. The associated costs can be substantial and
conceivably can hinder access.
might help explain the difference are (1) the patient s medical
Stil other considerations that 
condition and/or wilingness to accept a donor organ when it is offered, (2) the extent of the
social support available to the patient, (3) the fact that some patients ar on multiple waiting lists,
and (4) the factors used to determine who is actually placed on a kidney waiting list in the fIrst
place.
In a recent report on black-white disparties in health car, the American Medical Association
Council on Ethical and Judicial Affairs identified different rates of kidney transplantation as an
indication of broader disparties in medical treatment offered to blacks and whites. It further 41
noted that it was "unlikely" that medical factors alone accounted for the fact that whites were
more likely to receive a kidney transplant.
After reviewing disparties in varous medical treatment decisions, the CounCil concluded that in 
A2 It elaborated as follows:
part they "may reflect the existence of subconscious bias.'
years racial
This is a serious and troubling problem. Despite the progress of the past  25 
prejudice has not been entirely eliminated in this country. The health care system, like all 
" 43 
other elements -of society, has not fully eradicated this prejudice.
In our study, we found no infonnation to indicate that racial prejudice contributed to the 
differential in black-white waiting time. Yet, considering the statement of the AMA Council, we 
must recognize that it is possible that to some degree the differential may reflect such prejudice 
and "subconscious bias." 
Finally, the longer medan waiting times of blacks are especially significant since blacks have
much higher rates of kidney failure than whites. Although blacks account for only about 12
44 they account for 34 percent of dialysis patients in the End Stage
percent of theU.S. population,
Renal Disease Program. 
At the same time, it must be noted that blacks are less inclined to donate organs than are other
all cadaver kidney transplants involved the use of a
groups. In 1988, only about 8 percent of 
46 The possible explanations for this situation are many and
kidney from a black donor.
47 but certainly among them must be the relatively small number of black procurement
complex
48 In this regard, the president of
coordinators working for the organ procurement organizations.
American Society of Transplant Physicians, in comm nting on our drft report (appendix D), 
made an observation that warants serious consideration by all those associated with the field of 
organ transplantation. It is as follows: 
Some years ago we hired a black social worker in our ESRD program. Related donor
transplantation, which had previously been negligible in blacks in our program, rose
substantially soon after he took on the position. I strongly beJieve that cadaver organ
donation in blacks would increase significantly if blackfamiles were approached by black

would like to suggest that the OPO be
organ procurement coordinators. Therefore; 
strongly encouraged to train and hire black transplant coordinators. This effort could be 
coordinated through NATCO and AOPO. 
A second major respet in which we found patient access to organs to be
Transplant Center: 
unequal concerns the trnsplamcenter at which the patient was r gistered. For the October 1987 
through March 1989 period, the medan patient waiting time for a first kidney transplant ranged 
from a low of less than 1 month at pne center to a high of 71 months at another. Among the 202 
centers reviewed, the median waiting time at 79 was less than 6 months for non-highly sensitized 
patients; at 15 it was over 18 months (figure 3). Such wide varations existed even among 
centers in the same OPO service area.  ----.. .
-....--..._.._ ...-. ..-..-. -...-......-.-..
hazds 
From our proportonal  analysis, we also found that the size of a center s waiting list had 
some effect on how long a patient had to wait for a transplant. Thus, for instance, a patient 
fit 
awaiting a  transplant in a center with 25 registrts had a 7 percent better chance of 
receiving one at any point in time than a patient in a center with 100 registrts (see appendix B 
table B-5). 
Such differences in waiting time have developed because few trsplant centers have joined
together to develop a common list of trsplant candidates and then to distrbute donated organs
to those candidates on a fIrst come fit served basis, subject to medcal criteria. Some have 
joined together to establish a common list, but the crteria they have developed governing the 
distrbution of donated organs ar apt to devote as much or more attention to the distrbution of 
organs among centers as among patients. For instance, many transplant centers across the nation 
parcipate in an OPO approved argement where for each pair of cadaver kidneys they 
keep one for one of their own patients and give one to the common pool. The 
retreve, they 
kidney donated to the pool is then made available to another trsplant center in the service ara, 
argement. 
usuall y in accord with some rotational 
FIGURE 3
Estimated Median Waiting Times To First Kidney Transplant
By Transplant Center
100
ff 80  7.9 
60 
.- 40 
12 12-
18+ . 
MONTS TO TRNSPLANT
Data Source: OPTN Contractor
(October J. 1987. 31. 1989)
March 
Data Analysis: OIGIOEI Finally, as professionalsjn the transplant field would expect, we found 
Lel'el of Sensitization: 
that the highly sensitized patients had considerably less access to donated organs than did others 
on transplant waiting lists. Even some of the professionals, however, might be surprised at the 
extent of the difference. During the I8-month period we examined, the median time that 
thc? 
highly sensitize waited for donated kidneys was almost 4 times that of all others, 32.4 months 
compared with 8. 
From the available data, we cannot detennine whether or not this difference has widened or 
narowed in recent year. However, the data do indicate that proportionately more women are 
highly sensitized than men and for that reason tend to have longer waiting times than men. 
NATIONAL SYSTEM 
There has been considerable progress in developing a national organ distribution 
system grounded in unifonn policies and standards. However organ distribution 
remains heavily controlled by the individual transplant centers and confined primarily 
Organ Procurement Organizations. 
within the individual service areas of the  72 
Only a few years ago, some trsplant centers that could not use an organ they retreved would, 
on the basis of private conversations and infonnal argements, send that organ to another 
center. That centet might be in the same State, in another State, or, for that matter, in another 
countr. That is no longer allowed. The OPTN reuires that centers and OPOs have fonnally 
stated criteria governing the distrbution of organs and that OPOs use the national organ center 
for distrbuting any organs that they cannot use within their individual service areas. The organ 
center then distrbutes such donated organs, in accord with established criteria, to individuals on 
a national waiting list it maintains. 
In this and many other respects, the OPTN, as seyeral of the individuals we interviewed 
indicated, has been a positive force in the development ofa national system characterized by 
unifonn policies and standards. It has provided a valuable forum for bringing together diverse 
interests and multiple viewpoints and, where possible, for forging common approaches based on 
the national interest. It has established a computerize national waiting list as Congrss 
mandated. 50 And, in the sphere of kidney transplantation, it has re  uired that all donated 
1 be made available to that 
kidneys which match perfectly with a candidate on the national list 
candidate, wherever he or she may reside in the United States. 
ar 
The above  significant achievements. Yet, in considering these and others that could be cited, 
it is important to recognize that the actual distrbution of organs from donors to recipients 
remains highly localized. It is localize, firs  of all, in the sense that through the OPTN' s "local 
use" policy, the 250 transplant centers are allowed to retain almost all of the organs that they 
have retreved. 52 They enter into cooperative agreements with an OPO or other centers only at 
their own will. Indeed, if they so wish, they can make arngements concerning the distrbution 
of organs with a donor hospital and/or an OPO in a service area other than the one in which they 
are located.  Secondly, as would be expected from this local use policy, the distribution system is also 
localized in the sense that most organs procured within a service ara never leave that area. Only 
about 22 percent of all the kidneys retreved are distrbuted nationally, through the OPTN organ 
center. 53 This shar, which includes perfectly matched kidneys that OPOs are mandated to 
distrbute nationally and the larger number of other kidneys which they voluntarly make 
available to the national pool, has not changed appreciably in recent years. 
Whether or not the shar of organs that is distrbuted nationally should be increased is a matter 
of much debate within the transplant field. The debate centers around the extent to which tissue 
matching should be used to detennine who receives donated organs. One camp emphasizes that 
transplant recipients whose tissues, or, in paricular, whose identified human leukocyte antigens 
(HLA), are well matched with those of the donors wil have improved outcomes, both in tenns 
of their physical well being and the life of the transplanted organ. Thus, the proponents of this 
viewpoint point out that an organ distrbution system tha  allows for recipients to be matched 
with a large pool of potential donor organs, either in a few regions of the countr or, better yet, 
nationally, wil enhance patient outcomes and provide for the best use of a scarce resource. 
The other camp, while not necessarly discounting the gains from HLA matching, stresses that 
similar or even better outcomes can result by using proper drg regimens and by minimizing the 
time during which a retreved organ is held in storage prior to trsplantation. Thus, the 
advocates for this position call for minimizing the national distrbution of organs and confining 
distribution to a far more limited geographic scale, one that is no larger than an OPO service area 
and perhaps even smaller. 
COOPERATION
The developmellt of the Orgall Procuremellt alld Trallsplalltatioll Network is a 
signifcallt cooperative achievemellt of trallsplallt professionals alld others. Yet at the 
transplant center and OPO levels, the sense of local ownership that some trallsplallt 
professionals have towards orgalls they have procured impedes the del'elopmellt of all 
equitable and national system for distributing organs. 
OPT 
has been a constructive factor in the development of a national organ 
Just as the 
it been an important reflection of the readiness of many diverse 
distrbution system, so too has 
interests to work together cooperatively. The same can be said of many of the OPOs. 
Yet, among many transplant professionals and transplant surgeons in parcular, there remains a 
This orientation inhibits further 
sense of ownership of donated organs they have retreved. 
cooperative achievements and, as we have already noted, impedes the development of a more 
equitable system for distrbuting organs among patients. 
By a "sense of local ownership" we mean that in the course of procuring organs, many transplant
professionals, instead of viewing themselves as trstees of donated organs for all transplant 
candidates in the United States, regard themselves more as agents for patients associated with a 
particular transplant center or residing in a paricular service area.  . .
Thus, as ratioriale, we often hear that in order for trsplant surgeons to have suffcient 
car 
incentive to  out the demanding work of procuring organs, often during the middle of the 
night, they must have some assurces that their patients (and their paricular programs) wil 
derive some benefit from the effon. As furter rationale, we also heard that the incentive to 
donate organs might diminish if residents of a parcular OPO serviCe area found that organs 
doonratged ain nthesir .ar e5a w5ere  being sent to other aras that are less successful in obtaining donated
The latter rationale was expressed as follows by the OPTN' s Organ Procurement and 
Distribution Committee in response to a physician s recommendation that organs be allocated on 
a national basis, irspective of local or regional needs: 
The Committee pointed out that it is widely recognized and accepted that organ procure
ment is enhanced by local use. Or gaT)  donation.' Those who raise money 
donation is a 
for transplant recipients report that donations are highest where there are local patients 
waiting for organs. Furthermore, it is inequitable to force  OPOs to by-pass their 
ffcient 
own patients to subsidize the ineffciency of other OPOs.', 
Such concerns, along with the reservations about the benefits of tissue matching, have been 
extremely influential in limiting the geogrphic scope of organ distrbution. They provide the 
basis for the "keep one-share one" type of kidney distrbution system described earlier. And 
they offer the rationale for the "renal payback system  that the OPTN now applies in regard to 
kidneys that OPOs are mandated to donate to the national pool. Under that system, a transplant 
center receiving such a kidney must subsequently return one to the offering 
trnsplant center or 
57 Such an arangement was necessar to 
OPO. maintan support for the perfect match 
requirement, even though that requirement affects only  percent of all cadaver kidneys 
aJ:)Qut 8 
. transplanted. 
It should be noted that some transplant professionals do. not view the organs they procure as 
belonging to their trsplant progr or even their OPO service ara, and ar in fact opposed to 
the OPTN' s renal payback system and other such payback systems operating within OPO service 
areas. An indication of this point of view and the rationale behind it is offered in the following 
excerpt from a letter sent to the OPTN in Februar 1989 by a, ttansplantsurgeon who is the 
medical director of an OPO. 
Establishing a payback system also creates the ilusion that a kidney is the property of a 
given OPO. Clearly, we need to foster the notion that organs 
for transplantation are a na 
tional resource which should be used in the most effcient and successful manner possible. 
ey are not anyone s In 
LVL ua property. 
It should also be noted that the rationales supporting the ownership argument rest on fragile 
foundations. We found no valid statistical basis to support the contention that organ procurement 
will diminish if transplant centers and/or OPOs are not given some payback for procured 
kidneys. And, contrary to the OPTN Committee s suggestion that communities do not expect to 
supply organs to other parts of the countr without a reasonable return, we found that in a 
national public opinion poll, commissioned by the OPTN itself, over 75 percent of the 
1'\  respondents disagreed with the statement that "donor organs should go to someone in the area 
where the donor lived.  RECOMMENDATIONS
During the 1980s, there has been ttmendous progrss in the field of organ trnsplantation. At 
the beginning of the decade, kidney trnsplantation was stil a poor alternative for the great 
majority of dialysis patients, and hear and liver trnsplants were in the very early experimental 
stages. By the end of the decade, kidney trsplants had become a well established protocol for 
00 
a significant proportion of dialysis patients, with close to 9, such transplants being conducted 
on an annual basis in the United States. Similarly, hear and liver trnsplants had advanced well 
beyond the experimental stages, with more than 3,600 such trnsplants being carried out 
annually in the country. 
In this milieu of rapid medical advance, there has also been substantial advance "in the 
development of complex organizational systems responsible for the distrbution of organs, from 
the point of donation to the point of transplantation. This advance is reflected in the increasing 
sophistication of OPO operations and in the establishment of the OPTN as a policymaking and 
oversight body.
Yet, in the midst of this progress, we have found that there ar some disturbing disparities 
between the stated expectations governing organ distrbution and the practice realities. This is 
most especially the case with respect to the expectation that subject to medical criteria those on 
transplant waiting lists should have equal access to trsplants and the reality that in some 
respects the access is quite unequaL As the number of individuals awaiting a transplant 
increases, this disparty becomes an increasingly serious matter waranting national attention. 
In making our recommendations, we do not impose our own or others ' judgments about the three 
stated sets of expectations. A reexamination of the desirabilty of some or all of those 
expectations may be waranted, but is beyond the purview and data base of this study. 
Thus, we regard the expectations as given. Each is the product of long deliberation among a . 
broad base of paricipants, and each is rooted in law. In our recommendations, we focus on the 
practice realities and on how they might be modified to reflect more closely the three sets of 
ex pectations.
We direct our recommendations primarly to PHS and HCFA and focus primarly on the equity 
issue. Each agency has responsibility for addressing this issue: PHS, through its oversight of 
the OPTN, and HCFA, through its oversight of Medicare and Medicaidexpenditures in general 
and its certification of OPOs in paricular. We conclude with a recommendation to the American 
Society for Transplant Surgeons and th  American Society for Transplant Physicians.  THE PUBLIC HEALTH SERVICE 
The PHS, ill collaboratioll with the OPTN, should issue regulations to require that each OPO 
(1) establish a sillgle, ullifed list ofpatiellts  distribute 
awaitilzg trallsplantatiOlz alld  (2) 
dOllated organs to those patients on a first come first served basis, subject to established
medical criteria. 
What this means is that each trnsplant center located within an OPO's service area would 
register its own trnsplant candidates on one unified list maintained by the OPO. Each donated 
cadaver organ that then becomes available for transplantation in that service ara (except for 
those mandated by the OPTN to be distrbuted nationally), would then be offered to patients on 
that list in the order that they have been registered. The only basic exceptions would 
be those 
- warrnted in accord with established medical criteria (which, as we note subsequently, must be 
stated more explicitly). 
With this approach, the emphasis would be on equitable access among patients, not among 
trnsplant centers. Transplant centers would not "own" any organs that they or others have 
procure. All distrbution of organs would be based on the OPO' s list, nOt individual centers 
own lists. The result would be a system that is much more in accord with congressional intent 
as expressed in 1984 and clarfied 
in 1988. 
The PHS, in collaboratioll with the OPTN, should issue regulations to require that each 
trallsplant cellter alld donor hospital ill all OPO service area adhere to the celltralizedorga1l 
distribution policies of the OPO gover1ling that area. 
If the first recommendation is to achieve its objective of a more equitable, patient based system 
the above recommendation must also be cared out. If it were nOt, transplant centers would be 
able to undennine the first come first served approach by making organ distribution 
arangements, as some now do, with a donor hospital and/or an OPO outside the service area in 
ar 
which they  located. 
In this context, it is absolutely essential that OPOs, not trnsplant centers, be regarded as the 
engines of the organ distrbution system. They should have the authority to shape and oversee 
distribution policies in their service areas, in accord with guiding Federal requirements, and they 
should be held accountable for the exercise of this authority. In guiding the equitable 
distribution of organs, they must assure that the focus is on the equitable access of patients, nOt 
transplant centers. 
The PHS, in collaboration with the OPTN, should support the deJ e!opme1lt of medical 
practice guidelines addressing orga1l trallsplantatioll. 
Our recommendation callng for OPOs to distrbute donated organs on a first come first served 
basis responds to the National Organ Transplant Act s requirement that organs be allocated 
equitably among patients. It also responds to the Act s injunction that organs be allocated in 
accord with "established medical criteria.  Herein lies a certain problem. There are differences among professionals in the field concerning 
and how such criteria should be applied at a time when there 
the proper scope of medical crteria 
is a considerable shortage of donor organs. These differences involve, among other things, the 
6O 
degree of emphasis that should be given to age, sensitivity level, and HLA matching in 
distrbuting organs. Further, it is possible that the application of such criteria, at least in so far as 
they apply to HLA matching, can contrbute to the inequitable allocation of organs among blacks 
-and whites.
Thus, it appears that further examination of the content of these criteria and some resolution 
concerning them is relevant to any concerted national effort to reduce the racial and other 
disparties indicated in this report. In short, it is important to have a clearer definition of just 
what is meant by the widely used tenn "medical criteria. 
In that regard, PHS can make a valuable contrbution by supportng the development of 
transplant practice guidelines, based on medical outcomes, that would serve as an authoritative 
and useful reference point both for practicing professionals and for oversight bodies responsible 
for assuring that organs are in fact being distrbuted equitably. 
If in the effort to establish practice guidelines it emerges that certin choices concerning organ 
allocation are in essence societal ones more than medcal ones, then they should be identified as 
such and be addressed by the OPTN, the Deparment of Health and Human Services, and 
perhaps even the Congress. 
The PHS should fund a demonstration effort incorporating the followillg two features: (I) the 
establishment of a single, ullifed waitillg list includillg all patiellts awaiting all orgall 
transplallt in a Ilumber of 0 PO  the mandatory distributioll of dOllated 
service areas and  (2) 
organs to those patients on a first come first served basis, subject to established medical 
criteria. 
There is much to be gained by regularly distrbuting organs on a geographic basis larger than that 
of individual OPOs, of which there ar 72 in the countr. By allowing for a larger pool of 
potential donors, larger scale organization would enhance the trnsplant opportunities of the 
highly sensitized and allow for better tissue matching between donors and recipients. Also, by 
bringing transplant centers now in different OPO service aras under one distrbution system, 
would eliminate the differential access that patients in different OPO service areas now have to 
organ transplantation. 
Yet, some argue that such gains are outweighed by varous losses. Among them are the time and 
financial costs associated with transpoI1ng organs longer distances. A carfully constructed 
demonstrtion involving multiple OPOs could provide valuable data to infoml this debate and 
contribute to the development of national policy. If, in fact, the benefits of larger scale 
organization outweigh the costs, serious consideration should then be given to developing larger 
scale distrbution systems throughout the nation and even to reducing the number of OPOs. 
.19  THE HEALTH CARE FINANCING ADMINISTRATION 
AND THE PUBLIC HEALTH SERVICE 
The HCFA and the PHS should supportresearcll efforts that could help reduce racial 
disparities in organ allocation. 
Building on aleady initiated efforts, this research agenda should have at least two major thrusts. 
One should be to conduct a thorough examination of the varous factors, medical and 
nonmedical, that might help explain the differential access to trnsplantation of black and white 
trnsplant candidates. As those factors become understood more clearly, policymakers wil be 
tae 
able to  corrective actions with a 
grater degree of confidence. 
The second thrust should be to intensify research efforts to study the immunogenetics of blacks. 
With blacks accounting for 34 percent of those with kidney failure and 30 percent of transplant 
candidates, such efforts are of extreme imponance. Moreover, as more and better information 
becomes available about the antigen specificities of blacks, they will be able to participate more 
fully and equitably in organ distrbution systems that involve HLA matching. 
Before granting Medicare recertification to an OPO, HCFA, in collaboration with PHS, 
should assure that the OPO is distributing organs equitably among patients, according to 
established medical criteria. 
In the National Organ Transplant Act, Congress clearly set fonh its intent that organs be 
distrbuted equitably as stated above. Yet, we have found that across the nation the access to 
organ transplantation remains unequal in some important respects. This is a serious matter 
which it does not appear can be explained strctly on the basis of medical criteria. 
We recognize that a detennination of whether or not an OPO is distrbuting organs equitably is 
not a simple matter subject to a quick assessment. Howeyer, because it is so viral a matter, we 
think that HCFA must develop some way of making a reasonable judgment on it. In this regard, 
the PHS, through the OPTN, can be of considerable assistance by providing data, specific to 
OPO service areas, that indicate the median time of those on waiting lists and that compare the 
characteristics of those on waiting lists with those reeiving trnsplants. Such data can be useful 
in identifying outliers and in raising questions that HCFAshould addrss in making 
61 To overlook this matter, or to leave it as a matter for OPOs to certify 
recertfication decisions.
without any outside review, could impede the development of a more equitable system. 
Thus, we urge HCFA to collaborate with PHS to detennine the kind of quantitative indicatOrs it 
should rely upon to help determne if al) OPO is adhering to the congressional mandate to 
distribute organs equitably among patients according to established medical criteria. 
Before granting Medicare recertification to an OPO, HCFA, in collaboration with PHS, 
based orgall procurement effort. 
should assure that the OPO is conducting a rigorous, sOllndly 
Disparties in the rate of organ procurement from one OPO service area to another appear to 
inhibit professional support for the national distrbution of organs. The OPTN' s Procurement  and Distrbution Committee and others we interviewed have suggested that this is because OPOs
that are more effective in procuring organs are reluctant to serve as a source of supply for those
that are less effective.

To addrss this concern and to promote organ prourement generaly, we encourage HCFA and 
PHS to examine OPOs with relatively high rates of procurement over a 2- or 3-year period and 
to determne if there are lessons leared from their efforts that might usefully be shared with 
other OPOs. However, given the significance of the matter, in terms of both procurement and 
equity objectives, we also urge that HCFA use the recertification process to assure itself that 
OPOs ar caring out substantial, well-conceived prourement effort. 
We recommend that HCFA, in collaboration with PHS, identify appropriate indicators of such
62
efforts to help guide its recertfication reviews. In this regard, we urge that it give paricular 
attention to its perfonnance stadard governing OPO prourement. At present, HCFA has no 
such standard governing hear or liver procurement, but has one calling for OPOs to proure
kidneys at a rate of at least 23 per millon population.

Given the growth in the number of hear and liver transplants, it may be a good time to develop a 
procurement performnce standard that applies to them as well as to kidneys. Moreover, it may 
be more meaningful to base the standard on the number of hospital deaths reported in an OPO 
service area than on its population level. 
THEAMERICAN SOCIETY OF TRANSPLANT SURGEONS
AND THE AMERICAN SOCIETY OF TRANSPLANT PHYSICIANS
The ASTS and the ASTP should conduct their own inquiries of the factors leading to longer 
median waiting times  awaiting a kidney transplant and of all)' actiolls 
for blacks thaI' whites 
their associations should take to help reduce this disparity. 
The search for a constrctive response to the black-white disparty highlighted in this study
should not be limited to governmental entities. All professionals and professional organizations
in the transplantation field should be involved in this searh. That is parcularly importnt, we
believe, with respect to the ASTS and the ASTP, the two national organizations representing
physicians associated with organ transplantation. 

In any inquiries they undertake, we urge ASTS, ASTP, and other organizations to give careful
consideration to practice realities that might contribute, however inadvertently, to the disparities
noted in this report. In this context, w  urge particular attention to the following conclusion
reached by the American Medical Association s Council on Ethical and Judicial Affairs:
The social disparities in treatment decisions indicate that inappropriate considerations
may enter the decision-making process. The efforts of the specialty societies, with the 
coordination and assistance of the American Medical Association, to develop practice 
parameters should include criteria that would preclude or diminish racial di.\parities.  COMMENTS  ON THE DRAFT REPORT

Within the Deparent of Health and Human Services, we received comments from the Public 
Health Service (PHS), the Health Cae Financing Admnistration (HCFA), and the Assistant 
(ASPE). In addition, we received comments from many 
Secretar for Planning and Evaluation 
private organizations. These included the American Society of Trasplant Physicians (ASTP), 
the American Society of Transplant Surgeons (ASTS), the United Network for Organ Sharng 
(UNOS), the American Society for Histocompatibilty and Immunogenetics (ASHI), the 
Association of Organ Procurement Organizations (AOPO), the North American Transplant 
Coordinators Organization (NATCO), the New England Organ Bank (NEOB), and the 
South-Eastern Organ Procurement Foundation (SEOPF). 
In appendix D, we present the detailed comments offered and our response to them. As indicated 
there, PHS and HCFA agreed with all of the-recommendations directed to them. In response to 
our recommendation that ASTS and ASTP conduct their own inquiries of the factors leading to 
longer median waiting times for blacks than whites, ASTP indicated that its Patient Care and 
Education Committee has alady conducted such a study and arved at findings in agreement 
with our report. The ASTS responded that it was wiling to: (a) Define medical indices of 
patient suitabilty for being placed on transplant waiting lists; (b) Develop an allocation scheme 
that addresses all (racial included) factors that affect organ distrbution; and (c) Delineate 
. standards to assess OPO activity and perfonnance. 
Among those commenting, most focused on our finding concerning the racial disparity and our 
recommendations addressing that finding. In that regard, many noted that human leukocyte 
antigen (HLA) matching was an important factor contrbuting to the disparity and that the report 
should have given more consideration to this factor. Others noted that once a donor organ 
becomes available to black candidates they may be less likely to receive it because of medical 
, and/or personalconsiderations. In short, most of the respondents would have 
financial, social
liked the report to have delved more thoroughly into the possible causes for the racial difference. 
Two of those commenting expressed considerable concern that the report implied that racial 
prejudice might be contrbuting to the gap in black-white waiting times. A third (ASH!) added 
that a direct way to examine this matter would be "to examine the demographics of patients 
passed over for transplantation. 
for each OPO to develop a single, unified list of patients and to 
On our recommendation callng 
allocate donated organs to those persons on a first come first served basis, PHS, NATCO, and 
ASH! expressed support; the latter s support of the concept, however, was clearly based on the 
associated use of allocation criteria that give some emphasis to good HLA matches. At the other 
end, ASTP, ASTS, and ASPE opposed the recommendation, arguing that it would not necessarily 
The ASPE, which was critical of many of the report 
serve to reduce the racial disparty. 
findings and recommendations, added that a first come first served scheme was tOo simplistic 
and overlooked many important factors that must be considered in the organ allocation process.  Finally, three commenters (ASTP, ASTS, and ASHI) urged that more attention be given to the
need to increase organ donation rates, especially among blacks. In fact, ASTP indicated that this
was expressed by some
was a bigger problem than organ distrbution. Similar sentiment 
members of the National Kidney and Urologic Diseases Advisory Boar during a briefing which
we gave to that body. 
In response to these comments, we offer the following infonnation and considerations:
We revised our presentation on the factors that might contrbute to the longer median wait
ing time for blacks. Compared with the draf report the final report s discussion of these 
factors gives more emphasis to the possible influence of HLA matching, identifies a fuller
range of other possible factors, and offers a more precise explanation of the possibility of
racial bias. On the latter matter, we clearly state that we have no evidence of such bias, 
but that at least "subconscious bias" must be included on any list of possible causes.
We recognize that even with the revised text our finding concerning the racial disparty 
raises more questi  ns than it answers. It is for that reason that we call for HCFA and PHS 
to support research efforts that could help reduce the disparty. Some such inquiry, we un 
derstand, is already being supported and may help provide some answers. We urge that it 
continue and that parcular attention be given to research that seeks to add to the medical 
knowledge base on the immunogenetics of blacks (and other minorities). 
On our first recommendation callng for each OPO service ara to use a single waiting list 
and to allocate organs to patients on that list on a first come first serve basis, subject to 
medical criteria, we strss the following points: 
We recognize the complexity of the considerations governing organ allocation. At the
same time, we recognize the primacy of congressional expectations concerning allocation.
Our review of legislative history makes it quite clear that Congress intends for organs to
trsplant 
be distrbuted equitably among patients, not among  centers. Our discussions

with staff closely involved with this history also suggest that the first come fIrst served
principle is at the core of what Congrss means by equity and that medical factors provide
the only legitimate basis for deviating from that principle.
We recognize, as the New England Organ Bank indicates, that there is not a national
consensus on the medical criteria that should guide organ allocation and that there are
legitimate scientific disagreements concerning these criteria. Our intent here is nOt to
generate arificial national medical criteria, but to have the medical criteria being
employed in each OPO service area clearly stated and to have those criteria be the only
legitimate basis for deviating from the first come fIrst served rule.
This approach would allow for the continued evolution of medical criteria. But it would
not allow for the inclusion of criteria that are clearly not medical in nature. The "keep
one, share one" criterion would seem to be one such criterion. It is directed to achieving
equity among transplant centers more than among transplant patients and does not appear
to be in concert with the authorizing legislation. On the matter of organ donation, we cenainly agree that it is a vital issue requiring serious 
attention throughoUt the countr. BUt as long as we have a shortage of donor organs, it is 
also vital to addrss how to allocate that scare resource most equitably. Indeed, as organ 
waiting lists grow, the matter of who receives donated organs and who does not becomes 
increasingly signifcant
In this regard, it is pertnent to note that in a recent study of organ procurement conducted
by ABT Associates, the authors urged that the Organ Procurement and Transplantation Net-
work add a goal focusing on the equitable allocation of organs in place of one addressing
improved access to organs. In view of the congrssional concern about equity and the real 
ity that the OPTN is not able to affect many of the most imposing barrers to access, they
reasoned that such a shift would be timely. APPENDIX A
STATISTICAL METHODOWGY AND NOTES
POtential recipients of cadaver kidneys, after registering for a trnsplant, typically wait for 
several months before they actually receive one. Some potential recipients wait for years. This
appendix describes the statistical methods used for the analysis of medan waiting times to
transplantation of cadaver kidneys in the United States from October 1  1987 through March 31
1989. The analysis explored the relationship of medan waiting time to demographic factors and
biological factors. 
The Data
The analysis employs data routinely collected by the United Network for Organ Sharing 
(UNOS), an organization contrcted to operate the national organ procurement and transplant 
network by the Public Health Service. Data were assembled from computer fies which contain 
infonnation on all people registered with UNOS for kidney transplants from. October 1, 1987 
through'March 31, 1989. These data were then transmitted to the Offce of Inspector General on 
a computer tape. The tape contains infonnation on 23,632 people registered at either 202 
transplant centers or 38 organ procurement organizations (we employ the tenn registration center
in the future to refer to bOth groups).
The analysis focused on registrants awaiting their first trsplant. As a result, the calculations
exclude 4 770 people who received a transplant prior to October 1, 1987, and who were on the
second or third transplant during the time period covered by the analysis.
registr awaiting a 
The analysis employed median waiting times to receive a fIrst trnsplant. Because people can 
register at more than one center, it was necessar to define a unique "beginning date" and 
beginning center" for each person in the analysis. The rules used to define the beginning date 
and beginning center were as follows:
If a person registered at only one center, that center and registration date were used.
If a person:
registered at more than one center, and
(a) 
1989
(b)  had not yet received a transplant by March 
then the earliest registration 4ate, and the associated center, were used.
If a person:
(a)  registered at more than one center, and 
(b)  received a transplant at a center other than the ones at which 
he or she had registered, 
then the earliest registration date, and the associated center, were used.
A - I
 If a person: 
registered at more than one center, and 
(a) 
received.a transplant at one of them, 
(b) 
then the trsplanting center and the registrtion date at that center were used. 
Analysis of waiting times requires both a valid begining date and a valid trnsplant date. The 
In 939 
data used in the analysis excluded those individuals that did not have valid dates. 
instances, no registrtion date appeard on the tape. In 134 instances, the transplant date 
preceded the registration date. Table A-I summarzes the results of this fIrst exclusion of records 
from UNOS data. 
TABLE A-
GrQup First Set Of Exclusions From Data 
Construction Of Study 
Reason for exclusion  Number excluded  Number remaining 
Transplant prior to 
770 (20%)  18,862 (80%) 
10/1/87 
No registration date  939 (4%)  923 (76%) 
Transplant date precedes 
134 ( 1 %)  789 (75%) 
regislTation date 
Only a case-by-case audit can detemrine that all dates in the data are valid. This analysis 
are valid. As 
waiting times assumes that all dates for people not explicitly excluded, as above,-
fewer than one percent of the people in the data had clearly invalid dates, this assumption is 
probably reasonable. 
Of the 17,789 people remaining in the data set, 8,048 (45 percent) received a fIrst transplant 
which they obtained their 
from October 1, 1987 through March 31, 1989. The rOUtes by 
transplants, according to the rules specified earlier, are shown in table A-
A - 2  TABLE A- 2
The Relationship Between Registration center And Transplant
Center
Transplantation Routes Frequency
Registered at only one center, reeived trsplant at tht center 974 (74%)
Registered at only one center, received trnsplant elsewhere
 781 (22%)
Registered at more than one center, recived trsplant at center
125 (2%)
of ealiest registration

Registered at more than one center, received trsplant at 
132 (2%)
center of later registrtion
trsplant
Registered at more than one center, received 
36 ( 0%)
elsewhere
The relationship of waiting time to demogrphic and biological factors was included in this
analysis. The demographic factors include age, race, sex, and location of registration (i.
registration center). The biological factors include blood type and peak PRA, a nieasure of the
likelihood of finding an organ which wil not be rejected by the immune system of the recipient.
For some of the 17,789 people with valid waiting times to first trsplant, infonnation on
demogrphic and biological factors was not in the UNOS data. Because the number of people
missing values forthese factors was small, these people were excluded fonn the analysis. Table
3 summarzes the results of excluding these people.
TABLE A- 3
Construction Of Study Group Second Set Of Exclusions From Data
Reason for exclusion  Number excluded  Number remaining 
Missing pea PRA  224 ( 1%)  565 (74%) 
8 (0%)  557 (74%) 
Missing race 
1 (0%)  556 (74%) 
Missing blood type 
Unless otherwise stated, all results presented in this appendix wil derive from analysis of the

17,556 people who appear to have complete infonnationand valid dates. In appendix B, tables
B I and H2 summarize characteristics (age, race, sex, size of registration center, peakPRA, and
blood type) of this group.
A - 3 Median Waiting Times
median waiting time to first 
. The analysis of waiting times concentrates on estimation of the 
transplant. The median waiting time is an appropriate stat stic for summarizing the experience of 
different groups waiting for a kidney tr.nsplant. The median waiting time is the time by which 
50 percent of registrants wil have received a kidney. For example, analysis of first transplams 
from October 1, 1987 through March 31, 1989 indicates that the overall median waiting time is 
6 months. That is; half of the people included in this analysis received a kidney within 8.
months, and half waited longer. This result can be generalized to the current population 
assuming that (a) currnt registrts have demogrphic and biological charcteristics similar to 
those of people in the analysis, and (b) the process of organ recovery and distrbution remains 
the same.
We used survival analysis techniques to calculate the estimated median waiting times. The
waiting time for each recipient was defined 'as the number of months from the beginning date of
the period covered by the UNOS data, October 1, 1987, until the date of a first transplant. Those 
recipients nOt receiving a transplant during the study period ar considered right censored. 
While the time to first trarsplant is unknown in these recipients, they still contribute data to 
estimate fIedian waiting times. For these recipients, their  nsoring date is the ending date of
the covered period, March. 31, 1989. This date allows us to detennine the total number of
months contrbuted by censored recipients.
66 are used to calculate the estimated median waiting time to first
Kaplan-Meier survival curves
transplant. This method correctly. adjusts for right censoring and makes no assumptions about
the underlying distribution of the individual waiting times. In the analysis, we also provide 
percem confidence intervals for the median waiting times, using the methods of Brookmeyer and
Crowley.
A further adjustment is made in this analysis to account for what we define as prior registrants. 
Many of the recipients included in the UNOS data, among both those receiving a tr.nsplant and 
study period, registered at some point prior to the beginning 
those stil waiting at the end of the 
of the study period. Adjustment for these recipients is accomplished using techniques described 
by Cnaanan  Ryan.  -Th  analysis provides estimated median waitin  times b 
J) race, sex, bloo?
as measure by the number of regIstrants. The results of 
group, and SIze Of regIstrtIon center 
these analyses are presented in appendix B in tables B-3, B- , andB-
Most of the apparent difference between the waiting times for men and women is due to the
higher proportion of females with high PRA. When males and females are classifed into two
groups by PRA level, above and below 75, it is apparnt that women, on average, are more likely
to be highly sensitized than men (PRA =75). Table A-5 shows the median waiting times by sex
and peak PRA.
A - TABLE A-5
Median Time To Transplant By Average Peak
Panel Reactive Antibody (PRA) And Sex
Peak PRA  Peak PRA 
SEX  oC  ;: = 75 
Women  20.  92. 
Men  91. 
The longer waiting times for women in the K group largely reflect higher sensitivities than 
men-as measured by average peak PRA-within the grup. However, the longer waiting times 
for women in the =75 group do nOt seem to relate to a similar disparity in average PRA level. 
We also found that waiting times tend to be longer in the larger registration centers (see appendix 
, table B-5), where size of center is measured by the number of registrants for a fIrst transplant 
on the rolls at some time during the study period and classified into quariles. For registrants 
with peak PRA less than 75, the estimated median waiting time in the tOp 25 percent of centers 
was 9.5 months, compared to 5.7 months in the bottom 25 percent. 
Multivariate Survival Analysis

While the estimated median waiting times can provide insight into the singular effects of 
variables, they do not make effcient use of all of the infonnation available. Medians only take 
into account differences over the middle portion of the waiting time distrbution and do nOt show 
the extent of these differences over the total length of follow-up. Also, one cannOt fully adjust 
for the effects of continuously varing factors such as age and peak PRA. 
To satisfy these concerns, we used the proportonal hazads method of survival analysis?) This 
multivarate approach allows one to adjust simultaneously for multiple factors, whether 
continuous or discrete, over the length of the follow-up period. To adjust for the prior 
registrations, we stratified by registration date. This technique is referred to as blocking and is 
71 The registration periods, or blocks, used are presented in table A-
described by Cnaan.
A - 5  TABLE A-6
Blocking Periods Employed In Multivariate Analysis
Date of registration  Number of registrants 
433 
up to 09/30/84

10/01/84-03/31/85  142 
04/01/85-09/30/85  221 
10/01/85-03/31/86  404 
04/01/86-09/30/86  644 
10/01/86-12/31/86  421 
01/01/87-03/31/87  629 
04/01/87-06/30/87  796 
07/01/87-09/30/87  573 
10/01/87-03/31/89  12,293 
Total in study: 17,556 
In appendix B  table B-6 gives results of the proportonal hazards analyses. The analyses are 
also stratified, or blocked, by age and blood type, so that these factors are held constant in 
assessing the effects of the other variables. 
The table shows that a black has from 69 percent to 77 percent of an equivalent white registrant's 
chance of receiving a' kidney at any point in time after the date of registration. The 77 percent 
figure refers to bloo types Band AB;the 69 percent figure to blood types A and O. The 
probabilty of seeing a black-white disparty this great if kidneys were randomly allocated 
among equivalent blacks and whites is less than 1 in a bilion. This result is statistically 
signifcant. 
The proportional hazards analyses also examine the effect of different PRA levels on waiting 
times, holding constant other factors such as blood type. . The table also shows that a person with 
a peak PRA of 75 has 40 percent of the chance of a person with a PRA of zero of receiving a 
kidney at any parcular time after registering (blood type A or 0) and 33 percent of a PRA zero 
s chance for blood types Band AB. 
person 
Peak PRA appears to affect time to first transplant somewhat differently in the two different 
blood type subsets. For blood types A and 0, the effect of increases in PRA becomes 
increasingly severe at higher PRA levels (the PRA-squared tenn in the proportional hazards 
model is negative). In other words, a PRA increase from 70 to 80 decreases one s chances for 
receiving a transplant more than an increase from 10 to 20. 
A - 6  model is negative). In other word, a PRA increase from 70 to 80 decreases one s chances for 
from 10 to 20. 
receiving a trnsplant more than an increase 
For types Band AB, additional PRA increases at higher levels appear to have a diminishing 
effect. Of course, a person with bloo type B and a high PRA level already has only a very 
distant possibility of getting a kidney. The diminishing marginal effect of PRA increases for 
such people basically restates that fact 
Finally, this analysis confinns the preliminar result that waiting times increase with the size of 
the registration center. A person registering at a center with 100 registrants during the study 
period has 90-93 percent of a person s chance of receiving a kidney at any point after registering 
at a center where the wait list is size 25. 
The proportional hazards models reported here ar just two of a number of models studied in the 
course of this analysis. Other models and assumptions did not give results markedly different 
paricular, excluding short waiting times (some people got a 
from those reported above. In 
kidney the same day they registered), excluding long waiting times, restricting the analysis to 
registrants after 10/1/87, or incorporating "interactions" such as black and male, or different 
PRA effects for blacks and whites, did not alter the essential results regarding the significance of 
race, gender, peak PRA, and size of registrtion center. 
However, proportonal hazards models do assume proportonality of effect. That is, the effects 
of factors like race or PRA on the probability of receiving a kidney should be multiplicative over 
the entire follow-up period. Tests of proportionality show that the models used in this analysis 
fail to meet this requirement for center size (blood types Band AB) and for peak PRA and 
72 It appears that these 
factOrs may have some time dependence in 
gender (blood types A and 0).
their effects. That is, the effect of an increase in PRA for a blood type A person who has been 
waiting a long time may difer somewhat from the effect of an equivalent increase in PRA for the 
same person with a short waiting time. 
The investigation of such subtleties lies outside the scope of this analysis. There is no indication 
that such fluctuations from the proportonal hazads assumption would alter the principal results 
regarding the significance of race, gender, bloo type, PRA, and center size. 
Registration Center Specific Analysis
Additional analyses were conducted to examine the relationship between the median waiting 
time by characteristics of the registrtion center s waiting list. In these analyses, for each 
registration center, the median waiting time to trnsplants for white recipients and black 
recipients was calculated separately. It was also detennined what percent of the registration
centers ' waiting lists consisted of black patients. We then calculated the ratio of the black 
recipients ' median waiting time to that of the white recipients for each registration center. A mtio 
greater than one indicates that black recipients waited longer, on the averdge, than white 
recipients. 
A - To detennine the national applicability of the finding that black reipients wait longer for 
transplants than do white recipients, we categorized, where possible, each registration center into 
the appropriate region as defined by the Deparent of Health and Human Services (DHHS). 
Wree thesn caulcullatteds fo r eoach fre gitonh thei msean  raatio nof maedilany wasitinig stim.es . Table A-7 gives the
TABLE A-
Mean Ratio Of Black Recipients' Waiting Time To That Of White Recipients, 
By DHHS Region 
REGION  MEAN RATIO
(CT, ME, MA, NH, RI, VT
II (NY, NJ, PR, VI) 1.88
II (DE, MD, PA, VA, WV, DC)  1.82
IV 
(AL, FL, GA, KY, MS, NC, SC, 1N)
(IL, IN, MI, MN, OH, WI)  1.25
VI (AR, LA, NM, OK, TX) 1.89
VII (lA, KS , MO, NE)  1.94
VII (CO, MT, NO, SO, UT, WY) 1.03
(AZ, CA, HI, NV, GU, Trust TeITitory of 
1.85
Pacific Islands, American Samoa) 
(AK, 10, OR, WA) 
Unknown 1.64
TOTAL 1.81
The "unknown" category includes those registration centers, the identity of which is nOff1ally
encrypted by UNOS, that refused to be identified. An Analysis of Varance showed that Regions
I and VIII were lower than the other regions but that the other regions were not significantly
different from each other when using Duncan s Multiple Range Test. These data suggest that the
finding of longer waiting times to transplantation for blacks is a national problem and not
confined to any specific geographic locality. 
. In a second analysis, we wished to detennine the effect of the proportion of blacks on a
registration center s waiting list on this ratio of median waiting times. We perforn1ed a 
regression of the percent of blacks in a registration center s waiting list against this ratio. We 
first used a linear model, where the ratio is assumed to have a linear relationship to the percent of 
blacks on the waiting list. The gqph in figure A-I shows the plot of this ratio with the percent of 
2 for this model was 0.
blacks on the waiting list. The R 03, which indicates that only 3 percent of 
the varation in the ratio can be explained by the varation in the percent of blacks on a transplant
center s waiting list. The plot shows extremely wide confidence intervals (dashed line) around
the expected value (solid line), also indicating a poor fit to the model.
A - 8 the 
To detennine if there may be some curvilnear relationship, we also fit a quadratic model to 
2. The R2 for this model was increased (0 only 
data. The plot of this model is shown in figure A-
the variation 
05; that is, only 5 percent of the varation in the value of the ratio is explained by 
The results of both of these 
in the percent of blacks on a registration center s waiting list 
' median waiting time to 
anempts at model fitting would indicate that the ratio of blacks
, or potential 
transplant to that of whites is not affected by the percent of black recipients
recipients, residing on a registration center s waiting list. 
A - 9  ....-..... .. ----. - -----'.. .. .. ......- ... . . ..,.
 .-. ... ..... ...... ... ...
FIGURE A -
RATIO OF MTEDRIAS WPAm GC "MEES  
RA110 
BY PERCENT BLACK ON  WAJNG 
BLACK TO WHIT 
RA 110 
o 0
o ... 
..-c 
0 0
CD 0
000 
0 0 
00 0 0 
. 10  . to 
PERCENT BLACE OM rAITII' LIST
UNEA MODEL Y-B1 +B2*X
EXEC. 
SaUD UNE IS  DASHED UNE IS 95 " C.
A - 10
 . .
,------ ---
. - " "
A-2
FIGURE 
RATIO OF MTEDRIA SWAPm NG "MES
BY PERCENT BLACK ON  CENT WAJNG UST
BLACK TO WHIT RATIO
ROIO
o 0

o e

5 '
" -,,-.u.-e.
0 '
c c

a: C

00= 
0 0

00 0

. 10
 , '0
PERCENT  BlACI 01 IAITIIG LIST

QUADRATIC MODEL Y-B1+B2X+B3*X
EXEC, 
SaUD UNE IS  DASHED UNE IS 95  0.1. APPENDIX 
TABLES DERIVED FROM THE ORGAN PROCUREMENT 
AND TRANSPLANTATION NETWORK DATA BASE 
Following ar six tables presenting data that are relevant to our findings and that are based on 
our primar data  556 individuals in the United States who between OctOber 1 , 1987 
base of 17,
and March 31, 1989, were wai  ng for or actually received a first kidney transplant.  TABLE B-
Demographics Of Those Receiving And Waiting For Their First Kidney Transplant 
October 1 1987 - March 31, 1989 
TRANSPLANTED  WAITING  TOTAL 
AGE  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
0.5  115 
379  739 
19-45  4,551  57.3  521  57.4  10,072  57, 
46- 775  34.  3,478  36.  253  35, 
65+  164  213  377 
TOTAL  940  100.  616  100.  17,556  100. 
TRANSPLANTED  WAITING  TOTAL 
AGE  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
Black  792  22.  965  30.  757  27. 
While  205  65.  237  54,  10,442  59.5 
Other  943  11.9  414  14.  357  13.4 
TOTAL  940  100.  616  100,  556  lOtI.O 
TRANSPLANTED  WAITING  TOTAL 
SEX  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
Female  079  38.  4,424  46.  503  42. 
Male  861  61.2  192  54.  10,053  57.3 
TOTAL  940  100.  616  100.  17,556  lOO, 
TRANSPLANTED  WAITING  TOTAL 
QUARTILE  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
First  208  232  440 
Second  994  12.  945  10.5  889  11.6 
Third  860  25.4 .  968  21.9  828  23.5 
Fourth  309  58.  848  65.  10, 157  62. 
TOTAL  321  100.  993  lOO,  16,314  IOO, 
B- 2
 TABLE B-
Blood Type And Peak PRA Of Those Receiving And Waiting For Their First Kidney Transplant 
October 1, 1987 - March 31, 1989 
BLOOD  TRANSPLANTED  WAITING  TOTAL 
TYPE  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
943  37,  383  24,  326  30. 
318  197  515 
963  12,  1621  16.  584  14. 
716  46,  5,415  56,  131  52. 
TOTAL  940  100,  616  100.  17,556  100. 
PEAK  TRANSPLANTED  WAITING  TOTAL 
PRA  NUMBER  PERCENT  NUMBER  PERCENT  NUMBER  PERCENT 
303  79.4  330  65,  12,633  72. 
25 - 49  621  792  413 
50 - 420  5.3  678  098  6.3 
75 - 100
 596  816  18,  2,412  13. 
TOTAL  940  100.  616  100,  556  100.  TABLE B-
Estimated Median Waiting Times In Months To First Transplant By Race 
PRA 
Controllng For Blood Type And Peak 
18-
Ages 
PEAK PRA LESS THAN 

RACE
BLOOD TYPE  BLACK  WHITE  OTHER
3.1
17.4  10,  11.8
15.  14.4
OVERALL  12,
PEAK PRA GREATER THAN 
RACE
BLOOD TYPE  BLACK  WHITE  OTHER 
21.2  61.9 
10,  ' 20.4 
35.5  19. 
48.  31.  28.
OVERALL  48.  26.  43.
ALL BLOOD
TYPES AND 
13.  12.
ALL PRA
LEVELS
B - 4 TABLE B-4 
Estimated Median Waiting Times In Months To First Transplant
By Sex
Controllng For Blood Type And Peak PRA
Ages 18-4

PEAK PRA LESS THAN 

SEX 
BLOOD TYPE  FEMALE  MALE 
. 4.4

14.3  12. 
12,  11.3 
OVERALL  8.4 
PEAK PRA GREATER THAN 
SEX 
BLOOD TYPE  FEMALE  MALE 
31.3  23, 
20.4  2.5 
21. 
38,  25. 
OVERALL  36,  22. 
ALL BLOOD 
TYPES AND ALL  10. 
PRA LEVELS 
B - 5  TABLE B-
Months To First Transplant By Quartile 
Estimated Median Waiting  Times In 
Controllng For Blood Type And Peak PRA 
18-
Ages 
PEAK PRA LESS THAN 
QUARTILE
FIRST  SECOND  THIRD  FOURTH 
BLOOD TYPE 
4.5  4.1  5.4 
5.1 6.1 
12.3  15.5 
10.1  12, 
OVERALL 9.5
PEAK PRA GREATER THAN 
QUARTILE
BLOOD TYPE  FIRST SECOND  THIRD  FOURTH
17.5 21.2  19.  39.
27,
43, 22.  21.8
34. 30.3  32.4  34.3
OVERALL  23.4 27.  24.  38.
For an explanation a/the quartiles, see  section on "median waiting times.
appendix  A, 
B - 6 TABLE B-6 
Results Of Proportional Hazrds Analysis Time In Months To First Transplant 1 
Percent Confidence Intervals (Clf
Relative Risks and  95 
BLOOD TYPES A AND 0  BLOOD TYPES BAND AB
FACTOR  Relative  95%  Relative  95%
Risks  Risks
Mae  1.05  (1.00-1.11)  1.08  96-1.22)
Black  64-73)***  68- 87)**'
Pea PRA 
26.63)*** .33  11-98)**'
(75 vs 0) 
Center Waitig List Size
90-96)*** 84- 97)**
(100 vs 25)
659 Tralants  281 Trasplants 
798 Still Waiting 818 Stil Waiting
* p c:.  ** p -=0.  *** p -=0.001 
Age and blood type held constant by blocking and adjusting for all other variables in 
the models. Results derived from the models presented in table A-
TABLE B-
Date Of Registration Of Study Population 
DATE OF REGISTRATION  NUMBER  PERCENT 
Before 1986  967  5.4
- 616  506
1186 
- 121  798  4.5
7/86 
- 617  432
1187 
- 1217  649  20.
7187 
- 618  952  22.
1/88 
7188  12188  180  23.5
1/89 (cid:1) 3189 305  13,
TOTAL 17,789  99,
B - 7 APPENDIX 
ENDNOTES 
On April 2, 1990, the United NetWork for Organ Sharng report that there were 20, 171 
individuals on the organ Procurement and Trasplantation Network's national waiting list. 
939 awaiting a transplant for a kidney, 1,572 for a hear, 936 for a liver 
This included 16,
328 for a pancreas, 260 for a hearung, and 136 for a lung. 
In much of the. literature in the organ trsplantation field, this process is referrd to as the 
allocation" prOCess rather than the "distrbution" process, We use the latter tenn with the 
not only the factors used in allocating 
understanding that it is a broader one that addesses 
the' limited supply of organs to individuals on waiting lists, but also the actual results of 
that process-that is, the  ho actually received the donated organs. Given the 
individuals 
broad sense in which medical criteria are used to guide the final selection of patients, the 
distinction betWeen allocation criteria and final results is an important one, 
Our inquiry focuses on those already on transplant waiting lists, not on those who may be 
candidates for such lists, 
This. report follows-up on earlier Office of Inspector General reports concerning the access 
The Access of 
to organ transplantation and the costs of organ acquisition. These are: (1) "
Foreign Nationals to U,S. Cadaver Organs," August 1986; (2) "The Access of Dialysis 
Patients to Kidney Trasplantation," March 1987; "Organ Acquisition Costs: An 
Overview," September 1987; and (4) "Kidney Acquisition Costs: A Management 
Advisory Report," November 1988. 
Although the data are not available, kidney transplants almost certinly account for 
even higher proportion of Federal expenditures for organ acquisition and transplantations. 
While the Medicare progrm provides a near universal entitlement for those with kidney 
faiure, it covers expenditures for hear and even more so liver trnsplants under more 
transplants are still regarded as experimental, 
restrcted conditions. Other types of 
In the early 1980s, when hear and liver transplants were still experimental, organ 
procurement organizations (OPOs) were developing protocols for the varous activities 
associated with kidney donation, procurement (a term which in this report we use 
interchangeably with "retrev.al"), and distrbution. As hear and liver transplants have 
become m.ore common, the OPO  have been increasingly involved in multiple organ 
recoveries. While the established practices governing kidneys provided the framework for 
the donation, procurement, and distrbution practices governing these other organs, there 
are, .of c.oure, some differences. This is most especially the case with respect to allocation 
decisions, since the receipt of non-renal organs is more likely to be a life-saving 
dialysis 
development for the individuals involved (those with kidney failure have access to 
and an alternative treatment) and since the allowable preservation time for excised hearts 
and livers is much less than that for kidneys, 
c - 1
 The data were made avaiable to us by the United Network for Organ Sharng, the 
the Public Health Service to help operate the Organ Procurement 
contrctor selected by 
and Transplantation Network, 
The four OPOs selected were the Regional Organ Procurement Ag ncy of Southern 
California, the Shands Hospital at the University of Florida, the Uni  ersity of Wisconsin 
Hospital, and the Delaware Valley Transplant Progr, They account for 13.2 percent of 
all cadaver kidneys procured in the United States in 1988. 
Individuals (primarly presidents, but including some executive directors and designated 
vice-presidents) from the following organizations were interviewed: American Council on 
Transplantation Association of Organ Procurement Organizations, Nonh American 
Transplant Coordinators' Organization , American Society of Transplant Physicians, 
American Society of Transplant Surgeons, American Society for Histocompatibility and 
Immunogenetics, American Medical. Association, American Hospital Association, United 
Network for Organ Sharng, American Nurses Association, South-Eastern Organ 
Procurement Foundation, and the American Association of Kidney Patients. Others 
interviewed included individuals from PHS and HCFA, congressional staffs, the Institute 
of Medicine, private consulting finns, and varous OPOs, immunological laboratories, 
trnsplant centers, and universities, 
These included published research; newspaper and magazine aricles; the Repon of the 
Task Force on Organ Transplantation; testimony from hearings conducted by the House 
Committee on Science and Technology; legislation and committee reports; reports issued 
or commissioned by. American Council on Transplantation, Government Accounting 
Offce, Congressional Research Service, and the National Institute of Digestive, Diabetes 
and Kidney Diseases; UNOS anicles of incorporation, bylaws, policies, board minutes, 
publications, committee reports, proposed policies, and letters of comment on current and 
proposed policies; several OPO distribution protocols; and PHS and HCFA regulations, 
including the OPTN contrct. 
10.  See U.S. Congress, House of Representatives, Committee on Science and Technology, 
Organ Transplants,
Hearngs before the Subcommittee on Investigations and Oversight, 
98th Congrss, 1st Session , April 13, 14, and 27, 1983 and November 7 and 9, 1983, 
11.  National Organ Transplant Act P,L. No, 98-504  1984. The Act had five major 
components: (1) est blishment of a national Task Force on Organ Transplantation to 
examine and report to Congress on the aray of issues facing the transplant community; (2) 
establishment of the Organ Procurement and Transplantation Network (OPTN) to
coordinate and regulate the procurement, matching, quality assurance, distribution and
trnsplantation functions of the trnsplant community; (3) provision for a national 
scientific registry to collect transplantation data and facilitate evaluation research; (4)
authorization of funding for the creation or upgrading of qualified organ procurement
organizations; and, (5) prohibition on the sale of human organs,
c - 2
 12.  Repon of the Task Force on Organ Trasplantation  Organ Transplantation:  ssues and 
April 1986, 
Recommendations, 
frm 
13, The UNOS emerged  the South-Eatern Organ Procurement Foundation (SEOPF). 
Composed of numerous trsplant centers in southeastern and other States, SEOPF was 
established in the 1970s to faciltate the computerize matching of donors and recipients 
among the member institutions. In 1976, SEOPF made its computerize matching 
progrm available, for a fee, to all transplant centers in the United States that wished to 
register their patients, This program was called UNOS. In 1984, UNOS was incorporated 
as anorganization separte from SEOPF. See John McDonald, "UNOS and ASHI 
American Society  Winter 1989, 
for Histocompatibility and Immunogenetics Quarterly, 
Vol. 13, No. 1, pp, 18-20, 
14. The contrct requires UNOS to provide the PHS with statistics and reports on the 
composition of the waiting list and on. trnsplantation activity, 
15. The 1986 legislation was par of the Sixth Omnibus Budget Reconciliation Act of 1986 
(P.L. 99-509), 
Congress also passed legislation concerning organ trnsplantation, procurement, and(cid:1)
distrbution in 1988. That legislation included a number of amendments bearing on the(cid:1)
oro 
PHS grant program, level of  procurement activity, and the workings of the OPTN.(cid:1)
In regard to the latter were requirments that the pPTN "establish membership criteria and(cid:1)
can 
medical criteria for allocating organs" and  out studies and demonstration projects 
for the purpose of improving procedures for organ procurement and allocation, " See the 
Health Omnibus Program Extension Act of 1988, P,L. 100-607. 
universal 
16. Under the Social Security amendments of 1972, Congress extended near 
Medicare coverage for dialysis and transplantation services for individuals with end stage 
renal disease. 
17, The authorizing regulations stipulate criteria for covered trnsplant centers and guidelines 
for patient selection. 
18.  Here, too, the proposed regulations stipulate criteria for covered transplant centers and 
guidelines for patient selection, Medicare already covers liver trnsplants for Medicare 
eligible children with bilar atresia, Medicaid, at State government option, also covers 
liver transplants and thus far has been the major Federal source of funding for liver 
transplants. 
19.  April 1990. 
UNOS/OPTN, Facts About Transplantation in the United States, 
20. Among the 72 OPOs, 50 are independent and 22 are hospital based, The OPOs perform 
some or all of the following functions: encouraging organ donation; identif ing potential 
organ donors; obtaining consent from next-of-kin; .and overseeing or coordinating the 
surgical excision of organs, the varous laboratory tests associated with transplantation, the 
C - 3  '')) ')-  , " 
organs, and, where applicable, the operation of a central
trnsportation and storage of 
ara,
register of transplant candidates in the service 
21.  Early estimates, based on HCFA data, suggest that the number of cadaver and living-
related kidney trnsplants for 1989 may actually be lower than in 1986, 1987, or 1988: 
759 trsplants in 1989, compar with 8,931 in 1988,  967 in 1987, and 8,976 in 
1986, See Alan Hull  S. Donor Procurement in 1989: Same Song, Third Verse, 
Vol. 4, No. 3, pp. 32 and 34, 
Nephrology News and Issues, 
Throughout the report, our focus is on organs procured from cadaver rather than living-
related donors, The latter accounted for about 20 percent of all kidney transplants in 1988. 
Such donations are, of course, made with a parcular relative designated as the recipient. 
Donations of cadaver organs by the family of the deceased person cannot be targeted to 
specific individuals or places. 
23.(cid:1) Throughout the report, we often use the term "professional leaders. " In so doing, we drw
heavily on the views expressed by the individuals we interviewed (see endnote 8) and on
the expressions of the Task Force on Organ Transplantation, While the latter, as noted,
involved more than professional leaders in the organ transplantation field, it was strongly
weighted with and influenced by such leaders.
Further, the expectations we address are basic ones involving general principles, We
deliberately focus on them rather than on the more detailed issues about which there are
more vared expectations,
24.(cid:1) It should be noted that some individuals might add the expectation that the distribution 
system enhance the procurement of organs, This certainly is an important goal 
relationship to organ transplantation and is often used as a rationale to support particular 
configurations of the distrbution system, We address this issue further in our discussion 
of the finding concerning the cooperative relationships among transplant professionals. 
See National Organ Transplant Act, P,L. 98-507, Title n.
26.  Senate Report 98-382, p. 13, Labor and Human Resources Committee, April 6, 1984
accompanies Senate bil 2048 which was passed in lieu of House bil 5580. The House 
Conference Report 98-1127, p, 16, October 2, 1984, accompanies the Senate bil 2048 and 
The conferes are particularly concerned that OPOs adopt medical criteria
reiterates that: "
for the equitable allocation of donated organs among transplant centers and patient,;.
27.  See Task Force, p, 89,
28.  See the Health Omnibus Program Extension Act of 1988, P,L. 100-607,
29.  See Committee on Energy and Commerce, 
 House Report 100-383,  October 20, 1987, p. 6. 
. 30.  See National Organ Transplant Act, P.L. 98-507, Title II. 
C . 31. More specifically, those patients who ar "highly sensitize" have developed antibodies to 
many different human leukocyte antigens (HAs), which ar genetically predetermined 
proteins located on body tissues, The presence of the antibodies increases the chances that 
the body wil reject a trsplanted  nd thus become 
organ. Patients develop antibodes 
highly sensitize in a varety of ways-most especially through blood trnsfusions, 
through the trsplantation and rejection of an organ, and through pregnancies. See Task 
Force, pp. 66-7, 71. 
32,  Among paricipating institUtions in the South-Eastern Organ Procurement Foundation, 
there was a more pronounced operative commitment to formal, collaborative efforts 
trsplant 
involving many  centers. 
33,  See Task Force, p, 69. 
34.  Ibid" p, 68, 
35.  A commonly used measure of sensitivity is a patient s Panel Reactive Antibody (PRA) 
level. It is determned by mixing a sample of a trnsplant candidate s serum with rhat of a 
panel of sera representing the population as a whole. On the basis of that mixing of sem, a 
candidate is given a PRA number which represents an estimate of percentage of the 
population against which he/she possesses antibodies and from whom he/she cannot 
receive a transplanted organ. The higher the PRA number of a candidate, the less likely a 
donated organ wil be an acceptable  atch for that candidate, Thus, a candidate 
biological 
with a PRA of 90 would likely reject 90 of each 100 organs that became available. 
On the basis of advice from several immunologists, we use a PRA level of 75 or over to 
define "highly sensitize" and less than 75 as "non-highly sensitized. 
36. HCFA, ESRD Progrm Management and Medical Information System: November 1989 
update, The 23 percent cit d is for 1988. Through the 1980s, the annual percentage has 
1989, with the data 60-70 percent complete, black 
remained betWeen 22 and 24, In 
recipients accounted for 22 percent of all cadaver kidney trnsplants, 
37,  UNOS/OPTN, as reported by PHS. The percentage is for 1989. 
38, Through this statistical technique we also examined the independent effecrs of PRA level 
and transplant center waiting list size, while holding age and blood type constant, 
hazds 
analysis, we determined that when age and blood type were 
Through proportonal 
held constant, blacks on the waiting list were 23 to 31 percent less likely than whites to 
receive a kidney at any point in time (see appendix B, table B-6). 
39. As explained in appendix A, we use the term "registration center" because the OPTN data 
base we draw upon contains information on individuals registered at either transplant 
centers or organ procurement organizations. 
C - 5  , "  , ", "

40.	 See S. M, Greenstein, et al" "Does Kidney Distrbution Based upon HLA Matching Dis
criminate Against Blacks?"  21, December 1989, pp, 3874-
Transplantation Proceedings, 
75, This issue of the journal presents the proeeings of the Second International Samuel 
L. Kountz Symposium on Renal Disease and Trasplantation in Blacks, held on March 28-
, 1989, in Washington, D. 
41.	 Council on Ethical and Judicial Affais  Black-White Disparties in Health Care,  Journal 
263, No. 17, May 2, 1990, p. 2345, For other ari
of the American Medical Association, 
cles that address, at least in par, the racial differentials in access to kidney transplantation 
waiting lists, see Philp 1 Held et al.  Access to Kidney Transplantation: Has the United 
States Eliminated Income and Racial Differences?" Archives of Internal Medicine, 148, 
December 1988, pp. 2594-2600; and Paul Eggers, "Effect of Transplantation on the Medi
care End-Stage Renal Disease Progrm  318, pp. 223-
New England Journal of Medicine, 
229. 
42.  Council on Ethical and Judicial Affairs, p. 2346, 
43.  Ibid., p, 2346. 
44.  S. Census aureau Estimates, July 1 , 1988, 
45.  HCFA, Progrm Management and Medical Information System: May 1989 update. 
46.	 HCFA, ES  Progrm Management and Medical Information System: November 1989 
update, 
47.	 For a discussion of factors contrbuting to the lower rates of donations among blacks, see 
12, 
Callender, e.O.  The Results of Transplantation in Blacks: Just the Tip of the Iceberg, 
Vol. 21, No.3, 1989, pp. 3407-10; and McDonald, J.e., 
Transplantation Proceedings, 
Comment: Issues Related to Race in Transplantation  Vol. 
Transplantation Proceedings, 
, No, 3, 1989, pp, 3411-
48.	 The Division of Organ Transplantation in the Public Health Service indicates that it has re
ceivedinformation from an OPO official that there ar only about 14 black procurement 
coordinators working for OPOs. 
49.	 Among non-highly sensitized candidates, we found no significant difference between the 
median waiting time of males and females (see appendix B, table B-4), 
50.	 Every person in the United States that is on a trnsplant center waiting list is supposed to 
be included on the national list. However, as explained later, the great majority of donated 
the basis of this national list. 
organs that become available are not distrbuted on 
51.	 This policy of the OPTN ("mandatory sharng of phenotypically identically matched kid 
neys  ) can be found in Section 3.3 of the OPTN by-laws, 
C - 6  52,  See UNOS Artcles of Incorporation. Policy 3,  , May 31  1988, 
53, The proportion of kidneys leaving the OPO service area in which they are procured i 
somewhat higher than 22 percent because of the distrbution arangements that some 
trsplant centers have with donor hospitas outside the OPO services area in which they 
(the trsplant centers) ar locate, 
Sta, 
54. For furer elaboration on these arguments, see  T., et al" "A Multifactorial System 
for Equitable Selection of Cadaver Kidney Recipients, ournal of American Medical 
" 1 
257, 1984. pp, 3073-5; Congressional Researh Service, "Organ 
Association, 
Trasplantation in the United States: Analysis of Selected Ethical Issues, " February 1989; 
and "Patient Selection Crteria in Organ Transplantation: The Critical Question 
Vol. 21 , No. 3, 1989, pp, 3377-3445. 
Transplantation Proceedings, 
55, There is a wide rage in the rate of organ procurement from one OPO to another, In 1988, 
for 44 of 52 reportng OPOs  the Association of Organ Procurement Organizations 
(AOPO) found the rate to range from a low of 24 organs per millon population to a high 
of73. For kidneys alone, the rage was from 17 to 49. See Committee Report "AOPO 
Data Acquisition: June 1989," pp. 13 and 15. 
56. See Report of the Organ Procurement and Distrbution Committee to the Board of 
Directors," Washington, D,C., June 20, 1989, 
57. See OPTN, "Statements of Policy: Inter-Organ Procurement Sharing Agreements 
Definition of Resident Alien, Exportation of Organs, and Payback Syst m for Shared 
Kidneys," Undated, p. 8, 
58.  The letter is from Dr. Raben Kirkman, medical diector of the New England Organ Bank. 
59. See Evans, R. and Manninen, D" " Public Opinion Concerning Organ Donation 
Prourement, and Distrbution: Results of a National Probabilty Sample Survey, 
Battelle Human Affairs Research Centers, Undated. The survey 
Transplantation Studies, 
was conducted in Januar 1987. 
60. December 1989, parcularly the aricle by Greenstein 
See  Transplantation Proceedings, 
et at In this report. we use the tenn "medcal criteria" in a broad sense that would also 
encompass biologic criteria, This would appear to be consistent with the National Organ 
Transplant Act, which does not specifically refer to biologic criteria, 
61. A recertfication decision is not, of course,. simply a matter of whether or nOt to recertify 
an OPO. It can involve a decision to grant a conditional recertification, whereby the OPO 
concerns 
must develop and have approved a corrective action plan addressing specific 
raised by HCFA. 
C - , "  , "  pp. 
62,	 In 1988 the 42 OPOs responding to the AOPO' s sUIvey had an average procurement rate 
of 34 per millon; 4 had a rate below HCFA's minimum of 23 per milion, See Committee 
Repon, p. 16, 
63.	 For a useful overview ofperfonnance measures and standards, see  MAXlMUS,  Final 
Repon: Development of Organ Procurement Organization Descriptors, Performance 
Measures, and Criteria," Prepared for Office of Transplantation, Health Resources and 
Services Admnistrtion, Deparent of Health and Human Services, May 15, 1986, 
II-
13, 
I to lll-
64.  Council on Ethical and Judicial Affairs, p, 2346. 
65.  The study data ar not clear as to what date "age" of a registrnt is correct. Obviously, age 
changes with waiting time, However, since the rage of ages in the study is an order of 
magnitude greater than the range of w.aiting times, the ambiguity of age was not deemed 
imponant. 
66. . The original reference is Kaplan, E,  , and p, Meier, "Nonparmetric Estimation from 
53, 1958, pp. 
Incomplete Observations,"  Journal of the American Statistical Association, 
457-481. A good CUIent summar of the method and subsequent modifications appears in 
Kalbfleisch, J, John 
D., and R.L. Prentice,  The Statistical Analysis of Failure Time Data, 
Wiley, 1980, pp. 10-16, 
67.  Brookmeyer, R" and J. Crowley, "A Confidence Interval for the Median Survival Time, 
38, 1982, pp. 29-41. 
Biometrics, 
68.	 See Cnaan, A., and L. Ryan  Survival Analysis in Natural History Studies of Disease 
8, 1989, pp, 1255-1268, The authors also cite some earlier 
Statistics in Medicine, 
references regaring the adjustment of risk groups. Some of the adjustment methods have 
their origin in the study of AIDS, " ... where the onset time of infection is..,frequently 
unobservable. 
It isperfecdy 
69.	 Note that estimated medians do not behave like arthmetic averages, 
possible for a group to have an estimated median waiting time of 6 months (for example), 
and to divide into two subgroups with median waiting times of 3 months and 6 months, 
respectively, 
70.	 The original reference to proportonal hazards is Cox, D,R., "Regression Models and Life 
Tables,  JRSS- , 1972, pp, 187-220, A more recent summar again can be found in 
Kalbfleisch and Prentice, referenced above. We use the PHGLMcompUter program 
written by Frank Hatell for the SAS(TM) system described in F. Harrell  The PHGLM 
SUGl Supplemental Library User s Guide  Version 5, 1986, pp, 437-466. 
Procedure," 
71.  See Cnaan and Ryan, 
C - 8  72.  Deviation from strct proportonality was detennined by examining "paral residuals" tests 
Harll  Panial Residuals for 
as descrbed by F.  (1986), cited above, and Schoenfield, D" "
the Proponional Hazs Regression Model,  69, 1980, pp, 239-241. 
Biometrika,  APPENDIX D

DETAILED COMMENTS ON THE DRAFT REPORT 
AND OIG RESPONSE TO THE COMMENTS 
drt 
In this appendix we present the full comments of all the pares that responded to the  report 
and our brief response to each set of comments- Our response supplements that offere in the 
final section of the text. 
. The comments offer a wide range of views and much pertent infonnation bearg on the issues 
addressed in our report, We urge the reader to review them carfully. In order, the comments 
presented in this appendi are from the following: 
The Public Health Service 
The Health Care Financing Administration 
The Assistant Secreta for Planning and Evaluation 
The United Network for Organ Sharng
. The American Society of Transplant Surgeons 
The American Society of Transplant Physicians 
The American Society for Histocompatibilty and Immunogenetics 
The Association of Organ Procurement Organizations 
The North American Transplant Coordnators Organization 
The New England Organ Bank 
. The South-Eastern Organ Procurment Foundation  .. 
--- 
..------
--_._.._----
,.  ---  --.-..-- -- - -  ;" 
:::Z'z 
Memorandum 
DEC I 0 190 
Date 
From  Assistant Secretary for Health 
Subje  PHS Comments on 01G Draft Report " The Distribution of Organs
for Transplantation: Expectations and Practices  ()EJ-bl-r9- sstJ 
Inspector beneral. OS 
Attached are. the 
PHS comments on the subject draft r-eport
findings and' recommendations. Ve concur with all 
recommendations directed to PHS and have taken or plan to take
them. 
actions to implement  Regarding the recommendations
whereby PHS is to collaborate with the Health Care Financing
Administration 
(HCFA) in its Medicare recertification of organ
procurement organizations. we are prepared to provide
information or assistance to HCFA upon request. 
In the " gene ral commen ts " se ction of the attachment. we expres s
our concern that this report did not sufficiently consider
human leukocyte antigen (HLA) matching as a factor contributing
t. 
to racial disparity in estimated median waiting time 
for a 
kidney t ransplan 
fi rs t  Addi tionally. we s ta te tha t the
concept of a single. national list of patients awaiting
transplantation needs additiQnal study before 
conclusions can
be reached about its  omparable effectiveness. 
utility. and 
t2A
. fl 
. J  D.  1)-;
son. 
Attachment  '! 
TH  HETH 
COMMENS OF  PUBLIC  SERVICE (PHS) .ON  OFFICE 
RT .  STRIBUTION OF
OF INSPECTOR GENERA (OIG) . DRAT 

ORGANS FOR  EXPECTATIONS AN PRACTICES, 
TRSPLAATION 
OEI-01-89-00550, AUGUST 1990. 
GEN 
COMMENTS 
The OIG draft report states that access of 
importt  patients to donated
organs remains Unequal in some  respects. Under the 
Health Resources and Services Adstration's (URA) Organ
Procuement Transplantation Netwrk 
(OPTN) contract, the United
Netwrk for  conductg a 
Organ Shar.1g (ONOS) 1s  ar study of the 
organ allocation systems. Where disparities  found, the 
study will explain those differences and, where appropriate, 
elimnate them. 
propose measures to  This study is scheduled to
1991. Additionally, 
be completed in July  a study of OPTN and 
curently underwy. 
Scientific Registry data is  tie  The study will
evaluate the factors that affect wait.1g  for renal 
transplantation. This particular study evaluates data for all

patients added to the national kidney waitig list s.1ce the

inception of OPTN to identify the biologic, demographic and
Organ Procurement ,Organization (OPO) . related factors that 
impact time waiting for kidney transplantation. Ths study
Jourl 
of Hedc.1e .1
will be submitted to the New England 
early 1991. Furher, the Departent is devloping a Notice of
Proposed Ruleming 
(NPRM) that will address the wait.1g list 
issue and will be subject to public coment 
tht it 
A concern PHS has with the OIG report is  appears that 
the OIG did not sufficiently consider hum leukocye antigen
(HL) matching as a factor. 
contributing to ftihret  racial disparity 
in estimted median waiting times for the  kidney
signficat 
variable that 
transplant. PHS believes it is a 
lookig at 
should be considered when  the black versus white 
waiting times. Although the degree of antigen matchig that 
transplat contiues to
positively affects the outcome of a 
cuent 
a matter of much controversy,  ONOS policy requres that
the highest priority be given to six antigen matched Or 
s policy may place 
phenotypically identical recipients. 
blacks at a disadvantage because in may cases antigens in
blacks canot 
be identified.  Therefore, if one holds the 
belief that a six antigen match should be given the highest
priority -for transplantation, then by defintion, blacks are at 
term of organ allocation. 
a disadvantage in 
A prelimnary f.1ding of the study entitled "
Factors Affecting
Waiting Periods for Renal Transplantations in the Un! ted 
States. (See chart below), is that when ABO blood type, panel
BL 
reactive antibody sensitization,  antigen profiles and
recovery rate of organ procuement organzations are controlled 
for, much of the difference between white and black males
disappears. For reasons not yet clear, the difference betwen
white and black females remina 
about the same.  .. .
Median Wai tinq Times, Per UNOS 
(Months to Transplant) 
Black 
Whi te 
Male  Femle  Hale  Femle 
13.  16 . 0+ 
tinq Times, Adjusted by Varia 
Black 
Whi te 
Male  Femle  Hale  Female 
12.  15.  11. 
single, unfied 
The OIG advocates the use of a  waiting list of
patients awaiting transplantation for each OPO. 
PHS supports 
he concept of a single national list needs
this position. 
addi  an be reached about 
tional study before any conclusions 
its utility and comparable effectiveness. Those who favor 
local lists suggest several drawbacks to a national list. For 
example, seeking recipients and transporting organs nationwide 
results in greater time expenditures uwlhtiicthe mlayy  have an effect 
transplanted. 
on the quality of the organ .that is 
Specifically, preservation time becomes a critical issue and 
lengt 
success rates may be affected with the  of time that
elapses before transplantation can occu. Secondly,
distaces 
transporting organs long  leads to increased costs 
because in same cases a transplant team has to fly to the site 
procue the 
of the donation to  organ and then fly back to the
si te of the recipient to do the transplant. 
For OPOs, knowing 
that an organ would not be used locally, but shipped off to 
some other location in the United States may provide a 
procuement for the 
disincentive. to  beefit of one's patients. 
This might discourage those OPOs that are high producers 
because potential recipients in their ara mayor may not have 
mil  procued. S.1larly, 
. access to the organs they  national 
incentive for less 
sharing provides  ,successful OPOs to 
ow  will 
try to step up their efforts as their  procuement rate 
have little effect on the allocation of organs to individuals 
areas. 
on the waiting list in their serfvrioce   While PHS is 
concerned about the deviations  the approved allocation 
system and believes they should be reduced, we are not yet  conv  ced that tmplementing a national system is the 
appropriate solution to this problem. 
tht 
Finally, the OIG states that blacks are less inclined to donate 
in 1988, only 
organs than other groups and points out 
It furer 
about eight percent of all cadaver kidney transplantss taintevosl vthedat 
the use of Ii kidney from a black donor. 
procuement specialists working in 
of an est  ted 300 organ organzations, only about 14 are 
the 72 organ procurement 
black. PHS believes that any efforts to reduce racial 
disparities in organ allocation, should include education for 
potential donors, recruitment of blapcrko couregmane nptr occouorredmiennatt ors 
ethic 
specialists, and training of organ 
famlies of differing cultural and 
how to approach 
background. 
OIG RECOMMNDATION 
PHS, in collaboration wit(h1 )O PeTsN,ta slihsohul d issue regulatio
require that each OPO:  a single, unified list of 
(2) distribute donated 
patients awaiting transplantation, and  fixt-served basis, 
ans  to those patients on a first-come 
subject to established medical criteria. 
PHS RESPONSE 
We concur. 
that 
(1)  governng OPTN 
DHHS is developing regulations for 
will address these issues. The proposed regulations uwniollw bne at
The date of issuance is 
issued by means of a NPRM. 
contract requres that 
this time. 
Additionally, the OPTN 
estalishing a 
study be conducted of the feasibility of  comleted in 
This study is to be 
national waiting list. 
u1y 1991. 
(2)  includig organ distribution and 
DHHS is exploring  packg 
allocation policies as part of three qruegruelsa tions 
transplant hospitals 
imlementing P.L. 99-509, which  Geeral 
memers of OPTN. The Office of the  Counsel has 
to be 
Departent canot share the draft proposed 
advised that the  are issued. Howver, before 
regulations with OPTN until they ' distribtion allocation 
undertaking revisions to the organ  BL matching and other
system, PHS will ascertain the effect of  whtes. 
biological factors on waiting times for ubnladceksr eannd  if actual 
Additional qualitative studies will be 
dispariti 
are identified. . .
OIG RECOMMNDATION

PHS, in collaboration with OPTN, should issue regulations to

require that each transplant center and donor hospital in an

OPO service area adhere to the centralized organ distribution

policies of the OPO governing that area.

PHS RESPONSE

ths 
issue. 
We concur.  The proposed regulations will address 
OIG RECOMMNDATION

PHS, in collaboration with OPTN, should s pport the development

of medical practice guidelin s addressing organ

transplantation. 
PHS RESPONSE

We concur. Following the development andin itsisautaenc e of the 
discussions 
above-referenced regulations, HRSA will 
with the Agency for Health Care Policy and Research (AHCPR) and 
dete%'e  the
the National Institutes of Health (NIH) to 
feasibili ty of 
establishing medical practice guidelines 
guidelines. 
addressing organ transplantation. We expect that OPTN will 
play an active role in the development of the medical practice
AHCPR has awarded a grant for a 3-year research study which

will comence during the first quarter of fiscal year 1991. The

study will examne the legal, organizational, and health care

professional factors which affect the donation process of

organs and tissue for transplantation. Characteristics of the

donor and donor famly that will  sex, 
be studied include age, 
race, and insurance status. This study should provide useful
info2:tion that 
may address some of the questions raised in 
the OIG report and be of assistace in futur gudelines 
tw 
development. It will be conducted in  geographical areas in
which there are established -required request laws.  e draft 
coment on the 
report does not  fact that 44 States htahveg nsow 
passed a -required request law, - which, among other 
requres 
hospitals in those States to develop protocols related 
e study will also provide 
to organ and tissue procurement. 
for structured interviews with health care proiders and
admistrators 
and will assess various aspects of the donation 
process of organ and tissue transplantation, including the 
provider 
required request laws, hospi tal policies, and. 
knowledge and attitudes.  OIG RECOMMENDATION
PHS should fund a demonstration effort incorprating the
following two features: (1) the establishment of a single,
awating an organ

unified waiting list including all patients 
transplant in -a numer of  (2) the

OPO service areas, and 
mandatory distribution of donated organs to those patients on a
first-come, first-served basis, subject to estalished medical

cri teria . 
PHS RESPONSE
We concur in principle. HRSA supports the concept of a single,
unified waiting lis.t per OPO and an equitale organ
transplantation allocation 
system, and will be proposing these 
as part of the NPRM. 
OIG RECOMMENDATION
tht 
could help

HCFA and PHS should support research efforts 
reduce racial disparities in organ allocation. 
PHS RESPONSE 
We concur.  The OPTN contract has been modified to include the 
following: 
A specific monitoring requirement to identify and
explain  significant variations in waitig ties among 
ethic 
racial and  groups and to proote measues to
elimnate  exst. 
differences that 
cut 
exame 
A specific requirement to  policies
fr 
selection. 
and practices regarding organ recipient 
those 
Where disparities are found to result 
exlain 
policies and practices, the contractor is to 
those differences and, where appropriate, propose 
elimnate 
measures to  them. 
undertg 
Addi tionally, BCFA is  a study of patient access to 
transplantation. The study, being conducted by the 
exame  selecec for 
Corporation will  how patients are  trplanted 
into 
transplantation and why organs are frequently 
comuter as 
the UBS' 
patients other than those identified 
the best matched recipient.  OIG RECOMMENDATION 
Before granting Medicare recertification to an OPO, BCFA, in 
collaboration with PHS, should assure that the OPO is 
1. distributing organs equitably among patients, according 
to established medical criteria, and -
procuement
2. conducting a rigorous, soundly based organ 
effort. 
PHS RESPONSE 
assistace 
We concu. We will provide infor.ation or  requested
by HCFA to support their Medicare recertification decisions
regarding OPOs.  s Division of Organ 
PHS, through HRSA 
Transplanta tion, periodically meets with UNOS to review the
perfor.nce of 
acti vi ties and  the OPOs. The infor.tion and 
data obtained through this and other means will continue to be 
made available to BCFA. 
sureyors periodically 
Also, HCFA  visit OPOs to evaluate their 
stadars. 
perfor.nce and  or BCFA  The 
compliance with OPTN and  strengten 
proposed regulations that were 'discussed above will 
S standards especially regarding' equitable distribution of 
, OPTN  splantation. 
organs among patients awaiting tr  TECHNICA COMMS 
1. Page 6, 3rd paragraph 
Include the foot ote no. 31 in text to offer an explanation
of highly sensitized patients. 
Page 
2 .  last paragraph 
9., " 
registration center. to .
Change . transplant hospital. each 
place it occurs, since . registration center. is not a 
commonly used ter. in transplantation discussions. 
3. Page 13, 1st paragraph 
Insert .
then" after individuals. 
regiona1 lists 
4. Page 15, 3rd paragraph 
Change "keep one-donate one" to .keep one-share one. 
5. Page 18, Recommendation 
. Change .donor hospital. to -transplant hospital.  It is the 
mae decisions about 
transplant hospital and the OPO that 
organ distribution. If the intention here is to get the 
mang 
transplant center or surgeons out of the process of 
organ distribution policies, this recommendation may fall 
diected 
short of reaching that goal. Many OPOs are either 
boar 
' or 
by a transplant surgeon have a medical/advisory 
e recomendation 
that sets organ distribution policies. 
that OPOs serve as tJe "engine of the coorgman tdyis.t ribution 
Conversely, 
system" will be applauded by the OPO 
transplant surgeons/physicians who believe' thatt hOPsO s have 
too much control already, will strongly oppose 
recommendation. 
6. Page C-S, Footnote 24 
e footnote related to the underlying legitimcy and 
continued advancement of organ transplantation is vague and 
shae-one concept 
should specifically refer to the keep-opner ocuent efforts. 
and the idea that local use encourages 
Additionally, the last sentence which refers to variations 
in the distribution system is incorrect. It is possible to 
determe 
do a computer study to  whether OPOs with variances 
pe1:ts 
b(eestpteecri ally a variance that  par okfe tehp-eo nOeP Tsh acroe-notnre)a chtav,e 
procuement rates. As 
UNOS will conduct such study.  7. Page C-7, Footnote 41 
The articles in the footnote deal with access to thewai ting
list, not access to transplantation after getting on the
list.  GIG Resp onse To PHS  Comments 
We appreciate PHS' positive response to the report, We paricularly appreciate'its concurrence 
with the first two recommendations concerning the single OPO waiting lists. We look forward to 
the implementing regulations. 
On two of the recommendations, we are unclear about the scope of the PHS concurrence, One 
of these is the recommendation calling for PHS to fund a demonstration effort that applies the 
single list and first come first served concept to a number of OPO service areas. In response 
PHS indicated that it agree in principle but did not indicate if it would proceed with such a 
demonstration, Although the NEOB in its comments makes a good point about how the 
diversity of medical criteria being used may limit the practical effects of such a demonstration 
we continue to think, for the reasons put forth in the text, that such a demonstration could 
provide data quite useful to the further development of organ distrbution systems. 
The other recommendation is the one to PHS and HCFA calling for research efforts that could 
help reduce racial disparties in organ allocation. In this sphere, PHS makes no mention of one 
of the two types of research effort we caJ1ed for: those addrssing the immunogenetics of 
blacks. In this regard, we continue to urge, as the American Society Histocompatibility and 
Immunogenetics noted in its response, that funding be directed "toward improving definition of 
HLA antigens unique or nearly unique to blacks. 
In view of PHS' introductory comments concerning waiting lists, we wish to emphasize that we 
do not advocate the use of a single national waiting list as the basis for organ allocation. We 
recognize, as PHS states, that this concept "needs additional study before conclusions can be 
reached about its utility and comparable effectiveness." Our recommendations focus on the 
establishment of a single list within each OPO service area that would serve as the basis for 
organ allocation within that ara. 
It is in that context that we make our second recommendation calling for donor hospitals and 
trnsplant centers to abide by the policies of the OPO. Its intent is not, as PHS suggests in its 
makg 
Technical Comment #5, "to get the trsplant center or surgeons out of the process of 
organ distrbution policies," but rather to assure that the OPO' s policies are adhered to by all 
trsplant centers and donor hospitas in its service area. As NEOB notes in its response: " 
seems strnge to establish OPO terrtories and OPO/OPT rules and then allow individual 
hospitals to act outside of them. 
A further clarfication, in response to PHS' Technical Comment #2, concerns the tenn 
registration center, " We use that tenn deliberately, in accord with the methodological 
As noted there, when a transplant candidate is registered at more 
discussion on pp.  and  2, 
than one center, we use the transplant center having the earliest registration date as the focus of 
analysis. 
D - Finally, with respect to PHS' comment on the importace of HLA matching as a factor 
contrbuting to black-white racial disparties, we recognize, as noted in the comments portion of 
the text, that this is an important consideration and that further inquir concerning it is needed. 
D - 12  ./ 
---
------
--- ---.- --"'''..
- - ''---''
=-  --..
Memorandum 
, DEC 3 190 
Date 
,'Om 
- Gail R. Wilens, Ph.
D. 
Administrator 
Subject 
OIG Draft Report - 'The Distribution of Orga  for Trantplantation: 
Exectations and Practices , OEI-Ol-89-00550 
The Inspector General 
Office of the Secretary

We have reviewed the subject report y.hich concerns the distnoution of 
organs, primariy kidneys, from the point of procurement to the point of 
transpla ntation. 
The report found that there has been improvement in organ distnoution
practices. However, current practices fall short of providing patients equal
access to donated organs. Organ distribution remains heavily controUed by local 
Organ Procurement Organizations (OPOs), and OPOs and transplant centers 
imp.ede the national system for distributing organs by acting with a sense of local 
ownership of organs. they have procured. The findings are consistent with those
reported in the 
professional literature on the subject. 
In the report, OIG makes the following recommendations: 
HCFA and PHS should support research effort that could help 
reduce racial disparities in organ allocation; 
HCFA, in collaboration with PHS, should assure that the OPOs 
are distributing organs equitably among patients, accrding to 
established. medical criteria; and 
HCFA, in collaboration with PHS, should assure that the OPO 
is conducting a rigorous, soundly based organ procUment
effort. 
HCFA is concerned about the 
inequity of the current allocation system, and
has taken steps within this Agency s purview to remedy the situation. We
concur with all of OIG' s recommendations. Our specific comments on the 
report s recommendations are attached for your 
consideration.  Page 2 - The Inspector General 
Thank you for the opportunity to review and comment on this draft .report. 
We found the methodology and statistical analyses used in the report to be very 
reasonable, and the fidigs to be consistent with HCFA' s knowledge of this 
advise us whether you agree with our comments on the report 
subjec. Please 
recommendations at your earliest convenience. 
Attachment  Comments of the Health Care Financin Administration HCF
QDG 
Draft Report - The Distribution of Organs for 
Practices 
Transplantation: Expectations and 
OEI-01-89-00550 
HCF A and PHS Recommendation 
reduce 1acial 
HCFA and PHS should support research effort that could help 
disparities in organ allocation, 
Response 
report, 
HCFA concurs with OIG' s recommendation. In response to ths audit 
HCFA has contracted with the Rand Corporation to complete a study which wil 
study was started 
address racial disparities in organ allocation. The 
1991. 
September 30, 1990 and completion is expected by September 30, 
HCFA and PHS Recommendation 2 
collaboration 
Before granting Medicare recertification to an OPO, HCFA, in 
organs equitably among 
with PHS, should assure that the OPO is distributing 
patients, according to established medical criteria. 
Response 
HCFA concurs with OIG' s recommendation. We plan to publish manual 
surveyors of OPOs to determine if organs 
instructions that will require HCFA 
revid 
are distributed equitably among patients, It is anticipated that the 
manual instructions wil be issued in early December 1990. The first certification 
a) instructions are scheduled for January 1991. 
reviews using these manu 
authority to set the 
However, it should be noted that HCFA does not have the 
authority reSts with the Organ 
standards by which organs are distributed, This 
of the 
Procurement and Transplantation Network (OPTN), under the auspice 
. Public Health Servce. HCFA wil enforce the rules regarding the allocation of 
OPT. 
organs that are established by the 
HCFA and PHS Recommendation 3 
collaboration 
recertification to an OPO, HCFA, in 
Before grnting Medicare 
that the OPO is conducting a rigorous, soundly based 
with paS, should assure 
organ procurement effort.  Page 2

Response
42 CPR 485.306 
HCFA concurs with this recommendation. Regulations at 
outline the standards by which HCFA surveyors evaluate the procurement efforts 
of OPOs. If an OPO does n0t meet the procurement performance standards 
HCFA will not recertify the OPO, HCFA believes the standards for 
, but wil 
most 
procurement currently in effect, are for the  par appropriate
recived data on
strengthen the enforcement of those requirements. HCFA has
organ transplantation from the Public Health Servce, and will c ontinue to use

this information to make decisions regarding procurement performance 
standards. DIG  Res ponse  HCFA Comments
We are pleased with HCFA' s support of our methodological and statistical analysis and of our 
recommendations. In response, we make two brief points, 
First, concerning the recommendation that OPOs distrbute organs equitably among patients, we 
continue to urge that as a par of the process of determning the equity of an OPO' s organ 
allocation processes, HCFA examine the median waiting time in the OPO service area of those 
on transplant waiting lists and compare the characteristics of those on the lists with those 
receiving transplants. Although such data alone wil not indicate the equity of an OPO' s organ 
allocation efforts, it wil contrbute to more precise and effective inquiry along that line. 
, we 
Second, in regard to the recommendation that OPOs conduct rigorous procurement efforts
considered by HCFA. 
understand that varous types of performance indicators are now being 
This is a constructive development. It would also be constructive to keep a close look at the 
number of black transplant coordinators working for OPOs, If the numbers of such coordinators 
do not increase significantly, the prospects of increasing donations among blacks may be 
hampered, 
D - 17  ------ 
.._  . .
" \ 
-_. 
w.s 
RECEIVED  C. 202 
REGION  1 - O,G/OEI  oc: , 2 ' 
OCT f 9 '990 
TO:  Richard P. Kusserow 
Inspector General 
Assistant Secretary for
FROM: 
Planning and Evaluation 
SUBJECT:	 OIG Draft Report:  "The Distribution of Organs for
Transplantation:  Expecttions and Practices,
OEI-010S9-00550 
I appreciate the opportunity to review this draft report.
Because of its sensitive nature, my staff and I have examined it
with particular care. 
Based on that review, while I believe that
report raises substantial numers of important issues, I am
concerned that some of its findings, and the recommendations
which flow from them, may be  premature. 
For example, one of the recommendations is "to require that each 
OPO (1) establish a singJ.e, unified list of patients awaiting
transplantation, and 
(2) distribute donated organs to those
patients on a first come first served 
basis,. .
addition, ' 
timtheere is  a- finding that "While there has been progress,
current organ distribution practices fall short of congressional
and professional expectations in each of the three areas. 
The
discussion of this shortfall focuses on waiting lists and waiting
The inherent difficulty with these conclusions is 
that, while
perhaps appearing eminently equitable on its 
face, a focus on
waiting time with emphasis on "first 
come, first served" as an
allocation principle belies the complexity of the factors that 
are considered, and should be considered, in the organ allocation
process. 
Further, there appears to be an underlying assumption in the 
report that the principle of "first come, :first 
served" as an
organ allocation methodology was intended by the Congress. 
While
there is statutory language and legislative history to the effect 
tha t transplant patients should be protected by assuring
equitable allocation of the limited supply of 
organs, no specific
allocation methodology has been delineated in statute or
leqislat1ve history. 
In fact, the Organ Transplant Amendments of 1988 deleted the 
statutory requirement that the Organ Procurement and 
Transplantation Network (oPT) assist 
organ procurement
organizations 
(OPO) in the distribution of organs "which cannot  Page 2 -- Richard P. Kusserow 
be placed within the service area of the organizations.  The
-stated  lito 
purpose of the deletion was  remove any statutory bias
respecting the important question of criteria for the proper 
distribution of organs among patients.  . (See House Report 100-
383, page 7. 
The report also states that "The Committee does 
not wish the statute to be read as establishinq a perference
(sic) for, or against, distribution within the service area of 
the OPO.  This reflects what I believe Congress' intent to be: 
first, that there be equitable allocation of organs; second,
that extensive work be done to develop appropriate mechanisms to 
meet the desired goal. 
I am also concerned with statements (see, for example, pages
13, 15 and 18) to the effect that the OPTN imposes various 
organs. 
requirements on OPOs governing the distribution of  This
is not the case. 
CUrrently, policies developed by the OPTN are 
being followed voluntarily by OPOs anq transplant hospita 
Further, regulations governing organ distribution have not as yet 
Secretary. 
been promulgated by the  HRA has, however, convened a 
workgroup to develop an NPRM on several operational aspects of 
the OPTN, possibly including regulations directed at organ
distribution. 
. Addi t onal concerns are addressed in the following comments. 
Equity Issues 
Discarate wai tina Times  As previously noted, the 
report places great emphasis on "first come, first 
allocation8 
served" as a primary criterion for kidney 
However, medical criteria are primary. Thus, a finding 
that disparate waiting times based solely on a "first 
II principle 
come, first served  are inappropriate or 
inequitable appears somewhat arbitrary, in light 
other considerations which enter the decision to
transplant. 
Many of these are identified in the
report. 
See, for example page 10, where factors such 
as level of sensitization are discussed. 
Lower donation rates among blacks have also been 
associated with lower transplant rates of black' ESRD 
patients. But it is important to note that blacks seek 
(callender, 
transplant at a lower rate than do whites 
, 1987). 
other waiting time issues are raised for your
consideration in the attachment. 
I urge that these be 
report. 
explored more fully in the  Page 3 -- Richard P. Kusserow

Sinale List Per OPO  I agree that the distribution

system should provide for equitable allocation of

have 
donated organs, and that a single list per OPO 
 sharing. 
the potential to improve orqan  However, as
noted above, the focus on "waiting time" as a primary
cri terion for 
transplantation in two of the 
tex is 
inappropriate
recommendations and much of the 
and premature. 
socio-economic Considerations 
A numer of socio-economic factors may influence the 
decision to transplant, including an assessment of a
patient' 
s ability to comply with friugride rpo st-transplant
regimens  This is an area which  exploration
should be 
recommended. "Findings from the National 
Kidney Dialysis and Kidney Transplantation study" might
be consulted for 
data in these areas. 
discussion of ,
Also, there is no  the weight given to age 
in the transplant decision, and the age at which

diagnosed, i. 
different racial groups are  e., as 
adults, or the elderly. 
juveniles, young  Are younger 
persons expected to have. better outcomes -- longer 
graft survival -- or less likely to have co-morbid

condi?ti oInfs  that may contraindicate transplantation,

etc. 
younger persons are otherwise not better
candidates than older 
persons, doesn' t an orqan placed 
in a younger person nonetheless maximize the benefit

will
derived from that organ simply because it 
(statistically) 
provide- many more years of use? 
Eggers' 
Inclusion of data from  (1988) findings on graft 
informative. 
survival would be 
Such issues point to the need for additional research

to determine the causes of disparities rather than for

flatly stated recommendations for particular allocation

pol icies . 
Medical criteria. As noted above, medical criteria

governing organ allocation have not yet been

OPT has 
promulgated by the Secretary, although the 
developed consensus guidelines giving preference to

six-antigen matches. Additionally, the brief 
discussion of level of sensitization (page 12) fails to
, present the 
extent to which patients who are highly 
sensitized are more likely to reject organs. It is our 
understanding that this is a significant problem and 
that transplants for highly sensitized patients are  . .
Page 4 -- Richard P. Kusserow

likely not only to subject them to major trauma

(initial operation, rejection episodes and medication 
with major adverse side effects, and operation to
remove the rej ected organ), but also to lead to wastage
(i. 
e., non- ductive use) of scarce organs. 
This latter aspect is particularly significant as an

equi ty issue since an organ wasted is an organ

unavailable to anolitvheerd p.a t(iIetn t for whom it might have 
proven more long  also eliminates the 
savings to the Treasury which an earlier IG report
docuented. 
I recommend that the report discuss these 
matters explicitly and that the finding on sensitized

patients be modified to acknowledge prominently the

problem of non-productive organ use. An organ not 
wasted is effectively the same as an additional organ
procured. 
reguations, 
The draft recommends that the PHS require, by 
that transplant centers and donor hospitals adhere to 
distribution policies. The accompanying discussion fails to

point out that allocation rules have been under development

for several months and they will be published in the near
term.  monitored 
by PHS, the 
Although compliance will be 
imDlemented  by HCFA under section 1138 of the 
rules will be 
Social Security Act. How  ver, until these rules are 
policies. 
published, there are no binding distribution 
(pages 13 and 
In several places  18) the draft criticizes the 
right of a transplant center to make arrangements with an 
OPO in a service area other than the one in which it
located.  require that -
And, the report recommends that PHS "
each transplant center  . in an OPO service area adhere .-

to the centralized organ distribution policies of the OPO

governing that area.

The arrangement criticized, however, is specifically allowed
in HCFA regulations governing hospi tal/OPO interactions. 
Therefore, if a y recommendation is to be made it should be

couched in terms of HCFA modifying its present policy and

regulation. 
Such a recommendation, however, is inappropriate because the 
IG staff have neither recognized, nor balanced, the 
considerations which led to current HHS policy. The policy 
implemented in the current HCFA regulations prevents a 
hospital from being forced to deal exclusively with an 
inefficient or uncooperative OPO. Furter,. the policy gives  ! .
Page 5 -- Richard P 
8 Kusserow 
leverage on OPOs and was specifically designed to make clear 
n2 "govern" any areas. 
that OPOs do 
As the draft report elsewhere acknowledges, there are many 
OPOs whose performance in procuring organs could be 
improved, and the literature on monopolization makes 
abundantly clear that airtight monopolies almost without 
system allowing 
exception have worse performance than 
competition. These facts suggest the strong possibility 
that the recommendation, if implemented, could have the

perverse consequence of reducing organ procurement.

I certainly have no obj ection to a discussion of this issue 
pfraoivrildyed.  that the competing considerations are presented
Nonetheless, I do not see how existing evidence 
could support a strong recommendation to overturn current
. policy 
by establishing OPO monopolies. 
The discussion of the  local ownership" sentiment as it 
relates to procurement incentives on pages 14 to 16 is
generally well balanced. However, my staff is unaware of 
any statistical analysis of the incentives question having

been performed. If none has been, there seems no basis for

any conclusion other than that more research .should be done 
to determine whether organ procurement would be weakened if 
local 
local preferences were reduced (or strengtened if 
preferences were increased). 
Again, thank you for the opportunity to comment. 
Martin 
Attachments:	 Edi torial Comments 
Waiting List Issues  ' "
Editorial Comments
The "background" should be expanded (at page 3, after the
bullets) to state 
that, per F. R. 51802, Volume 54, No. 241, to 
date, no rules or requirements binding upon transplant hospitals
and organ procurement organizations have been approved or
implemented by the Secretary. With that background, care should
be taken to describe any fortcoming issuances as "rules and 
requirements approved by the Secretary.  In no instace should
the terms "mandatory OPT 
policies and/or regulations" be used. 
e.g., "
This applies to endnotes as well,  regulate" in note 11 
should be changed to "facilitate.  See also pages 13 and 15. 
Thus, at this time (and throughout the time covered by the IG 
study), all OPTN policies are voluntary. Whe  er the transplant 
community was aware of this HHS distinction or not, the OPT did 
ctivities to assure that memers 
DQ monitoring or compliance 
were following the policies. Therefore, the report should be 
OPT policies 
careful to couch references to the  and compliance 
with them in terms that reflect the voluntary nature of
compl iance.
Page 3, bullets 2 and 4:  regulations" should be cnanged to 
requirements" to conform to statutory and regulatory language. 
line: 
Also, In the penultimate paragraph, next to the last 
coverage of" should be inserted after "proposing. 
Page 4, 1 ine one, first word:  change " certified" to 
"designated. " 
Page 5, under "Expectations, " paragraph one, line one: the word
congr  ssional" preceding statutes is redundant. Also, docuents 
policies, 
developed by the OPTN should be characterized as " " not
as " regulations. 
Page 10, penultimate paragraph: Antigen frequency differences 
between blacks and whites are often cited as a possible 
explanation of the differences in transplantation rates. The 
this variable 
should analyze  (which we understand. was to be done) 
to determine whether it is explanatory. Possible explanations of 
tther difaferenntials mayp al"slo ianclunde datte .of  entry on list. For 
instance, do physicians tend to list blacks earlier than whites? 
Another explanation may be that blacks may have multiple complex 
medical conditions which tend to militate against receipt of a
Page 12: The discussion of the common "pool" arrangement shoulQ 
be followed by a sentence pointing out that this may serve 
important purposes in maintaining high donation rates and that 
study. 
the IG did not explore these in this  - 2 -
Page 13: Care should be taken not to link the OPT' s "local use" 
this 
philosophy with HCFA's OPO designations. To overcome .
appearance, the last sentence (after endnote 52) of the 
penultimate paragraph on page 13 should be deleted. The last 
sentence on the page (after endnote 53) also should be deleted. 
old. 
The database is only about three years 
Also  on page 13, two sentences in the second full paragraph
should be modified as follows:
"That is no longer the norm. 
Centers and OPOs have
formally stated criteria governing the distribution
of organs. OPOs use the national organ center for
distributing any organs that they cannot use within
their individual service areas.
Pages 13-14: The balanced discussion of tissue matching VB. drug
regimens is inconsistent with the recommendation to move to a
single, unified list" per OPO (see Recommendation 1).
" Page 14: omitted from the discussion on organ sharing are state 
laws that establish priority for intrastate matching. 
five:  insert "
Page 15, fifth paragraph, line  excerpt from a" 
following. " 
after 'te word 
Page 17: Rewri te the end of paragraph two to state that the OPT 
was established "to facilitate organ procuement and
transplantation nationally,
" not as a policy-making and oversight
body. 
5: 
Page A.  The description of the "quartile" differentiator is
not clear. Is the first quartile comprised of the centers with
the largest list or the smallest?
tales 
"Size of Cells. 
Appendices A and B:  Some  include the n 
of the cells. All tables should include this information.  , .
. '
Wai  st Issues 
tina 
There are many reasons why reliance on "waiting lists" and/or
"first come, first served" as organ allocation principles are
unsupportable. 
First, there is no definition of "waiting time" which would allow 
lists, 
comparison among individuals on the transplant candidate 
e., there is no agreed-upon point in the patienlti'sst .c ourse of 
Patients 
disease when that patient can be entered on the 
status. 
may be listed at any time, regardless of health  Newly 
diagnosed patients, never dialyzed, and patients who are in 
extremis may be listed on the same date. The recently concluded 
one-thrd of thos 
Abt study found that over  on lists for whom a 
perfectly matched organ was found were med cally unsuitable for 
transplantation, which may imply many people should be removed 
from current lists. There  ore, currently, "waiting time" is a 
meaningless measure.
Second, the repeated insistence on "first come, first served" as 
thical principle fails if weaxitpilneg ,l ists can be "gamed" by 
an  For 
physicians and patients.  the statistical analysis 
used in this report found that ODe percent of all transplants 
earlier 
date than registration on the waiting
olcciursredt a.t  an 
. If length of time on list became a more important 
allocation factor, thousands of additional unsuitable or 
premature candidates might be added to preserve a space. This 
would not only make such lists aeaningless, but would also impede 
organ matching by creating many -false positives" in the very
short period of time allowed to match organs. 
Potentially, if 
the persons longest on the lists were in fact unsuitable
candidates 
(and the unsuitable WDuld naturally gravitate to the
top of the list), almost all of the names at the top of a
computer "hit list" would be unsuitable.
Third, " suogate for 
waiting time" is not a  any medical 
condition and II first come, first served" is not a compelling
ethical principle. 
Nei ther should be unduly emphasized as an 
organ distribution criterion if there are any potential
al ternati ves. 
waitin 
Fourth, in the event that " time" became a significant 
osts would likely 
criterion for organ allocation, ESRD program 
increase significantly. Such an increase would be due to the 
perceivea advantage of being placed on the list early, regardless 
frequent, 
of health status, and the subsequent need for 
relatively expensive; PRA testing. - 2 -
Therefore, I recommend that consideration be given to developing 
both a finding and a recommendation on othre gneead tno scon.d uct 
research on lists of potential recipients and on improving their 
appropriateness for use in allocating 
I also recommend that the term "waiting list" be avoided wherever 
techically correct
possible and replaced with more neutral and 
terms. It is noteworty in this  carefuJ,ly 
regard that the law 
refrains from using the term "waiting list" and instead refers to
a "
national list of individuals who need organs. 
Finally, if the recommendations regarding waiting time are 
retained in any form, at the least they should be reworded along
the following lines: 
"Require that each OPO.  . (2 ) distribute all donated 
organs to patients based on criteria which maximize 
productive use of organs and consider arbitrary non-
medical factors such as waiting time (if at all) only 
as tie-breakers between equally qualified potential
recipients. "  OIG Response To ASPE Comments

The ASPE's crtical assessment of the report is obviously a fundaenta one encompassing many 
aspects of the study s methodology, findings, and recommendations. Below, we respond to 
of the major points. 
On the fist come ftrst selVed reommendation, we believe, as noted in the comments sec
tion of the report, that as expressed, it is fully in accord with congressional expectations. 
Further, as explained in the text, we do not view it as a straightjacket on OPT/OPO organ 
allocation policies. The "medical crteria" provision allows for the specifcation of excep
tions to fIrst come fIrst selVed as long as they are formally stated, in accord with 
HHS/OPTN policies, and based on mecal considerations. Such an approach would still 
allow for much innovation. However, it would not, in our view, allow for "keep one, share 
one" argements and other such exceptions not rooted in medical considerations. 
We recognize the point of ASPE' s comments about the volunta natur ofOPTN policies. 
After much review, the Deparent has determned that all OPT rules lack the force of 
Federa law because they have not been issued though the Deparent s formal rule mak
corrt 
ing process. Efforts ar now underway to  this situation. As ASPE notes, regula
tions wil soon be issued that will encompass "several operational aspects of the OPT. 
Accordingly, we have edte die text to miimize any implication that OPTN policies 
tantamount to Deparenta regulations. At the same tie, we recognize that since the es
tablishment of the OPT, the operational reality among OPTN members has been that 
OPTN policies ar not merely suggestions but rather authOlj.tative expressions of national 
policy. 
if" '
In its supportng comments on waitig list issues, ASPE indicates that  waiting time 
became a signifIcant crterion for organ alocation, ESRD program costs would likely in-
crease significantly." This is an importt point, one reinforced by ASTP 's expressed con
cerns that some of those on waiting lists might not be "bona fIde" transplant candidates, be 
it for medcal, financial, social or other reasons. 
We agr that this is an importt issue waranting furer inquir. It is an issue we rased 
in a September 1987 report entitled "Organ Allocation Costs: An OvelView." It could 
help explain the racial inequity we have documente in this report and, because of the on-
going tests conducted on the sera of those on waitig lists, could be adding unnecessary 
AprogrS  PE. 
to  costs. 
Finaly, we have made a number of edits in response to minor technical points raised by ..  - -.  . .
LNOS . 
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Richard P. Kusserow  H.1CI.   MM.... I 'I_t9.. 
Inpector Genera
Department of Health and Human Services 
Washington, DC 20201 
tJel-I9/-39- OOS.s 
Dear Mr. Kusserow: 
drt  rre 
We would like to tae the opportunity to comment on the  report entitled 
Distribution of Organ for Traplantation: Expectations and Practices" UNOS is gratiieds itghtn ycoaurt  
the development of the organ procurement and trplatation network is a 
rceopoopretr aftoiuvned  wachievement of trplant profesional and others. Just as the OPT ha been a 
constructive factor in the development of a national organ ditrbution system, so too ha it been an 
may 
important reflection of the readiess of  diverse interets to work together cooperatively. 
UNOS, too, is concerned about the difference in watig ties among miority grups and 
has been conducting an independent study of factors affectig tie watig for kidney patits. The 
donation rate among blacks was 8% in 1989, but despite tht low donation rate. blatrckpsl raenceti ved 21% 
over a thd of the U.s  centers, 
of ' all kidney traplants in 1989. ' We have found tht at 
is not universal.  described in your report
blacks wait less time than whites to receive a kidney. Thus, the problem 
One aspect of your report which we strongly urge you to personally review and change 
regards statements tht lead the reader to believe that your office ha found tht the diference in 
waiting tie are as a result of racial prejudice. It is unfortuate tht the popula pres foced on 
s Councll on Ethcal 
that aspect of the report and even quoted the American Medica Asociation 
and Judicial Affai out of context. (Te Council's comments about a wsutrbpcolansnctiaoutiso bni aa sa nd -racial 
prejudice  were about medicine in genera and were not directed at  the press 
racial bias wa presnted in 
seemed to infer from the report.) No evidence supportng a findig of 
the report and indeed we are unaware that any such evidence ha been fortcomig. Thus, the 
inclusion of even a collatera ,dicussion of such a speculative ise may have the unwanted effect 
This would be parcularly 
of further dampening the enthusaimaosmn go mf imnionroirtiietsi iess u tno vdeonrastye  aogrgraene.d  to be greatly needed 
trgic since increased donation 
furter inormtion to 
If we ca provide your office with any  asist you in your stUdy, please' 
do not hesitate to contact our office. 
Very truly your,
S. 
James S. Wolf, M. 
President 
GAP:gm 
THE NATIONAL ORGAN' PROCUREMENT AND TRANSPLANTATION NETORK  OIG Resp UNOS  Comments 
onse To 
As noted in the comments section of the report, we have amended the text to make it clear that
we are not claiming that the black-white discrepancies documented ar the result of racial 
prejudice. At the same time, we feel compelled to include at least "subconscious bias" in the 
inventory of possibly contrbutig factors. The comments of the AMA's Council on Ethical and 
Judicial Affairs would seem to support this decision.
We recognize, as UNOS notes, that the disparty in black-white waitig time is not universal 
the countr, 
throughout the countr and that the degree of the disparty vares across 
Appendix A provides some data to support these obselVations. nriet  nf  ltgenns 
WrnnspImr 
J\merirnn 
. President: 
Davi E. R. Sutherland. M.  , Ph.D.  SeCNtary: 
Univrsit of Minneso Hopitl & Clinic  Mar A. Har, M. 
Coumbia Unirsit 
UMAC Box 280
4M2i0n nDeealpaowliasr, eM SNtr e5e5t,5 S5.E .  N63e wW eY3so0tk ,5 1N65YB  1 S0t0re t 
(612) 625-76  (22) 
PrAesidren t Elect: TNaaurer: 
Cle 
G. Dihelm. M.  UnirFs.   P8nnnla 
of 
PIat President:
 Silvrsein Palion 
Barr D, Kahan, M.D.. PhD. 34 Spr Stee 4th Floo 
Councllorsat.Large:  Philad6e6lph.2ia.0 P A 19104 
Hans W. Sollnger, M.D.. Ph.  (25) 
Ronald M. Ferguson, M.D., Ph. 
R. Randal Bollnger, M.o. Ph. 
Byers W. Shaw. Jr., M. 
612-625-7600 Telephone 
612-625-8496 Telefax
September 28. 1990
The Honorable Richard P. Kusserow
Inspector General
Department of Health and Human Services
HHS North Building 

330 Independence Avenue. S.
C. 20201 
Washington. D.
Dear Mr. Kusserow:
The American Society of Transplant Surgeons (ASTS). welcomes the
opportunit to comment on the Draft Document: wThe Distribution of Organs for 
Transplantation: Expectations and Practices . The Draft has been distributed to 
the Members of the ASTS Council. its 
body. The Draft 
eJected  governing 
Document wil also be the topic of  discussion  and for active measures at the 
Annual Fall  Meeting  of the Council (October. 1990). The  following  comments 
represent a consensus opinion of  he ASTS Council on the Draft  circulated: 
The 450 Members of the ASTS perform the 
majority  of solid organ transplants 
the United States. and the  Society-s mission  is the advancement of scientific 
knowledge for the benefit of  patients.  The  Society  has been active in  providing
information to Congress. and several of its Members served on the Organ
Transplanttion Task Force. Thus. on the one hand. 
several of the points made
in the Document have already been endorsed by the ASTS and its Members.
since they coincide with the major goals of the National Transplantation Act of
1984. namely that: " .
Kusserow  Page 2 
Each person have equal opportunit to transplantation subject to 
1 )(cid:1)
established" medical criteria. 
There be uniform policies and standards for organ distribution. 
National cooperative mechanisms be established. 
On the other hand, the ASTS decries the implication in the Draft Document that 
the two-fold longer average waiting time for black versus white renal transplant 
recipients is due to "subconscious prejudice" by transplant centers and 
transplant surgeons in particular. .The ASTS and its Ethics Committee regard
discriminatory practices as cause for expulsion of a Member. 
The Draft Document explores possible causes of the differences in racial 
proportion of patients listed as waiting for a transplant and the patients who 
actually receive a transplant. The findings that the disparities exist within all 
blood groups, as well as the subgroups with pre-formed antibodies to less than 
and greater than 75% of the population. indicates a need to examine 
demographic and non-demographic factors that could be responsible for 
imbalance in organ distribution. The ASTS believes that examination of other 
recognized components of ttle recipient selection process probably wil show 
the cause for the difference between the demography of the patients listed as 
waiting, versus the demography of the patients that actually receive transplants. 
We also contend that prejudice wil not be a factor. No conclusions should be 
drawn until investigations are completed. 
. We note that the Document compares patients on the waiting list only with those 
who are- "transplanted". Each Transplant Center or Organ Procurement 
Organization (OPO) has priority criteria approved by the Organ Procurement 
and Transplantation Netwo* (OPTNl for selecti  g recipients for a given organ. 
No comparison was made of the racial demographics .of the individuals who are 
first offered an organ and who accept the offer, versus those who'are first 
offered the transplant and exercise an individual decision to refuse the offer. 
There also was no information on the racial demographics of the "back-up 
patients who are offered an organ after there was either a primary refusal, or the 
patient initially Identified as the prospective recipient could not be given the 
organ, for reasons such as a positive crossmatch or detection of a medical 
contraindication at the time the offer was made. 
Social and economic factors that may prevent patients from accepting offered 
organs must be examined. It needs to be determined whether there arEf 
differences In the racial prevalence of the factors that lead potential recipients to 
reject the opportunity to receive a transplant.  Kusserow  Page 3 
If the priority distribution schemes approved by the OPTN are being followed, 
the differences in the demography of the patients initially offered a transplant 
and the demography of those who are waiting for the transplant would reflect a 
bias that Is not prejudicial In origin, but inherent in algorithms designed to be 
objective. Most algorithms for priority of organ distribution are at least partially 
based on HLA matching. Since most donors are white, whites are more- likely to
have better HLA matches than blacks with a given donor; thus, among potential
recipients the proportion of whites first offered a kidney' could be greater than 
the proportion of whites waiting because of the increased probabilty of having a 
good match". Conversely, the proportion of blacks offered a kidney could be 
less than the proportion of blacks waiting because of the lower likelihood of 
having a good match. However, no data was given in the Draft Document on 
the HLA type of the recipients, nor on the racial and HLA demographics of those 
first offered an organ. Such data is needed. Access in terms of being "offered" 
transplant as well as actual "distribution" need to be examined. 
Some patients listed as waiting for a kidney, upon receiving an offer, reassess 
wheth  r to accept the travel and other costs incumbent upon acquiring and 
maintaining a transplant. Individual differences in trust of the health care 
system, as well as differences in the perceived diffculty of complying with a 
medical regimen, may also influence the decision to accept the offered 
transplant. There may be dissimilarities in the percentage of blacks and whites 
who decide to accept an organ. Disparities in education and in perception of 
the transplant process could. lead to a higher rate of refusal of the proposed 
transplant for patients from certain socioeconomic groups, and the proportion of 
such patients could be higher in the black than in the white population. This 
hypothesis needs to be critically examined. When a perishable organ is being 
allocated, such factors as telephone access of the patient, or abilty to rapidly 
come to the Transplant Center, are not trivial considerations. 
Although the Draft implies that these factors may not be suffcient to explain the 
data, the ASTS recommends that the Offce of the Inspector General examine 
the OPTN documentation (Forms A and B) by Transplant Centers, in order to 
ascertain the proportions of blacks, whites and other races that are firs offered 
the initial patient Identified 
the kidneys procured. The frequencies by which 
does not receive the transplant should also be determined, as well as the 
reason (e.g., ilness disclosed at time of offer, positive crossmatch, refusal of the 
offer). The frequency by which patients of different races accept or refuse 
offered organs, have medical contraindications, or positive cross matches 
should be tabulated. Such documentation should be possible, since the 
information on Forms A and B includes a compilation of telephone calls by 
organ procurement personnel and the patients' responses to these calls.  Kusserow  , Page 4 
The ASTS also points out that existent legislation contains financial 
disincentives for patients to undergo transplantation, and the impact could be 
disincentives include: 
greater in the black than in the white population. The 
cessatiw 
Automatic  disabilty payments three years after successful 
1 )
transplantation payments for dialysis patients continue 
. In contrast, 
indefinitely without question and without need to file for special 
dispensation. The ASTS recommends that the Offce of the Inspector 
General divide the recipients, and the patients on waiting lists, accrding 
to a) whether or not they are receiving ongoing disabilty payments, and 
b) whether they reside in a state that provides long-term reimbursement 
for immunosuppressive drugs. The racial proportions in each of these
subgroups shOuld be determined. 
coverage for immunosuppressive 
Ealure o  icare to Drovi 
drugs after tWLrst postransplant year. Previous ASTS surveys have 
documented that most transplant patients have serious problems paying 
for medications. The ASTS has continuously urged Congress to 
authorize funds for reimbursement of patients for the costs of anti-
rejection therapy. 
Lack of  sms to reimburse for multiple miscellaneous expenses 
jncurred by transolantation . For example, expenses for travel back to the 
Transplant Center for rejection episodes, procedures or routine follow-up 
and 
visits are not reimbursable. Is there a difference between black 
veled, or the 
white recipients in regard to the distances that must be t 
abilty to pay for travel as well as other expenses, such as baby-siters, 
etc. 
The considerations listed above underscore the need to examine transplant 
bona fide  transplant candidates. It 
waiting lists to ensure that those listed are 
is presumed that patients listed are not only medically, but also financially and 
socially, able to meet the commitments inherent to the transplant process. 
Documentation that this is so is missing. When a patient.(or the dialysis 
physician) repetitively refuses offered organs, steps should be taken to rectify 
the situation leading to the refusals, and if this is not possible the patient should 
be removed from the list. Such a measure would remove imbalances in the first 
tier of the recipient selection process. The perceived inequites in organ 
per se  but 
distribution may not be from deficiency in the distribution process 
, or social, that need our attention. 
related to other factors, medical, financial
There are also several other issues which require further examination. The 
study notes that Regions I and VII (a total of 12 States, a fair number of which  Kusserow  Page 5 
have only small minority populations) do not show any significant waiting time 
differential between black and white recipients. 
Unfortunately, the study did not 
focus on OPOs from either region and does not offer any explanation for this 
lack of a waiting time differential. Furthermore, the report does not analyze
white male: female versus black male: female ratios as accunting for the.
higher average panel reactive antibody (PRA). 
The Document's findings may also be flawed by its use of only a few broad. 
heterogeneous PRA and age categories for comparison purposes. For 
example. the Document itself shows (at Table B-2), that some individuals with 
RA levels less than 75% (i.e. those with 0-24%) have much higher 
transplantation rates that other individuals with PRA values less than 75% 0. 
those with 25-49% and 50-74%). If blacks are disproportionately represented in 
the latter categories, the Document's comparisons of whites and blacks with a 
PRA less than 75% may be misleading. The Document does not permit the 
reader to determine whether this might provide a partial explanation of waiting 
time differences. However, the failure of the statistical proportional hazard 
model on this data set suggests the parameter is flawed. 
The Offce of the Inspector General proposes that the second tier of allocation 
be designed to ensure that t  e ratio of whites and blacks receiving transplants 
be the same as those waiting ,racial equity") by having single waiting lists for 
each OPO. The data in .theDraft Document was not analyzed to determine 
whether there are significant differences in waiting times for the blacks and 
whites registered at the 30 OPOs serving multiple Transplant Centers with 
Document. 
single lists, versus the 13 with multiple, transplant center-based lists. Certainly 
this already existent dat  would fulfil the requirement for the "demonstration 
effort" proposed. and such an analysis should be incorporated into the final
S8 wil not ensure racial 
It is also important to point out that single lists  per 
balance in organ distribution unless other factors believed to improve transplant 
outcome, such as HLA matching, are ignored. If HLA is to be used as part of the 
selection creria, balance in allocation wil be achieved only if the proportion of 
black donors (currently 8%) is increased to approach .that oUhe proportion of 
blacks waiting for kidneys (currently 31 %). The fin  version of the Inspector 
Generals Document should advise the Secretary of Health and Human 
Services to initiate programs to increase organ donation rates, particularly in 
donation rates nation-wide. 
blacks. The ASTS also plans to reintensify efforts to increase the organ
Programs for organ distribution should be designed to improve the long-term 
function of transplants in blacks, and not to simply increase the black: white  Kusserow  Page 6 
ratio of recipients over that presently achieved. Specifcally, allocation schemes 
that might decrease the success rate should be avoided. Virtually eveT) paper 
presented at the "Second International Samuel L Kountz Symposium on Renal 
Transplantatlon Proceedinos 21 :December, 
Disease and Blacks" (published in 
1989), document an inferior transplant success rate (up to 20% difference), 
, increased. mortality, and higher incidence of non-compliance in the black versus 
other racial groups. The general transplant literature is in accrdance wih the 
papers presented at the Symposium. It is essential that the Final Document of 
the Inspector Generals Report not ignore the biological and other factors that 
affect transplant outcome. A first-come, first-served organ distribution scheme 
could produce a result just the opposite of that intended. Furthermore, although 
perhaps secondary, economics should not be ignored. Medicare, and more 
specifically, the End Stage Rena1 Disease (ESRD) program, are an important 
component of the federal dollar expenditure. Congressman Stark has 
estimated that a successful transplant saves $19,000 per year. All schemes 
designed to ensure equity must include outcome in the equation. 
Most current organ allocation algorithms use a combination of matching and 
waiting time on the list. Any scheme that uses one criterion is just as likely to 
lead to inequities as one which uses multiple factors. Using waiting time alone 
as a sole criteria isnot without medical concern. For example, a patient on 
thana 
dialysis for several years probably has less chance of rehabiltation 
patient who has never been dialyzed, is entering renal failure, and has only 
been on the list for one month hoping for a preemptive transplant without 
should children who do not grow on. dialysis wait for as long 
dialysis. Similarly, 
asa stable adult dialysis patient? Data is available showing poor neurologic 
development as well as poor growth for children on dialysis. Finally, there is the 
difficult situation of a "sensitized" patient who may have receiyed multiple prior 
transplants and is at increased risk to lose a subsequent graft. There is an 
equity issue about how many transplants should be given to a single patient 
when there is such a limited pool of donors. While abandoning allocations 
based upon HLA tissue matching would improve the access of black patients to 
organs, a simple mandate to distribute organs based upon time on the waiting 
list is not equitable to all patients. 
Concerns can also be raised about distribution schemes that would result in 
shipping" of organs across the United States. Donor and recpient 
. excessive "
pools are large enough such that allocation of organs within a single OPO 
should be equitable. Shipping adds to the costs and may reduce organ 
viabilty, impairing short-term function and long-term transplant success. Initial 
transplant nonfunction prolongs hospital stay, thus compromising abilty to 
hospitals to meet financial restrictions of the stipulated payment plan through 
diagnosis-related groups. The Draft Document brings up the topic of ownership 
in a way that implies the procurement and transplant processes can be  Kusserow 
Page 7 
divorced. It is diffcult to see how 
this can be achieved. or how It would be 
helpful. In the opinion of the ASTS it would be better for the Final Document to 
focus on such issues as the impact of prolonged 
Ischemia and transplant
dysfunction on the overall success rates of transplantation. 
The Document emphasizes the importance of 
evaluating OPO performance
relating to organ procurement activities. The ASTS supports 
this
recommendation. In particular, if OPOs could achieve higher levels of organ
retrieval from minority donors. this would improve the chances of 
obtaining
better matched organs for minority transplant 
candidates. The ASTS believes
there isa need to 
improve local OPO activities. and proposes that 
review/recertification procedures be strengthened through the following 
measures: 
1 ) , Individual OPOs should establish medical criteria for listing patients. as 
well as review/punishment procedures for violations. 
Each OPO should follow guidelines for distribution of organs based 
upon racial. matching;time on the list. as well as 
exceptional medical
situations (pediatric. preemptive recipients). The guidelines should be 
designed so that variances between OPOs are allowed. so as not to stifle 
innovation while maintaining fair:ness. 
Quality parameters. in terms of low rates of acute graft dysfunction and/or
primary non-function . should be set for each OPO to achieve. 
The Department of Health and Human Services should not only establish 
performance goals (number of transplantable kidneys retrieved) for 
local OPOs. but also use them as a basis (together with the above items). 
fora formal biannual review of OPO activities. Organizations that fail to 
meet performance or distribution goals should have well-defined. short 
timeframe plans to correct deficiencies. Procedures must be established 
to create new OPO structures in regions demonstrating poor OPO 
function.  ..  ; ,
Kusserow  Page 8 
Concludlno Statement
The ASTS is committed, professionally and ethically, to effcient and equitble
use of the national resource of cadaveric donor organs.  Indeed, the Society' 
Ethics Committee is prepared to investigate dereliction in this area. However, 
we are concerned that the Draft Doment did not include other readily 
available data that could have shown the causes of the apparent racial 
imbalance in org  n distribution. The ASTS recommends that such data be 
added to the Document and be thoroughly analyzed before .concluslons are 
drawn and before re  ommendations on organ allocation are formulated. The 
ASTS also recommends that the Document address the need to alleviate 
systemic defects in the Medicare and National Transplantation Acts that 
discourage some patients from accpting transplants for economic reasons, 
inadvertently resulting in inequitable distribution of organs. The ASTS has and 
continues to lobby Congress to make changes in both of the Acts that we feel 
wil encourage patients from the lower economic strata to undergo 
transplantation. In addition, the ASTS is willng to: a) Define medical Indices of 
patient suitabilty for being placed on transplant waiting lists;.b) Develop an 
allocation scheme that addresses all (racial included) factors that affect organ 
distribution; and c) Delineate standards to assess OPO activity and 
performance.
Finally, the ASTS is willng to work with the Office of the Inspector General in 
both the collection and analysis of the transplant data relative. to organ 
allocation and outcome. 
Again, the ASTS appreciates the opportunity to comment on the Draft 
Document.
Sincerely yours, 
David E.R. Sutherland, M.D. -
President, ASTS  - -
OIG Response To ASTS  Comments
The ASTS makes a number of goo points concerning the factors that might contrbute to 
black -white discrepancy in waiting time. Our revised text reflects most of these points. In fact, 
on the matter of HLA matching and its possible contrbution to the discrepancy, our text now 
includes a direct quotation from the ASTS response. 
On page 4 of its response, ASTS raises an extremely important consideration about the 
suitabilty of some candidates on transplant waiting lists. As we noted in response to ASPE' 
comments, we concur that this is an issue warnting further inquir. 
Finally, the ASTS raises important issues concerning the inclusion of expected graft survival 
time as a factor in allocating organs. Allocation approaches, such as first -come first selVed, that 
might decrease the success rate should be avoided, it says. 
We recognize that factor and accommodate it in our recommendation. The "medical criteria 
OPT 
exclusion provides an opportunity for the  and OPOs to addrss the factor. In this regard, 
ASHI's suggestion (page 5 of its response) for a thshold level of matching within a region 
wart 
would seem to  careful consideration. 
At the same time, we must all recognize that there is a point where reliance on HLA matching in 
allocating organs could necessitate policy guidance that goes beyond medical considerations 
however much matching may extend the grt survival time for the transplant recipients. If such 
reliance increases and is not accompanied by increasing rates of donations among blacks, the 
racial disparties noted in this report could increase significantly. Whether an increasing 
disparty of this kind could or should be accepted would appear to be a societal consideration, 
from governmental policymakers. 
callng for guidance 
D - 38  - .
. ..
.LI.  u\. 
-1 ..  L)' U  .L.&  .LO .I.&a.L .L  J' D.&'-.Au.A\: 
President:  AMERICA  SecretaryTreasurer: 
M. Roy Arst, M.
 Thomas A. Gonwa M. 
University of Cincinnati Medica Center
 SOCIEl OF  . TBaryal pUln  ers Medica Center
11585 -
 lRANSPlA  Servces 
Division of Nephrology 
231 Bethesda Avenue - 5363 MSB
 3500 Gan Avenue 
Cincinnati, Ohio 45267-0585
 PHYSICIANS Dallas, Texas 75246 
(513) 558.5471, F  (513) 55.3878 (214) 821-3939, F  21-'
Councllcnt- (214) 
President Elect:  Large: 
Ronald H. Kerman, Ph. PhU HaDan, M.D. r91) 
Past President: .  Edgar Miord, M. D. r93) 
Willam E. Braun, M.  . Terr B. Stm, M.D. r92) 
September 27, 1990 
Richard P. Kusserow 
Inspector General
Deparent of Health & Human Serces 
Washington, DC 20201 
Dear Sir:  IfEr-t/ -J"-IJ()5.s 
I would lie to than you for sendig me the draf report et\titled "Te Diswtn"ib ution ot 
Organ for Tranlatation: Exectations and Practices" for my review. I  th 
compliment you and your staf for the thoroughness of ths report, and to  you for 
(AS). 
asking for input from the Amercan Society of Tranplant Physician 
The ASTP is in complete agreement with the exectations outled in your report regardig 
the development of organ ditrbution practices. that are equtable, to thosea iln  need." There 
are a number of area in your report which 1 wish to address, and I would  like to 
respond to your recommendations to the ASTP, and to inorm you of the reprt which the 
AS ha 
Patient Care and Education Committee of the  recently completed. In May of 1988, 
AS 
the Executive Counci of the  asked the Patient Care and Education Commttee to
exaIe  Th 
the issue of racial inequalty in transplantation.  Commttee is chaied by
Ma 
Betr L 
Other membes of the Commttee are.  Kasiske, 
G. Whte, M.D. of Dalas. 
D. (Meapolis), John F. Neylan, M.D. (Atlanta), Robert R Riggio, M.D. (New York), 
Gabriel M. Danovitch, M.D. (Ls Angeles), and Lawrence Kahana, M.D. (Tampa). Thei 39 
page report, titled "The Efect of Race on Access and Outcome in Tranplantanon , was 
th  Jour  Medcie 
completed in July of  year and submitted to the New England  of 
NE 
(NJM  The intial review from the  was highly 
for consideration for publication. 
favorable and the reviewers have suggested certai changes in the manuscrpt. A revied 
NE 
paper has now bee reubmitted' to the NEJM fThie  editorial policy of the  prevents 
me from submittg thei report to you unti a  deciion has bee made regadig 
editorial deciion has been made by the NE, I shal forward 
publication. As soon as an 
the entie manuscrpt. Essentialy, the findigs of the Patient Cae and Education 
Committee are in agreement with your report. 
716 Lee Street  Des Plaines, IL 60016  (708) 824-5700  FAX (708) 824-0394  fidig 
AS  the  of the Patient Cae and 
The  Executive Commtte is in agreeent with  ths 
matchg on tranlant outcome. For 
Education Commttee on the potetial benefts of  orga 
to those 
reaon we do not agree with the recommendation to "Tdihtr bute donated  unortate 
sered  might wel have an 
patients on a fit come fit  basis" (page 18). 
and untended negative impact on alograft surval in black recpients. 
th 
problem  organ dibution is orga donation. As 
Overal, it would appear that a bigger 
tranplant numbe are levelg off, or even 
your report points out, cadaver kidney 
decreaing slightly, whie the number of patients waitig on .trlant lits contiues to 
dision 
litte  of ditrbution. The 
grow. If there wa no organ shortage, there would be  th 
of  scace commodity 
fist priority of al of us concerned about the equtable distrbution 
Ths could have a major impact in correctg the 
should be to increase organ donation. 
unequ acces of black patients to donated organ, even using the cuent crtera for 
trbuti  shows, blac: make up 30.8% of those waitig for a fist kidney 
. As your report 
tranplant, and only226% of those tranplanted. However, "in 1988 only about 8% of 
frm a black donor" (page 11). A 
cadaver kidney transplants involved the use of a kidney 
proO:ement 
disconcerg asec of the report is the fact that "of an estiated 300 organ 
cordiators workig in the 72 organ procuement organations,E oSnly  about 14 are black" 
ou 
(page 11). Some year ago we hied a black social worker in  prograpmr oRegart,e d 
donor trlantatioan,f w hich had previously bee neglgible in black in our  orga  rose 
substatialy son  he tok on the position. I strongly beeve tht cadaver 
donation in black would increae signcatly if black fames wee approached by black 
tr coorditors. Therefore, I.would lie to suggest tht the OPO be strongly 
orga procuement  Th 
tranplant coordiators.  efort could be coordiated 
encouraged to  and hie black 
though NATCO and AOPO.
trt  I would apprecate hearg your 
that my remarks have been of some value to you. 
fina report 
interested in a copy of the 
thoughts about ths letter and would be very 
Hopefuy, in the relatively near future we shal be lookig at a fa higher rate of organ 
patients awaitig tranplants 
donation with equitable organ distrbution for al concered; 
affeced.-by what we do! 
do not have forever and ultimately they are the ones most 
Sincerely yours,
M. Roy First, M.
Professor of Interal Medicie
Physician
President, Amercan Society of Transplant 
MRF:mcm  Comments To ASTP Comments
GIG 
arcle mentioned in the ASTP response was published in 
The New England Journal of Medicine 
the Januar 31 , 1991 issue under the title "The Effect of Race on Access and Outcome in 
Tmnsplantation." It is an informative piece that as ASTP notes is largely in accord with our
findings. However, in our view, it does not incorporate the information presented in our report
about the relative lack of influence of bloo type on the black-white discrepancy.
We welcomed Dr. First s comments concerning his own experience and views on the hiring of
, in the section
black transplant coordinatqrs and have incorporated his comments into our text
addressing black-white disparties.
Our response to the matters concerning the first come first selVed rule and the significance of 
organ donation has already been made-both in the comments section of the text and in prior 
responses. 
D - ..-.-....-... .....--...... --........--: 
Clll'
AMERiCAN  HISTOCOMPATILITY
AN IMOGENETICS
FOR 
O. Box 15804, Lenc KS 6615  913/  PAX 913/541-0156 
September 19, 1990 
00 
lNIM.a aE1o 0c7arP ID.
(310) 
AI 
Richard P. Kusscrow A. Z8hl. PhD.
Office of the Inector General 'V(2I1I 8) E c I'.
Deparent of Health and Human Services Davi) 1O3. 
ICMY
Room 5250 IZ 
NMA8 PhD.
Cohen Building
(812) 
330 Independence Avenue S.
E., mL "a'lni M..
Washington, D.C. 20201 I(l11T7)  I  PREI
PUT 
Tef8 
P'" L  PID,
781
(213) 
Dear Sir:
Tralantaton: 
We have reviewed the  The Distrbution of Organ for 
draf report "
Expectations and Practices report) and apreciate 
" t(hre ferrd to hereafer as the 
opportnity to comment on  important docuent. Organ tranldanetadtison , 
many aras of medicine, is undergoing a rapid evolution which  the 
intcrdction of exrts in multiple disciplines, reflectig dierentapl9acheS to 
achieving a common goal. Unle aany otherr fie:ld o f medcine, orga trlantation 
encumbered with an insuffcient supply of the therautic agent, donor organ 
Before commenting on the content of the 010 reQrt. we believe it is imrtant an 
. appropriate to note the achievements of the OPT in its four year exence. Th 
most notable of these achievements 
-establishent of policies and crtera governg professional crdentials 
medical practices; 
-establishmnt of geogrphic regions as a basis for intercton among
tranlant progrs;
unonn, 
-achievemnt of a  high level of qualty, nationay, in 
ar 
histocompatibilty testing (we  pleased to note that th was. achieved 
through a contractual agrement for ASH! to perfonn laboratory evaluation for 
OPT; 
the 
.establishmnt of an objective system for ditrbution of organ which assign 
HL 
points for waiting tie, presensitiation and  match. 
Despite these achievements, several problems persist and have been identified in the 
report. While we agree with the overa fmdings of the report, we comment on 
additional or alternative explanations for and solutions to certai problems. . 
Acc
Eqable 
If equity in acces is defmed as distrbution of organ to each 
group of patients
accordig to the proporton of the waiting lit they represent, it is clear that
equitable access docs not exit for several groups examined: Blac, women 
patients of blood tys 0 and B, sensitized patients, and  years old (as
chidren 
noted in Appendi B of the report). We question the use of median waitig  evauale acss of Blacks to tranlantation. Wenote 
time as the only stattic to  exames th raon of medan 
lead to a curous anomaly. If one 
that ths statitic  Figu 
for Black vs. Whte (as preented in  2, on page 9 of the 
waitig ties  tys 
al bloo  combined than for any single blood 
report) the ratio is greater for 
ty 
as follows: 
tie 
Ratio of media waitig 
Bloo Typ  Blacks vs. Whtes 
1.71 
1.60 
1.57 
al bloo tys  1.83 
"T 
is diCult to interpret. 
waig 
In addition  time doc not take into account severa facors. 
1. Organ frm a donor who is (HL) phenotyicay identical to a recipien 
tenn of extended 
must be offere to tbhaet r ecipient. The medical benefit,t ihn  
graf suval, has  accted widely enough that  is a madatory 
OP1. It is not suriing that when 92% of th donor pol is 
policy of the 
alo Whte and that 
Whte, the majority of patentS with  ty, 
such matches 
matches involve the most , common HL. these , patients 
, since these 
would' be trlanted more raidly than others on thtei weai tig li, on the 
average. Therfore, any analysis of medan waitig  should exclude 
the phenotyicaly iden ca malches. 
2. &  waig tie is proportona to the siz of th 
staed in the reort, 
An evaluaton of waitig tie should investigate the 
waitig lit. 
accordig to lit siz. "It is possible th a majority of 
Bdlitarcbkust iaorn' loift cB lwaciktsh  progr at large, uran medical cente with lare 
waitig lits. 
Patients who 
not inestigated the effect of multile litig. 
3. The rert has  progr 
multiple  have access to a lager donor pool 
ar lited with  progr.  who 
smgle  Multiply lited patents ar those 
those lited with a 
ar awar roef othu ardv antage provided by multiple liting and wbo have the 
fiancia  to severa intitutions. Patient
which pcnnt trvel 
rereentaves to the OP1t asgu rtht  multile litig, quite possiabnlyy sis 
bomef cmausuee dthl wyt iaaiprti gcal tpyiaebl  es lohfoi utlde exdam eap dtvhaean ptargtoepe.o Nrtononne tothfes lBesl.sa,  acn  among
tie 
4. Waitig  is afected by the avaiabilty of the patent at the tie of 
othr reasons ar not 
donor rccoveIY. Patents who for medical or  stat 
imedely avaiable" for r terssgplia.tn taation thasve th.eir   lited as 
inactve" in the compter  It should be detenned whether there 
is a dierence between Black and Whtes in the lengt of tie which 
patients have "inactve
(2)  .-- 
teon 
th  c --
, l'e-AsIs U '&1; VUt.h&"e".  p1o&8l&p""r,U ..o.n.  "w'a"i'ti'g' 'f'or' '''--0- ----- ---lantaon. We have noted in 
the Intitute of Medicin th.th dianty ca be acounted for, in lar par by 
th  preomtly  daa) Whte, 
tchoen sfiasct s of 3t9he% d bolnooord p ol.,  wAh itcdyho nios  rs and 45% blo(9o3 9t&y,  1098 8d UonNoOrsSa w nh e4 9t%h  
frequency of A and 0 brood  among Black patients ar 27%c a 
respectively. Furerore, setnusit iion to Lewis IDtigens, which  lead to a 
prohibits t(tlMant aon, is alost lited to 
positive crossmatch which, in  tie  prrton  trlants 
waitig  and  of 
Blacksd. Tihhuse, dwh ie both medan  caus 
roefv tehael  dihed aacccceessss .o Wf Bel aacdkds,r Ms tWhe  idssouees  onfo tH pLro vmidea ticnihggh tl ianttro.  tHheo weer, 
we note here that: 

fit ha  tie 
1. durg the  oran were

of the  period covered in the reort,  waig
point system which gave the highest value ntom   
ditrbuted using a  patnt ar 
tUe and  oc most
tht even under the prsent point system, 

often by waitig tie, excet when extrmely goo maches 
th 
2. data being preard for publicaton by one of our members showr eiviing t he 
experience of one lage intitution, the perctae of Blacw  ag tie 
tranlants did noct cuhatn ge when kidneyswcr ditruted by  eld, 
versus under the  UNOS point system whicb gives.more weight to 
HL match; more imrtantrleyi vwihnegn  t6r laantnigetns  maches wsearem   as 
the percntage of Blacks  \18S the 
Black on the waitig list. 
percentage of  ac 
raes  caue of inuity in 
The report  the pOssiblity of social bias as the  exae th deogrhics 
exame th question is to  li 
Black. A more dict way to 
eac donor, a  is gerate in 
of'patients passed over for trlantation. For 
which patients ar raned in descendig numerica order aCCordig to poin 
HL mach Patient with a posite 
arsseignged  for waitig tie, senitiation antdh  lit  offer to the 
crossmatch ar routiely elimated from  and organ ar to be 
. Whe 
patients accordig to reasons which 
opprtty for abus, we haavr epr inaroy  dat or anecdota inormon
system prvides an 
which suggests that racia bia afects organ ditrbution.

prcing racia 
the major facors 
With repect to recommendatons, we submit tht 
diarty in access are known: dierences in dibution of ABOand Lewis blood 
arpeady
contnDutig factors have been noted abve an ca be 
tys. Oter  tht
investigated frm exitig da. Based on th inormon, it seems 
incring  donon 
fudig  dicted priary towar  organ 
effort and  should be  HL anens unque 
among Blacks and seconday toward imrovig defition of 
Black. 
or nearly unque to 
Sys
ASioe NatOD 
Although the OPT has adopted a point system for ditrbution of kieys, we 
varces 
believe that it bas been a IDtake to pennt the many  requsted by 
fuer surt 
indiVidual program. We  the concept of a.singleregionalit which 
increases the lieliood of goo HLA matches and of fidig donors coatDle 
with highy' sensitizd patients. Regardig concern abut cost otif etr lantaon 
and increased ischemia tie, we note that trportation is a one  gr.c ost whie the
benefits derived from matchig extend thrughout the lie of the  Since 
tie 
surival  reflects the qualty of match it may be reasonable to establi a

(3) cer  gr 
matchig thshold which predict a  level of  surival. Regional
sharg should be madated for al situons in which othbe tmaagtc h exceeds that
thshold. Incrases in ischemia tis ar avoidale by  and testig donor 
specimens prior to recovel) of organ. ' We shar the dimay of those who believe 
that organ sharg should be practd for the benefit of the patients and should not 
requir a payback system. It is t1 th such a system reflects a sense of ownershi 
ttlant  1b 
on the pan of the  team or OPO.  is evident fromm thee faac t that
although there was unvers ackowlterclgaeenn', ofth benefit, as  by 
surival, of phenotyicay identica  trlatsit  was not possieblse ttoa elsitgl ih a 
policy of mandaOI) sharg for thesteh    witout alo  the 
wshpe   may be no madae to  preferece 
payback system. We note tht  acrd 
to the highy sensitid patient, tt1a.  imlemented 
procls and prctces must be 
in order for these patients to be  wai  To do oathprwciisael weo cuolds tb teo  ttoh  cpounbdliecm.   
these patients to spndig yea on  lits at an 
Finaly, we ar concerned wit th OIO's perction of the role of the OPO.
shap 
Specifcaly, we note the statement foun on pate il tht the OPO should "
tahned  OovePrTse et hdei torbrugtaionni oJn'li crieens.s iWbaele di nfctomre rde etv tehleo piinntgen td iobf uCtoiongnr sp otloic ibese,  .t ow mhiaee  
assur 
the OPO is responsible for  to those policies.
sha 
It is important to recogn that th ungness of may centers to  organs 
resuts from many factors, SOIJ of which ar dicused in the next section. 
be 
However, one facor has  the lack of fai play on the pan of a few center in 
which sharg is interpted as "receivig. ony. 
agr 
We strngly  with the rert s obsrvation tht a lare, and peIhap 
inappropriate, level of control lies with th trlant sueons.t rInl aadndit ion to the 
proportion of the OPT board of dictOI which they ocy,  sugeons 
domiate the medical boards of most OPO's; as UNOS regional counciors, 
surgeons have the oprttcyo mto omftn;,  aUnD  atdyi,o dreste nne region policies and
UNOS  as  of trlant progr,
reresentaton on oprtty to determ th choices for the single vote aforded 
sugeons have the  Th 
tottlant ceter for UNOS elctons andm by-elaawsn/ptli cies appr a1.  level 
wi  succs" accordg to 
of authority and/or inuence combind  of "
trlant  may, ha reulted in strng 
the number of  performed a miconceptdioen omf  on th  shag 
clreaeryc    organ 
oposition to organ shag. SBOPF ha  seitid 
chce for  patents to 
the single most effectve way to prvide a  HL tys, 
th extenive diersit of  organ 
be  because of 
trlanted. Funer,  degr of HL matchig. Since the 
sharg is the only way to imroe' th 
overwhebng majority of pheotyicay identical ttla occu at centrs 
other than tht at which the donor was reovered, it is clear th, in the abence of 
madaol) sharg  trlants which have far and 'away the longest 
tahvee rae gr surval apmomolincgay ,i ctthaaevisge  rtcn ed ocnooro trartloan nin, o rwgoanu lsd hnoatg ha tvhea ot OccPuTd . 
It is in establihig and 
has its most serious shortcomis. 
(4) yptir 
. m. 
We note that twice in th rert, HL machg is cited as a possible, signca 
facor conuibutig to die.nces in access betwee Blac and Whes. Fuer, the 
th cunt COtrvery regarg  HL matg. 
report alo notes  the beefiHt Lof  
We believe it is of utmos imrgtarnc e to clar th issume.  aatmdat cphgr is the 
afecg 
single major facutonr    success that can be 
tranlantaton,  imunosuresion, has no major advere afec, and alo 
tie 
wie imunosupsion, involves a one  cost. The beefits of 
matchig ar well docente Anysis of the UNOS da basT, rthael aUnC L 
Tralant Regitr Dat base and the Inteatonal gCrol labrave  StUdy 
suival as th degr of
data base al cleary show a stepwise incrment in  ra cmt 
HL matchg  although HL. match is one of the 
alocaton crteriim raotv aens .o pHeotwieovnearl,  level, patients ar effectely  alost 
suprsdi 
exclusively by waiting tie, with only very well matched patenttsh   that. 
The few hundrd HL phenotyicay identical tr  lants  have ben 
certy caot accoun for the diarty in waitig tis betWn 
perfonned  trlant 
Black and Caucasian. Neveieless, an important goal of the 
communty should be to extend the benefi of HL machg to morew inid riveiduuail . 
, Th wil requ  for Blac patents 
regionation and spcifcay, 
fuer  HL 
elucidaton of those  antigens found predomiately in: the Black 
importt t  encourge mcreed organ donation from 
populaton. It wil alo be 
the Black communty. 
cunt 
Many of our members beeve that the  contrvers is not realy about the 
benefits of HL' macshyg b ut raer abut sharg. As note earer, becase of the 
diversity of the HL  it is necessar to shar organ, at least at the regiona 
level, to achive any appciable numbe of goo HL maches. It, is evidet that 
there is.a strng reluctainncce,r odn  the par of many surgeons, to "shar orgainn. cAise wnet  
thoa .vwe naortte  tahbev ceo,s tt hinev olved (trbrteaetfoitn o..f  seotmce. )l.e sAss errhe magsao,tnc ahwbeslie tm hcao ym bep  ro is to 
establish a thhold leve of mach and to madate  wai rte gion, for 
organ for which a match better than the thshold level is found. the region 
shg ha 
Th concet of regiona  severa important benefits. FJIt, it provide the. 
opprtty of multile litig to aU patent. Second, for some patents to have a 
realistic oportty for trlantaon, they must have an incrased access. That 
is, they must have a larger donor pol avaiable. Th is parcuarly tre of th 
sensiti patient. Regional shag, when combined with the use of regiona 
provide the bet oprtty for trlantation of the sensitd 
crossmatch trys, 
patient. 
Pat 
010U: 
th 
It is of concem  the issue of patient choice is not addrsed in any legilation nor 
in' any policies of the OP'.  Imlicit in the right choice, is th' rementa fbort  
patient educaton. Under the prent  atents do notu htaiv$e  a choice 
system, 
s analysis of eqwty in access  waiting 
donor selecton. The rert'
which implies a diadvantae associated with waitig tie. However, soDi patents 
who ar awar of the beefits of HLA matchig and of their lielioo of fidig a 
not. Th 
well-matched donor, may elect to wait for such a donor. Oters may 
trlant  ar unown It 
factors which detenne selecton of a  center  is not 
unasonable to exct that at least some sensitized patients would choose to be 
(5)  trated at a center which panicipatesin regional sharg,i they weIe awar of the 
incIeascd lieliood of trlantation. 
fid 
In sumar, we  that:
.we agre with the conlusions of the Ieport that 
dihed 
- some groups of patents have  oponuty for trsplantaon 
progr of  sharg 
- a  mandaed Iegional  should be inestigated 
- goverance of the trlantation 
network should involve grater

parcipation by those in non-surgical aras
-the basis for the reuced access of Black has not been adquately. 
med 
investigated; because  waitig tie can be afected by so may 
varles, we recommend altemative aproaches, 
spcifcay propIton
trlants
, -since ABO diarty clearly reresents a major barer to 
trlantaton of 
Blac 
Blacks, effons should be diected at increasing organ donaon by 
sharg  HL 
-regional  should be mandated for certai  matches which extend
beyond the present level of mandatory sharg.
Nancy E. Goeken, Ph.
President, ASm
(6) , "
OIG Response To ASHI  Comments
The ASHI response is a thoughtful review of many imponant issues bearng on organ allocation. 
We have reflected some of their comments in our revised text concerning the, black-white 
disparties and have addrssed many of the points' in prior responses. We have also referenced 
some of their comments in some of our previous responses. 
notes 
One point that we have not addrssed is the one that ASH! raises concerning figure 2. It 
that in that ftgure, which provides the median waiting time for blacks and whites on the basis of 
the ratio is greater for all bloo types combined than for any single blood type." It 
blood type 
then notes that this result is difficult to interpret.
The explanation is that our data address the median waiting time, not the average waiting time.
In converting that data to ratios, as ASH! has done, it is tang a parametrc model (averages)
and applying it to a nonparametrc statistic (medians).
An additional clarfication concerns the role of the OPO. In urging that the OPOs "shape and 
oversee distrbution policies in their service areas," we do not intend to imply that they do that
independent of OPTN and HHS policies, rules, and guidelines. What we urge is that they, rather
than individual trnsplant centers be the primar, authoritative vehicles for allocating organs in
accord with those policies, rules, and guidelines. " .". . ':.
It) 
November 7 , 1990 
Association 
The Honorable Richard P. Kusserow
Inspector General
Departent of  Services
Health and Human 
of Organ  HHS Nort Building  RECEIVED
330 Independence Avenue, S. 
C.  REGION 1- OIG/OEI 
Washington, D.  20201 
INOV.L  . 1990 
Procurement  Dear Mr. Kusserow, 
the 
On behalf of  Executive Committee of the 
Association of Organ Procurement Organizations
(AOPO), I am pleased to be able to respond to the
Organizations  Draft Dpcument: 
"The Distributiaonn dof  Organs for
Transplantation: Expectations  Practices.
This 
response represents the consensus of the 
s Executive Committee. 
:.h ,' ""rl.1n. :.I.D.  AOPO 
""n l id,.IrJ,,'n  The AOPO, represents - .:ixty-two of the sixty-nine
\1.1n' ,\nn,' II..u,"  rienco gtnhieze du nOirtgeadn  SPrtoactueresm,e bnto tOhrg ainndizeapteinodnse n(tO PO)
and
l",,,.. :\".\1  hoovseprit anli bnaesetyd,  who are coll,e ctthiveel ys oinlviodlv ed in
percent of 
year.  organ
IIri.n 1\"'l.nl(1.  procurements that occur each  The AOPO' s 
R"-:.I .I :M 0  \\.  ,0., L0:'m. -:." :,  paunrdp orseec eipst itvoe neexspsa ntdo  thoer gpaunbl dico'n ataiwoanre.n Weses  aorfe, 
committed to promulgating tahen d istribution of
transplantable organs in  equitable 
and 
expeditious manner as determined by the designated
Organ  Transplantation 
Procurement and  Network. 
Lastly, its purpose is to study and evaluate the
organizational, administrative and educational 
methodologies which will lead to tbe att inment of 
the above purposes. 
all 
First, let me say that AOPO does not - at 
basic 
disagree with the  findings of the draft 
document your office has produced. ' We do ' agree
that there is a significant disparity between the 
percentage of Black Americans on the transplant
wai ting lists and the percentage transplanted each
year. 
Secondly, it certainly appears that a Black 
American waits significantly longer than a White 
Administrative Office 
1714 Hayes Street 
Nashvilie, TN 37203 
(615) 321-3756 
(0) 5) 329-2513 (Fax)  Mr. Kusserow 
November 7, 1990

- page Two 
American for a kidney transplant. And, AOPO would 
concur that these disparities do not seem to be 
aither recipient age or blood type. 
related to 
far 
Nonetheless, AOPO feels that this report is 
too limited to -
identify the causes of these very 
real disparities. 
It would seem to us that there are three broad 
adreeatsa tihla. t should be studied in much greater
First, are there 
medical-scientific 
biasgs - eithgr justified or unjustified - that 
account for these disparities? secondly, what
part do socia-economic and cuI tural factors play 
- distribution of transplantable
in the equi table
norogta ns? Thirdltyh, eA OPO would question iwnhe tchuerrr eonrt 
some of  seeming inequi ty 
arise 
practice might  from local organizational
strcture 
rather than from the system as a whole? 
Procuement organizations differ 
Certainly Organ 
just as regions differ. 
out, 
AOPO wouldi tpso int  however, that neither the 
distribution policy. 
AOPO nor  moeumbte.r s make 
determined by the 
They carry it  Policy is 
othrgean l oPrcoaculr ement Transplanstc iNeetnwtoirfki c( OPT) and
oversight
medical and 
committees. 
And, in the final analysis, whether
or not a 
given patient is transplantable with a 
that 
given donor organ is initially decided by 
in  s physician andt/hoer  spuargteioenn atn.d  Tevheen tually
patient  conj unction with  common 
algorith is 
thread throughout the  tthhee  tdroannsoprl ant 
physician or surgeon - both at  and 
recipient selection and  the 
evaluation, and at 
transplantation event. 
its 
and 
AOPO  member Organ Procurement 
Organizations are ready to assist your Qffice in
the design and/or  any studies 
performance of 
deemed appropriatei. nWh ent hreoo t pauses for the
racial disparity  distribution 
transplantable organs are determined, the AOPO and 
its members will be happy to assist in the design 
solutions. 
and implementation of appropriate  Mr. Kusserow 
November 7, 1990 
?age Three 
The AOPO thanks you for the opportunity to' comment 
happy to
on the draft report and wouldf ubret emro st 
information 
provide your office with any 
Our 
you require.  ongoing dedication is to the 
donor and recipient public and we stand ready to 
served. 
help you assure that they are equitably 
Thank you. 
Il1y
Mike P. K plan, M.
Preside 
Associa on of 
Organ 
Procurement Organizations 
MPK/krk To AOPO  Comments 
OIG  Response 
We agre that the report does not identify the causes of the black-white disparty. We have 
contrbute to that disparty (such as bloo type) have little or 
shown that some factors thought to 
no effect. Beyond that we have simply identified a number of possibly contrbuting causes and 
called for more research to examine such causes. Some such researh, such as the Rand study 
mentioned by HCFA, is already underway. 
We regret that AOPO was not more supportive of our observation that the OPOs rather than 
individual transplant centers should be regarded as the engies of the organ distrbution system. 
We recognize, as we noted in our response to ASH!, that allocation policies must be made in 
context, OPOs still have a very 
accord with OPTN (and HHS) policies. Yet, within that 
important role to play in developing and overseeing the particular approaches in their service 
trsplant centers have already been quite active and successful 
areas. Indeed, many OPOs and 
in obtaining varances from OPTN policies. 
D - 52 ~~~~~~~~
.,  :.. "'-.........-.......
October 
1, 1990

R I chard Kusserow 
NATCO  I nspector Genera I 
of the 
North  Of f I ce  CInsp.e ctor Gener: 
American  Department of Hea I th and Human Serv Ices 
Transplant  Washington, D.  20201 
Coordinators 
OrganizatCion  8REn:  I Gl Dr .aft' Repor t OE I -01-89-00550 
Dear Mr.  Kusserow: 
f'ld 
l\a 
A. EloCk 
consideration Is the response of the North

Enclosed for  your 
TPM ITl'i-p:IW11 'nglHnBuiin American Transplant Coordinators .organization (NATCO) to the

Ro2' 20 draft report titled, "The Distribution of Organs for
,:;es'  antat Ion: 
Transp I  Expectat Ions and Pract Ices"

....Id.Elect
JoS
Linda L. 
Lo.1o 01 0N Organ NATCO Is the pro esslonal society representing organ 
Proc.-II (LOO)  trf3nsplant coordinators. 
700 Acrmn 4A3o2.  Su 58  procureMent and clinical  . Our 
Cous. OH  membership totaling 1200 Is composed of practitioners from
over 300 transp I ant centers and organ procurement agenc I es 
TN.ty.. .S..  0D8.o.  Sennl.  the Un I ted  organ I zat Ion has pos I t I ve I y I r" 
States.  Our 
N1714a H.ir e. SItHI I nf I uenced the spec I a I ty of organ procurement and 
TN 3720 
T...... transplantation by assuring Quality care for organ donors and 
Ao C. SSoml.h o kC. aom  their families as well as recipients of organ transplants.

ROPA 01 
8SO V.Wan Ave, Ro 123 
LoAnIe. CA 804 We have developed and promoted the recognition of standards

Co 
of practice, provided professional and public education,

at 
Li Tuln  ertlflcatlon (by the American Board of Transplant

C8bfom T,anSl81 Do NeIW  encouraged  practitioners 
170 Caor Sl'Hl Su.. 36  In this specialty and

Coordinators)  for 
SCan FotI l. CA 84109 part I c I pated In ongo I ng research to advance Immunosuppress I ve

bill ty 
therap I es and hi stocompat I  techn I Ques.
T"'A SnIl'
Hilt"P Mteythl.Sn! iF or Woh ve 
I1301r    AVtnu Our proact I  I nvo I vement In Federa I and State government ha

fo Wo. TX 76104
'ut enab I ed us to work with profess I ona I sta f f and elected

LLoo M . Prnt Ag
 of f I c I a I s to further support our goa Is. : These are def I ned 

SeO rn  our organizational legislative policy statement, which I hav


AVt_. Su S2 
24SO 
Mell'., LA 701  rev I ew.
enc losed for  your 
ElIC 
De. GiSh Pada In - respond I  to each of the I ssues addressed I n your report. 
eo. 153
LeIl.., KS 6615 I w I I I f 0 I I ow  the format of the report coment I ng first on 
the Execut I ve  Sunvary and concluding WI th the rec  endatlon
sect'l on. 
1) THE REPORT CITES THAT BLACK PATIENTS ARE WAITING TWICE AS

LONG AS WHITE PATIENTS FOR FIRST KIDNEY TRANSPLANTATION.

I t 
appears that even when factors such as blood type and age
were taken I nto account, a d  ty was st 
I spar I  III found between 
the wa I t I ng time for black 'pat I ents and wh I te pat I ents. 
O. Box 1538 
. lenexa. KS 66215 . 913/492.3600  Richard Kusserow 
October 
1. 1990 
Page 2 
bill ty factors. 
hi stocompat I 
However. we are concerned that 
were not adequate I' y addressed 
spec I fica Ily HLA match I ng. 
your report. 1989 data from the Un I ted NetwSor.k  for Organ 
Sharing  kidney donors 
(UNOS) Indicates that only 8% of U. 
were black  This Is In sharp contrast wtth the fact that
blacks const  of the kl dney transp I ant rec I p lent 
. It 
tuted 22. 
population for that same year.  ls well known that the HLJ 
antigen  One 
pool for blacks differs from that of whites. 
reason for the d I spar I ty between black and wh I te pat I ents
that  difficult to 
Is more  locate HLA compatible kidneys 
that match black recipients when available kidneys are 
prlmarl ty from white donors. It Is our opinion that the 
I ssue of ant I gen match  g and dopor lrec I  lent poo I reQu I res 
specific analysis and strongly recomend that research In 
this area be Identl fled as a priority If the disparity 
between black and wh I te pat I ents I s based on pure I y 
histocompatibility factors. 
2) VAR I AT ION IN TIME AWA I T I NG TRANSPLANTAT ION 
transplan'
The time on a waiting" list varies dependent on the 
center. 
Some transp I ant 
occurs for many reasons. 
Th I s 
centers andlor organ procurement organizations (OPO' s) simp 
have longer wa I t f ng I I sts . Thus a pat lent' s chances are 
I t I ng II st I ncreases un I ess there I s an 
reduced as the wa 
onor kidneys procured I n the I oca I area. 
eHQua eI rrate 10i nof  lies the 
real Issue - the balance between the number
of 
locally procured kJdneys, the number of Imported kidneys. 
Clear I: 
and the number of patients awaiting transplantation. 
an' 
this balance differs from center to center and OPO to OPO 
Iy. 
subsequent Iy pat lent wa I t I ng times vary accord I ng 
A comparison between waiting times to transplant and the 
actual transplant does not take Into account patients who 
have declined the transplant or who have not been
transp I anted because of med I ca I or techn Ica I reasons. NATCO 
recomends closer  Identify 
analysis of existing data to 
accurate 
Information on which to base an assumption. 
3) fMPACT OF ANTIGEN MATCHING ON WAITING TIME 
locally procured kidneys Is higher In some areas 
The rate of 
than I n other areas. Certa I n transp I ant centers are ab I e 
Import more kidneys through regional and national sharing 
because they have pat I ents II sted who have been wa I t I ng
greater than three (or more) years and thus have a hi 
number of accumulated waiting points giving them priority 
accord I ng to the cur rent UNOS kidney shar I ng system.  R I chard Kusserow
October 
1. 1990 
Page 3 
Identified 
At some centers. both HLA-DR antigens cannot. be 
pat I ents due to a number of techn I ca I and/or med I ca I 
ar eI aI sons. Subsequent I y. pat I ents without comp I ete 
receive a si 
Identification will not have the opportunity to 
ant I gen or phenotyp I ca I I Y matched kidney on a na t I ona I 
Influence why patients 
sharing basis. All of these factors 
at some transplant centers walt longer than at other center
for kidney transp  antat Ion. 
4) HIGHLY SENSITIZED PATIENTS AWAITING TRANSPLANTATION

NATCO agrees that the highly sensitized patient walts much 
Ionger for a kidney transp I ant than other pat  ents. There 
no Question that this patient  placed at a disadvantage
because of the I r Immuno I og I ca I status and thus. may wa I t for 
a number of years before a suitably matched donor Is found. 
I t  is Important to note that a I arge percentage of high I Y 
sens I t I zed pat I ents are those who have rece I ved a pr lor 
sensltlzed-
kidney transplant and have become - ; although mal 
patients are sensitized due to pregnancy and blood

transfus Ions.

All sensitized patients experience great difficulty
find I n9 a su I tab I y matched kidney but have a better chance 
large 
for transplant If their sera Is crossmatched with a 
donors.  fel 
poo I of  Therefore. NATCO supports a system to of 
large pool which affords 
kidneys to these patients from a 
them the best tissue match. 
the 
A I so,  I ssue of eQu  ty must be addressed. to answer the 
many kidney transp  I d one have 
Quest Ion of how  ants shou 
access to with such a severe shortage of donor organs. 
5) ORGAN PROCUREMENT TRANSPLANT NETWORK (OPTN) 
NATCO Is coml tted to further I ng the deve lopment of the OPT! 
and a national system for organ sharing. We agree that muci 
work has been done and progress has been made 
In estab I I sh I 
dlstrlbutlol
a national system with uniform policies for the 
of organs since the creat Ion of the OPTN. 
The OPTN has 
I ncreased organ shar I ng I n an order I y, manner resu I t Ing 
formation. 
more equitable distribution than prior to their 
It Is a Iso true however. that organ d  str I but Ion Is st I II 
local level and within the reglol 
somewhat controlled on the  R I chard Kusserow
October 
1, 1990 
Page 4 
of each OPO. 
There are some acceptable reasons to maintain 
level: 
limited control at this 
a) assuring viable organs because of time constraints with 
preservat Ion
'b) limiting travel time to prevent wastage of the organ, an. 
c) exercising efficient and cost effective processing of 
transp I antab I e organs 
We be I , eve however, that. these factors can be taken Into 
account In a conso II dated rec I p lent wa I t I ng II st per 
des I gna ted OPO. 
6) ORGAN D ISTR IBUT JON 
There appear to be documented evidence that variances 
local scientific studies. Such 
distribution are based on 
pract I ces foster comun Ity I nvo I vement I n the organ 
procurement and transp I ant process and I ncrease organ donor 
referral and eventual consent to donate. As there exists 
dlffer 
ences In opinions as to histocompatibility matching
transplantation, local variances play an 
Important part 
antatl on. 
se I ect I ng pat I ents for transp  We support ongo I ng
research to effect I ve I y ana I yze the benef I ts and risks of 
histocompatibility matching but realize the Importance of 
system wh  akes I nto account accumu I ated wa I t I ng time. 
Ich 
7)" SINGLE UN I F I ED WA I T I NG LIST 
NATCO endorses the recomendation that there should be 
fled II  I ents  tint 
movement toward a sing I e un I  st for pat  areawaa. I  
transplantation per each designated OPO service 
first-served, 
add It Ion to us I ng the cr  ter I a of first-come 
'S Important that object I ve med I ca I cr I ter I a be emp loyed tc
address the urgency of the rec I p lent' s need for
bill ty 
transp I antat Ion as we II as hi stocompat I  factors such
HILA  meatcvh I eng  anId s en)s I  t I .za t  Ion rates (react I ve ant I body
A point system which Includes objective medical criteria a 
ng time I  assure. 
we II as the rec I p I ents wa It I  s Important to 
opt Imum resu I ts of the kidney transp I ant wi th reasonab I 
success. 
expectat Ions of  chard Kusserow
October 
1. 1990 
Page 5 
8) RELA T IONS WITH DONOR HOSP IT ALS 
recomendation that the 
NATCO has concerns relating to the 
Pub lie Hea I th Serv I ce shou I d Issue regu I at Ions reQu I ring each 
OPO and donor hosp I ta I to adhere to reQU I red organ 
dairsetrai.b ution arrangements within the designated OPO service
is a shared respons I b II I ty of the Organ Procurement 
I t 
Organ I zat Ion (OPO). re I ated tissue and eye banks. and the
p that 
donor hosp I ta I to create an open work I ng re I at lonsh I 
Ion and d  str I but Ion. 
fosters organ and tissue donat 
cautions 
As critical as this working relatl.onshlp Is. NATCO 
against the development of any regulations whIch have the
OpoPteOnst.  Ir ae  II  attoe dn etg Iasts uI eye a In yd  Iemype abcat nokns  tahned  reth Ie a td Io onnosrh  hI ops opf  I ttah eI s. 
9) RELA T IONS WITH TRANSPLANT CENTERS 
In the same spirit of fairness. NATCO supports a consistent 
eQualta.b le d.lstrlbutlon following 
system which assures 
ob Ject I ve med I ca I cr I ter I  As respons I b II I ty for organ 
dona t Ion I I es with the OPO. tissue and eye banks and donor 
I II ty  I ant  for 
hosp I ta I. res pons I b  for the transp  opportun I ty 
each pat lent '  shared by the transp I ant center and OPO and 
1 s  relationship. 
fostered by a sJmllar open working 
10) MEDICAL PRACTICE GUIDELINES 
NATCO endorses the deve lopment of med I ca I pract Ice gu I de II ne 
wh I ch address organ transp I antat Ion. Add I t I ona I stud I es and 
more conc I us I ve find I ngs are needed to assure that po I I c I es 
gover n I ng organ shar I ng are sc I ent I fica I I Y based and that we 
transplantation.  . to those seeking
continue to provide optimum patient care
11) DEMONSTRATIO PROJECT EVALUATION A REGIONAL DISTRIBUTION 
SYSTEM 
NATCO also supports funding for a demonstration effort which 
II st for 
wou I d estab II sh a sing Ie. un  fled wa I t1 ng  a II  areas 
pa t I ents I n a spec  fled number of comb I ned OPO serv I ce 
and mandates shar I ng of organs to those pat I ents on a 
medical
first-come first-served basis subject to objective 
criteria. 
Such a project would evaluate the potential of a 
regional patient driven distribution system as well as asses 
the cost ef fect I veness of such a system. Before undertak I ng 
system. a regional 
an attempt at a national distribution 
system demands further evaluation.  () 
Richard Kusserow 
October " 1990 
Page 6 
12) ORGAN PROUREMENT ORGAN I ZA T ION RESPONS I B I LIT I ES 
that 
NA TOO recogn I zes  is the respons I b I I I ty of the Organ 
I t 
Procurement Organ I za t Ion to assure eQu I tab le  d I str I but Ion of
organs and thus supports that th I s respons I bill ty be a 
criteria for Medicare recertification. In addition. rigorous 
and sound I y based organ procurement cr I ter I a shou I d be 
des I gned to measure the procurement efforts of the OPO as 
we I I as measure other per.formance beyond actua I recovery 
organs wh I ch has a direct Impact on organ donat Ion (I. e., the 
comunity outreach programs). 
development of 
tlon 
As organ donation and transplanta Is a responsibility
shared by the medical comunity. we encourage the 
professional associations, In particular the American Society 
of Transplant Surgeons (ASTS) and the American Society of 
Transp I ant Phys I clans (ASTP) to conduct the I r own ana I ys I s 
those factors wh Ich may lead. to longer med Ian wa I t Ing times 
for black patients versus white patients. NAToo would 
welcome the opportunity to work with these groups In studyl.ng
these Issues. 
As NATOO Is com  tted to assur I ng opt I mum standards of 
coment on this 
practice, we appreciate the opportunity to 
. look forward to providing additional
draft report and
Information to your office as the need arises. 
Thank you. 
S J ncere I y 
t-aJ 
Barbara A. Elick, R. N.. CCTC/CPTC
Pres I dent  OIG Resp NATCO  Comments
onse To 
The NATCO' s response to our recommendations was generaly supponive. We agree that more 
ofllA 
attention must be given to the influence  matching on the black-white differential and, as 
previously noted, have modfied the text accordingly. We also recognize, as NATCO notes, that 
there ar numerous other factors that might contrbute to the situation.
We welcome NATCO's support on our reommendation callng for a single waiting list per OPO 
service area as the basis for allocation. We fully agree that in accord with the first come first
served principle, it is importt to use "objective medical criteria" to indicate "the urgency of the
recipient s need for transplantation" and to use "histocompatibilty factors such as HLA
matching and sensitization rates. . .. 
On the matter of relationships with donor hospitals, we accept NATCO's caution about issuing 
regulations that would have a negative impact "on the relationship of the OPOs, related tissue
and eye banks and the donor hospitas." Indeed, the intent of our proposed regulation is to foster
and protect goo working relationships by calling for transplant centers and donor hospitals in an
OPO selVice area to abide by the policies developed by the OPO.
D - 59 Ouvo-
.... UUYI UU.&UUf&  s:UD 
Offcc number (617) 277-6200 
New England Organ Bank', Inc. 
-.nrw. 
IIJe 
December 27, 1990 

Richard P. Kusserow 
Inspector General

Department of Health and Human Services

HHS North Building 
330 Independence Avenue, S. 
Washington, D.C. 20201

Dear Mr. Kusserow:

The New England Organ Bank (NEOB) appreciates the opportunity to comment on 
II The 
the draft report issued by your office,  Distribution of Organs for 
Transplant  tion: Expectations and Practices. II  J'9- OtJ5.stJ 
NEOB is the oldest and Jargest organ procurement organization in the United 
States. Founded in 1968, NEOB now serves 11.5 milion people, more than 200 
hospitals, and 14 transplant centers in the six New England states. Giventhe 
number and diversity of institutions we serve, NEOB has had extensive experience 
dealing with many of the logistical  and scientific issues analyzed in 
, political 
the report. , While we are  of the 
generally supportive of the intent 
recommendations, equitable access for all in need of a transplant, we do not 
agree with some of the methods proposed to achieve this. Our concerns are based 
around three general issues: 
Although, (as quoted on page 7 of the report) the 1986 Task force on Organ 
Transplantation noted that transplantation had developed sufficiently to "allow 
for the establishment of certain standards of practice," we believe their 
conclusion was somewhat premature. Transplantation continues to be  rapidly 
evolving clinical field which is stil  protocols and
categorized by diverse 
practices. 
Within limits, it is  encourage this diversity if we are to 
essential to 
continue to progress. However, legitimate scientiic disagreements should not 
be allowed to obscure the issue of equal access. 
Promoting the procurement. preservation 
 and  distribution of organs  and  tissues lor transplantation  Kusserow 
Richard P. 
December 27, 1990 
Page 2 
appealing. It is more 
- - While an absolutely uniform national system is 
sufficient 
realistic and practical to organize at a regional level. This provides 
activity while minimizing logistical problems. 
scale of 
- Any system of organ distribution should focus on the outcome. i.e.. equal 
legitimate way of achieving that end. 
access. There wil be more than one 
national system should encourage multiple models In order to .assess which 
proves to be most effective. 
More specifically, we would offer the following thoughts on the report' 
recommendations. 
Issue 
- "The PHS. in collaboration with the OPTN. should 
Recommendation # 
each OPO '(1) establish a single, unified list of 
regulations to require that 
patients on a 
pCatients oawaitimng transpmlantation eand (n2) disttribuste o:rgan s to these 
first come first served basis. subject to established medical criteria.
- It is not reasonable to assume that -established medical criteria- have been 
agreed upon by the transplant community or that they could be in the immediate 
legiti,mate scientific disagreements on issues such as HLA 
future. There are 
While it is 
matching. prioritization of highly sensitized patients, etc. 
or transplant center to decide these issues 
inappropriate to allow any surgeon 
is only one correct 
unilaterally, it is equally unreasonable to suggest that there 
answer for all the nation. Instead we would suggest that equal access can best 
requiring that each region of the countr .establish an objective 
be assured by 
process for distribution. which is evenly applied to all waiting in the region. 
under the 
prospectively justified and should then be 
This system would have to be 
scrutiny of all the transplant centers in the region, the OPO(s). ,and a national 
bodysuch as UNOS. In addition, complete and timely sharing of data should be 
periodic retrospective analysis may be performed.. This would 
required so that 
allow comparisons among the regions. 
- Some proposals suggest the establishment of OPO-wide lists rather than region-
wide lists.  if the OPO encompasses a sufficient number of 
This is acceptable 
transplant centers to assure patient equity. If this option is adopted, it must be 
accompanied by rules preventing the proliferation of OPOs and encouraging 
existing ones. The alternative wil be the creation of new. one 
consolidation of 
or two transplant center OPO's to avoid impact of a shared list.  Kusserow
Richard P. 
December 27. 1990
Page 3 . 
Recommendation # 2 - "The PHS. in collaboration with the OPTN. should issue 
regulations to require that each transplant center and donor hospital in' an OPO 
' the centralized organ distribution policies of the OPO 
service area adhere to
governing that area.
Comments:
- Such regulations are appropriate. It seems strange to establish OPO territories 
and OPO/OPTN rules and then a1l0w individual hospitals to act .outside of them. 
- Such regulations wil need to be accompanied by compliance monitoring and 
reasonable  penaltes for violations. Current sanctions. (e.g.. denial of all 
Medicare and Medicaid payments), are so severe that they are never invoked. 
Recommendation # 3 - " The PHS, in collaboration with the OPTN, should support 
the development of medical practice guidelines addressing organ transplantation. 
Comment: 
It wil be difficult to develop guidelines given the disagreements within the 
on appropriate methods of selecting potential recipients. 
transplant C?ommunity 
matching organs to recipients. and protocols for post-transplant patient care. 
It may be possible for all transplant centers, within a regional OPO to agree on a 
criteria, b4t national consensus is unlikely. Whatever is 
general set of medical 
developed must have suffcient flexibilty to allow for the uniqueness of each 
patient. Unfortunately, guidelines which are developed in a' regulatory framework 
frequently become absolute rules when implemented. 
Recommendation # 4 - " The PHS should fund a demonstration effort incorporating 
the following two features: (1) the establishment of a single, unified waiting list 
including all patients awaiting an organ transplant in a number of OPO service 
areas and (2) mandatory distribution of donated organs to those patients on a 
first come first served basis, subject to established medical criteria. 
. Comment: 
impractical given the lack of 
Such a study, while desireable, is likely to be 
agreement on what constitutes "established medical criteria." (See comments 
. it 
above), and political concerns of adjacent OPO's. However might be more 
organ allocation at those larger OPO's which already have 
practical to  study, 
unified lists and  number of transplant centers. This would also 
include a large 
allow examination of different sets of "established medical criteria" which have 
been implemented in different regions of the country. Given the existing  , . 
. '
Kusserow 
Richard P. 
December 27, 1990 
Page 4

diversity of approaches to organ distribution, it would seem the structure Is 
already In place to determine which methods have proven effective In achieving 
the goal of equal access. Once again, we stress the plural nature of the answer 
based on our belief that there witl be more than one -right- way. 
Recommendation # 5 - - The HCFA and the PHS should support research efforts 
that could help reduce racial disparities in organ allocation. 
Comment: 
We strongly support this recommendation. It Is critical- to determine If the 
apparent di"sparities in waiting times are truly related to inherent clinical 
combination of 
issues. discriminatory behavior (intentional or unintentional), or a 
disparity among regions (e.g. no difference in waiting 
factors. Given the apparent 
most others) this is 
time NEOB's region but varyirig levels of difference In 
is there a significant difference between 
obvious a complex issue. For example, 
many 
the experience at single-transplant center OPO's versus those that serve 
transplant centers? Is there a difference between those OPO's that already have 
a single unified list and those that stil allocate among each individual center 
list? These dat already exist, could be analyzed further now, and the results 
included in the final version of the report. 
Finally, NEOB would be pleased to work with the Ofice of the Inspector General 
ifi collecting and analyzing data, as well as the testing of any proposals. 
staff 
We loo 
forward to conversations with  you  and/or members of  your 
important issues. 
concerning these 
Sincerely yours,CC 
Richard S. L 
Executive ' Director  OIG Response To NEOB  Comments
We recognize the importnce of NEOB 's caution on the danger of seeking premature consensus 
on medical practice guidelines concerning organ trsplantation. Yet, there is an extensive body 
of information which has been developed which, it appears, could be drawn upon to provide 
some authoritative framework for guiding (not prescrbing) medcal practice in this ara. If the 
medical criteria exception serves as the only legitimate basis for deviating from the first cOp1e 
first served rule, such a frework would seem to be especially imponant. The matter of 
determining a threshold level of match, as suggested by ASHI, might be one panicular to focus 
on in this regard. 
We also recognize the limitation that NEOB notes concerning the relevance of a demonstration 
as we note in the text, such 
project concerning the use of the first come first served concept. Yet,. 
an effort can provide some useful data and can help us gain a better understanding of the costs 
. and benefits of allocating organs from larger donor pools. If two or more adjacent OPOs are 
effon. 
ready to participate, we think such a demonstration warants the 
D- 64
 ' ( 
.... """... "'  - ,----.---,--
..  . . - -
ndation
n organ procurement fO. 
January 22, 1991

II.D.. 
PlI.t"r"ilIa .A"t".-..II.D  v". 
.I- II.
Soar
. Wil., III'..D,. 
WI. LeF.t,
11 
At utClliw'
A.  Do.afM-
Honorable Richard P. Kusserow

Inspector General

Department of Health and Human Services

BBS North Building

330 Independence Avenue, S.
C. 
Washington, D. 20201
Dear Mr. Kusserow:

(SEOPF) wishes to comme

The South-Eastern Organ Procurement Foundation 
on the Draft Document: "The Distribution of Organs for Transplantatio:
imprtant 
Ethxpaenct 2at0i ons and Practhtiec es . SEOPF hast rbaenesnp alna ntation inccoluntdriinbgu ttohre f uors emQ 

years to  science of 
(bibliograp:
histocompatibility matching as a basis for organ distribution 
attached).  orga'
Several issues concerning the equitable distribution of 
for transplantation raised in your Draft can be addressed by scientif
organizations such as SEOPF. These issues have sparked some controversy a

considerable debate within our organization. The observation that blacks wa

whites, the fin 
longer than ' ing that women wait longer than men, the foc

role of histocompatibili
upon short-term rather than long-term results, the '
testing and the availability of particular patients for transplantation wh

examles of 
important questions discussed with

an organ comes available are 
the committees of SEOPF. Data from a SEOPF Member Organ Procuremeindte nAtgiefni

indicate that black patients arOe ml)o.r e often Ynavailable for an 
donor organ than whites  SEOPF believes that additional da

collection and analysis will be important to a correct interpr. ePtartoijoenc otfs  

your Draft 
findings in  Document. The SEOPF Scientific
Publications  ttee is undertaking studies of Center effects and 

. Commi 
We exp

access of minorities to cadaver donor kidneys for transplantation. 
that the results of these SEOPF research studies will be helpful to you 2

the entire transplant community in our effort to understand the reasons

dliafferetnteial arcce sst ohf paritiscula r ypatieent garouprs t.o  cad aver organs f
Dr,
transplantation. SEOPF appreciates the opportunity to comment on the 
results ' rch
of its resea
Document and looks forward to sharing the  ,------_u--- 
Sincerely yours,

'J  ir'
R. Randal Bollinger, M.D., Ph.

President, SEOPF

RRB:lc
7740 Shradr Road. Suite A . Richmond. Virginia 23228 . Telephne 1801  672.2m  . FAX 1801672.2643 ~~~
OIG  SEOPF  Comments 
Response  To 
We are pleased that SEPOF has been examining many of the issues raised in our repon and that 
its Scientific Projects and Publications Committee is devoting panicular attention to the access 
EOPF and its member institutions bring much 
of minorities to cadaver kidney transplantation. 
expertise to such inquir. We look forward to the results.   MIlir 
In 
We note th twice in th rert. HL machg is cited as a possible, signca 
facor contrbutig to cdieurn ces in access betwee Blac and Whes. Furer, the 
rert also notes th  cotrvery regarg the beefit of HL matg. 
We believe it is of utmos imrgtarnc e to clar th issue. HL machg is the 
afecg  maatd pD
single major facutonr    success that can be  alo 
tranlantaton,  imunosuresion, htais eno  major advere afec, and 
une  cost. The beefits of 
inunosuppresion. involves a one  da 
well docented Anysis of the UNOS  bas, the UCL 
matchig ar  Tralan 
Tralant Regitr Dat base and the Interatonal gCro llabrave  Study 
suival as th degr of 
data base al cleary show a stepwise incrmentI iUn    cmt 
HL matchg imoves. However, although  match is one of the 
raed alost 
alocaton crteria, at an opetional level, patients ar effectely 
suprsdi 
exclusively by waitIinUg t ie, with only very well matche patentths   that. 
The few hundr  phenotyicay identical tranlants  tibsav e ben 
diarty in waitig  between 
pBerlfaocnn ed certy caot accoun for the  the trlant 
and Caucasia. Nevereless, an imIrUtan t goal of 
communty should be to extend the benefi of  matchg to more indriveiuuail . 
" Th wilrequ regionation and spcifcay, for Blac patents wil 
fuer elucidaton of those HL antigens found predomiately in the Black 
importt to. encourge mcrcdorgan donation from 
populaton. It wil alo be 
the Black communty. 
May of our membe beeve that the Cunt contrvers is not realy about the 
benefits of HL macshgy b ut raer abut sharg. As note earer, becase of the 
HL  necsar to shar organ, at least at the regional 
diverity of the  it is  HL 
appcible numbe of goo  maches. It is evidet that 
level, to achive any 
there is.a strng relucticne,c ornd t he par of many surgeons, to "shar orgainn. cAise nt 
lesser matches mcayo bme  p 
have note abve, the  beefi of some 
wart  involv (trrtaton,. etc.). A reasonable  is to 
to '  the cost  mada shg, with 
establis a thhold leve of mach and to  wa ire gion. for 
organ for which a match better than the thshold level is found. the region. 
shg ha severa important benefits. F11, it provide the 
The concet of regiona 
oprtty of multile litig to al patent. Second, for some patents to have a 
realistic oportty for trlantapoonl. a tvhaeiya bmlues. tT hahve i sa np ianrccruaaserldy  atcrcee sosf.  Tthha t 
is, they must have a larr donor 
sensiti patient. Regional shag, when combined with the use of regiona 
provide the bet oprtty for trlantation of the sensitd 
crossmatch trys, 
patient. 
Pat 
O1oke 
Iint .i sa noyf  cpoonlciceirens  tohf t hteh Oe iFseI.. o If mpaltiicenitt  icnh othicee  risi nto tc ahodidcers, eisd t hine.  arnC lmegeilantitao nfbo nrt o r 
patient educaton.. Under the prsent system, t'aUents do not have aw cahiogic e tie 
s analysis of eqwty in access u 
donor selecton. The rert' patents 
which implies a diadvantae associated with waitig tie. However, some 
who ar awar of the beefits of HLA matchig and of their lielioo of fidig a 
not. Th 
Oters may 
well-matched donor, may elect to wait for such a donor. 
factors which detenne selecton of a trlant center ar unown It is not 
unasonable to exct that at least some sensitized patients would choose to be 
(5)  sharg,i 
trated at a center which paricipatcs in regional  they were awar of the 
increased lieliood of trlantation. 
fid 
In sunar, we  that: 
tht 
.we agre with the conlusions of tdhei rhepeordt   
- some groups of patents have  oportty for trsplantaon 
- a program of mandaed regional sharg should be inestigated
- goverance of the trlantaion 
network should involve grater 
parcipation by those in non-surgica aras 
.the basis for the reumceedd a ccss of Black ha not been adquately. 
investigated; because  waitig tie caD be afected by so may 
varles, we recommend altemative aproaches, spcifcay proprton
trlants 
.since ABO diarty clearly reresents a major barer to trlantaton 
Blac 
Blacks, effort should be diected at increasing organ donaon by 
.regional sharg should be mandated for certai HL matches which extend 
shag. 
beyond the present level of madatory 
Nancy E. Goeken, Ph. 
President, ASID 
(6) OIG Response To ASHI Comments
The ASHI response is a thoughtful review of many importnt issues bearng on organ allocation.
We have reflected some of their comments in our revised text concerning the. black-white
disparties and have addrssed many of the points' in prior responses. We have also referenced
some of their comments in some of our previous responses.
. One point that we have not addrssed is the one that ASHI raises concerning figure 2. It notes
that in that figure, which provides the median waiting time for blacks and whites on the basis of
II It
blood type, "the ratio is greater for all bloo types combined than for any single blood type. 
then notes that this result is difficult to interpret.
The explanation is that our data address the median waiting time, not the average waiting time.
In convertng that data to ratios, as ASHI has done, it is takng a parametrc model (averages)
and applying it to a nonparametrc statistic (medans).
An additional clarfication concerns the role of the GPO. In urging that the OPOs "shape and
oversee distrbution policies in their service areas," we do not intend to imply that they do that
independent of OPT and IfS policies, rules, and guidelines. What we urge is that they, rather
priar, 
than individual trnsplant centers be the  authoritative vehicles for allocating organs in
accord with those policies, rules, and guidelines. ...' .';'''  "::.. - '-.-:':, 
November 7 , 1990 
Association 
The Honorable Richard P. Kusserow
Inspector General
Departent of  Services
Health and Human 
of Organ  HUS Nort Building 
RECEIVED
330 Independence Avenue, S.  REGION 1 - OIG/OEI 
C. 
Washington, D.  20201 
INOV,.  . J990 
Procurement  Dear Mr. Kusserow, 
the 
On behalf of  Executive Committee of the
Association of Organ Procurement Organizations
(AOPO), I am pleased to be able to respond to the
Organizations  Draft Document: 
"The Distribution of Organs for
Transplantation: Expectations and Practices.
This 
response represents the consensus of the 
ttee. 
S Executi ve 
:l1I!.,' K.rl.n.  I.O,  AOPO  Commi 
""n Rkh.IrJ....,  The AOPO represents - .:ixty-two of the sixty-nine
"..n' An..' II"u",'  rienco gtnhieze d Organ sPrtoactuersem,e bnto tOhr ganizations (OPO)
independent 
Uni t  and
hospital 
L'nw.. :\,'1.11  over nibnaesetyd,  who are coll.e ctthiveel ys ionlviodlv ed in
percent of 
year.  organ
IIr0i 0.0n .  Kn''-n..!.  procurements that occur each  The AOPO' 
'lII\'1 W,'rkm.  paunrdp orseec eipst itvoe neexspsa ntdo  toher gpaunb ldico'n ataiwoanre. nWeses  aorfe, 
committed to promulgating tahen d istribution of
transplantable organs in  equitable and: 
expeditious manner as determined by the designated
Organ  Transplantation 
Procurement and  Network. 
Lastly, its purpose is to study and evaluate the
organizational, administrative and educational 
methodologies which will lead to toe att inment of 
the above purposes. 
First, let me say that AOPO does not' at all
disagree with the basic 
draft 
findings of the 
document your office has produced. ' We do ' agree
that there is a significant disparity between the 
percentage of Black Americans on the transplant
waiting lists and the percentage transplanted each
year. 
Secondly, it certainly appears that a Black 
American waits significantly longer than a White 
Administrative Office 
1714 Haves Street 
Nashvilie, TN 
37203 
(615) 321-3756 
15) 329-2513 (Fax) 
u;  Kr. Kusserow 
November 7, 1990 
. J'ge Two 
American for a kidney transplant. And, AOPO would 
concur that these disparities do not seem to be 
aither recipient age or blood type. 
related to 
Nonetheless, AOPO feels that this report is far
too limited to -
identify the causes of these very 
real disparities. 
It would seem to us that there are three broad 
dareeatsa tihla. tF sihrostu,l da bree  sthtuedriee d in much greater
medical-scientific 
justified or 
biases - either  unjustified - that 
account for these disparities? Secondly, what
part do socio-economic and cul tural factors play 
" distribution of transplantable
in the equitable
norogta ns? . Thirdtlhy,e A OPO would question iwnhe tchuerrr eonrt 
some of  seeming inequi ty 
arise 
practice might  from local organizational
strcture 
rather than from the system as a whole? 
Procuement organizations differ 
certainly Organ 
just as regions differ. 
out, 
AOPO would point  however, that neither the 
distribution policy. 
AOPO nor its moeumbte.r s make 
They carry it  Policy is determined by the
Organ Procurement Transplant Network (OPT) and
the local  scientific 
oversight
medical and 
committees. 
And, in the final analysis, whether
or not a 
given patient is transplantable with a 
that 
given donor organ is initially decided by 
pinat ient' s physician andt/hoer  psuargteioenn atr.i dT ehvee ntually
conj unction with  common 
algorith is 
thread throughout the  at tthhee  transplant 
physician or surgeon - both  donor and 
recipient selection and  the 
evaluation, and at 
transplantation event. 
its 
and 
AOPO  member Organ Procurement 
organizations are ready to assist your Qffice in
the design and/or  any studies 
performance of 
appropriatei. n 
dreaecmiead l  Whent hreoo td icsatursiebsu ftioor nt he
dispari ty 
transplantable organs are determined, the AOPO and 
its members will be happy to assist in the design 
solutions. 
and implementation of appropriate  Mr. Kusserow 
November 7, 1990 
?age Three 
The AOPO thanks you for the opportunity to comment 
happy to
on the draft report and would be most 
provide your office wi th any furter information 
you require. Our ongoing dedication is to the 
donor and recipient public and we stand ready 
help you assure that they are equitably served. 
Thank you. 
i:1y
Mike P. K plan, M.
presidel'
Associa on of 
Organ
Procurement Organizations 
MPK/krk Comments
01 G Res p 
o n s  To  A O P 
We agre that the repon does not identiy the causes of the black-white disparty. We have 
bloo type) have little or
shown that some factors thought to contrbute to that disparty (such as 
no effect. Beyond that we have simply identified a number of possibly contrbuting causes and
called for more research to examine such causes. Some such research, such as the Rand study
mentioned by HCFA, is already underway.
We regret that AOPO was not more supponive of our observation that the OPOs rather than 
individual transplant centers should be regarded as the engies of the organ distrbution system. 
We recognize, as we noted in our response to ASHI, that allocation policies must be made in 
have a very 
accord with OPTN (and HHS) policies. Yet, within that context, OPOs still 
imponant role to play in developing and overseeing the particular approaches in their service 
trsplant centers have already been quite active and successful 
areas. Indeed, many OPOs and 
in obtaining vararces fromOPTN policies.  ~==~:~.~~~~
.:;-;.  ""...........-_.......
October 
1, 1990 
R I chard Kusserow 
NATCO  nspector Genera 
North  Of flee of the CInsp.e ctor Gener: 
American  Department of Health and Human Services 
Transplant  Washington , D.  20201 
Coordinators
OrganizatCion  eRER:  IG iDra.ft 'Report OEI-01-B9-00550
Dear Mr.  Kusserow: 
..1d 
8Ia 
A. Etok 
Enclosed for your consideration Is the response of the North
TPIIl TIirW811e1 ngl..n8uiin American Transplant Coordinators .organization (NATCO) to the
Ao2.20 draft report titled , li The Distribution of Organs for
Transplantation: 
Expectations and Practices.
Pr81.Elect
LLino L  Jos
01 0N OrQ8n NATCO Is the professional society representing organ 
Pt-II (LOI 
700 kkrmn R4o3d2.  Su 58  procurement and clinical tr nsplant coordinators. . . Our 
Cous. OH  membership totaling 1200 Is composed of practitioners from 
over 300 transp I ant centers and organ procurement agenc I es I r 
States. 
TN.ey_ S-.  DDaVoI SeNit  the Un I ted  Our organ I zat Ion has pos I t I ve I y 
S-I 
1714 Hayes  Influenced the spec I a I ty  of organ procurement and
. TN 3720 
TN.. transplantation by assuring Quality care for organ donors and 
fI 
their families as well as recipients of organ transplants. 
c. Sm .I.
Son Caom
ROPA 01 
L85o0  AV.n.s.a.n  ACvAe 8.0 4Ro 123 We have deve loped and promoted the recogn I t Ion of standards
CG 
of practice, provided professional and public education,
at 
Li Tuln ertlflcatlon (by the American Board of Transplant
CeIo Tranll Do NeIW  encouraged 
170 CaOM Slr"L Su 36  Coordinators) for practitioners In this specialty and
participated 
SCan Fora nc. CA 84'09  In ongoing research to advance Immunosuppressive
bill ty 
at  therap I es and hi stocompat I  techn I Ques.
T.r.sa Shfe'
H1a30m1s  Ma\lrs nFio A WVon8h   Our proact I ve I nvo I vement In Federa I and State government ha
FIom Wo.  "TX8 76I110. ' 
enabled us to work with professional staff and elected
to 
Los M.. O on I'Il  of f I oc rI ga aI ns izatfi.ounrtahle lre sguipsplaotritv oeu rp ogol ica yIs s. t.a Ttehmeseen ta,r we hdiecfh I  In ehda vI r,
2450  AlInu, Su $2  our  your rev 
MaLaria, LA 7001  enc losed for  I ew.
&tc 
De Git  In - respond I  to each of the I ssues addressed I n your repor t . 
I8.0nxe 1x a KS 66'5 I w I I I f 0 I I ow  the format of the report coment I ng first on
the Execut I ve  Summary and conc I ud I ng WI th the rec  enda t Ion 
sect 
on . 
1) THE REPORT CITES THAT BLACK PATIENTS ARE WAITING TWICE AS 
LONG AS WHITE PATIENTS FOR FIRST KIDNEY TRANSPLANTATION. 
I t 
appears that even when factors such as blood type and age
were taken I  y was st II I 
nto account , a d  found between
the waiting time for black '  I spar I 
patlents and white patients. 
O. Box 1538 . lenexa, KS 66215 . 913/492-3600  Richard Kusserow
October 
1. 1990 
Page 2 
bill ty factors. 
hi stocompat I 
However, we are concerned that 
adeQuatel"y addressed 
specifically HLA matching, were not 
your report. 1989 data from the Un I ted NetwSor.k  for Organ
Sharing  kidney donors 
(UNOS) Indicates that only 8% of U. 
were black  This Is In sharp contrast wtth the fact that
blacks const  tuted 22.4% of the kidney transp I ant rec I p lent 
popu I at Ion for that same year.  I t  is we II known that the HLJ 
antigen  One 
pool for blacks differs from that of whites. 
reason for the disparity between black and white patients 
difficult to 
that It Is more  locate HLA compatible kidneys 
kidneys are 
ha t match black rec I p I ents when ava I I ab I e 
prlmar11y from white donors. It Is our opinion that the 
Issue of antigen matchl g and dopor/reclplent pool reQuires 
research In 
recomend that 
specific analysis and strongly  arlty 
this area be Identlfled as a priority If the dls 
I te pat I ents I s based on pure I y
between black and wh 
histocompatibility factors. 
2) VAR I AT ION IN TIME AWAI T I NG TRANSPLANTAT ION
The time on a wa I t I ng  list var I es dependent on the transp I an' 
center. 
occurs for many reasons. Some transp I ant 
Th I s 
centers and/or organ prsotcsur.e ment organ I za t Ions (OPO' s) simp 
lent' s 
have longer wa I t I ng I I  ThUS a pat  Chances are 
reduced as the waiting' list Increases unless there Is an 
eQual ratio of ,donor kidneys procured In the local area. 
Hoefre  I n II es the rea I Issue - the ba I ance between the number
I oca I I Y procured k  dneys. the numtbrearn osfp lIamnpotarttieod nk.i dCnleeyasr,l  
and the number of patients awaiting 
this balance differs from center to center and OPO to OPO an 
accordingly. 
subseQuently patient waiting times vary 
I ant and the 
A campar I son between wa I t I ng times to transp 
I ant does not take Into ac  ount pat  ents who 
actua I transp 
ha ve dec I I ned the t r ansp I an t or WhO have not been 
technical reasons. 
transplanted because of medical or  NATCO 
recomends closer analysis of existing data to Identify 
accurate I nformat Ion on which to base an assumpt Ion. 
3) IMPACT OF ANTIGEN MATCHING ON WAITING TIME
The rate of locally procured kidneys Is higher In some areas
than I n other areas. Certa I n transp I ant centers are ab I e 
Import more kidneys through regional and national sharing 
because they have pat  ents II sted WhO have been wa I t I ng
greater than three (or more) years and thus have a hi 
number of accumulated waiting points giving them priority
accord I ng to the current UNOS kidney shar I ng system.  R I chard Kusserow 
October 
1, 1990 
Page 3 
At some centers, both HLA-DR antigens cannot. be Ident I fled 
all patients due to a number of technical and/or medical 
reasons. 
SUbseQuent Iy, pat I ents without comp  ete DR 
receive a si 
Identification will not have the opportunity to 
ant I gen or phenotyp I ca I I Y matched kidney on a na t I ona I 
shar I ng bas Is. A II of these factors I nf I uence why pat I ents 
at some transplant centers walt longer than at other center 
for kidney transplantation. 
4) HIGHLY SENSITIZED PATtENTS AWAITING TRANSPLANTATION 
NATCO agrees that the highly sensitized patient walts much 
There 
Ionger for a kidney transplant than other patients. 
no Question that this patient  placed at a disadvantage
because of the I r Invuno I og I ca I status and thus, may wa I t fOI 
a number of years before a su I tab Iy matched donor I s found. 
is Important to note that a I arge percentage of high I Y 
I t 
sensitized patients are those who have received a prior 
sensltlzed-
kidney transplant and have become - ; although mal 
pat I ents are sens I t I zed due to pregnancy and blood
transfusions.
All sen  ltlzed patients experience great difficulty 
finding a suitably matched kidney but have a better chance 
thel  sera Is  large 
for transplant If  crossmatched with a 
donors.  fel 
poo I of  Therefore, NATCO supports a system to of 
pool which affords
kidneys to these patients from a large 
them the best t 
Issue match. 
the 
A I so,  I ssue of eQu  ty must be addressed. to answer the 
Question of. how many kidney transplants should one have 
access to with such a severe shortage of donor organs. 
5) ORGAN PROCUREMENT TRANSPLANT NETWORK (OPTN) 
NATCO Is comitted to furthering the development of the OPT! 
and a natlon  1 system for organ sharing. We agree that muc 
work has been done and progress has been made In estab II sh I' 
a national system with uniform policies for the dlstrlbutlol 
of organs s1nce the creat Ion of the OPTN. The OPTN has 
I ncreased organ shar I ng I n an order I y. manner resu I t lng 
more eQu  tab le  d I str I but Ion than pr lor to the I r format Ion. 
It I.  also true howevert,h teh at organ distribution Is stili 
somewhat contro II ed on  I oca I I eve I and with I n the reg 101  R I chard Kusserow 
October 
1, 1990 
Page 4 
of each OPO. There are some acceptab I e reasons to ma I nta I ri 
level: 
limited control at this 
a) assur I ng v I ab I e organs because of time constra I nts with 
preservat Ion 
trave I time to 
'b) 11m I t I ng  prevent wastage of the organ t an 
c) exercising efficient and cost effective processing of 
transp I an tab I e organs 
however, that. these factors can be taken Into 
Wade bceelc  osuing'evet n Ina tae cdon sOoliPdaOte.d  recipient waiting list per
S) ORGAN DISTR IBUT JON 
There appear to be documented evidence that variances 
local scientific studies. Such 
distribution are based on 
pract I ces foster conun I"ty I nvo I vement I n the organ 
procurement and transp I ant process and I ncrease organ donor 
referra I and eventua I consent to donate. As there ex I sts 
d I f fer  nces In op I n Ions as to hi stocompat I bill ty match I ng f
I oca I var lances play an Important part
transp I antat lon, 
selecting patients for transplantation. We support ongoing 
research to effectively analyze the benefits and risks of
hlstoc.ompatlbl Uty matching but realize the Importance of 
system wh  akes I nto account accumu I a ted wa I t I ng t I me. 
I ch 
7)' SINGLE UNIFIED WAITING LIST 
NATCO endorses the reconendatlon that there should be 
movement toward a single unified list for patientasr eawaa.l tlnf 
transp I antat Ion per each des I gnated OPO serv I ce 
. add It Ion to us I ng the cr I ter I a of first-come first-served, 
Is Important that objective medical criteria be employed 
need for 
address the urgency of the recipient' s '
transplantation as well as histocompatibility factors such 
HILA  maetcvhieng  anId s en)si tiz.at ion rates (reactive antibody
A point system which Includes objective medical criteria 
we II as the reel p I ents wa It I ng time I s Important to assure. 
opt'mum resu' ts of the kidney transp I ant wi th reasonab I 
success. 
expectat Ions of  R I chard Kusserow
October 
1. 1990 
Page 5 
8) RELA T IONS WITH DONOR HOSP IT ALS 
recomendation that the 
NATCO has concerns relating to the 
Pub II c Hea I th Serv I ce shou I d Issue regu I at Ions reQu I ring each 
OPO and donor hosp I ta I to adhere to reQU I red organ 
dairsetrai.b ution arrangements withibni llt htey  doefs ignated OPO service
is a shared respons  the Organ Procurement 
I t 
Organ I zat Ion (OPO) , re I ated tissue and eye banks. and the 
that 
donor hospital to create an open working relationship 
Ion and d  str I but Ion. 
fosters organ and tissue donat 
cautions 
As critical as this working relatl.onshlp Is, NATCO 
agaInst the development of any regulations wh'ch have the 
potential to negatlyely Impact on the relationship of the 
OPOs, re I ated t I$sue and eye banks and the donor hosp I ta Is. 
9) RELA T IONS WITH TRANSPLANT CENTERS 
In the same spirit of fairness, NATCO supports a consistent 
system wh I ch assures. eQu I tab Ie d.l str I but Ion fo II ow I ng 
objective medical criteria. As responsibility for organ 
donat Ion I I es  nd eye banks and donor 
with the ObPO, itilslsu et y for  I ant  for 
hosp I ta I, respons  the transp  opportun I ty 
each pat lent '  shared 'by the transp I ant center and OPO and" 
1 s  relationship. 
fostered by a sJmllar open working 
10) MEDICAL PRACTICE GUIDELINES 
NATCO endorses the development of medical practice gUldellne 
wh I ch address organ transp I antat Ion. Add I t I ona I stud I es and 
more conclusive findings are needed to assure that policies 
govern I ang norgtaan stha rI I ong anre. s c I ent I fica I Iy based and that we 
. to those .seeklng 
continue to provide optimum patient care
transp I 
11) DEMONSTRATIO(cid:1) PROJECT EVALUATION A REGIONAL DISTRIBUTION 
SYSTEM 
Ich 
NATCO a I so supports fund I ng for a demonstrat Ion effort wh 
would establish a single, unified waiting list for all 
patients 
In a specified number of combined OPO service areas
and mandates shar I ng of organs to t'hose pat I ents on a 
medical
cfirristte-rcioame.  first-served basis subject to objective 
Such a project would evaluate the potential of a 
regional patient driven distribution system as well as asses 
system. 
the cost effectiveness of such a  Before undertaking 
system, a regional 
an attempt at a national distribution 
system demands further evaluation.  RI chard Kusserow
October 1. 1990

Page 6

12) ORGAN PROUR  MENT ORGAN I ZA T ION RESPONS I B I LIT I ES
NATCO recognizes that I t  is the respons  bill ty of  he Organ

Procurement Organization to assure equitable distribution of

or gans and thus suppor ts that th I s respons I b I I I ty be a

criteria for Medicare recertification. In addl  lon. rigorous

and sound I y based organ procurement cr I ter I a shou I d be
des I gned to measure the procurement efforts of the OPO as

wel I as measure other per.formance beyond actua I recovery 

organs which has a direct Impact on organ donation (I.e., the

comunity outreach programs).
development of 
As organ donat Ion and transp I ant  t Ion Is a respons I b II I ty
shared by the med I ca I comun I ty. we encourage the

professional associations, In particular the American Society

of Transp I ant Surgeons (ASTS)' and the Amer I can Soc I ety of

Transplant Physicians (ASTP) ttoo  conduct their own analysis of

those factors wh I ch may I ead  longer med I an wa I t I ng times
NATCO would

for black patients versus white patients. 
we I come the opportun I ty to work with these groups In study I.ng
these Issues.
Is comitted to 
As NATCO  assuring optimum standards of

coment on this
practice, we appreciate' the opportunity to 
, look 
draft report and forward to providing additional

I nforma t Ion to your of flee as the need ar I ses.
Thank you.
S J ncere I y,
6-aJf4
Barbara A. Ell ck, R. N., CCTC/CPTC
Pres  dent OIG Response To NATCO  Comments
The NATCO' s response to our recommendations was generaly supponive. We agree that more 
attention must be given to the influence of HLA matching on the black-white differential and, as 
previously noted, have modfied the text accordingly. We also recognize, as NATCO notes, that 
there ar numerous other factors that might contrbute to the situation. 
waiting list per OPO 
We welcome NATCO' s suppon on our reommendation calling for a single 
service area as the basis for allocation. We fully agree that in accord with the first come first 
served principle, it is importnt to use "objective medical criteria" to indicate "the urgency of the 
recipient s need for transplantation" and to use "histocompatibilty factors such as HLA 
matching and sensitization rates. . " 
s caution about issuing 
On the matter of relationships with donor hospitas, we accept NATCO' 
regulations that would have a negative impact "on the relationship of the OPOs, related tissue 
proposed regulation is to foster 
and eye banks and the donor hospitas." Indeed, iheintent of our 
and protect goo working relationships by calling for transplant centers and donor hospitals in an 
OPO service area to abide by the policies developed by the OPO. 
D- 59
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Offce n  mbcr (617) 277-6200
, t
New England Organ Bank-, Inc. 
neW' 8 IIIe
December 27, 1990 

Richard P. Kusserow
Inspector General

Department of Health and Human Services 
HHS North Building
330 Independence Avenue, S. 
Washington, D.C. 20201

Dear Mr. Kusserow:

The New England Organ Bank (NEOB) appreciates the opportunity to comment on 
the draft report issued by your office, . The Distribution of Organs fQr 
Transplant  tion: Expectations and  J'9- O()5$tJ 
Practices. -
NEOB Is the oldest and Jargest organ procurement organization in the United
States. Founded in 1968, NEOB now serves 11.5 milion people, more than 200 
hospitals, and 14 transplant centers in the six New England states. Given the 
number and diversity of institutions we serve, NEOB has had extensive experience 
dealing with many of the logistical, political and scientific issues analyzed in 
the report, While we are 
generally supportive of the intent of the 
recommendations, equitable access for all in need of a transplant, we do not 
agree with some of the  Our concerns are based
methods proposed to achieve this. 
around three general issues:
Although, (as quoted on page 7 of the report) the 1986 Task Force on Organ 
Transplantation noted that transplantation had developed suffciently to "allow 
for the establishment of certain standards of practice, - we believe their 
conclusion was somewhat premature. Transplantation continues to be  rapidly 
evolving clinical field which is stil  protocols and
categorized by diverse 
practices. 
Within limits, it is  encourage this diversity if we are to 
essential to 
continue to progress. However, legitimate scientific disagreements should not 
be allowed to obscure the issue of equal access. 
Promoting the procurement, preservation and distrlbullon of organs 
and IIssues for transplantallon  -'.
Kusserow 
Richard P. 
December 27, 1990 
Page 2 
appealing. it is more 
- - While an absolutely uniform national system is 
sufficient 
realistic and practical to organize at a regional level. This provides 
activity while minimizing logistical problems. 
scale of 
- Any system of organ distribution should focus on the outcome, i.e., equal 
legitimate way of achieving that end. 
access. There wil be more than one 
national system should encourage multiple models in order to .assess which 
proves to be most effective. 
More specifically, we would offer the following thoughts on the report' 
recommendations. 
- 8fhe PHS. in collaboration with the OPTN, should issue 
Recommendation # 
each OPO '(1) establish a single, unified list of 
regulations to require that 
patients on a 
pCatients oawaitimng transpmlantation eand (2n) disttribuste or:gan s to these 
first come first served basis, subject to established medical criteria.
- It Is not reasonable to assume that "established medical criteria- have been 
agreed upon by the transplant community or that they could be in the immediate 
future. There are legitimate scientific disagreements on issues such as HLA 
matching. prioritization of highly sensitized patients, etc  While it is ' 
issues 
inappropriate to allow any surgeon or transplant center to decide these 
is only one correct 
unilaterally, it is equally unreasonable to suggest that there 
answer for all the nation. Instead we would suggest that equal access can best 
requiring that each region of the countr establish an objective 
be assured by 
process for distribution, which is evenly applied to all waiting in the region. 
This system would have. to be prospectively justified and should then be under the 
scrutiny of all the transplant centers in the region, the OPO(s); -and a national 
bodysuch as UNOS. In addition, complete and timely sharing of data should be 
would 
periodic retrospective analysis may be performed.. This 
required so that 
allow comparisons among the regions. 
Some proposals suggest the establishment of OPO-wide lists rather than region-
wide lists. This is acceptable if the OPO encompasses a sufficient number of 
transplant centers to assure patient equity. If this option is adopted, it must be 
accompanied by rules preventing the proliferation ofOPOs and encouraging 
existing ones. The alternative wil be the' creation of new. one 
consolidation of 
or two transplant center OPO's to avoid impact of a shared list.  Kusserow 
Richard P. 
December 27, 1990 
Page 3 . 
- "The PHS, in collaboration with the OPTN, should issue 
Becommendation # 2 
hospital in an OPO 
regulations to require that each transplant center and donor 
' the centralized organ distribution policies of the OPO 
service area adhere to
governing that area. 
Comments: 
- Such regulations are appropriate. It seems strange to establish OPO territories 
outside  them. 
and OPOIOPTN rules and then allow individual hospitals to act . of". 
- Such regulations wil need to be accompanied by compliance monitoring and 
reasonable  penalties for violations. Current sanctions, (e.g., denial of all 
Medicare and Medicaid payments), are so severe that they are never invoked. 
Recommendation # 3 - " The PHS, in collaboration with the OPTN, should support 
practice guidelines addressing organ transplantation. 
the development of medical 
Comment:

within the

It wil be diffcult to develop guidelines given the disagreements 
transplant gomniunity on appropriate methods of selecting potential recipients. 
matching organs to recipients, and protocols for post-transplant patient care. 
agree on a 
It may be possible for all transplant centers . within a regional OPO to 
criteria, bqt national consensus is unlikely. Whatever is 
general set of medical 
allow for the uniqueness of each 
developed must have sufficient flexibilty to 
patient. Unfortunately, guidelines which are developed in a' regulatory framework 
frequently become absolute rules when implemented. 
- " The PHS should fund a demonstration effort incorporating 
Recommendation # 4 
the following two features: (1) the establishment of a single, unified waiting list 
number of OPO service 
including all patients awaiting an organ transplant in a 
those patients on a 
areas and (2) mandatory distribution of donated organs to 
.fi rstC comeo firsmt servemd basise, sunbjectt to: es tablished medical criteria.
impractical given the lack of 
Such a study, while desireable, is likely to be 
agreement on what constitutes "established medical criteria. - (See comments 
above), and political concerns of adjacent OPO's. However, it might be more 
organ allocation at those larger OPO's which already have 
practical to study. 
unified lists and include a large number of transplant centers. This would also 
of different sets of "established medical criteria- which have 
allow examination 
been implemented in different regions of the country. Given the existing  . .
Kusserow 
Richard P. 
December 27, 1990 
Page 4 
diversity of approaches to organ distribution, It would seem the structure Is 
already In place to determine which methods have' proven eff  ctive In achieving 
the goal of equal access. Once again, we stress the plural nature of the answer 
based on our belief that there witl be more than one -right- way. 
Recommendation # 5 - - The HCFA and the PHS should support research efforts 
that could help reduce racial disparities in organ allocation. 
Comment: 
We strongly support this recommendation. It Is critical' to determine If the 
apparent di"sparities in waiting times are truly related to inherent clinical 
issues, discriminatory behavior (intentional or unintentional), or a combination 
g. no 
factors, Given the apparent disparity among regions (e. difference in waiting 
time NEOB's region but varyirig levels of difference in most others) this is 
Is there a signifcant difference between 
obvious a complex issue. For example, 
many 
the experience at single-transplant center OPO's versus those that serve 
transplant centers? Is there a difference between those OPO's that already have 
a single unified list and those that stil allocate among each individual center 
list? These dat already exist, could be analyzed further now, and the results 
included in the final version of the report. 
Finally, NEOB would be pleased to work with the Ofice of the Inspector General 
iricollecting and  testing of any proposals. 
analyzing data, as well as the 
We loo~ forward to conversations with you and/or members of your staff 
important issues. 
concerning these 
Sincerely yours, 
chard. s. L 
Executive ' Director  OIG Response To NEOB  Comments
We recognize the importance of NEOB' s caution on the danger of seeking premature consensus 
on medical practice guidelines concerning organ trsplantation. Yet, there is an extensive body 
of information which has been developed which, it appears, could be drwn upon to provide 
some authoritative framework for guiding (not prescribing) medcal practice in this ara. If the 
medical criteria exception serves as the only legitimate basis for deviating from the first cOp1e 
first served rule, such a frework would seem to be especially imponant. The matter of 
determining a threshold level of match, as suggested by ASHI, might be one paricular to focus 
on in this regard. 
We also recognize the limitation that NEOB notes concerning the relevance of a demonstration 
as we note in the text, such 
project concerning the use of the first come first served concept. Yet, 
an effon can provide some useful data and can help us gain a better understanding of the costs 
. and benefits of allocating organs from larger donor pools. If two or more adjacent OPOs are 
demonstration warants the effon. 
ready to paricipate, we think such a  ;, .
 . .
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ndation
organ procurement fO. 
n -
January 22, 1991

11.0.. Prl
P.trila AU., 
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II.OD~  .5K
HW-~.  I.  Wil" M.
LeF.t, 1'.. 
n.. 
At utClliw'
A.  Do.afM-
The Honorable Richard P. Kusserow

Inspector General

Department of Health and Human Services

BRS North Building

330 Independence Avenue, S. 
C. 
Washington, D. 20201 
Dear Mr. Kusserow:

(SEOPF) wishes to comme: 
The South-Eastern Organ Procurement Foundation  for 
on the Draft Document: "The Distribution of Organs  Transplantatio' 
imrtant 
Ethxpaenct 2at0i oynesa ransd  tPor atchtiec essc i.e nSEcOeP Fo fha st rbaenesnp alna ntation incclonutdriinbgu ttohre  fuors em o 
histocompatibility matching as a basis for organ distribution (bibliograp 
attached) . Several issues concerning the equitable distribution of orga
for transplantation raised in your Draft can be addressed by scient 
organizations such as SEOPF. These issues have sparked some controversy a 
considerable debate within our organization. The observation that blacks wa
whites, the fin 
longer than ' ing that women wait longer than men, the foe
role of histocompatibili 
upon short-term rather than long-term results, the ' 
testing and the availability of particular patients for transplantation wh 

an organ comes available are examples of important questions discussed with

the committees of SEOPF. .Data from a SEOPF Member Organ Procuremeidnte nAtgief
i 
dinodniocra toer gtahnat t hblaanc kw phaittieesn ts arOe lm)o.r eS EoOfPteFn b eYlniaevvaeilsa btlhea tf oard daint ional da 
cfoilnldeicntigosn  iann d yaonaulry sDisr awfitl lD obceu immepnotr.t aTnth et oS Ea OcPoFrr Seccti einntteifripcr ePtartoijoenc otfs  
Center et.fects and 
Publications Committee is undertaking studies of 
We expe 
access of minorities to cadaver donor kidneys for transplantation. 
that the results of these SEOPF research studies will be helpful to you 

the entire transplant community in our effort to understand the reasons
dliafferetnteial arcc esst ohf pairtsicula r ypatieent garoupsr t.o cadaver organs f 
Dr, 
transplantation. SEOPF appreciates the opportunity to comment on the 
wit
of its research 
Document and looks forward to sharing the results '
Sincerely yours, .

Ja. 
R. Randal Bollinger, M.D., Ph.

President, SEOPF
RR:lc 
7740 ShraMr Road . Suil  A . Richmond. Virginia 23228 .  lephM (801 672.2m . FAX (80) 672.2643  OIG Resp SEOPF Comments 
onse To 
We are pleased that SEPOF has been examining many of the issues raised in our repon and that 
its Scientifc Projects and Publications Committee is devoting parcular attention to the access 
EOPF and its member institutions bring much 
of minorities to cadaver kidney transplantation. 
We look forward to the results. 
expertse to such inquir.