I . 

Department of Health and Human Services 

OFFICE 

INSPECTOR GENERAL 

THE DISTRIBUTION OF ORGANS 

FOR TRANSPLANTATION: 

EXPECTATIONS AND PRACTICES 

f.lwJcrs. 

Richard P. Kusserow 

INSPECTOR GENERAL '0 

Jy-l" ""d3'a GEl -01-89-00550
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 

with many individuals involved with the field of organ trnsplantation; and on a review of 

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 

trnsplant, subject to established medical criteria; 

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. 

Highly sensitized patients-those whose immune system makes it difficult for them 

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 

. remains heavily controlled by the individual transplant centers and confined primarily 

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 

transplant center and- donor hospital in an OPO service area adhere to the centralized organ 

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. 

Before granting Medicare recertification to an OPO, HCFA, in collaboration with PHS , should 

assure that the OPO is distrbuting organs equitably among patients, according to established 

medical criteria. 

Before grnting Medicare recertification to an OPO, HCFA, in collaboration with PHS, should 

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 

trnsplantation. The ASTS noted its readiness 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 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 ...................... ............................... .......... AAPPENDIX B


Tables Derived From The Organ Procurement And Transplantation 

Network Data Base.... .......... 

APPENDIX C 

Endnotes................... .....,................................................................................. CAPPENDIX 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 

awaiting a donated organ. 1 We examne the distrbution procss, from the point that an organ is 

procured to the point that it is transplanted.2 We pay parcular 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. 

Our methodology is based on four major lines of inquir: 

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 

1987 and March 31, 1989.6 The analysis focuses on demographic and other factors 

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 

professionals;8 and 

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 

categories of members to be appointed by the HHS Secreta. In addition to 4 ex-officio 

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 

OPTN called fodn the 1984 legislation. 12 

In September 1986, the Public Health Service (PHS) contrcted with the United Network for 

Organ Sharng (UNOS) 13 to develop the OPTN. 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; 

improve and increase the access to an optimal organ trnsplant; 

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 


identifying potential organ donors and for notify ng an OPO of such donors. €

written rotocols for€

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€

coverage accorded to individuals with end stage renal disease (ESRD). 16 However, in 1987 it€

made hear trnsplantation a covere service for Medcare beneficiares 17 and in March 1990€

issued a draft re coverage of liver transplants in adults under certain€

fulation proposing;
 circumstances. 1


Paraleling the above developments has been a steady incrase in the number of transplantation€

programs. By April 1990, there were 250 medcal institutions in the United States operating€

organ transplantation progrms. 19 There were 72 HHS designated OPOs that in 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 

cadaver organs22 are made available to the more than 20,000 people now awaiting them. We 

star by identifying the fundamental expectations which Congress and professionalleaders 

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 

COllgress and professional leaders ell vision the development of orgall distributioll practices 

that are (1) equitable to those in need (2) carried out in accord with a natiollal system, and (3) 

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€

legitimacy and continued advancement of organ trnsplantation.24 Each is briefly explained€

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€

underpinning of the above expectation. The trail begins with the National Organ Transplant Act€

of 1984. In that legislation, Congress specified that an OPO must "have a system to allocate€

donated o ans among 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 26€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€

applied. The Task Force also recommend that the criteria be developed by a broadly€

representative group that wil take into account both need and probability for success.€

Selection of patients otherwise medically qualifed should be based on length of time on€

t e walt ng 1st. €

Then, in 1988, Congress once again addressed the matter of organ distrbution. It amended the€

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€

trnsplant centers.28 In a report accompanying the amendment, the House Committee on Energy€

and Commerce noted that concerns had been raised about OPOs being "in a position to show€

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 

recognized that for these highly sensitized31 individuals, the opportunity to receive a medically 

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€

the distrbution of organs in many parts of the countr.32 It recognized that it was in the public 

interest to develop more fonnalized and systematic mechanisms guiding organ procurement, 

distrbution, and transplantation throughout the countr. In this regard, the legislation enjoyed 

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 

adoption of "unifonn policies and standards by which all wil abide. ,,33 Such policies and 

standads, it indicated, should address matters such as the acceptabilty of an organ for 

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 

but are by no means limited to trsplant 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€

While there has been progress, current organ distribution practices fall short of congressional€

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 

disparties related to an individual's race, transplant center, and level of sensitization. 

Race: First, with respect to race, we found that blacks were waiting almost twice as long as 

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 substatial difference, we were informed by professionals in the 

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 

highly sensitize35 and are between 18 and 64 years of a 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 

October 1, 1987 - March 31, 1989 

17. 

_"'H.__._.-..,,"-....._m... 

t- 10


All Blood Types 

BLOOD TYPE


Black (N=3 797) I2 White (N=8,360) 

Note: Ages 18-64, Not Highly Senstized (i.e., PRA =75) 

Data Source: OPTN Contractor 

Data Anlysis: OIG/OEI 

Thus, on the basis of the above-noted analysis and of a proportonal hazds analysis38 wherein 

we examined the independent effect of race, holding age and blood type constant, we are unable 

to explain the longer waiting time of blacks on the basis of bloo 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 

whites was about the same. In the other regions, blacks waited longer, with the ratios ranging 

from 1.25 to 2.74. 

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 

registration center ' waiting list against the ratio. We found that the ratio of blacks' median 

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 

allocation systems are at least parially based on human leukocyte antigen (HLA) matching.40 In 

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.€

Stil other considerations that might help explain the difference are (1) the patient s medical€

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€
more likely to receive a kidney transplant.€

noted that it was "unlikely" that medical factors alone accounted for the fact that whites were€ 41€

After reviewing disparties in varous medical treatment decisions, the CounCil concluded that in 

part they "may reflect the existence of subconscious bias.' A2 It elaborated as follows:€

This is a serious and troubling problem. Despite the progress of the past 25 years racial€

prejudice has not been entirely eliminated in this country. The health care system, like all 

other elements -of society, has not fully eradicated this prejudice. " 43 

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€

percent of theU.S. population,44 they account for 34 percent of dialysis patients in the End Stage€

Renal Disease Program. 

At the same time, it must be noted that blacks are less inclined to donate organs than are other€

groups. In 1988, only about 8 percent of all cadaver kidney transplants involved the use of a€

kidney from a black donor.46 The possible explanations for this situation are many and€

complex 47 but certainly among them must be the relatively small number of black procurement€

coordinators working for the organ procurement organizations.48 In this regard, the president of€

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


organ procurement coordinators. Therefore; would like to suggest that the OPO be€

strongly encouraged to train and hire black transplant coordinators. This effort could be 

coordinated through NATCO and AOPO. 

Transplant Center: A second major respet in which we found patient access to organs to be€

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. 
......._.._.. . ............

From our proportonal hazds 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 

awaiting a fit 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 

retreve, they keep one for one of their own patients and give one to the common pool. The 

kidney donated to the pool is then made available to another trsplant center in the service ara, 

usuall y in accord with some rotational argement. 

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.March 31. 1989)€

Data Analysis: OIGIOEI€
Lel'el of Sensitization: Finally, as professionalsjn the transplant field would expect, we found 

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 

within the individual service areas of the 72 Organ Procurement Organizations. 

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 

kidneys which match perfectly with a candidate on the national list 1 be made available to that 

candidate, wherever he or she may reside in the United States. 

The above ar 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. 

Just as the OPT has been a constructive factor in the development of a national organ 

distrbution system, so too has it been an important reflection of the readiness of many diverse 

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 

sense of ownership of donated organs they have retreved. This orientation inhibits further 

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 

incentive to car 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 

donated in their area were being sent to other aras that are less successful in obtaining donated organs. 55 

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 procurement is enhanced by local use. Or gaT) donation is a donation.' Those who raise money 

for transplant recipients report that donations are highest where there are local patients 

waiting for organs. Furthermore, it is inequitable to force ffcient OPOs to by-pass their 

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 

OPO.57 Such an arangement was necessar to maintan support for the perfect match 

requirement, even though that requirement affects only aJ:)Qut 8 percent of all cadaver kidneys 

. 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 national 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 

a significant proportion of dialysis patients, with close to 9,00 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 awaitilzg trallsplantatiOlz alld (2) distribute 

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 

which they ar 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 

the proper scope of medical crteria and how such criteria should be applied at a time when there 

is a considerable shortage of donor organs. These differences involve, among other things, the 

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.6O 

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 service areas and (2) the mandatory distributioll of dOllated 

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 

able to tae 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 

recertfication decisions.61 To overlook this matter, or to leave it as a matter for OPOs to certify 

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, 

should assure that the OPO is conducting a rigorous, sOllndly based orgall procurement effort. 

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€

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 62€ 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 for blacks thaI' whites awaiting a kidney transplant and of all)' actiolls 

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 

Secretar for Planning and Evaluation (ASPE). In addition, we received comments from many 

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 

financial, social, and/or personalconsiderations. In short, most of the respondents would have 

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. 

On our recommendation callng for each OPO to develop a single, unified list of patients and to 

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 

serve to reduce the racial disparty. The ASPE, which was critical of many of the report 

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 a bigger problem than organ distrbution. Similar sentiment was expressed by some€

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 waiting 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 understand, 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€

be distrbuted equitably among patients, not among trsplant 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€

registr awaiting a second or third transplant during the time period covered by the analysis.€

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:€

(a) registered at more than one center, and€

(b) had not yet received a transplant by March 1989€

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: 

(a) registered at more than one center, and 

(b) received.a transplant at one of them, 

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 

data used in the analysis excluded those individuals that did not have valid dates. In 939 

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 AConstruction Of Study GrQup First Set Of Exclusions From Data 

Reason for exclusion 

Transplant prior to 

10/1/87 

No registration date 

Transplant date precedes 

regislTation date 

Number excluded 

770 (20%) 

939 (4%) 

134 ( 1 %) 

Number remaining 

18,862 (80%) 

923 (76%) 

789 (75%) 

Only a case-by-case audit can detemrine that all dates in the data are valid. This analysis 

waiting times assumes that all dates for people not explicitly excluded, as above,- are valid. As 

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 

from October 1, 1987 through March 31, 1989. The rOUtes by which they obtained their 

transplants, according to the rules specified earlier, are shown in table AA - 2 
TABLE A- 2€

The Relationship Between Registration center And Transplant€

Center€

Transplantation Routes€

Registered at only one center, reeived trsplant at tht center€

Registered at only one center, received trnsplant elsewhere


Registered at more than one center, recived trsplant at center€

of ealiest registration


Registered at more than one center, received trsplant at €

center of later registrtion€

Registered at more than one center, received trsplant€

elsewhere€

Frequency€

974 (74%)€

781 (22%)€

125 (2%)€

132 (2%)€

36 ( 0%)€

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%) 

Missing race 8 (0%) 557 (74%) 

Missing blood type 1 (0%) 556 (74%) 

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€

. The analysis of waiting times concentrates on estimation of the median waiting time to first 

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.€

Kaplan-Meier survival curves66 are used to calculate the estimated median waiting time to first€

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 

those stil waiting at the end of the study period, registered at some point prior to the beginning 

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?

group, and SIze Of regIstrtIon center as measure by the number of regIstrants. The results of 

these analyses are presented in appendix B in tables B-3, B- , andBMost 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 

described by Cnaan.71 The registration periods, or blocks, used are presented in table AA - 5 
TABLE A-6€

Blocking Periods Employed In Multivariate Analysis€

Date of registration 

up to 09/30/84


10/01/84-03/31/85 

04/01/85-09/30/85 

10/01/85-03/31/86 

04/01/86-09/30/86 

10/01/86-12/31/86 

01/01/87-03/31/87 

04/01/87-06/30/87 

07/01/87-09/30/87 

10/01/87-03/31/89 

Total in study:€

Number of registrants 

433 

142 

221 

404 

644 

421 

629 

796 

573 

12,293 

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 

person s chance for blood types Band AB. 

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 

receiving a trnsplant more than an increase from 10 to 20. 

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 

from those reported above. In paricular, excluding short waiting times (some people got a 

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 

gender (blood types A and 0). 72 It appears that these factOrs may have some time dependence in 

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). 

We then calculated for each region the mean ratio of median waiting times. Table A-7 gives the results of this analysis. 

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)€

II (DE, MD, PA, VA, WV, DC) 

IV (AL, FL, GA, KY, MS, NC, SC, 1N)€

(IL, IN, MI, MN, OH, WI) 

VI (AR, LA, NM, OK, TX)€

VII (lA, KS , MO, NE) 

VII (CO, MT, NO, SO, UT, WY)€

(AZ, CA, HI, NV, GU, Trust TeITitory of 

Pacific Islands, American Samoa) 

(AK, 10, OR, WA) 

Unknown€

TOTAL€

1.88€

1.82€

1.25€

1.89€

1.94€

1.03€

1.85€

1.64€

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 

blacks on the waiting list. The R2 for this model was 0.03, 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€
To detennine if there may be some curvilnear relationship, we also fit a quadratic model to the 

data. The plot of this model is shown in figure A-2. The R2 for this model was increased (0 only 

05; that is, only 5 percent of the varation in the value of the ratio is explained by the variation 

in the percent of blacks on a registration center s waiting list The results of both of these 

anempts at model fitting would indicate that the ratio of blacks' median waiting time to 

transplant to that of whites is not affected by the percent of black recipients, or potential 

recipients, residing on a registration center s waiting list. 

A - 9 
....

.. ... .. . .. .. . . ......... . . ..,... ... ..... ...... ... ...

FIGURE A -€

RATIO OF MEDIA WAmG "MES 

BY PERCENT BLACK ON TRSP CE WAJNG 

BLACK TO WHIT RA110 

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€

SaUD UNE IS EXEC. DASHED UNE IS 95 " C.€

A - 10

. . . 

,

FIGURE A-2€

RATIO OF MEDIA WAmNG "MES€

BY PERCENT BLACK ON TRSP 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€

SaUD UNE IS EXEC, 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 base of 17,556 individuals in the United States who between OctOber 1 , 1987 

and March 31 , 1989, were wai ng for or actually received a first kidney transplant. 
TABLE BDemographics 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 BBlood 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 

Controllng For Blood Type And Peak PRA 

Ages 18-€

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€

PEAK PRA LESS THAN 


BLOOD TYPE 

OVERALL 

PEAK PRA GREATER THAN €

BLOOD TYPE 

OVERALL 

ALL BLOOD 

TYPES AND ALL 

PRA LEVELS 

Ages 18-4


SEX 

FEMALE MALE 

. 4.4


14.3 12. 

12, 11.3 

8.4 

SEX 

FEMALE MALE 

31.3 23, 

20.4 2.5 

21. 

38, 25. 

36, 22. 

10. 

B - 5 
TABLE B-€

Estimated Median Waiting Times In Months To First Transplant By Quartile 

Controllng For Blood Type And Peak PRA 

PEAK PRA LESS THAN 

BLOOD TYPE FIRST 

5.1€

OVERALL€

PEAK PRA GREATER THAN 

BLOOD TYPE FIRST€

17.5€

43,€

34.€

OVERALL 23.4€

Ages 18-€

QUARTILE€

SECOND THIRD FOURTH 

4.5 4.1 5.4 

6.1 

12.3 15.5 

10.1 12, 

9.5€

QUARTILE€

SECOND THIRD FOURTH€

21.2 19. 39.€

27,€

22. 21.8€

30.3 32.4 34.3€

27. 24. 38.€

For an explanation a/the quartiles, see appendix A, section on "median waiting times.€

B - 6€
TABLE B-6 

Results Of Proportional Hazrds Analysis Time In Months To First Transplant 1 

Relative Risks and 95 Percent Confidence Intervals (Clf

BLOOD TYPES A AND 0 

FACTOR Relative 95% 

Risks 

Mae 1.05 (1.00- 1.11) 

Black 64- 73)*** 

Pea PRA 

(75 vs 0) 26.63)***€

Center Waitig List Size€ 90- 96)***€ (100 vs 25)€

659 Tralants 

798 Still Waiting€

BLOOD TYPES BAND AB€

Relative 95%€

Risks€

1.08 96- 1.22)€

68- 87)**'€

.33 11- 98)**'€

84- 97)**€

281 Trasplants 

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 ATABLE B-€

Date Of Registration Of Study Population 

DATE OF REGISTRATION NUMBER PERCENT 

Before 1986 

1186 - 616 

7/86 - 121 

1187 - 617 

7187 - 1217 

1/88 - 618 

7188 12188 

1/89  3189€

TOTAL€

967 5.4€

506€

798 4.5€

432€

649 20.€

952 22.€

180 23.5€

305 13,€

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. 

This included 16,939 awaiting a transplant for a kidney, 1,572 for a hear, 936 for a liver 

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 

understanding that it is a broader one that addesses not only the factors used in allocating 

the' limited supply of organs to individuals on waiting lists, but also the actual results of 

that process-that is, the individuals ho actually received the donated organs. Given the 

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 

to organ transplantation and the costs of organ acquisition. These are: (1) "The Access of 

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 

restrcted conditions. Other types of transplants are still regarded as experimental, 

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 

development for the individuals involved (those with kidney failure have access to dialysis 

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 

contrctor selected by the Public Health Service to help operate the Organ Procurement 

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, 

Hearngs before the Subcommittee on Investigations and Oversight, Organ Transplants,€

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 

Recommendations, April 1986, 

13,€ The UNOS emerged frm 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 for Histocompatibility and Immunogenetics Quarterly, Winter 1989, 

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

distrbution in 1988. That legislation included a number of amendments bearing on the

PHS grant program, level of oro procurement activity, and the workings of the OPTN.

In regard to the latter were requirments that the pPTN "establish membership criteria and

medical criteria for allocating organs" and can 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. 

16.€ Under the Social Security amendments of 1972, Congress extended near universal 

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. UNOS/OPTN, Facts About Transplantation in the United States, April 1990. 

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 
) )) , 

trnsportation and storage of organs, and, where applicable, the operation of a central€

register of transplant candidates in the service ara,€

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, 

Nephrology News and Issues, Vol. 4, No. 3, pp. 32 and 34, 

Throughout the report, our focus is on organs procured from cadaver rather than livingrelated 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. 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. 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 

reiterates that: "The conferes are particularly concerned that OPOs adopt medical criteria€

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 organ. Patients develop antibodes nd thus become 

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 

involving many trsplant 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 biological atch for that candidate, Thus, a candidate 

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 

remained betWeen 22 and 24, In 1989, with the data 60-70 percent complete, black 

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, 

Through proportonal hazds analysis, we determined that when age and blood type were 

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 Discriminate Against Blacks?" Transplantation Proceedings, 21, December 1989, pp, 3874-

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 

of the American Medical Association, 263, No. 17, May 2, 1990, p. 2345, For other aricles 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 Medicare End-Stage Renal Disease Progrm New England Journal of Medicine, 318, pp. 223-

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 

Callender, e.O. The Results of Transplantation in Blacks: Just the Tip of the Iceberg, 

Transplantation Proceedings, Vol. 21 , No.3, 1989, pp. 3407- 10; and McDonald, J.e., 

Comment: Issues Related to Race in Transplantation Transplantation Proceedings, Vol. 

, No, 3, 1989, pp, 3411-12, 

48.	 The Division of Organ Transplantation in the Public Health Service indicates that it has receivedinformation 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 

organs that become available are not distrbuted on the basis of this national list. 

51.	 This policy of the OPTN ("mandatory sharng of phenotypically identically matched kidneys ) 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, 

54.€ For furer elaboration on these arguments, see Sta, T., et al" "A Multifactorial System 

for Equitable Selection of Cadaver Kidney Recipients," 1 ournal of American Medical 

Association, 257, 1984. pp, 3073-5; Congressional Researh Service, "Organ 

Trasplantation in the United States: Analysis of Selected Ethical Issues, " February 1989; 

and "Patient Selection Crteria in Organ Transplantation: The Critical Question 

Transplantation Proceedings, Vol. 21 , No. 3, 1989, pp, 3377-3445. 

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, 

Transplantation Studies, Battelle Human Affairs Research Centers, Undated. The survey 

was conducted in Januar 1987. 

60.€ See Transplantation Proceedings, December 1989, parcularly the aricle by Greenstein 

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 

must develop and have approved a corrective action plan addressing specific concerns 

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- I to lll- 13, 

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 

Incomplete Observations," Journal of the American Statistical Association, 53, 1958, pp. 

457-481. A good CUIent summar of the method and subsequent modifications appears in 

Kalbfleisch, J, D., and R.L. Prentice, The Statistical Analysis of Failure Time Data, John 

Wiley, 1980, pp. 10- 16, 

67. Brookmeyer, R" and J. Crowley, "A Confidence Interval for the Median Survival Time, 

Biometrics, 38, 1982, pp. 29-41. 

68.	 See Cnaan, A. , and L. Ryan Survival Analysis in Natural History Studies of Disease 

Statistics in Medicine, 8, 1989, pp, 1255- 1268, The authors also cite some earlier 

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. 

69.	 Note that estimated medians do not behave like arthmetic averages, It isperfecdy 

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 

Procedure," SUGl Supplemental Library User s Guide Version 5, 1986, pp, 437-466. 

71. See Cnaan and Ryan, 

C - 8 
72. Deviation from strct proportonality was detennined by examining "paral residuals" tests 

as descrbed by F. Harll (1986), cited above, and Schoenfield, D" "Panial Residuals for 

the Proponional Hazs Regression Model, Biometrika, 69, 1980, pp, 239-241. 
APPENDIX D


DETAILED COMMENTS ON THE DRAFT REPORT 

AND OIG RESPONSE TO THE COMMENTS 

In this appendix we present the full comments of all the pares that responded to the drt 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 

Date 

From 

Subje 

_._.._;

Memorandum 

DEC I 0 190 

Assistant Secretary for Health 

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 actions to implement them. 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 to racial disparity in estimated median waiting time for a 

fi rs t kidney t ransplan 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 utility. and omparable effectiveness. 

. fl 

. J son. 

D. 1)-;­

t2A

Attachment 
! 

COMMENS OF TH PUBLIC HETH SERVICE (PHS) .ON OFFICE OF INSPECTOR GENERA (OIG) . DRAT 
 RT . STRIBUTION OF

ORGANS FOR TRSPLAATION EXPECTATIONS AN PRACTICES, 

OEI-01-89-00550, AUGUST 1990. 

GEN COMMENTS 

The OIG draft report states that access of patients to donated organs remains Unequal in some importt respects. Under the 

Health Resources and Services Adstration' s (URA) Organ Procuement Transplantation Netwrk (OPTN) contract, the United Netwrk for Organ Shar.1g (ONOS) 1s conductg a study of the 

organ allocation systems. Where disparities ar found, the 

study will explain those differences and, where appropriate, 

propose measures to elimnate them. This study is scheduled to

be completed in July 1991. Additionally, a study of OPTN and 

Scientific Registry data is curently underwy. The study will

evaluate the factors that affect wait.1g tie 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 will be submitted to the New England Jourl of Hedc.1e .1 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 

A concern PHS has with the OIG report is tht it appears that 

the OIG did not sufficiently consider hum leukocye antigen (HL) matching as a factor. contributing to the racial disparity 

in estimted median waiting times for the firt kidney transplant. PHS believes it is a signficat variable that 

should be considered when lookig at the black versus white 

waiting times. Although the degree of antigen matchig that 

positively affects the outcome of a transplat contiues to a matter of much controversy, cuent ONOS policy requres that the highest priority be given to six antigen matched Or 

phenotypically identical recipients. s policy may place 

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 

a disadvantage in term of organ allocation. 

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

reactive antibody sensitization, BL 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. 

The OIG advocates the use of a single, unfied waiting list of patients awaiting transplantation for each OPO. PHS supports this position. he concept of a single national list needs addi tional study before any conclusions an be reached about 

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 which may have an effect 

on the quality of the organ .that is ultitely transplanted. 

Specifically, preservation time becomes a critical issue and 

success rates may be affected with the lengt of time that elapses before transplantation can occu. Secondly, transporting organs long distaces leads to increased costs 

because in same cases a transplant team has to fly to the site 

of the donation to procue the 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 

disincentive. to procuement for the beefit of one' s patients. 

This might discourage those OPOs that are high producers 

because potential recipients in their ara mayor may not have 

. access to the organs they procued. S.1larly, national 

sharing provides mil incentive for less ,successful OPOs to 

try to step up their efforts as their ow procuement rate will 

have little effect on the allocation of organs to individuals 

on the waiting list in their service areas. While PHS is 

concerned about the deviations fro 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. 

Finally, the OIG states that blacks are less inclined to donate 

organs than other groups and points out tht in 1988, only 

about eight percent of all cadaver kidney transplants involved the use of Ii kidney from a black donor. It furer states that 

of an est ted 300 organ procuement specialists working in 

the 72 organ procurement organzations, only about 14 are 

black. PHS believes that any efforts to reduce racial 

disparities in organ allocation, should include education for 

potential donors, recruitment of black organ procurement 

specialists, and training of organ procuement coordinators 

how to approach famlies of differing cultural and ethic 

background. 

OIG RECOMMNDATION 

PHS, in collaboration with OPTN, should issue regulatio require that each OPO: (1) estalish a single, unified list of 

patients awaiting transplantation, and (2) distribute donated 

subject to established medical criteria. 

ans to those patients on a first-come fixt-served basis, 

PHS RESPONSE 

We concur. 

(1) DHHS is developing regulations for governng OPTN that 

will address these issues. The proposed regulations will be unown at issued by means of a NPRM. The date of issuance is 

this time. Additionally, the OPTN contract requres that 

study be conducted of the feasibility of estalishing a 

national waiting list. This study is to be comleted in 

u1y 1991. 

(2) DHHS is exploring includig organ distribution and 

allocation policies as part of the regulations packg 

imlementing P.L. 99-509, which requres transplant hospitals 

to be memers of OPTN. The Office of the Geeral Counsel has 

advised that the Departent canot share the draft proposed 

regulations with OPTN until they 'are issued. Howver, before 

undertaking revisions to the organ distribtion allocation 

system, PHS will ascertain the effect of BL matching and other whtes. 

biological factors on waiting times for blacks and 

dispariti are identified. Additional qualitative studies will be underen if actual 
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


We concur. The proposed regulations will address ths issue. 

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 and issuance of the 

above-referenced regulations, HRSA will intiate discussions 

with the Agency for Health Care Policy and Research (AHCPR) and 

the National Institutes of Health (NIH) to dete%'e the feasibili ty of establishing medical practice guidelines 

addressing organ transplantation. We expect that OPTN will 

play an active role in the development of the medical practice guidelines. 

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 be studied include age, sex, 

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 

development. It will be conducted in tw geographical areas in

which there are established -required request laws. e draft 

report does not coment on the fact that 44 States have now 

passed a -required request law, - which, among other thgs requres hospitals in those States to develop protocols related 

to organ and tissue procurement. e study will also provide 

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 

required request laws, hospi tal policies, and. provider 

knowledge and attitudes. 
OIG RECOMMENDATION€

PHS should fund a demonstration effort incorprating the€

following two features: (1) the establishment of a single,€

unified waiting list including all patients awating an organ
 transplant in -a numer of OPO service areas, and (2) the


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€

HCFA and PHS should support research efforts tht could help


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 

racial and ethic groups and to proote measues to elimnate differences that exst. 

A specific requirement to exame cut policies and practices regarding organ recipient selection. 

Where disparities are found to result fr those 

policies and practices, the contractor is to exlain 

those differences and, where appropriate, propose 

measures to elimnate them. 

Addi tionally, BCFA is undertg a study of patient access to 

transplantation. The study, being conducted by the 

Corporation will exame how patients are selecec for 

transplantation and why organs are frequently trplanted into patients other than those identified the UBS' comuter as 

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 -

2. conducting a rigorous, soundly based organ €procuement effort. 

PHS RESPONSE 

We concu. We will provide infor.ation or assistace requested

by HCFA to support their Medicare recertification decisions regarding OPOs. PHS, through HRSA s Division of Organ 

Transplanta tion, periodically meets with UNOS to review the

acti vi ties and perfor.nce of the OPOs. The infor.tion and 

data obtained through this and other means will continue to be 

made available to BCFA. 

Also, HCFA sureyors periodically visit OPOs to evaluate their 

perfor.nce and compliance with OPTN and or BCFA stadars. The 

proposed regulations that were 'discussed above will strengten , OPTN S standards especially regarding' equitable distribution of 

organs among patients awaiting tr splantation. 
TECHNICA COMMS 

1. Page 6, 3rd paragraph 

Include the foot ote no. 31 in text to offer an explanation of highly sensitized patients. 

2 . Page 9., " last paragraph 

Change .registration center. to .transplant hospital. each 

place it occurs, since . registration center. is not a 

commonly used ter. in transplantation discussions. 

3. Page 13, 1st paragraph 

Insert . regiona1 lists then" after individuals. 

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 

transplant hospital and the OPO that mae decisions about 

organ distribution. If the intention here is to get the 

transplant center or surgeons out of the process of mang 

organ distribution policies, this recommendation may fall 

short of reaching that goal. Many OPOs are either diected 

by a transplant surgeon' or have a medical/advisory boar that sets organ distribution policies. e recomendation 

that OPOs serve as tJe "engine of the organ distribution 

system" will be applauded by the OPO comty. Conversely, 

transplant surgeons/physicians who believe' that OPOs have 

too much control already, will strongly oppose ths 

recommendation. 

6. Page C-S, Footnote 24 

e footnote related to the underlying legitimcy and 

continued advancement of organ transplantation is vague and 

should specifically refer to the keep-one shae-one concept 

and the idea that local use encourages procuent efforts. 

Additionally, the last sentence which refers to variations 

in the distribution system is incorrect. It is possible to 

do a computer study to determe whether OPOs with variances 

(especially a variance that pe1:ts keep-one share-one) have better procuement rates. As par of the OPT contract, 

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 

Technical Comment #5, "to get the trsplant center or surgeons out of the process of makg 

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 

discussion on pp. and 2, As noted there, when a transplant candidate is registered at more 

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 
./ 

... .. 

Date , DEC 3 190 

,'Om - Gail R. Wilens, Ph.D. 

Administrator 

Subject 

OIG Draft Report - 'The Distribution of Orga 

Exectations and Practices , OEI-Ol-89-00550 

The Inspector General 

Office of the Secretary


Memorandum 

for Trantplantation: 

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 

subjec. Please advise us whether you agree with our comments on the report 

recommendations at your earliest convenience. 

Attachment 
Comments of the Health Care Financin Administration HCF QDG Draft Report - The Distribution of Organs for 

Transplantation: Expectations and Practices 

OEI-01-89-00550 

HCF A and PHS Recommendation 

HCFA and PHS should support research effort that could help reduce 1acial 

disparities in organ allocation, 

Response 

HCFA concurs with OIG' s recommendation. In response to ths audit report, 

HCFA has contracted with the Rand Corporation to complete a study which wil 

address racial disparities in organ allocation. The study was started 

September 30, 1990 and completion is expected by September 30, 1991. 

HCFA and PHS Recommendation 2 

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. 

Response 

HCFA concurs with OIG' s recommendation. We plan to publish manual 

instructions that will require HCFA surveyors of OPOs to determine if organs 

are distributed equitably among patients, It is anticipated that the revid 

manual instructions wil be issued in early December 1990. The first certification 

reviews using these manu a) instructions are scheduled for January 1991. 

However, it should be noted that HCFA does not have the authority to set the 

standards by which organs are distributed, This authority reSts with the Organ 

Procurement and Transplantation Network (OPTN), under the auspice of the 

. Public Health Servce. HCFA wil enforce the rules regarding the allocation of 

organs that are established by the OPT. 

HCFA and PHS Recommendation 3 

Before grnting Medicare recertification to an OPO, HCFA, in collaboration 

with paS, should assure that the OPO is conducting a rigorous, soundly based 

organ procurement effort. 
Page 2


Response€

HCFA concurs with this recommendation. Regulations at 42 CPR 485.306 

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 

procurement currently in effect, are for the most par appropriate, but wil 

recived data on strengthen the enforcement of those requirements. HCFA has€continue to use
 organ transplantation from the Public Health Servce, and will €

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. 

Second, in regard to the recommendation that OPOs conduct rigorous procurement efforts, we 

understand that varous types of performance indicators are now being considered by HCFA. 

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 
\ .._ _. 

RECEIVED w.s C. 202 REGION 1 - O,G/OEI oc: , 2 ' 

OCT f 9 '990 

TO: Richard P. Kusserow 

Inspector General 

FROM: Assistant Secretary for

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, ' there 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 time -

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 purpose of the deletion was lito 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 

requirements on OPOs governing the distribution of organs. 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 

been promulgated by the Secretary. 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 

served" as a primary criterion for kidney allocation8 

However, medical criteria are primary. Thus, a finding 

that disparate waiting times based solely on a "first 

come, first served II principle 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 

transplant at a lower rate than do whites (callender, 

, 1987). 

other waiting time issues are raised for your consideration in the attachment. I urge that these be 

explored more fully in the report. 
Page 3 -- Richard P. Kusserow


Sinale List Per OPO I agree that the distribution


system should provide for equitable allocation of


donated organs, and that a single list per OPO 
 have 

the potential to improve orqan sharing. However, as noted above, the focus on "waiting time" as a primary cri terion for transplantation in two of the 

recommendations and much of the tex is inappropriate 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 rigid post-transplant regimens This is an area which furer exploration should be recommended. "Findings from the National 

Kidney Dialysis and Kidney Transplantation study" might be consulted for data in these areas. 

Also, there is no discussion of ,the weight given to age 

in the transplant decision, and the age at which


different racial groups are diagnosed, i. e., as 

juveniles, young adults, or the elderly. Are younger 

persons expected to have. better outcomes -- longer 

graft survival -- or less likely to have co-morbid


conditions that may contraindicate transplantation,


etc. ? If younger persons are otherwise not better candidates than older persons, doesn' t an orqan placed 

in a younger person nonetheless maximize the benefit


derived from that organ simply because it will (statistically) provide- many more years of use? 

Inclusion of data from Eggers' (1988) findings on graft 

survival would be informative. 

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


promulgated by the Secretary, although the OPT has 

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 another patient for whom it might have 

proven more long lived. (It 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. 

The draft recommends that the PHS require, by reguations, 

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. Although compliance will be monitored by PHS, the 

rules will be imDlemented by HCFA under section 1138 of the 

Social Security Act. How ver, until these rules are 

published, there are no binding distribution policies. 

In several places (pages 13 and 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. And, the report recommends that PHS "require that -

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 

that OPOs do n2 "govern" any areas. 

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 

exception have worse performance than system allowing 

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 

provided that the competing considerations are presented fairly. 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 preferences were reduced (or strengtened if local 

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. 

This applies to endnotes as well, e.g., "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 DQ monitoring or compliance ctivities to assure that memers 

were following the policies. Therefore, the report should be 

careful to couch references to the OPT policies 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. Also, In the penultimate paragraph, next to the last line: 

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 

developed by the OPTN should be characterized as "policies, " 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 

should analyze this variable (which we understand. was to be done) 

to determine whether it is explanatory. Possible explanations of 

the differential may al"so include date 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 transplant. 

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 

the IG did not explore these in this study. 
- 2 -€

Page 13: Care should be taken not to link the OPT' s "local use" 

philosophy with HCFA' s OPO designations. To overcome .this 

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. 

The database is only about three years old. 

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. 

Page 15, fifth paragraph, line five: insert "excerpt from a" 

after 'te word following. " 

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. 

Page A. 5: The description of the "quartile" differentiator is not clear. Is the first quartile comprised of the centers with€

the largest list or the smallest?€

Appendices A and B: "Size of Cells. Some tales include the n 

of the cells. All tables should include this information. 
, .

Wai tina st Issues 

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 

comparison among individuals on the transplant candidate lists, 

e., there is no agreed-upon point in the patient' s course of 

disease when that patient can be entered on the list. Patients 

may be listed at any time, regardless of health status. Newly 

diagnosed patients, never dialyzed, and patients who are in 

extremis may be listed on the same date. The recently concluded 

Abt study found that over one-thrd of thos 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 an thical principle fails if waiting lists can be "gamed" by 

physicians and patients. For exple, the statistical analysis 

used in this report found that ODe percent of all transplants 

occurred at an earlier date than registration on the waiting list. . 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, "waiting time" is not a suogate for 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. 

Fourth, in the event that "waitin time" became a significant criterion for organ allocation, ESRD program osts would likely 

increase significantly. Such an increase would be due to the 

perceivea advantage of being placed on the list early, regardless 

of health status, and the subsequent need for frequent, 

relatively expensive; PRA testing.€
- 2 -

Therefore, I recommend that consideration be given to developing 

both a finding and a recommendation on the need to conduct 

research on lists of potential recipients and on improving their 

appropriateness for use in allocating organs. 

I also recommend that the term "waiting list" be avoided wherever 

possible and replaced with more neutral and techically correct terms. It is noteworty in this regard that the law carefuJ,ly 

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 nonmedical 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 section 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 exceptions 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 making process. Efforts ar now underway to corrt this situation. As ASPE notes, regulations 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 establishment 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. 

In its supportng comments on waitig list issues, ASPE indicates that if" 'waiting time 

became a signifIcant crterion for organ alocation, ESRD program costs would likely increase significantly." This is an importt point, one reinforced by ASTP 's expressed concerns 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 ongoing tests conducted on the sera of those on waitig lists, could be adding unnecessary 

to progr costs. 

Finaly, we have made a number of edits ASPE. in response to minor technical points raised by
.. 

. . .

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Richard P. Kusserow 

Inpector Genera

Department of Health and Human Services 

LNOS . 

11 00 BOUERS PARAY. SUSDu AT &A-_Of IO OfDm PoOmBox13770 1lA.18A.. UoT. A. uu ION.IS. RI. VIRGINI 2322770 SI co M.. a. IO LOAOl. M.. 1AA.1U CCC

TIU (80) 33() . II w. tV f' CH Lf8, . FAX (8) 330517 IM L HOJlIS. 1IA.1W f'. TaI No 4950 UNO UI Mo S. um f' WI T.M&

JQ IA M. 

W. -.ftMI.H MU .. L om M. f'. II IO M. M.. September 25, 1990 ..IA A.IOL R.. I II ICIIT S. SM hc 

MU L n. f'. IA..


Co M.. I'M-€ OS W\ II. M.D. Ita,
 IO C. Mc. M.. It..€ H.1I M.. I'_9 

Washington, DC 20201 

Dear Mr. Kusserow: tJel-I9/-39- OOS.s 

We would like to tae the opportunity to comment on the drt report entitled rre 

Distribution of Organ for Traplantation: Expectations and Practices" UNOS is gratiied tht your 

report found wthe development of the organ procurement and trplatation network is a signcat 

cooperative achievement 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 

important reflection of the readiess of may 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. blacks received 21% 

of ' all kidney traplants in 1989. ' We have found tht at over a thd of the U.s trplant centers, 

described in your report blacks wait less time than whites to receive a kidney. Thus, the problem is not universal. 

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 

that aspect of the report and even quoted the American Medica Asociation s Councll on Ethcal 

and Judicial Affai out of context. (Te Council's comments about a wsubconscious bia and -racial 

prejudice were about medicine in genera and were not directed at trplantation as the press 

seemed to infer from the report.) No evidence supportng a findig of racial bias wa presnted in 

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 

of further dampening the enthusiasm of minorities to donate organ. This would be parcularly 

trgic since increased donation among minorities is unversy agreed to be greatly needed 

If we ca provide your office with any furter inormtion to 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 onse To UNOS Comments 

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 

throughout the countr and that the degree of the disparty vares across the countr, 

Appendix A provides some data to support these obselVations.€
J\merirnn 

. President: 

Davi E. R. Sutherland. M. , Ph.D. 

Univrsit of Minneso Hopitl & Clinic 

UMAC Box 280€

420 Delaware Street, S.E. 

Minneapolis, MN 5555 

(612) 625-76 

President Elect: Ar G. Dihelm. M. 

PIat President:


Barr D, Kahan, M.D.. PhD.€

Councllorsat.Large: 

Hans W. Sollnger, M.D.. Ph. 

Ronald M. Ferguson, M.D., Ph. 

R. Randal Bollnger, M.o. Ph. 

Byers W. Shaw. Jr., M. 

nriet nf WrnnspImr ltgenns 

SeCNtary: 

Mar A. Har, M. 

Coumbia Unirsit 

63 West 16B Stret 

New Yok, NY 100 

(22) 3055 

TNaaurer: 

Cle F. Unirs of P8nnnla 

Silvrsein Palion 

34 Spr Stee 4th Floo 

Philadelphia. PA 19104 

(25) 66.20 

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.€

Washington. D.C. 20201 €

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 eJected governing body. The Draft 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 

1 ) Each person have equal opportunit to transplantation subject to 

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 kidneys procured. The frequencies by which the initial patient Identified 

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 

greater in the black than in the white population. The disincentives include: 

1 )€ Automatic cessatiw disabilty payments three years after successful 

transplantation. In contrast, payments for dialysis patients continue 

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. 

Ealure o icare to Drovi coverage for immunosuppressive 

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 antirejection 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 

visits are not reimbursable. Is there a difference between black and 

white recipients in regard to the distances that must be t veled, or the 

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 

waiting lists to ensure that those listed are bona fide transplant candidates. It 

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 

distribution may not be from deficiency in the distribution process per se but 

related to other factors, medical, financial, or social, that need our attention. 

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 

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 Document. 

It is also important to point out that single lists per S8 wil not ensure racial 

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 

blacks. The ASTS also plans to reintensify efforts to increase the organ donation rates nation-wide. 

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 

Disease and Blacks" (published in Transplantatlon Proceedinos 21 :December, 

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 

dialysis for several years probably has less chance of rehabiltation thana 

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 

dialysis. Similarly, should children who do not grow on. dialysis wait for as long 

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 

. excessive "shipping" of organs across the United States. Donor and recpient 

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 

exclusion provides an opportunity for the OPT 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 

would seem to wart 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, 

callng for guidance from governmental policymakers. 

D - 38 
. .. 

 .

.LI. -1 .. u\. L)' U .L.& .LO .I.&a.L .L J' D.&'-.Au.A\: 

President: 

M. Roy Arst, M.


University of Cincinnati Medica Center


Division of Nephrology 11585 -


231 Bethesda Avenue - 5363 MSB


Cincinnati, Ohio 45267-0585


(513) 558.5471, F (513) 55.3878€

President Elect: 

Ronald H. Kerman, Ph.

Past President: . 

Willam E. Braun, M. 

September 27, 1990 

Richard P. Kusserow 

Inspector General

Deparent of Health & Human Serces 

AMERICA 

SOCIEl OF 

lRANSPlA 

PHYSICIANS€

SecretaryTreasurer: 

Thomas A. Gonwa M. 

. Bayl Uners Medica Center Trapl Servces 

3500 Gan Avenue 

Dallas, Texas 75246 

(214) 821-3939, F (214) 21-' Councllcnt-Large: 

PhU HaDan, M.D. r91) 

Edgar Miord, M. D. r93) . Terr B. Stm, M.D. r92) 

IfEr-t/ -J"-IJ()5.s 

I would lie to than you for sendig me the draf report et\titled "Te Distn"bution ot 

Organ for Tranlatation: Exectations and Practices" for my review. I wi 

compliment you and your staf for the thoroughness of ths report, and to th you for 

asking for input from the Amercan Society of Tranplant Physician (AS). 

The ASTP is in complete agreement with the exectations outled in your report regardig 

the development of organ ditrbution practices. that are equtable, to those in need." There 

are a number of area in your report which 1 wish to address, and I would al like to 

respond to your recommendations to the ASTP, and to inorm you of the reprt which the 

Patient Care and Education Committee of the AS ha recently completed. In May of 1988, 

the Executive Counci of the AS asked the Patient Care and Education Commttee to

exaIe the issue of racial inequalty in transplantation. Th Commttee is chaied by Ma G. Whte, M.D. of Dalas. Other membes of the Commttee are. Betr L Kasiske, 

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 

completed in July of th year and submitted to the New England Jour of Medcie 

(NJM for consideration for publication. The intial review from the NE was highly 

favorable and the reviewers have suggested certai changes in the manuscrpt. A revied 

paper has now bee reubmitted' to the NEJM The editorial policy of the NE prevents 

me from submittg thei report to you unti a fi deciion has bee made regadig 

publication. As soon as an editorial deciion has been made by the NE, I shal forward 

the entie manuscrpt. Essentialy, the findigs of the Patient Cae and Education 

Committee are in agreement with your report. 

Washington, DC 20201 

Dear Sir: 

716 Lee Street Des Plaines, IL 60016 (708) 824-5700 FAX (708) 824-0394 
The AS Executive Commtte is in agreeent with the fidig of the Patient Cae and 

Education Commttee on the potetial benefts of matchg on tranlant outcome. For ths 

reaon we do not agree with the recommendation to "ditrbute donated orga to those 

patients on a fit come fit sered basis" (page 18). Th might wel have an unortate 

and untended negative impact on alograft surval in black recpients. 

Overal, it would appear that a bigger problem th organ dibution is orga donation. As 

your report points out, cadaver kidney tranplant numbe are levelg off, or even 

decreaing slightly, whie the number of patients waitig on .trlant lits contiues to 

grow. If there wa no organ shortage, there would be litte dision of ditrbution. The 

fist priority of al of us concerned about the equtable distrbution of th scace commodity 

should be to increase organ donation. Ths could have a major impact in correctg the 

unequ acces of black patients to donated organ, even using the cuent crtera for 

trbuti . As your report shows, blac: make up 30.8% of those waitig for a fist kidney 

tranplant, and only226% of those tranplanted. However, "in 1988 only about 8% of 

cadaver kidney transplants involved the use of a kidney frm a black donor" (page 11). A 

disconcerg asec of the report is the fact that "of an estiated 300 organ proO:ement 

cordiators workig in the 72 organ procuement organations, only about 14 are black" 

(page 11). Some year ago we hied a black social worker in ou ES program Reated 

donor trlantation, which had previously bee neglgible in black in our progr, rose 

substatialy son af he tok on the position. I strongly beeve tht cadaver orga 

donation in black would increae signcatly if black fames wee approached by black 

orga procuement coorditors. Therefore, I.would lie to suggest tht the OPO be strongly 

encouraged to tr and hie black tranplant coordiators. Th efort could be coordiated 

though NATCO and AOPO.€

trt that my remarks have been of some value to you. I would apprecate hearg your 

thoughts about ths letter and would be very interested in a copy of the fina report 

Hopefuy, in the relatively near future we shal be lookig at a fa higher rate of organ 

donation with equitable organ distrbution for al concered; patients awaitig tranplants 

do not have forever and ultimately they are the ones most affeced.-by what we do! 

Sincerely yours,€

M. Roy First, M.€

Professor of Interal Medicie€

President, Amercan Society of Transplant Physician€

MRF:mcm 
GIG Comments To ASTP Comments€

The New England Journal of Medicine arcle mentioned in the ASTP response was published in 

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€

black transplant coordinatqrs and have incorporated his comments into our text, in the section€

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 -
..

........ ... ........ ........: 

AMERiCAN Clll'€ FOR HISTOCOMPATILITY€ AN IMOGENETICS€

O. Box 15804, Lenc KS 6615 913/ PAX 913/541-0156 

September 19, 1990 

Richard P. Kusscrow€

Office of the Inector General€ Deparent of Health and Human Services€

Room 5250€

Cohen Building€

330 Independence Avenue S.€

Washington, D.C. 20201€

Dear Sir:€

We have reviewed the draf report "The Distrbution of Organ for Tralantaton: 

Expectations and Practices" (referrd to hereafer as the report) and apreciate 

opportnity to comment on th important docuent. Organ tranlantation, 

many aras of medicine, is undergoing a rapid evolution which deds the 

intcrdction of exrts in multiple disciplines, reflectig dierentapl9acheS to 

achieving a common goal. Unle any other field of 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 

ar: €

governg professional crdentials 

medical practices; €

-establishmnt of geogrphic regions as a basis for intercton among€

tranlant progrs;€

-achievemnt of a unonn, high level of qualty, nationay, in 

histocompatibilty testing (we ar pleased to note that th was. achieved 

through a contractual agrement for ASH! to perfonn laboratory evaluation for 

the OPT; 

.establishmnt of an objective system for ditrbution of organ which assign 

points for waiting tie, presensitiation and HL 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. . 

Eqable Acc€

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 chidren years old (as noted in Appendi B of the report). We question the use of median waitig 

NM Eo 00 PID.€

(310) a107a€ lI.acr€ AI A. Z8hl. PhD.€

(218)€ VI €

Davi O. Ec I'.€ )13€ ICMY€

(812) IZ NMA8€ PhD.€ 'I€

E., L "'li M..€

(117) man€ IlTI PUT PREI€ P'" L Tef8 PID,€

(213) 781€
time as the only stattic to evauale acss of Blacks to tranlantation. Wenote 

that ths statitic lead to a curous anomaly. If one exames th raon of medan 

waitig ties for Black vs. Whte (as preented in Figu 2, on page 9 of the 

report) the ratio is greater for al bloo tys combined than for any single blood 

ty as follows: 

Bloo Typ 

al bloo tys 

"T is diCult to interpret. 

Ratio of media waitig tie 

Blacks vs. Whtes 

1.71 

1.60 

1.57 

1.83 

In addition waig time doc not take into account severa facors. 

1. Organ frm a donor who is (HL) phenotyicay identical to a recipien 

must be offere to that recipient. The medical benefit, in tenn of extended 

graf suval, has be accted widely enough that th is a madatory 

policy of the OP1. It is not suriing that when 92% of th donor pol is 

Whte, the majority of patentS with such matches alo Whte and that 

, since these matches involve the most , common HL.ty, these , patients 

would' be trlanted more raidly than others on the waitig li, on the 

average. Therfore, any analysis of medan waitig tie should exclude 

the phenotyicaly iden ca malches. 

2. & staed in the reort, waig tie is proportona to the siz of th 

waitig lit. An evaluaton of waitig tie should investigate the 

ditrbution of Blacks accordig to lit siz. "It is possible th a majority of 

Blacks ar' litc with progr at large, uran medical cente with lare 

waitig lits. 

3. The rert has not inestigated the effect of multile litig. Patients who 

ar lited with multiple progr have access to a lager donor pool 

those lited with a smgle progr. Multiply lited patents ar those who 

ar awar of th advantage provided by multiple liting and wbo have the 

which pcnnt trvel to severa intitutions. Patient fiancia reour 

rereentaves to the OP1 surt multile litig, quite possibly 

because thy ar capable of tag th advantage. Nonetheless, an anysis 

of med waitig tie should exame the proporton of Blac among multiply lited patents. 

4. Waitig tie is afected by the avaiabilty of the patent at the tie of 

donor rccoveIY. Patents who for medical or othr reasons ar not 

imedely avaiable for trsplantation have their stat lited as 

inactve" in the compter regi. It should be detenned whether there 

is a dierence between Black and Whtes in the lengt of tie which 

patients have "inactve" stats. 

(2) 
.

'-AI U'&1; VU.&"". 1&8&"", .... "'"'''''''''--0- ----- --- c --

, less th the polprUon waitig for lantaon. We have noted in teon 

the Intitute of Medicin th.th dianty ca be acounted for, in lar par by 

the fac th the donor pol, which is preomtly (939&, 1988 UNOS daa) Whte, 

consists of 39% blood . A donors and 45% bloo ty 0 donors whe th 

frequency of A and 0 brood ty among Black patients ar 27% an 49% 

respectively. Furerore, sensitiion to Lewis IDtigens, which ca lead to a 

positive crossmatch which, in tu prohibits ttlantaon, is alost lited to 

Blacks. Thus, whie both medan waitig tie (M and prrton of trlants 

reveal dihed access of Blacks, MW does not provide inight into the caus 

of the dihed access. We addrs the issue of HL matchg latr. Howeer, 

we note here that: 


1. durg the fit ha of the tie 

ditrbuted using a point system which gave the highest value to waig period covered in the reort, oran were


tUe and tht even under the prsent point system, 


often by waitig tie, excet when extrmely goo maches oc€ patnt ar nm most€

2. data being preard for publicaton by one of our members show th in the 

experience of one lage intitution, the perctae of Blac reivig 

tranlants did not change when kidneyswcr ditruted by wag tie 

versus under the cut UNOS point system whicb gives.more weight to 

HL match; more imrtantly when 6 antigen maches were eld, 

the percntage of Blacks reiving trlants \18S the sam as 

percentage of Black on the waitig list. 

The report raes the pOssiblity of social bias as the caue of inuity in ac 

Black. A more dict way to exame th question is to exae th deogrhics 

of' patients passed over for trlantation. For eac donor, a li is gerate in 

which patients ar raned in descendig numerica order aCCordig to poin 

assigned for waitig tie, senitiation and HL mach Patient with a posite 

crossmatch ar routiely elimated from th lit and organ ar to be offer to the 

reg patients accordig to reasons which ar priary . Whe 

system prvides an opprtty for abus, we have no dat or anecdota inormon€

which suggests that racia bia afects organ ditrbution.


With repect to recommendatons, we submit tht the major facors prcing racia 

diarty in access are known: dierences in dibution of ABOand Lewis blood 

tys. Oter contnDutig factors have been noted abve an ca be readytht investigated frm exitig da. Based on th inormon, it seems ap

effort and fudig should be dicted priary towar incring organ donon 

among Blacks and seconday toward imrovig defition of HL anens unque 

or nearly unque to Black. 

ASioe NatOD Sys€

Although the OPT has adopted a point system for ditrbution of kieys, we 

believe that it bas been a IDtake to pennt the many varces requsted by 

indiVidual program. We fuer surt 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 of trlantaon 

and increased ischemia tie, we note that trportation is a one tie cost whie the€

benefits derived from matchig extend thrughout the lie of the gr. Since €

surival tie reflects the qualty of match it may be reasonable to establi a


(3)€
matchig thshold which predict a cer level of gr surival. Regional€

sharg should be madated for al situons in which the match exceeds that€

thshold. Incrases in ischemia tis ar avoidale by obtag 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-€

on the pan of the ttlant team or OPO. 1b is evident from the fact that€

although there was unvers ackowlecgeen'ofth benefit, as mea by 

surival, of phenotyicay identica trlan, it was not possible to estlih a 

policy of mandaOI) sharg for these trlats witout alo estalig the 

payback system. We note tht whe th may be no madae to acrd preferece 

to the highy sensitid patient, sp procls and prctces must be imlemented 

in order for these patients to be tt1a. To do othrwise would be to condem 

these patients to spndig yea on wai lits at an apciale cost to th public. 

Finaly, we ar concerned wit th OIO's perction of the role of the OPO.€

Specifcaly, we note the statement foun on pate il tht the OPO should "shap 

and oversee ditrbution J'licies. We intmret the intent of Congrs to be to mae 

the OPT the organion rensible for developing dibution policies, . whie 

the OPO is responsible for assur adce to those policies.€

It is important to recogn that th ungness of may centers to sha organs 

resuts from many factors, SOIJ of which ar dicused in the next section. 

However, one facor has be the lack of fai play on the pan of a few center in 

which sharg is interpted as "receivig. ony. 

We strngly agr with the rert s obsrvation tht a lare, and peIhap 

inappropriate, level of control lies with th trlant sueons. In addition to the 

proportion of the OPT board of dictOI which they ocy, trlan sugeons 

domiate the medical boards of most OPO's; as UNOS regional counciors, 

surgeons have the oprtty to oftn, UDaty, detenne region policies and€

reresentaton on UNOS comm; an as diors of trlant progr,€

sugeons have the oprtty to determ th choices for the single vote aforded 

tottlant ceter for UNOS elctons and by-laws/plicies appr a1. Th level 

of authority and/or inuence combind wi meant of "succs" accordg to 

the number of trlant performed a miconception of may, ha reulted in strng 

oposition to organ shag. SBOPF ha cleary demon th organ shag 

the single most effectve way to prvide a rec chce for seitid patents to 

be trlanted. Funer, because of th extenive diersit of HL tys, organ 

sharg is the only way to imroe' th degr of HL matchig. Since the 

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 

the madaol) sharg policy, thes trlants which have far and 'away the longest 

averae gr surval among caverc donor trlan, would not have occud. 

It is in establihig and maitaig tne cooraton in organ shag that OPT 

has its most serious shortcomis. 

(4)€
. m. yptir 

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 

report alo notes th cunt COtrvery regarg the beefit of HL matg. 

We believe it is of utmos imrtance to clar th issue. HL matchg is the 

single major factor afecg gr success that can be maatd pr tranlantaton, un imunosuresion, has no major advere afec, and alo 

wie imunosupsion, involves a one tie cost. The beefits of 

matchig ar well docente Anysis of the UNOS da bas, the UCL 

Tralant Regitr Dat base and the Inteatonal Collabrave Tralan StUdy 

data base al cleary show a stepwise incrment in gr suival as th degr of HL matchg imroves. However, although HL. match is one of the cmt 

alocaton crteri at an opetional level, patients ar effectely ra alost 

exclusively by waiting tie, with only very well matched patents suprsdi that. 

The few hundrd HL phenotyicay identical tr lants th have ben 

perfonned certy caot accoun for the diarty in waitig tis betWn 

Black and Caucasian. Neveieless, an important goal of the trlant 

communty should be to extend the benefi of HL machg to more individual. 

, Th wil requ regionation and spcifcay, for Blac patents wi reui 

fuer elucidaton of those HL antigens found predomiately in: the Black 

populaton. It wil alo be importt t encourge mcreed organ donation from 

the Black communty. 

Many of our members beeve that the cunt contrvers is not realy about the 

benefits of HL' machg but raer abut sharg. As note earer, becase of the 

diversity of the HL sy 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 reluctance, on the par of many surgeons, to "shar organ. As we 

have note abve, the incrd beefit of some lesser matches may be incient 

to .wart the cost involved (trrtaton.. etc.). A reasonable compro is to 

establish a thhold leve of mach and to madate shg, with a region, for 

organ for which a match better than the thshold level is found.wit the region 

Th concet of regiona shg ha 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 

crossmatch trys, provide the bet oprtty for trlantation of the sensitd 

patient. 

Pat 010U: 

It is of concem th 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' rement for 

patient educaton. Under the prent system, atents do not have a choice abt 

donor selecton. The rert's analysis of eqwty in access uti$ waiting 

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 

well-matched donor, may elect to wait for such a donor. Oters may not. Th 

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) 
trated at a center which panicipatesin regional sharg,i they weIe awar of the 

incIeascd lieliood of trlantation. 

In sumar, we fid that:€

.we agre with the conlusions of the Ieport that 

- some groups of patents have dihed oponuty for trsplantaon - a progr of mandaed Iegional sharg should be inestigated 

- goverance of the trlantation €

parcipation by those in non-surgical aras€

network should involve grater


-the basis for the reuced access of Black has not been adquately. investigated; because med 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 Blacks, effons should be diected at increasing organ donaon by Blac 

-regional sharg should be mandated for certai HL 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. 

One point that we have not addrssed is the one that ASH! raises concerning figure 2. It notes 

that in that ftgure, which provides the median waiting time for blacks and whites on the basis of 

blood type the ratio is greater for all bloo types combined than for any single blood type." It 

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) 

Association 

of Organ 

Procurement 

Organizations 

:.h ,' ""rl.1n. :.I.D. 

""n l id,.IrJ,,'n 

\1.1n' ,\nn,' II..u," 

l",,,.. :\".\1 

IIri.n 1\"'l.nl(1. 

R"-:IIM \\ ,.,L:m. . . : 0 . 0 0'. -:":, 

Administrative Office 

1714 Hayes Street 

Nashvilie, TN 37203 

(615) 321-3756 

(0) 5) 329-2513 (Fax) 

November 7 , 1990 

The Honorable Richard P. Kusserow€

Inspector General€ Departent of Health and Human Services€

HHS Nort Building RECEIVED

330 Independence Avenue, S. REGION 1- OIG/OEI 

Washington, D. C. 20201 INOV.L . 1990 

Dear Mr. Kusserow, 

On behalf of the Executive Committee of the 

Association of Organ Procurement Organizations

(AOPO), I am pleased to be able to respond to the Draft Dpcument: "The Distribution of Organs for Transplantation: Expectations and Practices. This response represents the consensus of the AOPO s Executive Committee. 

The AOPO, represents - .:ixty-two of the sixty-nine recognized Organ Procurement Organizations (OPO) in the united States, both independent and hospital based, who are collectively involved in over ninety percent of , the solid organ procurements that occur each year. The AOPO' s 

purpose is to expand the public' awareness of, and receptiveness to organ donation. We are 

committed to promulgating the distribution of transplantable organs in an equitable and 

expeditious manner as determined by the designated Organ Procurement and Transplantation 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. 

First, let me say that AOPO does not - at all 

disagree with the basic 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 
organ 

Mr. Kusserow 

November 7, 1990


- page Two 

American for a kidney transplant. And, AOPO would 

concur that these disparities do not seem to be 

related to aither recipient age or blood type. 

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 

areas that should be studied in much greater detail. 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 

in the equi table- distribution of transplantable organs? Thirdly, AOPO would question whether or not some of the seeming inequi ty in current 

practice might arise from local organizational strcture rather than from the system as a whole? 

Certainly Organ Procuement organizations differ 

just as regions differ. 

AOPO would point out, however, that neither the 

AOPO nor its members make distribution policy. 

They carry it out. Policy is determined by the 

Procurement Transplant Network (OPT) and the local medical and scientific oversight committees. And, in the final analysis, whether or not a given patient is transplantable with a 

given donor organ is initially decided by that patient s physician and/or surgeon and eventually in conj unction with the patient. The common 

thread throughout the algorith is the transplant 

physician or surgeon - both at the donor and 

recipient selection and evaluation, and at the 

transplantation event. 

AOPO and its member Organ Procurement 

Organizations are ready to assist your Qffice in the design and/or performance of any studies 

deemed appropriate. When root pauses for the racial disparity in the distribution 

transplantable organs are determined, the AOPO and 

its members will be happy to assist in the design 

and implementation of appropriate solutions. 
Mr. Kusserow 

November 7, 1990 

?age Three 

The AOPO thanks you for the opportunity to' comment 

on the draft report and would be most happy to

provide your office with any furter information 

you require. Our ongoing dedication is to the 

donor and recipient public and we stand ready to 

help you assure that they are equitably served. 

Thank you. 

Il1y€ Mike P. K plan, M.

Preside Associa on of Organ 

Procurement Organizations 

MPK/krk€
OIG Response To AOPO Comments 

We agre that the report does not identify the causes of the black-white disparty. We have 

shown that some factors thought to contrbute to that disparty (such as bloo type) have little or 

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 

accord with OPTN (and HHS) policies. Yet, within that context, OPOs still have a very 

important role to play in developing and overseeing the particular approaches in their service 

areas. Indeed, many OPOs and trsplant centers have already been quite active and successful 

in obtaining varances from OPTN policies. 

D - 52€
., :.. .. .......... ....

October 1, 1990


R I chard Kusserow 

NATCO I nspector Genera I 

North Of f I ce of the Inspector Gener: 

American Department of Hea I th and Human Serv Ices 

Transplant Washington, D. C. 20201 

Coordinators 

Organization RE: I G Dr aft Repor t OE I -01-89-00550 

f'ld Dear Mr. Kusserow: 

l\a A. EloCk 

Enclosed for 

TM T'-:I11 C8nl.'your consideration Is the response of the North
 PIlipW'nglHnBuiin American Transplant Coordinators .organization (NATCO) to the


,:;es' Ro2' 20 draft report titled, " The Distribution of Organs for€

Transp I antat Ion: Expectat Ions and Pract Ices"
 ....Id.Elect€

Linda L. JoS€

Lo.1o 01 0N Organ€

Proc.-II (LOO) 

700 Acrmn Ao. Su 58 

Cous. OH 432 

Nty S. 08.. T..... Do Sennl. 1714 Hire. SItHI Na. TN 3720 

T......€

Ao C. Sm. ok.€

ROPA 01 Solh Caom 

8SO V.Wan Ave, Ro 123 LoAnIe. CA 804

Co at 

Li Tuln 

C8bfom T,anSl81 Do NeIW 

170 Caor Sl'Hl Su.. 36 

San FtIl. CA 84109

Co 

T"'A SnIl'€

Hilt" Meth.S! For Woh€

1301 Ptylni AVtnu€

fo Wo. TX 76104€ Ir 'ut€ Lo M.€ Lo Orn Prnt Ag
 24SO Se AVt_. Su S2 Mell'., LA 701 

ElIC €

De. GiSh Pada€ eo. 153€

LeIl.., KS 6615€

NATCO Is the pro esslonal society representing organ 

procureMent and clinical trf3nsplant coordinators. . Our 

membership totaling 1200 Is composed of practitioners from over 300 transp I ant centers and organ procurement agenc I es I r" 

the Un I ted States. Our organ I zat Ion has pos I t I ve I y I nf I uenced the spec I a I ty of organ procurement and 

transplantation by assuring Quality care for organ donors and 

their families as well as recipients of organ transplants.


We have developed and promoted the recognition of standards


of practice, provided professional and public education,


encouraged ertlflcatlon (by the American Board of Transplant
 Coordinators) for practitioners In this specialty and
 part I c I pated In ongo I ng research to advance Immunosuppress I ve


therap I es and hi stocompat I bill ty techn I Ques.€

Our proact I ve I nvo I vement In Federa I and State government ha


enab I ed us to work with profess I ona I sta f f and elected


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


our organizational legislative policy statement, which I hav

 enc losed for your rev I ew.€

In - respond I to each of the I ssues addressed I n your report. 

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 I spar I ty was st 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 

However. we are concerned that hi stocompat I bill ty factors. 

spec I fica Ily HLA match I ng. were not adequate I' y addressed 

your report. 1989 data from the Un I ted Network for Organ 

Sharing (UNOS) Indicates that only 8% of U. S. kidney donors 

were black This Is In sharp contrast wtth the fact that

blacks const tuted 22. of the kl dney transp I ant rec I p lent 

population for that same year. . It ls well known that the HLJ 

antigen pool for blacks differs from that of whites. One 

reason for the d I spar I ty between black and wh I te pat I ents that Is more difficult to 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 

The time on a waiting" list varies dependent on the transplan' center. Th I s occurs for many reasons. Some transp I ant 

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 

reduced as the wa I t I ng II st I ncreases un I ess there I s an 

eQua I rat 10 of onor kidneys procured I n the I oca I area. 

Herein lies the real Issue - the balance between the number of locally procured kJdneys, the number of Imported kidneys. 

and the number of patients awaiting transplantation. Clear I: 

this balance differs from center to center and OPO to OPO an' 

subsequent Iy pat lent wa I t I ng times vary accord I ng Iy. 

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 analysis of existing data to Identify accurate Information on which to base an assumption. 

3) fMPACT 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 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 

At some centers. both HLA-DR antigens cannot. be Identified 

a I I pat I ents due to a number of techn I ca I and/or med I ca I 

reasons. Subsequent I y. pat I ents without comp I ete 

Identification will not have the opportunity to receive a si 

ant I gen or phenotyp I ca I I Y matched kidney on a na t I ona I 

sharing basis. All of these factors Influence why patients 

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 

kidney transplant and have become - sensltlzed- ; 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 

for transplant If their sera Is crossmatched with a large 

poo I of donors. Therefore. NATCO supports a system to of fel 

kidneys to these patients from a large pool which affords 

them the best tissue match. 

A I so, the I ssue of eQu ty must be addressed. to answer the 

Quest Ion of how many kidney transp ants shou I d one have 

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 

a national system with uniform policies for the dlstrlbutlol 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 

more equitable distribution than prior to their formation. 

It Is a Iso true however. that organ d str I but Ion Is st I II 

somewhat controlled on the local level and within the reglol 
R I chard Kusserow October 1, 1990 

Page 4 

of each OPO. There are some acceptable reasons to maintain 

limited control at this level: 

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 

distribution are based on local scientific studies. Such 

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 

se I ect I ng pat I ents for transp antatl on. 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 Ich akes I nto account accumu I ated wa I t I ng time. 

7)" SINGLE UN I F I ED WA I T I NG LIST 

NATCO endorses the recomendation that there should be 

movement toward a sing I e un I fled II st for pat I ents awa I tint 

transplantation per each designated OPO service area. 

add It Ion to us I ng the cr ter I a of first-come first-served, 

'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€

transp I antat Ion as we II as hi stocompat I bill ty factors such€

HLA match I ng and sens I t I za t Ion rates (react I ve ant I body I eve I ) . 

A point system which Includes objective medical criteria a 

we II as the rec I p I ents wa It I ng time I s Important to assure. 

opt Imum resu I ts of the kidney transp I ant wi th reasonab I 

expectat Ions of success. 
chard Kusserow October 1. 1990 

Page 5 

8) RELA T IONS WITH DONOR HOSP IT ALS 

NATCO has concerns relating to the recomendation that 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 

distribution arrangements within the designated OPO service

area. I t is a shared respons I b II I ty of the Organ Procurement 

Organ I zat Ion (OPO). re I ated tissue and eye banks. and the

donor hosp I ta I to create an open work I ng re I at lonsh I p that 

fosters organ and tissue donat Ion and d str I but Ion. 

As critical as this working relatl.onshlp Is. NATCO cautions 

against the development of any regulations whIch have the

potent I a I to negat I ye I y Impact on the re I at I onsh I p of the 

OPOs. re I ated t Issue 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 which assures eQultable d.lstrlbutlon following 

ob Ject I ve med I ca I cr I ter I a. As respons I b II I ty for organ 

dona t Ion I I es with the OPO. tissue and eye banks and donor 

hosp I ta I. res pons I b I II ty for the transp I ant opportun I ty for 

each pat lent ' 1 s shared by the transp I ant center and OPO and 

fostered by a sJmllar open working relationship. 

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 

continue to provide optimum patient care . to those seeking transplantation. 

11) DEMONSTRATIO€ PROJECT EVALUATION A REGIONAL DISTRIBUTION 

SYSTEM 

NATCO also supports funding for a demonstration effort which 

wou I d estab II sh a sing Ie. un fled wa I t1 ng II st for a II 

pa t I ents I n a spec fled number of comb I ned OPO serv I ce areas 

and mandates shar I ng of organs to those pat I ents on a 

first-come first-served basis subject to objective medical 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 

an attempt at a national distribution system. a regional 

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 

NA TOO recogn I zes that I t is the respons I b I I I ty of the Organ 

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 

development of comunity outreach programs). 

As organ donation and transplantatlon 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 

practice, we appreciate the opportunity to coment on this 

draft report and. look forward to providing additional

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 onse To NATCO Comments€

The NATCO' s response to our recommendations was generaly supponive. We agree that more 

attention must be given to the influence ofllA 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€
.... UUYI UU.&UUf& Ouvo- 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 

the draft report issued by your office, II The 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 , 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 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 categorized by diverse protocols and

practices. Within limits, it is essential to encourage this diversity if we are 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 
Richard P. Kusserow 

December 27, 1990 

Page 2 

- - While an absolutely uniform national system is appealing. It is more 

realistic and practical to organize at a regional level. This provides sufficient 

scale of activity while minimizing logistical problems. 

- Any system of organ distribution should focus on the outcome. i.e.. equal 

access. There wil be more than one legitimate way of achieving that end. 

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. 

Recommendation # - "The PHS. in collaboration with the OPTN. should Issue 

regulations to require that each OPO '(1) establish a single, unified list of 

patients awaiting transplantation and (2) distribute organs to these patients on a 

first come first served basis. subject to established medical criteria. Comments: 

- 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 legiti,mate scientific disagreements on issues such as HLA 

matching. prioritization of highly sensitized patients, etc. While it is 

inappropriate to allow any surgeon or transplant center to decide these issues 

unilaterally, it is equally unreasonable to suggest that there is only one correct 

answer for all the nation. Instead we would suggest that equal access can best 

be assured by requiring that each region of the countr .establish an objective 

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 

required so that periodic retrospective analysis may be performed.. This would 

allow comparisons among the regions. 

- Some proposals suggest the establishment of OPO-wide lists rather than regionwide 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 of OPOs and encouraging 

consolidation of existing ones. The alternative wil be the creation of new. one 

or two transplant center OPO's to avoid impact of a shared list. 
Richard P. Kusserow€

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 

service area adhere to' the centralized organ distribution policies of the OPO 

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 

transplant C?ommunity on appropriate methods of selecting potential recipients. 

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 

general set of medical criteria, b4t national consensus is unlikely. Whatever is 

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: 

Such a study, while desireable, is likely to be impractical given the lack of 

agreement on what constitutes "established medical criteria." (See comments 

above), and political concerns of adjacent OPO's. However. it might be more 

practical to study, organ allocation at those larger OPO's which already have 

unified lists and include a large number of transplant centers. This would also 

allow examination of different sets of "established medical criteria" which have 

been implemented in different regions of the country. Given the existing 
, . . 

Richard P. Kusserow 

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 

issues. discriminatory behavior (intentional or unintentional), or a combination of 

factors. Given the apparent disparity among regions (e.g. no difference in waiting 

time NEOB's region but varyirig levels of difference In most others) this is 

obvious a complex issue. For example, is there a significant difference between 

the experience at single-transplant center OPO's versus those that serve many 

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. 

We loo forward to conversations with you and/or members of your staff 

concerning these important issues. 

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 

project concerning the use of the first come first served concept. Yet,. as we note in the text, such 

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 

ready to participate, we think such a demonstration warants the effon. 

D- 64

.. .... 

... 

 ( . . 

,.,

n organ procurement fO. ndation€

January 22, 1991


II.D.. €

P.trila A"-.. II.D v". € lI""I."t. II.€ .I- . Wil., II.D. Soar€

WI. LeF.t,I'.,€

11 A. At utClliw'Do.afM-€

Honorable Richard P. Kusserow


Inspector General


Department of Health and Human Services


BBS North Building


330 Independence Avenue, S.€

Washington, D.C. 20201€

Dear Mr. Kusserow:


The South-Eastern Organ Procurement Foundation (SEOPF) wishes to comme


on the Draft Document: "The Distribution of Organs for Transplantatio:€

Expectations and Practices . SEOPF has been an imprtant contributor for mQ


than 20 years to the science of transplantation including the use €

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 scientif€

organizations such as SEOPF. These issues have sparked some controversy a


considerable debate within our organization. The observation that blacks wa


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


upon short-term rather than long-term results, the ' role of histocompatibili€

testing and the availability of particular patients for transplantation wh


an organ comes available are examles of important questions discussed with


the committees of SEOPF. Data from a SEOPF Member Organ Procurement Agen


indicate that black patients are more often Ynavailable for an identifi€

donor organ than whites Ol). SEOPF believes that additional da


collection and analysis will be important to a correct interpretation of 


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


access of minorities to cadaver donor kidneys for transplantation. We exp


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
 differential access of particular patient groups to cadaver organs f€

transplantation. SEOPF appreciates the opportunity to comment on the Dr,€

Document and looks forward to sharing the results 'of its research€ later this year. €

Sincerely yours,


,------_u----€

'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 Response To SEOPF Comments 

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 

of minorities to cadaver kidney transplantation. EOPF and its member institutions bring much 

expertise to such inquir. We look forward to the results. 

In MIlir 

We note th twice in th rert. HL machg is cited as a possible, signca 

facor contrbutig to diernces in access betwee Blac and Whes. Furer, the 

rert also notes th cu cotrvery regarg the beefit of HL matg. 

We believe it is of utmos imrtance to clar th issue. HL machg is the 

single major factor afecg gr success that can be maatd pD

tranlantaton, un imunosuresion, has no major advere afec, and alo 

une inunosuppresion. involves a one tie cost. The beefits of 

matchig ar well docented Anysis of the UNOS da bas, the UCL 

Tralant Regitr Dat base and the Interatonal Collabrave Tralan Study 

data base al cleary show a stepwise incrment in gr suival as th degr of 

HL matchg imoves. However, although IU match is one of the cmt 

alocaton crteria, at an opetional level, patients ar effectely raed alost 

exclusively by waiting tie, with only very well matche patents suprsdi that. 

The few hundr IU phenotyicay identical tranlants th bave ben 

perfonned certy caot accoun for the diarty in waitig tis between 

Blac and Caucasia. Nevereless, an imrtant goal of the trlant 

communty should be to extend the benefi of IU matchg to more indiviual. 

" Th wilrequ regionation and spcifcay, for Blac patents wil reui 

fuer elucidaton of those HL antigens found predomiately in the Black 

populaton. It wil alo be importt to. encourge mcrcdorgan donation from 

the Black communty. 

May of our membe beeve that the Cunt contrvers is not realy about the 

benefits of HL machg but raer abut sharg. As note earer, becase of the 

diverity of the HL sy it is necsar to shar organ, at least at the regional 

level, to achive any appcible numbe of goo HL maches. It is evidet that 

there is.a strng reluctce, on the par of many surgeons, to "shar organ. As 

have note abve, the incrd beefi of some lesser matches may be incient 

to ' wart the cost involv (trrtaton,. etc.). A reasonable comp is to 

establis a thhold leve of mach and to mada shg, with a region. for 

organ for which a match better than the thshold level is found.wi the region. 

The concet of regiona shg ha severa important benefits. F11, it provide the 

oprtty of multile litig to al patent. Second, for some patents to have a 

realistic oportty for trlantaon. they must have an incrased access. That 

is, they must have a larr donor pol avaiable. Th is parcuarly tre of th 

sensiti patient. Regional shag, when combined with the use of regiona 

crossmatch trys, provide the bet oprtty for trlantation of the sensitd 

patient. 

Pat O1oke 

It is of concern th the ise. of patient choice is not addrsed in an legilation nor 

in. any policies of the OFI. Imlicit in the rit choice, is the. rCment for 

patient educaton.. Under the prsent system, t'aUents do not have a choice abt 

donor selecton. The rert's analysis of eqwty in access u waig tie 

which implies a diadvantae associated with waitig tie. However, some patents 

who ar awar of the beefits of HLA matchig and of their lielioo of fidig a 

well-matched donor, may elect to wait for such a donor. Oters may not. Th 

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) 
trated at a center which paricipatcs in regional sharg,i they were awar of the 

increased lieliood of trlantation. 

In sunar, we fid that: 

.we agre with the conlusions of the report tht 

- some groups of patents have dihed 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 reuced accss of Black ha not been adquately. 

investigated; because med 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 

Blacks, effort should be diected at increasing organ donaon by Blac 

.regional sharg should be mandated for certai HL matches which extend 

beyond the present level of madatory shag. 

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€

than individual trnsplant centers be the priar, authoritative vehicles for allocating organs in€

accord with those policies, rules, and guidelines.€
..

. .;:.. .::, 

Association 

of Organ 

Procurement 

Organizations 

:l1I!.,' K.rl.n. I.O, 

""n Rkh.IrJ...., 

"..n' An..' II"u",' 

L'nw.. :\,'1.11 

IIri.n Kn''-n..!. 

0 00 . 

'lII\'1 W,'rkm. 

Administrative Office 

1714 Haves Street 

Nashvilie, TN 37203 

(615) 321-3756 u; 15) 329-2513 (Fax) 

November 7 , 1990 

The Honorable Richard P. Kusserow€

Inspector General€ Departent of Health and Human Services€

HUS Nort Building RECEIVED 330 Independence Avenue, S. REGION 1 - OIG/OEI 

Washington, D. C. 20201 INOV,. . J990 

Dear Mr. Kusserow, 

On behalf of the Executive Committee of the

Association of Organ Procurement Organizations (AOPO), I am pleased to be able to respond to the Draft Document: "The Distribution of Organs for Transplantation: Expectations and Practices. This response represents the consensus of the AOPO S Executi ve Commi ttee. 

The AOPO represents - .:ixty-two of the sixty-nine recognized Organ Procurement Organizations (OPO) in the Uni t states, both independent and hospital based, who are collectively involved in over ninety percent of . the solid organ procurements that occur each year. The AOPO' 

purpose is to expand the public' awareness of, and receptiveness to organ donation. We are 

committed to promulgating the distribution of transplantable organs in an equitable and: 

expeditious manner as determined by the designated Organ Procurement and Transplantation 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 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 waiting lists and the percentage transplanted each

year. Secondly, it certainly appears that a Black 

American waits significantly longer than a White 
Organ 

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 

related to aither recipient age or blood type. 

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 

areas that should be studied in much greater detail. First, are there medical-scientific 

biases - either justified or unjustified - that 

account for these disparities? Secondly, what

part do socio-economic and cul tural factors play 

in the equitable" distribution of transplantable organs? . Thirdly, AOPO would question whether or not some of the seeming inequi ty in current 

practice might arise from local organizational strcture rather than from the system as a whole? 

certainly Organ Procuement organizations differ 

just as regions differ. 

AOPO would point out, however, that neither the 

AOPO nor its members make distribution policy. 

They carry it out. Policy is determined by the

Procurement Transplant Network (OPT) and the local medical and scientific oversight committees. And, in the final analysis, whether or not a given patient is transplantable with a 

given donor organ is initially decided by that 

patient' s physician and/or surgeon arid eventually in conj unction with the patient. The common 

thread throughout the algorith is the transplant 

physician or surgeon - both at the donor and 

recipient selection and evaluation, and at the 

transplantation event. 

AOPO and its member Organ Procurement 

organizations are ready to assist your Qffice in the design and/or performance of any studies 

deemed appropriate. When root causes for the racial dispari ty in the distribution 

transplantable organs are determined, the AOPO and 

its members will be happy to assist in the design 

and implementation of appropriate solutions. 
Mr. Kusserow 

November 7, 1990 

?age Three 

The AOPO thanks you for the opportunity to comment 

on the draft report and would be most happy to 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€
01 G Res p €o n s To A O P € Comments€

We agre that the repon does not identiy the causes of the black-white disparty. We have 

shown that some factors thought to contrbute to that disparty (such as bloo type) have little or€

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 

accord with OPTN (and HHS) policies. Yet, within that context, OPOs still have a very 

imponant role to play in developing and overseeing the particular approaches in their service 

areas. Indeed, many OPOs and trsplant centers have already been quite active and successful 

in obtaining vararces fromOPTN policies. 
:..:;;. .... ......._.......

October 1, 1990 

R I chard Kusserow 

NATCO nspector Genera 

North Of flee of the Inspector Gener: 

American Department of Health and Human Services 

Transplant Washington , D. C. 20201 

Coordinators€

Organization RE: IG Draft Report OEI-01-B9-00550€

..1d Dear Mr. Kusserow: 

8Ia A. Etok 

Enclosed for your consideration Is the response of the North TII Tr8111 CeRi.' PlIiWengl..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€

Lin L Jos Lo 01 0N OrQ8n

Pt-II (LOI 

700 kkrmn Rod. Su 58 

Cous. OH 432 

Ney S. DaVI

T._- Do SeNit 

1714 Hayes S-I 

. TN 3720 

TN..€ fI c. Sm .I.€ ROPA 01 Son Caom€ 850 V...an Ave. Ro 123€

Lo Ans. CA 804€

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170 CaOM Slr"L Su 36 

San Franc. CA 84'09 

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NATCO Is the professional society representing organ 

procurement and clinical tr nsplant coordinators. . . Our 

membership totaling 1200 Is composed of practitioners from over 300 transp I ant centers and organ procurement agenc I es I r 

the Un I ted States. Our organ I zat Ion has pos I t I ve I y 

Influenced the spec I a I ty of organ procurement and

transplantation by assuring Quality care for organ donors and 

their families as well as recipients of organ transplants. 

We have deve loped and promoted the recogn I t Ion of standards€

of practice, provided professional and public education,€

encouraged ertlflcatlon (by the American Board of Transplant€

Coordinators) for practitioners In this specialty and€ participated In ongoing research to advance Immunosuppressive€ therap I es and hi stocompat I bill ty techn I Ques.€

Our proact I ve I nvo I vement In Federa I and State government ha

enabled us to work with professional staff and elected€

of f I c I a I s to f.urther support our go a Is. . These are def I ned I r,€

our organizational legislative policy statement, which I hav€

enc losed for your rev I ew.€

In - respond I to each of the I ssues addressed I n your repor t . 

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 nto account , a d I spar I y was st II I found between the waiting time for black ' patlents and white patients. 

O. Box 1538 . lenexa, KS 66215 . 913/492-3600 

1301 
Richard Kusserow October 1. 1990 

Page 2 

However, we are concerned that hi stocompat I bill ty factors. 

specifically HLA matching, were not adeQuatel"y addressed 

your report. 1989 data from the Un I ted Network for Organ

Sharing (UNOS) Indicates that only 8% of U. S. kidney donors 

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 pool for blacks differs from that of whites. One 

reason for the disparity between black and white patients 

that It Is more difficult to locate HLA compatible kidneys 

ha t match black rec I p I ents when ava I I ab I e kidneys are 

prlmar11y from white donors. It Is our opinion that the 

Issue of antigen matchl g and dopor/reclplent pool reQuires 

specific analysis and strongly recomend that research In 

this area be Identlfled as a priority If the dls arlty 

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 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. Th I s occurs for many reasons. Some transp I ant 

centers and/or organ procurement organ I za t Ions (OPO' s) simp 

have longer wa I t I ng I I sts. ThUS a pat lent' s Chances are 

reduced as the waiting' list Increases unless there Is an 

eQual ratio of ,donor kidneys procured In the local area. 

Here I n II es the rea I Issue - the ba I ance between the number of I oca I I Y procured k dneys. the number of Imported kidneys, 

and the number of patients awaiting transplantation. Clearl 

this balance differs from center to center and OPO to OPO an 

subseQuently patient waiting times vary accordingly. 

A campar I son between wa I t I ng times to transp I ant and the 

actua I transp I ant does not take Into ac ount pat ents who 

ha ve dec I I ned the t r ansp I an t or WhO have not been 

transplanted because of medical or technical reasons. 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 

Identification will not have the opportunity to receive a si 

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 

Ionger for a kidney transplant than other patients. There 

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. 

I t is Important to note that a I arge percentage of high I Y 

sensitized patients are those who have received a prior 

kidney transplant and have become - sensltlzed- ; 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 

for transplant If thel sera Is crossmatched with a large 

poo I of donors. Therefore, NATCO supports a system to of fel 

kidneys to these patients from a large pool which affords them the best t Issue match. 

A I so, the 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 however, that organ distribution Is stili 

somewhat contro II ed on the 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 

limited control at this level: 

a) assur I ng v I ab I e organs because of time constra I nts with 

preservat Ion 

'b) 11m I t I ng trave I time to prevent wastage of the organ t an 

c) exercising efficient and cost effective processing of transp I an tab I e organs 

We bel 'eve however, that. these factors can be taken Into 

account In a consolidated recipient waiting list per designated OPO. 

S) ORGAN DISTR IBUT JON 

There appear to be documented evidence that variances 

distribution are based on local scientific studies. Such 

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€

transp I antat lon, I oca I var lances play an Important part

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 I ch akes I nto account accumu I a ted wa I t I ng t I me. 

7)' SINGLE UNIFIED WAITING LIST 

NATCO endorses the reconendatlon that there should be 

movement toward a single unified list for patients awaltlnf 

transp I antat Ion per each des I gnated OPO serv I ce area. 

. 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 

address the urgency of the recipient' s ' need for 

transplantation as well as histocompatibility factors such 

HLA matching and sensitization rates (reactive antibody I eve I ) . 

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 

expectat Ions of success. 
R I chard Kusserow October 1. 1990 

Page 5 

8) RELA T IONS WITH DONOR HOSP IT ALS 

NATCO has concerns relating to the recomendation that 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 

distribution arrangements within the designated OPO service

area. I t is a shared respons bill ty of the Organ Procurement 

Organ I zat Ion (OPO) , re I ated tissue and eye banks. and the 

donor hospital to create an open working relationship that 

fosters organ and tissue donat Ion and d str I but Ion. 

As critical as this working relatl.onshlp Is, NATCO cautions 

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 with the OPO, tissue nd eye banks and donor 

hosp I ta I, respons bill ty for the transp I ant opportun I ty for 

each pat lent ' 1 s shared 'by the transp I ant center and OPO and" 

fostered by a sJmllar open working relationship. 

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 ng organ shar I ng are sc I ent I fica I Iy based and that we 

continue to provide optimum patient care . to those .seeklng 

transp I antat Ion. 

11) DEMONSTRATIO PROJECT EVALUATION A REGIONAL DISTRIBUTION 

SYSTEM 

NATCO a I so supports fund I ng for a demonstrat Ion effort wh Ich 

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 

first-come first-served basis subject to objective medical criteria. Such a project would evaluate the potential of a 

regional patient driven distribution system as well as asses 

the cost effectiveness of such a system. Before undertaking 

an attempt at a national distribution system, a regional 

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


development of comunity outreach programs).€

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) to conduct their own analysis of


those factors wh I ch may I ead to longer med I an wa I t I ng times€

for black patients versus white patients. NATCO would


we I come the opportun I ty to work with these groups In study I.ng€

these Issues.€

As NATCO Is comitted to assuring optimum standards of


practice, we appreciate' the opportunity to coment on this€

draft report and, look 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. 

We welcome NATCO' s suppon on our reommendation calling 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 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. . " 

On the matter of relationships with donor hospitas, 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, iheintent of our proposed regulation is to foster 

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

, t€

... ..""... ......."'''. UVV""V-I.' 

Offce n mbcr (617) 277-6200€

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 Practices. - J'9- O()5$tJ 

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 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 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 categorized by diverse protocols and€ practices. Within limits, it is essential to encourage this diversity if we are 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 
.

Richard P. Kusserow 

December 27, 1990 

Page 2 

- - While an absolutely uniform national system is appealing. it is more 

realistic and practical to organize at a regional level. This provides sufficient 

scale of activity while minimizing logistical problems. 

- Any system of organ distribution should focus on the outcome, i.e., equal 

access. There wil be more than one legitimate way of achieving that end. 

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. 

Recommendation # - 8fhe PHS. in collaboration with the OPTN, should issue 

regulations to require that each OPO '(1) establish a single, unified list of 

patients awaiting transplantation and (2) distribute organs to these patients on a 

first come first served basis, subject to established medical criteria. Comments: 

- 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 ' 

inappropriate to allow any surgeon or transplant center to decide these issues 

unilaterally, it is equally unreasonable to suggest that there is only one correct 

answer for all the nation. Instead we would suggest that equal access can best 

be assured by requiring that each region of the countr establish an objective 

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 

required so that periodic retrospective analysis may be performed.. This would 

allow comparisons among the regions. 

Some proposals suggest the establishment of OPO-wide lists rather than regionwide 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 

consolidation of existing ones. The alternative wil be the' creation of new. one 

or two transplant center OPO's to avoid impact of a shared list. 
Richard P. Kusserow 

December 27, 1990 

Page 3 . 

Becommendation # 2 - "The PHS, in collaboration with the 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. 

Comments: 

- Such regulations are appropriate. It seems strange to establish OPO territories 

and OPOIOPTN rules and then allow individual hospitals to act .outside of". them. 

- 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 

the development of medical practice guidelines addressing organ transplantation. 

Comment:


It wil be diffcult to develop guidelines given the disagreements within the


transplant gomniunity on appropriate methods of selecting potential recipients. 

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 

general set of medical criteria, bqt national consensus is unlikely. Whatever is 

developed must have sufficient 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: 

Such a study, while desireable, is likely to be impractical given the lack of 

agreement on what constitutes "established medical criteria. - (See comments 

above), and political concerns of adjacent OPO's. However, it might be more 

practical to study. organ allocation at those larger OPO's which already have 

unified lists and include a large number of transplant centers. This would also 

allow examination of different sets of "established medical criteria- which have 

been implemented in different regions of the country. Given the existing 
. .

Richard P. Kusserow 

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 

factors, Given the apparent disparity among regions (e.g. no difference in waiting 

time NEOB's region but varyirig levels of difference in most others) this is 

obvious a complex issue. For example, Is there a signifcant difference between 

the experience at single-transplant center OPO's versus those that serve many 

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 analyzing data, as well as the testing of any proposals. 

We loo~ forward to conversations with you and/or members of your staff 

concerning these important issues. 

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 

project concerning the use of the first come first served concept. Yet, as we note in the text, such 

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 

ready to paricipate, we think such a demonstration warants the effon. 
.. 

.... ... ( / . , .. ...., . ..

n -organ procurement fO. ndation€

January 22, 1991


11.0.. 

P.trila AU., II.D~ v". Prl lI""I"'t. II.O~ 

H-~. Wil" M.D.5K WI. LeF.t, 1'.. 

n.. A. At utClliw'Do.afMThe Honorable Richard P. Kusserow


Inspector General


Department of Health and Human Services


BRS North Building


330 Independence Avenue, S. 

Washington, D.C. 20201 

Dear Mr. Kusserow:


The South-Eastern Organ Procurement Foundation (SEOPF) wishes to comme: 

on the Draft Document: "The Distribution of Organs for Transplantatio' 

Expectations and Practices . SEOPF has been an imrtant contributor for mo 

than 20 years to the science of transplantation including the use 

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

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

upon short-term rather than long-term results, the ' role of histocompatibili 

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 Procurement Age


indicate that black patients are more often Ynavailable for an identifi 

donor organ than whites Ol). SEOPF believes that additional da 

collection and analysis will be important to a correct interpretation of 

findings in your Draft Document. The SEOPF Scientific Projects 

Publications Committee is undertaking studies of Center et.fects and 

access of minorities to cadaver donor kidneys for transplantation. We expe 

that the results of these SEOPF research studies will be helpful to you 


the entire transplant community in our effort to understand the reasons differential access of particular patient groups to cadaver organs f 

transplantation. SEOPF appreciates the opportunity to comment on the Dr, 

Document and looks forward to sharing the results 'of its research wit later this year. 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 onse To SEOPF Comments 

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 

of minorities to cadaver kidney transplantation. EOPF and its member institutions bring much 

expertse to such inquir. We look forward to the results.