The Surgeon General's
Workshop on

INCREASING ORGAN
DONATION

PROCEEDINGS

Washington, DC.
July 8-10, 1991

U.S. DEPARTMENT OF
HEALTH & HUMAN SERVICES
Public Heaith Service


ACKNOWLEDGEMENTS

The Surgeon General's Workshop on Organ Donation was supported by the
Division of Organ Transplantation, Bureau of Health Resources Development,
Health Resources and Services Administration.

Veretta W. Blake was a much valued con-
sultant to the Division of Organ Transplan-
tation, bringing courage and inspiration to
the many lives she touched. Her contribu-
tion to the planning and conduct of this
workshop was invaluable. Ms. Blake died
on January 5, 1992. She will remain an
inspiration to her colleagues and friends and
she will be dearly missed.

All material in this volume is in the public domain and may be used or
reproduced without permission from the Office of the Surgeon General, the
Division of Organ Transplantation, or the authors. Citation of the source is
appreciated.

The opinions expressed herein are the views of the authors and participants and
do not necessarily reflect the official position of the Office of the Surgeon
General, the U.S. Public Health Service, rhe Health Resources and Services
Administration, or any other agency of the U. S. Government.

ii


FOREWORD

Ihe Surgeon General's Workshop on Increasing Organ Donation held in
July 1991 was a response to the critical need to raise donation levels.
The workshop brought together approximately 125 individuals from very
diverse backgrounds including medicine, nursing, law, bioethics, hospital
administration, public relations, and funeral homes. Other participants
included transplant recipients, lawmakers, social workers, members of
donor families, and representatives of national health associations.
Minority groups were also represented.

After two days of careful thought and discussions, the participants
submitted a list of recommendations on how to increase donation levels.
Those recommendations are presented in this document. A companion
publication contains the background papers written specifically for this
workshop.

It is my sincere hope that these publications, representing the collective
thoughts of some of the best minds in the transplant field, will motivate
more people to promote organ donation and confirm the efforts of those
already fighting for this important cause. Most important, I hope that the
results of this workshop and the ensuing implementation of the recom-
mendations will translate into a second chance at life for all who await
donor organs.

AntoniaC.Novello,M.D.,M.P.H.
Surgeon General

. . .
111


                                                    I
ADVISORY COMMI'ITEE TO -ON GE-
                    DON-

Patricia Aiken-O'Neill, Esq.
Executive Director
Eye Bank Association of America
Washington, D.C.

Nancy Ascher, M.D., Ph.D.
Professor of Surgery
Chief, Liver Transplant Division
University of California - San Francisco
San Francisco, California

Charles K. Atkin, Ph.D.
Professor
Department of Communications
Michigan State University
East Lansing, Michigan

Ashley Baquero, M.D.
Medical Director
Organ Transplant Institute
Schumpert Medical Center
Shreveport, Louisiana

Christopher Blagg, M.D.
Executive Director
Northwest Kidney Center
Seattle, Washington

Clive 0. Callender, M.D.
Director, Transplant Center
Howard University Hospital
Washington, D.C.

James F. Childress, Ph.D.
Professor of Religious Studies
Department of Religious Studies
University of Virginia
Charlettsville, Virginia

iv


Jeptha W. Dalston, Ph.D.
Chief Executive Officer
Hermann Hospital
Houston, Texas

John Davis
Executive Director
National Kidney Foundation
New York, New York

Barbara A. Elick, BSN, RN, CCIVCPTC
President
North American Transplant Coordinators Organization
Chief Transplant Coordinator
Transplant Center
University of Minnesota Hospital and Clinic
Minneapolis, Minnesota

Roger W. Evans, Ph.D.
Research Scientist
Health and Population Study Center
Battelle Human Affairs Research Centers
Seattle, Washington

M. Roy First, M.D.
President

American Society of Transplant Surgeons
Professor of Internal Medicine
Director of Section on Transplantation
University of Cincinnati Medical Center
Cincinnati, Ohio

Louise Jacobbi
Executive Director
Louisiana Organ Procurement Agency
Metairie, Louisiana

Olga Jonasson, M.D.
Chairperson
Department of Surgery
Ohio State University
Columbus, Ohio


Michael Kaplan, M.D.
President
Association of Organ Procurement Organization
Associate Professor of Surgery
Wayne State University
Harper Hospital
Department of Surgery
Detroit, Michigan

Jeanne Mowe
Executive Director
American Association of Tissue Banks
McLean, Virginia

Jeffrey Prottas, Ph.D.
Research Professor
Bigel Institute
Brandeis University
Walston, Massachusetts

Sarah Sanford, R.N., M.A.
Executive Director
American Association of Critical Care Nurses
Aliso Viejo, California

Edith Servino, R.N.
Director of Education
United Network for Organ Sharing
Richmond, Virginia

Charles Shield, M.D.
General Surgeon
Wichita Surgical Group
Wichita, Kansas

David E.R. Sutherland, M.D., Ph.D.
Professor of Surgery
University of Minnesota Hospital and Clinic
Minneapolis, Minnesota

vi


Phyllis Weber, R.N.
Executive Director
California Transplant Donor Network
San Francisco, California

Andrea A. Zachary, Ph.D.
Chief

Transplantation Section
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, Maryland

vii


FEDERAL PARTICIPANTS

WORKSHOP COORDINATING COMMITTEE

Antonia C. Novello, M.D., M.P.D., Surgeon General, U.S. Public Health Service

Judith B. Braslow, Director, Division of Organ Transplantation, Bureau of Health
Resources Development, Health Resources and Services Administration

Mary L. Ganikos, Ph.D., Chief, Public and Professional Education Branch,
Division of Organ Transplantation, Bureau of Health Resources Development,
Health Resources and Services Administration

Margaret D. Garikes, Executive Assistant to the Surgeon General, Office of the
Surgeon General, Public Health Service

Dushanka Kleinman, D.D.S., MScD, Special Assistant to the Surgeon General,
Office of the Surgeon General, Public Health Service

Gwen Mayes, MMSc, CPTC, Public Health Analyst, Operations and Analysis
Branch, Division of Organ Transplantation, Bureau of Health Resources
Development, Health Resources and Services Administration

Consultant: Veretta Blake, Liver Transplant Recipient

      OFFICE OF THE SURGEON GENERAL

Antonia C. Novello, M.D., M.P.H., Surgeon General, U.S. Public Health Service

0. Marie Henry, R.N., D.N.Sc., Deputy Surgeon General

Rice C. Leach, M.D., Chief of Staff

Jan Aamodt, Communications and Correspondence Coordinator

Mary Jane Fingland, Director of Public Affairs

Margaret D. Garikes, Executive Assistant to the Surgeon General

Dushanka Kleinman, D.D.S., MScD, Special Assistant to the Surgeoil General

. . .
Vlll


BUREAU OF HEALTH RESOURCES DEVELOPMENT
HEALTH RESOURCES AND SERVICES ADMINISTRATION

Judith B. Braslow, Director

Jon L. Nelson, Deputy Director

Remy Aronoff, Chief, Operations and Analysis Branch

Janice K. Bennett, Special Assistant to the Chief, Public and Professional
Education Branch

Veretta Blake, Consultant, Public and Professional Education Branch

Nan Buczek, Secretary, Operations and Analysis Branch

Doreen Brandes, Secretary, Public and Professional Education Branch

Joyce Brown, Public Health Analyst, Public and Professional Education Branch

Mary L. Ganikos, Ph.D., Chief, Public and Professional Education Branch

Philomena Green, Public Health Analyst, Operations and Analysis Branch

Evelyn Klitsch, Division Secretary

Michelle Holland, Secretary, Public and Professional Education Branch

Vera Lake, Public Health Analyst, Public and Professional Education Branch

Gwen Mayes, MMSc, CJTC, Public Health Analyst, Operations and Analysis
Branch

. .

of m

Dorothy M. Bailey, Chief, Resources Information Branch

Patricia Delaney, Senior Public Health Analyst, Resources Information Branch

ix


Devu

Emily L. Haley, Director

Allison A. Hammond, RN, BSN, Legislative Analyst

Larry Wannemacher, Senior Public Health Analyst


ABBREVIATIONS

AA-l-B

ABTC

ACl-

AHA

AOPO

ASHI

ASTP

ASTS

CDC

DHHS

DOT

EBAA

ESRD

HCFA

HHS

HIV

HRSA

IHS

M0-r-r~~

American Association of Tissue Banks

American Board of Transplant Coordinators

American Council on Transplantation

American Hospital Association

Association for Organ Procurement Organizations

American Society for Histocompatibility and
Immunogenetics -

American Society for Transplant Physicians

American Society for Transplant Surgeons

Center for Disease Control

Department of Health and Human Services

Division of Organ Transplantation

Eye Bank Association of America

End Stage Renal Disease

Health Care Financing Administration

Health and Human Services (Department of)

Human Immunodeficiency Virus

Health Resources and Services Administration

Indian Health Service

Minority Organ/Tissue Transplant Education Center

xi


MHC

NATCO

NIH

NKF

OPO

OPT-N

PHS

RFC

RFP

SEOPF

TRIO

UNOS

USRDS

Major Histocompatibility Complex

North American Transplant Coordinators Organization

National Institutes of Health

National Kidney Foundation

Organ Procurement Organization

Organ Procurement and Transplantation Network

Public Health Service

Request for Contract

Request for Proposal

South-Eastern Organ Procurement Foundation

Transplant Recipients International Organization

United Network for Organ Sharing

United States Renal Data System

xii


CONTENTS

Page

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Advisory Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  iv

Federal Staff . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  viii

fi&viations . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi

Remarks and Presentations

Monday, July 8,199l . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Judith Braslow

Robert G. Harmon, M.D., M.P.H.
Antonia C. Novello, M.D., M.P.H.

Tuesday, July 9, 1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Antonia C. Novello, M.D., M.P.H.
Judith B. Braslow
M. Roy First, M.D.
Louis A. Sullivan, M.D.

Wednesday, July lo,1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Judith B. Braslow

Antonia C. Novello, M.D., M.P.H.

Recommendations k

Work Group I-A . . . . . . + . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
   A National Campaign: Focusing on the
    General Public

Work Grou  I-B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
     A R ational Campaign: Focusing on Diverse
   Socio-Economic and Cultural Groups

Work Group I-C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
    A National  Campai
   Children, Youth, and oung Adults
        r :   Focusing on

Work Group II-A . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . 59
   The Delivery System

Work Group II-B . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . 67
    Professional Education

Work Group III-A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
   Re-examining Donor Criteria: Cadaveric
    Donors

   Work Group III-B . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
       Re-evaluating Donor Criteria - Live Donors
List of Participants  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77


Monday, July 8, 1991

NG REMARKS

Judith B. Braslow
Director
Division of Organ Transplantation
Bureau of Health Resources Development
Health Resources and Services Administration
U.S. Department of Health and Human Services

Good afternoon. I'm Judy Braslow, Director of the Division of Organ Trans-
plantation. We are delighted you are here. We've spent the last 15 months
preparing for this Surgeon General's workshop. It's required a great deal of time,
planning, and assistance from many people, from staff in the Division of Organ
Transplantation, staff in the Office of the Surgeon General, and commitment
from the HRSA Administrator, Dr. Robert Harmon. Dr. Harmon has been the
HRSA Administrator since February 1990. previous to coming here, he was the
Director of the Missouri Health Department, and prior to that, he was the county
health officer in Maricopa County. While at HRSA, he's spent a great deal of
his time and energy improving relationships between State and county health
departments and the Federal Government. He has been of enormous support to
the Division of Organ Transplantation.  Without his support we wouldn't be
doing this workshop today, and so it is my pleasure to introduce to you
Dr. Robert Harmon.

Robert Harmon, M.D., M.P.H.
Administrator
Health Resources and Services Administration
U.S. Department of Health and Human Services

Thank you, Judy, and welcome. I bring you greetings from the Health Resources
and Services Administration. We are very honored to have this opportunity to
be part of the Surgeon General's Workshop on Increasing Organ Donation.

HRSA was created in 198'2, and is one of eight agencies that comprise the U.S.
public Health Service.  We've been given the leadership responsibility in
Promoting access to health care services for medically underserved populations,
and for special populations, such as the homeless, persons with HIV infection,
and persons who need organ transplantation.  HRSA is composed of four
bureaus, all of which focus on developing community-based health resources
which will improve access for those populations in need.

The Division of Organ Transplantation is located in OUT Bureau of Health
Resources Development. It has worked long and hard to bring to the attention

1


of the public and health care professionals the need for more organ and tissue
donors. In conjunc!ion with the Office of the Surgeon General, the Division has
brought together leaders in the field to tackle the issue of increasing donation.
HRSA is working closely with Secretary Sullivan, Assistant Secretary for Health
Dr. James Mason, the Surgeon General, and the PHS agencies, in this important
task.

I would like to introduce to you the Surgeon General. Dr. Antonia Novello is
the fourteenth Surgeon General of the U.S. Public Health Service. She was
sworn in on May 9, 1990. She entered the PHS in 1978 after practicing
pediatrics and nephrology in the private sector. Prior to her appointment as the
Surgeon General, her PHS career was spent at the National Institutes of Health,
where she served in various capacities, eventually becoming the Deputy Director
of the National Institute of Child Health and Human Development. In that
position, she directed extramural programs and coordinated pediatric AIDS
research. Also while at NIH, Dr. Novello was detailed to the Senate Committee
on Labor and Human Resources, where, as a legislative fellow, she worked with
Sen. Orrin Hatch and was directly involved in drafting the National Organ
Transplant Act of 1984. I'm sure most of you are aware of the significant impact
of this legislation.  From the Transplant Act, we have the Organ Procurement
and Transplantation Network and the Scientific Registry. These two programs
provide the basis for most of the transplant activities in this country.

Dr. Novello is acutely aware of the need for more organ donors and has seen
first hand the impact of renal disease in children. Among the major public
health issues that are brought to her attention, she has singled out the need for
more organ donors as a major priority. In Dr. Novello, the transplant community
has a dedicated, outspoken advocate.  I know she is committed to seeing that
your recommendations receive maximum attention, both in the Public Health
Service and by the general public. Please welcome the Surgeon General of the
U.S. Public Health Service, Dr. Antonia Novello.

Antonia C. Novello, M.D., M.P.H.
Surgeon General of the U.S. Public Health Service
U.S. Department of Health and Human Services

Good afternoon, dear colleagues and friends. Welcome. Thank you for
committing yourself to working on this important issue.

This is the second Surgeon General's Workshop on Organ Donation. The first
was held in June 1983. There has been considerable change in these 8 years.
We can acknowledge that and still know that we need to accelerate progress.
There is no question in my mind of the urgent need to address organ donation.

2


Today we need to reach all Americans, but especially members of minority
groups, and convince them of the value of organ donation. We need to allocate
the donated organs in the most effective and efficient way, and with due respect
for these gifts of life.

We need to get to the American public and convince them that organ donation
saves lives, in some cases lives of their friends and families. We need to honor
the needs of both: the donor and the recipient of these gifts of life.

Organ donation is a complex medical issue that cannot be considered in isolation
from social issues. Organ donation must be considered with a sophisticated
awareness of the racial, ethnic, religious, and educational diversity of this
country.

Those of you present today represent a broad cross-section of professionals and
individuals committed to increasing the supply of organs and tissues for
transplantation in this country.  I urge you to bring your insights and your
cultural sensitivities into play, so that as we listen to one another we can come
up with sound recommendations.

Whether you are a transplant recipient, a surgeon, a nephrologist, a nurse, an
organ procurement specialist, a health policy analyst, a teacher, a student, or a
lawyer, I urge you to bring and share your own personal knowledge and percep-
tions regarding organ donation. You know a great deal about other people of
similar backgrounds. Bring all that awareness, all that knowledge, and all that
sensitivity to the discussions, so that we can all benefit from it.

I cannot talk about the issue of organ donation as Surgeon General without being
aware of my minority heritage and my professional life as a pediatric nephrolo-
gist. We may not agree on every point, and depending on our background, we
might have to take practical realities into account. But there is no question that
we all agree on the importance of organ donation. Few issues reach so far into
the human heart.

Ahhot@ many of the issues related to organ donation might be called technical,
we must not disregard the issues of the heart and soul. I want you to draw on
Your own experiences, I want you to look into your heart. This is an issue where
we need to try and understand the most serious human realities: life and death.

Since we will be concentrating on problem issues -- and I intend to drive YOU
hard in this meeting -- I think we can take just a moment to celebrate progress.

I know many of you here today contributed to magnificent improvements in the
field of transplantation.  I want to acknowledge that.

3


For example, in the past 8 years we have seen the number of patients receiving
kidney transplants almost double from 5,358 in 1982 to 9,560 in 1990, and the
number of patients receiving dialysis for end-stage renal disease increasing from
65,000 in 1982 to 125,000 in 1991.

Eight years ago about 100 patients had heart transplants, while last year about
2,085 procedures were performed at 150 hospitals across the country.

At a pioneering transplant center at the University of Pittsburgh, 62 liver
transplants were performed in 1982, and last year 2,656 transplants were
performed.

We've also seen major changes in legislation. We have landmark legislation
combining all organ procurement and transplant activities into a single national
network. There is Federal assistance for organ procurement organizations,
increased coverage and reimbursement for heart and liver transplants, and
extensive legislation requiring hospitals to incorporate the option of organ
donation into routine practice. Breakthroughs in immunosuppressive therapies,
donor screening, organ preservation, and techniques to diagnose rejection have
also brought improved graft survival rates for over 15,000 patients who had
transplants in 1990.

Now having said all this, I must turn all of us to reality.

There are over 23,000 patients on lists today, waiting to receive an organ.
Before this workshop is over, at least another 50 transplant candidates will be
added to the list. Some will receive a transplant and go on to live a near normal
and productive life. Others will not be so fortunate.

Each of you here today has a responsibility.' Each of you has been assigned to
one of seven workgroups depending upon your area of expertise and/or interest.
You will be asked to discuss some very specific issues, develop recommenda-
tions, and come up with sound strategies for implementation.

We're not going to avoid the hard issues. We're not here for that. We're going
to confront head-on some serious controversies and address complex technical
problems, such as the importance of matching, of living donors, of informed
consent -- and I mean ~nrly informed consent.

We're going to talk about money -- about the policy of stopping payment for
immunosuppressants after 1 year or continuing to finance immunosuppressive
drugs for longer than that. We're going to face the truth about high rejection
rates, about dialysis versus transplantation survival, and even about the
risks/benefits of either dialysis or transplantation.  We're going to talk about
educating health care workers, particularly those in emergency rooms, so that
they can be both committed and comfortable in talking to grieving relatives about

4


organ donation. We'll be thinking about b and h is the right time to talk
to families of donors and indeed when and how to talk to prospective donors
themselves.

We have a priceless opportunity in this workshop to make major changes for the
good.

I want all of us to give our best while we are here. You have very hard work
ahead of you.

Thank you.

Tuesday, July 9, 1991

Dr. Novello: Good morning. I am pleased to see that you are ready for action.
We have 2 days to address the issues and draft recommendations.  We have a
terrific sense of urgency to accomplish all of this.

Transplants started in 1954. We have almost 40 years of experience, and with
it we have a climate of acceptance.  For the most part, people are willing to
donate. But they need to be reminded that only people can donate for people.

It is clear that the field of organ transplantation continues to develop. The goal
of this workshop is to increase organ donation, particularly donation from
minority groups. This workshop also gives us the opportunity to look back and
to anticipate the future of organ transplantation.

Today we have better ways to prepare and preserve organs, better matching
procedures, and better immunosuppressive treatments.  Cyclosporine was
approved by FDA in 1983, and today FIG06 appears very promising. Through
research, the future will bring tolerance induction, genetic engineering, and
xenotransplantation.

We have learned to transplant portions of organs, such as split livers and portions
of lungs. A new procedure permits the recovery of kidneys from non-heart
beating donors. Today, tissues and organs can be obtained from virtually every
Person who dies.  We are close to an artificial pancreas, and as genetically
engineered tissues become a reality, to other artificial organs as well.

We have the possibility of using animal organs in some future cases. We may J
have new gene therapies for diabetes and lung diseases. We have made progress,
but we have also created some serious problems.

5


In 1986, Congress required that hospitals receiving Medicare and Medicaid funds
establish a written protocol to identify potential organ donors. By April 1989,
43 States and the District of Columbia had enacted legislation for this &
Ieouesr.

Nevertheless, written donor agreements account for a very small fraction of
today's donor pool, perhaps only 3 percent of all organ and tissue donations.

i   Although they may be valuable as a notice to families of the individual's
d   preference and commitmen! to donate, surgeons still routinely require family
  approval. Reasons for this include the fear of legal liability and respect for
   grieving relatives.

Taking all of this into account, the fact remains that we might not only have an
\!  absence of donors, we might have an absence of a,&rs as well. Too many
people are not receiving the organs they need and too many people go unasked
for organs they can donate. It is estimated that based on age, cause of death, and
other criteria, that as many as 14,000 of the 2.2 million Americans who die every
year could donate life-saving organs to those on waiting lists. A recent report
noted that in 1990, 2,206 people died while waiting for organs. As I stated
earlier, while we are here today, about 50 more people will be added to the
  transplant list. The process is never ending.

Let me briefly review the history of organ transplantation so we can put the issue
in its true perspective.

In 1984, Congress passed the National Organ Transplantation Act. This required
the Secretary of Health and Human Services to contract for an Organ Procure-
ment and Transplantation Network with a private, non-profit entity. In 1986, the
Secretary awarded the contract to the United Network for Organ Sharing (UNOS)
with the understanding that all transplanting hospitals, when participating in
Medicare and Medicaid, must become members of UNOS. UNOS, in turn,
maintains the Nation's computerized list of individuals waiting for organ
donations. For the first time in this country, the Transplant Act and the contract
with UNOS created an equitable and efficient national system of tracking organ
donations and transplantation.

As of mid-June, there were almost 19,000 patients waiting for kidney trans-
plants; 2,000 waiting for a heart transplant; almost 1,500 waiting for a liver; 171
waiting for a heartflung transplant; almost 600 waiting for a pancreas; and nearly
500 waiting for a lung transplant.  About 12 percent of these will need a
repeated transplant.

We also know that approximately half of those on waiting lists are between the
ages of 19 and 45, and over 90 percent are between the ages of 19 and 64.
About 40 percent are women and 60 percent are men.

6


&Each year about 15,000 whole organs from 4,500 donors are transplanted at 261
transplant centers, with the help of 69 organ procurement organizations. We
have come a long way, but something is interfering with the momentum.

Approximately 2,000 new patients are added to the list of those already waiting
L for organs each month. Sadly, between a third to a half of all Americans on
transplant waiting lists will die before a transplantable organ is found.

`Ihe recommendations generated by the National Kidney Foundation in February
gave us points for discussion and innovative strategies to consider solutions. The
participants emphasized obtaining organs from living donors and examined the
\,  issue of econsenr, concluding that it is not yet ready for acceptance in
this country. In addition, Medicare payments for the life of a transplanted organ
was discussed for those patients who have no other insurance.

When we look at the issues from the Kidney Foundation meeting, and remember
the article in the June 1st yew Ym which reported the successful
transplantation of the small intestine in three children and two adults, a medical
first, we realize once and for all that we do have important issues to consider in
this workshop.

-G- The issues, no matter what they are, intertwine: the relative importance of

i  matching and the need for minority donors; and the appeal for scarce organs to
be used in the community of origin and the imperative of finding the best
possible match.

There are difficult decisions to be made. Which patient should receive a given
  organ -- the patient with the most urgency or the patient with the best match?
Should live organ donations be given only to those with economic means? If
~ i there were more organ donations, and organ availability for all, some of these
I -* issues would vanish.

In the absence of that, we have issues of money and social status which we must
review. The United States has come a long way in assuring that lack of money
is not a barrier to organ transplantation -- but have we come far enough, and
should it be reevaluated in today's world? Although nearly all kidney transplant
candidates are reimbursed by Medicare, those who are not may find costs
prohibitive. The estimated cost of a kidney transplant is $51,000. Furthermore,
the Medicare program only covers the cost for immunosuppressive drugs for the
first year after transplantation, and those drugs may cost as much as $3,000 a
Year. Many patients, especially minorities, might find this cost too high.
Worries about lifelong cost of immunosuppressive drugs can cloud their relief
at having an organ transplant. We must work at removing this disincentive.

7


There are also co-insurance and deductible requirements which can substantially
limit access to kidney transplants. Can you imagine what happens with other
organ transplants?

Are transplant patients really able to go back to work? Can they start paying for
their immunosuppressive drugs when Federal funding stops after one year? Is
one year enough to rehabilitate, and if not, do we need to readdress this issue in
detail?

  We must look at socioeconomic status and disease -- poverty breeds disease and
  often limits care. How does this affect the need for organ transplantation? Let
  me illustrate. I don't think we have to document the link between minority status
  and low socioeconomic status at this meeting. The risk of end-stage renal
  disease among blacks is four times higher than for whites. The prevalence is
also higher. Blacks make up approximately 12 percent of the U.S. population,
yet in 1987 they accounted for 27 percent of the patients with end-stage renal
  disease. Although blacks have an increased prevalence of hypertension and
  diabetes, the increased incidence of end-stage renal disease among blacks versus
  other minorities cannot be attributed to any one cause. The 1989 Report of the
Department of Health and Human Service's Office of the Inspector General
stated that there were problems in equitable distribution of organs. For instance,
the report found that blacks on kidney waiting lists waited `almost twice as long
--+ as whites for a first transplant:  14 months compared to 8. Patients at some
centers waited as long as 18 months while at others they waited less than 6
months. Thirty percent of those waiting were black, yet only 23 percent of
cadaver kidneys went to blacks. The report also said that in 1988,mly about
8 percent of all cadaver kidney transplants were from black donors. Since most
donors are white, whites were more likely to have a better chance at matching.

These problems can be found in other minority groups as well. For adult Native
Americans living in the U.S., the overall risk of end-stage renal disease is
approximately three times higher than for whites. We don't know much more
about renal disease and Hispanics. One study of Hispanics in California showed
a risk about the same as whites, but a study in Texas repotted a three times
higher risk of end-stage renal disease in this population. To make things more
complicated, what we refer to as "Hispanic" is really a number of different
genetic groups and, therefore, the antigens among Latin0 subgroups may vary,
making matching more difficult.

In 1985, HCFA indicated that for blacks the percentage of end-stage renal cases
was larger than the percentage of transplants. A smaller percentage, however,
had transplants from living donors. Even in the presence of this bleak picture,
some black families are not willing to give permission for the donation of even
one cadaveric organ. Is this small percentage of donations due to cultural or
religious patterns, educational levels, or basically the way these families are
approached? We need to address this.

8


You will be hearing from experts pertaining to this issue. Some of the reasons
cited for this have been religious objections, fear that organs will be taken before
the person is dead, a desire to spare the departed more suffering, fear of
mutilation of the body or a desire to bury the body intact, or even distrust of the
medical system as a whole. Is it part of the consequence of minority status to
be more fearful of exploitation? Is it that the one who asks for the donation is
not cognizant of the minority individual's cultural sensitivities, or is not perceived
as understanding such sensitivities ? Would it help if the person raising the issue
of donation was black or Hispanic ? Probably so, and all these issues must be
discussed.

We know that a higher socioeconomic status and a higher level of educational
J attainment allows individuals to be willing to talk about organ donation. What
. we do not know is whether other groups, including minority groups, would be
more willing if they were approached in a more culturally sensitive and
compassionate manner. We must address this as well.

Throughout medicine and biomedical research, we have made assumptions that
are increasingly being questioned. For instance, there is an assumption that
minorities are less likely to comply with medical regimens or less likely to
donate organs. Truth or prejudice? We all must look at this.

Look dispassionately at the issues that affect minority donations and minority
transplants. Differences in ABO blood groups, the major histocompatibility-co-
mplex antigens, inadequate financial coverage, the knowledge that transplant
outcomes in blacks might be worse than in whites, the presence of cultural
barriers and countless other factors -- these affect the rate of transplantation but
might not be the whole problem. These issues have to be factored into the
discussion but are not to be used as scapegoats to avoid looking further into
other issues.

We know that there are racial differences in the distribution of major histocom-
patibility-complex antigens. The racial differences in AE30 blood groups and
phenotypes also make it more likely that a candidate for transplantation will
receive a well-matched kidney from a member of the same race; however, we
must not be limited by this. We have overcome less than perfect matches with
the advent of better immunosuppressant drugs, but research must continue in this
field.

These are undoubtedly issues we have to interpret for potential donors and their
families, and these are some of the barriers we need to overcome in order to
increase donations from minority groups -- issues I expect to be thoroughly
discussed and skillfully addressed in this meeting.

Consider for example, the standards for brain death and the need to communicate
these standards to a desperately grieving relative.  Should we remove this

9


definition altogether, as it confuses the public, or explain it more sensitively to
the ones in need?

I want this group to consider everything that will increase donation, not only
donations from biologically related family members but also those "related"
through marriage, friendships, and strong emotional ties.

Discuss the well recognized use of living donors for kidney transplantation, and
explore the practice as it relates to liver, pancreas, and lung transplantation.

Also, don't be afraid to discuss and list the hidden costs associated with being a
living donor -- not just surgery, but the added cost of health insurance and time
lost from work. Consider as well the need to think about Dresumed and
the potential legal issues attached to this.

As Surgeon General, I cannot talk about this issue without being aware of my
Hispanic heritage and my professional life as a pediatric nephrologist. We may
not always agree on every point, and we have to take practical realities into
account, but there is no question that we agree on the importance of organ
donations and the fact that there was never a better time, or a better team, to help
implement your recommendations and move the field forward.

Although many of the issues related to organ donation are technical, many are
issues of the heart -and soul, no matter how we disguise them. In the next 2
days, I want you to draw on your own experience and look into your own heart.
Organ donation is an issue where we need to try and understand the most
sophisticated medical knowledge and the most serious human issues, and
translate them into action.

We need to continue to look at education of the public to encourage organ
donation. In doing so, we must face hard issues, such as how tissues and
organs should be obtained from one donor and then be transplanted? How do
we assure the public that their specific donation request will be honored?

What about AIDS, hepatitis, and other infectious diseases? The FDA, under the
auspices of Dr. Mason, is setting a process in motion to address this problem.

What limits are there on donors -- how old and how sick can they be? Should
children and babies donate organs. 7 How do we address these ethical issues?

We must also address the issue of what constitutes informed. How
should people be protected against pressure to be a living donor? Can they be
protected, or is the natural stress in a family when a member is dying beyond
control? Should we hesitate to ask? Should we routinely ask? We know that
some countries such as Norway have 50 percent of their organs donated by living
donors, and nearly 100 percent in Japan.

10


We need to look at the large picture. Can the transplant networks be improved?
How do we educate health professionals, particularly those who work in
emergency rooms or intensive care units, to regularly and compassionately talk
with surviving relatives about organ donation? When is the right time? Who is
the right person?

I urge you to focus on increasing organ donation in this country, particularly
minority organ donation. I urge you to develop strategies suggesting how these
recommendations might be implemented for all those in need.

Today your primary assignment is to develop recommendations. Tomorrow
morning your chief assignment will be to develop strategies. In both of these
tasks, please be as specific as possible and indicate which agencies, both public
and private, need to be involved in the implementation.

Keep in mind that your recommendations will be shared with the individuals and
organizations in charge of implementing them, such as health care professionals,
private institutions, and non-profit organizations, as well as many levels of
Government. Do not let that repress you. Speak candidly about the issues.

Once you present me with the recommendations, I will review them with the
Advisory Committee over the next few months and work with the Division of
Organ Transplantation to develop the report from the workshop.

We will publish the valuable background papers prepared for this meeting, as
well as the relevant recommendations and implementation strategies proposed at
this workshop. After this, the Advisory Committee that helped plan this
workshop will continue to provide guidance in implementing the recommenda-
tions and strategies, and will monitor the field progress in carrying out such
tasks.

I've been using a motto: "Good Science, Good Sense," since I've been Surgeon
General. Rarely has my motto been so appropriate as at this workshop. Before
me, I see the best people in the field of transplantation.  Before us is the
challenge of drafting the agenda for organ donors and recipients for the next
millennium. The possibility of saving future lives makes it all worthwhile.

Thank you.

W OF W-P AND CHARGE

Ms. Braslow: Thank you, Dr. Novello. This morning I want to show YOU
where the Department is on some of the key issues related to transplantation and
how your work at this meeting will fit into that context.

11


An important project is the release of center-specific data. In the transplant
amendments of 1990, Congress asked us to provide to the public, information
related to center-specific survival rates. We've received a lot of comment about
this. Institutions are concerned that if the Government releases the information,
it won't be interpreted correctly. It is not, however, a judgment call on our part.
The Ccngress has told us that this is what we are going to do. We have to find
the most acceptable and meaningful way to release this information. We've
worked very closely with the Scientific Advisory Committee of UNOS. We've
brought in a group of consultants and people from the Health Care Financing
Administration, which had lead responsibility for the Mortality Data Report. If
you recall, the first time HCFA released those data several years ago, it caused
a major storm, so we thought we could learn from their experiences. We've
discussed it with the UNOS Board, and we are now moving ahead.

We are trying to have a few variables that will distinguish one center from
another and one kind of transplant from another. The variables were determined
by the organ-specific subcommittees of the UNOS Scientific Advisory
Committee. In 1991, we will look for kidneys. We will model the data so that
we look at "first" vs. "subsequent" transplant, race, and cadaveric vs. living-
related donors. There will be two time points: 3 month survival and 12 month
survival.                                          i .

For liver, the criteria will be age, the medical status at the time of transplant, and
3 and 12 month points in time. For heart, it will be first vs. subsequent
transplant, the medical status of the individual at the time of transplant,
congenital vs. all other disease categories, and 1 and 12 month points in time.
For pancreas, we're looking at first vs. subsequent transplant, and also at the
recipient category. We will want to know whether it was a simultaneous
kidney/pancreas transp!ant, just pancreas, or pancreas transplant following a
kidney transplant. For pancreas, it will be a 3 and 12 month data point as well.
That data will be delivered to HRSA by UNOS near January 1, 1992. Then the
Department will decide how that data will be released.

Another important concern, as Dr. Novello has indicated, is the recent case of
HIV transmission through transplanted organs. The UNOS Board appointed a
committee to study recommendations of a DHHS Workgroup established to
examine issues of HIV and other communicable disease transmission in relation
to organ and tissue transplants.

As a result of our deliberations, we are suggesting that there be a pre-transplant
HIV serology. We are not suggesting that the transplant be held up while
awaiting results, but should the patient develop HIV, we want to know if that
patient was seropositive. The workup 2 or 3 months prior to transplant routinely
has an HIV serology; however, we want one immediately prior to transplant.

12


Secondly, we want post-transplant serologies at 6 and 12 months, which will
cover the window period for almost 99 percent of patients.  When HIV is
identified in the post-transplant follow-up, we want it immediately reported to
the UNOS Scientific Registry Data System. That allows us to identify other
individuals who received organs from the same donor. Obviously, all donors are
screened and we are very confident that the organ procurement agencies and
transplant centers are doing a good job of donor screening. Their job is limited,
however, by the sophistication of the tests available. Because that window
period exists, it's important that we know when somebody is HIV positive post-
transplant so that we can identify individuals who received organs from the same
donor. And it's important that we receive immediate reports of AIDS and HIV-
related death of a transplant recipient.  We have asked UNOS to develop a
system for how they're going to identify those individuals and what actions they
will take when a red flag is raised. These are the HIV testing guidelines that we
have begun to put in place, and I'm pleased with the response we've received
from the transplant community.

There is a national effort that 1 think is very exciting, and we're interested in
receiving your reaction to it. The Association of Organ Procurement Agencies
decided about a year ago to begin a national campaign and contracted with an
advertising agency to develop the campaign. At the Association's annual meeting
a few weeks ago, the results of that effort were released. For the first time we
had an effort that has been bought by virtually all the organ procurement
agencies in this country which have agreed to adopt this slogan, "Be an organ
[d onor, it's the chance of a lifetime." They will be using this on billboards and
brochures throughout the country in their donor education and awareness efforts.
YOU have copies of these materials. Please look at them. We're very interested
in your reaction.

NOW, let's get to the major task for these 2 days: developing recommendations
on how to increase organ donation in the United States and developing strategies
suggesting how these recommendations might be implemented. Each of you is
assigned to one of seven workgroups, focusing on a specific topic related to
donation. Each Workgroup is lo develop a set of recommendations on how to
increase organ donation horn the perspective of its specific focus. Today your
Prhar)' assignment is to develop recommendations. Tomonow morning your
chief assignment will be to develop specific strategies and to indicate which
agencies, both public and private, need to be involved in their implementation.

The seven issues fall into three categories:  public education, including the
general public, minority groups, and children; the health care environment,
including regulatory practices and professional education; and revaluating donor
criteria, including those used for cadaveric donors as well as live donors.

Th e groups addressing public education will zero in on the issues related to
inducting a national campaign. Group I will make recommendations with the

13


general public in mind. How should such a campaign be structured? Group I-B
will also help answer that question by recommending ways to increase donation
among individuals from various cultural backgrounds. What unique barriers need
to be overcome before minorities will feel equally as interested in donation?
Group I-C will focus on children, youth, and young adults, an important
component of a public education campaign because they are often the most
receptive to the idea of donation. Establishing their beliefs at a very young age
will help insure that donation is acceptable to them now and in their adult life.
Most important, children are often catalysts for educating parents about important
public health issues.

Groups II-A and II-B will focus on the health care environment in which
donation is likely to occur. The first group has one of the hardest tasks:
examining the regulations, laws, and policies that shape the practices of health
care professionals involved with donation, and making recommendations for
improvement. This group will need to decide if new laws and regulations are
needed or whether we should make better use of the instruments that are already
available.

Group II-B will hone in on the measures necessary to educate the various health
care professionals directly or indirectly involved with the donor process,
assessing current educational efforts, and recommending future programs.

The last two groups will focus on the actual criteria for donation. One will
discuss criteria for cadaveric donors, both adult and pediatric. It seems we must
expand the limits of traditional donor criteria in order to obtain more organs for
transplant. Much discussion and some research has focused on expanding the
upper and lower age limits for cadaveric donors. Besides expanding the age
criteria, what traditional medical contraindications can be reexamined in hopes
of increasing the number of donors?  Is there an acceptable gray zone for
diabetics or donors with histories of hypertension, drug abuse, or less than
perfect organ function? What research needs to be done in order to assist the
transplant community in reaching a consensus on these criteria? By transplanting
these marginal donors, are we jeopardizing the recipient's chance for a healthy
recovery?

The final Workgroup will focus on issues surrounding the use of live donors for
transplantation, not just clinical issues of donor suitability, but also ethical and
legal cancer-ns. We want you to consider not only donations from biologically
related family members, but those related through marriage, friendship, and other
emotional ties. We want you to discuss the well recognized use of live donors
for kidney transplant along with the practices that relate to liver, pancreas, and
lung transplantation.

You have all received background papers which are to serve as catalysts for your
discussion. However, do not feel limited in your discussion by the points that

13


have been made in the background papers. Please make your recommendations
as specific and realistic as possible. Those recommendations must be imple-
mented by health care professionals, private institutions, non-profit organizations,
and many levels of Government.

Our final charge is that you speak candidly about the issues before you.

Again, our sincere thanks to all of you.

OFDR.

Dr. Novello:  Our speaker is Dr. Roy First, who is Professor of Internal
Medicine and Director of the Section of Transplantation in the Division of
Nephrology and Hypertension at the University of Cincinnati Medical Center.
He graduated from medical school at the University of Witwatersrand in Johan-
nesburg in 1966. After completion of his military service, he did his internship
and residency at the Johannesburg General Hospital. This was followed by a
fellowship in nephrology which was done at Michael Reese Hospital in Chicago,
Iliinois. He was appointed to the staff of the University of Cincinnati Medical
Center in 1974. He has been active in the field of transplantation over the past
15 to 20 years, and has become a national and international authority in the field.
He is the immediate past President of the American Society of Transplant
Physicians. He has over 120 manuscripts and 13 book chapters published in the
transplant literature. In addition, over 140 of his abstracts have been presented
at the national and international transplant meetings.

The topic of today's address by Dr. First is `Transplantation in the Year 2010."
Obviously, this is a highly speculative topic, but I can think of no one more
suitable than Dr. First to give this address.

                              WILL WE BE IN
ZQUE

M. Roy First, M.D.
Professor of Medicine
Division of Nephrology and Hypertension
University of Cincinnati Medical Center

Dr. Novello, ladies and gentlemen, it is indeed a pleasure and a privilege to be
here today. The talk I've been asked to give this morning, transplantation in the
Year 2010, is obviously very speculative.  I thought we should look at where
transplantation has come to the present time, and then speculate some about the
future. If we look at the current l-year survival rates for first transplants (Table
1 - this data was recently published by UNOS for all 1988 transplants for which

15


12 month follow-up is available), we can see rhat the results have reached an
all-time high: patient and graft survival for living-related donor kidneys are 97
and 91 percent, respectively; for cadaver kidneys, 92 and 81 percent; for
pancreas, 89 and 71 percent: for liver, 76 and 69 percent; for heart, 83 and 82
percent; for heart/lung, 57 percent; and for lung transplantation, 48 percent. The
last two are in their infancy relative to the other organ transplants, and I'm sure
that over the next decade we'll see substantial improvements in heart/lung and
lung transplant results.

Over rhe past 8 years, transplantation has grown, and as you're all aware, last
year over 15,000 solid organ transplants were done in the United States, a record
number (Table 2). Of these, 9,560 were kidney transplants. There were over
2,600 liver transplants, 2,085 heart transplants, and a large growth in pancreas
transplantation, which reached 549 last year, largely due to the pioneering efforts
of Dr. Sutherland in Minneapolis.

With these excellent results, and the increased number of transplants, what is the
problem? The problem is why so many experts are here today. The problem is
one of organ donation. The UNOS organ transplantation waiting list released last
week has over 23,000 people on it. Of major concern are the deaths of those on
this waiting list. In 1989, almost one in three potential heart transplant recipients
died while waiting. Almost a quarter of those awaiting a liver transplant died.
The figures out for 1990 reveal that there were 2,206 deaths of patients on the
waiting list. This translates to over six a day: every 4 hours, one patient on the
waiting list for solid organ transplantations is dying.

                 TABLE 1.
ONE YEAR SURVIVAL RATES FOR FIRST TRANSPLANTS IN 1988 *

ORGAN

KIDNEY (RELATED DONOR)
KIDNEY (CADAVER DONOR)

PANCREAS

LIVER

HEART

HEART-LUNG

LUNG

o Data from UNOS report

PATIENT
SURVIVAL

97%

92%

89%

76%

83%

57%

48%

GRAFT
SURVIVAL,

91%

81%

71%

69%

82%

57%

48%

16


TABLE 2.

SOLID ORGAN TRANSPLANTATION IN THE UNITED STATES
                1982-1990

KIDNEY      5,358     6,112    6,968    7,695    8,975    8,967    9,123     8,706    9,560

LIVER           62      164      308      602      924    1,199     1,682    2,164    2,656

HEART         103      172      346      719    1,368     1,438     1,644     1,700     2,085

PANCREAS       35       61       87      130      140      142      242      419      549

HEART-LUNG      0       20       22       30       45       41       71       68       50

LUNG                                                        32       119      262


I have some numbers, supplied by Dr. Alan Hull, on kidney acquisition per
million population per year from a number of different countries (Table 3). If
we look at roughly the middle of the decade of the '80s - `84 and `85 - we can
see that the figures for the U.S. reveal that organ acquisition in this country was
on a par with many European countries (Table 4). Nevertheless, organ
acquisition in the U.S. still lags far behind the leaders of Western Europe:
Belgium has 41 kidneys per million population per year; and Austria, where laws
of presumed consent are actively applied, has over 52 kidneys per million
population per year.

What are some of the possible solutions to the dilemma of organ donation and
distribution? (Table 5) There's no question in my mind that the major issue
remains improved professional and public education. This meeting is going to
go a long way towards improving the public knowledge about what is needed in
this country with regard to organ donation. The recently published report of the
Office of the Inspector General notes that there is a paucity of minority donors
in this country. This is another area that needs to be actively pursued, especially
considering that approximately 30 percent of the patients on the waiting list for
kidneys are black. Relaxed donor criteria need to be looked into further. The
recent increase in organ donation last year is largely a result of the use of donors
who may not have been accepted in the past, largely older donors, and I think
this is an area that's going to be addressed at this meeting and has been
addressed in the past by my colleague from Cincinnati, Dr. Wesley Alexander.

The question of the use of non-heart beating donors prior to obtaining consent
also has been raised recently. Increasing the number of donors by using living,
unrelated donors; the whole question of improved application of the routine
request; and the possibility of going to routine referral of potential organ donors

-- all need to be considered. Presumed consent, while effective in many
European countries, probably would not be acceptable in this country to the
general public. One area that has been discussed extensively over the past year
has been the question of financial incentives to donor families, and I personally
think that this is an area that deserves further study. And finally, research into
xenotransplantation so that animal organs may be used to overcome the shortage
is something that one might look at in transplantation 20 years from now.

So where are the future directions that I see transplantation going? (Table 6)
First, a number of new immunosuppressive agents are on the horizon. Some
have been used in laboratory animals with excellent results; others have been
used in clinical studies with very impressive and exciting results. Over the next
5 years, we will hear a lot more about many of these drugs. To complement
this, a number of new monoclonal antibodies are on the horizon and should be
relcascd in the next few years. Beneficial effects also have been shown by drugs
that affect the prostaglandin-thromboxane system.

18


             TABLE 3.
KIDNEY TRANSPLANTATION WORLDWIDE 1989 *

CDUNTRY'

CADAVER KIDNEYS2   KIDNEYS TRANSPlJINTm
               LRD (% TOTAL)

BELGIUM (9.9)            41.3           409

AUSTRIA (7.5)             52.1           391

W. GERMANY (60.5)         30.5        1,847

LUXEMBOURG (0.37)        16.2            6

NETHERLANDS(14.8)         24.4          361

SWEDEN (8.4)             34.5          290      81 (22)

NORWAY (4.2)             20.0            84       76 (48)

DENMARK (5.1)            25.3           129      18 (12)

FINLAND (5.0)             29.2          146       39 (17)

MCE (56.2)             33.8        1,900       57 (3)

nxLY (57.4)                            604         10.5

U.K. (60.9)                28.4        1,732      x22 (7)

tM (248.8)               27.5        6,844      1,862 (21)

o Data from Hull. A

`country and population (in millions)
khda veric kidney retrieval rate in number of kidneys per million population per year

19


TABLE 4.

KIDNEY ACQUISITION IN THE DECADE OF THE EIGHTIES*
       (MILLION POPULATION/YEAR)

* Data from HuII, A.


          TABLE 5.
POSSIBLE SOLUTIONS TO THE DILEMMA OF
ORGAN DONATION AND DISTRIBUTION

1. Improve professional and public education

2. Train minority requestors

3. Relax donor criteria

4. Use of non-heart-beating donors

5. Use of living unrelated donors

6. Routine request and routine referral

7. Presumed consent'

8. Financial incentives to donor families

9. Xenotransplantation

Other future directions involve the question of: 1) cellular transplantation, 2)
small bowel transplantation, 3) tolerance induction, 4) xenotransplantation, and
5) genetic engineering. These are the areas that are going to receive attention in
the next lo-20 years. For the remainder of my talk, I want to focus on each of
these 5 areas.

First, vtransolants. Islet cell transplantation has been successful in
animals. In humans, amelioration of diabetes has been incomplete or transient,
and there's a need for multiple islet donors for a single recipient. Some of these
problems are related to the fact that the islets are exquisitely sensitive to
biophysical or immunological injury when they are separated from the pancreas.
An interesting attempt to overcame this problem has been the recent report and
development of the biohybrid perfused artificial pancreas, which is designed to
incorporate islet tissue and a selectively permeable membrane that isolates this
tissue from the immune system of the recipient. This device is reseedable
through silicone rubber ports in the event the islets must be replaced periodically.
Work on this perfused artificial pancreas by the group in Boston, led by Tony
Monaco, was reported recently in Science. A vascular graft, made of P'TFE, is
incorporated into the circulation in the experiments in dogs in much the same
WaY as an arteriovenous shunt. This vascular graft is surrounded by a housing
device and then a hollow fiber membrane. The pancreatic islets are inserted
through the seeding port and are separated from the circulation by this hollow
&r membrane. This hollow fiber is of a size that allows glucose to pass

21


through to stimulate the islets; it allows insulin to pass through in the other
direction, and also allows nutrients to reach the islets. However, it prevents
lymphocytes and antibodies from getting through to the transplanted, or the
seeded, pancreatic islets, Using this device, they were able to keep dogs
euglycemic without any need for insulin and no immunosuppression for up to 6
months. This is certainly something that's going to warrant future consideration,
and might well play a role in the treatment of the many diabetics with and
without end-stage renal disease.

There are a number of areas where cellular transplants have been used, for
example, in Parkinson's disease.  In Parkinson's disease, there is selective
destruction of the dopaminergic neurons of the substantia nigra of the brain. The
cells of the adrenal medulla release dopamine, and clinical trials have been done
utilizing either adrenal medullary autografts (taking the person's own adrenal
medulla), and fetal neural tissue grafts into the caudate nucleus. Reports on this
research come from Mexico and Scandinavia, and are somewhat conflicting;
some showing significant improvement in the neurological symptoms of
Parkinson's disease; others have not been that impressive. But certainly this is
a fertile area for future research on the use of cellular transplants.

Next, v which is in its infancy, and has had only a
few cases described. In small bow;1 transplantation, predominant problems are:
acute and chronic rejection, graft vs. host disease, diagnosis of rejection, and the
digestive and non-digestive functions of the small bowel graft. In experimental
animals, the use of FK506 has been shown to prevent acute rejection and the
fatal graft vs. host disease. A few isolated clinical papers show excellent results,
and of these, the most prominent come from Toronto. There, patients have
survived almost 2 years with normal bowel functions. Excellent results also
come from Pittsburgh and other centers. The successful clinical results have
occurred with vigorous pre-treatment of the donor with monoclonal and
polyclonal antibodies to the donor of the small bowel, and in very vigorous
immunosuppression of the recipient. In this way, it has been possible to control
both the acute and chronic rejection phases, and the transfer of donor lympho-
cytic tissue in the graft that causes the graft vs. host disease. The application of
new surgical techniques, the diagnosis and treatment of rejection, and the
availability of new immunosuppressive agents, will undoubtedly result in
successful transplantation of the small intestine by the year 2010.

The next area is the w, which is the induction of a state of
antigen-specific unresponsiveness, so that an individual would be unresponsive
to the particular tissues of the donor but would maintain other immune functions.
Experimentally, this is possible to do in animals using donor bone marrow, anti-
lymphocyte serum, and cyclosporine. In other animal experiments, conducted
largely by David Sachs at the N.I.H., the use of monoclonal antibodies, whole
body irradiation, thymic irradiation, and allogeneic bone marrow transplantation,
have resulted in the induction of chimerism. Tolerance has also been achieved

22


in concordant animals against the xenogeneic barrier. In human beings, partial
tolerance has been achieved in humans with post-transplantation bone marrow
transfusion, as has been described by the University of Alabama in Birmingham,
and with total body irradiation, In the Birmingham studies, the patients who
received the donor bone marrow had far less rejection and very good outcomes
when compared with the matched controls. However, this is difficult to achieve.
In our institution, led by Wes Alexander, we've been studying the role of donor-
specific blood transfusions in living-related and cadaveric donor transplantation.
This involves taking blood from the donor, giving it to the recipient, and
delaying the transplant for 12-18 hours. The early results have been encourag-
ing, although there has been a fair amount of rejection: one graft out of about
20 has been lost.

Next is the issue of xenotransolantation , or cross-species transplantation. If this
could be achieved, the successful use of animal organs for transplantation into
humans could solve the organ shortage that exists. If this can be achieved
through advancements in immunobiology and immunopharmacology, 20 years
from now we won't have to worry about people dying due to a lack of organs.
However, this will be difficult to achieve because humans have natural, or
preformed, antibodies against all animal species.

Clinical xenotransplantation has been performed approximately 30 times. In
some instances, the organs function for a very short while and then fail. The
most recent case that comes to mind is the one in Loma Linda in which a
chimpanzee or-baboon heart was transplanted in a young girl for whom no donor
could be found. The girl lived only a few days. Cross-species transplantation
has been successful in concordant animal species, such as rodents, mice, and rats,
because those are the types of animals that lack preformed antibodies against the
donor. There's been renewed interest in xenotransplantation with the introduction
of FK506, lSdeoxyspergualin, new monoclonal antibodies, and with tolerance
induction. Xenografting has been classified into two functional groups: the
concordant, or species combinations, in which the graft survives several days and
rejection tends to be along classical pathways, with cellular and humoral immune
mechanisms; and the discordant, where there's immediate or hyperacute
destruction of the graft. This is mediated by preformed natural antibodies, the
complement cascade, activation of endothelial cells lining the vessels of the
donor organ, and platelet aggregation. Attempts have been made to achieve
accommodation of the xenograft so that the natural antibodies can be removed
by plasmapheresis or immunoadsorption. This has been successful in the
laboratory. Production of a transgenic pig, which expresses a human DAF (a
mokcule that inhibits activation of C3 and C5) also has been performed,
preventing activation of the complement cascade. In the third level, involving
internal damage and platelet aggregation, models have used the platelet activating
factor antagonists to prevent the platelet aggregation. There's a lot of experi-
mental work going on in this field.  It is conceivable that early in the 21st
century, we might see clinical xenotransplantation evolving successfully.

23


Another very interesting model of xenotransplantation was recently described by
the group in Boston. This involved prevention of the xenograft rejection by
masking the donor HLA class I antigens. Rejection of human pancreatic islets
and liver cells were circumvented by masking the donor antigens with W6-32,
an antibody to HLA class I. This is done before transplantation of these cells
under the kidney capsule of mice.  In this model, the islets have functioned
without immunosuppression beyond 200 days, as demonstrated by normal
histology and C-peptides secretion in response to a glucose load. This might be
another way IO fool the immune system and prevent rejection, and to get animals
and humans to accept tissues from other species.

Finally, we come to the issue of Beneineerine. Using molecular biological
techniques, entire genes or groups of genes can be produced and inserted into the
genome of specific cells; that is, into the genetic material of the cells. Gene
alteration therapy could be used to correct metabolic diseases, leading to end-
stage organ failure, or to alter the host immune response. It's very likely that 20
years from now, we'll see genetic engineering therapy aimed at changing the
genes for insulin-dependent diabetes, or polycystic kidney disease, or to alter the
immune response of an organ recipient to prevent rejection.

Transplantation has also been used in the treatment of genetic disease. Bone
marrow and liver transplantations provide the necessary feasibility tests of gene
transfer therapy for many genetic diseases.  Transplantation allows for
assessment of a single organ correction of a specific enzyme deficiency by the
introduction of normal genes. There are a number of conditions where the basic
abnormality is in a single organ due to a genetic or inherited metabolic disease
(such as alpha-one antitrypsin disease, Wilson's disease, and primary hyperoxal-
uria), and where replacement of that organ has resulted in correction of the
genetic disease. Another example of gene transfer therapy is the use of pigs as
potential blood donors to humans.  Copies of the human DNA that make
hemoglobin are inserted into a one-cell fertilized egg from a pig. In about 0.5
percent of these cases, the DNA successfully copies itself and is inserted into the
DNA of the pig. The pig then gives birth to transgenic piglets, meaning they
carry the genes of both the maternal pig and the human DNA inserted into it.
The offspring of these pigs permanently carry the human DNA, make hemoglo-
bin, and pass it on to their offspring. Such pigs have a mixture of human and
pig hemoglobin. The human hemoglobin can be separated and theoretically used
for transfusion into humans.  In much the same way, one can imagine other
modifications of genes to overcome diabetes and diseases that cause liver
damage, or to alter the immune system.  Therefore, genetic engineering, by
adding or deleting genes involved in the immune responses or by induction of
tolerance, can be done at the embryonic level, leading to a transgenic strain, or
at a later level by inserting a vector for DNA transfer. There are a number of
different levels at which one can alter the DNA of an animal, and this may one
day be true of human beings as well.

24


It is very likely that over the next 20 years, many of these areas will come to
fruition. However, for the foreseeable future, there will be a shortage of organs,
and that is going to be the focus of the next couple of days.

Once again, thank you very much for inviting me here today.

      LOUIS W. SULLIVAN, M.D.
SECRETARY OF HEALTH AND HUMAN SERVICES

Good afternoon.  I appreciate the invitation to participate in this important
meeting.

Let me begin by saying to you, Dr. Novello, that I have been very impressed
with your work. You have been at the forefront of the efforts to make organ
transplants a reality for more Americans, particularly minority citizens. I thank
you for your leadership and dedication on this vital area of national health.

I'd like to spend a few minutes discussing organ donation specifically within
minority populations, and then talk about current Federal efforts to improve rates
of donation and the recent successes we've seen across the country through
heightened public awareness.

The sessions today paint a picture of transplantation in this country -- a picture
often not as encouraging as we would like it to be. Today, almost 24,000
Americans are waiting for an organ transplant -- and little more than half are
likely to receive one.

Major advances in science, medicine, and biotechnology have given US the
capability and the know-how to perform successful transplants. Last October
Dr. Vaughn Stames of Stanford University, a participant in this workshop,
performed the world's first single-lung transplant using a lung segment from a
living related donor. In January, he successfully repeated the procedure in a
one-month-old baby girl. Dr. Stames, your work is clear testimony to the
tremendous potential for transplantation.  This is truly one of the wonders of
medicine to replace a deteriorated vital organ with a healthy one.

Rut, as the Washington noted last week, "the biggest constraint on organ
transplantation is neither technology nor cost but the shortage of available donor
organs." Indeed, the number of available organs has leveled off after doubling
during the 198Os, while waiting lists have continued to lengthen. Fortunately we
have seen an encouraging break in this plateau -- during 1990, donation
increased by approximately 11 percent, but this still falls short of the need.

25


Rates of organ donation are especially low among members of minority
communities, and require particular attention.  We have well-documented
evidence of the substantially lower rates among Hispanic and black populations
than among white communities. I am pleased to note that an entire session of
this workshop has been devoted to improving rates of donation among minority
communities.

Overcoming the myths and misunderstandings that surround organ transplantation
to increase rates of donation will require the efforts of everyone -- from
Federal, State, and local governments to community leaders, from health
professionals to church organizations.

The Federal Government has a number of initiatives underway to address these
problems, including efforts to help educate the public about the need for
donations and to improve the medical aspects of transplantation.

One of the barriers to donation is the perception of inequality in transplantation.
The report published by the Office of the Inspector General this spring raised the
key issue of disparities among populations. The report indicates that citizens of
the black community wait 0 as LQQJ as do people of the white
communities for a kidney transplant -- nearly 14 months compared to only
seven-and-a-half months, even when controlling for blood type, age, and
locational factors.

While the Report presents a disturbing picture, I'm pleased that we are moving
quickly to put in place its recommendations and to further evaluate the results
of the study. Projects to increase donation among minorities have been given
high priority in my Department.

For example, the Office of the Assistant Secretary for Planning and Evaluation
is overseeing research to evaluate and identify the causes of the disparity in
kidney transplantation among population groups.

Additionally, the National Institutes of Health have numerous clinical trials
underway that will be important in increasing the success of organ transplanta-
tion. For example, the National Institute of Allergy and Infectious Disease is
conducting studies of the immune system, with the goal of helping to control
transplant rejection and increasing the quality of tissue typing.

But we need to do more than study the factors behind the dilemma. Increasing
the rate of organ donation and access to transplantation for members of minority
communities demands our urgent attention.

The Division of Organ Transplantation is devoted to managing the Organ
Procurement and Transplantation Network and Scientific Registry contracts and

26


providing special grants, contracts and educational programs for projects
designed to improve rates of donation among minority groups.

Public education is clearly the critical element. We need to reach people about
the increasing need for organs, but other issues must also be addressed.

As the transplantation field expands with new successes and more people come
to depend on transplants, it is important that organizations for organ donation
maintain high standards of safety. Commissioner David Kessler will spear-head
a group of representatives of PHS agencies to determine the most effective
strategies to prevent the transmission of lifethreatening infections through organ
transplantation. While we cannot guarantee that it is completely risk-free, the
risks involved in receiving a life-saving organ far, far outweigh the very remote
chance of contracting any infection -- including the AIDS-virus.

Additionally, since 1988, the Health Care Financing Administration has been
certifying organ procurement organizations to assure that they meet certain
qualifying criteria for designation and meet minimum standards of performance.
Such regulation helps to ensure that unnecessary risks are eliminated from
donation procedures.

I am encouraged by evidence that in some areas of the country, donation rates
among minority groups are on the rise. In St. Louis for example, the Mid-
American Transplant Association (a grantee of the Division of Organ Trans-
plantation) reports that donations among blacks rose from 8 percent in 1989 to
16 percent in 1990. The success of the program has been attributed to minority
public education campaigns and to including more minorities in programs
requesting donations from minority families.

In fact, I am encouraged by the increase in overall organ donation last year --
a significant move up from previous levels. A great deal of dedication and hard
work have gone into crafting sound legislation and implementing programs
geared towards increasing donations nationwide.

I am especially pleased that Dr. Novello has agreed to lend her support and
direction in the drive to increase organ donation. The recommendations from
this workshop will provide us with a progressive and sound approach for
increasing organ and tissue donation in this country.

Today thousands of Americans are waiting for an organ transplant. Hundreds
of thousands of others could be helped with a tissue or cornea1 transplant. If this
waiting list grows as projected, the decisions we face will only get harder, and
the choices before us will become more difficult.

we must work together to increase public awareness and to help those who need
an organ to receive a transplant, and we must strive to make sure that this

27


process is equitable and just. I want to thank each of you for your interest and
input. I am confident that our work together will help more people receive the
gift of life.

Thank you, and Godspeed you in your work.

Wednesday, July 10, 1991

Ms. Braslow: This has been very exciting for all of us who have spent the last
1.5 months preparing for this workshop. The discussions in the workgroups over
the last 2 days have been extraordinarily exciting and interesting, and I hope we
can collectively capitalize on this enthusiasm and take it back to our respective
places of work.

I want to make a few general comments about the recommendations and
strategies we have received. The first thing I noticed was that there are common
themes. Even though the charges to the groups were often different, some of the
recommendations that carve back were very similar.

Several of the recommendations called for creating a task force. If we were to
create all these task forces, we would have no money left to do anything else.
So we will rely on our Advisory Committee to help us address some of the
issues you recommended be addressed by task forces.

Some of the recommended projects can be done through our grant program.
Some can be done through evaluation funds which support research studies.
Some can be done by other Public Health Service offices that may not be
represented here. And some of the projects can be done by you. For example,
if a transplant center or an OPO is interested in taking the lead on a particular
project or recommendation, we would be very interested in hearing about that.
The Public Health Setvice cannot do everything. We do not have the resources,
and we need your help. This is a community effort, and we want to hear your
ideas on how to accomplish many of these recommendations.

Dr. Novello: We have come to the moment of truth. We have met for 2 days
to come up with recommendations for the future. I would love to work on each
recommendation myself, but the Surgeon General must work on other programs
as well. However, organ donation has personal meaning for me and I will
definitely keep abreast of the progress made on these recommendations.

As we proceed with the presentation of recommendations if anyone has a
minority opinion, please present it - despite our time constraints. It would be
nice to have a consensus, but we are all human beings with different opinions.


However, the more we agree on these recommendations, the better our chances
of successfully implementing them.

Before we begin with the presentations there are two issues I would like to
mention. First, in talking to the public, if I tell them that we have 23,000 people
waiting today for organs, I am sure that will have an impact. But I also need to
inform the public that even greater numbers of Americans are at risk of needing
a transplant in the future. Therefore, I plan to share with them the following
data:

o more than 13 million Americans have kidney and urologic disease
today.

o 190,862 Americans were listed in 1989 as having end-stage renal
disease.

058 million Americans have high blood pressure -- 30 percent of all
adults ages 18-74' have high blood pressure; 38 percent of Blacks
compared with 28 percent of Whites suffer from high blood pressure.

0122,257 end-stage renal disease patients were on dialysis on 12/31/89
out of a total of 163,069 end-stage renal disease patients at that same
point in time. More than 100,000 end-stage renal disease patients have
high blood pressure; 43,000 have diabetes. Additionally,

o 16,500 Americas have chronic heart disease;

o 14,000 Americans have chronic liver disease;

o 4,500 have chronic heart and lung disease;

o 4,100 patients have non-functional pancreas; and

o 3,300 have chronic lung disease.

If I talk about these numbers, the public will realize that while I am worried
about 23,008 today, we must plan for all of these patients who, until we find
better preventive methods, might be added to the transplant waiting list. We
must take responsibility for making the public aware of this situation.

I wish to share one other thing with you.  We have been told that sometimes
donor families receive little attention or appreciation for their most altruistic gift.
It was suggested to us that there be a medal or certificate for donor families in
recognition of their gift of life. The Office of the Surgeon General, together with
the Division of Organ Transplantation, designed a certificate of appreciation for
donor families which we would like to distribute through the OPOs. I wanted

29


to tell you about the certificate and show you this slide so you can see what it
might look like. It is a certificate of appreciation from the Surgeon General with
the name of the donor on it, and will include a little note of appreciation.  We
would hope to send it in recognition of every donor in the United States
recognizing them for having given the most precious gift -- the gift of life.

Now we will turn to the presentation of the recommendations.

30


SURGEON GENERAL'

This certificate is presented to

famb of the late

in recognition of their supreme humanitarion spir% in
consenting to eive the `%ift of Me" to others.

31


WORK GROUP I-A: A NATIONAL CAMPAIGN:
FOCUSING ON THE GENERAL PUBLIC

   Chairperson:
Co-Chairperson:
Background Papers:

Staff Assistant:
Group Members:

Jeffrey Prottas, PhD
Wanda W. Bond
Elaine Bratic Arkin
John Davis
William DeJong, PhD
Emily Haley
Charles Atkin, PhD
Charles Brown
Maggie Coolican, RN, MS
Rebecca J. Davis
Frederick N. Griffith
Louise M. Jacobbi, CPTC, CCTC
Rita Guajardo Lepicier
Daniel Maier
Jeanne C. Mowe
Joann Ellison Rodgers, MS
Cynthia Rodriquez-Harriman, LVN
Charles F. Shield, III, MD
Sylvester Sterioff, MD
Moraima Trujillo, MD

INTRODUCITON

The appropriate goal of public education in organ donation is to increase the
number of organ donors. This occurs primarily by increasing the number of
families who say yes when asked to donate.

To achieve this, the goals of public education should be to create a more
favorable predisposition by:

1. Increasing family discussions of the issues.

2. Increasing the signing of organ donor cards.

3. Decreasing misconceptions and fears of the public regarding organ
  donation.

33


RECOMMENDATIONS TO INCREASE ORGAN DONATION
        THROUGH PUBLIC EDUCATION

I-A. 1. The Surgeon General should become the national spokesperson for organ
and tissue donation and transplantation. (short-term)

I-A.2. There should be a consistent, uniform, national theme, nomenclature, and
symbols for the promotion of organ and tissue donation. (short-term)

I-A.3. The Surgeon General should support an independent evaluation and
testing of the AOPO public education campaign. If successful, the campaign
should be endorsed as a national public education campaign. (short-term)

I-A.4. Form a task force of experts including communications specialists tip
review existing public education campaigns and establish criteria for future
donation campaign design and evaluation. (short-term)

I-A.4.Str.l: This task force should develop methods to gather information
about minorities and other target audiences, message content, persuasive
appeals, and communications channels.

I-AS. Collect and analyze existing and new data regarding why families & or
do not donate and develop strategies to increase donation. (short-term)

I-A.6.  Conduct research to identify opportunities for increasing family
discussion. In designing campaigns, attention should be given to the importance
of stimulating family discussion. (short-term)

I-A.7. Develop a national effort to encourage signing and carrying organ donor
cards. (intermediate)

I-A.7.Str.l: Develop a comprehensive long-term plan in cooperation with
organizations not currently involved in the organ and tissue business such as
the National Highway Traffic Safety Administration.

I-A.7.Str.2: Obtain support of the Advertising Council for this campaign.

I-A.8. Obtain and publicize donor card signatures of U.S. Congresspersons,
governors and mayors at annual meetings of appropriate organizations including
the National Governors Association and U.S. Conference of Mayors. Encourage
similar support from local political leaders. (short-term)

I-A.9. Develop methodologies and implement a project to establish standardized
donor information on drivers licenses throughout the United States. (long-term)

34


I-A.10. Create a task force to explore ways of recruiting voluntary health
organizations to disseminate messages to increase organ and tissue donation.
(intermediate)

I-A.ll. The Surgeon General should seek support from the business community
to promote organ and tissue donation and transplantation. Equivalent activities
should be encouraged at the State and local levels. (intermediate)

I-A.12. The Surgeon General should seek support from the Business Round
Table to promote organ and tissue donation and transplantation in the work place.
(short-term)

I-A.13. The Surgeon General should approach individual national labor and
union organizations (e.g., AFL-CIO) and ask them to promote organ and tissue
donation among their members. (short-term)

I-A.14. The Surgeon General should seek support from the religious community
through the National' Council of Churches and other major religious groups in
order to dispel misconceptions about organ and tissue donation. Equivalent
activities should be encouraged at the State and local levels. (short-term)

I-A.14.Str.l:  Encourage leaders of U.S. churches and synagogues to
communicate to their members the churches' support for organ and tissue
donation.

I-A.15 The Surgeon General should seek support from national fraternities and
sororities throughout the United States.  Equivalent activities should be
encouraged at the State and local levels. (intermediate)

I-A.16. The Surgeon General should approach the national PTA regarding
education strategies for regional/local implementation. (intermediate)

I-A.17. Develop and maintain relationships with health educators and develop
strategies to encourage them to educate individuals about organ and tissue
donation. (intermediate)

I-A.18. Develop and maintain relationships with mass media executives,
journalists, producers, and TV and movie script writers to encourage accurate
programming and articles about organ and tissue donation, including family
discussions of organ and tissue donation. (intermediate)

I-A.18.Str.l: Develop relationships with organizations such as the American
Society of Newspaper Editors and the National Association of Science
Writers and Writers Guild of America. Also encourage science writers'
seminars through the National Institutes of Health and other organizations.

35


I-A.19. Promote the UNOS l-HOO-24-DONOR Line as a 24-hour-a-day hot
line with access to bilingual callers. (short-term)

36


WORK GROUP I-B: A NATIONAL CAMPAIGN:
FOCUSING ON DIVERSE SOCIO-ECONOMIC AND
CULTURAL GROUPS

       Overall Chairperson: Oscar Salvatierra, Jr., MD
Chairperson African American Section: Will R. Ross, MD
         Co-Chairperson: Karen L. Smith, MS
   Chairperson Hispanic Section: Oscar Salvatierra, Jr., MD
     Hispanic Co-Chairperson: Ashley Baquero, MD
        Background Papers: Clive 0. Callender, MD
                 Jorge Chapa, PhD
         Staff Assistants: Larry Wannemacher
                 Joyce Brown
                     Veretta Blake

Croup Members: Christopher R. Blagg, MD
       Margaret F. Devney, RN, MSN
        Eunice Diaz, MS, MPH
        Luz Diaz-Schreiber, BS, MA
       Steven D. Helgerson, MD, MPH
        Octavia Hudson, PhD
       J. Raul Magana, PhD
       Rudolph C. Morgan
       Raymond Pollak, MD, FRCS, FACS
       Anita L. Principe, BSN, MPA
         Cozette Proctor

Ernest0 Rive-Mora, MD
Maritza R. Sanchez
Eduardo A. Santiago-Delpin, MD
Mark E. Whitlock, MS

INTRODUCTION

The Surgeon General should be highly commended for facilitating the first forum
to allow minorities to present their problems regarding organ donation and to
suggest solutions to their problems in a unified way.

The charge to the group for "A National Campaign Focusing on Minorities" has
been to make recommendations to increase donations amongst diverse socio-
economic and/or cultural groups within the U.S. population. Two groups were
to serve as models: African-Americans and Hispanics. Discussion of Native
Americans was also included in this group's deliberations. Asians and Pacific
Islanders are another important minority which should be involved in future
forums.

37


The entire work group met to discuss issues that cut across different minority
populations. The members then divided into two sections, one focusing on
Hispanics and the other on African Americans, in order to address issues that are
specific to these two populations.  The group members representing Native
Americans participated in the Hispanic section. The following preamble and
recommendations focus on minorities as a whole.  This is followed by
recommendations and strategies for African Americans and Hispanics with a few
comments focused specifically on Native Americans.

OVERALL PREAMBLE AND RECOMMENDATIONS

There are some well recognized considerations that cut across the three minority
groups discussed at this forum (African Americans, Hispanics, and Native
Americans). These commonalities are:  1) each minority group represents a
different and distinct culture; 2) the amount of poverty in each group is greater
than that for the general U.S. population; 3) the education level in each group is
less than that of the general U.S. population; 4) the overall health status of each
group is lower than that of the general population; 5) the mean age in each group
is significantly less than the White population. The fifth issue has particular
importance as we embark on campaigns to increase organ donation in minority
                                                     .
groups.

RECOMMENDATIONS

I-B.l. Current Federal funding for organ/tissue donation education for minorities
is inadequate and should be allocated at an amount not less than $10 million a
year for 5 years.

I-B.2. The funds identified in I-B.l. should be used to improve organ donation
and to study all aspects of ESRD in all minorities.

I-B.3. The funds identified in I-B.1. should be used for African Ameri-
cans/Blacks, LatinosMispanics and Native Americans as outlined in the
subsequent recommendations and for other minority groups which were not
addressed specifically during this workshop, such as Asians/Pacific Islanders.

I-B.4. The development of a minority coalition is absolutely necessary to allow
minorities to address their concerns related to organ/tissue donation and
transplantation. There should be adequate funding to enable this dialogue to
continue on an on-going basis and to allow minorities to frame and implement
solutions to their own problems, emphasizing interventions at the community and
"grass roots" levels.

38


I-B.5  A national minority organ/tissue transplant educational program
(MOTIEP) should be supported and funded at a level commensurate with the
successful pursuit of its goal of increasing organ/tissue donation and transplanta-
tion among all minorities.

AFRICAN AMERICANS

Preamble

It should be the right of every American citizen to have equal access to the
benefits of modem science and medicine. In the field of organ transplantation,
discrepancies have been cited in the procurement and dispensation of donated
organs. Specifically, African-Americans are less likely than whites to have
undergone kidney transplantation and are over-represented on transplant waiting
lists. Potential explanations for such disparities include: 1) limited fund of
knowledge of the benefits of organ transplantation, due mostly to reduced access
to medical care; 2) decreased rate of organ donation, and 3) institutional bias.
These and other barriers to organ transplantation in African-Americans can be
overcome by implementing a broad-based educational program utilizing mass
media as well as community grass roots organizations.

Comprehensive educational efforts should proceed with the firm support of
poIicy:makers and appropriations committees at the Federal, State, and local
levels. Programs should have a precise target population, well-defined goals and
tracking measures, and should be under the scrutiny of a central coordinating
group. The overall, long-term goal of the educational campaign is to positively
influence the attitudes and behavior of the target group towards acceptance of
organ donation as an unselfish, "right" thing to do. The hallmark of the
campaign in the African-American community, or with any ethnic minority, is
the use of culturally sensitive instructional tools and emphasis on volunteerism.
Based on these premises, the following recommendations are offered.

RECOMMENDATIONS

1. PROBLEM IDENTIFICATION

I-B.6. Allocate funds, no less than $5 million per year, for an in-depth analysis
of medical and socio-economic factors that contribute to a low rate of organ
donation and transplantation among African Americans.

I-B.6.Str.l: Develop and convene a minority coalition encompassing the
previously identified ethnic groups (African Americans/Blacks, Latinos-
Hispanics, American Indians, and Pacific Island/Asian) to guide public
education efforts targeted at these populations.

39


I-B.6.Str.2: Using extensive surveys and questionnaires, conduct large
multi-center comparative studies of attitudes of all cultures toward organ and
tissue donation.

I-B.7. Allocate funds for the development of a national campaign geared at
increasing the rate of African American organ and tissue donors. This funding
should be commensurate with the disproportionate degree of ESRD in African
Americans.

I-B.7.Str.l: Examine replication of MOlTEP at regional and local levels.

I-B.7.Str.2: Conduct a mass media communication campaign aimed at
minorities.

I-B.8. Funding should be made available for scientific projects that help
determine the role of MHC tissue antigens and ABO blood types in graft survival
and how immunogenetics impact upon graft allocations.

I-B.8.Str.l:  Clarify indeterminate antigens in African Americans and
examine their impact on allocation of organs.               %

I-B.8.Str.2: Identify specific HLA-A, B and DR antigens and subtypes and
their correlation with graft survival.

I-B.9. Funding should be made available for exhaustive studies on why African
Americans are disproportionately afflicted with kidney disease and other
end-stage organ disease.

II. PUBLIC AND PROFESSIONAL EDUCATION

I-B.lO. Public and professional education initiatives should incorporate the
organized use of culturally sensitive instructional tools to increase the awareness
of organ donation in the targeted populations.

I-B.lO.Str.1: Mass media campaigns should be conducted which use clearly
identifiable, positive, ethnic role models, including children. Information
should be targeted to and appropriate for use at the community "grass roots"
level.

I-B.10.Str.2: Convene a consensus conference of minority and majority
participants to discuss utilization of minority requesters.

I-B.lO.Str.3:  Expand and replicate existing effective minority-focused
donation education programs, such as those developed by the St. Louis OPO,
the Howard University Program, and the Houston OPO.

40


I-B.lO.Str.4: Develop proposed curricula for institutions of higher education
which encompass donation and transplantation information. Disseminate
curricula to all institutions of higher education, with a special emphasis on
historically Black colleges and universities.

I-B.lO.Str.5:   Use Black History Month to emphasize dona-
tion/transplantation and the contributions of the African American community
to the field of organ transplantation.

I-B.lO.Str.6: Use culturally sensitive and ethnically similar speakers (donor
families, recipients, clergy, etc.) to address religious concerns of minority
populations.

I-B.ll. Encourage medical and nursing schools to provide transcultural
curriculum that sensitizes students to issues in organ donation specific to African
Americans.

I-B.12. Private sector sponsorship of donor and transplant awareness programs
should be aggressively pursued at Federal, State, and local levels.

I-B.13. African American organ donors (cadavericfliving) and recipients should
participate in public education efforts and provide personal accounts of their
transplant experiences to overcome major obstacles of apathy and fears that
inhibit donation.

III. LEGISLATIVE INITL4TIVES

I-B.14. This work group firmly opposes the use of any financial incentives for
organ donation. However, medical expenses for living related donors should be
subsidized.

I-B.14.Str.l: Funding should be made available for a recuperation period
and hidden costs associated with live donation.  Such costs might accrue
from:

a. child care
b. surgery-related medical expenses
c. expanded period of disability and loss of work

I-B.15. Burial expenses for all cadaver organ donors should be made available.

I-B.lS.Str.1: OPOs should contribute a set amount of monies to a general
fund managed by a non-profit independent organization to which any donor
family can apply.

41


I-B.16. States should incorporate questions on organ donation in their respective
drivers manuals and examinations.

IV. ADDRESSING INSTITUTIONAL BARRIERS WITHIN ORGANIZA-
TIONS SUCH AS HOSPITALS, OPOs, AND TRANSPLANT CENTERS

I-B.17. Transplant centers and OPOs must recruit culturally sensitive and
ethnically similar staff.

I-B.17.Str.l: National transplant organizations (ASTS, ASTP, NATCO,
AOPO) should encourage the education and training of minority profes-
sionals.

I-B.17.Str.2: Transplant centers, OPOs and hospitals should hire culturally
sensitive and ethnically similar transplant coordinators and other personnel
to enhance transplantation and donation among minorities.

I-B.18. Culturally sensitive and ethnically similar personnel must be recruited
at all levels of transplant policy-making and implementation.

I-B.19. The Surgeon General must continue to address the presence of
institutional barriers to organ transplantation for African Americans and should
be commended for her current efforts.

HISPANICS

Preamble

Hispanics are one of the largest and fastest growing minority groups in the U.S.
They comprise 9 percent of the Nation's total population and grew by 53 percent
between 1980 and 1990. Hispanics are an aggregation of different national
origin subgroups (primarily Mexicans, Puerto Ricans, and Cubans) with different
geographic distributions A few States and several cities contain the majority of
the U.S. Hispanic population. Although Hispanics share a common language,
they are acutely aware of the country of origin and of historic and ethnic
differences among these subgroups.

The Hispanic population is concentrated primarily in five States: California,
Texas, Florida, New York, and Illinois. In California, Hispanics make up one-
fourth of the State's 30 million population, and are projected to exceed Whites
in numbers by the year 2030.

The major health problem facing Hispanics is that they have much less access
to health care providers and institutions than any other group in the United

42


States. Factors which limit access include lower rates of insurance coverage
(private or public), lower income levels, language differences, and scarcity of
Hispanic health providers. Uninsured rates are:

37 percent of Mexican Americans
20 percent of Cuban Americans
15 percent of Puerto Ricans compared to 10 percent of the non-Hispanic
White population

Another major problem is that there are less national data available about the
health status of Hispanics than for any other ethnic group. For example, the
incidence of ESRD in the general Hispanic population or any Hispanic subgroup
is essentially unknown.

Although studies exist on the demography and epidemiology of renal disease in
the country or area of origin of the sub-groups (which can serve as comparative
databases) only a few local U.S. studies address these issues in Hispanic
populations. At best, therefore, one can only estimate the incidence of disease
in the U.S. Hispanic population. The best study appears to be the San Antonio
study where Mexican Americans were found to have an incidence of ESRD three
times that of non-Hispanic Whites.

Other San Antonio data are also important for transplantation: 52 percent of the
population are Hispanic, 80 percent of organ recipients are Hispanic, but
Hisjknics account for only 14 percent of organ donors. In general, cadaveric
donation in Latin America follows a similar pattern with 64 percent of
transplants being performed from live related donors as an overall average.

In the U.S., a number of additional factors have been identified as affecting
organ donation. Sometimes decisions are made by a group, sometimes by the
elders, sometimes by prominent members who are respected by the family, and
frequently these do not coincide with the next-of-kin. Also, discussions are
very lengthy, and family members frequently wait for calls or visits from
members living far away.  This "extended family" affects the request and
donation process, especially with its time constraints.

Secondly, the emotional reaction of the family upon the news of death is often
overtly expressed, frequently as uncontrolled anguish, many times to the point
of a contagious form of hysterics. During this time, communication with the
family is almost impossible.

Other factors affecting the donation rate of Hispanics relate to the small number
of Hispanic coordinators/requesters with the necessary cultural awareness and
sensitivity to communicate effectively with this population. Language is an
important barrier as well. Ignorance of the donation process, of Hispanic disease
statistics, and of the need for donation may result in a climate of distrust of the

43


health care system, creating an additional barrier to donation. Most studies do
not signal religion as a major disincentive or barrier to donation or transplanta-
tion for Hispanics, but a significant minority do regard organ donation as against
their religion.

RECOMMENDATIONS

Immediate Action

I-B.20. Identify principal decision-makers and next-of-kin upon the potential
donor's admission to the hospital.

I-B.20.Str.l: Develop education document for transplant community: "What
Works for Hispanic Organ Donation." (Identify barriers and suggest how to
overcome them).

I-B.20.Str.2: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.20.Str.3:  AHA and State hospital associations shall establish
guidelines for identifying decisionmakers and next-of-kin.

I-B.21. Establish awareness and understanding by requestors of the role of the
extended family in Hispanic populations, their emotional reaction to death, and
the grieving process.

I-B.21.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.22 Make educators, counselors, and requestors aware of the importance of
cultural and sub-group differences.

I-B.22.Str.l:  Develop education document for transplant community:
"What Works for Hispanic Organ Donation." (Focus on barriers and how to
overcome them).

I-B.22.Str.2: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.22.Str.3: Provide education and scholarship funds for Hispanics to work
in the organ donation field.

I-B.23. Increase the number of trained Hispanic requestors.

44


I-B.23.Str.l: Develop education document for transplant community: "What
Works for Hispanic Organ Donation." (Focus on barriers and how to
overcome them).

I-B.23.Str.2: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.23.Str.3: OPOs serving large Hispanic populations shall hire and train
Hispanic requesters.

I-B.24. Increase the participation of Hispanic donor families, live donors, and
recipients and their families in the public education and donation process.

I-B.24.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.24.Str.2: The Surgeon General shall plan, direct, and fund a national
campaign on organ donation using national Spanish speaking media.

I-B.25. Use bilingual consent forms and donor cards.

I-B.25.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.25.Str.2:  OPOs with large Hispanic populations shall assure that
bilingual consent forms and donor cards are used.

I-B.25.Str.3: Federal documents on organ donation shall be bilingual.

I-B.26. Train and encourage Hispanic physicians to participate in public and
professional education related to organ donation and transplantation.

I-B.26.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.26.Str.2: Use teleconferencing to target large populations for education
and discussion.

I-B.27. Increase the participation of Hispanic clergy in donation education
activities.

I-B.27.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

45


I-B.27.Str.2: Establish in schools of medicine, allied health, and theology
curriculum on organ donation and transplantation with an emphasis on
minority communities.

I-B.27.Str.3: Use teleconferencing to target populations for education and
discussion.

I-B.28. Encourage intra-family discussion of the donation process.

I-B.28.Str.l:  Send information to households of card signatories (e.g.,
Motrain).

I-B.28.Str.2:  Develop education document for transplant community:
"What Works for Hispanic Organ Donation." (Focus on barriers and suggest
how to overcome them).

I-B.28.Str.3: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.29. Eliminate use of the term "brain death." Use "death" only.

I-B.29.Str.l: Establish culturally sensitive hospital-based resource teams
with a focus on minority needs and issues.

I-B.29.Str.2:  The Surgeon General shall communicate to neurological
specialists and other appropriate physicians the need for timely declaration
of death.

I-B.30. Present a simple, direct message of the need for and benefits to
Hispanics to consent to organ donation.

I-B.30.Str.l: Conduct ongoing basic evaluation research on all education
materials for the Hispanic community.

I-B.30.Str.2:  Translate and disseminate the Pope's message on organ
donation and encourage similar messages from other religious leaders.

Intermediate Action

I-B.31. Identify effective mechanisms and methods of communicating the
subject of organ donation to the Hispanic population.

I-B.31.Str.l: OPOs shall actively recruit and encourage participation of
Hispanic clergy, organ donors, recipients and their families in education
about donation.

46


I-B.31.Str.2: Federal documents on organ donation shall be bilingual.

I-B.31.Str.3: Develop slide or video presentation in Spanish for use in
public education initiatives targeted at Hispanics.

I-B.31.Str.4: Include bilingual information on organ donation in States'
departments of motor vehicles, IRS, and Social Security documents.

I-B.31.Str.5: OPOs shall develop and distribute during Hispanic Heritage
Week an information packet in Spanish on organ donation and transplanta-
tion.

I-B.32. Educate the public and professionals about the different roles of health
care professionals in the donation process.

I-B.32.Str.l: Establish in schools of medicine, allied health, and theology
curriculum on organ donation and transplantation with an emphasis on
minority communities.

I-B.33. Reduce delays in declaration of death.

I-B.33.Str.l: Establish hospital-based resource teams,

Legislative Action

I-B% Determine demographic and epidemiological characteristics of Hispanic
populations and sub-groups including genetic studies. Target studies to ESRD
networks and OPOs serving large Hispanic populations in the United States.

I-B.34.Str.l: DHHS shall develop an RFC to establish a database on
epidemiological parameters of the U.S. Hispanic population.

I-B.35. Improve access of Hispanics to the health care system, especially the
medically and socially indigent.

I-B.35.Str.l: `he minority coalition should develop a strategy to address
this issue.

I-B.36 Provide financial assistance for health care and child care during
rehabilitation of living organ donors.

I-B.36.Str.l: The minority coalition should develop a strategy to address
this issue.

I-B-37. Investigate minimizing or eliminating burial costs to donor families.

47


I-B.37.Str.l: The Surgeon General shall encourage the identification of
groups or panels of funeral homes who donate burial or provide burial at
lower costs.

AMERICAN INDIAN/ALASKAN NATIVE (AI/AN)

In discussing means to increase organ donation in various socio-economic and/or
cultural groups, there are two key issues which are important for American
Indian/Alaska Native (AI/AN) populations in the U.S.: diversity and data.

1. Diversity:

o  In the 1990 census approximately 2 million persons identified themselves
as American Indian/Alaska Native.  These people comprise a very
diverse group. There are more than 400 Federally recognized tribes and
nations in the U.S., each tribe/nation representing a distinct cultural
entity. While many people think of American Indian/Alaska Natives as
living in rural reservations, more than half now live in urban (or near-
urban) areas.

2. Need for more accurate data:

o Too little is known about the characteristics of AI/AN with regard to
awareness and attitudes related to organ donation, organ donor rates,
reasons why AI/AN people do not donate organs, and accurate measures
of need for organ transplantation.  Similarly, too little is known about
health care providers' attitudes and understanding. of AI/AN individuals
with whom they work.

RECOMMENDATIONS

I-B.38. The following organizations and groups should collaborate immediately
to determine key organ donation and transplantation characteristics of AI/AN
tribes and nations from all regions of the U.S.: AI/AN tribal leaders, the Indian
Health Service, USRDS, OPOs, UNOS, HCFA, and HRSA.

I-B.38.Str.l: Develop an information base on American Indians/Alaskan
Natives.

A. Describe awareness and attitudes related to organ donation issues for
AI/AN groups in at least six regions of the U.S.

B. Describe and publish accurate information related to AI/AN pop-
ulations on the following issues:

48


1. prevalence of diseases that result in end-stage organ failure
2. transplantation rates for these diseases
3. organ donation rates

I-B.38.Str.2: Conduct a workshop on the need for, current status of, and
ways to increase organ donation in AI/AN. This workshop shall be
organized by the DOT/HRSA and IHS. Participants at the workshop shall
include at least the following: leaders of AI/AN tribes and nations; leaders
of AI/AN urban clinics; health care workers who serve AI/AN people; and
selected experts from the field of organ procurement, transplantation,
education, and public relations.

OBSERVATION

Virtually all of the recommendations and action steps developed in this work
group for Hispanics are pertinent to understanding organ donation in AI/AN.
While it is likely that many AI/AN leaders would concur with these recommen-
dations it is not possible to speak on behalf of all AI/AN. Recognizing the
diverse cultural backgrounds and sensitivities of AI/AN is of paramount
importance to improving the health of these people.

49


WORK GROUP I-C: A NATIONAL CAMPAIGN:
FOCUSING ON CHILDREN, YOUTH, AND YOUNG
ADULTS

  Chairperson: Stephen P. Dunn, MD
Co-Chairperson: Ellen Bethel Yeager, MS
Background Paper: Robert E. Shoenberg, PhD
Staff Assistant: Allison A. Hammond, RN
Group Members: Patricia Aiken-O'Neill, JD
         Vicki L. Albright, MPH
           Hester Clark

Elias S. Cohen, JD
William DeJong, PhD
John A. Del Gatto
Joan L. Di Costanzo, MEd
Richard N. Fine, MD
Vicki S. Freimuth, PhD
Karen G. Kuperberg, RN, BSN, CCTC
Veronica K. Meury
Elizabeth Nuckolls, BSN, CPTC
Donna M. Oiland
Alejandro Vasquez

PREAMBLE

Any improvement in organ donation depends in large part on the education of
children, youth, and young adults. This can only be achieved though the
development of a wide variety of educational vehicles and opportunities in the
public and private sector. Coordination of these educational activities and
programs requires the leadership of the DOT. Educational efforts will also
require the involvement of professional educators, transplant care givers, minority
group representatives, and advocates for children, youth and young adults in a
unique partnership which the DOT must foster. This task must begin now. We
are pleased to be part of the Surgeon General's Workshop and hope that our
efforts contribute to this important goal.

RECOMMENDATIONS

I-Cl. The DOT grant program should be substanrially increased to encourage
experimental programs to increase awareness among children, youth, and young
adults, overcome barriers to donation, and promote family discussion of the
issue.

51


Immediate Action:

I-C.l.Str.1:  Approach minority groups to encourage organ donation
education among children, youth, and young adults and to fund pilot projects.

I-C.l.Str.2:  Require local OPOs and tissue banks to offer educational
awards to schools for student essays and dramatizations which promote organ
and tissue donation awareness.

I-C.l.Str.3: Support through grants the experimental programs Teens for
Transplant, MOTRAIN, Kids On The Block, and the D.C. Organ Donor
Committee's curriculum.

I-C.l.Str.4: The anticipated decrease in grant funds available for F'Y 92 is
inconsistent with the growing donor gap and the educational needs identified
by this work group and should be reversed through increased Congressional
funding.

I-C. 1 .StrS: Offer specific grant support for developing educational materials
for students that have as a goal encouraging family discussion.

I-C.2: The DOT should expand its role in making basic research and other
resource materials available to OPO officials and other advocates of organ and
tissue donation.

Immediate Action:

I-C.2.Str.l: Develop a Current Health Information Database (CHID) subfile
on organ and tissue donation for the purpose of identifying and making
available unpublished reports, educational materials, and other "fugitive"
literature.

Intermediate Action:

I-C.2.Str.2: Collaborate with other DHHS research agencies to sponsor new
research (see I-C.2.Str.l.) on children, youth, and young adults.

I-C.2.Str.3: Compile existing survey and focus group research and conduct
new research as necessary to:

1.  Identify distinct target audiences among children, youth, and young
  adults.

52


2. Survey current knowledge, attitudes, and psychological barriers to
donation; and,

3. Develop strategies for motivating increased donation.

I-C.2.Str.4: DOT/DHHS-funded research findings must be submitted
to DOT, and made available to the public and to the CHID database (see
I-C.2.Str.3).

I-C.3. The DOT should form partnerships with professional organizations to
enhance education regarding organ donation in children and youth.

Immediate Action:

I-C.3.Str.l: Identify appropriate organizations which have an interest in
donor awareness education directed at children, youth, and young adults
and encourage these efforts through provision of materials, resources for
presentations, and/or consultation for expanding programs. Specific
attention should be directed to the eduction field, minority organizations,
and pre-professional groups (medical, nursing, and education students).

I-C.3.Str.2: Undertake efforts through DOT staff and/or OPOs to respond
to calls for papers and otherwise get on the agenda for national professional
meetings to promote donor awareness education programs.

Intermediate Action:

I-C.3.Str.3: Convene national and/or regional meetings of representatives
from education-related and professional organizations (e.g., pediatricians) to
provide information, training, and materials to raise the awareness of their
members regarding their role in organ donation awareness programs.

I-C.3.Str.4: Generate and make available generic education materials to
professional organizations.

I-C.3.Str.5: Establish and maintain a Donor Education Network to facilitate
communication and sharing among organizations involved in awareness
education to enhance the potential of developing partnership efforts, materials
development, and the establishment of an educational materials library.

I-C.4. The DOT should encourage the development of model educational
curricula that will teach about organ transplantation and donation.


Immediate Action:

I-C.4.Str.l: Identify and review existing curricula and materials which
should be evaluated by interested groups and disseminate the best to
appropriate groups for adoption and/or adaption.

Intermediate Action:

I-C.4.Str.2: Work with textbook writers and publishers to get organ and
tissue transplantation into textbooks in a variety of appropriate curricular
areas. Developers of educational materials should be similarly addressed.

I-C.4.Srr.3: Assemble curriculum experts in several academic disciplines to
develop a comprehensive model curriculum addressing children from early
childhood through high school.

1. The curriculum should be designed so that it can be adopted as a
whole by a school system or in component parts - or adapted to
  meet individual needs.

2. The curriculum should emphasize the integration of organ and tissue
donation and be developed for inclusion into subjects usually
addressed in existing courses, e.g. study of organ systems in a health
science course, study of public policy issues in a social science class.

3. DOT should enlist as a partner in this enterprise a national or-
ganization of educators whose advocacy for the curriculum can have
a significant impact on its adoption, e.g. National Science Teachers
Association, National Education Association, and National As-
  sociation for Social Studies Teachers.

4. Prior to dissemination, the curriculum should be. reviewed by a
variety of interested groups, e.g. educators on areas such as religion,
minority issues, health, etc.

5. Develop model curricula for inservice and continuing education for
teachers (such as curriculum developed by the D.C. Organ Donor
Committee for the National Kidney Foundation).

I-C.5. The DOT should require the OPTN to incorporate into its goals and
planning process organ donation educational objectives appropriate to youth.

54


Immediate Action:

I-C.S.Str.1: Include representatives of children, youth, and young adults
interests on appropriate UNOS committees.

I-C.S.Str.2 Expand OPO guidelines to include educators and youth
representatives on advisory boards.

I-C.S.Str.3: Collaborate with appropriate organizations to implement youth-
related educational activities.

Intermediate Action:

I-C.S.Str.4: Organize and disseminate scientific registry data related to
children, youth, and young adults.

I-C.6. The DHHS should encourage the Department of Education, the Centers
for Disease Control, and other relevant Federal agencies to make organ
transplantation and donation education a national objective.

Immediate Action:

I-C.6.Str.l:  Form a liaison with HCFA to implement educational re-
quirements as a condition of participation for transplantation organizations
within the agency's programs.

I-C.6.Str.2: Form a liaison with the Department of Education to establish
organ donation education for children, youth, and young adults as a national
priority.

Intermediate Action:

I-C.6.Str.3: Incorporate organ and tissue donation into CDC Teenage Health
Teaching Modules, and "Growing Healthy."

I-C.6.Str.4: Encourage the Department of Education and CDC to develop
grant programs to encourage innovative education programs at the local level.

I-C.6.Str.S: Appoint ombudspersons to coordinate various Federal efforts to
          .

increase donatron among children, youth, and young adults.

55


I-C.7. The Secretary of DHHS, the Surgeon General, and DOT should
encourage private, voluntary efforts by youth, student, and community groups to
promote organ and tissue donation.

Immediate Action:

I-C.7.Str.l:  Explore opportunities for collaboration with insurance
companies, public utilities, and other private corporations to educate their
customers about organ and tissue donation.

I-C.7.Str.2: Offer awards/recognitions to youth organizations which promote
organ donation education.

I-C.7.Str.3:  Collaborate with American Red Cross commercial blood
donation programs and other appropriate organizations to develop methods
for encouraging the completion of donor cards as a part of their operations.

I-C.7.Str.4: Identify recipient and recipient-family support groups (such as
TRIO) and donor-family and hospital-based support organizations. Support
groups and encourage their involvement in educational activities with
children, youth, and young adults.

I-C.7.Str.5: Encourage the establishment of a permanent merit badge for
organ and tissue donor awareness among scouting, campfire, and other
similar youth organizations.

I-C.7.Str.6:  Form a partnership with the American College Health
Association to encourage donation among the students they serve.

Intermediate Action:

I-C.7.Str.7: Convene a conference of leading social, religious, and service
organizations for youth, including minority youth, to encourage their
involvement in stimulating organ and tissue donation among their member-
ship and disseminating innovative program ideas.

I-C.7.Str.8:  Support the activities of Teens for Transplants and other
organizations whose sole purpose is donation and transplant related projects.

I-C.8. All DHHS Agencies awarding grants and contracts in the area of organ
donation education for children and youth should make specific provisions for
adequate evaluation of program outcomes.

56


Immediate Action:

I-C.S.Str.1: Require that applications for grants and contracts include
adequate research designs to assess program outcomes.

I-C.8.Str.2: Designate a proportion of grant funds for evaluation.

I-C.9. DOT should reinvigorate efforts to enroll drivers' license applicants as
potential organ and tissue donors.

Immediate Action:

I-C.9.Str.l: Review procedures in each State for encouraging the completion
of donor cards by drivers' license applicants, the success of these procedures,
and factors that discourage or fail to encourage potential donors.

Intermediate Action:

I-C.9.Str.2: Work with the officials of Departments of Transportation and
State to develop strategies for increasing the number of completed donor
cards by drivers' license applicants, including changes in State law or
regulation, staff training for DMV employees, and enhanced public
information/education programs.  This should include a special focus on
student drivers.

I-C.9.Str.3: Develop model legislation to enable the designation of donor
status as a permanent part of the driver's license, subject to revision at the
time of license renewal.

I-C.9.Str.4: Fund demonstration projects for increasing student enrollment
in donation, including programs involving school-based and private driver
training programs and the MOTRAIN system.

I-C.10. DOT should seek opportunities for promoting organ and tissue donation
through local mass media.

Immediate Action:

I-C.lO.Str.1: Identify appropriate celebrity spokespersons to represent its
promotional efforts and to serve as role models for children, youth, and
young adults.

57


I-C.lO.Str.2: Seek cooperation with the OFTN in the development of mass
media campaigns directed toward increasing organ donation awareness
among children, youth, and young adults.

Intermediate Action:

I-C.lO.Str.3: Expand the DOT grant program to encourage experimental
programs that combine local mass media and community organization
approaches to increase awareness among children, youth, and young adults;
to overcome barriers to donation; and to promote family discussion of the
issue.

I-C.lO.Str.4: Develop video and/or audio news releases for use by local
television and radio news programs.

I-C.lO.Str.S: Establish a public relations program to stimulate favorable
coverage of organ and tissue donation, with special attention to national
youth-oriented publications, college newspapers, and newsletters for social,
religious, service, and educational organizations for youth.

I-C.lO.Str.6: Develop a program of media training for local OPO`officials
and other advocates of organ and tissue donation. Special attention should
be paid to eliminating medical terminology that reinforces public mis-
perceptions and to develop, instead, more appropriate terminology for
specific lay audiences.

58


WORK GROUP II-A: THE DELIVERY SYSTEM

  Chairperson:
Co-Chairperson:
Background Paper:

Staff Assistants:

Group Members:

Jeptha W. Dalston, PhD
Isabel P. Dunst, JD
Arthur Caplan, PhD
Robert Arnold, MD
Laura Siminoff, PhD
Jon L. Nelson
Vera Lake

Jesse B. Barber, MD
Lori E. Brigham, MBA
Ronald L. Dreffer, BS, CPTC
Michael J. Evanisko
Roger W. Evans, PhD
Jerold R. Mande
Mark J. Mannis, MD, FACS
Maxwell J. Mehlman, JD
Sharon Mellor, RN, CPQA
Luis A. Morales Otero, MD
John J. Requard, III, BS
Sarah J. Sanford, RN, MA, CNAA
Otis L. Story, Sr.
Arthur L. Trask, MD, FACS

RECOMMENDATIONS

II-A.1 Maintain the current approach of organ and tissue donation based on
voluntary, altruistic choice and family participation, but continue to explore the
potential impact of possible alternative approaches, such as financial incentives
and presumed consent.

II-A.l.Str.1: DHHS should support the collection and further analysis of
existing data on the attitudes of the public as well as those involved in the
donation process regarding the issues of financial incentives and presumed
consent.

II-A.l.Str.2: In addition, DHHS should lead and promote development of
a research agenda for alternative approaches to organ acquisition and
development of a program of demonstration projects which would include
other approaches which might be pursued.

59


II-A.l.Str.3: The Surgeon General should publicly support and promote the
programs of the National Organ Transplant Act including the OPTN and
OPOS.

II-A.2. Improve the outcome of requests to families to donate by assuring that
the individual responsible for making the request is appropriately trained to make
an effective request.

II-A.2.Str.l: HCFA should clarify its regulatory requirements on hospitals
to clearly permit hospital protocols to provide that OPOs can be delegated
the responsibility to make the donation request of the family.

II-A.2.Str.2: The Division of Organ Transplantation should convene an
advisory group to develop standards for individuals making requests for
donation.

II-A.2.Str.3: Identify and establish means to eliminate barriers that prevent
active participation of neurosurgeons, emergency care physicians, critical care
nurses, neurologists, and other related personnel in the organ donation
process.

II-A.3. Improve the compliance of hospitals with the current statutory and
regulatory requirements of routine inquiry and required referral.

II-A.3.Str.l: HCFA should immediately develop a comprehensive strategy
for increasing hospital compliance which includes mechanisms for policy
implementation, monitoring, enforcement, and evaluation.

II-A.3.Str.2: HCFA should develop measures of hospital performance for
identification and referral of organ and tissue donors and feedback of
compliance data to hospitals and OPOs.

II-A.3.Str.3:  UNOS should require transplant centers to demonstrate
compliance with routine inquiry and required referral as a condition of
UNOS membership.

II-A.3.Str.4: DOT shall identify successful routine inquiry and required
referral programs, and establish and maintain a clearinghouse that facilitates
and promotes these models.

II-A.3.Str.S: DOT, through its grant program, will encourage the develop-
ment of successful strategies intended to improve routine inquiry and
required referral.

II-A.3.Str.6: The DOT grants and contract program should be expanded to
include funds to develop model required referral/routine inquiry protocols.

60


II-A.4. Enhance the effectiveness of decision-making by potential donors.

II-A.4.Str.l:  DHHS should publish a compendium of effective State
strategies for increasing numbers of individuals choosing to donate their
organs and tissues, and disseminate it to State lawmakers for possible State
action.

II-A.4.Str.2: HCFA's policies and procedures to implement the Patient Self
Determination Act should incorporate organ and tissue donation.

II-A.4.Str.3: DOT should fund a study on how donor cards can become
more effective tools for donation. The study should include alternative sites
for signing donor cards, ways of increasing family involvement in signing
donor cards, and ways of assuring that families and health care providers
know that an individual has signed a donor card.

II-A.4.Str.4: .The Surgeon General should encourage the use of Durable
Powers of Attorney (DPA) to make wishes known about donation and to
clarify which family members or other persons should be consulted by
providers in making organ procurement decisions.

II-A.4.Str.S: DOT should evaluate the possibility of replacing the current
donor card format with a donor DPA.

II-A.4.Str.6: The Surgeon General should encourage the National Commis-
sion on Uniform State Laws to establish the legal sufficiency of donor DPAs
and to clarify the legal immunity of health care providers in adhering to the
terms of the DPA.

II-A.4.Str.7: DOT should explore methods to increase the use of donor
DPAs in minority populations.

II-A.4.Str.8: DOT should develop methods for making donor DPAs and
other advanced directives known to hospitals and OPOs in the case of
nonelective admissions.

II-A.5. Increase the effectiveness of the organ and tissue procurement system.

II-A.5.Str.l: DHHS should widely publicize the results of studies concer-
ning the reasons for widely varying rates of procurement by OPOs.

II-A.S.Str.2: DOT should develop a targeted grant program to assist poorly
performing OPOs develop structures that would result in improved perfor-
mance. Special consideration should be provided to applicants proposing
collaboration with hospitals.

61


II-A.S.Str.3: The Assistant Secretary for Health and the Administrator of
HCFA should convene a meeting of representatives from the procurement
community to identify, disseminate, and encourage the adoption of successful
strategies associated with organ and tissue procurement.

II-A.S.Str.4: AOPO, EBAA, AATB and DOT together should develop
standardized policies and procedures to enhance effectiveness and efficiency
of procurement.

II-A.5.Str.5: Eliminate the current inconsistencies and confusion in the
identification of organ donors by establishing standardized criteria for donor
selection.

II-A.5.Str.6: DOT, in conjunction with AOPO, OPTN, and tissue and eye
banks, should create a centralized data base on hospital and procurement
success rates.

II-A.S.Str.7: DOT should intensively review outlier OPO performance.

II-AS.Str.8: DOT should gather, disseminate, and support adoption of
strategies which are known to provide donor family support, decrease care
giver burdens, and increase organ and tissue recovery rates.

II-A.S.Str.9: DOT, in conjunction with professional societies, hospitals, and
hospital representatives, should develop strategies to educate and support
physicians and nurses in positions of triage and management of potential
organ and tissue donors.

II-A.S.Str.10: The Surgeon General should encourage the Secretary of
DHHS to have proposed rules governing the policies of the OPTN published
within 30 days.

II-A.6. Investigate the competitive and financial disincentives for hospitals to
participate actively in the procurement process, including costs associated with
medical management of potential donors.

II-A.6.Str.l: HCFA should conduct a study of hospital costs relating to
organ donation to ascertain the extent to which unrecovered costs are
hindering hospital involvement in organ donation. Examples of such costs
are physician services, laboratory tests, and other very extensive services in
critical care units to maintain organ viability after brain death pending
retrieval.

II-A.6.Str.2: Based upon the study results, HCFA should develop proposals
to eliminate such disincentives.

62


II-A.6.Str.3:  The Surgeon General should become apprised of these
disincentives and exert leadership to understanding of the organ procurement
inhibition arising from the competitive disincentives on trauma centers which
regularly furnish organs to competing transplant centers. While hospitals
operating these trauma centers are reimbursed for the cost of organ retrieval,
they are not compensated for the very large financial losses associated with
operating the trauma centers. Negative motivation sets in when trauma
personnel of one hospital are expected to extend themselves for retrieval of
an organ which has the effect of enhancing the competitive reputation of a
transplant center at a rival hospital. This dynamic may be unfortunate, but
it exists and materially inhibits organ procurement.

II-A.7. Increase the ability of the hospital to manage brain dead' potential
donors and preserve organs prior to recovery in order to provide adequate time
to obtain family consent in a sensitive manner.

II-A.7.Str.l: The Secretary of DHHS shall develop an RFP for basic bench
research to identify chemical, biological, and other compounds research
which will preserve anatomic and physiologic viability of donor organs and
tissues prior to recovery but after determination of brain death.

II-A.7.Str.2: The Secretary of DHHS shall initiate multicenter studies on
optimal clinical management for patients determined to be brain dead.

IIiA.7.Str.3: Required referral protocols should be developed by UNOS and
DHHS that will provide OPOs notification as early as possible of a potential
organ donor so that the OPO can assist the hospital personnel in appropriate
donor management to assure that families are given the opportunity to
donate.

II-A.8. Evaluate the extent to which there are financial disincentives for live
donation.

II-A.8.Str.l: DOT should expand its analysis of funding sources for living
donor expenses.

II-A.9. Encourage cooperative efforts between OPOs, tissue banks, and eye
banks.

II-A.9.Str.l: DOT should encourage and facilitate joint public and profes-
sional education programs by OPOs, tissue, and eye banks.

m Until medical certification of brain death, patient management should
continue with the goal of patient survival.

63


II-A.9.Str.2: DOT should encourage and facilitate the publication of joint
public relations materials.

II-A.9.Str.3: DOT should encourage cross-training of staffs of OPOs, tissue
banks, and eye banks.

II-A.9.Str.4: Encourage where applicable the community-based one number
concept.

II-A.9.Str.5:  The Surgeon General should work with national groups
representing funeral directors, coroners, medical examiners, and emergency
medical services personnel to develop guidelines that would facilitate their
professional involvement in the donation system.

II-A.9.Str.6:  The Surgeon General together with HCFA shall exert
leadership to call for professional membership in OPOs' Boards of Directors
by community leaders who demonstrate stature, capability, and commitment
in enhancing organ availability.

II-A.9.Str.7: Congress should enact legislation that encourages and facilitates
cooperative relationships among OPOs, tissue banks, and eye banks that
includes promoting single number calling.

II-A.lO. Assure equal opportunity for transplants in order to ensure the public's
enthusiastic participation in donation.

II-A.lO.Str.1: Eliminate the 3-year Medicare eligibility limit for successful
transplant patients and extend coverage for payment of immunosuppressive
medications for transplant patients to be made coterminous with the period
of entitlement.

II-A.lO.Str.2: Encourage public and private insurers to offer both coverage
and reimbursement for transplant procedures considered to constitute
established therapy.

II-A.lO.Str.3:  Identify medical treatments and social behaviors which
prevent or delay onset of end-stage organ failure. Develop strategies for
increasing access to such treatments and enhancing such social behaviors.

II-A.lO.Str.4: Certificate of Need and OPTN membership approval should
require disclosure of strategies that assure access to transplants regardless of
ability to pay.

II-A.lO.Str.5: DOT will require that the OPTN eliminate all variances in the
organ allocation system, except in those cases where the variance assures
equitable patient access.

64


II-A. 11. Provide adequate resources to DOT to successfully carry out its many
critical missions.

II-A.ll.Str.1: The Secretary of DHHS should request a FY93 budget of $7
million, including at least $3 million to expand and enhance the grants and
contracts program.

65


WORK GROUP II-B: PROFESSIONAL EDUCATION

  Chairperson: Louis J. Kettel, MD
Co-Chairperson: Ellen Heck, MT, MA
Background Paper: Charles Hostetter, MD, MPH
         Phyllis Weber, RN
  Staff Assistant: Philomena Green
Group Members: Sandra E. Conradi, MD
         Lowell W. Hooper
         Dean F. Kappel
         Jackie D. Lynch
          Michelle' Morse, RN, MSN, CCRN
        Gigi Politoski
         Barbara K. Redman, PhD, RN, FAAN
           Ken E. Richardson
         Edith M. Servino, RN
           Jane Warmbrodt

RECOMMENDATIONS

A. GENERAL

For purposes of this series of recommendations health care professionals include
the categories as described by Hostetter and Weber in "Increasing Donation by
Focusing on the Health Care Environment:  Professional Education" (in
                                  t  OV
     v g-10.) The first category includes "those who are already
members of the transplant community, such as transplant physicians and
surgeons, clinical transplant coordinators, and organ procurement coordinators."
The second category includes "those professionals whose roles bring them into
direct contact with the transplant community." Examples here are social
workers, critical care physicians and nurses, trauma physicians, neurosurgeons,
and neurologists." The third category includes professionals such as clergy,
morticians, medical examiners, coroners, and attorneys whose roles, though not
directly related to the organ donation and transplantation process, place them in
positions to significantly influence individuals' attitudes and decisions related to
organ donation.

II-B.1. To begin immediately and continue into the long-term, the Division of
Organ Transplantation (DOT) should play a facilitative role with practitioners
and educators in each health care profession. Educational goals for organ and
tissue procurement (hereafter referred to as "organ") and transplantation learning
for health care professionals at all levels of preparation should be defined. In

67


order to ensure preparation of those who will teach undergraduates, special
attention should be directed to graduate education in the various professions.
Specific educational approaches should be developed which are appropriate for
each profession. Evaluation of learning appropriate to the specialty should be
included in licensure and certification/recertification requirements. The rapidly
changing environment of organ procurement and transplantation requires the
continued education of established practitioners at all professional levels.

II-B.l.Str.1:  The Surgeon General should encourage utilization of the
existing and proposed curricula developed by UNOS for health professionals.

II-B. l.Str.2:  The Surgeon General should encourage the appropriate
licensing and certifying agencies to include the field of organ donation and
transplant practices in examination development.

II-B.2. In the intermediate term, comprehensive education programs addressing
perceptions, attitudes, and knowledge which are barriers to organ procurement
should be developed targeting physicians, nurses, and hospital administrators.
The foundation for the development of these programs should begin by involving
the target audience in the creation, implementation, and distribution of the
program. The target audience should identify the content and teaching strategies
to be used.

II-B.2.Str.l: The existing model developed by the American Association of
Critical Care Nurses and the National Kidney Foundation to train critical care
nurses in the donation process should be used to develop comparable
programs for the identified groups.

B. RESEARCH

II-B.3. In order to determine effective educational strategies an understanding
of the causes for the present low rate of procurement is needed.

II-B.3.Str.l: Beginning immediately, conduct research studies to inventory
and assess the outcomes of existing formalized educational programs at
undergraduate and graduate levels of health professional training. These
should include, but not be limited to, academic institutions and professional
associations.  Publicize the results and promote the utilization of these
assessments to develop new more effective programs.

II-B.3.Str.2:  Identify the components of OPO programs which lead to
successful practices.

68


II-B.3.Str.3: Study the experience and attitudes of families approached for
donation to determine factors which influence their decision to accept or
decline the option of donation.

II-B.3.Str.3A: Convene a small group of experts appropriate to each
research question. This group or groups will develop the parameters of a
study or studies for subsequent use in developing an RFP with funding to be
identified by the Surgeon General. Simultaneously, the Surgeon General
should publicize the need for research in these areas in appropriate
professional journals.

II-B.4.  In order to develop more successful educational strategies and
operational programs, the Surgeon General should immediately encourage
appropriate agencies (for example, AHA, PHS, OPOs) to collaborate with
hospitals and OPOs to:

1. Identify all potential organ donors through on-going comprehensive
  medical chart review.

2. Report data based on the following categories:

a.  Cases referred to the OPOs who became actual donors and those lost.
Donor loses would be explained.

b. Cases not referred to the OPO.

3. Develop strategies that ensure that all identified potential organ donors
are referred to the OPO. Determine where and from whom referrals
originate and who facilitates or impedes the referral. Identify the cause
of donor losses and propose strategies for improvement.

II-B.4.Str.l: The Surgeon General working through appropriate agencies
needs to assure that policies exist which allow OPOs to accomplish the
actions desired for these recommendations.

II-B.S. In the intermediate term, encourage and solicit publications pertaining
to the legal, moral, and ethical issues relating to organ and tissue donation in
widely read professional journals. Topics should include but not be limited to
the frequency and nature of litigation brought against health care professionals
and to the rights of donor families.

II-B.5.Str.l: The Surgeon General`s office should take a leadership role to
assure the publication of this information.

II-B.6. In order to enhance and promote the professional practice of OPOs, a
study should be conducted within the current year to determine markcting-

69


education and training needs. Based on the results of this survey, the curriculum
for comprehensive OPO marketing and training should be developed in
collaboration with NATCO, AOPO, and UNOS.

II-B.6.Str.l: The Surgeon General should convene a focus group at a
convenient time to determine baseline needs.

II-B.6.Str.2: The Surgeon General should form a marketing and training
advisory group with representatives including, but not limited to, UNOS,
NATCO, and AOPO to develop a content curriculum for the training of OPO
personnel.

II-B.7. Beginning immediately, training focusing on ethnic diversity and cultural
differences should be conducted for OPO staff and key donor hospital staff to
heighten their awareness of these issues.

II-B.7.Str.l: The Surgeon General should identify an advisory group of
experienced trainers in the area of ethnic diversity and cultural differences
who can develop appropriate training materials.

II-B.8.  Beginning immediately, the organ procurement community should
establish a relationship with the local medical examiner/coroner's office and
coordinate efforts to promote mutual professional education. The learning objec-
tive of this mutual education should be the rapid identification of potential
donors who may come under the medical examiner/coroner's jurisdiction in order
that investigation and clearance for donation can occur in a timely manner.

II-B.8.Str.l: The Surgeon General should, through appropriate publications,
express interest and concern for this issue emphasizing that OPOs should be
developing relationships within the medico-legal community.

II-B.9. Other groups crucial in the organ donation process should be targeted
for educational programs. These groups include the clergy, attorneys, and
morticians.

II-B.9.Str. I: The Surgeon General should, through appropriate publications,
express interest and concern for this issue. The Surgeon General should
encourage the transplant community to develop partnerships with these
groups.

70


WORK GROUP III-A: RE-EXAMINING DONOR
CRITERIA: CADAVERIC DONORS

  Chairperson: Nancy L. Ascher, MD, PhD
Co-Chairperson: Leonard Lee Bailey, MD
Background Paper: J. Wesley Alexander, MD, ScD
Staff Assistant: Remy Aronoff
Group Members: R. Randal Bollinger, MD, PhD
         Brian A. Broznick, CPTC
        Mary Beth Danneffel, RN, BSN
         William E. Harmon, MD
         Vernon Henderson, MD
        Linda L. Jones, RN, CPTC, CCTC
        Michael J. Joyce, MD
         Ronald H. Kerman, PhD
         Howard M. Nathan, BS, CPTC
        John F. Neylan, III, MD
        Byers W. Shaw, Jr., MD
         Daniel Whiteside, DDS
        James B. Young, MD

The objectives pursued by Work Group III-A fell into two categories:

1. Increase organ transplantation activity by increasing the pool of
acceptable brain dead cadaver% donors.

2. Increase organ transplantation activity by identifying and utilizing a pool
of non-heart beating donors.

The major motivation is to provide safe organs for transplant patients.

RECOMMENDATIONS

III-A.l. The use of donors at both extremes of age is recommended. Specific
criteria should be developed for each organ.

1114.2. It is recommended that HIV-positive donors not be utilized 10 Protect
recipients against transmission of this disease.

1114.3. It is recommended that Hepatitis B surface-antigen-positive donors not
be utilized.

71


III-A.4 It is recommended that there be acceleration and approval of newer
more sensitive tests for HIV and Hepatitis B infection on the donor population.

III-AS. It is recommended that organs and tissues from Hepatitis C positive
donors be offered and used selectively.

111-A-6. It is recommended that organs and tissues from systemically infected
donors be used selectively.

III-A.7. The medical climate has changed considerably over the past 5 years.
We must consider expanding the donor pool in light of severe donor shortages.
The use of an expanded pool of donors, e.g., those with diabetes, hypertension,
past treatment of cancer, should be considered.

III-A.8. A national study of attitudes toward presumed consent in the U.S.A.
should be conducted.

III-A.9. A pilot project of presumed consent within a subpopulation (such as the
military) should be conducted. This could be supported by a grant from DOT.

III-A.lO. Required referral should be implemented as part of routine hospital
accreditation.

III-A. 11. A pilot project which eliminates the disincentives associated with
organ donation should be conducted under grant or contract from DOT.

III-A.12. A national study of attitudes toward incentives to organ donation in
the U.S.A. is needed. The results could lead to a pilot project on incentives.

III-A.13. Stronger liaisons are needed between OPOs and medical examination
offices to facilitate the organ donation process.

III-A.13. It is recommended that non-heart beating donors be used for
transplantation.

72


WORK GROUP III-B: RE-EVALUATING DONOR
CRITERIA - LIVE DONORS

  Chairperson: Arnold G. Diethelm, MD
Co-Chairperson: Andrea Zachary, PhD
Background Paper: John D. Lantos, MD
        Mark Siegler, MD

Staff Assistant: Gwen Mayes, MMSc, CPTC
Group Members: James F. Childress, PhD
         David J. Cohen, MD
         Barbara Elick, RN, BSN
        M. Roy First, MD
        Michael P. Kaplan, MD, FACS
        Edgar L. Milford, MD
        Barbara A. Schanbacher, RN, BSN
       Aaron Spital, MD
        Vaughn A. Stames, MD
        Mary L. Stoeckle, RN, MSN, CCRN
        David E.R. Sutherland, MD, PhD
       Pedro Vergne-Marini, MD, FACP
        Peter F. Whitington, MD

RECOMMENDATIONS

The work group recommends that:

III-B.1.  The criteria for selection of living donors should consider the
physiologic conditions of the donor rather than the chronologic age. Those
donors who have health conditions which involve minimal risk of morbidity and
mortality may be acceptable. (Policy/Medical criteria)

III-B.l.Str.1:  The Surgeon General develop a position paper about living
donation that addresses the following:

A. reaffirming living donor transplantation
B. re-evaluation of live donor criteria
    - age
    - unrelated live donor
C. medical risk factors
D. issues of consent (especially for those less than the age of eman-
cipation) (Immediate)

73


III-B.;?. Transplant teams should determine that prospective live donors are
competent to consent to or refuse donation, have adequate information to make
an informed choice, and can choose voluntarily without coercion or undue
influence. Donors below the age of emancipation may be considered with the
appropriate safeguards. (Policy/Medical criteria)

III-B.3. Potential live donors receive full and unbiased information about the
short- and long-term benefits and risks of donation. (Education)

III-B.3.Str.l: Overall recommendation for all education recommendations:
Federal funds be allocated to establish a national clearinghouse for education
related to all aspects of organ donation and transplantation. (short-term
within 2-3 years.)

III-B.l. Potential recipients and families receive full and unbiased information
about the short- and long-term benefits of all options for transplantation
including living related and unrelated donors. (Education)

III-B.l.Str.l: The Division or Organ Transplantation, in collaboration with
Federal agencies and transplant-related health organizations, review
educational materials developed for informing patients and families about the
treatment therapies for end stage-renal disease. Additionally, the ESRD
networks should be required to develop a mechanism for verifying that these
materials have been reviewed by patients and families. (ongoing review,
ESRD documentation within l-2 years)

III-B.S. Health care professionals have current information about the appropriate
use of live donors for transplantation in order to adequately provide counsel and
education to potential recipients and live donors. (Education)

III-B.S.Str.1:  Medical and nursing school curriculum currently being
developed by UNOS' Education Committee should incorporate information
about the use of live donors. (immediate-ongoing)

III-B.6 Public education should emphasize the potential benefits and minimal
risks of living donation. (Education)

III-B.6.Str.l: Any national campaigns should include information about
using live donors for transplantation.

III-B.7. Financial disincentives to live donors should be removed. (Poli-
cy/Financial)

III-B.7.Str.l: A work group comprised of representatives from NATCO and
UNOS will study and assess the financial burdens of being a live donor and

74


develop a set of recommendations and strategies to eliminate financial
disincentives to live donation.

III-B.8. Public and private payors should recognize the therapeutic benefits of
transplantation with living donors and not discriminate against these procedures.
(Policy/Financial)

III-B.8.Str.l: The Surgeon General should encourage the Secretary of
Health and Human Services to request HCFA and private payors not to
differentiate between donor source for the reimbursement of an approved
transplant procedure. (Immediate)

III-B.9. An ongoing program of data collection should be implemented to
continue to evaluate the risks and benefits of live donation. (Research/Data)

III-B.9.Str. 1:  Charge the OPTN Scientific Registry with developing a
registry of live donors for long-term follow-up. (Immediate)

75


List of Participants

Patricia Aiken-O'Neill, JD, President/CEO, Eye Bank Association of
America, Inc., Washington, DC

Vicki L,. Albright, MPH, Director, Teens for Transplant, LifeGift Organ
Donation Center, Houston, TX

J. Wesley Alexander, MD, ScD, Professor of Surgery, University of Cincin-
nati, Cincinnati, OH

Elaine Bratic Arkin, Health Communications Consultant, Arlington, VA

Nancy L. Ascher, MD, PhD, Professor of Surgery, University of California,
San Francisco, CA

Charles Atkin, PhD, Department of Communications, Michigan State
University, East Lansing, MI

Leonard Lee Bailey, MD, Professor of Surgery, Loma Linda School of
Medicine, Loma Linda, CA

Ashley Baquero, MD, Transplant Surgeon, Schumpert Medical Center,
Shreveport, LA

Jesse B. Barber, MD, Neurosurgery Department, D.C. General Hospital,
Washington, DC

Christopher R Blagg, MD, Executive Director, Northwest Kidney Center,
Seattle, WA

R Randal Bollinger, MD, PhD, Chief, Surgical Transplantation, Duke
Medical Center, Durham, NC

Wanda W. Bond, Director of Communications, UNOS, Richmond, VA

Lori E. Brigham, MBA, Executive Director, Washington Regional Transplant
Consortium, Washington, DC

Charles Brown, Director of Public and Patient Services, National Kidney
Foundation, Atlanta, GA

Brian A. Broznick, CPTC, Director, Pittsburgh Transplant Foundation,
Pittsburgh, PA

77


Clive 0. Callender, MD, FACS, Director, Transplant Center, Howard
University Hospital, Washington, DC

Arthur L. Caplan, PhD, Director, Center for Biomedical Ethics, University
of Minnesota, Minneapolis, MN

Jorge Chapa, PhD, Professor, LBJ School of Public Affairs, University of
Texas, Austin, TX

James F. Childress, PhD, Professor of Religious Studies, University of
Virginia, Charlottesville, VA

Hester Clark, RN, Golden State Regional Organ Procurement Agency,
Sacramento, CA

David J. Cohen, MD, Medical Director, Renal Transplantation, New York,
NY

Elias S. Cohen, J.D., Community Services Institute, Narbeth, PA

Sandra E. Conradi, MD, Associate Professor of Pathology and Laboratory
Medicine, University of South Carolina, Charleston, SC

Maggie Coolican, RN, MS, Donor Mother, East Hampton, CN

Jeptha W. Dalston, PhD, Chief Executive Officer, Hermann Hospital,
Houston, TX

Mary Beth Danneffel, RN, BSN, Executive Director, Sierra Regional Eye
and Tissue Bank, Sacramenta, CA

John Davis, Executive Director, National Kidney Foundation, New York, NY

Rebecca J. Davis, MS, CPA, Executive Director, LifeGift Organ Donation
Center, Houston, TX

William DeJong, PhD, Lecturer, Harvard School of Public Health Boston,
MD

John A. Del Gatto, Executive Director, MOTRAJN, Inc., Manhattan Beach,
CA

Margaret F. Dewey, RN, MSN, Transplant Coordinator, California Trans-
plant Donor Network, San Francisco, CA

Joan L. Di Costanzo, MEd, Elementary School Teacher, Rockville, MD

78


Eunice Diaz, MS, MPH, Health Care Consultant, Cerritos, CA

LUZ Diaz-Schreiber, BS, MA, Family Services Coordinator, Regional Organ
Procurement Agency of Southern California, Los Angeles, CA

Arnold G. Diethelm, MD, Professor and Chairman, Department of Surgery,
University of Alabama at Birmingham, Birmingham, AL

Ronald L. Dreffer, BS, CPTC, Executive Director, Ohio Valley Organ
Procurement Center, Cincinnati, OH

Stephen P. Dunn, MD, St. Christopher's Hospital for Children, Philadelphia,
PA

Isabel (Lii) P. Dunst, JD, Hogan and Hartson (Lawyer), Washington, DC

Barbara Eli&, RN, BSN, President, Chief Transplant Coordinator, Trans-
plant Center, University of Minnesota, Minneapolis, MN

Michael J. Evanisko, Partnership for Organ Donation, Boston, MA

Roger W. Evans, PhD, Research Scientist, Battelle Human Affairs Research
Centers, Seattle, WA

Richard N. Fine, MD, Professor and Chair of Pediatrics, State University of
New York, Stoney Brook, NY

M. Roy First, MD, President, Chief Transplant Coordinator, Transplant
Center, University of Maryland, College Park, MD

Vi&i S. Freimuth, PhD, Associate Professor, Department of Communication,
University of Maryland, College Park, MD

Frederick N. Griffith, President, CEO, Tissue Bank International, Baltimore,
MD

William E. Harmon, MD, Director, Pediatric Nephrology, Boston Children's
Hospital, Boston, MA

Ellen Heck, MT, MA, Administrative Director, Texas Aeroic Center, South-
western University Center, Dallas, TX

Steven D. Helgerson, MD, MPH, Indian Health Service, Epidemiology
Program, Seattle, WA

79


Vernon Henderson, MD, Staff Surgeon for the Department Surgery, Univer-
sity of California Davis, Oakland, CA

Lowell W. Hooper, Treasurer, National Funeral Directors Association,
President Hooper Funeral Home, President Hooper Funeral Home, Inverness,
FL

Charles L. Hostetter, MD, MPH, San Francisco, CA

Octavia Hudson, PhD, Director of Media Programs, Prevention Resources
Center, Buffalo State College, Buffalo, NY

Louise M. Jacobbi, CPTC, CCTC, Executive Director, Louisiana Organ
Procurement Agency, Metairie, LA

Linda I,. Jones, RN, CPTC, CCTC, Co-Director Lifeline of Ohio Organ
Procurement, Columbus, OH

Michael J. Joyce, MD, Associate Professor of Orthopedic Surgery, Metro-
health Medical Center, Cleveland, OH

Michael P. Kaplan, MD, FACS, Association Professor of Surgery, Wayne
State University, Harper Hospital, Detroit, MI

Dean F. Kappel, Chief Executive of Mid-American Transplant Association,
St. Louis, MO

Ronald H. Keman, PhD, Professor of Surgery, University of Texas Medical
School, Houston, TX

Louis J. Kettel, MD, Vice President for Academic Affairs, Association of
American Medical Colleges, Washington, DC

Karen G. Kuperberg, RN, BSN, CCTC, Nurse Transplant Coordinator,
Tallahassee, FL

Rita Guajardo Lepicier, Director of Hispanic Projects, Educational Enter-
prises, Los Angeles, CA

Jackie D. Lynch, Hospital Community Development Specialist, Regional
Organ Bank of Illinois, Chicago, IL

Lin Johnson McGaw, RN, MEd, United Network for Organ Sharing,
Richmond. VA

80


J. Raul Magana, PhD, Vice President, BuenaCare, Alta Med Services
Corporation, Irvine, CA

Daniel Maier, Director, Department of News and Information, American
Medical Association, Chicago, IL

Jerold R Mande, Legislative Assistant, Office of the Honorable Senator
Albert Gore, Jr., Washington, D.C.

Mark J. Mannis, MD, FACS, Chairman, Eye Bank Association of America,
Professor of Ophthalmology, University of California at Davis, Sacramento,
CA

Maxwell J. Mehlman, JD, Director, Law and Medicine Center, Case Western
Reserve University, School of Law, Cleveland, OH

Sharon Mellor, RN, CPQA, Director, Quality Assurance, Children's Mercy
Hospital, Kansas City, MO

Veronica K. Meury, Executive Director, Transplant Recipients International,
Pittsburgh, PA

Edgar L. Milford, MD, Director of Clinical Services, Brigham Women's
Hospital, Tissue Typing Lab, Boston, MA

Luis A. Morales Otero, MD, Puerto Rico Transplant Program, Auxillo
Mutuo Hospital, Hato Rey, PR

Rudolph C. Morgan, Upstate New York Transplant Services, Buffalo, NY

Michelle Morse, RN, MSN, CCRN, Coordinator Medical-Surgical, Nursing
Staff Development, University Hospital of Cleveland, Twinsburg, OH

Jeanne C. Mowe, Executive Director, American Association of Tissue Banks,
McLean, VA

Howard M. Nathan, BS, CPTC, Executive Director, Delaware Valley
Transplant Program, Philadelphia, PA

John F. Neylan, III, MD, Medical Director, Renal Transplantation, Emory
University Hospital, Atlanta, GA

Elizabeth Nuckolls, BSN, CPTC, Tennessee Donor Services, Nashville, TN

Donna M. Oiland, Executive Director, University of Washington Medical
Center, Seattle, WA

81


Gigi Politoski, Director of Communications, National Kidney Foundation,
Inc., New York, NY

Raymond Pollak, MD, FRCS, FACS, University of Illinois at Chicago,
Department of Surgery, Division of Transplantation, Chicago, IL

Anita L. Principe, BSN, MPA, Senior Transplant Coordinator, Montefiore
Medical Center, Bronx, NY

Cozette Proctor, Donor family member. Works with the Washington
Hospital Center, Washington, DC, in transplantation research. Annandale, VA

Jeffrey Prottas, PhD, Research Professor, Bigel Institute, Brandeis Univer-
sity, Waltham, MA

Barbara K. Redman, PhD, RN, FAAN, Executive Director, American
Nurses Association, Kansas City, MO

John J. Requard, III, BS, Executive Director, Mid-America Eye and Tissue
Bank, St. Louis, MO

Kenneth E. Richardson, Executive Director, Kentucky Organ Donor Afi
tiliates, Louisiana, KY

Ernest0 Rive-Mora, MD, Assistant Chief, Veterans Administration Medical
Center, San Juan, PR

Joann Ellison Rodgers, MS, Director of Media Relations, John Hopkins
Hospital, Baltimore, MD

Cynthia Rodriquez-Harriman, LVN, Family Services Coordinator, UCLA
Regional Organ Procurement Agency, Los Angeles, CA

Willie R Ross, MD, Director, Renal Unit, St. Louis Regional Medical
Center, St. Louis University School of Medicine, St. Louis, MO

Oscar Salvatierra, Jr., MD, Executive Director, Pediatric Renal Transplan-
tation, Presbyterian Medical Center, San Francisco, CA

Maritza R Sanchez, Donor Family Member, Silver Spring, MD

Sarah J. Sanford, RN, MA, CNAA, Executive Director, American As-
sociation of Critical Care Nurses, Alisa Viejo, CA

Eduardo A. Santiago-Delpin, MD, Transplant Director, Puerto Rico Trans-
plant Program, Auxello Mutiro Hospital, Hato Rey, PR

a2


Barbara A. Schanbacher, RN, BSN, Transplant Services, University of Iowa
Hospital, Iowa City, IA

Edith M. Servino, RN, Director of Education, United Network for Organ
Sharing, Richmond, VA

Byers W. Shaw, Jr., MD, Chief, Transplant Service, University of Nebraska
Medical Center, Omaha, NE

Charles F. Shield, III, MD, General Surgeon, Wichita Surgeon Group,
Wichita, KS

Robert E. Shoe&erg, PhD, Education Consultant, Silver Spring, MD

Karen L.. Smith, MS, Education Liaison, LifeGift Organ Donation Center,
Houston, TX .

Aaron Spital, MD, Clinical Assistant, Professor of Medicine, University of
Maryland School of Medicine, College Park, MD

Vaughn A. Starnes, MD, Associate Professor of Cardiothoracic Surgery,
Director of the Heart-Lung and Lung Transplant Program, Lucile Salter
Packard Children's Hospital, Stanford, CA

Sylvester Sterioff, MD, Professor of Surgery, Director of Transplantation,
Mayo Clinic, Rochester, MN

Mary L. Stoeckle, RN, MSN, CCRN, Donor, Critical Care Instructor/Organ
Procurement Coordinator, Mercy Hospital Anderson, Cincinnati, OH

Otis L. Story, Sr., University of Medicine and Dentistry of New Jersey,
Newark, NJ

David E. R Sutherland, MD, PhD, Professor of Surgery, University of
Minnesota Hospital and Clinic, Minneapolis, MN

Arthur L Tmsk, MD, FAG, Director, Trauma Services, Fairfax Hospital,
Falls Church, VA

Moraima Trujillo, MD, Clinical Assistant Professor, University of Miami
School of Medicine, Miami, FL

Alejandro Vasquez, Teens for Transplant, Houston, TX

Pedro Vergne-Marini, MD, FACP, FACC, Clinical Professor of Medicine,
University of Texas Southwestern Medical School, Dallas, TX


Jane Warmbrodt, Fairway, KS

Phyllis G. Weber, RN, Executive Director, California Transplant Donor
Network, San Francisco, CA

Daniel Whiteside, DDS, Government Relations Director, American As-
sociation of Colleges of Osteopathic Medicine, Washington, DC

Peter F. Whitington, MD, Director, Section of Pediatric Gastroenterology,
Hepatology and Nutrition; Departments of Pediatrics and Medicine, University
of Chicago, Chicago, IL

Mark E. Whitlock, MS, Health Education, Mid-American Transplant
Association, St. Louis, MO

Ellen Bethel Yeager, MS, Assistant Principal, Woodrow Wilson High
School, Washington, D.C.

James B. Young, MD, Associate Professor of Medicine, Multi-Organ
Transplant Center, Methodist Hospital, Houston, TX

Andrea Zachary, PhD, President, American Society for Histocompatibility
and Immunogenetics, Histocompatibility and Immunogenetics Laboratory,
Cleveland Clinic Foundation, Cleveland, OH

*U.S. GOVERNMENT PRINTING OFFICE: 1992--619-268/41331

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