INCREASING ORGAN AND TISSUE DONATION:

WHAT ARE THE OBSTACiES, WHAT ARE OUR OPTIONS?*

Arthur Caplan, Ph.D., University of Minnesota
Laura Siminoff, Ph.D., University of Pittsburgh
Robert Arnold; M.D., University of Pittsburgh
Beth Virnig, M. P. Hi, University of Minnesota

The Procurement of Organs and Tissues in the, United States:
Grappling with Scarcity

Inadequacy in the supply of organs and tissues has been a constant and frustrating
reality in the field of transplantation for more than a decade. While no reliable
statistics existed as to the number of Americans waiting for solid organs until
1987, and no precise-numbers exist now as to how many Americans are waiting
for tissues, scarcity has long been a fact of life for those in need of transplants.

At the end of 1987, the United Network for Organ Sharing (UNOS) waiting list for
solid organs showed 13,396 names. In 1989 there were 19,173 names. At the
end of 1990, there were 22,008 names on the list, an increase of more than 40
percent from the previous year. The list has been growing despite the fact that a
record number of solid organ transplants, 15,162, were performed in 1990, a.
significant increase over the 13,.176 organ transplants done in 1989.

Two thousand new patients are added to the list of those waiting for organs each
month. Between a third to a half of all Americans on transplant waiting lists for
hearts, livers, lungs, and heart and lungs die before a transplantable organ is found.
Some experts estimate that a new name is added to the list of those waiting for
organ transplants every 30 minutes.

As of March 11, 1991 the number of persons on the UNOS waiting list were:

Kidney    18,205    Heart/lung   181
Lung      410    Pancreas    524
Liver      1,311     Heart     1,899

* work for this paper supported in part by a grant from the Agency for Health Care Policy and
Research (AHCPRI No. 5RO 1 -HSO65 79-020

199


Between 2,500 and 4,000 Americans are on waiting lists for cornea transplants
during any given month. Tens of thdusands more await transplants of skin, bone,
ligament, joints, dural matter, heart valves, and bone marrow.

The shortage of organs for newborns and very you'ng children is especially acute.
Twenty five percent of those waiting for liver transplants are children less than 10
years of age. In 1990, nearly 400 infants born with congenital defects of the
heart died because there were no donor hearts available for them.

There are many reasons to believe that the demand for organs and tissues will
continue to increase at a rapid rate. There have been'major improvements in the
efficacy rates associated with all forms of transp!antation. The shift i,n the
demographics of our nation's c'itizenry toward an older population means that more
individuals are likely to need transplants. Improvements in immunosuppressive
drugs combined with a better understanding of the genetics of the immune system,
provided by knowledge acquired through the human genome project, hold out the
promise of continuing improvements in efficacy rates and for increasing the
number of potential recipients of transplants. And, there are more and more
centers capable of perfarming transplants.

In the past two decades there has been an explosion in the number of medical
centers performing both tissue and organ transplants (Russell, 1986). Whereas
only a decade ago a mere handful of medical centers were capable of even
attempting bone marrow transplants, today dozens of centers have done so. In
1985 one center had done pediatric heart transplants. In. 1990, `35 medical
centers reported experience with at least one pediatric heart transplant, In 1991.,
20 more medical centers had indicated to the International Heart Transplant
Registry that they intended to perform pediatric heart transplants (personal
communication, 1991). Rapid increases in the number of centers capable of
performing liver, lung, pancreas, intestinal, and heart transplants means that there
will be increased demand for these solid organs. Similarly, the number of medical
centers willing to undertake non-related bone marrow transplants has been growing
at a very rapid pace.

As transplant surgeons begin to fully master the techniques of transplantation and
as. newer forms of immunosuppressive drugs become available, the eligibility
standards for potential recipients are expanding. Broader standards of candidacy
promise to fuel a continued demand for organs and tissues Kaplan, 1989). Age
limits of 55 for heart and liver transplants that prevailed in the 1970s have long
since been broken.' Diabetes is no longer an absolute contraindication for kidney
transplantation. Persons suffering liver failure resulting from alcohol abuse have
.been. successfully transplanted. Fetus to fetus bone marrow transplantation has
been attempted for various metabolic disorders.

200


All of these factors contribute to what will be an inevitable increase in the demand
for organs and tissues. Improvements in t.echniques for `bridging' those in need of
transplants, new forms-of cellular transplantation such as myoblast transplants for
those with muscular disorders, atid the modification of the immune system of
donor and recipient through genetic engineering will only add to the demand.
Scarcity is the single greatest challenge facing those.in need of transplants and
those who wish to help them and will be so for the foreseeable future. The
challenge facing our nation is to understand the organizational, legal, moral,
regulatory, educational, and financial factors that currently underpin organ and
tissue procurement' in order to see whether there are any changes that can be
made which will help bridge the gap between. supply and demand in
transplantation.

The His r
t
     to v o f Publi P lit
           c o v and Ethics Reaardina Procu remen

Organs and tissues have historically been obtained almost.exclusively from human
sources. The primary source of organs and tissues in the United States has been
cadavers. While living donors have been used to obtain kidneys, bone marrow,
and, in recent years, segments of pancreas, lobes of lung and liver, cadaver
donation is the single most important source of transplantable organs and tissues.
Yet, because of the particular way in which transplantation techniques have
evolved over the past four decades, public policy, law, and morality regarding
cadaver donation has been strongly influenced by policies that were formulated
primarily in response to the practice of using living donors.

Voluntary Choice

The first organ transplants were attempted in the early 1950s. These early efforts
involved kidneys from living donors. Since there were no reliable methods for
overcoming immunological differences between donors and recipients, no
techniques for preserving organs outside the body, or for artificially maintaining
bodily functions in cadavers, the only possible donors and recipients of kidneys
were twins or biological siblings.

Law, religion, and public policy viewed the early days of transplantation with
apprehension. Kidney transplants were seen as highly experimental. Some
religious leaders worried that organ donation involved the mutilation of the body
solely for the benefit of another and, as such, constituted an immoral act (Vatican,
1960, Meyers, 19901. Still other religious groups were concerned that God's gift
of stewardship over one's body might not permit organ d,onation (May, 1985).

Those asked to provide donor kidneys were seen as requiring the protection of the
state and the legal system so that neither coercion or ignorance were allowed to

201


play roles in efforts to secure orbans. Since the outcome of kidney transplantation
was not known; American courts would only permit the use of living sources if
organs were voluntarily donated. Donors had to give informed consent knowing
that their sacrifice might not eventuate in success. Courts held surgeons
responsible for making sure that no one served as. a donor as a result of coercive
pressure from the potential recipient or other family members.     

American courts and State legislatures generally held that incompetent persons
such as children or p.ersons who were either severely mentally ill or retarded could
only donate organs if surrogate consent was provided by family members or    '
guardians. The imposition of risk on incompetent persons was only'allowed under
the presupposition that the decision to donate is one that the incompetent person
would have made were they to suddenly become competent (substituted
judgement) or that the prospective donor could be harmed by the knowledge that a
sibling had died because an organ,was not available (best interest) (Meyers, 1990).
The norm of voluntary choice is amply reflected'in a long series of state court
decisions to allow incompetents to donate based upon the doctrine of substituted
judgement (Scott, 1982).

The emphasis on voluntary choice as the moral basis for permitting donors to
assume risks in the face of uncertain benefits was carried over to cadaver
donation. The concern about informed consent grew when it was discovered that
during the 1960s some physicians had surreptitiously removed pituitary glands
from cadavers in order to obtain growth hormone to help children born with
congenital dwarfism (Caplan, 1984). ,Public and Congressional outrage over the
removal of tissues from bodies without consent was so overwhelming that it
resulted in an effort by health care professionals, government officials, and lawyers
to create a means wherein voluntary choice could be guaranteed as a condition of
cadaver organ or tissue procurement (Sadler and Sadler, 1984).

In the 1960s a flood of new technologies including respirators, heart-lung bypass
machines, and artificial feeding tubes swept into medicine. These technologies
allow physicians and nurses to keep organs functioning in individuals in whom no
brain functions can be detected. This led physicians to call for a modification in-
the definition of death to include not only the traditional definition of the cessation
of cardiac and respiratory function but also the complete and irreversible cessation
of all brain function. Various model statutes were advanced proposing a brain
death standard in the late 1960s (Capron and Kass, 1972) and had been adopted
by more than 30 State legislatures by 1975.

As the concept of brain death gained acceptance in medical and nursing circles, it
became clear that a mechanism was needed to allow individuals who wanted to
donate organs or tissues upon their deaths to do so. The concern about the need
for voluntary consent and the deeply held conviction that removing organs or

202


tissues from a cadaver without consent was manifestly, immoral and repugnant led
to the idea of an advance written directive for donation--the donor card (Sadler,
Sadler and Stason, i 968).

Altruism

By the late 1960s transplantation had made great progress. Kidney transplantation
could be succes;sfully accomplished using cadaver sources. Techniques had
emerged for preserving and shipping kidneys and other solid organs. Surgeons
were experimenting with transplantation of the liver and heart. Cornea
transplantation had become a well-established therapy.

This progress led to a good deal of public debate about whether public policy
should be changed with respect to organ and tissue procurement. Some analysts
argued that the success of transplantation justified abandoning the prerequisite of
informed consent in favor of laws and public pdlicies which would permit the
routine salvaging of cadaver organs (Dukeminier and Sanders, 1968, Columbia Law
Review, 1969). Others argued that, rather than abandon informed consent, the
time had come to consider permitting financial rewards to those willing to make
organs and tissues av&able after their deaths (Michigan Law Review, 1974).

Neither of these proposals to change the moral and legal foundation of organ and
tissue procurement was successful. Critics of presumed consent and routine
salvaging argued that it was unfair to imperil the rights of those opposed to organ
and tissue donation on religious grounds (Ramsey, 1970). Others were concerned
that public policies which allowed either the routine removal of organs and tissues
from cadavers or financial incentives to encourage making organs available would
corrode social attitudes toward the dignity of the body and the sanctity and worth
of the individual (May, 1973). The argument that prevailed was that public policy
and law should favor both voluntary.choice and altruism because these moral
values were consistent with the desire of Americans to respect individual
autonomy and liberty and that public policies based on these values might permit
an adequate supply of organs and tissues to be obtained from cadaver sources if
adequate efforts were made to encourage public altruism (Caplan and Bayer,
1985)

These moral values, informed choice and altruism, still constitute the ethical
foundations of organ and tissue procurement in the United States today. One
option that exists to increase the supply of organs and tissues from either cadaver
or living sources is to institute laws and public policies that are not grounded by
these values; Any assessment of the desirability of pursuing such strategies
requires some understanding of the nature of existing State and Federal laws.

203


State and Federal Laws Pertainincr to Donation

The concern that the donation of organs and tissues be voluntary and altruistic
was reflected in the earliest national legislation dealing with donation.. In 1968,
the National Conference of Commissioners on Uniform State Laws adopted the
Uniform Anatomical Gift Act (UAGA). By 1972, versions of this law had been
passed in all 50 States. The Act specifies .who may execute an anatomical gift
and how individuals may do so--by signing a donor card. State laws recognized a
signed card as, in and of itself, completely sufficient for donation. There was and
remains no need for next-of-kin to be approached or to consent when a donor card
exists. Health care professionals who make a good faith effort to locate
next-of-kin prior to relying on a donor card to remove organs and tissues are
immune from legal action, To ensure that decisions to donate were autonomously
and altruistically made, subsequent State and Federal legislation, the National
Organ Transplant Act of 1984, explicitly prohibited the sale of organs.

If a deceased person has-not completed a donor card then the UAGA permits
donation based on the consent of relatives or guardians. In such circumstances
family members are given the right to veto a donation. The law clearly recognizes
that family members have a legitimate interest in the fate of the cadaver, but does
not recognize a property interest.

Initial efforts to increase organ and tissue procurement were tied to this legislation.
Public education campaigns encouraged'persons to sign organ donor cards. These
early campaigns appealed to altruistic motivations to encourage donation. People.
were encouraged to "Make the Gift of Life". Many States enacted laws allowing a
modification of their driver's license applications to permit the indication of a
willingness to serve as an organ or tissue donor.

In the 1980s two major legislative changes were introduced in an effort to increase
procurement. One set of changes aimed at increasing the efficiency and
proficiency of organ procurement organizations. The other aimed at encouraging
greater awareness of the option of donation and more opportunities for donation to
occur.

The National Organ Transplant Act of 1984 established a grant program whereby
the Secretary of the Department of Health and Human Services could make grants
for the establishment, initial operation, and expansion of qualified organ
procurement organizations. These organizations were to establish procurement
agreements with hospitals and health care professionals regarding donations. Later
legislation, including the Omnibus Budget Reconciliation Act of 1986 and the
Health Omnibus Act of 1988, attempted to further increase OPO efficiency and
power by setting minimal standards for procurement performance. Tissue
procurement organizations were not affected by these laws.

204


Legislation was also enacted requiring that request for donations be made of family
members at the time of death. Initially, required request laws were enacted by
States. Both Oregon and New York passed such legislation in 1985. By 1988; 44
States and the District .of Columbia had enacted some form of "required request"
legislation governing both organs and tissues from cadaver sources.

TWO types of required request laws were passed. Twenty-six states and the
District of Columbia have "strong" required request laws. These laws require
health care professionals to document in writing on the death certificate that a
request was made and the outcome of the request. The remaining States have
"weak" laws which simply require that hospitals develop protocols to ensure that
family members are made aware of the options of organ and tissue donations.

In 1986, the United States Congress enacted legislation requiring hospitals to
institute weak required request policies. The Health Care Financing Administration`
issued regulations on July 31., 1987 and made. the existence of protocols for
informing families of the option of donations a prerequisite for Medicare
reimbursement eligibility. These regulations went into effect on March .31, 1988.
Shortly thereafter, the Joint Commission on Accreditation of Health Care
Organizations established a policy of weak required request for hospital
accreditation. It is important to note that the National Organ Transplant Act
explicitly affirmed the prohibition on the sale of organs and some tissues. The Act
was modified in 1988 to include a ban on the sale of fetal organs. Numerous
States have also acted to ban the sale of organs and some tissues. Exceptions to
these policies have been made for certain types of replenishable tissues such as
plasma and sperm.

It is interesting (and an exception to the general voluntarism and altruism of
procurement policy) that 10 States and a small number of cities have enacted
legislation granting authority to medical examiners and coroners' offices to procure
organs and tissues from unclaimed bodies undergoing autopsy. For example,
Louisiana, Florida, Ohio, San Francisco, and Denver permit procurement from
bodies under the control of medical examiners when no family members can be
found and there is no reason tc assume any prior objection to procurement.

lea
P bli Su                                         i

There are a variety of ways of measuring public opinion on organ and tissue
donation. One strategy is to see how well informed members of the general public
are about various aspects of donation and transplantation. Another indicator is
determining `how willing individuals say they are to donate their own organs, or
assessing the reported willingness of the public to donate the organs of their family
members. In addition to prospective attitudinal studies, actual donation rates can


be determined as.can the percentage of people carrying organ donor cams. These
indicators offer somewhat inconsistent findings about public support for organ and..
tissue donation.

According to numerous public opinion surveys and polls.conducted over more than
10 years, public education campaigns unde.rtaken by various organ and tissue
procurement organizations, community groups, government agencies, and private
foundations have been quite effective in increasing public awareness regarding
transplantation (American Council on Transplantation, 1985; Caplan and Bayer,
1985; Task Force on Organ Transplantation, 1986). Recent polls show that 98.7
percent of Americans are aware of transplantation (Evans and Manninen, 1988).
Over 78 percent of adults- say their overall feeling about being an organ donor is
favorable. A majority accept the idea that being an organ donor helps other people
and is the "right thing to do."

Various public opinion polls have indicated that between one-half and
three-quarters of those polled would want to donate their qwn organs'after death
(Caplan and Bayer, 1985). People'are more likely to report being willing to donate
their loved ones organs than their own (62.5 percent vs. 49.3 percent in Evans
and Manninen, 1988)

Some studies in the early 1980s showed consent to donation rates as high as 80
percent being obtained by some OPOs (Prottas, 1984). But more recent studies
indicate that there may be a serious gap between hypothetical responses and real
world behavior. Health care professionals report that roughly three-quarters of all
families they approach are very likely or likely to refuse (Caplan and. Virnig, 1990).
Some States report consent rates:at 15 percent or less (Edwards, Ohio Department
of Health, 1991).

The disparities reflect inaccuracies inherent in asking questions about hypothetical
behavior. For example, a frequently cited reason for the disparity between
willingness to donate their loved ones' organs and their own is based on the fear
that their families will allow their organs to be removed before they are `really
dead' Kaplan, 1992).

Some of the disparity between the small proportion of people who report carrying
donor cards and the larger proportion who report being willing to donate their
organs can be attributed to uncertainty about the donation process (Manninen and
Evans, 1988). Some people, while sympathetic to transplantation, appear not to
have actually thought about the donation process (Nolan, 1989).

Among families who have actually donated a relative's organs surveys reveal that
they overwhelmingly did so from the belief that something positive would come
out of a tragedy. They also felt that donating helped them in their grieving process

206


and they were motivated by the hope`that someone else might live. Of the
families who have donated, 89 percent report they would do so again (Prottas and
Batten, 1986).

Questions of allocation are important to the public,--black and white alike. Evans
and Manninen (1988) report that over 88 percent of those surveyed were
concerned that `organs be distributed fairly and equally,' and over 81 percent
reported that `medical need, not social or economic factors should be the only
criterion used to select transplant recipients.' Likewise, Watts (1991) reports that
participation in organ donation programs is inhibited by doubts about fairness in
the allocation of organs and tissues.

public opinion polls support the hypothesis that blacks are less sudportive of
donation than whites (Callender, 1989; Watts, 1991). There are several possible
explanations for this cultural difference. One study suggests that there may be a
tendency for white health care professionals to be less willing to ask black families
to donate (Maximus, Inc., 1985). Callender (1989) suggests that blacks are less
likely to donate because of a lack of awareness'about transplantation, religious
fears, distrust of the medical community, fear that donors will be declared dead
prematurely, racism (blacks do not want to give their organs to non-blacks).
Interestingly, similar reasons are cited in explaining low donation rates generally
(Basu, 1989, Watts, 1991). Among the reasons cited for a lack of willingness to
donate are: religious objections (Watts, 1991), a fear that they will be allowed to
die prematurely, (Nolan, 1989; Watts, 1991), a desire to bury the body intact
(Nolan, 1989) and uncertainty about whether anyone wil! really benefit from
donation or that everyone has a fair chance of benefitting (Watts, 1991).

In recent years, social scientists have studied the factors influencing people's
views regarding organ donation and their decisions to sign (or not sign) an organ
donor card. These studies show that:

1.   Persons of color are somewhat less enthusiastic about transplantation
  and are less likely to sign donor cards than are whites. In a recent
  survey (Gallup, 1991 for Partnership for Organ Donation) 76 percent
  of whites and 45 percent of blacks say they would be likely to
   donate.

2.

Favorable attitudes toward donation are also more common among
women, persons with a higher socio-economic status, greater
education, and serious health problems. A variety of psychometric
studies show that people who are more materialistic view their organs
as more central to their sense of self. Interestingly, some studies
suggest that patients are more likely to donate when told about the
benefits to themselves rather than emphasizing the benefits to others.

207


3.

Despite the generally positive public opinion toward transplantation
and donation, at most only a quarter of the public has signed an organ
donor card. This rate is especially low among teenagers and young
adults. A variety of explanations for this relatively low percentage
have been offered including:

a)

People do not fill out organ donor cards-because to do so would
make them aware of their own mortality (Watts; 1991).

b)

People's positive views regarding donation are outweighed by
their fears concerning organ donation. The most common
concerns are being declared dead prematurely so that organs
may be procured for others and the fear of mutilation. One
study found that two facts about death - the attitude toward
death and the fear of being declared dead too soon - are

predictive of organ donation behavior with respect to carrying a
d&or card.

cl

There is growing evidence that people's concern regarding the
fairness of organ distribution adversely affects the decision to
sign donor cards (Watts, 1991).

d)

Donor cards are not where the public wants them. A recent
public opinion poll. found that a substantial minority did not
know where to obtain donor cards; they are not available in
health care facilities where the public expects to find them
(Watts, 1991 I.

Empirical inquiry via polls, surveys, and studies reveals high levels of public
understanding about transplantation and relatively high levels of general support for
transplantation. On the other hand, respondents to surveys are more likely to say
they would be willing to consent to the donation of an organ by a relative than
they would be to donating their own organs or tissues. There are many fears and
doubts about the process of donation which seem to trouble large numbers of
Americans. Most importantly, the hypothetical levels of support are not born out
in practice either with respect to the number of Americans who have donor cards
or with respect to the number of families who actually give their consent to
donation when a death occurs.

gr clan Donor Cardg

Forty-five States allow people to indicate organ donor status on their. drivers
licenses (Overcast, 1984). The proportion of persons reported in the literature as
carrying a donor card varies, ranging from less than 8 percent (Bermel, 1984) to

208


over 37 percent. (Basu, 1989). Data consistently indicate that more highly
educated people are.likely to report .carrying a donor card (Simmons, Bruce,
Bienvenue and Fulton, 1974; Mannienen and Evans, 1985; easu, 1989). Some
studies have also found that younger people and women are more likely to carry
donor cards (Simmons, 1974; Lewis, 1986).     

The actual value of organ donor cards in obtaining organs is unclear. Some
suggest that their primary value is encouraging discussion with families, rather
than as an indicator of patient's wishes at the.time of death (Prottas, 1983;
Caplan, 1984). Others have noted that physicians and nurses very rarely look for
donor cards prior to making requests of families, and that the presence or absence
of a donor card is not overly influential to health care professionals. (Caplan, 1984;
Overcast, 1987).

There are other important limitations to donor cards' ability to increase donation.
The most important limitation is that most organ procurement agencies will not
procure organs without family consent, regardless of the p.resence of a donor card.
Overcast et al:, (1984) surveyed OPO and district attorney offices in all 50 States
and the District of Columbia to determine the extent to which donor cards were
effective in obtaining organs. Few donors were known by hospital personnel to be
carrying cards at the time of death. Caplan informally. polled groups of OPO and
tissue bank personnel in 1984 and 1985 and found no reported instance in which
an organ or tissue had been procured solely on the basis of a donor card. Despite
the legal sufficiency of donor cards, misunderstanding of existing State laws plus
the fear of adverse publicity has led hospitals to de facto require family consent
prior to donation.

Cards do not seem to be effective as a means to facilitate donation. However,
they may play a pivotal role in influencing the attitudes of family members if they
are approached about donation.

The Performance of the Current Svstem for Obtainina Oroans and Tissues

There are many steps in the process of procuring organs. These include:

1.  a traumatic injury or accident occurs
2.   resuscitation efforts are made
3.  transfer to hospital
4.   treatment attempts
  recognition of the inevitability of death
5.
6.  recognition of potential donor status
7.  decision to cease treatment efforts
8.  discussion with family of imminence of death

209


9.  diagnosis and declaration of death

10.  discussion with family concerning donation
11.  request to family for donation
12.  consent
13.  establishment of donor suitability '
14.  notification of OPO for procurement
     (adapted fr.om Waltzer, 1983)

All of these steps `must occur in the order described for procurement to happen
under the laws, regulations, and practices that currently control cadaver organ
procurement. Tissues differ in that the sequence begins with the pronouncement
of death. Modifications can be attempted at any one of a number,of points in this
sequence in the attempt to `elicit increases in organ and tissue procurement. We
will only focus on four especially crucial stages in the sequence: identification of
donors, discussion of donation with donor families, obtaining consent, and the
procurement of organs concurrent with OPO identification.

Identification of donors

The donation of internal organs such as liver, heart, kidney, and lung is restricted
largely to brain dead, heart beating cadavers. Thus, most organ donors are found
in hospital Intensive Care Units (ICUs), having suffered an acute catastrophe such
as.a car or gunshot accident, a drug overdose, or a cardiac arrest. Tissues, such
as cornea, bone, and skin, can be obtained within 6-24,hours of a cardiac arrest.
In many cases those who could-not donate organs may be eligible to donate
tissues since organs are currently taken only from those pronounced brain dead.

There is some disagreement about the frequency with which organ donors are
distributed in acute care hospitals. Some studies indicate that the majority of
prospective organ donors cluster in hospitals which hand.le high volumes of trauma
(Partnership for Organ Donation, 1990; Garrison, et. al. in piess). Other studies
indicate a much broader distribution of prospective organ donors (Nathan, et. al.,
1991) throughout various sizes and, types of hospitals. Potential tissue donors are
generally thought to be widely distributed throughout the acute care hospital
system.

A recent study of the size of the potential donor pool in a large eastern State
showed that the number of donors was between 38 and 55 per million population
(Nathan, et. al., 1991). This was estimated to be about three times the rate
currently procured nationwide. Other research suggests that patients admitted
because of traumatic intracranial injury were identified as possible donors most
frequently while patients suffering vascular or anoxic catastrophes were identified
less frequently. Unidentified donors had bee,n admitted to three major services

210


(neurosurgery, neurology, and internal medicine). The percentage of `missed'
potential donors was highest among internists.                             

Unrecognized donors tended to be older and had longer hospital stays,
Interestingly, there was no clear influence of hospital size, trauma center
designation, or the number of KU beds on the number of missed .potential donors.

Health care professionals fail to- identify medically suitable donors for a variety of
reasons (Toole, 1983). Failure may result from the lack of a comprehensible
hospital policy clearly designating the health care professionals responsible for
assessing patient's medical suitability. Some .hospitals require that attending
physicians or their designees carry out this task, but make little effort to educate
physicians.

Health care professionals' lack of knowledge may decrease their ability to identify
eligible donors. Some doctors and nurses have trouble understanding or accepting
the concept of brain death. In one study only 35 percent of 195 physicians likely
to be involved in procurement correctly identified the legal and medical criteria for
brain death (Youngner, 1989). Some ICU nurses and physicians are uncertain
about the validity of brain death (Martyn, Wright and Clark, 1988). OPO directors
claim that in roughly 12 percent of cases, brain death is either unrecognized or
recognized but not declared.

Other studies have documented a more general lack of knowledge regarding
procurement criteria (Diamond, Campion and Mussoline,. 1987). In one study
roughly one-half of ICU nurses said that doctors were unaware of donor eligibility
criteria and one-third said that nurses were unsure (Prottas and Batten, 1988).

Problems of donor identification may relate less to a lack of knowledge or
responsibility than to lack of time or interest. Other responsibilities may be more
salient to health care professionals than determining donor eligibility (Robinette,
1985). Nurses are especially likely to feel too overburdened with other
responsibilities to spend a great deal of time identifying potential organ donors
Kaplan and Virnig, 1990).

Discussion of donation with families

Numerous studies over the past decade show that a relatively small percentage of
hospitals were responsible for supplying a large percentage of organs and tissues.
For example, one small study found out that one-third of 105 hospital patient
deaths were eligible to donate corneas, but that families' were approached in only
16 percent of cases. In a recent survey of neurosurgeons, over two-thirds were
hesitant to cooperate with organ procurement because they feared speaking with
families.

211


A study of organ procurement in a trauma population in Vanderbilt Hospital from
1984 through 1987 revealed that 23 percent of eligible donors were not asked to
donate. Why is there such resistance to approaching family members. to discuss
donation?

First, in many hospitals no person or group of persons is clearly responsible for
talking with families about organ and tissue donation (Captan and Virnig, 1990).
Consequently, families may never be approached about donation.

Second, health care professionals who do discuss procurement with families may
be uneasy about performing this task or lack training as to how to do so.. One
study found that 50 percent of health professionals reported that their fear of
upsetting a grieving family inhibited their initiating discussions. Other health
professionals were concerned about the amount of time such discussions require
(Robinette, 1985). Another study found that 20 percent of ICU nurses had
strongly ambivalent feelings about the organ procurement process which may
interfere with their ability to discuss donation (Sophie, 1983). In some instances
physicians and nurses are reluctant to approach families when they feel a sense of
guilt or responsibility for the death of their patient. This `is especially so in the case
of children and newborns. Finally, concern regarding legal liability is common
among physicians and may also affect discussions regarding donation (Prottas and
Batten,- 1988).

Consent

Although, as noted earlier, numerous public opinion polls report that families are
`willing to donate their relatives' organs, these polls and surveys do not provide
accurate predictions of actual behavior.. As Manninen and Evans (1985) note,
people are likely to want to respond positively to a hypothetical question about
donation because of the high value our society places on voluntarism and altruism.

In fact, family refusal to donate is a key, reason procurement efforts failure.
Nathan, et al. (1991) found that between 29 and 39 percent of the unrealized
potential donors were attributable to family refusal. Studies which have directly
examined potential donor families' willingness to donate find that between 23
percent and 63 percent of families consented to donation. According to a 1989
survey of OPO Directors, 38 percent of donors are lost due to family's refusal to
consent--the most frequent barrier to procurement.

Fewer studies have examined the situational factors affecting the procurement of
tissue and organs. These include the surroundings in which the request takes
place and the attitudes of hospital personnel approaching the family. Anecdotal
accounts claim that a brusque approach or one that consists of nothing more than
the mere invocation of a State or Federal requirement are unsuccessful in obtaining

212


consent (Perkins, 1987). Others feel that confusion and equivocation regarding
the declaration of death is likely to ,result in confusion regarding the patient's
condition, decreasing the likelihood that the family will donate (Caplan, 1988;
Wikler and Weisbard, 1990). Asking in the presence of family and friends or in an
informal, quiet, private setting also appear to be dissociated with higher rates of
family consent (Simmons, 1987).

Recent data suggest that an .especially critical determinant of consent is the timing
of a request relative to the pronouncement of. death. There is reason to think that
there is a real need to delay requests for donation until after the family has
acknowledged the death of their loved one; In a retrospective study, University of
Kentucky researchers found that 53 of 93 families agreed to donate,.if they had
clearly understood that their loved one was dead before they were asked. When
the request for donation accompanied the notification. of death only 11 of 62
families consented to donation (Garrison, et. al.., forthcoming).

The identity of the person who interacts with the family may also be important.
Researchers at Vanderbilt Medical Center found that families were more receptive
to donation requests when they were asked by health care professionals with
whom they had a good rapport. Pre-existing factors such as the requestor's
professional background and training, race, and personal characteristics may also
influence the effectiveness of requests for donation.

Some have argued that organ procurement agency personnel, because of their
greater expertise and interest, are more likely to obtain family consent (Prottas,
1990). Others feel that the mpst important determinants of consent are social.
demographic factors or the circumstances surrounding the patient's death.
Unfortunately, there is no systematic data concerning the factors associated with
family consent.

Little is known about why families refuse to donate. Their refusal may reflect a
conscious rejection of altruism and voluntarism. On the other hand, families'
refusal may be the result of inadequate communication and misunderstanding.
There is some evidence that many families who refused, when approached long
after the patient's death, had changed their minds and wish they had donated.

Procurement of organs and OPO contacts

After the family consents to donation, care must be taken to support the heart
beating cadaver until solid organs can be retrieved. A recent British study revealed
that a significant percentage of organs were lost because the patient's heart
stopped before organs could be procured. It is not clear what factors, financial or
otherwise, influence a hospital's decision to institute a brain death protocol.

213


There are currently 69 HCFA-certified organ procurement organizations ,in the
United States. Individual OPO rates of cadaver organ procurement range from a
low of 5.6 donors per million to a.high of 32.5 per million. .There is little
explanation for these differences in OPO performance (Nathan and, Jarrell, 1991).

There is some evidence available that hospital personnel.historical$ have been
uncertain about exactly which OPO to contact regarding procurement. As the
number of OPOs has consolidated, this problem is decreasing at least in some parts
of the country. However, hospital personnel.still report confusion in deciding who
to contact among organ, cornea, skin, and other kinds of tissue banks. Moreover,
their confusion is increased by variations in the eligibility standards used by these
agencies. In some parts of the United States agencies do not do a good job of
referring potential donors among themselves.

Another source of complaint by hospital personnel and some donor families is that
OPOs and tissue banks do not always do a good job of follow-up to report on what
happened to donated organs and tissues. While many OPOs and tissue banks
insist that letters and other contacts are made to let those involved in donor
identification and maintenance know the results of their efforts there is at least a
groundswell of anecdotal reporting that says these attempts are not effective.

Clearly, each of the steps in the donation sequence can be impeded or derailed by
many different factors. While the opportunities for change are numerous, the risk
of unintentionally harming or compromising the requisite sequence of events is
high.

The lmoact of Required Reauest/Routine lnquirv Leaislation

One of the most significant attempts to modify public policy on organ and tissue
donation during the past 10 years has been the creation of State and Federal laws
mandating hospital personnel to make requests. This policy, while respectful of
the value base of donation, decreases the autonomy and freedom afforded health
care professionals in the hope that b.y asking for organs and tissue more
voluntarism and altruism will be forthcoming.

Unfortunately, little data exist documenting the effect of this public policy on the
procurement process. In part this is a function of the fact that organ and tissue
procurement do not exist in a vacuum. A variety of other changes including shifts
in the organization and number of organ procurement agencies, changes in laws
governing drinking and seatbelt use, gun control measures, the proliferation of
emergency services, and the rise of the AIDS epidemic makes it difficult to analyze
the specific impact of a required request policy. In part, the lack of study is a

214


function of the fact that the laws. are so new that it will take time to see their
impa.ct.

Capian and Welvang (1989). polled health departments; eye banks, organ
procurement agencies, and hospitals in the first 10 States to pass required requ.est
laws. While most reported increases of 20 percent or more in the number. of
cornea, skin, and bone donors since the enactment of required request -laws, the
increase was still substantially less than might have been expected based on the
estimates of eligible donors. Organ donation increased 10 to 20 percent in four
States surveyed, while in the remainder, the number of donors was constant or
decreased. The reasons for this disappointing response varied from `poor
compliance, to the absence of formal training programs, to problems in developing
a workable method to monitor requests and donations.

Data from individual States on the impact of required request policies is quite
varied. New York has some information available because its law required the
State health department to report to the legislature on the effects of required
request by July 1987. In 1986, heart donations increased by 94 percent, livers by
96 percent, and.kidneys by 23 percent (Miller, 1991). There was a 58 percent
increase in eye donors and skin availability increased by 180 percent (Miller,
1991). Oregon also reported dramatic -increases in cornea, bone, and skin donors
and a slight increase in organ donors during this same period.

The State of Ohio has attempted to monitor the impact of its required request law.
Organ donation in Ohio increased nearly 50 percent during the first 6 months the
law was in effect. However in subsequent years donation levels remained
stagnant. In 1989, the third year of required request, a serious effort by the health
department to enforce compliance' by hospitals resulted in a 24 percent increase in
the number of livers, a 30 percent increase in kidneys, and a 74 percent increase in
cornea donors (Edwards, 199 1).

In other areas the data is more discouraging. Both Los Angeles and San Francisco
reported temporary increases in referral following the passage of required request.
laws but the number of donors stayed the same. In Tennessee, the total donor
referrals increased in the year following implementation of required request laws
but fell to pre-required request levels over the next year. New Jersey's enactment
of. a strong required request law did not result in a statistically significant change in
organ procurement. Although there was a large increase in the number of
referrals, the number of families consenting to donation decreased. Minnesota saw
a rapid increase in cornea and skin donors in the month in which the State's
required request laws went into effect, but a negligible impact on organs.

The reasons required request laws have not fulfilled expectations are not well
understood. With rare exceptions, the majority of studies have not empirically

215


examined the problems of donor procurement as a process constituting several
steps, each of which is affected by structural and organizational variables as well
as by health care professionals attitudes. Assessments of the policy have tended
to focus almost exclusively on organ donations to the exclusion of tissue
donations.

Probably the critical factor.behind the failure to obtain an immediate response to
the creation of State and Federal laws was the poor record`of hospital compliance
with those laws (Capian and Welvang, 1989; Caplan and Virnig, 1990). In th.e
past year there is some evidence that more hospitals are beginning to comply with
the new public policy and that more health care professionals are asking about
donation. This is born out by the latest figures from the AOPO and' UNOS which
show significant increases in the number of organs available during the' past year
(Caplan, 1991 I.

Localism

Some transplant surgeons and OPO officials argue against creating a single national
list for allocating tissues and organs, claiming that people donate with the intent
that the donation will benefit someone from their region or State (Edwards, 1991).
A preference for localism and regionalism is often cited by transplant surgeons and
procurement personnel from States which are net exporters of organs and tissues
on the grounds that a `neighbors first' policy is of concern to donors. Yet there is
little empirical evidence to support the claim that localism, while important to
transplant centers, is important to donors or donor families.

OPOs and tissue banks

Since organ procurement agencies began to operate on a large scale about 15
years ago, there have been two distinct organizational forms: .hospitaI-based and
independent. For most of the history of organ procurement, hospital-based OPOs
have predominated. As late as l-982, two-thirds of OPOs were hospital-based.
These hospital-based OPOs are usually located in a Department of Surgery, or
Division of Transplantation, are generally under the direct supervision of the
transplant surgeon, and are often staffed by nurses previously employed at the
hospital's transplant service. Hospital-based OPOs generally tend to serve only the
transplant hospitals in which they are located whereas, free-standing OPOs are
separately incorporated entities providing only procurement services. They also
serve several hospitals. Independent OPOs are larger than hospital-based ones and
have more full-time as opposed to part-time employees. They have been a more
effective segment of the organ procurement system (Prottas, 1989).

Nonetheless, larger does not necessarily mean more efficient. The 16 largest
OPOs, servicing 85 million people, had retrieval rates of less than 5 donors per

216


million and 13 other OPOs covering 4 million inhabitants had retrieval rates of 10
donors per million. The national average donor retrieval rate was 16 donors per.
million. The most s.uccessful procurement organizations in the nation had retrieval
rates of 30 to 35 donors per million (Nathan and Jarrell, 1991). These were
generally small OPOs covering populations of a few million people, and operating
almost exclusively at the local community level in close contact with their
transplant centers (Rapaport and Anaise, 1991).

The National Organ Transplant Act of 1984 was the first federal legislation
designed to organize; control, and establish accountability in organ donation and
transplantation. This legislation mandated the formation of the Organ Procurement
and Transplantation Network (OPTN). A T&k Force was commissioned to examine
and report on pressing issues in the field of transplantation, such a& networking for
organ sharing, education, procurement, research, and patient access to transplant
services (Rogers, 1989). The Act established a grant program for the
establishment, initial operation, and expansion of qualified organ procurement
organizations. The Act requires OPOs to establish procurement agreements with
hospitals located within their service areas. Professional responsibilities of OPOs
include public and professional education, procurement, and preservation of
donated organs, allocation of donated organs according to established protocol,
and coordination of activity with other transplant programs (Rodgers, 1989).

The United States operates the largest organ procurement system in the world.
Medicare has been the main source of financing for OPOs since the passage of the
End-stage Renal Disease Act in 1972. There are currently 69 federally funded,
HCFA-certified organ procurement organizations, a significantly smaller number
than the 90 which existed in 1985; Fifty OPOs are independent free-standing
organizations; the rest are hospital-based. All OPOs are non-profit organizations or
part of not-for-profit organizations or hospitals. With minor exceptions, every
region in the United States is served by an OPO (Abt Associates, 1990) since there
are OPO arrangements with over 4500 community hospitals. In 1988, the number
of procurement organizations decreased for the first time as. a result of Federal
pressure to consolidate a number of these agencies. Many of these OPOs have
been restructured as free-standing entities (Prottas, 1989).

Federal law does not mandate the relationships which should exist among hospitals
and health care professionals and procurement organizations, namely, OPOs, tissue
banks, and eye banks. Although no formal survey has ever been conducted that
systematically examines this question, anecdotal evidence supports the claim that
the structure and nature of these relationships varies geographically.

The Omnibus Budget Reconciliation Act of 1986 (OBRA) was another step in the
process of institutionalizing, refining, and regulating organ donation and
transplantation, inclu,ding the relationship between the potential source of body

217


parts (i.e., the. hospitals) and the agents of procurement and distributi0.n (Le., the
OPOs). OBRA, institut/onalizing required request, mandated that hospital's
receiving Medicare and Medicaid must establish written protocols that reasonably
assured that families of potential donors will be offered the option of donation, and
that the appropriate regional OPO will be notified of all potential donors.

Moreover, institutions that perform transplant procedures must participate in and
abide by the rules of UNOS, a private, nonprofit, national organ sharing
organization authorized by the OPTN to facilitate the equitable distribution of
organs. For OPOs to receive reimbursement for costs associated with organ
recovery, the organization must be certified as qualified by the Secretary of Health
and Human Services. Thus, OPOs are required to participate in UNOS and to abide
by its policies. Only one OPO per service area is designated by.the secretary.
Failure to comply with the statute means revocation of Medicare funding (Rodgers,
1989). This has encouraged hospitals and OPOs to work together to procure solid
organs.

During the late 1970~ and early 198Os, concern increased over the allocation
policies used to distribute donated organs.  UNOS was awarded the contract to
fulfill the goals of OPTN, and today, develops the national policies of organ
distribution.  All potential organ recipients must be listed on the UNOS computer.
Organs are shared based upon a point system. The potential recipient with the
highest point rating will receive an available organ. The current point system tends
to emphasize the importance of need and medical urgency over prognosis
post-transplant.

There is no evidence that the general public is aware of the standardization of
allocation policies. This is a serious problem given the frequent concerns of
prospective donors and the general public about the degree to which the allocation
of organs and tissues is fair.

One significant difference between organ and tissue procurement organizations is
that the latter may be for-profit. The National Organ Transplant Act requires that
OPOs receiving Medicare funding be non-profits. The Act prohibits the sale of any
human organs but does not address tissue.

Most for-profit tissue banks are involved in the preparation, storage, and shipping
of bone implants or heart valve implants. The preparation of bone for medical use
requires expensive equipment and highly trained personnel and such tissue banks
require considerable capital outlay. Non-profit agencies.are less able to provide
these services. As a result they are more likely to have to compete for these
particular tissues with for-profit organizations. With the exception of bone
marrow, Congress is not extending Medicare funding to tissue banking activities.
As a result, for-profit tissue banks face little competition (Rodgers, 1989).

218


Much of the controversy surrounding for-profit tissue banking is ethical in nature.
Donors and donor families voluntarily give their anatomical gifts. Most are
stimulated by altruistic feelings, the belief that a part of them lives on or the death
of a loved one is not in vain,. It is questionable how these individuals would accept
the knowledge that their gift was resold at a profit to somebody else. Public anger
over stories (Gaul, 1990) detailing the ways in which voluntarily donated whole
blood is resold and reprocessed into saleable products suggest that the reaction
would not generally be positive.

However, until non-profit organizations provide equal services, for-profit tissue
banks seem secure, provided they do not violate the Federal prohibition on the
purchase of organs or any applicable State laws dealing with the sale of organs.
The reality is that hospitals and surgeons demand these tissues in trehting their
patients and, to date, the for-profit sector of tissue banking has been the only
sector capable of meeting the demand.

It is also true that organ distribution remains heavily controlled by the individual
transplant centers. Only a few years ago, transplant centers that could not use an
organ they retrieved would, on the basis of private conversations, send that organ
to another center. That center might be in the same State, another State, or for
that matter, in another country. Local discretion over distribution of organs is no
longer allowed. The OPTN requires that centers and OPOs have formally stated
criteria governing the distribution of organs and that OPOs use the national organ
center for distributing any organs they cannot use within their own service areas.

Through the OPTN's local use policy, the 250 transplant centers are. allowed to
retain almost all the organs they have retrieved. They enter into cooperative
agreements with an OPO or other centers only at their own volition. If they wish,
they can make arrangements concerning the distribution of organs with the donor
hospital and/or an OPO in other service areas. The distribution system is also
localized in the sense that most organs procured in a service area never leave that
area. These arrangements represent institutional agreements between hospitals
and OPOs. However, we know little about the key relationship; that is, the
interface between OPOs and the health care professionals upon whom the OPOs
depend to identify potential donors.

Many OPOs make themselves visible to hospital personnel through providing
educational "in-services" with hospital staff, especially nurses. Many hospitals
now have standing committees or designated staff who are specially trained to
deal with donation issues. To make all hospital personnel aware of the OPOs'
activities, hospitals often post stickers, posters and incorporate information about
the donation process into their procedural manuals. Hospitals also often enter into
voluntary agreements with OPO staff. For example, some hospitals have
volunteered to inform their local OPOs about every hospital death. The OBRA Act

219


of 1986 and the passage of State laws which required that hospitals formulate and
carry out a required request protocol have no,doubt acted as catalysts for these
agreements.

Communication among OPOs, tissue banks, and eye banks varies according to
locale. There is very little communication between those involved in the newly
created National Marrow Donor Program and other organ and tissue organizations.

In certain regions, there are close relationships between OPOs and tissue banks,
with the organizations working as a team. For instance, a central office might take
all calls concerning donation and advise on eligi,bility for solid organs., tissues, and
corneas. In other regions, these organizations are more atomized. Hospitals may
find themselves dealing with three, and sometimes more, organizations. The
advantages or disadvantages of a unitary vs. individual procurement system are
unknown.

Exoerience of Other Nations with Oraan and Tissue Donation.

Most nations in the western world have made a strong commitment to the same
moral foundation of cadaver organ transplantation, voluntarism and altruism, as
has the United States. The system of donation in Canada, Holland, the United
Kingdom, Australia and nearly all of Central and South America is very similar to
that which exists in the United States.

Some nations which operate with a voluntaristic, altruistic values foundation and
an opt-in, donor card approach to cadaver donation have resisted the formal
recognition of brain death, i.e., Japan, Denmark. However some others with
similar dominant value frameworks have recently enacted brain death laws or
witnessed their courts affirm this definition i.e., Israel, Sweden.

Some nations have decided to pursue an opt-out policy of routine salvage or
presumed consent. France enacted a presumed consent law in 1976. Austria has
had what amounts to a routine salvage policy for nearly 100 years with a
reaffirmation of this policy taking place in 1988. Belgium moved to institute a
presumed consent policy in 1988. Also in 1988, Singapore instituted a donation
policy wherein those willing to serve as donors would receive priority of access to
transplants as against those who were not, for whatever reason, willing to list
themselves 3s potential cadaver donors.

Following enactment of its presumed consent law, France saw a small increase in
kidney donation but most of the increase has been used to decrease the number of
kidney transplants involving living donors so there has been no overall increase in
transplant `rates. Austria saw a significant increase in kidney availability in the year

220


following enactment of its law but organ availability fell significantly in 1990
                                              
(Eurotransplant, 1991).

A few nations permit financial incentives for living donors including India, the
Pnilippines, and Brazil. No nation appears to allow.financial rewards with respect
to cadaver donation though there have been recent reports of payment for both
live and cadaver kidneys emanating from China, Haiti, and. Hong Kong (Crosette,
New York Times; 1991).

Distribution of organs and some tissues is handled on a regional basis in Europe.
The Benelux countries and Germany cooperate with one another through the
Eurotransplant Foundation. A similar regional group exists for Scandinavia.

Most European countries do not have specialized personnel serving as organ or
tissue procurement specialists (Prottas, 1984). But this may be changing as at
least some countries, i.e., Sweden, are moving toward the creation of organ and
tissue procurement specialists.

Conclusions and ODtion3

lncieasing Public Knowledge and Encouraging Altruism

Polls indicate many Americans still have reservations about the effect of organ and
tissue donation on a cadaver. Public education efforts co.uld be mounted which
specifically address concerns about mutilation and destruction of the cadaver.
Similarly, educational campaigns could be undertaken to assuage public concerns
that prospective donors will not receive aggressive treatment and that organs and
tissues are fairly and equitably distributed among those in need. These efforts
need to involve the mass media which, in recent years, has conveyed erroneous
and frightening images to the public about organ donation in a number of prime
time, popular television programs and movies. And continuing efforts need to be
undertaken to inform the public about the brain death standard and the tests used
to establish that brain death has occurred.

Donor Cards

A variety of strategies are available for trying to increase the percentage of
Americans who carry donor cards. All persons applying for licenses could be
required to select a donor status as a condition of licensure. Or all persons
admitted to hospitals or nursing homes could routinely be asked about their donor
status as part of the Patient Self Determination Act of 1990. State provisions
requiring two witnesses to validate a donor card could be modified. Videotapes

221


and educational materials could be created which target high school and college
age persons about the importance of donor cards.

OPO and Tissue Banks

Efforts could be made to help consolidate the relatidnships that exist between
procurement organizations and hospitals. If a multiplicity of procurement
organizations.proves confusing to hospital personnel in terms of understanding
donor eligibility or whom to call for help, then OPOs could be encouraged to create
`one stop' hot lines for contacting all procurement organizations through a single
telephone number. The need for clear, unambiguous, current and uniform national
eligibility standards must be addressed to see whether uncertainty and confusion
about OPO and tissue bank standards can be reduced.             s

There is some evidence available (Caplan and Virnig, 1990) that hospital
administrators are poorly informed about organ and tissue donation laws,
regulations, and policies. Moreover, administrative responsibility for monitoring
institutional performance with respect to donation is not always clearly assigned
and is not routinely a part of licensure and accreditation requirements in many
areas.

`It is important that competition among organ and tissue banks and between tissue
banks be kept to a minimum. Continuing attention needs to be paid to the domain
of tissue procurement especially in light of the tension that exists in some parts of
the country between profit and not-for profit tissue banks.

OPOs and tissue banks need to be encouraged to focus their educational efforts on
donor identification and the proper techniques for making requests. In their
educational efforts, some OPOs and tissue banks do not attend to the early stages
of identification, eligibility, and requests to families in ways that reflect current
empirical studies about how best to handle these issues.

OPOs and tissue banks need to understand the importance of adequate feedback
to both hospital personnel, administrators, and donor families. These organizations
must also realize that the general public does not distinguish between tissue and
organ transplantation (they are seen as the same) so that inappropriate or negligent
behavior on the part of one procurement organization adversely reflects upon all
others.

Expanding the Pool of Cadaver Donors

One possible strategy for increasing the number of organs and tissues available is
to increase the size of the cadaver donor pool. This could by done by instituting
efforts to improve the identification of brain dead patients. A variety of studies

222


show that between a third and two-thirds of eligibie patients either are not
identified as eligible, or their families are not approached for donation. Strenuous
educational efforts as well as monitoring could be instituted in certain key hospitals
in order to make sure that all potential brain dead donors are identified.

Efforts could be made to identify institutions where brain dead patients are likely to
be. There is still much controversy over which hospitals and trauma centers are
likely to see the. largest number of potential donors. Similarly it is not known
which sorts of institutions are most likely to have potential tissue donors.
Identifying such institutions would help focus .educational and training efforts
concerning donor identification, interactions with families, and contacts with OPOs
and tissue banks.

Unrealized potential donors are disproportionately admitted to internal medical
services, have long lengths of stay, and tend to be older. These facts emphasize
the importance of educating internists regarding eligibility as well as neurologists
and neurosurgeons.

A recent study by a team of Welsh physicians suggests that it may be advisable to
think about the elective use of mechanical ventilation solely to permit organ
donation in persons who otherwise would have died. -In persons dying from
cerebrovascular accidents where life-support has not been used it would be
possible to institute a policy to ask families for their consent to the use of
mechanical ventilation in order to make organ donation possible.

Another strategy for expanding the cadaver donor pool would be to support
research on allowing the use of organs from persons who arrive at hospitals DOA.
It may be possible to develop preservation techniques that allow organs to be
salvaged in vivo. It will also be necessary to develop appropriate public policy and
consent procedures to accompany this sort of strategy.

It may be possible to make more efficient use of the cadaver donor pool than is
currently the case. For example, if waiting list allocation rules were to place less
emphasis on severity of illness and waiting time and more on likely prognosis, the
same number of cadaver organs might be able to save more lives. Similarly, if
more selective criteria were used in determining eligibility for transplants including
discouraging or prohibiting retransplantation or, in some cases, the use of assist
devices and bridging technologies, overall survival rates post-transplant might be
increased.

Improving Consent Rates

During the last 2 years there has been increasing evidence that families frequently
refuse health care professionals' requests to donate. Despite public opinion polls

223


showing widespread support for organ donation, family, refusal is a. barrier to
procurement. It is not clear whether this is a failure of voluntarism or a iesult of
health care professionals insensitively or inadequate explanations of the reasons for
organ donation. Without adequate empirical-information, it is impossible to
determine whether the appropriate public policy response is more training for
health care professionals, more public education, changes in the timing, setting or
identity of those making requests, or abandoning voluntarism in favor of a policy
that is more responsive to self-interest. .

Recent revisions in the UAGA suggest that hospitals ask all patients upon
admission about their organ donor status. Some States have enacted this
requirement into law. The Patient Self Determination Act of 1990. mandates that
all prospective patients be appraised of the importance of having a living will and
many of the standard forms of this document contain a provision regarding organ
donation. These steps may increase consent rates but there is some fear among
organ and tissue procurement professionals that asking at the time of hospital
admission is as likely to produce refusals as it is prior consent (personal
communication, 19911..

Health care professionals' attitudes about organ and tissue transplantation as well
as brain death need to be assessed and, if necessary, enhanced. This may
facilitate more enthusiastic compliance with existing State and Federal laws
regarding requests. Stronger efforts are needed to ensure compliance with existing
routine inquiry and required request laws prior to concluding that existing policies
are inadequate. Unfortunately, most State laws contain. neither provisions nor
monies to assure adequate compliance. Developing adequate methods of quality
assurance is an essential aspect of any public policy. We are quite encouraged by
efforts such as Nathan et al. to develop a computerized program which allows
OPOs to track hospital performance, identify outliers, and then investigate the
reasons for procurement problems.

Without clear data about the impediments to procurement, one cannot be
absolutely confidant which changes will improve the system. To date, studies of
donation have been piecemeal, focusing on only one part of the entire process.
Most studies have relied strictly on chart review or public opinion polls. The few
reports about actual consents or refusals rely on nonsystematic observations or
anecdotal reports. Only systematic data regarding the organizations, health care
professionals, and situational factors affecting organ/tissue donation will provide
the information necessary to improve the procurement process. It is essential that
further research be conducted on families who did and did not agree to donation to
better understand their motives, knowledge, fears, and feelings.

224


Policy Changes--required referral

Prottas and others have suggested requiring that OPOs be called about all deaths.
This might increase. identification of eligible donors and ensure that the health care
professionals who discuss the issues are adequately trained to do so. Information
regarding how such a proposal would work or evidence regarding its feasibility
should be required prior to this proposal's adoption. Would the organ procurement
agencies be called about all patients admitted to the hospital? To an intensive care
unit? Who would do the calling? What role should OPOs have in managing the
care of the "near brain-dead?" Would such a screening process be cost or time
effective?

The Use of Financial Incentives to Encourage Dqnations

There are a host of ideas about the ways in which families might be encouraged to
donate by appeals to self-interest. These inc1ud.e the payment of funeral expenses,
direct cash payments, discounts on estate taxes, or tax deductions to surviving
family members (Cohen, 1990, Peters, 1,991). .All such proposals need to be
closely evaluated on both empirical and philosophical grounds. Putting aside the
ethical concerns that financial incentives may raise (Pellegrino, 1991), there is no
empirical evidence that families will be more willing to donate if offered incentives
such as burial cost. Post hoc surveys of families who have agreed to donate or
nation-wide Gallup polls of what people say they will do in the abstract are not
predictive of what families will actually do when faced with these decisions. Nor
is there any empirical evidence to support the claim that a significant segment of
the American public either wants or expects financial incentives as a condition of
donation.

Prior to accepting any new proposals the Federal government could evaluate their
likely impact on donation through demonstration projects. Before changing our
deeply entrenched, national public policy regarding cadaver procurement, strong
empirical evidence is needed to show that these proposals will increase the number
of transplantable organs.

Presumed Consent and Routine Salvage

It may be possible to persuade Americans that it is more reasonable to presume a
willingness to donate and subsequently to construct public policy so that the
burden of proof falls upon those who wish to `opt out' of this presumption.
However, it is important to keep in mind that the nations which have moved
toward this type of public policy have encountered strong resistance from health
care professionals who are reluctant to take organs without routinely asking the
family about their willingness to donate. It is also important to keep in mind that

225


the increases in organ donation as reflected in kidney ,donations, have not been
especially impressive in France or ,Austria--two nations with long-standing public
policies of presumed consent.

Alternative Sources of Organs and Tissues to Cadavers

The demand for transplants will outstrip our ability to procure cadaver organs. The
number of heart beating cadavers is limited. Given the increasing success of organ
transplantation, it is likely that the number of organs needed will always be greater
than the number of potentially or even possibly available cadavers; It is therefore
imperative that the transplant community and public officials begin discussing
alternatives to cadaver donation.

There has been some discussion of broadening the definition of, or the criteria used
to determine, death. For example, some have suggested permitting the use of
different criteria for determining brain death in anencephalic infants in order to
facilitate their use as organ donors (Kaufman, ,1988). Others suggest that the
concept of donor be expanded to include persons in permanent vegetative states
(Cranford, 1989).

Increased reliance on living donors may be one way to respond to the shortage of
cadaver organs. Nearly one-third of all kidneys transplanted in the United States
are obtained from living donors. Some programs have turned to unrelated persons
as possible sources of kidneys. Transplant surgeons have also obtained bone
marrow, lobes of liver and lung, and segments of pancreas from living donors. The
use of living donors, especially those not capable of giving informed consent,
raises many complex ethical questions that will have to be addressed if live
donation is to expand as an alternative to cadaver sources.

Another strategy to increase the pool of organs and tissues available is to turn to
animal sources. There are obvious ethical, psychosocial, and public policy issues
involved in pursuing this alternative. Many Americans believe that it would be
immoral to kill animals, particularly primates, for the sole purpose of harvesting
their organs. Others note that the use of animals is currently so experimental that
informed consent procedures must be especially rigorous and peer review
exceedingly conscientious before any potential recipients can be recruited.

226


CCNCLUSION

The scarce supply of transplantable organs and tissues is the greatest challenge
facing transplantation professionals as well as those in need of transplants.
Unfortunately, changes in public policy or public education are not going to solve
the problem of donor scarcity. For the foreseeable future, modest increases in the
supply of human cadaver organs and tissues will not meet increases in the
demand.

However, we must continue efforts directed toward increasing the number of
cadaver organs and tissues that are available for transplant. Much .public and
professional attention has, in recent years;focused on the prospects for
dramatically changing existing public policy on obtaining organs and tissues. Some
believe that the United States either ought to permit a market of some sort in body
parts or should move toward a system of presumed consent where those who do
not wish to make their organs and tissues available would have to make their
objections known. However, public support and trust in the system of
procurement and distribution of organs and tissues plus deeply held values within
American society make radical change unlikely. Refusal rates to requests to
donate are in the 60 to .70 percent range or worse, and many major religious
groups insist that cadaver donation be based on altruistic choice. These realities
show that the prospect is poor for a shift to a public policy which has as its sole
moral concern an increase in the supply of cadaver organs and tissues.

Moreover, many aspects of the existing policy (permitting cadaver donation only by
a voluntary written directive from the deceased or consent of their next of kin or
guardian) can and should be examined before there is any attempt to drastically
alter that policy. The public needs more education concerning the concept of brain
death and the realities of organ distribution in order to persuade more persons to
donate. Health care professionals need to exert greater efforts to routinely identify
prospective donors and to make requests of their families. Medical examiners,
coroners, and funeral directors need to become more actively involved in matters
pertaining to donation. Organ and tissue procurement agencies must try to more
closely coordinate their efforts in both education and procurement. Government
and professional societies need to make sure that health care professionals
understand their obligations and responsibilities with respect to offering the option
of donation and in making sure that those gifts which are obtained are
acknowledged and handled with respect and fairness.

Scarcity is likely to be a reality in transplantation for the rest of this century. The
steps that are taken to minimize the problem must be cons&tent with the values of
autonomy, altruism, and voluntarism which have dominated American attitudes
toward the procurement of cadaver organs and tissues since the beginning of this
century.

227


References

Abt Associates, Inc. Evaluation of the Organ Procurement and Transplantation Network.
Cambridge, Mass, August 21, 1990.

American Council on Transplantation.  The U.S. Public's Attitudes To ward Organ Transplant/Organ
Oona tion, 1985.

American Red Cross, St. Paul, MN. Number of Potential Donors Rises. Tissues, Summer, 199 1: 3.

Anaise D, Smith R, lshimeru M, Waltzer WC, Shabtai M, Hurley S, Rapaport PT. An approach to
organ salvage from non-heartbeating cadaver donors under existing legal and ethical requirements
for transplantation. m, 49, 2, 1990:290-94.

Basu PK, Hazariwaza KM, Chipman ML. Public attitudes toward donation of body parts,
particularly the eye. av 1989; 24/51:2 16-9.
              n di n

Bermel J. Barriers to organ procurement: why donor cards fail. Hastinas Center Reoort, 14, 4,
1984:6.

Brahems 0. Kidney for sale by live donor. The Lancet 1989: 285-6

Callender CO. Organ donation in blacks: a community approach. Transolant Proceedinag 1987a;
19: 1551-7.

Callender CO. Organ donation in the black population: where do we go from here? Transplant
Proceedinas 19876; 19:36-40

Caplan AL. Organ transplants: the costs of success. H-t, 13, 6, 1983: 23132

Cepl8n AL. Org8n procurement: it's not in the cards. Hastinos Center Reoort, 14, 5, 1984: 6-9.

Caplan AL. Professional arrogance and public misunderstanding. Hastinas Center Reoort, 18, 2,
1988: 34- 7.

Caplan AL. Problems in the policies and criteria used to allocate organs for transplantation in the
United States.  Transolantation Proceedinos, 2 1, 3, 1989: 338 l- 7.

Caplan AL. "Assume nothing", Journal of Transolant Coordination, 1, 2, 1991: 78-83.

&plan AL, Bayer. Ethical, legal and policy issues pertaining to solid organ procurement.  Hastinas
Center..Emoire Blue Cross-Blue Shield, October 1985.

Caplan AL, Welvang P. Are required request laws working? Clinical Transplantation, 3,3, 1989:
170-6

Caplan AL, Virnig B. Is altruism enough? Critical Care Clinics, 6,4, 1990: 1007- 18.

Capron A, Kass L. A statutory definition of the standards for determining human death: an
appraisal and a proposal. gniversitv of Pennsvlvania Law Review, 87, 19 72: 98- 108.

228


Cleveland SE. Changes in human tissue donor attitudes: 1969- 1974. Psvchosomatic Medicine
3 7/4/, 1975-306-3 12.

Cohen LR. Increasing the supply of transplant organs: the virtues of a futures market. 58, 1,
Georae Washinaton Law Review, 1989.

Cohen LR. A market for increasing the supply of cadaveric organs. Clinical Transolantation,
forthcoming, 1992.

Corlett S, Robinette MA, Stiler CR. Public attitudes toward human organ donation. Transolant
Proceedinas, 17, 6, 1985: 103- 10.

Cranford RE, Roberts JC. Use of anencephalic infants as organ donors: crossing a threshold. In:
H. Kaufman, ed. Pediatric Brain Death and Organ Donation, New York: Plenum, 1987: 59-74.

Dukeminier J, Sanders D. Organ transplantation: a proposal for routine salvaQing of cadaver organs.
New En&and Journal of Medicine, 279, 1968: 413-19.

Edwards BC. Evaluating required request: lessons to date. Division on Organ Transplantation
Consensus Conference, Washington, D. C., 199 1.

Eurotransplant Newsletter. Statistics, 85, 4, 199 la: 1-2.

Eurotransplant Newsletter. Statistics. 86, 5, 199 lb: l-2.

Evans'RW, Manninen DL. Public attitudes and behavior regarding organ donation. Journal of the
American Medical Association 1985: 25312 II: 3 11 l-5.

Evans RW, Mannien LX. U.S. Public opinion concerning the procurement end distribution of donor
organs. Transplant Proceedinas. 1988: 20151: 78 l-5

Evers S, Farewell VT, Halloran PF. Publjc awareness of organ donation. Canadian Medical
Association Journal, 1988: 138:237-39.

Gallup. For partnership for organ donation, Americans and organ donation: current attitudes and
perceptions, 199 1.

Garrison RN, Eentfe y FR, Raque GH, Polk HC, et.al. There is an answer to the orQan donor
Shortage. Suroerv. Gvnecoloov and Obstetrics, forthcoming.

Gaul G. The blood brokers. The Philadelohia lnauirer, Sept. 24-28, 1989.

Gore. SM, Ross Taylor RM, Wallwork J, Availability of transplantable organs from brain stem dead
donors in intensive care units. British Medical Journal, 302, 199 1: 149- 152.

Holtkamp S, Nuckolls ES. The incomplete gift exchange. Journal of Transplent Coordination, 1,
1991: 31-5.

International Heart Transplant Registry (personal communication). 199 1.

John Paul II, Statement on organ donation. First International Congress for the Society for Organ
Sharing, Rome, Italy, June 2 1, 199 1.

229


Kandela P. India: kidney bazaar, The Lancet, 337, 199 1: 1534

Kaufman H, ed. Pediatric brain death and organ procurement. New York: Plenum, 1989.

Lee PP, Stark WJ, Yang JC. Cornea donation laws in the United States. A-of
$ph thalmoloav 1989; 107: 1585-g.

Martyn S, Wright R,' Clark L. Required request for .organ donation: moral, clinical and legal
problems. -center, ?8, 2, 1988: 27-34.

Maximus, Inc. Phase I report, Assessment of the Potential Organ Donor Pool: Literature Review and
Data Source Assessment. McLean, VA, 1985.

May WF, Attitudes toward the newly dead. Hastinas Center Studies, 1, 2, 1973: 10; 12.

May WF. Religious justifications for donating body parts. Hastinas Center Reoorr, 14, I, 1984: 38-
42.

May WF. Religious obstacles and warrants for the donation of body parts. Transolant Proceedinas
1988; 20/ 1): 1079-83.

McReavy D. OrQanic transplantation-a reported condemnation. The Clerov Review, 4 I, 1956: 764-
168.

Meyers DW. The human body and the law. Stanford, California: Stanford University Press, 1990.

Michigan Law Review, The Sale of Body Parts. 72, 1974: 12 15-28.

Miller T. The New York State experience with required request. Division of Organ Transplantation,
Consensus Conference, Washington, DC, 199 1.

Nathan HM, Jarrell BE, Broznik 8, Kochik R., et. al. Estimation and characterization of the potential
renal organ donor pool in Pennsylvania. Transolantation, 5 1, 1, 199 la: 142-49,

Nathan HM, Jarrell BE. National multi-center potential donor study. Presented to A HCPR, March ?8,
199 lb.

Nolan BE, Spanos NP. Psychosocial variables associated with willingness to donate organs.
Canadian Medical Association Journal 1989; ?4/:2 7-32.

Overcast TD, Evans RW, Bowen LE, et. al. Problems in the identification of potential organ donors.
JAMA, 251, 12, 1984: 1559-1562.

Overcast TD. Legal aspects of death and informed consent in organ Transplantation.  In Human
Organ Transplantation, eds., DH Cowan, J Kantorowitz, J Moskowitz, PH Rheinstein, Ann Arbor,
Ml; Health Administration Press, 1987: 55-80.

Partnership for OrQan Donation, Inc., Solving the Organ Donor Shortage, 7990.

Perkins KA. The shortage of cadaver donor organs for transplantation: can psychology help?
American Psvcholoaist, 42, 1987: 92 I-30.

230


Peters TG. Life or death: the issue of payment in cadaveric organ donation. JAMA, 265,
1991: 1302-5

Pius Xl. Casti Connubi, A.A.S., XXII, 1930: 33-4.

Prottas JL. Encouraging altruism: public attitudes and the marketing of organ donation. Milbank
Memorial Fund Quarterlv 1983; 6//21:278-305

Prottas JL. An effective approach to o.rgan procurement. Lecture Presented at the Hastings Center,
November 19, 1984.

Prottas JL. Shifting responsibilities in organ procurement: a plan for routine referral. JAMA, 260, 6,
1988: 832-3.

Prottas JL. Organization of American organ procurement. Journal of Health Policv, Politics and
Law, 14, 1, 1989: 41-55.

Prottas JM, Batten HL. Attitudes and incentives in organ procurement. Report to Health Care
Financing Administration, 1986.

Ramsey P. The patient as person. New Haven; Yale, 1970.

Robinette MA, Stiller CR. Summary of task force frndings. Transolantation Proceedinos, 17, 3,
1985: 9- 12.

Robbins RA. Signing an organ donor card: psychological factors. Death Studies, 14, 1990: 2 19-
229.

Rodgers St3. Legal framework for organ donation and transplantation. Nursino Clinics of North
America, 24, 4, 1989: 837-850,

Russell PS. Centers for transplantation-how many should we have? Suroerv 100, 5, 1986: 867-
76.

Sadler AM, Sadler BL, Statson E8. The uniform anatomical gift act. JAMA, 206, 11, 1968: 2501-
06.

Sadler AM, Sadler 8L. A Community of givers not takers. Hastinas Center Report, 14, 5, 1984: 6-
9.

Scott R. The Body As Property. New York; Viking, 1981.

Simmons RG, Klein SD, Simmons RL. Gift of life: the social and ps ychofogicaf impact of organ
transplantation. New York; Wiley, 1987.

Simmons RG, Bruce J, Bienvenue R, et. al. Who signs an organ donor card: traditionalism versus
transplantation. Journal of Chronic Diseases, 1974; 27: 49 l-502.

Sophie LR, Sallowa y JC, Sorock G, Voleck P, Merkel FK. Intensive care nurses' perceptions of
cadaver organ procurement. Heart and Luna, 12, 1983: 263-7.

Swerdlow JS. Matching needs, saving lives. Washington, DC, The Annenberg Program, 1989.

231


Task Force on Organ Transplantation. Organ Transplantation. Washington, DC: HHS, April, 1986.

Tufts A. Germany: kidneys. from Moscow. The Lancef 337, 199 1: 605.

Waltzer WC. Procurement of cadaveric kidneys for transplantation. Annals of Internal Medicine 98,
1983: 534-8.

Watts M. How people feel about organ donation. Lieberman Research, Inc., 1991.

Wolstenhome GEW, O'Connor M, eds., Ethics in Medical Progress with Special Reference to
Transplantation. London; Churchill, 1966.

World Health Organization, Guiding principles on human organ transplantation. The Lancer, 337,
1991: 1470-l.

Youngner SJ, Landefeld S, Coulton CJ, et. al. Brain death and organ retrieval. JAMA, 261, 1989:
220522 10.

232