Organ and Tissue Procurement: I. Medical and Organizational Aspects
I. MEDICAL AND ORGANIZATIONAL ASPECTS
Organ transplantation is high-technology medicine in one of its most extreme forms. It is very expensive, employs advanced biotechnologies, and requires large teams of highly trained specialists. It is used to intervene when the final stage of an illness is reached, and although it can save lives, it does not provide a "cure" or a return to a preexisting condition of health. Patients with transplants require constant, ongoing treatment with highly sophisticated and often quite dangerous medications.
But unlike most other advanced medical technologies, organ and tissue transplantation also depends on people. The only source of human organs and tissues is donations. In most instances these donations must be obtained from a young person who has died under sudden and tragic circumstances: by automobile accident, suicide, murder, and so forth. The organ procurement system's role is to provide a bridge between human tragedy and high technology.
The Supply of Organ Donors
During the first half of the 1980s the supply of cadaveric organ donors grew continually and rapidly. In 1982, there were 3,681 cadaveric kidney transplants. In 1986, there were 7,089, an increase of almost 100 percent (or almost 25% a year). Since 1986, the rate of increase has slowed. In 1992, 7,202 cadaveric kidney transplants were performed, representing donations from about 4,500 donors. In 2000, 8,089 cadaveric kidney transplants were done, representing 5,986 donors. According to the United Network for Organ Sharing (UNOS), the number of donors increased to 6,081 in 2001 and the number of transplants to 8,203. Although this was one of the largest number of organ donors in any year in U.S. history, the leveling out of the donor supply in the United States continues to cause disquiet and debate over the efficacy of the organ procurement system and the adequacy of the principles underlying it.
While organs have been transplanted in most nations of Western Europe, in Japan, and in some places in the Middle East, the infrastructure necessary to obtain organ donors routinely exists only in North America and Western Europe. (While Japan certainly has the necessary resources and expertise, cultural factors, including discomfort with brain death and a strong commitment to intact burial, have militated against the development of such a system there.) The Eurotransplant International Foundation, serving Germany, Austria, the Benelux nations, and Slovenia, is the second-largest organ procurement system in the world and the largest in Europe. In 2000, 3,099 cadaveric kidneys were transplanted in the Eurotransplant region, as well as more than 642 hearts and 1,285 livers. France and the United Kingdom have both operated national organ procurement systems since the 1980s, and 1,486 cadaveric kidneys were transplanted in the United Kingdom and Ireland in 2000 and 1,840 in France. Scandia Transplant (serving Scandinavia) is an organization of long standing; it provided kidneys for 630 transplants in 2000. Since the early 1990s, both Italy and Spain have developed transplantation and organ procurement systems. Spain's program now provides about 1,350 donors a year—the highest rate of donation in Europe. Over 1,900 cadaveric kidney transplants were done in Spain in 2000. Italy has been less successful, but 1,308 kidneys were transplanted there in 2000. About 19,000 kidney transplants were done in Western Europe in 2000, considerably more than in the United States. But the U.S. system remains the largest single system in the world, with almost 17,600 cadaveric kidney transplants completed in 2000 (UK Transplant; UNOS).
Of course kidneys are not the only organs being transplanted. In 1990 over 4,700 livers and over 4,100 hearts were transplanted worldwide, along with more than 1,000 pancreases and 250 lungs or heart–lung combinations. By 2000, 2,202 hearts and 4,664 livers were transplanted in the United States alone. In Europe an additional 1,991 hearts and 4,733 livers were transplanted. Since 1990 others organs have joined the list: intestines, lungs, and pancreases in particular. During the late 1980s, the total number of heart and liver transplants grew very rapidly, although the number of donors did not. This reflected an increase in multiple-organ donation. Donors who previously donated only kidneys were increasingly providing hearts, livers, and/or pancreases. In the United States, by 1992, 72 percent of all organ donors provided more than one organ (UNOS). In 2001 the percentage certainly exceeded 76 percent and was, perhaps, higher still. While trustworthy data are difficult to obtain, it is probable that in 1982 the percentage was less than 25 percent.
The number of actual donations must be understood in relation to the number of potential donors. A groundbreaking study headed by Kenneth J. Bart and conducted for the Centers for Disease Control estimated that in 1975 between 54.5 and 115.8 donors per million persons—about 25,000 to 26,000 potential donors—were available that year in the United States (Bart et al., 1981b). More recent work has applied more restrictive criteria to the examination of hospital death records, with one study finding an estimated national donor pool of between 10,000 and 12,500 (Nathan et al). Although divergent, these estimates both show that actual donation rates are not close to exhausting the potential supply of donors. They also indicate that the size of the donor pool is very sensitive to donor criteria, especially age. Medical criteria for acceptable donors are not fixed by immutable laws but change as transplant experience changes, and perhaps as the need for organs changes. The donor pool is itself a somewhat flexible and changing concept.
CRITERIA FOR DONATION. The one immutable medical criterion for organ donation has been brain death, or more exactly, the determination of death by brain-death criteria. Once the circulation of blood ceases, an organ very rapidly becomes useless for transplantation unless it is cooled. For this reason organ donors must be kept on machines that maintain respiration and heartbeat after death. Because the heart must be kept pumping, death must be declared on the basis of total and irreversible cessation of brain function— brain death. The causes of death that are consistent with organ donation are therefore sharply limited to those involving damage to the central nervous system. Trauma is the most common cause of such damage. Almost 43 percent of all donors in 2000 died of head trauma (about 25 percent died in auto accidents) and over 41 percent of kidney donors died of strokes (OPTN).
The need for organs is believed to be so severe that even the brain-death criterion is being questioned. Efforts are under way in a number of locations to test the feasibility of employing donors whose hearts are not beating for organ donation (i.e., donors who suffer cardiac arrest before organ retrieval). Professional support for this approach is reflected in the Institute of Medicine's 2000 report on non-heartbeating organ transplantation. This report cites studies estimating that up to a 20 percent increase in kidney donation could result from organ procurement organizations (OPOs) actively seeking non-heart-beating donors. Actual change, however, has been slow. As of 1998 only half of all OPOs had a protocol for obtaining donations from non-heart-beating donors. No more than a dozen OPOs are actively engaged in such efforts and less than 3 percent of all donors fall into that category.
Other medical criteria also limit the potential supply of organs. Cancer, systemic infections, HIV, hepatitis, and other diseases can exclude a donor because of the possible transmission of the disease to the organ recipient. High blood pressure, diabetes, and many other conditions can damage an organ and thereby render it unsuitable for transplantation.
The most general limiting factor is the age of the donor. There is little unanimity among transplant centers on acceptable donor age. In general the criteria for kidney donors is the least exclusive, and that for heart donors the most exclusive. Young donors are preferred; in the 1980s kidney donors over fifty-five were considered unsuitable, as were male heart donors older than forty. Over time, age criteria have loosened noticeably. From 1978 to 1987 the percentage of kidney donors over fifty went from 5 percent to 10 percent, and the percentage over thirty grew from about 30 percent to 40 percent (Takemoto and Terasaki). According to UNOS, in 2000 about 31 percent of cadaveric organ donors were fifty years old or older; almost 8 percent were over sixty-five. Eurotransplant protocols now consider kidney and liver donors up to age seventy-five as suitable— subject to individual evaluation. Increases in acceptable donor age can enlarge the donor pool substantially, especially when combined with an increasing percentage of donors dying from causes other than trauma.
The Procurement Systems
Organ donation requires an institutional structure to identify willing donors, obtain consent, procure the organ, and distribute it to the transplant team. These are the tasks of the organ procurement system.
LOCAL CONTEXT. The earliest organ procurement organizations in the United States were founded around 1970. They were purely local organizations that grew up around kidney transplantation teams and were meant to address those teams' needs for transplantable organs. By the mid-1980s, over ninety of these organizations had been formed; virtually no area of the nation was unserved.
While the organ procurement system has undergone many changes since the early 1980s, the local components of organ procurement success have not changed. The central factor in successful organ procurement is timely information about potentially suitable donors. Only a very small percentage of deaths can lead to an organ donation, and the window of time available for action is short. Cooperation from hospital personnel, specifically doctors and nurses in intensive care units (ICUs), is essential. A referral from these professionals (i.e., notification that a potential donor is under treatment) is required for the donation process to begin. OPO personnel typically spend more of their time encouraging doctors and nurses to make referrals than they do on organ procurement itself. This persuasion takes the form of in-service training sessions, one-on-one visits, and visits to the ICU itself. Success in obtaining referrals is the key determinant of successful organ procurement (Prottas, 1989).
A second factor of great importance is targeting appropriate hospitals. Not all hospitals are equally good sources of potential donors: Some see little trauma, and some lack the capacity to make brain-death determinations. OPOs that target their professional education efforts where the return can be the greatest are likely to be more successful than those that work with every hospital in their area.
The final step in the procurement process is obtaining permission from families. This is a very delicate matter. Families of potential donors have suffered a terrible loss. Some OPOs prefer to have their own, experienced staff approach the family. Others depend more heavily on hospital staff. All depend on the physicians involved to inform the family that their relative has died. U.S. law forbids paying families to permit donation. All organ donation decisions are therefore voluntary and altruistic.
THE DONATION DECISION. The American public, indeed the publics of all Western nations, appear to be very supportive of organ donation (Gallup Organization; Bergström and Gäbel; Moores et al.). Support levels for organ donation of 90 percent are routinely found in large-scale surveys. In the United States these rates vary by race/ethnicity, education, and income. White Americans, middle-class Americans, and well-educated Americans are more supportive of organ donation than are nonwhites and poorer and less-educated citizens. The differences, however, are all within the context of very high levels of support. African-American levels of support approach 80 percent (Prottas, 1994).
Actual willingness to donate is lower but still large. Survey data indicate that 75 to 80 percent of the population is willing to give permission for organ donation by a relative when they know that the person has been declared dead, even if they never discussed this issue with the deceased (Batten and Prottas). Here, too, there are significant differences across social classes and ethnicities. Actual permission rates obtained are another measure of public willingness to donate—although they are somewhat obscured by who is asked and the skills of those requesting permission. Permission rates vary among OPOs but generally lie between 45 and 50 percent (Siminoff et al., 2001).
There are two general categories of reasons that the public gives for being willing to donate the organs of a deceased relative. The more important is a desire to help another person. Families that have actually allowed a donation and the general public both report that they support donation so that someone's life can be saved. The families of donors also assert that they permitted donation in order that something positive could come out of the death of their relative—a factor that is only slightly less likely to be mentioned than the desire to save a life. The general public is less likely to give the solace of donation as a reason for its support of donation, but it still is the second most commonly given reason. Indeed, families and the general public agree that organ donation can help the families of the donor in the grieving process (Prottas and Batten; Batten and Prottas).
The reasons people give for their unwillingness to donate seem to reflect a mistrust of the medical establishment and the donation process. Among the most commonly given reasons is a fear that permission will compromise the care received or prolong the suffering of the relative. The second reason, closely aligned to the first, assumes that donation-related activities are occurring while the patient is still alive. From 45 to 65 percent of those unwilling to give permission for donation give answers of this sort as the explanation for their unwillingness. Of this group, 60 percent also say that they would not give permission because the donation process is too complicated. Finally, about a third attribute their unwillingness to expected resistance from other family members (Prottas and Batten).
Some of these reservations relate directly to the donation process itself and to communication between OPOs and the public. Others may reflect more basic mistrustful or alienated attitudes toward medical institutions. In this regard the greater unwillingness to donate found among ethnic minorities and among poorer citizens becomes more comprehensible.
The donation process itself seems to have important effects on willingness to donate. The core process of asking to donate is the same for all OPOs and hospitals, but differences in details can matter. Once the medical suitability of a patient has been determined, the family must be approached with the patient's terminal prognosis and—then or somewhat later—with a request for donation. A physician must present the fact of brain death, but the request for donation can be made by a doctor, a nurse, or a member of the local OPO. In different places the patterns vary. In some cases the organ procurement specialists carry the main burden of talking with the families because they are trained and experienced in this kind of encounter. In other locales, nurses will assume the responsibility because they often have the best rapport with the family, developed while the patient was being treated. A well-managed process, based on good communications and good relationships between families and the clinicians caring for the patients, can influence the permission rate (Siminoff et al., 2001).
The most common cause of death for an organ donor is accident trauma, and most donors are young; as a result, most family decision makers are parents. In recent years the age of donors has increased, and a larger percentage have died from cerebrovascular accidents. This has led to an increase in the percentage of decision makers who are spouses—most generally wives, because male donors outnumber female donors.
Donor families generally feel that the donation process was well handled, and almost 90 percent would make the same decision over again. The criticisms that do emerge usually regard the timing of the request and the clarity of the brain-death explanation (Batten and Prottas). Some of these criticism can be met by improved permission-seeking behavior (Siminoff et al., 2001), but others may reflect reactions to the loss of a loved one itself.
SYSTEM CONTEXT. Prior to 1986 the Southeastern Organ Procurement Foundation was the only regional OPO in the United States. It operated the United Network for Organ Sharing, a computer system listing most of the patients in the United States awaiting an organ. This computer list was simply a compilation of individual OPO lists, was readily accessible, and made inter-OPO organ sharing possible. However, the disposition of kidneys (few other organs were procured at that time) remained solely in the hands of the procuring agency.
Some OPOs were far more effective than others. Some procured forty kidneys per million population served; others, only eight. Cost per kidney also varied tremendously, from lows of $6,000 to $7,000 to highs of over $20,000. The percentage of organs not actually transplanted—in effect, wasted—was also very high and variable. In Europe 4 to 5 percent of the kidneys procured were discarded; the U.S. rate was almost 20 percent (a difference now virtually eliminated by improvements in the United States). Organ distribution criteria were different in different areas; often they were unwritten and inconsistently applied. Some transplant hospitals believed that when donor and recipient had similar immunological characteristics, the probability of successful transplantation was much higher. Others felt such matching was of little importance. Those who believed in matching offered to share organs more frequently than those who did not, and this tended to decrease access to transplants for their patients.
PUBLIC INVOLVEMENT. The dual issues of system efficacy in organ procurement and equity in organ allocation induced the U.S. Congress to become directly involved in organ procurement and transplantation matters. In 1972, Congress established the End Stage Renal Disease (ESRD) Program through an amendment to the Social Security Act. Under this program, people suffering from renal failure automatically became eligible for Medicare coverage. Although most of the budget of this several-billion-dollar program pays for renal dialysis, renal transplantation and organ procurement costs are also covered. Under the ESRD Program, the federal government began paying the expenses of the nation's ninety OPOs. This financial involvement of the government, coupled with public concerns about efficacy and equity, led to major changes in the organ procurement system in the late 1980s.
Starting in 1984 with the Organ Transplantation Act, Congress moved to restructure two key aspects of the organ procurement system by supporting the formation of a national organization to oversee the sharing of organs and by reforming the governance of OPOs themselves. By 1986 certain principles and structures were agreed upon that have come to define the U.S. organ procurement system. The most basic principle was that human organs are a public resource and that the organ procurement system was a steward of the public in its handling of organs. Each OPO and each transplant surgeon could be held accountable for organ allocation decisions. OPOs were now required to have public representatives on their boards.
A federally funded agency, the Organ Procurement and Transplantation Network (OPTN), was established to act as the public's agent in matters of organ allocation. This organization was given the authority to set rules controlling organ allocation at both the local and the interagency level and to enforce those rules on all OPOs. Only member agencies of OPTN could procure organs; only member hospitals could transplant organs, on pain of losing Medicare reimbursement. OPTN was also given the authority to set membership standards, including those regarding personnel training and transplant outcomes. These standards had to be met if an OPO or a hospital was to be involved in organ procurement or transplantation. While OPTN has been very conservative in the use of its powers, deferring to local practices and preferences whenever possible, the federal government now essentially has final say on how human organs are to be allocated to patients.
In the late 1980s, the Health Care Financing Administration (HCFA) exercised its right to set standards for the certification of OPOs, which included the definition of a service area for each OPO that was, to a large degree, the grant of a monopoly to procure organs in that area. Because HCFA rules precluded multiple OPOs in a single service area, there was a significant decrease in the number of OPOs in operation. As of 2000, the United States had some sixty-seven certified OPOs.
The next major increase in government involvement was the passage of "required request" laws at both the federal and the state level. The philosophical underpinning of these laws is the belief that organ donation is a right that families have and that medical institutions have an obligation to facilitate the exercise of that right. While there are differences among the various required request laws, they all share the same basic elements. Each requires that hospitals have a system in place to ensure that the family of every medically appropriate donor is asked if they wish to permit an organ or tissue donation. Reimbursement under Medicare can be denied to any hospital without such a system. These laws appear to have been reasonably successful in ensuring that families are given the option of donation (Siminoff et al., 1995). It is less clear that they have increased actual donation rates (Anderson and Fox; Viring).
In 1998 an additional step was taken when "routine referral" rules were promulgated. These rules require that hospitals inform OPOs of all imminent deaths. The goal of this regulation was to ensure that organ donation professionals are involved in the process from its earliest stages. It was predicated on a concern that not all suitable donors were being identified and that in-hospital personnel lacked the skills necessary to effectively request donation (OPTN). No systematic evaluation of the effect of this approach has been done but there is little indication of a system-wide increase in donation.
Finally, in the last years of the 1990s, the federal government became more actively involved in issues of organ allocation. There is a long-standing dispute over whether the queue for a transplant should reflect only patient characteristics or whether the OPO or the region procuring the donation ought to be given some form of preferred position. The dispute is complex and until recently the federal government took little active part. In the last half of the 1990s, however, the Department of Health and Human Services became actively involved in the debate and finally promulgated rules designed to minimize all allocation factors that did not pertain to the individual patient's characteristics. This appears to be the last in a decade-long series of changes that increased the influence of public bodies over professional ones in structuring the transplantation system.
DONATION RULES. Federal law defines the terms of exchange in organ donation. It is against federal law to buy or sell human organs and tissues. Organ and tissue donation requires explicit consent from the donor's family or a signed donor card. An alternative system exists called "presumed consent." This system reverses the burden of proof regarding family permission. Under it, if a family does not express an objection to organ donation, their permission is presumed. Austria, Belgium, Finland, France, Greece, Norway, Portugal, and Spain have presumed-consent laws (Eurotransplant), but it is unclear how often they are implemented. Certainly some nations do not actually procure organs under these laws but insist on obtaining explicit permission from families. Spain may be the only general exception, although even there detailed hospital-level data is hard to find.
In the United States, about half the states have some form of presumed-consent laws with regard to cornea donations. According to these laws, corneas can be removed from cadavers under the jurisdiction of the medical examiner, based on permission from the medical examiner's office. Some states require a minimal effort to contact families, but others do not.
ORGAN TRANSPLANTATION AND TISSUE PROCUREMENT SYSTEMS. The laws regarding organ procurement apply to tissue procurement in most ways. Tissue donation, too, must be voluntary and uncompensated, and families have the right to be given the option to donate when the medical circumstances are appropriate. However, the organizational structure of the tissue banking system is different from that of organ banking. Organ procurement is a closely regulated, federally financed system; tissue procurement is neither.
The system for procurement of musculoskeletal tissue (bone, tendons, fascia, ligaments) is virtually unregulated, except insofar as it falls under laws forbidding payments, certain Food and Drug Administration quality regulations, and required-request laws. Shared professional and technical concerns have begun to translate into discussion of procurement and distribution practices. Few rules have been agreed to, and there are no enforcement mechanisms. Government involvement in tissue banking is very recent and has occurred in response to public health concerns about the spread of AIDS and hepatitis via transplanted tissue.
The organ and tissue procurement systems, however, increasingly overlap at the operational level. Cooperation of hospitals and their medical staffs is central to the success of both, and there is overlap in terms of donor families as well. Because of this, OPOs and tissue banks have found themselves in conflict regarding access to hospital staff and to families. In response, most OPOs have expanded their activities to include tissue banking. Over 80 percent of OPOs report being involved in tissue procurement. Detailed data on the exact nature of those involvements is not available, but it appears that most OPOs now have some permanent organizational relationship within the tissue procurement field. This may take the form of having a tissue division or being within a larger organizational umbrella with a tissue procurement agency. In other cases, local agreements, especially with eye banks, have generated cooperation. The large size and unregulated nature of tissue banking, however, has left the relationships between the two systems diverse and complex.
jeffrey m. prottas (1995)
revised by author
SEE ALSO: Cybernetics; Death, Definition and Determination of; Dialysis, Kidney; Healthcare Resources, Allocation of; Medical Futility; Medicare; Mistakes, Medical; Organ and Tissue Procurement; Organ Transplants, Medical Overview of; Organ Transplants, Sociocultural Aspects of; Technology;Xenografts; and other Organ and Tissue Procurement subentries
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