Public Policy Governing Organ and Tissue Procurement in the United States

A shortage of organs and tissues for transplantation has been present throughout most of the history of transplantation. As of 31 January 1995, 37 873 patients in the United States were awaiting solid-organ transplantation ([1]). It has been estimated that about one third of patients with heart or liver failure die before a transplantable organ is found ([2]). Other types of transplants are also scarce. On average, 3500 patients are awaiting corneal transplantation during any given month, and many more are awaiting transplants of bone, skin, and other tissues ([3]). The shortage will probably worsen as transplantation becomes more successful and is offered to sicker and older patients ([3], [4]). The number of organ donors is unlikely to keep pace with this increased demand. Although the largest source of potential organ donors are persons who have been declared dead according to neurologic criteria (brain dead), estimates of this potential pool of donors have been revised downward from a high of 32 000 to between 6000 and 10 000 potential donors annually. This downward revision is due to overly optimistic initial estimates and improved public health measures such as the use of seat belts and motorcycle helmets ([5], [6]). Given the limited number of potential donors, there is a constant effort to increase the efficiency of the procurement system. The current system is based on the voluntary decisions of patients or their families to donate organs to help others. This emphasis on voluntariness is consistent with the value of respecting individual autonomy and the dignity of the body after death. Supporters of the current system of organ donation argue that altruism must be the overriding factor in the decision to donate ([7], [8]). Education campaigns are designed to make the public aware of the good that can come from transplantation. Public opinion surveys show that these campaigns have been effectivemore than 95% of Americans are aware of transplantation and as many as 75% say that they would be willing to donate an organ after death (9; The Gallup Organization, The American public's attitude toward organ donation and transplantation. Survey conducted for the Partnership for Organ Donation; 1993). This overwhelming public support for donation, coupled with the low number of procured organs, led U.S. public policy analysts to conclude that the low procurement rate was due to the failure of health providers to request donation from families of donor-eligible patients ([10]). Various findings seem to support this diagnosis. These include wide variations in procurement rates among hospitals; results of attitudinal surveys of health care professionals that reflected misunderstandings about eligibility criteria; legal concerns; and ambivalence regarding talking with families about procurement ([11], [12]). These data, juxtaposed with the widespread public support of organ transplantation, persuaded legislators that if health care professionals would only identify and talk to families, families would be willing to consent to donation. Twenty-six states and the District of Columbia passed some variant of a law (called Required Request) requiring that hospitals ensure that health care professionals approach the families of eligible donors to give them the opportunity to donate. Subsequently, the Health Care Financing Administration required hospitals to develop Required Request policies as a prerequisite for Medicare reimbursement, and the Joint Commission on Accreditation of Health Care Organizations made it a requirement for hospital accreditation ([13]). Required Request legislation has not, however, resulted in the expected increase in the number of procured organs, tissues, or corneas. Studies in several states have shown that although there was a small immediate increase in procurement after the passage of Required Request laws, these increases were modest and leveled off after the first 2 years ([11], [14]). Without clear data on how the organ procurement system in the United States works, one cannot be confident about how to improve the process. Unfortunately, the development of public policy on organ procurement has relied more on theory than on empiric data. Procurement of tissues and corneas has suffered from benign neglect and has merely been folded into policies designed to procure organs with no regard to their applicability. The few studies that have examined the organ procurement process have reached different conclusions about how the system should be modified to increase procurement. Some blame the failure of Required Request legislation on the continued failure of health care professionals to approach families about donation and call for legislation strengthening the role of organ procurement organizations ([15]). Others claim that the fear of legal liability impedes health care professionals from approaching families about donation and call for intensive education ([16], [17]). One factor that has not received enough attention is the willingness of families to consent to donation when asked. Available data raise questions about the long-held belief that most families will consent to donation (18; Seamons TC. Unpublished data; 1989). Little is known about the request process itself and what affects families' willingness to donate ([19]). Two small studies of families that consented to donation reported that provision of information and the need for time to accept the death of the patient were important factors ([20], [21]). Although educating health care professionals to perform this function is probably crucial, current recommendations on how to make the request (for example, communicate the concept of brain death clearly and discuss donor options after declaration of death) are our best guess as to what works ([22]). No good empiric data definitely show which techniques are best. Therefore, recent proposals challenging the fundamental underpinnings of the current system are of concern because we do not really understand how to motivate people to donate. Financial incentives, for example, assume that self-interest, rather than the desire to help others, is the overriding factor in the decision to donate ([25], [26]). Whether such a strategy would be effective is unknown. Our study was designed to provide the first comprehensive, empiric analysis of how organ, tissue, and cornea procurement works in actual clinical practice. Our objectives were to determine the ability of health care professionals to identify donor-eligible patients, the frequency with which health care professionals approach families about donation, rates of consent to donation by families, and the factors associated with successful procurement. Methods Study Sample We obtained a representative sample of hospitals in the Pittsburgh, Pennsylvania, and Minneapolis-St. Paul, Minnesota, greater metropolitan areas, each of which comprises a diverse rural-urban mix of about 2 000 000 people. It is expected that awareness and knowledge of transplantation would be high in these areas because major, world-renowned transplantation centers are located within them. Thus, the data obtained in both areas are likely to reveal practices and values that are at least as well informed about transplantation as those anywhere else in the United States. Nevertheless, organ procurement rates from these two metropolitan areas mirror the national average. A stratified random sample of 23 hospitals was chosen from the 62 acute-care hospitals in the two regions. The strata represent 3 large trauma hospitals, 2 of which have active transplantation services; 2 children's hospitals; 6 medium-to-large non-trauma hospitals; and 12 small (<200 beds) nontrauma hospitals. Determination of Donor Eligibility Each week during the study, the medical charts of all patients who had died at all 23 hospitals were reviewed to determine the patient's eligibility for organ, tissue, and cornea donation. The chart review form developed for this purpose was initially conceived during a pilot study done in Pittsburgh ([27]). The chart review form was developed using the existing literature on eligibility and after extensive discussions with personnel from local organ, tissue, and eye procurement organizations ([28], [29]). Eligibility criteria were finalized through structured informational interviews with all procurement organizations in the study's catchment areas. The interviewers asked questions about the effect on eligibility of more than 100 diseases, the use of various drugs, and the use of medical technologies such as ventilators and dialysis machines. A pilot of the chart review form was used to review sample charts. These charts were then reviewed with procurement organizations to validate our eligibility criteria ([27]). The final chart review form used a decision-tree model to establish donor eligibility. Age was the starting cut-off point; patients were then excluded on the basis of major diseases, infections, medications, and the use of certain medical technologies. This strategy allowed us to distinguish among organ, tissue, and cornea donors because an individual person might be eligible to donate, for example, organs but not tissues or corneas. Patients younger than 37 weeks' gestation or older than 70 years, those with metastatic cancer or active tuberculosis, and those who were seropositive for the human immunodeficiency virus were ineligible to donate organs. (Since the completion of our study, the criteria have changed. In the Pittsburgh area, patients as old as 90 years are evaluated for donation. Criteria also vary with locality.) In contrast, cornea donors as old as 75 years are eligible to donate; they may also have cancer and may have died of cardiopulmonary disorders. The chart review form also accounted for local variations in eligibility. Data on patient demographic characteristics and on other variables (for example, type of health insurance and le