Although the number of donors is not growing as quickly as the demand for organs, the number of donors has steadily increased since 1988. The major reason for this increase is because many more older people are becoming organ donors than in the past. Nearly two-thirds of cadaveric donors were between the ages of 18 and 49 in 1988, but, by 1996, only about one-half of donors were in this age group. The proportion of donors aged 50 and older doubled from about 12 percent in 1988 to about 26 percent in 1996. Another reason for the increase in donors is because more minorities are consenting to donate organs. Between 1988 and 1996, the percentage of organ donors who belonged to racial and ethnic minority groups increased from about 16 to 23 percent. The organ donation process usually begins at a hospital when a patient is identified as a potential organ donor. Only those patients pronounced brain dead are considered for organ donation. Most organ donors either die from nonaccidental injuries, such as a brain hemorrhage, or accidental injuries, such as a motor vehicle accident. Other causes of death appropriate for organ donation are drowning, gunshot or stab wound, or asphyxiation. Once a potential organ donor has been identified, a staff member of either the hospital or the OPO typically contacts the deceased’s family, which then has the opportunity to donate the organs. If the family consents to donation, OPO staff coordinate the rest of the organ procurement activities, including recovering and preserving the organs and arranging for their transport to the hospital where the transplant will be performed. One donor may provide organs to several different patients. Each cadaveric donor provides an average of three organs. In 1996, OPOs procured kidneys from 93 percent of organ donors and livers from 82 percent of them; other organs were procured at lower rates (see fig. 1). The national system of 63 OPOs currently in operation coordinates the retrieval, preservation, transportation, and placement of organs. For Medicare and Medicaid payment purposes, HCFA certifies that an OPO meets certain criteria and designates it as the only OPO for a particular geographic area. OPOs must meet service area and other requirements. As of January 1, 1996, each OPO must meet at least one of the following service area requirements: 1. Include an entire state or official U.S. territory. 2. Either procure organs from an average of at least 24 donors per calendar year in the 2 years before the year of redesignation or request and receive an exception to this requirement. 3. If it operates exclusively in a noncontiguous U.S. state, territory, or commonwealth, procure organs at the rate of 50 percent of the national average of all OPOs for both kidneys procured and transplanted per million population. 4. If it is a new entity, demonstrate that it can procure organs from at least 50 potential donors per calendar year. In addition, each OPO must have a board of directors or an advisory board with the authority to recommend policies on donating, procuring, and distributing organs. The board must have a transplant surgeon from each transplant center in the OPO’s service area and representation from hospital administrations, tissue banks, voluntary health associations, and either intensive care or emergency room personnel, the public, and physicians or people skilled in human histocompatibility and neurology. OPOs must also meet other requirements. Among these, an OPO must be a nonprofit entity and have accounting and other procedures to ensure its fiscal stability. It must also have the appropriate staff and equipment to obtain organs from donors in its service area and have working relationships with at least 75 percent of the hospitals in its service area that participate in Medicare and Medicaid. OPOs must also conduct systematic efforts to acquire all usable organs from potential donors. Furthermore, OPOs must have arrangements to cooperate with tissue banks to ensure that they obtain all usable tissues from donors. To ensure the fair distribution and safety of organs, OPOs must have a system to equitably allocate organs to transplant patients. OPOs must also arrange for appropriate tissue typing of organs and ensure that donor screening and testing for infectious diseases, including human immunodeficiency virus (HIV), are performed. OPOs use a variety of methods for increasing donation such as raising public awareness of organ donation and developing relationships with hospitals. The goal of public education is to promote the consent process, giving people the information they need to make decisions about organ and tissue donation and encouraging them to share their decisions with their families. Such public education campaigns include mass media advertising; presentations to schools, churches, civic organizations, and businesses; and informational displays in motor vehicle offices, city and town halls, public libraries, pharmacies, and physician and attorney offices. The racial and ethnic makeup of an OPO’s service area can affect its ability to procure organs because minority families often do not consent to organ donation. One study found that African American families’ refusal rate for organ donation was 60 percent compared with 29 percent for white families. Organ donation among minority populations, however, has increased over time. For example, African Americans accounted for 8.9 percent of organ donors in 1988 and 12 percent in 1996. The OPOs realize the need to emphasize organ donation by minorities and are focusing on increasing donation by minority populations. To help increase minority donation, OPOs have staff sensitive to the needs of and accepted by the minority population to conduct outreach and request donations and have established ethnic task forces. These efforts have increased the number of minority organ donors. (See fig. 2.) In addition, education efforts help hospital staff clarify organ and tissue recovery policies to ensure that potential donors are consistently recognized and referred. Such activities as educating staff both in seminars and informally and featuring hospital newsletter articles about organ donation help OPOs educate hospital staff. OPOs also conduct hospital development activities to build strong relationships with service area hospitals to promote organ donation. OPOs try to have representatives at their larger hospitals so that they can facilitate donation when a potential donor becomes available. In addition, OPOs encourage hospital staff to get involved in the organ donation process through such activities as post-donor recovery conferences to brief staff on the results of transplantations, inform them of recipients’ status, and discuss the strengths and weaknesses of the organ recovery process. Most OPOs, as part of their hospital development activities, conduct medical records reviews to determine their procurement process’ strengths and weaknesses and to share data on missed potential donors and donation consent rates with donor hospitals. Many potential donors referred to OPOs do not meet OPO acceptance criteria; for others, the donors’ families do not consent to donation. In addition, sometimes after donation consent is obtained, doctors find that potential donors have diseases or physical conditions that make their organs unusable. As figure 3 shows, a high proportion of potential donors do not become organ donors. These data, from an AOPO annual survey of member OPOs, indicate that in 1995 about two-thirds of patients identified as potential donors were eliminated either because the family refused consent or because the donor was ultimately judged to be unsuitable for such reasons as HIV or hepatitis infection or poor condition of the organs upon inspection. HCFA’s regional offices oversee the entire OPO certification process.Regional offices handle the OPO application process, conduct on-site reviews of OPOs, redesignate or terminate OPOs, and settle OPO territory disputes. HCFA headquarters provides the regional offices with advice and technical assistance, reviews corrective action plans submitted by OPOs that did not fully qualify for recertification, and calculates the results of the performance assessments. During our review, four HCFA headquarters staff oversaw OPO performance as part of their duties in the End Stage Renal Disease Program. HCFA has recently reorganized the headquarters staff, however, and assigned overseeing OPO performance to the Division of Integrated Delivery Systems within the Center for Health Plans and Providers and the Clinical Standards Group in the Office of Clinical Standards and Quality. Regional office staff are involved only during the few months every 2 years when OPO recertification takes place. HCFA has developed a standard for assessing OPO performance. Starting on January 1, 1996, OPOs were required to achieve at least 75 percent of the national mean in four of the five performance categories averaged over the 2 calendar years before the year of redesignation. During the 1996 transition period, OPOs meeting numerical goals in three of the five categories were recertified if they submitted an acceptable corrective action plan to increase organ donation. Recertification was granted to five OPOs that met numerical goals in three categories and submitted corrective action plans. In addition, five OPOs met goals in fewer than three categories, failing the performance standard. Of these OPOs, adjacent OPOs took over the service areas of two and a portion of the third’s. The fourth OPO merged operations with another OPO, and the fifth, determined to be a new entity, was exempt from meeting the performance standard. Recent legislation allows HCFA to change the cycle time from 2 to 4 years for OPOs meeting the standard during the previous cycle. The five performance categories for which OPOs must achieve numerical goals based on 1 million population in the OPO service area are number of actual organ donors; kidneys recovered; kidneys transplanted; extrarenal organs (heart, liver, lung, and pancreas) recovered; and extrarenal organs transplanted. HCFA may grant exceptions from its performance standard for OPOs operating exclusively outside the contiguous United States such as in a U.S. territory or commonwealth. Because distance from the U.S. mainland can make transporting organs difficult, the procurement rate for such areas tends to be lower. OPOs typically do not recover organs unless they can identify suitable recipients. OPOs in these areas must, however, meet a standard of 50 percent of the national average of all OPOs for kidneys recovered and transplanted per 1 million population.