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How the system functions. The roles of the United Network of Organ Sharing, the organ procurement and transplantation network, and the organ procurement organization in heart transplantation.

Have the limits for suitable recipient candidates for heart transplantation been exceeded? Does the current legislation and policy instituted at all levels, from DHHS to individual transplant programs, critically address the use of a dangerously limited resource? These and other questions must be the focus of future discussions regarding equitable and efficient heart transplantation in this country. The past has shown that many individuals working cooperatively within committees at federal and organizational levels have already made great strides in making organ transplantation a successful reality. Many factors influence the broadening gap between supply and demand. Each level of the system can make contributions that bring positive and creative solutions to old and new problems. Each team and committee must continue to demand representation from diverse, yet attentive, members to ensure that the specific needs of the thoracic organ recipients are properly reviewed and addressed. UNOS and its membership must continue to work together to meet the challenges of the growing acceptance of organ transplantation and the limited supply of donor organs. Continued efforts of politicians, health care professionals, and the general public must seek newer and more creative ways to manage the critical organ shortage and the ever-growing population of patients who seek heart transplantation as the only viable treatment option for their disease process. OPOs must continue their efforts to educate and promote organ donation and continue to work diligently toward increasing the pool of acceptable organ donors through improved patient management and the development of improved preservation and transport techniques. The transplant community must take the initiative to modify current legislation and to author new legislation to serve as better representors for the transplant patient population that desperately needs it.

Health Care Costs↗

Agreement of immunosuppression regimens described in Medicare pharmacy claims with the Organ Procurement and Transplantation Network survey.

The Organ Procurement and Transplantation Network (OPTN) collects intermittent survey data on immunosuppressive medication use that are studied frequently as research measures. Pharmacy billing claims may provide an accurate measure of immunosuppression use over time. Herein is characterized the agreement of Medicare pharmacy claims for immunosuppressive medications with OPTN reports. Data were drawn from the United States Renal Data System. Participants received a kidney transplant in 2000 to 2001 and had an OPTN record and a Medicare pharmacy claim for an immunosuppressive drug at transplant discharge and 6 mo and 1 yr after transplantation. The concordance (kappa) of the OPTN and claims (+/-30 d of survey) for indicated medication use was compared, and sensitivity, specificity, and predictive values for claims were computed, assuming OPTN as a "gold standard." Clinical trial participation and regimen changes were examined as explanations for discordance. A total of 4357 eligible subjects were identified. Concordance over observation ranged from excellent for calcineurin inhibitors (kappa > 0.86) to generally very good for adjunctive agents (kappa = 0.49 to 0.75) to poor for corticosteroids (kappa <0.15). Claims demonstrated high positive predictive values (> or =97%) but low negative predictive values (< or =13%) for OPTN-reported corticosteroid use. Regimen changes (28 to 75%) but not clinical trial participation (< or =21%) were identified frequently among cases with discordant indications of nonsteroid medication use. Close agreement of Medicare billing claims and the OPTN for indicated use of nonsteroid immunosuppressive medications supports both as useful measures of drug exposure. Low detection rates of OPTN-indicated corticosteroid use within claims require further examination.

Data Collection↗

Direction of the Organ Procurement and Transplantation Network and United Network for Organ Sharing regarding the oversight of live donor transplantation and solicitation for organs.

The Organ Procurement and Transplantation Network (OPTN) operated by United Network for Organ Sharing (UNOS) has taken recent steps to address public solicitation for organ donors and its oversight of live donor transplantation. This report provides the direction of the OPTN regarding deceased donor solicitation. The OPTN has authority under federal law to equitably allocate deceased donor organs within a single national network based upon medical criteria, not upon one's social or economic ability to utilize resources not available to all on the waiting list. The OPTN makes a distinction between solicitations for a live donor organ versus solicitations for directed donation of deceased organs. As to live donor solicitation, the OPTN cannot regulate or restrict ways relationships are developed in our society, nor does it seek to do so. OPTN members have a responsibility of helping protect potential recipients from hazards that can arise from public appeals for live donor organs. Oversight and support of the OPTN for live donor transplantation is now detailed by improving the reporting of live donor follow-up, by providing a mechanism for facilitating anonymous live kidney donation, and by providing information for potential live kidney donors via the UNOS Transplant Living website.

Directed Tissue Donation↗

Organ Procurement and Transplantation Network; final rule revision of comment period and effective dates--HRSA. Extension of comment period and delay of effective date for the Organ Procurement and Transplantation Network.

This document sets forth the revisions required by the Fiscal Year 1998 Supplemental Appropriations Act, Public Law 105-174, signed into law by the President on May 1, 1998. Section 4002 of that Act states that public comments on the Organ Procurement and Transplantation Network (OPTN) Final Rule are permitted until August 31, 1998, and that the OPTN rule will not become effective before October 1, 1998. This document is provided to notify the public about these provisions and to make corresponding changes to the regulation.

Humans↗

Living kidney donors in need of kidney transplants: a report from the organ procurement and transplantation network.

BACKGROUND: Our aim was to use the Organ Procurement and Transplantation Network (OPTN) database to determine the number of renal waitlist candidates who previously had been living donors. METHODS: All living renal donors in the OPTN database were cross-checked against the renal waitlist history files. Additionally, renal transplant programs were contacted that had listed candidates as qualified for four additional allocation points available to patients who previously had donated an organ. Confirmatory phone calls to transplant programs yielded additional cases previously unreported to the United Network for Organ Sharing. RESULTS: A total of 56 previous living donors were identified as having been subsequently listed for cadaveric kidney transplantation. Forty-three have received transplants; 36 currently have functioning grafts. One died after transplantation. Two candidates died while waiting. CONCLUSIONS: Living renal donation has long-term risks that may not be apparent in the short term. The numbers here reported underestimate the actual number of living donors with renal failure, because they include only patients listed for a kidney transplant. To determine risk factors for postdonation renal failure, long-term living-donor follow-up data are needed.

Databases as Topic↗

The UNOS OPTN waiting list: 1988 to 1994. United Network for Organ Sharing. Organ Procurement and Transplantation Network.

1. On November 30, 1994, the combined waiting list contained 37,138 registrations. This number represents an 11.4% annual increase in registrations from 33,352 registrations as of December 31, 1993. This percentage of annual increase in registrations is the lowest since 1988. Kidney registrations account for 73.2% of all registrations. It should be noted that the number of registrations increases every year, but the percentage of annual increase tended to decline. 2. In general, the median waiting times for kidney, kidney-pancreas, liver, heart, and lung registrants have increased since 1988. For pancreas registrants, the median waiting times tended to decrease. Overall, heart-lung registrants have the longest median waiting time, whereas liver registrants have the shortest median waiting time, among all registrants on the combined waiting list. Registrants waiting for a kidney-pancreas transplant have a shorter median waiting time than registrants waiting for a kidney or pancreas transplant alone. 3. Kidney, liver, heart, and lung registrants who were listed in 1992 with blood type O waited longer than those with other blood types. Of kidney-pancreas and pancreas registrants, those who had previous transplants waited longer than those who did not. Blacks on the kidney, kidney-pancreas, liver, and heart waiting lists waited longer than patients of other races. Median waiting times varied among different age groups, for different organs. 4. The reported deaths on the kidney waiting list increased each year since 1988, but the percentage of deaths among all kidney registrants in a selected year remained within a range of 3.3-3.8%. Similarly, the number of deaths on the liver, heart, and lung waiting lists increased yearly, whereas the percentage of deaths on these waiting lists remained static over the years. For liver, heart, and lung, the percentage rates of death were 8.5%, 13.7%, and 11.5%, respectively. 5. Among registrants removed from the waiting lists for transplantation, about 58% of the removals were for kidney transplants, 20% for liver transplants, and 16% for heart transplants. Kidney-pancreas and liver transplant rates were higher than those of other organs. Kidney-pancreas transplant rates were higher than those of kidney or pancreas alone. Heart transplant rates were lower than those of kidney-pancreas and liver, but higher than those of other organs. Note that the kidney-pancreas and liver transplant rates have declined over the years.

Adolescent↗

Outcomes of renal transplantation for recipients with lupus nephritis: analysis of the Organ Procurement and Transplantation Network database.

Prior analyses of transplant outcomes in lupus transplant recipients have not consisted of multivariate analyses in the modern immunosuppressive era. Here, we compared patient and graft outcomes in lupus and non-lupus recipients transplanted between 1996 to 2000 using the United Network of Organ Sharing/Organ Procurement Transplant Network database. We evaluated the impact of recipient and donor demographic factors, time on dialysis and the initial immunosuppression regimen on rejection rates and transplant outcomes. Univariate analysis showed similar graft but better patient survival rates for primary lupus and non-lupus transplant recipients (5-year patient survival rates for lupus cohort 85.2% for deceased donor transplants and 92.1% for living donor transplants as opposed to 82.1% and 89.8% respectively for the non-lupus cohort; P=0.05 and 0.03) but similar patient survival rates for deceased donor retransplant patients. After controlling for confounding factors, no differences in patient or graft survival were seen between the two groups. No difference in acute rejection rates were observed in deceased donor transplants, but there was a small but significant increase in the risk of acute rejection in living donor lupus transplant recipients (hazard ratio=1.19, P=0.05). Risk of graft failure was lower for deceased donor recipients receiving MMF (five-year graft loss rate=29.6% for MMF vs. 40.2% for those not receiving MMF, P<0.0001), but no differences were seen among living donor recipients. Outcomes were similar regardless of type of calcineurin inhibitor, induction therapy, and time on dialysis. We conclude that lupus transplant recipients have outcomes generally equivalent to non-lupus transplant recipients.

Adult↗

Organ Procurement and Transplantation Network--HRSA. Final rule with comment period.

This document sets forth the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), which performs a variety of functions related to organ transplantation under contract with HHS. The document also offers a 60 day period for additional public comment. The rule will become effective 30 days following the close of the comment period. If the Department believes that additional time is required to review the comments, we will consider delaying the effective date. In combination with a new National Organ and Tissue Donation Initiative, this rule is intended to improve the effectiveness and equity of the Nation's transplantation system and to further the purposes of the National Organ Transplant Act of 1984, as amended. These purposes include: encouraging organ donation; developing an organ allocation system that functions as much as technologically feasible on a nationwide basis; providing the bases for effective Federal oversight of the OPTN (as well as for implementing related provisions in the Social Security Act); and, providing better information about transplantation to patients, families and health care providers.

Catchment Area, Health↗

Organ Procurement and Transplantation Network. Health Resources and Services Administration, HHS. Final rule.

This document sets forth improvements to the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), published in 1998. It reflects the advice of a panel convened by the National Academy of Science's Institute of Medicine, as called for in the Department's appropriation act for 1999. It also reflects comments on the 1998 rule and consultation with representatives of the organ transplantation community, as recommended in the same legislation; and it summarizes new transplant data developed in the period since enactment of the appropriations act.

Community Networks↗

Cost of organ procurement and transplantation network data collection for a large transplant center.

Collection of data on transplant candidates and recipients for the Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR) is a burden that falls primarily on the transplant centers. We examined the cost of data collection at one large transplant center. The average number of forms per year submitted more than 3 years was 5245. For the 3 years, 2.46 full time equivalents (FTEs) were committed to this data collection. Annual salaries in addition to benefits (calculated at 22% of salary) for these FTEs were US dollars 143026.22. The calculated annual cost per form submitted amounted to US dollars 27.27. Collection of data on transplant candidates and recipients is expensive and the cost of data collection should be understood before the institution of new data collection requirements for the transplant centers.

Costs and Cost Analysis↗

Medicare and Medicaid programs; organ procurement and transplantation network rules and membership actions--HCFA. General notice.

This notice sets forth the Secretary's interpretation of certain provisions of section 1138 of the Social Security Act. That section requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act. Section 1138 also requires that for organ procurement costs attributable to payments to an Organ Procurement Organization (OPO) to be paid by Medicare or Medicaid, the OPO must be a member of and abide by the rules and requirements of the OPTN. No other entity (for example, a histocompatibility laboratory) is required to be a member of or abide by the rules of the OPTN under the provisions of the statute. This notice states that no rule, requirement, policy, or other issuance of the OPTN will be considered to be a "rule or requirement" of the Network within the meaning of section 1138 unless the Secretary has formally approved that rule. It also provides that no action of the OPTN to deny an applicant or member membership status in the OPTN will be considered effective under section 1138 unless the Secretary has ratified that action.

Legislation, Hospital↗

Liver transplantation in the United States: a report from the Organ Procurement and Transplantation Network.

UNLABELLED: TRANSPLANTS AND CENTERS: Between 1988-1999 the number of annual liver transplants performed in the United States more than doubled, from 1,713 to 4,689; the number of centers increased from 59 to 117. The number of living donor, segmental, and multiple organ transplants also increased over time, particularly between 1997-1999. The rate of increase in the number of centers has slowed over the last few years. OUTCOMES: Survival among pediatric recipients The one- and 10-year graft survival rates for pediatric recipients were 76% and 63%, respectively. The one- and 10-year patient survival rates were 85% and 78%. Patient survival did not decrease much after the first 2 years and graft survival stabilized after 5 years. Some of the factors associated with increased odds of graft failure and patient death at 6 months after transplantation included having a previous transplant; being hospitalized, in the ICU, or on life support at the time of transplant; a creatinine level > 2 mg/dl; donor race/ethnicity; and transplant type. Factors associated with decreased odds of graft failure or patient death were recipient gender, having a metabolic disease, and a shorter than average cold ischemia time. Among grafts, recipients surviving the first 6 months after transplantation, recipient and donor race/ethnicity, primary liver disease, and having a previous transplant were associated with a greater relative risk of graft failure and mortality. The risk of graft failure was reduced for recipients in the ICU at the time of transplant and for those receiving organs from younger donors. Survival among adult recipients The one- and 10-year graft survival rates among adult recipients were 79% and 51%, respectively. The one- and 10-year patient survival rates were 85% and 59%. Survival rates decreased steadily at all time points following transplantation. Some of the factors associated with increased odds of graft failure and mortality at 6 months were increasing recipient and donor age; recipient and donor race/ethnicity; primary liver disease; having a previous transplant; being hospitalized, in the ICU, or on life support at the time of transplant; longer cold ischemia time; having a non-identical recipient/donor blood type match; transplant type; and year of transplant. Younger recipient and donor ages, having cholestatic liver disease/cirrhosis, shorter cold ischemia times, and matching male recipients with male donors were associated with decreased odds of graft failure and mortality. Many of these characteristics also affected grafts and patients surviving the first 6 months, including recipient and donor age, recipient and donor race/ethnicity, primary liver disease, previous transplant, and year of transplant.

Adolescent↗

The UNOS OPTN (Organ Procurement and Transplantation Network) waiting list: 1988 through November 30, 1992.

Based on data from the OPTN Waiting List and the Scientific Registry between 1988 and 1992: 1. The number of registrations on the overall waiting list increased by 81% between December 31, 1988 and November 30, 1992. On November 30, 1992, there were 29,047 registrations for a transplant in the United States. Organ-specific waiting lists showing strong increases during the period were lung (1,277%), liver (262%), and heart (162%). The number of heart-lung registrants decreased during the period. 2. Overall, Whites comprised the largest percentage of waiting-list registrants, followed by Blacks and Hispanics. This frequency distribution remained relatively constant between 1988 and 1991. On the organ-specific waiting lists, the percentage of Whites ranged from 80% on the liver waiting list to 90% on the pancreas waiting list. Blacks make up about 12% of the United States population, but about 32% of the kidney waiting list, due to the high incidence of end-stage renal disease among Blacks in the United States. 3. The frequency distribution of age on the waiting lists is shifting toward a greater proportion of potential recipients age 45 or older. This trend was especially true for the liver, lung, and pancreas waiting lists. 4. The percentage of highly sensitized registrants (PRA > or = 80%) on the kidney waiting list decreased by 8% between 1988 and 1991. The percentage of registrants with PRA less than 20% increased by 11.3%, probably as a result of longer waiting times for low-PRA registrants. 5. A result of the growth of the waiting lists was an increase in the median waiting time to transplant during the period. This effect was observed on every waiting list except the heart-lung. The wait for a liver transplant was the shortest (67 days in 1991), whereas the wait for a heart-lung transplant was the longest (543 days in 1990). 6. The overall death rate remained relatively stable, but was up slightly in 1991, when 6.1% of registrants died while waiting for a transplant (compared with 5.6% in 1990). The death rate on the heart-lung waiting list fell from 23.5% in 1988 to 14.8% in 1991, probably because of fewer heart-lung registrations. In 1991, the death rates were highest on the thoracic waiting lists (11.7-14.8%), followed by liver (9.3%), kidney (3.7%), and pancreas (3.0%). 7. The percentage of patients in the most urgent medical status categories remained stable on the heart waiting list and has decreased on the liver waiting list.

ABO Blood-Group System↗

U.S. system for organ procurement and transplantation.

The establishment and responsibilities of the organ procurement and transplantation network in the United States are discussed, and the process of receiving an organ transplant through the system is described. The National Organ Transplant Act of 1984 provided for a federally funded network for organ procurement and transplantation, which would function as a private, non-profit organization. This organization is the United Network for Organ Sharing (UNOS). UNOS monitors the activities of and provides service to transplant centers and organ procurement organizations (OPOs). The names of all candidates awaiting cadaveric organ transplants are placed on a central waiting list maintained by UNOS; UNOS also is responsible for maintaining a scientific registry to collect relevant data from transplant centers on the recipients of organ transplants. Although there is a national list of more than 25,000 persons waiting at any given time for a cadaveric organ, there are far fewer actual organ donors (less than 5000 in 1991). The hospital's best resource with respect to the donation process is the local OPO, which provides services related to organ donor referral, evaluation, and surgical recovery. The organ donation process consists of eight components: donor identification, referral, evaluation, consent, management, recovery of organs, allocation, and follow-up. An organ recovery coordinator from the local OPO helps the hospital staff in determining donation potential, seeking consent from the next of kin, and managing the donor after consent has been obtained. The OPO--never the donor's family or their insurer--is billed for charges relating to the donation. The OPO then bills the costs associated with the donation to the transplant centers receiving each organ for implantation.(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗