Detailed Information on the
Organ Transplantation Assessment

Work with States to increase the effectiveness of Organ Donation Registries.

Work with clinical and development leaders (known collectively as "improvement leaders") from the 58 donation service areas (DSAs) to increase the national organ donation conversion rate to 75%.

Work with transplant hospitals to increase the number of transplants performed in the U.S. to 35,000 annually.

Improve the organ donation rate by expanding the Organ Donation Breakthrough Collaborative to an additional 150 hospitals.

Reduce the variation in organ donation rates by completing an evaluation in July 2005 to study factors that influence the number of organs procured per deceased donor.

Measure: Increase the annual number of deceased donor organs transplanted.

Explanation:

Measure: Increase the total number of expected life-years gained in the first 5 years after the transplant for all deceased kidney and kidney-pancreas transplant recipients compared to what would be expected for these patients had they remained on the waiting list

Explanation:Kidney transplants account for approximately 50 percent of the deceased donor organ transplants. (See 2.1 and 2.2)

Measure: Increase the annual number of non-cardiac death donors.

Explanation:

Measure: Increase the annual number of cardiac death donors.

Explanation:

Measure: Increase the average number of organs transplanted per non-cardiac death donor each year.

Explanation:

Measure: Increase the average number of organs transplanted per cardiac death donor each year.

Explanation:

Measure: Increase the average number of expected life-years gained in the first 5 years after transplant for deceased kidney/kidney-pancreas transplants.

Explanation:

Measure: Decrease the total OPTN operating costs per deceased organ transplanted

Explanation:

Measure: Increase the annual number of deceased donor organs transplanted.

Explanation:

Is the program purpose clear?

Explanation: The purpose of the Organ Transplantation program is to increase the supply of organs through awarding contracts to maintain a national network for organ procurement and allocation. The program accomplishes the purpose by 1) making grants to increase the number of deceased donor organs available for transplantation; 2) making grants to the Organ Procurement and Transplantation Network (OPTN) to facilitate the allocation and distribution of organs to patients; and 3) making grants to the Scientific Registry of Transplant Recipients (SRTR) to track the outcomes of organ transplantation.

Evidence: 1. Public Health Service Act Sec. 371-377 2. Federal Register Notice (42 CRF Part 121) 3. OPTN Contract 4. SRTR Contract

Does the program address a specific and existing problem, interest or need?

Explanation: Congress established the Organ Transplantation program to ensure an equitable national system for the allocation of organs. The program, in consultation with the OPTN, establishes policies governing the allocation of organs. The program also addresses the need to increase the number of organs available for transplantation. The demand for organs for transplantation far exceeds the supply of organs made available from deceased and living donors combined. The program and key program partners support efforts to increase the supply of decreased donor organs.

Evidence: The program's Final Rule sets forth procedures for modifying organ allocation policies. As of April 1, 2004, there were more than 84,000 individuals on the national organ transplant waiting list maintained by the OPTN. In calendar year 2003, 6,455 deceased donors provided organs for 20,392 transplants to 18,648 recipients and an additional 6,803 transplants were performed using organs from living donors. In this same year, 5,989 individuals died while waiting to receive a transplant. Over, the past 10 years, the waiting list has grown at a rate of 10% per year and the number of deceased donors has increased at a rate of only 2.9% per year. Currently, only about 50% of eligable donors consent to donation.

Is the program designed so that it is not redundant or duplicative of any other Federal, state, local or private effort?

Explanation: The authorizing legislation established the Federal government's role in overseeing a national system for facilitating the allocation and distribution of decreased donor organs. The statute requires that the program contract with the SRTR for the collection and analysis of transplantation data and the OPTN for the management of the nation's organ procurement organizations (OPOs).

Evidence: The program has three main components, the Organ Procurement and Transplantation Network (OPTN), Organ Procurement Organizations (OPO), and Scientific Registry of Transplant Recipients (SRTR). The OPTN is charged with increasing the effectiveness and efficient of organ sharing and equity in the national system of organ allocation, and to increase the supply of donated organs available for transplantation. By statute, the OPTN is operated by a private, non-profit organization under federal contract and is funded mainly through fees charged to transplant programs to register patients on the national donor waiting list. United Network for Organ Sharing (UNOS) has held the contract since the program's inception. The OPOs coordinate organ procurement in designated service areas, which may cover all or part of a State. They evaluate potential donors, discuss donation with family members, and arrange for the surgical removal of donated organs. They are charged with preserving organs and arranging for their distribution according to national organ sharing policies. By Federal law, the OPO is the only entity permitted to facilitate decreased organ procurement and transplantation. The SRTR is charged with providing analytic support to the OPTN to assistant its policy-development and evaluation process. The contract is fully funded by HRSA and is currently held by University Renal Research and Education Association (URREA).

Is the program design free of major flaws that would limit the program's effectiveness or efficiency?

Explanation: The program balances the benefits of a system operated by a private organization, the OPTN, with expertise in transplantation with the need for Federal oversight to ensure public accountability. The program's authorizing legislation and final rule allow the program to adapt as medical science and the organ donation and transplantation evolve. The Final Rule requires that the OPTN use evidence-based policy-making and the need for continuous quality improvement to work towards the best use of the nation's scarce organ resources. In 2002, only 3% (n=370) of organs from standard creteria deceased donors were not used. These organs were unused for a variety of factors inlcuding expected biapsy results and anatomy or surgical errors that prevented transplantation. The OPTN is administered though a cost-share contract. The authorizing legislation limited annual appropriation for the contract to $2 million; the program currently allocates $1.5 million annual to the OPTN. The remainder of the OPTN's $20 million annual operating costs is funded by fees changes to register patients on the nation transplant waiting list. This provides for a highly-leveraged use of government funds. The authority to collect registration fees is contained in the OPTN final rule.

Evidence: 1. Public Health Service Act Sec. 371-377 2. Federal Register Notice (42 CRF Part 121) 3. OPTN Contract 4. OPTN/SRTR 2003 Annual Report

Is the program effectively targeted, so that resources will reach intended beneficiaries and/or otherwise address the program's purpose directly?

Explanation: The beneficiaries of this program are the individuals in need of organ transplants. The Program awards grants to increase organ donation and targets resources to three entities: the OPTN, the OPOs and the SRTR. These intermediaries serve the following roles to address the Program's purpose: ' The OPTN facilitates the nationwide placement of organs to individuals in need of transplants using a computerized waiting list and an allocation algorithm that matches donor organs to individuals on the list. The OPTN also develops the policies that determine how these scarce resources are allocated. ' The SRTR conducts the necessary analyses to evaluate the effectiveness of OPTN policies and to identify alternatives to current policies. ' OPOs, transplant hospitals, and other entities with expertise in transplantation receive grants to increase the supply of organs for transplantation.

Evidence: 1. Sections 371 - 372 of the Public Health Service Act. 2. OPTN Contract 3. SRTR Contract 4. "Social and Behavioral Interventions to Increase Organ and Tissue Donation and Clinical Interventions to Increase Organ Procurement" FY 2004 grant guidance. 5. "Clinical Interventions to Increase Organ Procurement" FY 2004 grant guidance.

Does the program have a limited number of specific long-term performance measures that focus on outcomes and meaningfully reflect the purpose of the program?

Explanation: The first long-term goal is to increase the number of deceased donor organs transplanted from 20,392 in 2003 to 42,800 in 2013, a 110% increase. The second long-term goal is to increase the expected life-years gained for kidney transplant recipients for the 5-year period post-transplant as compared to what would be expected for these patients had they remained on the waiting list. The program aims to increase the expected life-years gained within the 5-year post-transplant period from 3,871 in 2003 to 8,543 in 2013, a 120% increase.

Evidence: Unlike other organ systems for which there are no or limited shorter-term treatment options for end-stage organ failure, end-stage renal disease may be treated with dialysis therapy for long periods of time. The long-term mortality rate of kidney transplant recipients is 48 - 82 percent lower than patients who receive dialysis and remain on the waiting list, depending on the characteristics of the patient. [Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaver transplant. NEJM. 1999;341:1725-30]. The methodology employed in this journal article is being used for this long-term measure.

Does the program have ambitious targets and timeframes for its long-term measures?

Explanation: The Program has established ambitious targets and timeframes for the two long-term performance measures. The first long-term goal is dependent on two major factors: 1.) increasing the number of deceased organ donors; and 2.) increasing the number of organs from each deceased donor that are made available for transplant. Historically, only approximately 50% of individuals or families acting on behalf of the deceased agree to donate. Increasing the number of individuals and families that consent to donate requires education campaigns intensive efforts and regulation of the organ procurement organizations and hospitals. The number of organs used from each donor is highly dependent on the characteristics of the donor and the ability to identify a suitable transplant candidate and transport the organ to that candidate within the cold ischemic time constraints that limit the viability of the organ. The second long term goal is to increase the expected life-years gained from kidney transplantation as compared to remaining on the waiting list and receiving dialysis. This long term goal is being driven by increasing the number of kidney transplants directed toward those patients that will receive a benefit from transplantation. This involves two components: 1.) increasing the number of deceased donor kidneys available for transplantation; 2.) increasing the benefit of kidney transplantation for those patients transplanted. This second component is quite complex and difficult to project. The increased benefit of kidney transplantation involves identifying which patients on the transplant waiting list can most benefit from a kidney transplant. This is accomplished through the organ allocation policies developed by the OPTN. Therefore, effecting improvements through this mechanism will require modification of OPTN policy. Another component of this improvement is anticipated advances in post-transplant management of patients which is dependent on improvements in pharmaceuticals and clinical practices and anticipated improvement in dialysis therapy.

Evidence: First Long-Term Goal: The number of deceased organ donors grew at a annual rate of just 2.6 % over the 5-year period between 1999 and 2003. The proposed PART long-term goal assumes that the grow rate in deceased donors will grow at an average rate of 5.7 % over the 10-year period between 2004 and 2013. This is a highly ambitious goal that represents more than a doubling of the rate of growth in deceased donors. Second Long-Term Goal: Kidney transplants account for approximately 50% of the deceased donor organ transplants and kidney patients represent approximately 70% of the individuals on the national organ transplant waiting list. If this proportion is maintained in the future, the number of kidney transplants will be closely linked to the first long-term goal to increase the number of transplants using organs from deceased donor. The second component of this long-term measure is increasing the expected number of life-years gained from kidney transplantation. This measure is hard to project, because it is highly dependent on the technology of both transplantation and dialysis. For purposes of the long term goal, the improvement is projected to be approximately 7% over the 10-year period. This is based on the best clinical judgment on the improvements of transplantation relative to dialysis.

Does the program have a limited number of specific annual performance measures that can demonstrate progress toward achieving the program's long-term goals?

Explanation: The annual measures associated with the first long-term measure are: 1.) increase the number of organs transplanted each year in accordance with projections until 42,800 organs are transplanted in 2013; 2.) increase the number of 'non cardiac-death' donors by 333 each year until the number of 9,251 'non cardiac-death' donations occur in 2013; 3.) increase the number of 'cardiac death' donors by 175 each year until the number of 2,018 'cardiac-death' donors is achieved in 2013; 4.) increase the average number of organs transplanted per 'non cardiac death' donor each year by .080 until the average of 4.00 is achieved in 2013; and 5.) increase the average number of organs transplanted per 'cardiac-death' donor each year by .096 until the average of 3.00 is achieved in 2013 . The annual measures assiciated with the second long-term measure are: 1) Increase the average number of years of life gained in the first 5 years after the transplant for deceased kidney/kidney-pancreas transplanted by 0.003 life-years until the goal of 0.436 life-years gained per transplant is achieved in 2013. 2) Increase the total number of expected life-years gained in the first 5 years after the transplant for all deceased kidney and kidney-pancreas transplant recipients compared to what would be expected for these patients had they remained on the waiting list.

Evidence: The program categorizes the deceased donor population into two groups: 'non-cardiac death' donors and 'cardiac death' donors. Cardiac death donors death determination is typically based on neurologic or 'brain death' criteria. The organs from these donors can be maintained in the body for a period of time after declaration of death using medical interventions, including ventilators to perfuse oxygen to the organs and pharmacologic agents that manage blood pressure and blood chemistry. Cardiac death donors are donors whose death was caused by the cessation of circulation due to the failure of the heart. There is greater urgency in removing organs from these donors because oxygen cannot be supplied to the organs due to the cessation of circulation. Given current technology, these donors yield fewer organs. It is anticipated that advances in donor management will result in a significantly greater number cardiac death donors and an increased average number of transplantable organs from these donors.

Does the program have baselines and ambitious targets for its annual measures?

Explanation: The Program has established 2003 baseline measurements and ambitious targets and timeframes for its annual measures. (See Measures Tab)

Evidence: The average number of organs that were transplanted from the non-cardiac donors was 3.20 in 2003. The goal is to increase this average to 4.0 in 2013. This is an ambitious target because the average number of transplants from this category of donors has been relatively stable from year-to-year. An increase by .8 if applied to the number of non-cardiac death donors in 2003 would result in nearly 5,000 additional transplants. Similarly, the average number of organs transplanted from cardiac-death donors was 2.04 in 2003 and the goal is to increase this average to 3.0 in 2013. This increase in the average number of organs transplanted from this category of donors, coupled with the projected large increase in cardiac-death donors (268 in 2003 to 2,018 in 2013), will result in an increase of 5,507 organs transplanted from cardiac-death donors by the year 2013.

Do all partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) commit to and work toward the annual and/or long-term goals of the program?

Explanation: The OPTN and SRTR contract is not currently performance based. This is largely because the final rule governing the operation of the OPTN was not effective during the last competition. The program plans to incorporate performance-based elements in the next competition. While the current contracts are not performance-based, program partners are aware that inadequate contract performance may lead to HRSA not extending the contract and re-competing it for a more accountable entity.

Evidence: 1. OPTN Contract 2. SRTR Contract

Are independent evaluations of sufficient scope and quality conducted on a regular basis or as needed to support program improvements and evaluate effectiveness and relevance to the problem, interest, or need?

Explanation: The program has regularly scheduled, objective, high quality, independent evaluations that evaluate how well the program is accomplishing its mission. These reviews were conducted by the General Accounting Office (GAO), the Department of Health and Human Services Office of the Inspector General (HHS OIG) and the Institute of Medicine (IOM).

Evidence: 1. HHS OIG, Variation in Organ Donation Among Transplant Centers, May 2003. 2. HHS OIG, Organ Donor Registries -- A Useful, but Limited Tool, February 2002. 3. IOM, Organ Procurement and Transplantation, July 1999. 4. GAO, Organ Procurement and Transplantation Network: Legal Liability and Data Confidentiality, May 1999. 5. HHS OIG, Fostering Equity in Patient Access to Transplantation -- Differences in Waiting Times for Liver, May 1999. 6. HHS OIG, Fostering Equity in Patient Access to Transplantation -- Differences in Waiting Times for Kidneys, May 1999. 7. HHS OIG, Racial and Geographic Disparity in the Distribution of Organs for Transplantation, June 1998. 8. GAO, Assessing Performance of Organ Procurement Organizations, April 1998. 9. GAO, Organ Procurement Organizations ' Alternatives Being Developed to More Accurately Assess Performance, April 1993. 10. GAO, Organ Transplants ' Increased Effort Needed to Boost Supply and Ensure Equitable Distribution of Organs, November 1997.

Are Budget requests explicitly tied to accomplishment of the annual and long-term performance goals, and are the resource needs presented in a complete and transparent manner in the program's budget?

Explanation: The program does not provide a presentation that makes clear the impact of funding, policy or legislative decisions on expected performance nor does it explain why a particular funding level/performance result is the most appropriate.

Evidence: HRSA FY 2005 Justification of Estimates for Appropriations Committees

Has the program taken meaningful steps to correct its strategic planning deficiencies?

Explanation: To date, HHS/HRSA has not tied their budget requests to the accomplishments of the annual and long-term performance goals. HHS does plan to submit a performance-based budget beginning in FY 2006, but is it unclear whether this budget will show the marginal impact of funding decisions.

Evidence:  

Does the agency regularly collect timely and credible performance information, including information from key program partners, and use it to manage the program and improve performance?

Explanation: The program regularly collects performance information from the OPTN and SRTR contractors, transplant centers, and grantees. Federal program managers and the OPTN contractor use this information to manage performance.

Evidence: The program requires that grantees receiving funds to increase organ donation and procurement file 2 progress reports each year. Some practices found to be effective in the Social and Behavioral grant program have been incorporated into the Organ Transplantation Breakthrough Collaborative and promoted to OPOs and hospitals. The program requires that the OPTN and SRTR contractors submit, as contract deliverables, information such as a data dissemination plan, a policy development plan, and monthly data reports. The Program uses this information to assess whether the contractors are effectively carrying out their responsibilities and to determine if the Program needs to provide additional guidance or take corrective steps. The OPTN and SRTR are required to collect, analyze, and publish data from transplant centers and OPOs. Federal program mangers and individual transplant programs use center-specific analysis to compare risk-adjusted center and OPO performance, and to identify centers or OPOs that may require corrective action. Members of the Advisory Committee on Organ Transplantation (ACOT) use OPTN data to assist them in their recommendations to the Secretary on ways to improve the organ transplantation system. OPTN committees requested approximately 50 unique analyses from the SRTR to assist them with policy decisions to improve system performance.

Are Federal managers and program partners (including grantees, sub-grantees, contractors, cost-sharing partners, and other government partners) held accountable for cost, schedule and performance results?

Explanation: Federal managers are evaluated based on the program's performance. Annual performance appraisals contain elements relating to program oversight and the most critical elements of program performance. HRSA reports that all of its non-Commission Corps SES personnel have performance contracts that hold the manager accountable for performance. The OPTN and SRTR are held accountable for fulfilling the requirements of the Federal contract. While the contracts are not performance-based, inadequate contract performance may lead to HRSA not extending the contract and re-competing it for a more accountable entity. Past performance is given a heavy weight in the competitive selection of the contractor; poor performance could result in loss of the contract. The OPTN contractor is required to review each OPTN's member's compliance with rules and OPTN regulations. OPTN is required to implement a review process to ensure that members are following the regulations.

Evidence: 1. The program's federal managers recieve annual performance evaluations. In FY 2004, mangers will be evaluated on several key program performance measures, including the conversion rate of eligible organ donors to actual donors. 2. OPTN Contract 3. SRTR Contract 4. Federal Register Notice (42 CRF Part 121)

Are funds (Federal and partners') obligated in a timely manner and spent for the intended purpose?

Explanation: To date, all program funds have been obligated and disbursed in a timely manner. The OPTN and SRTR contracts are incrementally funded cost reimbursement contracts. Funds for these contracts are budgeted for in the Program's operating plan, and the Program obligates adequate funding to ensure continuous performance. The program reviews and pays monthly vouchers within the prescribed time frames; there have been no interest penalties for late payments to either contractor. The Program's contracts to increase donation also are budgeted for in the Program's operating plan. These smaller contracts are paid upon completion of work or on receipt of vouchers. Funds for the program's grant programs are also routinely obligated in a timely manner. In the Social and Behavioral Research program, all projects have focused on increasing willingness to donate and/or family consent for donation when a death has occurred. All grants in the Clinical program have focused on increasing procurement from available deceased donors.

Evidence: Contract vouchers include cost information by task and cost element (labor by person, travel, consultants, subcontracts and associated indirect costs) for the month, and cumulative totals. This comprehensive, up to date cost information facilitates the Project Officers' ability to continuously review and monitor spending with respect to progress of the work being accomplished by the contractors. The Project Officers promptly submit recommendations for payment electronically to the contracting officer. Vouchers, Project Officer and OPTN committee meetings, deliverables, and progress reports document that contractor performance is in accordance with the terms and conditions of the contracts, and that funds are spent for the intended purpose. Each fiscal year, the Program sets milestones for execution of the grant program for the next fiscal year, from announcement of funds availability to obligation of funds, and publishes this information in the HRSA Preview. Each year the Program has met the funding deadlines set forth in the grant application guidances and the HRSA Preview.

Does the program have procedures (e.g. competitive sourcing/cost comparisons, IT improvements, appropriate incentives) to measure and achieve efficiencies and cost effectiveness in program execution?

Explanation: The Program awards the OPTN and SRTR contracts based on competitive sourcing. The final rule governing the operation of the OPTN (42 CFR Part 121) was not effective during the last competition cycle. Therefore, to assure that the features of the rule were accomplished under this solicitation, the statement of work for the OPTN contract was more prescriptive than is now necessary with the final rule in effect. The program plans to incorporate performance-based elements in the next OPTN and SRTR contracts. Effective January 2001, all OPTN data are submitted by OPTN-member transplant centers and OPOs via an on-line application known as UNet. UNet replaced the previous paper-based data submission system, enhanced data collection efficiency and accuracy, and minimized data collection costs to the OPTN without shifting costs to OPTN-members. The OPTN contractor is responsible for data validation to verify the accuracy of information submitted to UNet. In addition, UNet serves as a platform for Internet-based communications among OPTN committees (discussion boards, proposal voting), and for regional review board deliberations about wait-listed transplant candidates and policy proposals. New uses for UNET continue to emerge, including on-line sharing of deceased donor information to facilitate organ placement

Evidence: The current OPTN and SRTR contracts were awarded in September 2000 as a result of full and open competitive acquisition, and have three-year base periods with two one-year option periods (currently HRSA is the first of its two one-year options on both contracts). The current OPTN contract is a cost-share contract (8.6% paid by Federal appropriated dollars and 91.4% paid by patient registration fees collected to place individuals on the transplant waiting list); the SRTR contract is a cost reimbursement contract.

Does the program collaborate and coordinate effectively with related programs?

Explanation: The program works closely with several organiations, including CMS, CDC, FDA, and ASPE, to ensure that agencies and organizations with separate but related roles are acting to support one another's purposes and to effectively utilize financial and human resources. The program also works with HHS' Advisory Committee on Organ Transplantation. This committee was created ensure that the organ transplantation system is using the best medical science and is distributing the organs as equitably as possible.

Evidence: Examples of collaboration include: ' The Program collaborated with the Office of the Deputy Secretary and CMS (then HCFA) to get provisions included in the Medicare and Medicaid Conditions of Participation that require donor referral and donation requestor training practices more conducive to donation. ' The Program spearheads the Workplace Partnership of the Secretary's Gift of Life Donation Initiative and with the assistance of OPOs and other transplant-related groups, has involved more than 10,000 corporations, associations and organizations in this effort to educate the American workforce about organ donation. ' The Program is collaborating with the Department of Education to launch a donation curriculum developed as part of the Secretary's Gift of Life Initiative for high school classes and driver's education.

Does the program use strong financial management practices?

Explanation: In FY 2003, HHS OIG conducted an HHS financial statement audit. The audit reported that the Department had serious internal control weaknesses in its financial systems and processes for producing financial statements. OIG considered this weakness to be material. The audit recommended that HHS improve their reconciliations, financial analysis, and other key controls. The September 30, 2002 HRSA independent auditor's report found that the preparation and analysis of financial statements was manually intensive and consumed resources that could be spent on analysis and research of unusual accounting. The audit also found that HRSA's interagency grant funding agreement transactions were recorded manually and were inconsistent with other agencies' procedures. Finally, the audit found that HRSA had not developed a disaster recovery and security plan for its data centers.

Evidence: 1. HHS FY 2003 Performance and Accountability Report 2. HRSA's 2002 audit report

Has the program taken meaningful steps to address its management deficiencies?

Explanation: HHS' long-term strategic plan is to resolve the internal control weaknesses is to replace existing accounting systems and other financial systems within HHS with the Unified Financial Management System (UFMS). HHS plans to fully implement the UFMS Department-wide by 2007. HRSA developed a corrective action plan to address the reportable conditions identified in the September 30, 2002 independent auditor's report. For each aspect of the five reportable conditions, HRSA assigned an office responsibility. The plan also outlines milestones and target completion dates. HRSA has conducted several efforts to address weaknesses identified in independent evaluations. To address and improve the rate of consent for donation and the variation in donation rates among transplant centers, HRSA launched the Organ Donation Breakthrough Collaborative in September 2003. This initiative is designed to close the gap between the number of eligible donors and the number of actual donors. To date, there has been a 10% increase in donors in the hospitals participating in the Collaborative ' twice the rate of increase in non-Collaborative hospitals. As recommended by the IOM report, the program increased Federal oversight of the OPTN and OPOs. Also in response to the IOM report, the OPTN final rule directed the OPTN to use the broadest geographic area possible within the parameters of the other allocation goals. The current OPTN liver allocation policy provides for regional sharing for Status 1 candidates ' those candidates with the highest likelihood of dying without a transplant. The OPTN has also increased the allocation area to regional sharing for all patients with an intermediate or greater urgency. The OPTN also changed the lung allocation system to one based on calculation of medical urgency and survival benefit, rather than time waiting time, after demonstration that waiting time is not an effective allocation measure.

Evidence: 1. HHS FY 2003 Performance and Accountability Report 2. HRSA Corrective Action Plan for FY2002 Financial Statement Audits as of 4/30/2003. 3. Federal Register Notice (42 CRF Part 121) 4. Organ Donation Breakthrough Collaborative website (organdonation.iqsolutions.com)

Are grants awarded based on a clear competitive process that includes a qualified assessment of merit?

Explanation: The OPTN and SRTR contracts are competed on a regularly scheduled basis. The program issues a 'Sources Sought' announcement approximately a year before the current contract period expires. The Program supports two grant programs, and a third will begin in FY 2004. The two extant programs are: Social and Behavioral Interventions to Increase Organ and Tissue Donation, which began in FY 1999, and Clinical Interventions to Increase Organ Procurement, which began in 2002. The Program convenes an objective peer review panel to evaluate all new applications for scientific and technical merit using the review criteria specified in the grant application guidance. New grant awards are made on a competitive basis; continuation applications for years 2 and 3 of the project are reviewed by staff.

Evidence: 1. OPTN Sources Sought 2. OPTN Contract 3. SRTR Sources Sought 4. SRTR Contract 5. Grant Announcments

Does the program have oversight practices that provide sufficient knowledge of grantee activities?

Explanation: The OPTN and SRTR contractors submit deliverables that are posted in contract-specific databases and can be tracked or viewed by staff with access to the system. The program requires grantees of the Social and Behavioral and Clinical Interventions grant programs to provide two progress reports per year for each year of the project, most of which are for three years. The progress report asks grantees to report on three areas: tasks and goals addressed in the reporting period including expenditures; personnel involved; difficulties encountered and steps taken to overcome difficulties; tasks in progress and expected completion dates; and challenges encountered and solutions employed. The continuation application serves as the second annual progress report and requires similar information. The Program requires Social and Behavioral program grantees to attend two technical assistance (TA) meetings the first year, one of which is pre-implementation, and one TA meeting per year for each subsequent project year. Clinical Intervention program grantees attend the pre-implementation TA meeting. The primary aim of the TA meetings is for Program staff to keep abreast of grantee progress and problems and to assist grantees to implement the best projects possible. The Program also assigns to each project in the Social and Behavioral and Clinical Interventions grant programs a Project Officer who offers assistance and keeps up-to-date on grantee progress throughout the project period. Site visits may be conducted on an infrequent as-needed basis. Grantees complete an annual financial status report and submit requests for carryover balances, if needed.

Evidence: 1. OPTN Contract 2. SRTR Contract 5. Grant Announcments

Does the program collect grantee performance data on an annual basis and make it available to the public in a transparent and meaningful manner?

Explanation: Making data widely available to the public has been one of the program's major goals over the past several years. The OPTN contractor publishes Center- and OPO-specific descriptive data regarding the number of organs transplanted; candidates waiting; and living and deceased organ donors. Local, regional, and national data are maintained and are updated on a monthly basis. Prior to the availability of this website, such information was available only through the hard copy annual report. As project results from their social and behavioral and clinical program grants become available, the program makes the results available to the public (www.organdonor.gov).

Evidence: Center specific data are available in a user-friendly format on the SRTR's website (www.ustransplant.org). Examples of data available are hospital-specific donation rates and patient survival rates. The SRTR updates the data every 6 months.

Has the program demonstrated adequate progress in achieving its long-term performance goals?

Explanation: First Long-Term Goal: The number of deceased donor organs transplanted increased from 19,869 in 2001 to 20,392 in 2003, the base year for this new long-term measure. This represents an average annual increase of 262 transplants over this time period or +2.6% per year. This rate of increase can be improved. The Program has several targeted projects underway that the Program believes will rapidly increase the number of deceased donor organs made available for transplant. Second Long-Term Goal: The number of total expected life-years gained for kidney transplant recipients for the 5-year period post-transplant as compared to what would be expected for these patients had they remained on the waiting list increased from 3,658 in 2001 to 3,871 in 2003, the base year for this new long-term measure. This represents an average annual increase of 107 life-years. In 2002, the annual percentage increase was 6.8%; in 2003 the increase was -0.9%. This rate of increase can be improved. The improvements are dependent on both increasing the number of deceased donor kidneys to transplant from the programs donation initiatives and improved life-years gained per transplant, as a result of implementation of policies based on outcomes.

Evidence: 1. Question 2.1-2.4 2. Measures Tab

Does the program (including program partners) achieve its annual performance goals?

Explanation: First Long-Term Goal: The number of non-cardiac death donors increased from 5,866 in 2000 to 6,187 in 2003. This represents an average annual increase of 107 non-cardiac donors over this time period, far below the target increase of 333 per year. The number of cardiac death donors increased from 119 in 2000 to 268 in 2003. This represents an average annual increase of 50 non-cardiac donors over this time period, or a 41% annual increase. This increase is below the target increase of 175 per year. The The number of organs transplanted per non-cardiac death did not increase from 2000 to 2003. The number of organs transplanted per cardiac death increased from 1.860 in 2000 to 2.040 in 2003. This represents an average annual increase of 0.06, below the target increase of 0.096 per year. Second Long-Term Goal: The average number of total expected life-years gained per kidney/kidnet pancreas transplant increased from 0.401 in 2001 to 0.406 in 2003. This represents an average annual increase of .0025 life-years and is comparable to the annual increase of 0.003. The total number of expected life-years gained in the first five years after transplant increased from 3,658 in 2001 to 3,871 in 2003. This represents an average annual increase of 107 life-years. In 2002, the annual percentage increase was 6.8%; in 2003 the increase was -0.9%. This rate of increase can be improved.

Evidence: 1. Question 2.1-2.4 2. Measures Tab

Does the program demonstrate improved efficiencies or cost effectiveness in achieving program goals each year?

Explanation: The average cost to the OPTN per deceased donor organ transplanted increased from $709 in 2001 to $763 in 2002 to $795 in 2003.

Evidence: See Measures tab. The program believes that greater througout can be achieved in the future through moderate increases to the OPTN infrastructure, primarily in information technology hardware and Organ Center personnel.

Does the performance of this program compare favorably to other programs, including government, private, etc., with similar purpose and goals?

Explanation: The authorizing legislation established the Federal government's role in overseeing a national system for facilitating the allocation and distribution of decreased donor organs and to collect and report data on the outcomes. By statute, no other Federal, state, local government, or private entity can regulate the allocation of organs. The program is also authorized to make grants and enter into contracts with organ procurement organization and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors. There are other organization that are engaged in similar activities. However, many of these organizations are funded or were funded in the past by the program.

Evidence:  

Do independent evaluations of sufficient scope and quality indicate that the program is effective and achieving results?

Explanation: Independent evaluations have shown that the program is carrying out its mission. Recent evaluations have identified areas where HRSA should devote additional efforts. HRSA efforts to address weaknesses identified by the evaluations is discussed in Question 3.7. The objective of the May 2003 HHS OIG report was to present data on variation in organ donation amount transplant centers. The OIG found that the rate of consent for donation varies widely among transplant centers at the national level, as well as within geographic regions. The OIG recommended that HRSA examine steps to reduce the variation in organ donation consent rates. The objective of the February 2002 was to assess the value of donor registries as a stregy for increasing organ donation. The OIG found that the contribution that registries can make to increasing the number of organ donors is limited. The OIG recommended that HRSA exercise caution in to avoid over-promising on the contributions of organ donor registries on increasing donation and foster ways of improving their effectiveness. The objective of the August 2000 HHS OIG report was to provide an early assessment of hospitals' and OPOs' responses to Medicare conditions of participation designed to increase organ donation. The OIG found that while progress has been made in implementing the donation rule, OPOs and hospitals had not taken full advantage of the donation rule. HRSA has adopted the OIG recommendation to require OPOs to submit hospital-specific data. The objective of the 1999 IOM report was to provide an independent assessment of the current policies and potential impact of the March 16, 1998 Final Rule on the system of organ procurement and transplantation. The IOM identified the need for larger organ allocation areas and appropriate consideration of patient waiting times. The IOM also had a series of recommendations to increase federal oversight and review.

Evidence: 1. HHS OIG, Variation in Organ Donation Among Transplant Centers, May 2003. 2. HHS OIG, Organ Donor Registries -- A Useful, but Limited Tool, February 2002. 3. HHS OIG, Medicare Conditions of Participation for Organ Donation: An Early Assessment of the New Donation Rule, August 2000. 4. IOM, Organ Procurement and Transplantation, July 1999. 5. The General Accounting Office, Organ Procurement and Transplantation Network: Legal Liability and Data Confidentiality, May 1999. 6. HHS OIG, Fostering Equity in Patient Access to Transplantation -- Differences in Waiting Times for Liver, May 1999. 7. HHS OIG, Fostering Equity in Patient Access to Transplantation -- Differences in Waiting Times for Kidneys, May 1999. 8. HHS OIG, Racial and Geographic Disparity in the Distribution of Organs for Transplantation, June 1998. 9. GAO, Assessing Performance of Organ Procurement Organizations, April 1998. 10. GAO, Organ Procurement Organizations ' Alternatives Being Developed to More Accurately Assess Performance, April 1993. 11. GAO, Organ Transplants ' Increased Effort Needed to Boost Supply and Ensure Equitable Distribution of Organs, November 1997.