U.S. Department of Health and Human Services
Summary Recommendations to the Secretary
Recommendation 1: That the following ethical principles and informed consent standards be implemented for all living donors.
The person who gives consent to becoming a live organ donor must be:
- competent (possessing decision making capacity)
- willing to donate
- free from coercion
- medically and psychosocially suitable
- fully informed of the risks and benefits as a donor and
- fully informed of the risks, benefits, and alternative treatment available to the recipient.
Recommendation 2: That each institution that performs living donor transplantation provide an independent donor advocate to ensure that the informed consent standards and ethical principles described above are applied to the practice of all live organ donor transplantation.
Recommendation 3: That a database of health outcomes for all live donors be established and funded through and under the auspices of the U.S. Department of Health and Human Services.
Recommendation 4: That serious consideration be given to the establishment of a separate resource center for living donors and their families.
Recommendation 5: That the present preference in OPTN allocation policy — given to prior living organ donors who subsequently need a kidney — be extended so that any living organ donor would be given preference as a candidate for any organ transplant, should one become needed.
Recommendation 6: That the requirements for HLA typing of liver transplant recipients and/or living liver donors should be deleted.
Recommendation 7: That a process be established that would verify the qualifications of a center to perform living donor liver or lung transplantation.
Recommendation 8: That specific methods be employed to increase the education and awareness of patients at dialysis centers as to transplant options available to them.
Recommendation 9: That research be conducted into the causes of existing disparities in organ transplant rates and outcomes, with the goal of eliminating those disparities.
Recommendation 10: That legislative strategies be adopted that will encourage medical examiners and coroners not to withhold life-saving organs and tissues from qualified organ procurement organizations.
Recommendation 11: That the secretary of HHS, in concert with the Secretary of Education, should recommend to states that organ and tissue donation be included in core curriculum standards for public education as well as in the curricula of professional schools, including schools of education, schools of medicine, schools of nursing, schools of law, schools of public health, schools of social work, and pharmacy schools.
Recommendation 12: That in order to ensure best practices, organ procurement organizations and the OPTN be encouraged to develop, evaluate, and support the implementation of improved management protocols of potential donors.
Recommendation 13: That in order to ensure best practices at hospitals and organ procurement organizations, the following measure should be added to the CMS conditions of participation: each hospital with more than 100 beds should identify an advocate for organ and tissue donation from within the hospital clinical staff.
Recommendation 14: That in order to ensure best practices at hospitals and organ procurement organizations, the following measure should be added to the CMS conditions of participation: Each hospital should establish, in conjunction with its OPO, policies and procedures to manage and maximize organ retrieval from donors without a heartbeat.
Recommendation 15: That the following measure be added to the CMS conditions of participation: Hospitals shall notify organ procurement organizations prior to the withdrawal of life support to a patient, so as to determine that patient's potential for organ donation. If it is determined that the patient is a potential donor, the OPO shall reimburse the hospital for appropriate costs related to maintaining that patient as a potential donor.
Recommendation 16: That the regulatory framework provided by CMS for transplant center and Organ Procurement Organization certification should be based on principles of continuous quality improvement. Subsequent failure to meet performance standards established under such principles should trigger quality improvement processes under the supervision of HRSA.
Recommendation 17: That all hospitals, particularly those with more than one hundred beds, be strongly encouraged by CMS and AHRQ to implement policies such that the failure to identify a potential organ donor and/or refer such a potential donor to the organ procurement organization in a timely manner be considered a serious medical error. Such events should be investigated and reviewed by hospitals in a manner similar to that for other major adverse healthcare events.
Recommendation 18: That the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) strengthen its accreditation provisions regarding organ donation, including consideration of treating as a sentinel event the failure of hospitals to identify a potential donor and/or refer a donor to the relevant Organ Procurement Organization in a timely manner. Similar review should be considered by the National Committee on Quality Assurance (NCQA).
Recommendation 19: That the primary principle in organ donation be honoring the donor's wishes and fulfilling the donor's intent. This principle is known as donor designation.
Recommendation 20: That updated provisions of the Uniform Anatomical Gift Act with respect to donor rights be fully implemented in all states where the UAGA has been adopted, and that those or substantially similar provisions be enacted in all other states.
ACOT specifically recommends that every OPO and hospital in a state that has enacted the UAGA, as amended, should be educated in the implications and enforcement of the UAGA. ACOT further recommends that OPOs and hospitals in states that have not adopted the amendments to the UAGA, or substantially similar provisions, should work with their state legislatures to enact laws that enforce the donor designation model.
ACOT recommends that a comprehensive review and updating of the laws governing anatomical gifts take place in each state and that all states be encouraged to adopt laws intended to uphold the intent of donors.
Recommendation 21: That HHS direct the OPTN and SRTR to rename and broaden the scope of the present cadaver donor registration form to meaningfully capture whether donor wishes are expressed prior to the time of death, to determine whether donor wishes are being honored, and, if not, to ascertain what conditions prevented the fulfillment of the donor's wishes. Deceased Donor: ACOT supports a change in the OPTN form, and in all donation and transplantation nomenclature, from "cadaveric" to "deceased donor."
Recommendation 22: That the use of split livers be encouraged as a matter of national policy.
Recommendation 23: HHS should convene a consensus conference, involving key members of the transplant community and insurance industry representatives, with the goal of identifying a single reporting mechanism for clinical outcomes data.
Recommendation 24: That HHS issue a request for proposals for research to define and collect from OPOs and transplant centers those donor and recipient factors in extra-renal organ transplantation that would better explain relative risk of graft loss after transplant.
Recommendation 25: That a minimum listing criterion, called the MELD score critical level, should be established by the OPTN/UNOS liver committee based on the MELD score that provides no significant addition of life following transplantation relative to life on the wait list. The MELD score critical level should be reevaluated on a continuing basis, and changes made when appropriate.
Recommendation 26: That Section 105 of Senator Frist's bill (S. 573) be endorsed, so as to make clear that the term "valuable consideration," in the National Organ Transplant Act of 1984, does not include familial, emotional, psychological, or physical benefit to an organ donor or recipient.
Recommendation 27: That HHS support legislation providing for elimination of the current three-year time limit on Medicare coverage for immunosuppressive drugs for the ESRD population.
Recommendation 28: That HHS support legislation providing for elimination of the current requirement that recipients must have been Medicare eligible when they underwent organ transplantation, in a Medicare approved facility, to later receive the immunosuppressive drug benefit when they become Medicare eligible through age or disability.
Recommendation 29: HHS should fund necessary research initiatives, and convene a national consensus conference, updating the criteria involved in end of life issues related to the determination of death in the context of organ donation and transplantation. The three specific areas for review would be brain death, cardiac death, and imminent death.
Recommendation 30: HHS should review the results of the research conducted and national consensus conference convened in response to Recommendation 29 and seek to resolve the many reimbursement issues related to the determination of death in the context of organ donation and transplantation. These deal with determination of brain death, cardiac death, and imminent death, particularly with regard to ECD organs. CMS and other appropriate HHS agencies should also review their procedures with regard to living donors to ensure that living donors are fully reimbursed, and further that living donors are not disadvantaged with respect to their other insurance needs.
Recommendation 31: The OPTN should continue its efforts at developing a national standardized transplant quality of life (QOL) tool that could be made available to all transplant centers for assessing transplant end points in addition to mortality. In this context, transplant centers should be encouraged to establish and implement back to work programs for transplant recipients and living organ donors because of their proven ability in improving post-transplant quality of life, and the OPTN should consider including such programs in their criteria for transplant centers.
Recommendation 32: HHS should fund or conduct a review of all underlying issues related to recipient selection criteria.
Recommendation 33: So as to identify more kidneys, and more appropriate kidneys, that can be used for transplantation, HHS should fund a clinical multi-center trial to determine whether, and under what circumstances, pre-transplant kidney biopsies are a predictor of post-transplant kidney function.
Recommendation 34: HHS should review and report on factors affecting multicultural donation, and present data on transplantation by race, ethnicity, sex, and region.
Recommendation 35: HHS should conduct an evaluation of materials presently used by various centers and organizations across the nation to educate potential transplant recipients; the purpose of this review would be to develop improved patient information and education as part of the informed consent process. HHS should also ensure that appropriate hospital personnel undergo annual training in the organ donation process; such training would include OPO reporting requirements.
Recommendation 36: The Advisory Committee on Organ Transplantation (ACOT) recommends that the Secretary of Health and Human Services (HHS) seek authority to identify and exclude certain practices from the definition of "valuable consideration" in section 301(a) of the National Organ Transplant Act, as amended.
Recommendation 37: The ACOT recommends that the Secretary of HHS encourage States to undertake demonstration projects to test the feasibility of adopting a model of presumed consent to organ donation.
Recommendation 38: The ACOT recommends that the Secretary of HHS continue to incorporate the constructs and concepts of Burden of Disease (BOD) into ongoing analytical efforts. These constructs must include both patient and objective standpoints.
Recommendation 39: The ACOT recommends that the Secretary of HHS encourage the OPTN to evaluate allocation policies to expand the utilization of hearts.
Recommendation 40: The ACOT recommends that the Secretary of HHS authorize HHS oversight for whole-body donation.
Recommendation 41: The ACOT recommends that the Secretary of HHS direct the OPTN to develop allocation policy pertaining to nondirected, living-donor organs.
Recommendation 42: ACOT recommends to the Secretary that the OPTN be asked to expeditiously consider all issues associated with the development of a registry for matching living donors and recipients, paying particular attention to informed consent and the monitoring of long-term outcomes of the donors.
Recommendation 43: The Advisory Committee on Organ Transplantation (ACOT) recommends to the Secretary that the Medicare program allow donation after cardiac death direct organ acquisition expenses be reimbursable to the organ procurement organization under the Federal program.
Recommendation 44: ACOT recommends to the Secretary that he promote collaboration between the transplant community and the insurance industry to adopt standards of coverage for living organ donors specifically relating to future adverse events (e.g., hernia repair, biliary tract reconstruction) resulting from the donation.
Recommendation 45: ACOT recommends to the Secretary that he take action intended to provide Medicare eligibility for any living donor who loses insurability as a result of disability on the basis of previous organ donation.
Recommendation 46: The ACOT recommends to the Secretary that he direct the OPTN to develop and distribute within the transplant community, particularly to transplant programs and OPOs, a set of practice guidelines to be followed with respect to public solicitation of organ donors. The objective of these guidelines is to maintain the effectiveness and fairness of the existing organ allocation system and to protect the safety of the living donor.
Recommendation 47: ACOT recommends that the Secretary use the resources available to and within HHS to cause the collection of data concerning transplants on patients who are United States citizens or residents who received their organ transplants outside of the United States.
The processes could include, without limitation, data collection by the OPTN and/or CMS on matters such as where the transplant occurred, type of transplant, information about the donor, and basic post-transplant health condition information.
Recommendation 48: ACOT recommends that the Secretary facilitate cooperation with international organizations and/or foreign governments to identify and address risks of exploitation to, and risks to the health of, unrelated living donors to United States recipients.
Recommendation 49: ACOT recommends that the Secretary take actions to ensure that data on the general health status of living donors are collected on a nationwide basis by a centralized entity. The ACOT recommends that such data be collected, at a minimum, on an annual basis for a period of 10 years post-donation. The ACOT further recommends that the transplant program that performed a donor’s transplant be principally responsible for the data submissions or ensure that another institution providing ongoing medical care to, or follow up on, the donor collect and submit such data.
Recommendation 50: The ACOT recommends that the Secretary take action to require accreditation of all establishments required to be registered with the FDA as manufacturers of human cells, tissues, and cellular- and tissue-based products (HCT/Ps).
Recommendation 51: The ACOT recommends that the Secretary take steps to ensure the OPTN develops evidence-based allocation policies which are not determined by arbitrary administrative boundaries such as OPO service areas, OPTN regions and state boundaries.
Recommendation 52: The ACOT recommends that the Secretary encourage HRSA and CMS to resolve the regulatory inconsistencies between CMS and OPTN policies.
Recommendation 53: The ACOT recommends that the Secretary redefine Vascularized Composite Allografts (VCA) as “organs” under the National Organ Transplant ACT.
Recommendation 54: The ACOT recommends to the Secretary that the FDA recognize and accept laboratory-developed testing performed in CLIA-certified, high-complexity histocompatibility laboratories.
Recommendation 55: The ACOT recognizes that the current CMS and HRSA/OPTN structure creates unnecessary burdens and inconsistent requirements on transplant centers (TCs) and organ procurement organizations (OPOs) and that the current system lacks responsiveness to advances in TC and OPO performance metrics. The ACOT recommends that the Secretary direct CMS and HRSA to confer with the OPTN, SRTR, the OPO community, and TC representatives, to conduct a comprehensive review of regulatory and other requirements, and to promulgate regulatory and policy changes to requirements for OPOs and TCs that unify mutual goals of increasing organ donation, improving recipient outcomes, and reducing organ wastage and administrative burden on TCs and OPOs. These revisions should include, but not be limited to, improved risk adjustment methodologies for TCs and a statistically sound method for yield measures for OPOs. The ACOT recommends that this review be completed within one year and that action be taken within two years.