U.S.
Department of Health and Human Services
Advisory Committee on Organ Transplantation
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.
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