U.S. Department
of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendations 1–18
Following more than a year of deliberations and meetings,
the Committee met on November 18-19, 2002, in Arlington, Virginia,
and unanimously agreed on its first 18 consensus recommendations.
The first day of that meeting was devoted by the Committee
to responding to Secretary Thompson's specific request to
them that they look into several concerns he had with respect
to the process of live organ donation and transplantation
— particularly regarding the kidney, liver and lung
— so as to ensure that the donation and transplantation
process would be as safe and effective as possible, for both
the living organ donor and the recipient of the donor's organ.
ACOT believes that the implementation of these first seven
recommendations will ensure the protection of potential living
donors and simultaneously enhance the effectiveness of living
donation and transplantation.
Recommendation 1: That the following ethical principles
and informed consent standards be implemented for all living
donors.
The Secretary's first request was that ACOT consider the
desirability of national disclosure standards. ACOT responded
by recommending a series of ethical principles and elements
of informed consent that should be implemented for all living
donors.
ACOT agrees upon a set of Ethical Principles of Consent to
Being a Live Organ Donor, which includes the view that 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.
Two related ethical principles that ACOT endorses are:
- Equipoise; i.e., the benefits to both the donor and the
recipient must outweigh the risks associated with the donation
and transplantation of the live donor organ; and
- A clear statement that the potential donor's participation
must be completely voluntary, and may be withdrawn at any
time.
ACOT recommends that each institution develop an informed
consent document that would be understandable to all potential
donors. Such a document should be accessible to people at
all educational levels, and appropriate for the potential
donor's level of education. Apart from the need to employ
specifically defined medical terms, the document should in
most circumstances be written for readers with no higher than
an 8th or 9th grade level of education. If the potential donor
does not speak English, there should be an independent interpreter
to facilitate understanding in the patient's language. Where
appropriate, translations of such a document and accompanying
materials should be made available.
ACOT further recommends that the following Standards of Disclosure:
Elements of Informed Consent be incorporated in the informed
consent document given to the potential live organ donor,
with specific descriptions that would ensure the donor's awareness
of:
- the purpose of the donation
- the evaluation process — including interviews, examinations,
laboratory tests, and other procedures — and the possibility
that the potential donor may be found ineligible to donate
- the donation surgical procedure
- the alternative procedures or courses of treatment for
potential donor and recipient
- any procedures which are or may be considered to be experimental
- the immediate recovery period and the anticipated post-operative
course of care
- the foreseeable risks or discomforts to the potential
donor
- the potential psychological effects resulting from the
process of donation
- the reported national experience, transplant center and
surgeon-specific statistics of donor outcomes, including
the possibility that the donor may subsequently experience
organ failure and/or disability or death
- the foreseeable risks, discomforts, and survival benefit
to the potential recipient
- the reported national experience and transplant center
statistics of recipient outcomes, including failure of the
donated organ and the possibility of recipient death
- the fact that the potential donor's participation is voluntary,
and may be withdrawn at any time
- the fact that the potential donor may derive a medical
benefit by having a previously undetected health problem
diagnosed as a result of the evaluation process
- the fact that the potential donor undertakes risk and
derives no medical benefit from the operative procedure
of donation
- the fact that unforeseen future risks or medical uncertainties
may not be identifiable at the time of donation
- the fact that the potential donor may be reimbursed for
the personal expenses of travel, housing, and lost wages
related to donation
- the prohibition against the donor otherwise receiving
any valuable consideration (including monetary or material
gain) for agreeing to be a donor
- the fact that the donor's existing health and disability
insurance may not cover the potential long-term costs and
medical and psychological consequences of donation
- the fact that the donor's act of donation may adversely
affect the donor's future eligibility for health, disability,
or life insurance
- additional informational resources relating to live organ
donation (possibly through the establishment of a separate
resources center, as separately recommended)
- the fact that Government approved agencies and contractors
will be able to obtain information regarding the donor's
health for life and
- the principles of confidentiality, clarifying that:
- communication between the donor and the transplant
center will remain confidential;
- a decision by the potential donor not to proceed with
the donation will only be disclosed with the consent
of the potential donor;
- the transplant center will share the donor's identity
and other medical information with entities involved
in the procurement and transplantation of organs, as
well as registries that are legally charged to follow
donor outcomes; and
- confidentiality of all patient information will be
maintained in accord with applicable laws and regulations.
ACOT also prepared two specific informed consent documents
that embody these principles and elements. The first relates
to the potential donor's initial consent for evaluation as
a possible donor, Living Liver Donor
Initial Consent for Evaluation (Appendix 1). The second
deals with the potential donor's informed consent for surgery,
Living Liver Donor Informed Consent
for Surgery (Appendix 2).
ACOT recognizes that institutions operating in different
states across the nation may have different laws and needs
that will affect the precise wording of the informed consent
document(s) they will use. For that reason, these consent
documents are submitted as examples and possible models only.
Note as well that, although the specific examples are for
living liver donation, ACOT is recommending such forms for
all potential living organ donors.
Moreover, ACOT does not believe that these or any forms are
a substitute for in-person communication between physicians
and other involved professionals and the potential donor.
These forms should be viewed instead as only the written evidence
of discussions leading to informed consent based upon full
disclosure.
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.
The Secretary's second request was that ACOT consider the
desirability of an independent donor advocate (or advocacy
team) to represent and advise the donor so as to ensure that
the previously described elements and ethical principles are
applied to the practice of all live donor transplantation.
ACOT agrees with this principle and herein provides detailed
recommendations as to how such an independent donor advocate
should be established, as well as the role and qualifications
of such an advocate.
ACOT recommends that each transplant center identify and
provide to each potential donor an independent and trained
patient advocate whose primary obligation would be to help
donors understand the process, the procedure and risks and
benefits of live organ donation; and to protect and promote
the interests and well being of the donor.
ACOT recognizes that there is an acknowledged limitation
of objectivity and independence, given the realities of the
processes that take place within a transplant center among
medical colleagues who regularly interact professionally;
a modern, practicing physician does not work in a vacuum and
cannot perform in a way that is wholly apart from other institutional
staff. Moreover, the donor advocate should not be totally
independent of events affecting the recipient, as there must
be interaction of the advocate with the transplant surgeon
of the recipient team. However, the concept of preserving
a separate care physician for the donor is underscored as
the reason to retain the word independent in the identity
of the advocate.
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.
The Secretary's third request was that ACOT consider the
desirability of establishing a living organ donor registry.
ACOT concurs with the Secretary's suggestion and recommends
that a database of health outcomes of all live donors be established
and further recommends that the registry or database should
build upon existing smaller databases, but believes that a
comprehensive national database will be necessary to answer
the Secretary's desire that all potential organ donors be
fully informed and aware of the likely consequences of their
decisions.
The Secretary asked ACOT where such a database should be
established and ACOT believes that only the Department of
Health and Human Services has the authority and resources
to establish such a registry. There are valid competing arguments
as to what component of DHHS should have primary responsibility
for funding and managing such a registry, and ACOT therefore
offers no consensus suggestion on this question, but ACOT
stands ready to assist the Department in further deliberations
on this question.
ACOT further stands ready to assist the Secretary in suggesting
information or data elements (and the time periods for the
collection of such data) that should be included in such a
registry, but it was felt that further discussions within
the Department, and with the OPTN, as well as with the SRTR,
would be necessary, given ACOT's understanding that the substantial
cost implications in establishing and maintaining such a registry
must be fully explored.
In order to guide Departmental deliberations on those questions,
ACOT responds to the Secretary's request for its opinion on
how the information collected should be used. ACOT believes
that the primary purpose of such a registry should be to enable
the medical community to define accurately the donor risks
and benefits of live organ transplantation so as to give potential
donors an accurate risk assessment.
Recommendation 4: That serious consideration be given
to the establishment of a separate resource center for living
donors and their families.
ACOT recommends advancing the information and resources available
to living donors and their families through the implementation
of detailed consent forms, the creation of independent donor
advocates and the establishment of a living donor registry.
To similar effect, ACOT recommends the establishment of a
separate office, a resource center, for potential living donors,
those who choose to donate, as well as their families. The
primary function of such a resource center would be to ensure
that each potential donor receives a complete and current
set of information about living organ donation.
An existing model for such a resource center is in place
at the OPTN, which has both a person to contact for information,
and a web site with information specific to the needs of transplant
candidates and recipients. The resource center could either
be located under the aegis of the OPTN or the living donor
registry. Such a distinct resource center would have the benefit
of being clearly distinguished as separate and apart from
the transplant team and hospital. Until such time as such
an independent resource center is established, ACOT recommends
that transplant centers should give consideration to providing
such a resource center on their own, again with the purpose
of ensuring that each potential donor receives a complete
and current set of information about living organ donation.
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.
This recommendation states that there should be a preference
accorded to the living organ donor. The point value or other
means of assigning such a preference is left to the OPTN.
Recommendation 6: That the requirements for HLA typing
of liver transplant recipients and/or living liver donors
should be deleted.
This testing may, however, be appropriate for some donors
and recipients and in such cases should be compensated by
Medicaid, Medicare or private insurers as appropriate, when
specifically ordered, as for all other appropriate laboratory
tests.
Recommendation 7: That a process be established that
would verify the qualifications of a center to perform living
donor liver or lung transplantation.
ACOT believes that a process needs to be established that
would verify the qualifications of a center to perform living
donor liver or lung transplantation. ACOT believes that the
process for performing living kidney transplantation is sufficiently
mature and established that no further verification processes
are required. ACOT believes that, owing to the relative newness
of the procedures, as well as the inherent intricacies of
the operations, that centers performing and seeking to perform
living donor liver and living donor lung transplantation each
require further review and verification within the medical
community.
The purpose of such a verification process would be to give
patients an increased level of confidence in the institutions
performing such operations, and to provide a guide for centers
seeking to enter this field.
Although the Secretary's recent letters to the Committee
have focused on living donation, his overall charge to the
Committee has been much broader, and ACOT has responded to
that charge by promulgating an additional series of recommendations
not specific to living donation.
The second day of the ACOT meeting was devoted by the Committee
to issues affecting equitable access to transplantation, and
those relating to deceased or cadaveric donors.
ACOT believes that the implementation of the following two
recommendations, which relate to access to transplantation,
will especially benefit minority populations.
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.
Available information indicates that too many patients at
dialysis centers are unaware of the transplant options available
to them. Too many of these patients are members of minority
groups. Given the cost of sustained dialysis treatment, both
to patients and to the Centers for Medicare and Medicaid Services,
as compared to the cost of transplantation, this would also
be cost-effective as well as life-saving.
In order to assure the accuracy of this assessment, ACOT
recommends that procedural methodologies be developed to evaluate
dialysis patient access and referral for organ transplant,
as well as an accurate cost/benefit analysis, using existing
data and/or new sources of data.
ACOT further recommends that, as soon as possible, a health
education program be implemented, and/or that an educational
coordinator be placed on site at individual dialysis centers
so as to provide patients with adequate education about transplant
options available to them. This would be a reinforcement of
the implementation of existing regulations stipulating that
dialysis patients be educated and evaluated by personnel from
the transplant center concerning this therapeutic option.
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.
The fact of such disparities, particularly with regard to
kidney transplantation rates, appears to be undisputed, and
data developed by the SRTR for ACOT highlights this issue.
HRSA, NIH and other DHHS agencies are presently committed
to research aimed at ending such disparities with respect
to health care delivery in other areas, and research should
be undertaken to establish whether any separate reasons may
exist for such disparities within the transplantation area,
and, if so, how they may be eliminated.
ACOT believes that the implementation of the following nine
recommendations, which primarily relate to increasing the
supply of deceased donor organs, will ultimately, and in some
cases very quickly, mean many more additional organs becoming
available to potential recipients.
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.
Studies indicate that coroners and medical examiners across
the United States are not uniform in their approach to making
organs available to organ procurement organizations, and that
many unnecessarily withhold from retrieval organs that could
be used for transplantation. Indeed, it is estimated that
if all states followed the example of Texas, which has enacted
a law containing a provision similar to the one below, then
700-1,000 additional organs would be made additionally available
each year.
The Secretary is specifically encouraged to use his good
standing with the National Governor's Association, the National
Association of State Legislatures, the Uniform Commissioners
of State Laws, and/or with individual states to seek the following
change:
To amend the Uniform Anatomical Gift Act (UAGA) to add a
new subsection at the end of section 4, as follows:
(d) If the medical examiner is considering withholding one
or more organs or tissues of a potential donor for any reason,
the medical examiner shall be present during the removal of
the organs or tissue. In such case, the medical examiner may
request a biopsy of those organs or tissue, or deny their
removal. If the medical examiner denies removal of any organ
or tissue, the medical examiner shall explain in writing the
reasons for the denial and shall provide the explanation to
the qualified organ procurement organization.
In the alternative, the Secretary is asked to encourage individual
states to adopt state laws to the same or similar effect.
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.
The Secretary of HHS, in collaboration with the Secretary
of Education, should identify relevant core curriculum standards,
and survey those courses and curricula that presently include
education as to organ and tissue donation, with a view to
promoting a model standard that can be broadly employed in
public education. This would, at a minimum, include all high
schools.
In addition, hospitals should establish ongoing basic introductory
(new hire) programs, focused on organ and tissue donation
that would be similar to CPR certification and recertification,
and might in fact be accommodated within the same new hire
program.
Efforts should also be made to ensure that organ and tissue
donation be a part of the professional educational curricula
at all professional schools related to health. Law schools
are included because of the relevance of such issues to courses
in elder law, estate planning, and health law.
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.
This recommendation builds upon those made at previous conferences
held by various transplantation related organizations, as
well as work performed under contract to the Department. A
novel and improved standard of titrated care for heart and
lung donors has been established and ACOT believes that it
should be more generally implemented. It is known as the Critical
Pathway for the Organ Donor (Appendix 3, Adobe Acrobat
— get the free
Reader). Similar improved standards of management and
care should be developed to optimize the potential recovery
of other organs.
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.
Such a designated advocate for organ and tissue donation
would be responsible for assuring that the facility is in
compliance with the Conditions of Participation as well as
any other policies that pertain to organ and tissue donation.
In addition, this designated advocate's responsibilities would
include assuring that efforts are made to promote donation
in the local community. (Given varying hospital management
structures, such an advocate may not always be a member of
the clinical staff; what is essential, however, is that the
advocate have the institutional authority to effect change.)
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.
Such donation is often referred to as donation after cardiac
death, and such donors are variously referred to as donors
without a heartbeat or non-heart-beating donors, These policies
and procedures will need to be developed in collaboration
with the OPTN, the transplant centers and AOPO.
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.
The relevant committee of the OPTN is encouraged to develop
baseline measures/principles to guide the process of continuous
quality improvement, a part of which process is the development
of baseline measures. The quality improvement process envisioned
by ACOT might resemble one that is presently utilized in some
hospitals/facilities, and known as FOCUS-PDCA
(Appendix 4).
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.
This measure could be added to the sort of physician profile
which most facilities currently employ. (See example
physician profile (Appendix 5, Adobe Acrobat — get
the free
Reader). ACOT expects that this Recommendation will have
its greatest impact at those hospitals with trauma centers,
as well as those with residency programs and/or academic affiliations.
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).
JCAHO presently defines and identifies a sentinel event as:
An unexpected occurrence involving death or serious physical
or psychological injury, or the risk thereof. Serious injury
specifically includes loss of limb or function. The phrase,
"or the risk thereof" includes any process variation for which
a recurrence would carry a significant chance of a serious
adverse outcome. Such events are called "sentinel" because
they signal the need for immediate investigation and response.
Failing to identify or refer a potential donor in a timely
manner carries the serious risk of that donor's organs not
being made available to a potential recipient. Given the shortage
of organs and the fact of so many potential recipients dying
while awaiting the possibility of transplantation, such a
failure would appear to fall within the JCAHO definition of
a sentinel event.
Monitoring hospitals for compliance with organ donation standards
should become an integral part of the JCAHO hospital survey
process. In addition to examination of the standard, the hospital
JCAHO survey should include the OPO referral records which
are submitted back to the hospital, as well as the supporting
documentation of corrective measures or follow-up. There should
be a compliance benchmark set (e.g., 90-100%), with anything
below that benchmark requiring a gap analysis.
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