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, .pdf -- 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, .pdf -- 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.