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Advisory Committee on Organ Transplantation
U.S. Department of Health and Human Services
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:
Two related ethical principles that ACOT endorses are:
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:
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.