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Non-Heart-Beating Organ Transplantation: Practice and Protocols APPENDIX C Workshop Participants ROUNDTABLES I AND II: PROTOCOL CONTENT AND DEVELOPMENT Danielle Cornell, R.N., B.S.N., C.P.T.C., University of Florida/SHANDS (hospital-based OPO), Gainesville. As a hospital-based organ procurement organization (OPO), SHANDS has just developed a protocol for its home hospital in Gainesville, based on the protocol used by its satellite office in Jacksonville. It started with meetings between a development team and physicians (intensive care, surgery, anesthesiology). Protocol development took two and half years from idea to implementation, with ten months from first draft to approval. The approval process included legal, ethics, policy and procedure, and executive committees. In-services and grand rounds have been provided for operating room staff, surgery and anesthesia. Education is in progress for intensive care staff, social services, neurosurgery, the medical examiner, and the media. Francis Delmonico, M.D., New England Organ Bank (independent OPO) Newton, Mass. The NEOB started protocol development with a medical group and the OPO Board of Trustees. Its protocols have been submitted to New England state transplantation advisory boards, hospital associations, clergy, and the media. Protocol development took one year. It has addressed concerns among local surgeons about the ethics of non-heart-beating donation, and about physician staffing for organ recovery.
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Non-Heart-Beating Organ Transplantation: Practice and Protocols Michael DeVita, M.D., University of Pittsburgh (hospital program) The University of Pittsburgh initiated non-heart-beating organ donation in response to patient and family requests, and initiated protocol development in response to staff and physician concerns about the withdrawal of support and the determination of death. Protocol development took 18 months of weekly meetings of both an ethics group, which dealt with the ethical issues of patient care at the end of life, and a procedural group, which set standards for withdrawing support, determining death, and auditing compliance. The protocol was approved by nursing, anesthesia, critical care, and medical personnel, and by a joint committee of hospital administrators, physicians, and board members. It was shared with ethics leaders and with the media, and published along with a series of articles in a special issue of the Kennedy Institute of Ethics Journal (Vol. 3, June 1993). John Edwards, R.N., C.P.T.C., Gift of Life Donor Program (independent OPO) Philadelphia Gift of Life developed its protocol (a draft it provides for local hospitals to follow or to use in developing their own protocols) in response to patient and family requests and in response to early referrals resulting from Pennsylvania’s routine referral legislation (passed in 1994). This OPO has found that non-heart-beating donation requires greater resources than anticipated for hospital outreach and education, including two coordinators for each donation. Gift of Life has found it particularly helpful to meet with hospital administrative and medical leaders and to attend protocol review meetings held by hospital committees. David Lewis, R.N., B.S.N., Ohio Valley Life Center (independent OPO), Cincinnati Ohio Valley Life Center developed its protocol in response to family requests. In preparation for protocol development, it conducted qualitative interviews with eight families who were unable to donate because of the lack of a protocol. The protocol was developed and is overseen by an advisory board consisting of clergy, social services, physician specialists, nurses, hospital administrators, and family members. Development took eight months. Lewis emphasized the need for cooperation among OPOs, hospitals and practitioners, good media relations, and protocol revision as needed. Jimmy Light, M.D., Washington Hospital Center (hospital program), Washington, D.C. Washington Hospital Center developed its program in response to a high incidence of trauma deaths combined with a high need for kidney transplantation within the local community. A working group presented the idea to the hospital and then to the community in the form of a consensus conference, out of which a community oversight board was established. The process took two years. During
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Non-Heart-Beating Organ Transplantation: Practice and Protocols this time, the oversight board met monthly, and media outreach, community education, and surveys were conducted. The District of Columbia passed legislation in 1994 that allows the insertion of cannulae and the initiation of cold preservation of organs prior to family consent under limited conditions. Washington Hospital Center is particularly committed to a program of family advocates. ROUNDTABLE III: PROTOCOL IMPLEMENTATION Mark Reiner, P.A., C.P.T.C., University of Florida OPO, North American Transplant Coordinators Association (NATCO) Transplant coordinators are OPO field personnel who act as liaisons with referring hospitals, transplant centers, and families. NATCO is the professional organization that represents these coordinators. NATCO has four areas of concern: (1) the need for national, standardized criteria for non-heart-beating organ donation, including the definition of suitable donors; (2) the need for education and training for practitioners; (3) the need for national standardized criteria for recovering and accepting these organs; and (4) the need to account for the impact on OPO performance of increased costs and discard rates associated with non-heart-beating organ recovery. Patricia Weiskittel, R.N., M.S.N., American Nephrology Nurses’ Association (ANNA) ANNA is the professional organization for nurses who work in dialysis units and with hospitalized patients with end-stage renal disease. These nurses take care of kidney recipients both before and after transplantation and thus can play a significant role in developing and implementing non-heart-beating organ donation, including the development of national standardized criteria that ensure nursing input; education, training, and guidance for nurses; participation in ethics committees and forums; and the identification of nursing concerns and educational needs. Jacqueline Sullivan, R.N., Ph.D., Neurosurgery Intensive Care Clinical Nurse Specialist, Thomas Jefferson University Hospital, Philadelphia Critical care nurses are strategically involved in non-heart-beating organ donation. Critical care nursing priorities include consensus and consistency in protocols, and nursing education and preparation. Lessons from donation following death by neurological criteria can be transferred to non-heart-beating donation, particularly in the areas of decoupling, standards for declaring death, and family education and support. Collaboration between OPOs and hospitals is essential. Anne Freeman Cook, M.P.A., High Mountains High Plains Bioethics Project A number of donation concerns arise in rural, low-income, medically underserved areas. These include limited educational and ethics resources; limited expe-
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Non-Heart-Beating Organ Transplantation: Practice and Protocols rience and training for referral and donation; limited understanding of the issues involved in conflict of interest, informed consent, and diversity; and a medically underserved population with limited trust in the health care system. Thus, there is considerable need for decoupling, patient and family advocacy, hospital and community education, and increased access to health care resources. Louise Jacobbi, C.P.T.C., Louisiana Organ Procurement Agency The Louisiana OPO has not undertaken non-heart-beating donation because of several unresolved concerns: resources for OPO and hospital education; staff time; equipment; and limited outcome data. There is an urgent need for followup studies on costs, organ discard rates, transplant outcomes, impact on OPO and hospital staff, and effect on family consent. It is difficult to move forward when local transplant centers do not want to use non-heart-beating donor organs, when the OPO is concerned about costs, when the organ discard rate is higher, and when adequate follow-up data are not yet available.
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