4
Non-Heart-Beating Donation Protocols: Content

Recommendation 5: Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued. The 1997 Institute of Medicine (IOM) report recommended specific protocol provisions based on underlying clinical and ethical standards. Substantial agreement was achieved during this study (Chapter 4). However, some variations persist, and ongoing efforts towards consensus are needed.

This recommendation is based on the roundtable discussion on protocol content held during the study’s dissemination workshop. In this discussion, six programs that recover organs from non-heart-beating donors compared their non-heart-beating donor protocols. These comparisons helped to highlight and account for areas of consensus and variation in protocol content.

Roundtable participants represented hospital and Organ Procurement Organization (OPO) programs with different levels of non-heart-beating donation experience and activity. In addition, the workshop was attended by more than 50 transplant professionals who contributed their own experiences and insights to the discussion. The roundtable provided an opportunity for open communication and comparison among programs.

There was strong consensus at the workshop about the need for locally developed, publicly accessible protocols and for a strong national climate supporting these local efforts. There was strong consensus also on the underlying ethical standards for non-heart-beating donation: avoiding harm, avoiding conflicts of interest, and respecting patient and family decisions. Differences in



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Non-Heart-Beating Organ Transplantation: Practice and Protocols 4 Non-Heart-Beating Donation Protocols: Content Recommendation 5: Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued. The 1997 Institute of Medicine (IOM) report recommended specific protocol provisions based on underlying clinical and ethical standards. Substantial agreement was achieved during this study (Chapter 4). However, some variations persist, and ongoing efforts towards consensus are needed. This recommendation is based on the roundtable discussion on protocol content held during the study’s dissemination workshop. In this discussion, six programs that recover organs from non-heart-beating donors compared their non-heart-beating donor protocols. These comparisons helped to highlight and account for areas of consensus and variation in protocol content. Roundtable participants represented hospital and Organ Procurement Organization (OPO) programs with different levels of non-heart-beating donation experience and activity. In addition, the workshop was attended by more than 50 transplant professionals who contributed their own experiences and insights to the discussion. The roundtable provided an opportunity for open communication and comparison among programs. There was strong consensus at the workshop about the need for locally developed, publicly accessible protocols and for a strong national climate supporting these local efforts. There was strong consensus also on the underlying ethical standards for non-heart-beating donation: avoiding harm, avoiding conflicts of interest, and respecting patient and family decisions. Differences in

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Non-Heart-Beating Organ Transplantation: Practice and Protocols protocol content represent differences in considered judgment about how to put these standards into practice. PROTOCOL CONTENT Roundtable participants provided their protocols for discussion, and for inclusion in this report (Appendix F). Table 4-1 summarizes the content of these protocols in relation to four specific recommendations from the 1997 IOM report. There are minor local variations in protocol provisions for medications and for family options during the withdrawal of support. These variations are based on the preferences and practices of hospitals, OPOs, and organ recovery and transplant surgeons. There is substantial consensus on obtaining patient or family consent for premortem cannulation. There is one exception in this area. When a patient has died following failed resuscitation efforts, Washington Hospital Center places cannulae and begins in situ organ preservation to keep the option of donation open until the family can be contacted. This intervention for uncontrolled non-heart-beating donation was developed through a program of community outreach and oversight and is permitted by local legislation. There is substantial consensus on allowing a five-minute interval to elapse between the cessation of cardiopulmonary function and the start of organ recovery. There are variations in the way this interval is specified in the protocols. The declaration of death always precedes organ recovery. If the declaring physician incorporates the five minute interval into the declaration of death, organ recovery follows immediately. If not, the organ recovery team waits five minutes after the declaration of death before proceeding with recovery. The University of Pittsburgh declares death and begins organ recovery after two minutes of pulselessness, apnea, and unresponsiveness (Appendix F). This center finds the empirical data on autoresuscitation adequate to support a two-minute interval. This variation is based on considered judgment about clinically and ethically acceptable practice and on expert interpretation of the available data. These variations suggest that even with a strong commitment to ethical practice and a reliance on the best clinical data available, there is room for significant differences of opinion on non-heart-beating donation practices. Workshop participants recognized the value of consistency in key areas to avoid confusion and to maintain public, provider, and family trust in the donation system. The committee concurred with the 1997 IOM report in recommending that a five minute interval be allowed to elapse between the cessation of cardiopulmonary function and the declaration of death. However, full consensus was not achieved at the workshop. This is an area in which well-considered judgments continue to differ. As such, it is a decision point at which different options may be followed, but the grounds for selecting one option over another should be clearly specified.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 4-1 Non-Heart-Beating Donor Protocols: Institute of Medicine Workshop, May 1999 Program Medications Consent for Premortem Cannulation Organ Recovery After Death Location for Withdrawing Support Gift of Life Donor Program Philadelphia 71 cases, 1995–1998 (6.5%) Heparin given routinely; phentolamine case by case Yes After 5 minutes of asystole In the OR. The family may be present. New England Organ Bank Newton, MA 7 cases Case-by-case May be given following withdrawal of support Yes or postmortem After 5 minutes of asystole ICU with cold perfusion in OR. Ohio Valley Life Center Cincinnati 33 cases, 1994–1998 (13%) Case-by-case Yes After 5 minutes of pulselessness ICU or OR Shands Hospital University of Florida Gainesville 4 cases prior to protocol 1 case under new protocol Controlled only Case-by-case Yes 5 minutes after death is declared ICU with cannulation or in OR. Family may be present in ICU, not in OR

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Non-Heart-Beating Organ Transplantation: Practice and Protocols University of Pittsburgh 17 cases, 1993–1998 (20%) Controlled only Postmortem Postmortem 2 minutes of pulselessness, apnea, unresponsiveness ICU, OR, or preop holding area Washington Hospital Center Washington, DC 26 cases, 1994–1998 (30%)   Controlled: yes or postmortem Uncontrolled: postmortem pending consent (per Community Oversight Committee and DC legislation) Organ recovery a minimum of 5 minutes after death is declared ICU or OR NOTE: ICU = intensive care unit; OR = operating room.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The following section identifies the major decision points in the donation process and the variations that are found at each of these points. DECISION POINTS Table 4-2 identifies decision points along the path of non-heart-beating donation. This table highlights the points at which the decisions that are made have significant implications for patients and families. The recommendations are based on clinical and ethical standards for patient and family care. Variations from these recommendations call for careful consideration of the grounds for such variations, their impact on patients and families, and their implications for public trust in organ donation. The Patient Who Becomes a Non-Heart-Beating Donor Decision In most cases, the patient who becomes a non-heart-beating donor has suffered devastating neurological damage, most often from trauma or stroke. In rare cases, a conscious, paralyzed, ventilator-dependent person has requested non-heart-beating donation (Snyder and DeVita, 1993). These requests are rare, but workshop participants reported an occasional request of this kind. Recommendation The decision to withdraw life-sustaining treatment or to stop cardiopulmonary resuscitation should be made before the option of organ and tissue donation is discussed. These are patient, family, and patient care decisions, based on the legal, ethical, and clinical grounds outlined in Chapter 2. OPO protocols may specify the patients to whom these protocols apply; this supplements but does not alter prior decisions to stop support. Consensus and Variations Provider, family, and public confidence in non-heart-beating organ and tissue donation depends on confidence that the decision to stop aggressive treatment has been made appropriately, on its own grounds, independently of organ procurement interests. The patient, family, and patient care team should share this decision, with ethics consultation as appropriate. As discussed in Chapter 2, there are limits to consensus on decisions to stop support. Similarly, there are limits to consensus on who may be a non-heart-beating donor. For example, opinion is divided on the option of non-heart-beating donation for the patient who is ventilator dependent but conscious and who wants to stop life-sustaining treatment.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 4-2A Decision Points: Controlled Non-Heart-Beating Donation Process Step Decision Points Recommendations Other Comments Clinical situation: Patient is neurologically devastated and ventilator dependent. A decision has been made to discontinue life-sustaining treatment What is the basis for the decision to stop life-sustaining treatment? Will this protocol apply to the patient who is ventilator dependent but alert (e.g., spinal cord injury, ALS)? The decision to stop treatment should be made prior to any discussion of donation. It should be based on patient and family choice and on established clinical, ethical, and legal guidelines The donation team should not be involved in making the decision to stop treatment or in setting criteria for this decision The conscious, ventilator-dependent person represents a special case where experience and consensus are limited Decision to donate When will the option of donation be raised? After the decision to discontinue support or when the family asks about donation. Per HCFA guidelines, all deaths and impending deaths are referred to the local OPO. OPO staff may follow the case while a treatment decision is being made. Patient and family wishes are paramount   Who will raise the option of donation? A trained professional familiar with non-heart-beating donation Per HCFA guidelines   Who offers the option? Trained professional Per HCFA guidelines

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Process Step Decision Points Recommendations Other Comments Withdrawal of life-sustaining treatment Location? Flexibility per family wishes and needs ICU, OR, preop holding area   Process? Extubation? Sedatives or analgesics? Determined by patient care team and hospital protocols The withdrawal of support should be the same whether the patient will become a donor or not. Comfort measures should never be withheld   Family presence? Family preference   Declaration of death Who will declare death? Attending M.D. or designee, not associated with donation Uniform Anatomical Gift Act   Criteria? What interval should pass between the cessation of cardiopulmonary function and the declaration of death? How should the cessation of cardiopulmonary function be verified? Cessation of cardiac function for 5 minutes, confirmed by EKG, arterial pressure monitoring, and unresponsiveness. Further study is recommended Procedures Will arterial cannulae be placed? What diagnostic tests will be done? Postmortem or with patient’s or family’s consent and full disclosure Analgesia or local anesthesia, if indicated Cannulation is an invasive procedure for which consent and pain management are required

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Medications to maintain organ quality What drugs and doses will be given? Drug indications? Explanation to family? Case by case, with full disclosure Further research to verify need for medications is advised Organ recovery Allowable warm ischemia time after death and prior to organ recovery? Per OPO guidelines Further research to establish effect of warm ischemia time on transplant outcomes is advised   Procedures for handling organs including pumping (kidneys), placement, and sharing? Per OPO guidelines Further research to establish effect of organ handling on transplant outcomes is advised Financial arrangements What charges will be transferred from the hospital and family to the OPO? When? No family financial liability for costs associated with donation Development of standard guidelines Examples: lab tests, biopsies, medications, procedures, ICU time, OR time Family support What resources will be provided for family support? What arrangements will be made for family leave-taking? Family support staff should have specific training and skill in traumatic bereavement support and thorough understanding of non-heart-beating donation Clergy, social services, nursing—with adequate preparation Family advocates Bereavement counselors NOTE: ALS = amyotrophic lateral sclerosis.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 4-2B Decision Points: Uncontrolled Non-Heart-Beating Donation Process Step Decision Points Recommendations Other Comments Clinical situation: cardiopulmonary arrest Following death by neurological criteria (brain death) Unsuccessful resuscitation   Proceed with donation? Offer donation to family?   Rapid organ recovery may proceed with family consent Patient may be maintained pending family contact under carefully specified conditions Rapid organ recovery in the patient who has been declared dead by neurological criteria and for whom consent to donate does not raise issues of conflict of interest, consent, or harm. Rapid organ recovery following failed resuscitation raises these issues, and may only proceed with careful foresight and program development. Declaration of death Criteria for declaring death. Physician judgment per individual situation (IOM, 1997, p. 60) The physician who declares death cannot be associated with the organ procurement team (by law) Current uncontrolled practices include: 30 minutes of unsuccessful CPR; 10 minutes of absent heartbeat after CPR is stopped (IOM, 1997, p. 60)

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Donation When will the option of donation be offered? In arrest following death by neurological criteria, trained requester should approach the family (if this has not already been done) An institution that wishes to recover organs after failed resuscitation should have the following: Immediate access to a trained requester not associated with the patient care team Specific guidance for maintaining the patient pending family contact Because of the need for rapid intervention and decision making in this situation, hospitals that carry out uncontrolled non-heart-beating donor procurement should establish mechanisms for request and referral Patient wishes concerning donation (e.g., signed donor card) are relevant Clinical management prior to organ donation May organ preservation be undertaken (intravenous cannulation and cold perfusion)? These measures are appropriate only within specific community, legal and institutional guidelines. Maintaining the patient following failed resuscitation requires invasive procedures prior to consent       Careful consideration should be given to what procedures are permissible, and how long they may be continued   Administration of drugs? Case by case, with full disclosure Further research to verify need for medications advised.   Diagnostic tests? Case by case, with full disclosure  

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Process Step Decision Points Recommendations Other Comments Organ recovery Procedures for handling organs including preservation, placement and shipping. Per OPO procedure Further research to establish effect of organ handling on transplant outcomes is advised. Financial arrangements What charges will be transferred from hospital and family to OPO? When? No family financial liability for costs associated with donation Development of standard guidelines Examples: lab tests, biopsies, medications, procedures, ICU time, OR time Family support What resources will be provided for family support? What arrangements will be made for family leave-taking? Family support staff should have specific training and skill in traumatic bereavement support and thorough understanding of non-heart-beating donation Clergy, social services, nursing—with adequate preparation Family advocates Bereavement counselors (hospital or OPO) NOTE: CPR = cardiopulmonary resuscitation.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Consensus on this option was not attempted at the workshop. There are compelling legal and ethical grounds for the right of the conscious person to refuse life-sustaining treatment. However, experience with organ and tissue donation in this situation is too limited to provide a basis for general conclusions and guidelines. Individual cases must be approached with the primary focus on patient comfort and palliative care. The Decision to Donate Decisions Referring patients to the local OPO and approaching the family with the option of donation fall within Health Care Financing Administration (HCFA) guidelines for routine referral and trained request. The decision points involve how the referral and the approach to the family are handled and whether non-heart-beating donation will be offered or discussed only at patient or family request. Recommendation Both the timing and the content of interactions between the OPO and the family require the greatest possible sensitivity. Requesters should be trained to handle the option of non-heart-beating donation. Consensus and Variations As discussed in Chapter 1, routine referral and trained request create an opportunity for non-heart-beating donation. Variations in hospital and OPO resources for outreach education and training affect the way this option is developed and handled Both hospitals and OPOs have a role in required request. Consistent, uninterrupted information and support for patients and families depends on cooperation between hospital and OPO staff. Trained requesters may be OPO staff or hospital staff not associated with the care of the patient. Withdrawing Life-Sustaining Treatment Decisions Decision points include the location where support will be withdrawn and the management of terminal care, including whether or not to extubate and to administer sedatives and analgesics. Recommendation The withdrawal of life-sustaining treatment, including terminal weaning from the ventilator, extubation, and the administration of sedatives and analge-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols sics, should be determined by the patient care team according to established hospital protocols. The withdrawal of support and the provision of palliative care should be the same for both donors and nondonors. In particular, comfort measures should not be withheld because a person is going to be a donor. Consensus and Variations Hospital protocols for withdrawing support and providing palliative care are prerequisites for non-heart-beating donation. Workshop participants reported that OPO, hospital, and physician experience in this area varies, and identified this as an area for further in-hospital education and development. The University of Pittsburgh non-heart-beating donor program attaches its protocol for withdrawing support to its protocol for non-heart-beating organ and tissue donation. This ensures that the protocol for withdrawing support will be followed in all cases of non-heart-beating donation. Medications Decisions Medications administered to maintain organ viability include heparin (an anticoagulant) and phentolamine (a vasodilator). These medications do not provide any benefit to the donor patient. A decision must be made about what medications can be given without harm to the patient. Recommendation As recommended in the 1997 IOM report, case-by-case decisions should be made about the administration of medications. Their use may be contraindicated in cases of active bleeding or low blood pressure (IOM, 1997b, p. 52). These decisions should be guided by the medical team caring for the patient. The patient and family should be fully informed about the use of medications that do not directly benefit the patient. Consensus and Variations Two protocols allow heparin to be given routinely. Otherwise, all six protocols stipulate that medications will be given on a case-by-case basis or postmortem.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols Although this is not universally agreed, many transplant professionals find that these medications contribute to organ viability, successful transplantation, and the acceptance of non-heart-beating donor organs by transplant physicians and surgeons. Thus, they make the option of non-heart-beating donation possible for patients and families. Variations in the administration of medications are based on differences in clinical judgment among patient care physicians, transplant surgeons, and OPO staff. These judgments are based on clinical experience and on a limited number of empirical studies. More experience with non-heart-beating donation and further outcome studies are needed to provide a strong empirical basis for the use of medications. Pending such studies, a local variation in the use of medications is to be expected. Premortem Cannulation Decisions In the process of non-heart-beating organ donation, some centers place large intravascular cannulae into the femoral vessels. These cannulae are placed before or after death. After death has been declared, they are used to drain blood and to replace it with cold preservation solution. In addition, cold preservation solution may be infused into the abdominal cavity through large catheters. Preserving organs in this way allows the family to remain at the bedside for an hour or more after death. If this procedure is not done, organ recovery must begin immediately after death. Thus, decisions about cannulation affect family options for leave-taking. Recommendation Although the insertion of cannulae does not harm the patient, it does not provide any benefit. It may cause discomfort that can be alleviated with analgesia, sedation or local anesthetic. Cannulation is an invasive procedure that may appear particularly so to a grieving family. Thus, the procedure should be explained to families and their consent obtained if cannulation is to take place prior to death. Consensus and Variations There is strong consensus that all procedures and interventions should be explained to family members and that consent should be sought for invasive measures such as cannulation. Among the workshop participants, all obtain family consent for premortem cannulation in controlled non-heart-beating donation; two postpone cannulation until after death.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols As described at the beginning of the chapter, the rapid recovery program for uncontrolled donation at Washington Hospital Center is an exception. At this center, committee oversight and local legislation allow the placement of cannulae and the initiation of cold preservation following death and pending family contact. There is evidence both of strong support for this option (Braun and Drobny, 1998) and of lingering individual and community concerns (Hunt, 1998). This variation requires considerable forethought and public scrutiny, as Washington Hospital’s program illustrates. Declaring Death Decisions The physician who declares death cannot be associated with organ donation or transplantation. Decision points include the patient care physician who will declare death (attending, designee, anesthesiologist) and the time at which organ recovery may begin. Recommendation The 1997 IOM report recommends that an interval of five minutes elapse between the cessation of cardiopulmonary function and the declaration of death, and that the cessation of function be verified by electrocardiogram (EKG) and arterial pressure monitoring. Consensus and Variations Workshop participants agreed on the value of consistent criteria for declaring death. Most of their protocols specify a five minute interval between the cessation of cardiopulmonary function and the initiation of organ recovery. Rather than specifying criteria for declaring death, which they consider to be the responsibility of the declaring physician, three centers await the declaration of death and add in the five-minute interval if the declaring physician has not done so. As discussed in Chapter 2 and in the section on protocol content above, full consensus on the five-minute time interval has not been established and depends on further study and dialogue. Organ Recovery Decisions Several decisions are made about organ handling: the length of warm ischemic time to allow; whether or not to perform in situ organ preservation or to “pump” the kidneys (i.e. to circulate cold preserving solution through the kid-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols neys during storage and transport). United Network for Organ Sharing (UNOS) provides uniform standards on packaging and storage; other decisions are based on clinical judgment and empirical data (Hoffman et al., 1996). Recommendation Decisions about organ handling and preservation are the responsibility of the OPOs, with monitoring from UNOS. Tracking transplant outcomes according to methods of organ handling is a suggested research agenda. Consensus and Variations Most centers limit warm ischemia time to one hour; local practices for preservation and pumping may vary. More research is needed to establish the efficacy of organ preservation measures. Ohio Valley Life Center allows three hours of warm ischemia time and does not find that this interval affects kidney transplants adversely (Appendix F). Variations among protocols presented at the workshop reflect the current state of knowledge on non-heart-beating organ viability. Family Options Decisions Decisions about where support is withdrawn and who may be in attendance affect family options for leave-taking and for being present at the time that death occurs. If cold perfusion cannulae are placed, the family may remain with the patient after death has occurred. If cannulae are not in place, organ recovery must take place immediately after death. Recommendation Non-heart-beating donation should affect family options as little as possible. Hospitals and OPOs should exercise maximum flexibility so that families may remain with the dying patient without forgoing the option of donation. Options should be explained clearly to family members when they are making the decision about non-heart-beating donation. Consensus and Variations All roundtable participants reported that they attempt to accommodate family wishes for leave-taking. Generally, cannulae are placed and cold perfusion is begun if support is withdrawn in the intensive care unit (ICU). One center withdraws support in the ICU and transfers the patient to the operating room (OR) immediately after death. The family may be present if support is withdrawn

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Non-Heart-Beating Organ Transplantation: Practice and Protocols without cannulae in place (in the ICU, OR, or preoperative holding area) but must leave the bedside immediately after death so that organ recovery can proceed. This is an area in which local variation can be expected among hospitals and practitioners. Cooperation between the patient care and organ procurement teams can provide maximum flexibility for accommodating family wishes. Financial Arrangements Decision Arrangements for covering the costs of non-heart-beating organ must be arranged between the OPOs and hospitals, including what costs will be covered and when costs will be shifted from the hospital and the patient to the OPO. Recommendation The family should not bear any donation-related costs. Further study and guidelines are needed to identify and cover the costs associated with non-heart-beating donation. Full disclosure to the family should include the information that every effort will be made to identify and pay for donation related costs. The family should be provided with the means to contact the OPO with any billing questions. Consensus and Variations Each workshop participant has mechanisms for identifying and covering donation-related costs. These mechanisms rely primarily on case-by-case assessment and review. Each participant saw a need for establishing consistent guidelines for these costs. Limited experience with non-heart-beating donation leads to variation as to when and how OPOs assume donation costs. The cost of ICU time and the cost of OR time until death is declared are gray areas. Some variation is to be expected pending common guidelines for covering non-heart-beating donation costs. Conclusion This summary of decision points highlights the complexity involved in developing non-heart-beating donation practice and protocols, even when there is substantial agreement on underlying scientific and ethical standards. Table 4-2. serves as a decision pathway to guide protocol development. Hospitals and OPOs working on protocol development will find a range of options to consider at each point.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The recommendations from the 1997 IOM report, and the consensus and variations from the 1999 workshop are summarized in this chapter, and provide a range of options. Not every protocol will match every other protocol on every point. However, differences among protocols highlight points at which the grounds for variation should be thoroughly examined and explained. The decision pathway involves both the patient care team and the donation team. Each team has separate but intersecting responsibilities regarding medications, procedures, arrangements for the family, withdrawing support and declaring death, and financial arrangements. Each decision point involves cooperation between the OPO and the hospital, to specify roles and responsibilities. Workshop participants identified the central role of the OPO in facilitating the development of non-heart-beating organ donation activity. However, participants recognized that OPOs may find that they have few financial incentives and limited local support for developing this option. Hospital and physician support, adequate funding, and family requests encourage OPO efforts in this area. Finally, the pathway suggests areas where full consensus has not been achieved at this time; where greater empirical certainty may alter protocol provisions; and where discussion, dialogue, and comparison have to continue. Ongoing dialogue and consensus building can contribute to the further development and implementation of non-heart-beating donor protocols. These processes are discussed in the next chapter.