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--> 5 Survey of Organ Procurement Organization and Transplant Program Policies The National Organ Transplantation Act of 1984 (NOTA) established the national Organ Procurement and Transplantation Network (OPTN) to coordinate organ sharing among transplant centers in the United States. The United Network for Organ Sharing, which was incorporated in 1984, is a private entity composed of individual transplant centers and organizations responsible for obtaining organs from donors and allocating and distributing organs to recipients within the United States. UNOS was given the contract by the Division of Transplantation of the Department of Health and Human Services (DHHS) to oversee and maintain the OPTN in 1986. This contract assigns UNOS responsibility for developing organ allocation policies and includes a limited number of specific projects to increase the supply of organs. UNOS also oversees the recipient waiting list, collects information on donors, and maintains the Scientific Registry, which tracks recipient data after transplantation. According to UNOS, its role is ''to establish a national Organ Procurement and Transplantation Network under the Public Health and Safety Act, in order to improve the effectiveness of the nation's renal and extrarenal organ procurement, distribution, and transplantation systems by increasing the availability of, and access to, donor organs for patients with end-stage organ failure; to develop, implement, and maintain quality assurance activities; and to systematically gather and analyze data and regularly publish the results of the national experience in organ procurement" (UNOS Articles of Incorporation). Organ procurement organizations, as established under NOTA, must belong to the OPTN and report data to the Scientific Registry. Each OPO orchestrates and oversees the organ donation process at one or more transplant centers. OPOs are responsible for organ quality including appropriate preservation and
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--> packaging and assurance that adequate material for tissue typing is procured, divided, and packaged (UNOS Policies as of March 7, 1997). OPOs also act as liaisons between individual hospitals and UNOS. Eligibility for reimbursement under Medicare requires that transplant centers be members of the OPTN. OPOs are responsible for identifying, evaluating, and maintaining the donor; obtaining consent from the patient or patient's family for the removal of organs; verifying pronouncement of death; and ensuring that information about the donor is entered into the UNOS national computer system, and that the approved UNOS organ allocation program is executed for each donor organ. Interest In OPO NHBD Protocols All 63 organ procurement organizations in the United States were identified by UNOS for an IOM survey of their NHBD protocols, carried out in May, June, and July 1997, which simply asked for a copy of OPO NHBD protocols and followed up all nonresponders to obtain a protocol or to confirm the absence of a protocol and elicit reasons for such an absence. (See Appendix C for the request letter, a listing of the OPOs, and a map.) Protocols were evaluated as described below using a checklist including: approved; draft; for controlled NHBDs; for uncontrolled NHBDs; cannula use; determination of death; use of heparin and regitine; OPO referral, life support withdrawal decision making, and donation discussions; and family contacts and location of withdrawal. Additional anecdotal information elicited during telephone follow-ups is included when judged to be worthwhile. The survey was performed to provide a basis of information on actual NHBD procurement practices. This information assisted in the analysis and preparation of conclusions and recommendations on issues identified earlier in this report. Fifty-four of the surveyed OPOs are independent. Nine are located in specific hospitals. According to UNOS data, 20 donor hospitals and OPOs recovered organs from NHBDs in 1996, and 36 recovered organs from NHBDs from 1993 to 1996. Protocol Statistics All of the OPOs responded to the IOM request for a copy of their NHBD protocols, either by mail or via phone interview. Twenty-five OPOs have approved NHBD protocols in effect. Nine OPOs reported that they were in the process of drafting, approving, or reevaluating their NHBD protocols. A few OPOs reported that their NHBD protocols were being reevaluated by medical and ethics committees after the recent adverse national publicity and other negative reactions.
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--> Twenty-nine OPOs indicated that they did not have an NHBD protocol, were not actively engaged in developing one, and did not recover organs from NHBDs. Explanations given for the absence of an NHBD protocol and program included lack of member hospital interest (OPOs have no jurisdiction over hospitals in this regard); lack of equipment; lack of a sufficient population in the OPO area; desire to focus on heart-beating (brain-dead) donors; inability of the OPO and hospitals to resolve concerns regarding NHBDs; fear of negative media coverage; community opposition; and potential for less viable organs from NHBDs. Many of the OPOs without NHBD protocols expressed an interest in learning more about the issues surrounding NHBD procedures and hearing the findings of this report. The IOM received a total of 29 NHBD protocols from various OPOs (25 approved, 4 in draft form or in the approval process). Twenty-four protocols are limited to controlled NHBD organ procurement. Five protocols cover both controlled and uncontrolled NHBDs, although in one of these the coverage of uncontrolled NHBDs includes only category IV (a category where the distinction between controlled and uncontrolled is somewhat vague in this country). The following analysis pertains only to controlled NHBDs unless otherwise noted. This analysis also includes information from protocols currently in draft form, which are subject to change. Nevertheless, both the approved and the draft protocols received and reviewed by the IOM reflect current thinking regarding NHBDs. Areas of important procedural differences exist among protocols beyond what might be expected as reflecting the local needs and concerns of regional hospitals and OPOs. These include variation in the involvement of an OPO in approaching the family for consent for donation, OPO interventions and preparation of the donor prior to death, medications administered prior to death, and criteria for the determination of death once life support has been withdrawn. Some hospitals have different NHBD provisions than the OPO, and some protocols are really those of the sole NHBD transplant center covered by the OPO. Identification Of Potential Donors Each protocol begins with an identification of and criteria for potential NHBD candidates. Most describe the conditions for a potential NHBD as a "patient (who) has severe head injury but does not meet brain death criteria, and is ventilator dependent." Thereafter, however, the sequence of events for contacting OPOs, securing consent from families, and assessing donor suitability varies among protocols. Some differences simply reflect procedural preferences, but others appear to reflect ethical differences. A majority of protocols set limits for the age of NHBDs. Most require donors to be between 5 and 55 years of age. The narrowest age range is infant to age 35, and the widest, newborn to age 80. Most protocols also stipulate that the potential NHBD must have a known cause of death, not be classified as high-risk
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--> by the Centers for Disease Control and Prevention (CDC) (intravenous [IV] drug users, homosexual or bisexual males, HIV positive status, etc.), and have no known history of hypertension, sepsis, or cancer except for primary brain tumors. All protocols emphasize that the medical evaluation of the donor by the physician prior to decisions to withdraw life support shall not be influenced by the possibility of donation. The policy of drawing a strict line between patient and donor is present in each. However, the protocol for implementing and safeguarding this policy varies greatly among OPOs. Candidates for organ donation are identified based on evaluation of their medical records and clinical data. Five NHBD protocols specify notification about such potential donors to the OPO before the decision to withdraw life support has been made by the family and physician. Most OPOs are contacted only after the decision to withdraw support has been made and before the option of donation is presented and discussed with families. Routine referral of dying patients to the OPO, pursuant either to state law or to hospital-OPO policy, undoubtedly introduces donation as a possibility in the course of care of terminal patients, as discussed in the following sections of this chapter. Four OPOs begin evaluating and testing the donor for suitability (including clinical evaluation, medical history review, and laboratory tests) before the decision to withdraw life support has been made, and about half of the OPOs begin clinical evaluation before obtaining consent for donation. A few protocols describe discussion among attending physicians and transplant surgeons before the decision to withdraw life support, and a large majority before decisions to donate. One protocol states that the "OPO representative will discuss the possibility of procurement with the attending physician to ensure that the physician agrees with termination of support on medical grounds" before the decision to terminate support is made. Many OPO protocols outline the tests and procedures for determining donor suitability. An apnea test to reveal how dependent the patient is upon a ventilator is often used to determine whether the patient will die relatively quickly after withdrawal of life support. One detailed evaluation specifies the laboratory and diagnostic tests, serology tests, blood specimens for tissue typing, and apnea tests that should be performed to evaluate the donor. Other protocols are less technical and do not detail the tests to be performed: "potential donor meets OPO standard medical criteria for donation." Five OPO protocols restrict the type of organs that can be procured from NHBDs to kidney or liver and kidney (other organs may be used for research) due to concern about damage to other organs caused by time without circulation.
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--> Approach To Family For Consent All OPO protocols explicitly require that discussion of donation and the informed consent process with the patient or family take place only after a decision to withdraw life support has been made. The protocols have different views on who should initiate discussion of donation with family members. A few prefer that the attending physician initiate this discussion. If the family expresses interest, OPO coordinators are then contacted for further explanation and discussion of the donation process. Other protocols do not require attending physician involvement and indicate that the "option to donate shall be presented to the family by the OPO transplant coordinator." Still other protocols emphasize the collective presence and cooperation of the attending physician, OPO coordinator, hospital witness, and patient advocate during discussions of donation with families. These provisions are interesting given the increasing body of state legislation and reporting in the medical literature requiring or strongly suggesting that trained and experienced personnel participate in donation discussions. One protocol allows donation only if the interest in organ donation is initiated by the family of the patient: "NHBD will never be offered as an option for any patient by a member of the health care team, transplant team, OPO, etc. … NHBD can only be discussed if an unprompted family member brings up organ donation as an important priority of the patient as his/her 'last wish.' If the family discusses the issue prior to a level-of-care decision being made, NHBD will never be considered as an option." This contrasts with another protocol that allows the possibility that families may inquire about organ donation before deciding to withdraw life support and permits OPO personnel to inform them that a decision to withdraw support should not be influenced by any considerations of organ donation. OPO personnel are allowed to return thereafter to discuss donation. About half of the protocols mention the need to inform the family that the patient may not die within the time required to allow donation. In such cases if the patient is in the operating room, he or she will be returned to the intensive care unit (ICU) until expiration. The amount of information provided to the family during or after informed consent is not clear in many protocols. About half of the protocols describe an informing process. Some are explicit, "The procedures necessary to perfuse and preserve the vascular organs will be explained, as will the necessity for disease testing, tissue typing, and moving to the OR [operating room] in a rapid manner following cardiopulmonary arrest. The family will be told that they may change their decision about donation at any time up to the actual removal of organs. In addition it will be explained that prior to any perfusion of organs, the patient must be declared dead by a physician. If the family so chooses, the OPO Coordinator will again verify consent after the pronouncement of death." Another states that "the OPO Coordinator will sit down with the family and fully explain the NHBD procedure and answer any questions which the family may have."
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--> Some protocols devote little attention to the informing of families, and a few do not mention an explanation of the donation procedure to the family at all. After discussion of donation with the patient or family, many protocols require the OPO coordinator to obtain the necessary written consent. A few others specify the attending physician or attending physician's designee. OPO And Procurement Team Intervention Before Death As noted, some OPOs assess donor suitability with various tests (apnea, serology, blood tests, tissue typing, etc.) before decisions to donate are made. The extent of OPO and procurement team preparation of the patient for organ retrieval also differs among protocols and has definite ethical implications. The point at which the procurement team inserts femoral arterial cannulas in anticipation of in situ organ flushing and preservation after death is of particular interest. Half of the OPO protocols allow the transplant surgeon to insert femoral arterial cannulas before the withdrawal of life support. Ten protocols require consent for cannulation. The other four do not explicitly mention any consent. Eight protocols prescribe cannulation immediately after death is pronounced. The location of withdrawal of life support affects the timing of cannulation in a few protocols. If withdrawal is to take place in the ICU, the transplant physician places cannulas before withdrawal of support with a separate consent from the family. If withdrawal takes place in the OR, cannulas are placed after death. Another protocol implies that the timing of cannulation permits different choices for the location of withdrawal and death. If a cold perfusion catheter is in place, discontinuation of support may take place in the ICU or the OR with family present. If catheters are not in place prior to withdrawal, withdrawal must occur in the OR and family may not be present. The implications are the same. The availability of cannulation and early cooling is compatible with procurement delays caused by transit to the OR and concessions to family presence and sensibilities, or the likelihood of these delays encourages provisions for early cooling. Yet another protocol seems ambiguous as to when cannulation occurs. This protocol calls for "consent for cannulation of the femoral artery and veins immediately after the declaration of death." In the rest of the protocol's description of procedures, the cannulation step is listed before the termination of support, and statements such as, "the time of death is the start of warm ischemic time on the OPO chart, if cannulae are placed after death" cause further ambiguity. A few protocols are imprecise regarding patient preparation for donation and simply note that the "patient is prepped and draped prior to the withdrawal of support." One protocol allows hospital personnel including the attending physician
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--> or the physician pronouncing death to "participate in … the procedures to preserve the donor's tissues or organs" if there is a shortage of help. Medication The administration of certain medications prior to donor death, in particular the anticoagulant heparin and the vasodilator phentolamine (Regitine), has generated public controversy and led, at least in part, to the request for this report from DHHS. These medications increase blood flow and preserve organs, but some observers allege that they also hasten the death of donors. OPO NHBD protocols disagree on the procedural use of heparin and phentolamine and the ethics of their use (see Table 5.1). Of the 29 OPO protocols reviewed, as noted in Table 5.1, 15 specify using heparin or the combination of heparin and phentolamine at some point during the death and donation process. Five OPOs administer heparin prior to termination of life support. One OPO administers heparin at the termination of support before death. Another gives heparin immediately after death is declared and circulates it through the donor's body with chest compression. This is also done in uncontrolled donors by yet another OPO. Two OPOs give heparin and phentolamine before the termination of life support. Single OPOs administer heparin and phentolamine after withdrawal, but before death, or after death but circulated by chest compression (also sometimes as a flush solution). Three OPOs use heparin and phentolamine only after death as part of flush and preservation solutions. TABLE 5.1. Administration of Heparin and Phentolamine Included in Protocols No. of OPOs Medications Administered 5 Heparin before withdrawal of life support 1 Heparin after withdrawal of life support, before declaration of death 2 Heparin after death, circulate with cardiac massage 2 Heparin and phentolamine in intravenous (IV) push before withdrawal of life support 1 Heparin and phentolamine after withdrawal of life support, before declaration of death 1 Heparin and phentolamine after declaration of death, circulate with chest massage 3 Heparin and phentolamine after declaration of death as part of flush solution 15 OPOs that mention using heparin or heparin and phentolamine combination 3 OPOs that explicitly forbid use of heparin and phentolamine or other drugs that "may hasten death"
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--> The remaining 14 OPO protocols either (1) forbid the use of phentolamine and heparin: "This protocol forbids any intervention which intentionally hastens the death of the patient. The administration of medications (such as Regitine and heparin) are [sic] forbidden. No interventions are to be justified by their being effective in preserving a more useful transplant or in regulating the time of death"; (2) do not specify the medications to be used—"patient given IV fluids, medications, blood products, etc. to prepare for donation"; or (3) do not mention the use of medications at all, although in some cases it is known that affiliated programs use heparin before support is withdrawn. Other medications used in various protocols include Thorazine, Verapamil, mannitol, cephalosporin, penicillin, insulin, trifluoperazine, and SoluMedrol and other steroids "to reduce ischemic damage." Withdrawal Of Life Support And Declaration Of Death Withdrawal of life support and declaration of death in controlled NHBDs differ among OPO protocols. In order to avoid conflicts of interest, all protocols explicitly require that the physician who declares death must not be affiliated in any way with the OPO, recovery team, or transplant team. The President's Commission and the Uniform Determination of Death Act define death as the "irreversible cessation of circulatory and respiratory functions." However, each individual physician, under applicable state laws, can determine when cessation is "irreversible," and criteria for the determination of death in NHBDs vary among OPO protocols. Several protocols thoroughly detail standards for the determination of death by the attending physician or a physician without any conflict of interest: "death shall be pronounced when the patient meets the following cardiopulmonary criteria: 1. confirm correct EKG lead placement, AND 2. confirm a pulse of zero via arterial catheter, AND 3. confirm patient is apneic, AND 4. confirm patient is unresponsive to verbal stimuli, AND 5. A) two minutes of ventricular fibrillation OR B) two minutes of electrical asystole OR C) two minutes of electromechanical disassociation" (capitalization in original). Most protocols refer more vaguely to the determination of death as being performed by the attending physician. Six to eleven (protocol language unclear) protocols specify electronic monitoring of the heart for determination of death after withdrawal of support. Others either use auscultation and palpation to monitor pulse or do not specify methods of determining death. Twelve OPO protocols dictate that the declaration of death and beginning of organ removal shall occur a few minutes (60 seconds, 2 minutes, 4 to 5 minutes, etc.) after detection of cardiac arrest. Presumably, this window of time is to ensure that the cessation of cardiac and pulmonary function is indeed irreversible.
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--> Several protocols declare death and begin procurement immediately "after determination of cardiac arrest," making no reference to any pause after the final heartbeats. It should be remembered that these provisions are for controlled NHBDs. The variation in timing of the events surrounding death is exemplified by comparing the following protocols. One OPO withdraws support and declares death, continues chest compression to circulate heparin and phentolamine, and then inserts catheters for cold perfusion before procuring organs. Another OPO performs this sequence in reverse: it inserts cannulas, withdraws support, administers phentolamine and heparin, and then declares death before procuring organs. Still another protocol appears imprecise in its timing of termination of support and declaration of death: "A non-transplant physician is present to pronounce death … ventilator is discontinued … at the word of the recovery surgeon life support is terminated if not already done … at the time of EMD [electronic dissociation], a non-transplant physician will make the declaration of death if not already done." Most protocols specify an interval during which death must occur following the withdrawal of support if procurement and donation are to continue. This interval averages about 1 hour, with extremes of 30 minutes and 4 hours. A majority of protocols prescribe that in cases where death does not occur within the established time, the family will be notified and patients returned to the ICU until death. The location of withdrawal of support and the possibility of family attendance are also areas of incongruity. Most protocols allow patient preparation and withdrawal of life support to occur in either the ICU or the OR. A few indicate that the OR has to be scheduled and reserved in advance, before withdrawal of support. Planning ahead for the location of procedures such as withdrawal of life support, determination of death, and initial cooling and procurement seems important given the tight timetable that must be followed to ensure the procurement of viable organs. One protocol views the location of withdrawal of support and patient death as having ethical implications: "To maintain the necessary level of separation between death and donation, life support will be withdrawn in the ICU, CCU [critical care unit], PICU [pediatric ICU], Post-Op, the Emergency Department, or such place, other than the Operating Room, that the patient may be located." In all cases when withdrawal of support followed by declaration of death occurs outside the OR, the patient is promptly transferred to the OR for organ procurement. A few protocols dictate that withdrawal of support is to take place only in the OR in order to "maximize the prospect for survival of transplanted organs." More than half of the protocols provide some flexibility in location of declaration of death, and many of these mention the family option of attending withdrawal. The remaining protocols either do not mention or do not allow family presence during the withdrawal, death, and donation procedures. Protocols
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--> that require withdrawal and death in the OR occasionally state that the family may not be present at this time. A few protocols in which withdrawal and death occur in the ICU explicitly allow families to be at the bedside at this time. The donor is moved to the OR for organ recovery after the family has said its good-byes and left the ICU. Some protocols allow family presence at withdrawal of support and death contingent on the location of these two events. One of these protocols gives the following choice to families: "Protocol A: if discontinuation of life support and death pronouncement will occur in the OR, the final viewing of patient by family and friends will occur in the ICU prior to the patient being moved to the OR. The primary care team responsible for discontinuing life support and pronouncement of death will move with the patient or meet the patient in the OR, and retrieval personnel may be present in the OR at the discretion of the attending physician. Protocol B: if discontinuation of life support and death pronouncement will occur in a private holding area in the OR recovery room, family may be present, and donor personnel will not enter the patient care area until the family has completed their visitation and death has been pronounced" (emphasis in the original). Another protocol stipulates, "Should a cold perfusion catheter be in place, the terminal wean may take place in the block room of the OR, the isolation room in the recovery room, or the patient's ICU bed. Family members may be present during the terminal wean in either of these locations. If no catheter is in place, the terminal wean shall take place in the OR and no family members may be present." Uncontrolled NHDs Several OPOs seem uncertain of the definition of NHBD, especially an uncontrolled donor. Five OPOs represented to the IOM that they do not have an NHBD protocol and do not formally practice recovery and transplantation of organs from NHBDs. Nevertheless, they have occasionally procured organs from patients who arrested in the OR. One OPO representative stated, "My surgeon and I have taken training for pump perfusion for kidneys, and we have recovered organs from heart-beating, brain-dead patients who arrested in the OR. We gave them heparin and cardiac massage until we could get the organs out." These patients—brain-dead donors who arrest unexpectedly before organ procurement—fall into the uncontrolled NHBD category (Maastricht category IV), but in this country such uncontrolled NHBDs often are not formally defined as such by physicians. As noted earlier, they may be considered controlled NHBDs. One physician felt that "everyone in the country practices this type of organ recovery … from patients who crash in the OR." Seven OPOs that said they did not practice procurement of organs from NHBDs have hospitals in their areas that, according to UNOS data, procured organs from NHBDs sometime between 1992 and 1996. Another OPO reported that it has no protocol but has recovered organs from fewer than 10 NHBDs at
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--> family request. Still another OPO stated that, although it has no NHBD protocol, hospitals in its area may develop their own. One hospital in this OPO area performs ''infrequent NHBD transplants." It seems likely that the NHBDs from this group of OPOs and hospitals include some controlled as well as uncontrolled donors. Five OPOs have approved protocols explicitly for uncontrolled NHBDs in addition to their controlled NHBD protocols. One of these, however, covers only the salvage of category IV donors whom are resuscitated for a short period to allow organ recovery. The additional issues that arise in uncontrolled donors (primarily categories I and II) include OPO interventions such as cannulation and cooling before family consent is given and decisions about the timing, initiation, and discontinuation of CPR. Because of time restrictions on the viability of organs, cannulation and initial cooling to preserve organs in uncontrolled NHBDs (who have been pronounced dead) is sometimes done without consent if the family is not immediately available. Cooling is intended to keep the option of donation open by allowing the family, once located, a few hours to decide whether or not to give consent to donate organs. One of the four OPO protocols that describe uncontrolled NHBDs allows this type of cannulation and cooling without consent to occur if the family is not immediately present. Two OPOs require that the family be notified of the patient's death and give consent prior to initial core cooling. After consent for cooling, the OPO is contacted and arrives on-site to cannulate and begin perfusion. The remaining uncontrolled NHBD protocols do not specify whether consent for cooling must be obtained; one that covers only category IV does not discuss this issue. Regardless of whether or not cannulation and cooling take place prior to consent, each OPO protocol for uncontrolled NHBDs prohibits actual organ procurement without family consent. Another procedure sometimes used during uncontrolled NHBD procurement that deserves consideration is the use of CPR after the patient has been pronounced dead. CPR after death is done for the purpose of keeping organs viable by continuing circulation. Drugs such as heparin and phentolamine and others can also be circulated. One protocol states that after determination of death by the attending physician, CPR is resumed in the emergency room (ER) while attempts are made to locate the family. If the family is not located within 30 minutes, CPR is discontinued and organ recovery is not pursued. The protocol that covers category IV donors prescribes CPR and circulation of heparin to allow organ retrieval. One protocol (not uncontrolled) specifically forbids post-mortem chest compression. Conclusion The overall length and detail of OPO protocols for NHBDs vary greatly. Some contain explanations of the donation crisis, the value of NHBDs, the
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--> OPO's philosophy of the donation process, principles, and a detailed protocol. Others are more general, with little reference to important aspects of the process. One protocol is constructed as a framework within which hospitals may tailor their own NHBD protocols. This protocol allows considerable freedom within some areas while setting minimum standards in others. In general, the NHBD protocols received and reviewed by the IOM have been written or approved within the last 4 years. The oldest was revised and approved in 1993, and the most recent was approved in July 1997. With respect to OPOs that have approved protocols in place, it is important to bear in mind that organs are procured from very few NHBDs (only one or two) by most OPOs each year. The fact that there are 25 OPOs with approved NHBD protocols and that UNOS reports 65 NHBDs in 1996 provides confirmation of the low rate of procurement of organs from NHBDs by most OPOs. Currently, OPOs located at hospitals tend to procure more organs from NHBDs. Review of the NHBD protocols submitted to the IOM reveals a consensus among OPOs in two areas: (1) discussion of organ donation with families and informed consent should take place only after an independent decision to withdraw life support has been made; and (2) the physician who declares death after withdrawal of support shall not be affiliated in any way with the OPO, procurement team, or transplant team. Outside of these two areas, OPO protocols for NHBDs differ greatly. Some variations are merely procedural whereas others imply ethical differences. The criteria for determining death; medical interventions, including the use of heparin and phentolamine, which are directed toward preparation for transplantation rather than donor patient care; intervention by the OPO to assess and prepare the donor before consent for donation and declaration of death; and the timing, approach, and detail of obtaining family consent—all are problematic issues discussed next in this report. A consensus on these issues, expressed in more standardized and detailed protocols would help to avoid conflicts of interest, safeguard quality care for donors and promote procurement of viable organs. The great variation found in OPO protocols and the increasingly urgent demand for more organs suggest the value of a discussion of NHBD programs in the United States with the objective of a more effective use of the costly Organ Procurement and Transplantation Network.
Representative terms from entire chapter: