Timely Referral of Potential Organ Donors

Abstract

Considerable advancements in the field of transplantation have been realized since the first successful kidney transplantation was performed in 1954. Since this monumental event, more than 300000 patients have received a transplant in the United States.1 Despite the advances in transplantation, a disparity remains between the number of patients who could benefit from transplantation and the number of organs available for transplantation.The greatest potential for increasing the number of organs available for transplantation in the United States lies in improving organ donation rates in the nation’s largest hospitals. According to estimates,2 the annual number of brain-dead potential donors in the United States is between 10500 and 13800. Of these potential organ donors, 90% are found in 951 of 4919 hospitals3 (nonfederal, short-term general and special hospitals; see TableT1). Conversion rates (ie, the percentage of eligible donors who actually become donors) in the largest 200 hospitals vary tremendously, from less than 10% to more than 90%.5The process of organ donation is complex and relies on multiple parties working in concert toward common goals.6 Hospitals and organ procurement organizations (OPOs) with high donation rates have integrated donation into the missions and cultures of the hospitals and have created donation systems that involve cooperation between both hospitals and OPOs to optimize outcomes during all aspects of the donation process, especially identification of potential donors, timely referral of potential donors, and the donation conversation.6 In contrast, hospitals with low donation rates are characterized by problems related to focus and attention, a situation that reflects organizational priorities. These hospitals have been slow to create a culture in which organ donation is a priority.7In the past, hospitals were given the responsibility to establish their own policies and procedures for identifying potential organ donors. When this approach is used, between 27% and 47% of potential donors were lost because they were not identified as potential donors, were not approached about donation, or decided not to donate.8 In a regulatory effort to address this significant loss of potential organ donors, the Health Care Financing Administration (now known as the Centers for Medicare and Medicaid Services) issued revised hospital conditions of participation related to organ donation.9 One of the key elements of these revised regulations, which became effective August 1998, was the requirement that all acute care hospitals have policies in place that define imminent death and require timely notification of the appropriate OPO about all patients who meet that definition. The Centers for Medicare and Medicaid Services did not define imminent death, because it was thought that such a definition involved clinical judgment and was best left to hospitals and OPOs. The only guidance provided to hospitals and OPOs was that a definition of imminent death would most likely include any patient who has been pronounced dead on the basis of neurological criteria or is severely brain injured and receiving mechanical ventilation.10 Many hospitals and their affiliated OPOs quickly moved forward to implement the new regulations by defining imminent death, revising referral systems, and, most importantly, holding each other accountable for adhering to the standards that were set. However, some hospitals have yet to develop a definition of imminent death and protocols for referring patients who meet the definition to an OPO.On the basis of suggestions from the OPO and physician communities, in 2004 the Centers for Medicare and Medicaid Services developed guidelines for hospitals and OPOs to use in developing a definition of imminent death. The guidelines9 suggest that the definition include the following: A patient with severe, acute brain injury who requires mechanical ventilation, is in an intensive care unit (ICU) or emergency department, andIn addition, many hospitals and OPOs have incorporated the absence of certain brain stem reflexes (ie, pupillary light response, corneal reflex, caloric response, gag reflex, cough reflex, and respiratory effort) into their definition of imminent death.The definition of imminent death agreed on by a hospital and its OPO is often referred to as a “clinical trigger” or “referral trigger.” Any referral trigger must strike a balance between the goals of the OPO and the needs of the hospital. The OPO wants to make sure that a definition is broad enough to ensure that all potential donors are identified and referred. On the other hand, the hospital must ensure that the definition is not so broad as to make it appear that the hospital is abandoning treatment options for a patient solely for the sake of organ donation.Many referral triggers list both mechanical ventilation and brain injury as criteria. For example, a referral trigger might read, “Any patient with a severe, acute brain injury who is receiving mechanical ventilation . . .” Although the term mechanical ventilation is necessary in any definition of imminent death as the term pertains to the identification of potential organ donors, the term brain injury may not be necessary, especially for organ donors whose death is declared on the basis of neurological or cardiopulmonary criteria. Clinicians commonly associate the term acute brain injury with head trauma in the identification of potential donors. Head trauma was listed as the cause of death in 39% of actual organ donors in 2004.11 If a hospital limits its definition to patients with acute brain injury, and brain injury equates to head trauma, then a considerable number of potential donors may not be referred, or may be referred so late in the process that their organs are no longer suitable for transplantation. For example, in comatose survivors of cardiac arrest who lack pupillary and corneal reflexes 24 hours after cardiac arrest and have no motor response 72 hours after cardiac arrest, the chance of meaningful neurological recovery is extremely small.12 These patients may not be readily identified as potential organ donors if acute brain injury is part of the hospital’s referral trigger.Thus, hospitals and OPOs should carefully consider whether the term acute brain injury should be included or removed from their referral trigger. In order to ensure that every potential organ donor is identified, a referral trigger whose initial criteria are related to mechanical ventilation and unresponsiveness will help make sure that those patients whose brain injury is due to another acute event are included.The next element of many referral triggers is clinical findings. The 2 most common clinical findings used in referral triggers are a patient’s GCS score and brain stem reflexes. The GCS score is the most universally recognized and accepted grading system for neurological conditions, including closed head trauma, gunshot wounds to the head, spontaneous intracerebral hemorrhage, nontraumatic coma, and subarachnoid hemorrhage.13 Studies support the claim that the GCS score is the most important factor in predicting survival.14–16 The score is used primarily because it is simple, has a relatively high degree of interobserver reliability, and correlates well with outcome after severe brain injury. The probability of poor outcome increases in a continuous, stepwise manner as the GCS score decreases. Prehospital- and hospital-based study data indicate that a GCS score of 3 to 5 has at least a 70% positive predictive value for poor outcome.17(p186)Similarly, the testing of brain stem reflexes is part of a complete neurological examination. Like the GCS score, the absence of brain stem reflexes has a strong predictive value for poor outcome,18,19 and thus this criterion is often incorporated into referral triggers. The brain stem reflexes that can be readily assessed by nurses at the bedside include pupillary light response, corneal reflex, gag reflex, and cough reflex.The evaluation of clinical signs of imminent death for the purpose of referral triggers should occur after hemodynamic, pulmonary, and surgical resuscitation measures have been taken. A referral trigger that includes clinical findings consistent with a GCS score of 5 or less or the absence of 2 or more brain stem reflexes is adequate for determining which patients have a predictive value for poor outcome.Withdrawal of life-sustaining therapies is an issue in intensive care medicine because life can now be maintained for long periods in patients who would otherwise die.20 Requests to discontinue life support are common in critical care, especially when devastating neurological injuries leave a patient with little or no chance of meaningful recovery. The number of patients who have undergone withdrawal of life-sustaining therapies has increased over time.21 In many instances in which patients’ families request that life support be discontinued, the families want the opportunity to donate but do not want to prolong the process while waiting for a diagnosis of brain death, because the criteria for brain death might never be met.21 This fact has led many hospitals and OPOs to include the intention to withdraw life-sustaining therapies in their referral triggers. A referral trigger that includes plans to withdrawal life-sustaining therapies, or the discussion of such plans by a patient’s family and physician, will help identify patients who could donate after cardiac death.In summary, referral triggers for organ donation should include an unresponsive patient receiving mechanical ventilation who has clinical findings consistent with a GCS score of 5 or less or the absence of 2 or more brain stem reflexes, or for whom plans to withdraw life-sustaining therapies will be discussed or are being discussed by the patient’s family and physician.In addition, the guidelines of the Centers for Medicare and Medicaid Services for organ donation require hospitals to notify the appropriate OPO in a timely manner once a patient meets the criteria for imminent death so that the patient’s suitability as an organ donor can be evaluated and to ensure that donor organs remain viable for transplantation.9Timely notification of imminent death is a positive factor in increasing donation rates.22 A referral by a hospital is considered timely if it made as soon as possible after a patient meets the criteria for imminent death, ideally within 1 hour.10 Timely notification of the OPO about patients who meet the criteria for imminent death is crucial, because 62% of brain-dead donors will experience cardiac arrest as a result of physiological instability within 24 hours of meeting those criteria; 87% will experience cardiac arrest within 72 hours.23 In addition, once discussions about the withdrawal of life-sustaining therapies begin, the final decision to withdraw support is made within 24 hours in 66% of cases.24 Hospitals report that the organ donation process works best when referrals are timely and are based on standards that are agreed upon by both the hospital and the OPO.6It is widely agreed that increasing consent rates for organ donation is the most critical need in transplantation, and efforts to study the processes involved in making the decision to donate organs are ongoing.25 The essential logistics (who, how, and when) of the donation conversation generate a wide range of views and opinions among both OPO and hospital personnel.The process of obtaining consent for donation has evolved from a onetime interaction with a patient’s family to a dynamic interactive process among the patient’s family, the OPO staff, and hospital personnel. Research indicates that a collaborative effort between hospitals and OPOs is the most effective way to improve donation rates.26 Recently, through the Organ Donation Breakthrough Collaborative, this shared effort has been termed the “huddle.” Huddles are coordinated, short, timely, frequent exchanges of critical information between hospital and OPO staff aimed at meeting the unique needs of each family in order to create and establish an effective request process.27 Huddles provide an opportunity for hospital and OPO staff to discuss the status of death declaration, assess the family’s dynamics and comprehension of the patient’s prognosis, and begin to plan for the donation discussion in an unhurried and deliberate manner. Huddles are also one of the key evidence-based best practices for improving donation rates.6When asked, the general public overwhelming reports a desire to donate. The major reasons given for this desire to be an organ donor are altruistic28: “I want to help people.” “It saves lives.” “It is the right thing to do.” However, donation rates have not reflected this support. Traditionally, the donation conversation has centered on providing information about the donation process in an impartial manner while trying to address concerns and objections.29 Rarely, if ever, did the donation conversation focus on the altruistic reasons for being a donor.In an attempt to address this inconsistency, the University of Pennsylvania, supported by a grant from the Health Resources and Services Administration, designed a study called the Presumptive Approach to Consent for Organ Donation.30 This study brought to the forefront a new approach philosophy: that most people will donate because it is the right thing to do, and that when given an opportunity to save a life, most people will do so.31 By altering the way in which the information is presented, the requestor presumes that a patient’s family does wish to donate the patient’s organs and that donation is the right thing to do when death occurs.4 Simple shifts in language are key to this approach. For example, phrases such as “When you donate” (rather than “If . . .”) and statements such as, “Thousands of people have been helped by organ donation and have gone on to live long and happy lives,” and “Most people believe that donation is the right thing to do in this situation; I am here to provide you with information to help you with your decision to donate,” take a positive stance toward donation and more accurately reflect society’s values.32Preliminary results from the 4 study sites indicated that donation rates increased 10% when a presumptive approach was used in the donation conversation.4 Regardless of how the donation conversation is structured, a patient’s family members must be given all the necessary information to enable them to make an informed decision.Historically, many OPOs have promoted and adhered to a principle of requesting organ donation known as decoupling. Decoupling refers to the clear separation of the notification of brain death and the request for consent for organ donation.32 Results of recent studies33,34 do not prove that decoupling is the universal remedy for improving consent rates. Families of dying patients need to know whether death is imminent and, if so, what to expect.35 Hospital and OPO personnel report that spending time preparing a patient’s family for imminent death contributes to improved donation rates by preparing the family to make necessary decisions, one of which is about organ donation.6The timing of the donation discussion does not lend itself to a strict protocol because the circumstances for each potential donor are unique, and hospitals and OPOs must be able to quickly adjust to the needs of each patient’s family. Early mention of the possibility of donation (once considered unthinkable by OPO staff, although often practiced by hospital staff ) may not be problematic when a family’s needs and understanding of the patient’s prognosis are taken into account. When death is imminent and the family understands the prognosis, the hospital staff and OPO, working collaboratively, can introduce organ donation as a possibility and provide information to assist the family in understanding what to expect. Donation rates are higher when patients’ families are not surprised by the donation request, and higher donation rates are positively correlated with the amount of time that OPO staff spend with the patient’s family before the request for organ donation.36Significant improvements in organ donation rates are possible. Recently, 184 of the largest hospitals in the United States were awarded the Department of Health and Human Services Medal of Honor for Organ Donation. Each of these hospitals was able to achieve a 75% or greater conversion rate for an extended period. An additional 30 hospitals were able to achieve a 65% to 74% conversion rate. These improvements were the direct result of hospitals and OPOs working together to redesign donation systems and implement evidence-based best practices. Clearly, “Every system is perfectly designed to get exactly the results that it gets.”5 Donation rates can be significantly increased if each hospital examines and improves its donation system.