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Organ Donation: Opportunities for Action 4 Systems to Support Organ Donation Organ transplantation involves a complex, collaborative set of interactions among patients, family members, healthcare professionals, organ procurement and transplant coordinators, the hospital where the donation occurs, the organ procurement organization (OPO) that facilitates the acquisition and distribution of organs, and the transplant center. Although any hospital may have a patient who is a potential organ donor, specialized hospitals that treat many patients with traumatic injuries and other serious conditions (particularly those that can result in neurologic determination of death) are the ones that, to date, have been most likely to have potential organ donors in their patient populations. Current debate and discussions about changing the organ donation process to increase the supply of transplantable organs occur within the context of ongoing efforts to improve the healthcare system as a whole. One major challenge facing the United States is improving the overall quality of health care. The increasing complexity of new technologies, the inadequate organization of the healthcare delivery system, the increased proportion of health care devoted to chronic conditions, and current constraints on taking full advantage of changes in information technology have all contributed to a healthcare system that is overburdened, inefficient, and often inequitable. In view of these problems, the Institute of Medicine (IOM) reports on healthcare quality have identified six improvement aims for the healthcare system (IOM, 2001, 2004a): Safe—avoiding injuries to patients from the care that is intended to help them
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Organ Donation: Opportunities for Action Effective—providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and avoiding overuse, respectively) Patient centered—providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions Timely—reducing waits and sometimes harmful delays for both those who receive and those who give care Efficient—avoiding waste, including waste of equipment, supplies, ideas, and energy Equitable—providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status These goals are highly relevant to the challenges facing the organ donation and transplantation system. These challenges include ensuring a patient- and family-centered system, providing equitable access to transplantation through the elimination of economic and ethnic or cultural barriers, increasing trust and confidence in the system, and providing the care needed to optimize the value of the transplant to the recipient. As previous IOM studies on improving the quality and safety of U.S. health care have concluded, improving care requires a focus on systems, not on the individuals within those systems (IOM, 2000a). “[E]very system is perfectly designed to achieve the results it achieves” (Berwick, 1996, p. 619). Hence, if the results are unacceptable, the system’s design must be changed. This chapter focuses on the clinical systems issues that are specific to the organ donation process. It is important to note, however, that an equitable allocation system and ongoing attention to the recipient are vital to maintaining the value of the donated organ and sustaining the integrity of the entire organ transplantation system (Box 4-1). Although these allocation issues are beyond the scope of this report, addressing them is indispensable to achieving a trustworthy organ donation system and thereby increasing the rates of donation. Additionally, several aspects of tissue donation and the market for tissue-related products need attention in order to ensure the credibility of the entire donation system. The chapter begins with a brief overview of the issues facing the U.S. organ donation system, provides a snapshot of ongoing efforts, and concludes with recommendations for next steps to improve the system. As discussed throughout this chapter, there are many opportunities to build on existing practices and to leverage ongoing quality improvement efforts to expand knowledge and implement best practices. Clinical care at the end of life receives the main attention in this chapter, while emergency care and resuscitative care are examined in Chapter 5.
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Organ Donation: Opportunities for Action BOX 4-1 Issues in Allocation and Distribution of Organs Equitable Access to Transplantation: Medical, technical, ethical, and other issues arise in the referral for transplantation, admission to the waiting list, and selection to receive a donated organ. The criteria for each of these actions continue to need close attention by both professionals and the public to ensure equity. Particularly important is the role of the so-called green screen (which screens for insurance coverage and the ability to pay for the transplant) for nonrenal transplants and, often relatedly, the problems of access faced by minority populations. Access to Immunosuppressive Medications Following Transplantation: Immunosuppressive medications, estimated to cost more than $10,000 per patient annually, are needed for the rest of the patient’s life after transplantation; their discontinuation can result in organ rejection and the need for retransplantation (Chisholm and Garrett, 2001). It has been estimated that medication noncompliance results in the loss of 13 to 35 percent of transplanted kidneys (Yen et al., 2004), but it is difficult to determine the extent to which noncompliance is tied to the high cost of medication. Medicare currently provides initial coverage for immunosuppressive medications after most solid-organ transplants that occur in Medicare-approved facilities. However, for many patients this coverage is limited to 3 years posttransplantation. An analysis of the effects of extending immunosuppression coverage from one to three years found improved graft survival (Woodward et al., 2001) suggesting the importance of uninterrupted access to immunosuppressive medications for optimal outcomes from donation. Research models that explored extending to lifetime coverage found improved transplant and economic outcomes (Yen et al., 2004). For individuals who are eligible for Medicare because of age or disability, the Benefits Improvement and Protection Act (incorporated into Public Law 106-554) extended the benefits to lifetime coverage of immunosuppressive medications; however, this full coverage applies to only a fraction of total transplant recipients. Private insurers offer some patient assistance programs to provide medications to patients who lack Medicare coverage or the ability to pay, but these programs are highly individualized to specific insurance companies. Immunosuppressive medications offer the dual protection of maintaining the health of the recipient and protecting a scarce resource, a transplanted organ. A 2000 Institute of Medicine analysis of the effectiveness and cost savings of extending the Medicare coverage benefit found strong evidence for eliminating the time limits for coverage of immunosuppressive drugs for all solid-organ transplant recipients (IOM, 2000b). CONTEXT OF THE CURRENT U.S. ORGAN DONATION SYSTEM The U.S. organ donation system has evolved over the past half century, having been shaped by a series of federal and state laws and regulations, private-sector oversight, and individual hospital policies. The system has focused primarily on deceased donors with neurologic determination of death. More recently, living donation, which is rapidly increasing, has
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Organ Donation: Opportunities for Action largely been regulated through hospital policies (Chapter 9). Internationally, some countries have developed extensive systems for organ donation and recovery, particularly in countries with national systems of health care. In addition, individuals whose deaths are determined by circulatory criteria represent a largely untapped group of potential organ donors (Chapter 5). In the United States, people become organ donors either after the determination of death by established criteria (together with their prior consent or the consent of their family) or after an autonomous decision by a living person to donate all or part of an organ. Each circumstance presents distinct clinical, ethical, legal, emotional, spiritual, and cultural issues. This chapter focuses on the donation of organs by deceased donors (deceased organ donation). Organ donation by living donors is discussed in Chapter 9. Under the existing legal and ethical framework of deceased organ donation in the United States, organ donation must not cause or hasten death (the dead donor rule) and the individual’s wishes regarding donation must be honored. Some donors have indicated their preferences to donate before their death (e.g., on their driver’s license, in an advance directive, or by signing a donor registry); others have not and the decision to donate organs is left to the family or surrogate at the time of the individual’s death. Regardless of the cause of death or the decision-making pathway, one person’s death creates the opportunity for others to benefit from the donation of one or more organs. With some exceptions (for instance, where there is valid evidence of the deceased person’s wish to donate, perhaps backed by state law and OPO policy), the current practice of obtaining consent for deceased organ donation generally involves hospital or OPO staff talking with the patient’s family or surrogate about what is known about the potential donor’s wishes and providing information on the opportunity for organ donation. This practice is consistent with other decisions made by surrogates at the end of life and the requirements for informed consent (Beauchamp and Childress, 2001; National Consensus Project Steering Committee, 2004). The family’s knowledge of the wishes of the deceased individual is often a key factor in the decision about donation (Sque and Payne, 1996; Siminoff and Lawrence, 2002; Jacob Arriola et al., 2005; Sque et al., 2005; Rodrigue et al., 2006). There is wide variation from case to case and among hospitals and OPOs in who talks with the family and when and how those discussions occur (HRSA, 2003). Systems of Care: An Organizational Perspective Organ transplantation generally involves interactions among three organizations: the donor hospital, the OPO, and the transplant center(s).
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Organ Donation: Opportunities for Action Each organization has unique features but must meet conditions of participation established and regulated by the Centers for Medicare & Medicaid Services (CMS). To be accredited each organization must meet the accreditation criteria of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and those of other organizations (Box 4-2). The challenges to the system—as well as the opportunities for improvement—are found in the variations among organizations. Of the 58 OPOs (recently designated collectively as “donate life organizations”) in the United States, 50 are independent and 8 are hospital or university based. Each OPO serves a unique geographic area (a donation service area [DSA])1 with specific donor hospitals and transplant centers; in 2003, the populations served by individual OPOs ranged from 1 million to 17 million people and the OPO coverage areas ranged from approximately 3,600 to more than 850,000 square miles (AOPO, 2004). Similarly, the range in the number of acute-care hospitals in a DSA is also wide, with from 12 to 220 hospitals in a single DSA. Some OPOs recover organs from many different hospitals, whereas others work with only a few hospitals. In 2003, from 6 to 78 hospitals within a single DSA reported one or more organ donors (AOPO, 2004). Also in 2003, the number of organ donor referrals to an OPO varied from a low of 52 to a high of 2,627 and the number of organs locally recovered by OPOs ranged from 86 to 1,181 (AOPO, 2004). As a result of the demographics of a region, the demand for services in a particular region, and the administration and management of OPOs, the structures, staffing, and financing of OPOs vary widely. Most OPOs (72 percent in the 2003 Association of Organ Procurement Organizations [AOPO] survey) recover tissue as well as solid organs, and a few OPOs are involved in tissue processing; additionally, several OPOs operate an eye bank or a histocompatibility testing laboratory. The OPOs in St. Louis and Philadelphia have built, or are in the process of building, facilities for organ recovery. The financing of organ transplantation largely occurs through the health insurance costs paid by Medicare or private insurers. In 2004, private insurance was the primary payment source for 47.9 percent of transplant recipients, with 39.3 percent having Medicare as the primary source, and 9.0 percent using Medicaid (HRSA and SRTR, 2006). OPOs develop standardized fees (standard acquisition charges) representing the average cost for each type of organ. The fees include direct costs, organ acquisition overhead, and general and administrative costs. 1 The DSA is the geographic area that is served by one OPO, one or more transplant centers, and one or more donor hospitals.
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Organ Donation: Opportunities for Action Direct costs consist of donor-related medical costs after declaration of death (including operating room costs, surgeon fees, tissue typing, transportation of the organ and surgical teams). Organ acquisition overhead includes donor approach and public awareness costs. General and administrative costs include finance, human resources, information technology, and occupancy costs. The standard acquisition charge is billed to the transplant center receiving the organ. The center develops its own organ acquisition fees in addition to the transplantation fees and bills them to the recipient’s insurance company or other payer. The OPO does not conduct any financial transaction with the recipient or the recipient’s insurance company (third party payer). In 2003, the median local standard acquisition charge for kidneys was $20,500 (AOPO, 2004). Medicare Part A, specifically the End-Stage Renal Disease program, is authorized to pay acquisition fees for organ acquisition and organ transplantation. OPOs are subject to annual federal audits after each fiscal year to reconcile their costs and the acquisition fees billed to transplant centers. In 2003, total Medicare expenditures totaled $14.8 billion for dialysis and $0.8 billion for organ acquisition and transplantation (USRDS, 2005). CMS provides oversight to the transplantation system through the Medicare/Medicaid conditions of participation. Only transplant centers that meet the conditions of participation are eligible for Medicare or Medicaid reimbursement. OPOs must meet separate certification criteria. CMS is currently revising the conditions of participation including the process and outcome measures and the certification cycles (Box 4-2). OPOs also vary in their approaches to staffing and hospital interaction. In 2003, 28 OPOs responding to a survey reported that they had 31 or more employees, with only one OPO reporting fewer than 10 employees (AOPO, 2004). OPO staff members include organ and tissue procurement staff (e.g., laboratory managers and technicians, coordinators), executive staff, donation request and family care staff, public education personnel, and call center staff. Some OPOs have established in-house coordinator programs in which full-time OPO staff work at Level I trauma centers and are fully integrated into hospital operations (HRSA, 2003). Other OPOs have staff who are based in multiple hospitals, whereas others, particularly those in rural settings, have staff based at the OPO office who travel to various hospitals in the region as needed. The heterogeneity of OPOs is evident in the range of donation rates. The Scientific Registry of Transplant Recipients calculates observed donation rates (calculated as the number of actual donors per the number of individuals eligible for donation) and expected donation rates (the expected donation rate accounts for the variations in age, sex, race, and cause of death among notifiable deaths). Among OPOs the observed donation rates
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Organ Donation: Opportunities for Action BOX 4-2 Regulation and Accreditation Centers for Medicare & Medicaid Services (CMS): CMS is responsible for certifying OPOs and transplant center hospitals for Medicare coverage. The conditions of participation for OPOs and transplant centers are in the process of being revised to address requirements of the Organ Procurement Organization Certification Act of 2000. The proposed rules increase the recertification cycle from 2 to 4 years and establish multiple outcome and process performance measures, including changes in measurements of donor potential by replacing the current use of population data with data based on hospital referral calls to OPOs. Data submission and outcome requirements for transplant centers are also proposed to be modified to consider the care being provided rather than relying on underlying policies and procedures. The proposed rule expands outcome measures to include graft survival rates (CMS, 2005). Organ Procurement and Transplantation Network (OPTN): OPTN develops policies and procedures for organ recovery, allocation, and transplantation and conducts reviews and evaluations of each member OPO and transplant center for compliance with OPTN policies. Joint Commission on Accreditation of Healthcare Organizations (JCAHO): Since January 1988, JCAHO has required its member hospitals, as a prerequisite for accreditation, to develop policies and procedures on the identification and referral of potential donors. JCAHO requires hospitals that recover organs to have an agreement with an appropriate OPO and at least one tissue bank and one eye bank. JCAHO describes procedures for notifying the family of the option to donate and for maintaining the records of potential donors. A standard which became effective in July 2005 requires hospitals to measure the effectiveness of their organ procurement efforts. According to this standard, the conversion rate data must be collected and analyzed, and steps must be taken to improve the rate whenever possible (JCAHO, 2005). Association of Organ Procurement Organizations (AOPO): AOPO sets organizational and ethical standards for OPOs and offers a voluntary accreditation program to its members. The peer review accreditation process helps ensure compliance with federal regulations as well as AOPO standards. The period of accreditation is 3 years, after which the OPO must apply for reaccreditation to maintain its status. Recent standards include an emphasis on continuous quality improvement practices. American Board for Transplant Certification (ABTC): ABTC develops certification standards and programs for certification testing for transplantation clinicians. Specifically, clinicians may receive certification as a certified procurement transplant coordinator, a certified clinical transplant coordinator, or a certified clinical transplant nurse.
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Organ Donation: Opportunities for Action in 2004 varied from 34.3 percent (with an expected rate of 54.9 percent) to 77.9 percent (with an expected rate of 51.3 percent) (SRTR, 2005) (Table 4-1). These statistics refer only to deaths determined by neurologic criteria. Wide variations in the number of cases of donation after circulatory determination of death (DCDD) also occur (Chapter 5). In 2004, 21 of the 58 OPOs had completed five or more DCDD cases, whereas 18 OPOs had not had a DCDD case in that year. Variations among OPOs and among transplant centers are being addressed through quality improvement processes and practices through the Organ Donation and Transplantation Breakthrough Collaboratives, which are described below. According to the best estimates, approximately 200 of the nation’s hospitals host half of the nation’s eligible donors (HRSA, 2005a). A 2003 report by the Office of the Inspector General of the U.S. Department of Health and Human Services found that the 190 transplant centers obtained consent from a mean of 51 percent of potential donors, with 30 centers (16 percent) having consent rates of 70 percent or higher and 18 centers having consent rates of less than 30 percent (DHHS, 2003). Hospitals with the largest potential for donation may also be the most stressed because their intensive care units (ICUs) typically run at peak capacity, despite shortages of nurses and other key personnel (JCAHO, 2004). Because of ongoing concerns about the serious shortages of nurses (IOM, 2004b) and other personnel, the extent to which the current system will be able to accommodate large increases in the numbers of donors and transplant recipients is unclear. Currently, specialized operating room and critical care professionals must be available for donation surgery and the TABLE 4-1 OPO Donation Rates, 2004 Number of OPOsa Donation Rateb (%) Range 7 34–45 8 45–50 14 50–55 7 55–60 8 60–65 9 65–69 6 70–78 aIn 2004, there were 59 OPOs; a merger occurred in 2005, and currently there are 58 OPOs. bThe donation (or conversion) rate is calculated as the number of actual donors per the number of eligible donors expressed as a percentage. Eligible donors are defined as heart-beating individuals who meet or who will imminently meet criteria for neurologic determination of death, who are aged 70 years or under, and who have not been diagnosed with exclusionary medical conditions. SOURCE: SRTR (2005).
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Organ Donation: Opportunities for Action subsequent transplantation procedures. In an already stressed system, shortages of nurses or anesthesiologists, for example, could limit the options for timely donation and the quality of care of either the donor or the recipient. Given these system challenges, strategic planning for such increases would need to be undertaken to ensure that these scarce resources will be able to be used the most effectively and that the necessary human resources are available. Required Request and Required Referral Several systemwide initiatives have focused on increasing the donation rate by ensuring that all potential donor families are asked about donation (required request) and that OPOs are notified of all imminent deaths (required referral). Beginning in 1986, the Health Care Financing Administration (HCFA; now CMS) stipulated that Medicare reimbursement to hospitals was contingent on the hospital having a required request policy to ensure that the families of patients who are eligible to be donors are given the opportunity to donate (Nathan et al., 2003). In 1998, HCFA published the stipulations, known as the Final Rule, that imposed several additional requirements, including the requirement for hospitals to have an agreement with an OPO and to put in place mechanisms to contact the OPO in a timely manner about individuals who die or whose death is imminent (required referral) (DHHS, 1998). The regulations also require hospitals working with the local OPO to inform the family of every potential donor of the option to donate organs or tissues. JCAHO has incorporated required request and referral policies into requirements for hospital accreditation (JCAHO, 2005). Increases in the numbers of referrals to OPOs have occurred; from 2002 to 2003 the number of referrals increased by nearly 10 percent (from 1,022,280 to 1,121,392) (Delmonico et al., 2005). However, the extent to which increases in donation rates can be attributed to required referral practices alone is unclear. One potential gap in the current system is that the referrals most often involve patients whose deaths are imminent as determined by neurologic criteria and do not often include deaths determined by circulatory criteria (Bernat et al., 2006) (Chapter 5). ORGAN DONATION AND TRANSPLANTATION BREAKTHROUGH COLLABORATIVES In recent years, many initiatives to increase the rates of organ donation have been undertaken. Several of these efforts are early in their implementation phases and have not yet been fully evaluated. Although organ donation rates have risen in the past 5 years, it is difficult, if not impossible, to
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Organ Donation: Opportunities for Action determine exactly how much each initiative or regulatory change has contributed to that rise. Taken together, the data suggest that a multipronged approach is necessary to realize the potential of organ donation in the United States. A major new initiative is the series of Organ Donation Breakthrough Collaboratives. Directed by the Health Resources and Services Administration (HRSA), the collaboratives attempt to increase rates of organ donation by encouraging hospitals and OPOs to use methods of continuous quality improvement to enhance the process of deceased organ donation. The process of identifying and referring potential donors, requesting donation, recovering the organs, and ensuring that they are successfully transplanted is complex. It takes place under difficult circumstances, with time pressure and emotional stress, and in environments that vary widely across the country. In these circumstances, mobilization of the personnel involved in the local settings to identify ways to improve the process, use quality improvement methods to explore the process, and share the results BOX 4-3 Quality Improvement in Health Care Quality improvement can be defined as systematic activities that are guided by empirical evidence and that are designed to bring about immediate positive change. A wide variety of methods are used to achieve quality improvement, all of which involve deliberate actions to improve processes involving the provision of health care in local settings. These actions are guided by data on the effects of the methods that have been introduced. For example, introducing quality improvement methods often means encouraging people in the local setting to use their daily experience to identify promising ways to improve the quality of the care that they provide, implement changes on a small scale, collect data, and assess the results. The goal is to find interventions that work well, implement those interventions more broadly, and thereby improve local practice. Alternatively, a quality improvement activity might begin with a review of aggregate data at the patient, provider, clinical unit, or organizational level to identify a clinical care or management change that can be expected to be an improvement over the existing procedures. The change is made, the effects are monitored, and conclusions are drawn about whether the change should be made permanent. Quality improvement can also be brought about by collecting data from multiple organizations, analyzing those data to understand what drives positive change, and using the results to design and implement a strategy to achieve a specific improvement across organizations (Berwick, 1989; Kilo, 1998; McLaughlin and Kaluzny, 1999).
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Organ Donation: Opportunities for Action with others has significant potential to increase the supply of organs available for donation (Box 4-3). The collaboratives began with HRSA partnering with the Institute for Healthcare Improvement (IHI), a nonprofit organization that is a leader in promoting the application of quality improvement methods to healthcare systems. IHI developed the Breakthrough Collaborative model, which brings healthcare organizations together to identify, learn, adapt, replicate, and celebrate breakthrough practices that can help them achieve specific improvement goals (IHI, 2003). The collaborative’s initial analysis of data on organ donation found wide variations in donation rates (also termed conversion rates) among hospitals and OPOs. (It is important to note that conversion rates are based on data from donation after neurologic determination of death and do not reflect the larger potential population of donors after circulatory determination of death [Chapter 5].) The data also showed that large urban hospitals with busy trauma centers hold the greatest potential for increasing donor conversion rates because approximately half of the eligible donors are concentrated in slightly more than 200 of the largest hospitals nationwide (HRSA, 2005a). On the basis of site visits, extensive interviews, and a review of the best practices at six OPOs and 16 OPO-affiliated hospitals with high donor conversion rates (HRSA, 2003), the collaborative leaders developed a change package that comprised a set of shared strategies to boost organ donation rates. Broadly, those strategies advocate organ donation as the mission, involve senior leadership to achieve results, deploy a self-organizing OPO/hospital team, practice early referral and rapid response, learn effective requesting, and implement DCDD. The first two collaboratives focused on organ donation. In 2003 and 2004, the first collaborative began with 95 hospitals and 43 OPOs as participants (personal communication, D. Wagner, HRSA). To share best practices among participating OPOs and hospitals, the collaboratives conduct regular learning sessions, in which participants describe their experiences, discuss problem-solving techniques, and celebrate their successes. Through these interactions, a community with a shared vision and a commitment to improving the donation process has developed. Data on several process and outcome measures are voluntarily submitted: the organ transplant conversion rate, the referral rate, the number of medical examiner denials, the use of timely notification, the use of the appropriate requester, and donor before nondonor statistics. These measures serve as benchmarks
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Organ Donation: Opportunities for Action gan donation. The confidence and trust in quality health care needed to promote and encourage organ donation are the same goals as those needed to ensure optimal end-of-life care. To isolate organ donation from the broader context of end-of-life care has the potential to ultimately undermine the effectiveness of efforts to increase donation rates. Emphasis on Patient and Family Relationships An end-of-life care framework acknowledges that care is for the patient and his or her family and continues through the patient’s death and the family’s bereavement. Respect for individual choices is central to a framework of end-of-life care. Likewise, respect for a person’s competent choice about organ donation will guide decisions at the end of life. Ideally, patients will have formally designated a proxy decision maker by executing a durable power of attorney for health care. In some cases, however, patients may not know or may not have discussed their preferences with family members or healthcare professionals. In a study focusing on surrogate decision making in end-of-life care, researchers found that the surrogate decision makers experienced less stress when they knew their loved one’s preferences and when those preferences were documented in an advance directive (Tilden et al., 2001). By themselves, however, advance directives cannot eliminate the burdens of decision making at the end of life, in part because they are rarely clear enough or specific enough to dissolve all uncertainty and ambiguity (Tulsky, 2005). In situations in which the deceased person’s wishes have not been documented, an end-of-life care framework suggests that conversations with families be framed in terms of what most people would want if they were alive to state their desires and what most aggrieved families would want if they were able to step outside their grief. Attitude surveys consistently show that most people would want to donate and that most families are touched by the message that organ donation is an opportunity to bring some good out of their tragedy. Because families are the most common surrogate decision makers at the end of life, it is essential that a framework for end-of-life care and organ donation be family centered. Shannon (2001) asserts that the families of critically ill patients play three important roles: they contextualize the patient’s life, they serve as proxy decision makers, and they are themselves the recipients of care. Families are often the people who know the critically ill patient best and are able to help healthcare professionals understand the patient’s values; preferences; and interpretations of the meaning of treatment, dying, and death. They also commonly serve as proxy decision makers when patients are no longer able to speak for themselves, for instance, because of a severe brain injury or some other catastrophic disease process.
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Organ Donation: Opportunities for Action Although concerns are frequently raised about families overriding patient’s preferences, there is little or no empirical evidence that this practice is widespread (Chapter 2). In an end-of-life care framework, the presumption would be that decisions about organ donation would be consistent with the patient’s recorded wishes in the absence of current and compelling evidence that the patient changed his or her mind. This presumption is consistent with clinical, ethical, and legal practices in decisions about other forms of end-of-life care. In view of the importance of the potential donor’s prior wishes, it is appropriate to elicit and document the individual’s views about organ donation at different times in the context of discussing a range of preferences about end-of-life care. Use of Interdisciplinary Healthcare Teams Increasingly, hospitals are developing interdisciplinary palliative care teams, inpatient hospice units, and bereavement programs (Manfredi et al., 2000). Consistent with an end-of-life care model, interdisciplinary teamwork is essential (National Consensus Project Steering Committee, 2004). Recently, models of training in the organ donation process have highlighted the importance of an interdisciplinary team that includes OPO staff and that closely collaborates with OPO staff. Although various roles within the process can be handled by individuals from different disciplines, there is a consensus that an interdisciplinary team approach is the most effective for achieving positive donation outcomes (DHHS, 2000). An expansion of this approach would include the integration of organ donation and recovery practices into end-of-life protocols. The Nebraska Health System, for example, created the Acute Bereavement Service to ensure a consistent and caring approach to potential donor families (DHHS, 2000). Its interdisciplinary team provides comprehensive services to potential donor families and reports a nearly 100 percent rate of referral of hospital deaths to the OPO. New partnerships among critical care professionals, palliative care and bereavement specialists, and OPO staff would help to achieve full integration. Enhance Training in End-of-Life Communication and Decision Making The healthcare professional’s level of comfort in discussing organ donation is associated with an increased likelihood that families will donate their loved one’s organs (Siminoff et al., 1996, 2002). Increasingly, critical care professionals have access to education and resources aimed at enhancing their competencies in palliative and end-of-life care, particularly communication skills (Tulsky, 2005). These skills, which are transferable to the process of caring for a dying person who is also a donor candidate, include
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Organ Donation: Opportunities for Action the provision of humane and compassionate care, whatever the decision about donation; the relief of suffering; maintenance of respect and dignity; and nonabandonment of the patient or the patient’s family (Heyland et al, 2002, 2003). Also important is the responsibility of all members of the team to foster an environment with an adequate infrastructure and sufficient resources in which patients and their families are given the opportunity to consider the option of organ and tissue donation (HRSA, 2003). Building on the successes of the Organ Donation Breakthrough Collaboratives and HRSA’s demonstration projects, national initiatives for interdisciplinary training and models of collaboration should continue to be supported and expanded. Effective communication about organ donation and end-of-life care is difficult in a culture of critical care that focuses on rescuing patients from death rather than integrating the goals of critical care with palliative and end-of-life care (Danis et al., 1999; Lo et al., 1999; Rushton et al., 2002; Curtis and Rubenfeld, 2005). Families of ICU patients often express concerns about the adequacy, reliability, and timeliness of communication about healthcare issues (SUPPORT Principal Investigators, 1995; Pierce, 1999; Azoulay et al., 2000; Heyland et al., 2002, 2003); and research on communication at the end of life continues to document deficiencies (Pierce, 1999; Azoulay et al., 2000; Kirchhoff et al., 2000; Heyland et al., 2002). Dissatisfaction with care at the end of life focuses on communication and decision making (SUPPORT Principal Investigators, 1995) and often arises from the perception of a lack of complete and consistent information and of inadequate respect and compassion for the patient and family (Heyland et al., 2002, 2003). These problems likely affect the process of organ donation in critical care settings. Although there are curricula for end-of-life care, there are “few, if any, validated training models in EOL [end of life] care developed specifically for organ donation” (Williams et al., 2003, p. 1571). Few physicians and nurses have been trained in the skills of communication and problem resolution that may be important when clinicians broach end-of-life issues and options with patients and their families (Murphy et al., 2001). Clinicians often have misconceptions about basic ethical principles and beliefs that are widely shared in the bioethics literature and promoted by national professional organizations (May et al., 2000). Such misconceptions can make end-of-life decision making more difficult by erecting unwarranted barriers. Added to this mix are the comfort levels of healthcare team members discussing organ donation, along with misconceptions and misperceptions about neurologic determination of death, organ donation, and procurement (Siminoff et al., 2001a,b). Recent preliminary work with an experiential learning model suggests that interdisciplinary training can significantly increase consent rates (Tartaglia and Linyear, 2000; Williams et al., 2001).
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Organ Donation: Opportunities for Action A comprehensive meta-analysis of the effectiveness of such models is warranted, and the best ones should be replicated for interdisciplinary training. SUMMARY AND RECOMMENDATIONS This report is being written at a time when significant efforts are under way to improve the organ donation system, particularly those focused on improving the consent rates for donation after neurologic determination of death. The Organ Donation Breakthrough Collaboratives are working to galvanize the efforts of hospitals and OPOs to develop and implement continuous quality improvement methods and thereby create changes in policies, practices, and structures. Future support for continuous quality improvement efforts is critical to the progress of organ donation efforts. The opportunity to decide whether to be an organ donor is an important dimension of end-of-life decision making. Patients and their families should be offered this opportunity as standard end-of-life care, and information on organ donation processes should be an integral part of the many other decisions that are faced at this time. For the organ donation process to be fully integrated into end-of-life care, a wide range of healthcare professionals need enhanced awareness of and training regarding the donation process. Moreover, it will be necessary for healthcare institutions to develop or improve their end-of-life care processes and competencies. Recommendation 4.1 Sustain Continuous Quality Improvement Initiatives. HRSA should be sufficiently funded to provide technical assistance to hospitals and OPOs for continuous quality improvement efforts, including the identification and dissemination of best practices. An infrastructure that can support the collaboration, the dissemination of findings, and evaluations of the Breakthrough Collaboratives should be funded. Furthermore, Individual OPOs and hospitals should develop, implement, and evaluate continuous quality improvement processes. Accrediting and monitoring organizations, such as the Association of Organ Procurement Organizations, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and National Committee for Quality Assurance (NCQA) should require and monitor measures of continuous quality improvement, including process measures as well as conversion rates. HRSA, the Centers for Medicare & Medicaid Services, and private insurers (where appropriate) should ensure that organizational quality improvement efforts are recognized as part of normal healthcare operations and should be reimbursed accordingly.
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Organ Donation: Opportunities for Action Recommendation 4.2 Increase Research on Innovative System Changes. HRSA, the National Institutes of Health, and the National Center on Minority Health and Health Disparities should be allocated funds sufficient to increase research efforts to identify further innovative and effective system changes for improving the organ donation process and increasing the rates of organ donation and to evaluate the impacts of such changes on the healthcare system. Research efforts should be evidence based, interdisciplinary, and culturally relevant. Recommendation 4.3 Strengthen and Integrate Organ Donation and Quality End-of-Life Care Practices. Hospitals, OPOs, and other healthcare entities should consider how best to integrate the organ donation process with quality end-of-life care practices. Interdisciplinary teams should align end-of-life protocols, practices, and guidelines with organ donation protocols. Recommendation 4.4 Enhance Training for Healthcare Professionals. HRSA, in collaboration with palliative care and other professional associations representing diverse disciplines and specialties (including, but not limited to, critical care professionals, transplantation professionals, social workers, and clergy), should strengthen training in end-of-life practices and organ donation, including processes of communication and decision making, with the goal of establishing a knowledgeable and positive environment that supports organ donation. REFERENCES AACN (American Association of Colleges of Nursing). 1998. Peaceful Death: Recommended Competencies and Curricular Guidelines for End-of-Life Nursing Care. [Online]. Available: http://www.aacn.nche.edu/Publications/deathfin.htm [accessed March 20, 2006]. AOPO (Association of Organ Procurement Organizations). 2004. 2003 AOPO Annual Report. McLean, VA: Association of Organ Procurement Organizations. Australian and New Zealand Intensive Care Society. 1998. Recommendations on Brain Death and Organ Donation. [Online]. Available: http://www.anzics.com.au/uploads/200005braindeathorgandonation.pdf [accessed March 20, 2006]. Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. 2000. Half the families of intensive care unit patients experience inadequate communication with physicians. Critical Care Medicine 28(8):3044–3049.
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