National Academies Press: OpenBook

Non-Heart-Beating Organ Transplantation: Practice and Protocols (2000)

Chapter: 5 Protocol Development and Implementation

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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
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5
Protocol Development and Implementation

Recommendation 6: Adequate resources must be provided to sustain non-heart-beating organ and tissue donation. Adequate resources are required to cover (1) the costs of outreach, education and support for Organ Procurement Organizations OPOs, providers and the public, and (2) any increased costs associated with non-heart-beating organ and tissue recovery. Adequate funding for education and outreach is needed to develop professional and public understanding of non-heart-beating donation and to prepare patient care providers and organ donation personnel to participate in non-heart-beating donation. Adequate data and reimbursement mechanisms are needed to cover the costs of patient care and organ recovery.

This recommendation is based on the findings from two roundtable discussions at the workshop. In the roundtable discussion on protocol development, six active non-heart-beating donation programs described the development of their protocols. In the roundtable discussion on implementation, six patient care and donation experts identified issues that need to be addressed in the implementation of non-heart-beating donor protocols. The suggestions in this chapter are based on the participants’ professional experience and familiarity with the available data.

Roundtable participants identified several components of successful non-heart-beating protocol development and implementation:

  • the participation of all concerned parties (medical specialists, nurses, families, and community representatives);

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
  • drafting and revising protocols, and obtaining approval from various committees, boards, and professional and community groups;

  • initial and ongoing education, training, and support for practitioners;

  • community and media outreach and education; and

  • ongoing oversight and review, and ongoing protocol revision.

Each of these steps places demands on hospital and OPO resources, requiring specific attention to how these resources will be made available.

CONSTITUENTS

Development

Take as much time as you need. Put all the adversaries on the committee and they will talk to you in the same room. (J. Light)

I didn’t anticipate that I would have trouble on the surgical side. There is a transplant center in my region that doesn’t have a dedicated transplant surgeon (i.e. someone whose practice is dedicated to transplant only); a vascular surgeon does the surgery in that locale. At three in the morning it’s not going to be easy to get a person to come out, stand there either in the operating room or in the intensive care unit, and await yes or no that the patient is indeed declared dead. (F. Delmonico)

Our biggest surprise was anesthesia. We really didn’t expect the anesthesiologists to give us such a hard time as far as volunteering services to come in and pronounce death. (D. Cornell)

The patient who becomes a non-heart-beating donor comes under the care of physicians, nurses, and other hospital staff in the emergency room (ER), intensive care unit (ICU), and operating room (OR). Staff concerns about non-heart-beating donation arise when the process is not understood fully, or when the staff is not prepared fully for the new responsibilities involved. They arise also when staff members have unresolved ethical, legal or patient care concerns about the non-heart-beating donation process.

In many cases, practitioner concerns can be addressed through early participation in the protocol development process and through education that explains the process of non-heart-beating donation and identifies practitioner responsibilities. They can be addressed also through ongoing education and follow-up during each non-heart-beating donor case.

The challenge is identifying and involving all concerned parties. All of the programs encountered unanticipated resistance, each from different practitioners. Direct communication and education help to clear up misunderstandings and to resolve concerns and issues. Involving all of the concerned parties from start to finish can avert misunderstandings at the beginning of the process.

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

Implementation

Nurses in the appropriate roles and with the appropriate expertise must have a defined role in the development and establishment of these protocols. Registered nurses will provide an essential perspective and must be full participants in ethics committees and forums regarding non-heart-beating donation along with physicians, transplant coordinators, and other health care professionals, as well as the public. (P. Weiskittel)

We really do support some kind of national standardized criteria for which patients fall in the box and which ones don’t. We need recommendations that all OPOs and transplant centers participate in non-heart-beating donation. We would like to see the entire transplant community involved in this process even if the organs will not be used locally. (M. Reiner)

From the perspective of OPO and patient care practitioners, clear and consistent protocols provide a source of guidance for practice. Being involved in developing the protocols that they will be responsible for implementing helps practitioners to make the critical connection between protocol content and its applications in practice.

These comments point to the need for patient care and transplant professionals to be involved in non-heart-beating protocol development at both the national and the local level. At the local level, transplant coordinators and health care practitioners have the ultimate responsibility for implementing the protocols. Successful protocol development will draw on their familiarity with their practice settings and with particular needs and concerns of their communities. At the national level, professional organizations are a valuable resource for developing guidelines that meet professional practice standards and promote local consistency.

PROTOCOL APPROVAL

Development

Our arduous approval process involved approval first by the ethics committee and then by the policy review committee, the hospital lawyers. Then it went to the medical executive committee, and then we brought it to a quarterly staff meeting; so not only did we get the medical leadership, we also took it to the medical staff for their approval. Then it went to a joint conference committee—that is, medical, administrative and board member leaders—and then finally we took it to the board. (M. DeVita)

The approval process is complex, multileveled, and prolonged. The time each program spent from initiating the idea of non-heart-beating donation to full approval varied from eight months to three years. This process requires the commitment of considerable paid staff and volunteer professional time. An OPO

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

or hospital that wishes to develop a protocol must be able to commit the staff time required to see it through this process.

Implementation

Looking at organizational considerations, I would propose that it would be good to cultivate advocates within institutions, as I sometimes think of myself. We can help. (J. Sullivan)

Although the participation and support of frontline practitioners is essential, there is a role for institutional advocates in moving new practices and protocols along. Protocol development and implementation require effective leadership. The involvement of OPO and hospital leaders and authorities can contribute significantly to the process. Administrators, board members and medical, surgical, and nursing directors can provide the leadership and support needed to facilitate protocol development and approval.

EDUCATION, TRAINING AND SUPPORT

Development

The protocol needs the partnership of hospitals, health care professionals, and OPOs. It is not enough to go out and say, “Now we have a protocol.” Now you have to go out and educate, educate, educate within the health care system and you cannot overlook any one group. I can tell you we overlooked one group, of operating room nurses. It didn’t cause major problems but it is something that we had to go back and deal with, so I think you need to cast a broad net in your educational efforts. (D. Lewis)

Not only were we educating the hospital community, but we were educating our [OPO] staff, as well as the transplant surgeons. It was important to us that if these surgeons were coming out to the hospital they understand the impact that it would have on operating room personnel. We also utilized their assistance in family meetings or operating room meetings, talking with the nursing staff and anesthesia personnel who were going to be involved. (J. Edwards)

Outreach, education, training and support must involve medical, OPO, and hospital practitioners, as well as a variety of educational strategies: nursing inservice, grand rounds, presentation at professional meetings. Education starts with the initial discussions of non-heart-beating donation, and continues through the entire process of development and implementation.

OPO staff must be prepared to address questions and concerns that arise when hospital personnel are unfamiliar with or have reservations about the non-heart-beating donation process. The large number of staff involved and the limited number of non-heart-beating donators provide little opportunity for direct

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

experience with non-heart-beating donation. Non-heart-beating donation may be unfamiliar in spite of substantial educational efforts.

Workshop participants noted that staff participation in non-heart-beating donation requires staff support as well as education and training. Non-heart-beating donation is a new and unfamiliar process for most hospitals. A meeting with the staff immediately following the process was recommended as an opportunity for staff to discuss questions and concerns that may arise during the process. In addition, staff may find ethics consultation a valuable resource when non-heart-beating donation is being considered. One OPO sends two donation coordinators on every non-heart-beating case: one to handle the donation and one to educate and support the staff and family.

Both formal and informal education and support efforts are time consuming and costly. The ability of a hospital or OPO to pursue non-heart-beating donation depends to a great extent on the personnel and funds available for education, training and support.

Implementation

Without adequate preparation and education of hospital staff, negative consequences for donation could develop. Appropriate resource material and personnel need to be available to nurses during the donation process. It is also an excellent opportunity for nurses to be involved in writing the resource materials and to facilitate when needed as experts in the process. (P. Wieskittel)

Health care personnel have a difficult time understanding policies and protocols that surround organ donation in general, whether it is non-heart-beating or not. About 35% of the nurses in our area have two years of training or less, and the vast majority have been in their position for only one to five years.

One rural provider said, “Sure, you just want to educate us until we come around to your point of view.” (A. Cook)

Educational efforts must be tailored to the groups that they are intended to serve. The ethical and practical concerns and the information needed will vary somewhat among different nursing specialties and other groups. Each group should be involved in developing appropriate educational resources and programs. It is especially important to be sensitive to the diverse social, economic, and ethnic backgrounds of practitioners. These factors can affect practitioner perceptions and reactions, just as they affect the perceptions and reactions of the patients and their families. A mechanism for addressing this kind of diversity is to involve practitioners from diverse backgrounds in protocol development and implementation.

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

PUBLIC OUTREACH

Development

I think the biggest surprise to me has been the level of buy-in from the public, the acceptance it has had, the level of it being okay in that we are doing the right thing and that if families want that option, they should have it. (D. Lewis)

Somebody called up a local reporter and said we were doing funny things. They came in and we gave them the policy, showed them all the documentation, explained exactly what was happening, and it was funny, the cameras went down and the reporter said, “What is the big deal?” The TV report was, “No, they are not killing people and this is a good thing and you should be a donor.” (M. DeVita)

Workshop participants agreed that public and media awareness of non-heart-beating donation contributes to its acceptance. Lack of openness and lack of information can lead to misrepresentations and misunderstandings. Several of the participants advocate active media outreach to keep organ and tissue donation in the public eye.

Public involvement in hospital ethics committees, OPO boards, and community oversight committees contributes also to public awareness and support for donation.

Most importantly, donor and nondonor families are the final judges of the donation system. Their experiences, and their reactions to the non-heart-beating donation process constitute the strongest measure of public acceptance.

Implementation

We have started talking with our rural health care providers about organ donation. First, it is very clear that prior to the most recent Health Care Financing Administration (HCFA) regulations, they had very limited involvement with this issue, but the required request and referral is changing that. There are very, very few formal mechanisms to mitigate any problems that develop. In our area of the country, most of our states have out-of-state OPOs so that there is a very limited presence.

In some of our counties, 25 or 30 percent of the people are uninsured. With the uninsured or underinsured, there is sometimes a sense that they need to repay society for the health care that they can’t afford and there is an expectation of the hospitals that they will donate. In a rural hospital with very narrow cost margins, it is obviously a considerable value if the final day of care is paid for and that has been somewhat problematic for some of our health care providers; they fear the risk of coercion. We have talked about the need for things like public forums to talk this issue out. As long as it is seen as a gift for the insured and the wealthy, there is going to be skepticism. (A. Cook)

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

Like educational efforts, community and media outreach must be tailored to the local situation. Interests and perceptions vary according to local conditions and prior experience (positive or negative) with the health care system or with organ and tissue donation. Active non-heart-beating donation programs point to family request as a primary reason for protocol development. Rather different strategies may be needed if no family or community interest in this approach to donation has been identified.

OVERSIGHT AND REVIEW

Development

We invested about three years in a community oversight committee following a consensus conference, which guided the efforts and facilitated the discussion. Part and parcel of all of this effort was establishing a system of family advocates. (J. Light)

Mechanisms for ongoing oversight include community groups, ethics committees, professional bodies and public agencies. Assurance that such review is being conducted, and access to the findings, are important contributions to public and professional confidence in non-heart-beating donation.

Workshop participants suggested the need for an ongoing audit process for non-heart-beating donation, similar to the hospital quality assurance process. Developing such an audit process was beyond the scope of the current study but is suggested as an undertaking for professional groups.

Implementation

One of the hospitals I work with is planning a community forum. It is an experiment to see if we can bring the issue up and talk about it in a community forum, and maybe do a newspaper insert before, and try to look at it in a planned, controlled way. (A. Cook)

The questions I have are outcome more than anything else. We are trying to be advocates for the donor family, for the recipients, the services that we offer. What are the positive outcomes that can occur for both these groups? (L. Jacobbi)

These comments suggest the need for two kinds of outcome review: (1) overview of the donation process and its adherence to recommendations and protocols, and (2) empirical review of the transplant outcomes, organ recovery costs, and discard rates associated with non-heart-beating donation. A formal review process can provide both kinds of review, as well as contribute to a growing body of outcome data available to other programs.

Workshop participants raised particular concerns about the outcome of non-heart-beating organ transplantation. The 1997 IOM report cited a number of

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

outcome studies that found comparable transplant outcomes for heart-beating and non-heart-beating donor organs (Alvarez-Rodrguez et al., 1995; Hoshinga et al., 1995; Nicholson et al., 1997) with the exception delayed kidney function following transplantation (Wijnen et al., 1995). Several subsequent studies confirm these findings (Alonso et al., 1997; Kievit et al., 1997; Valdes et al., 1997; Pokorny et al., 1997; Yong et al., 1998). However, small numbers and multiple confounding variables limit the conclusions that can be drawn from these studies, and lead some experts to conclude that further study is needed to establish how organ quality and organ handling affect outcomes for non-heart-beating transplantation (Butterworth et al., 1997; IOM, 1999, 78–87.)

RESOURCES

Development

Problems we did not anticipate were the amount of resources it took. We are committed to providing additional staff, as well as getting back into the institution immediately because it is on the second and third day after the case has been completed that we are getting whispers down the line, and some of the negative impressions that people have. (J. Edwards)

Practice innovation, with its requisite training, education, and review, requires an adequate resource base. The successful development and implementation of non-heart-beating donation protocols requires the commitment of financial and staff resources to support the process.

At present, these resources are made available when an individual hospital or OPO places a high priority on non-heart-beating donation and commits the resources needed to bring it about. In order for non-heart-beating donation to be adopted more widely, sources of funding for program development must be identified, and any reimbursement barriers must be eliminated.

Implementation

If you don’t have a local transplant center that is willing to use these organs, you probably are going to have a higher discard rate which means that the OPO will take on a larger financial burden and perhaps some accommodation can be made for this. (M. Reiner)

Our agency is based on maximizing our donors. Everyone says don’t worry about cost but we are stewards of a very dear resource. We have to think about the health care dollar. What is the discard rate that we are looking at? Where can we develop means of evaluating these organs so that we can assure that outcomes are the same from both populations of donors? (L. Jacobbi)

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×

The actual costs of non-heart-beating donation are difficult to assess. Patient care costs must be factored in and compared to the costs of maintaining donors after death by neurological criteria. The costs of the education, outreach, and staff time required for the more complex donation process must be assessed. In addition, the costs of higher rates of organ discard and delayed organ function following transplantation must be factored in (Elwell et al., 1997). Cost considerations are a potential impediment to participation in non-heart-beating organ recovery. A sound empirical study of the costs of non-heart-beating organ recovery is urgently needed.

Conclusion

The findings from this study and the workshop highlight the need for further research on many aspects of non-heart-beating organ and tissue donation. Chapter 6 discusses a research agenda and presents a paper commissioned by the committee. It identifies research priorities and suggests methodological approaches for research that addresses these priorities.

Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Suggested Citation:"5 Protocol Development and Implementation." Institute of Medicine. 2000. Non-Heart-Beating Organ Transplantation: Practice and Protocols. Washington, DC: The National Academies Press. doi: 10.17226/9700.
×
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Next: 6 A Research Agenda for Non-Heart-Beating Organ and Tissue Donation »
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In 1997, the Institute of Medicine published a report entitled Non-Heart- Beating Organ Transplantation: Medical and Ethical Issues in Procurement. The findings and recommendations of that study defined the ethical and scientific basis for non-heart-beating organ donation and transplantation, and provided specific recommendations for practices that affirm patient welfare, promote patient and family choice, and avoid conflicts of interest.

Following the 1997 study, the Department of Health and Human Services requested a follow up study to promote such efforts. The central activity for this study was a workshop held in Washington, D.C., on May 24-25, 1999. The workshop provided the opportunity for extensive dialogue on non-heart-beating organ donation among hospitals and organ procurement organizations (OPOs) that are actively involved in non-heartbeating organ and tissue donation and those with concerns about whether and how to proceed.

The findings and recommendations of this report are based in large measure on the discussions and insights from that workshop. Non-Heart-Beating Organ Transplantation includes seven recommendations for developing and implementing non-heart-beating-donor protocols. These recommendations were based on the findings and recommendations from the 1997 IOM report and consensus achieved among participants at the national workshop. The committee developed these recommendations as steps towards an approach to non-heart-beating-donor organ donation and procurement consistent with underlying scientific and ethical guidelines, patient and family options and choices, and public trust in organ donation.

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