The History of Living Donor Advocacy in Living Donor Transplantation

Abstract

The history of living donor advocacy importantly highlights the maturation of the field of transplantation. The first successful kidney transplant performed on identical twins in 1954 confirmed the feasibility and efficacy of the surgical procedure. The process that led up to the operation itself set the groundwork for the concepts that would evolve into living donor advocacy. In this chapter, we hope to provide a historical overview of the dynamics that formed the concept of advocacy for living donors including kidney as well as extrarenal donation. As the language of living donor advocacy is now coded into Centers for Medicare and Medicaid Services (CMS) regulations, it is extremely helpful to examine the historical origins of the concept of advocacy in relationship to the development of living donor transplantation.

People need to be reminded more often than they need to be instructed.

Samuel Johnson, English poet (1709–1784)

Appendix 7.1

Center for Medicare and Medicaid

Standard: living donor selection

The living donor selection criteria must be consistent with the general principles of medical ethics. Transplant centers must carry out the following procedures.

Ensure That a Prospective Living Donor Receives a Medical and Psychosocial Evaluation Prior to Donation

Instructions to the surveyor:

For a center that performs living donor transplants, verify that the transplant program’s policy requires that prior to donation the prospective living donor receives a medical and psychosocial evaluation that is completely independent of the recipient evaluation. An independent evaluation requires that the transplant recipient (or other individuals vested in the recipient’s transplant) may not be present during the donor’s psychosocial and medical evaluation. The donor and recipient evaluations must be filed in respective individual medical records and must not be dually documented in both medical records.

The transplant program’s policy is expected to: (1) indicate the length of time in which the medical and psychosocial evaluations are deemed to be current; (2) identify the type of qualified health-care professional(s) who may complete these evaluations; and (3) include the follow-up and referral procedures if a living donor requires such activities.

The post-June 28, 2007, sample of living donor medical records to verify that the psychosocial and medical evaluations were completed independently from the evaluations of the transplant recipient: were done within the time frame established by the program’s policy; completed prior to the donation; and performed by the person(s) identified in the transplant program’s policy as qualified to conduct such evaluations.

The medical evaluation is expected to address not only the living donor’s medical suitability for donation, but also any of the donor’s health issues that would be affected by the donation: for example, if the donor were taking any medications treating an existing condition and this medication regimen would have to be stopped or altered for any period of time following the donation.

While the transplant program has flexibility in the specific psychosocial tool to be used, the psychosocial evaluation is expected to be completed and to be focused on the individual’s suitability for donation. It is expected that a psychosocial evaluation of this nature would address the following:

• 1. Social, personal, housing, vocational, financial, and environmental supports

• 2. Coping abilities and strategies

• 3. Understanding of the risks of donation

• 4. Ability to adhere to a therapeutic regimen

• 5. Mental health history, including substance or alcohol use or abuse and how it may impact the donor following the donation

Document in the Living Donor’s Medical Records the Living Donor’s Suitability for Donation

Instructions to the surveyor:

Review the sample of living donor medical records to verify that each donor’s suitability for donation is documented. At a minimum, the surveyor will verify that there was a discussion by the multidisciplinary team (which would include the independent living donor advocate) of the relevant findings of the medical and psychosocial evaluations and the impact of those findings on the donor’s suitability for donation.

If the multidisciplinary team has a meeting to discuss the donor’s suitability for donation, this would comply with the requirements of the regulation. If there is not an actual meeting by the multidisciplinary team, then there must be evidence in the medical record and/or other documentation that there is a formal process for all members of the multidisciplinary team to raise concerns and discuss any issues that they may have regarding the donor’s suitability.

This process must be managed such that:

• 1. There is clear written evidence that multidisciplinary team members have reviewed, discussed, and are aware of one another’s concerns about the donor’s suitability.

• 2. There is a process for the members of the multidisciplinary team to register their agreement/disagreement regarding the donor’s suitability.

Document that the Living Donor has Given Informed Consent, as Required Under § 482.102

Instructions to the surveyor:

The medical record should provide evidence that the living donor has provided consent and that it is informed consent. “Informed consent” generally means the individual participates in his or her health-care decision-making through a process which: (1) provides information about the decision and procedures, alternatives, risks, relevant uncertainties, benefits, and other pertinent information; (2) is provided to the individual in a manner suitable for comprehension; (3) includes an assessment by the informing practitioner that the person understands and can articulate this understanding; and (4) that there is voluntary consent by the living donor.

The surveyor should review the documentation in the medical record that describes the completed informed consent process and review all dated and witnessed forms signed by the living donor.

Regulations Developed by the OPTN

In bylaw Appendix B attachment 1. XIII, D.,2, a, vi related to staff required for the transplant program that performs living donor surgery:

… the center has an independent donor advocate (IDA) who is not involved with the potential recipient evaluation, is independent of the decision to transplant the potential recipient and, consistent with the IDA protocol referred to below, is a knowledgeable advocate for the potential living donor. The goals of the IDA are:

• 1. To promote the best interests of the potential living donor

• 2. To advocate the rights of the potential living donor

• 3. To assist the potential living donor in obtaining and understanding information regarding the:

  • (a) Consent process

  • (b) Evaluation process

  • (c) Surgical procedure

  • (d) Benefit and need for follow-up