[LD101 note: This document was composed to illustrate the unique situation, circumstances and experience of living donors and living donation. As such, living donors deserve a Bill of Rights specific for them, In July 2010, Nancy Scheper-Hughes, a world renowned expert on organ trafficking, penned her own Organ Donor Bill of Rights]
Living Organ Donor Bill of Rights
Live Organ Donor Education & Protection Project (www.lodepp.org)
Historically, the supply of organs suitable for transplantation from deceased donors has not kept pace with the demand (especially for kidneys). In 2001, the number of living donors surpassed deceased donors for the first time in U.S. history. As a result of these trends, there are ongoing efforts to promote live organ donation. These efforts include getting organs from non-familial or non-related donors, anonymous donors, and publicly solicited donors – from public appeals via the media to bulletin boards and the Internet. Additional efforts include desensitization protocols, a movement toward a national paired kidney exchange program which “swaps” donors who do not match their candidate in order to find an optimal match, and acceptance of ‘expanded criteria” live donors which includes those who are older, obese or even with hypertension.
The Cabinet Secretary of the Division of Health and Human Services (DHHS) has statutory authority and responsibility for the oversight of organ donation and transplantation. While the first living kidney donor surgery was performed over 50 years ago, a nationwide system to promote donor safety, informed consent, and mandate data submission to a long-term living donor registry has not been implemented. To date, nearly 100,000 live donors have put themselves at risk when there are no uniform standards of care for donor selection/evaluation, informed consent, or donor aftercare. There are no insurance industry standards for donor care especially in the post-donation period; leaving donors vulnerable for out-of-pocket medical expenses especially for complications.
In June, 2004 the Organ Procurement Transplantation Network (OPTN) Board of Directors approved a policy to certify all transplant programs involved in live donor liver and kidney surgeries. On March 1, 2005, liver transplant programs were mailed applications to be certified as Live Donor Liver Centers. As of June 30, 2006, only 32 of 126 transplant centers had been certified. The process of certifying 72 programs took 2 years to complete; others opted out and are not doing live donor liver surgeries. The certifications for live donor kidney programs are not completed. In 2007, two key initiatives were put forth. The Centers for Medicare and Medicaid Services (CMS) Rules and Regulations for Transplant Programs, Final Rule mandated an independent donor advocate to assure proper donor evaluation and consent. And as OPTN members, transplant programs are required per mandatory policy (under the Final Rule, 2000) to submit donor follow-up data for 24 months post-donation (previously 12 months.)
This document, adapted from the American Hospital Association’s “Patient Bill of Rights”, is provided for the prospective organ donor, for transplantation professionals, government officials, and interested parties in order to better understand and appreciate the unique needs of live organ donors.
Living Donor Advocacy
The living organ donor has the right to considerate and respectful care.
The living organ donor has the right to contact information (name, credentials, and phone number) for the individual who has primary responsibility for his/her care from the time of the initial appointment until transfer of care to the donor’s primary care physician.
The living organ donor has the right to designate an independent advocate who is not employed by the transplant center.
The living organ donor has the right to a donor team consisting of, at least, an internal medicine physician (or an organ-specific specialist), the independent donor advocate, a transplant social worker, and a psychiatrist.
The living organ donor has the right to request assistance from the donor advocate team in the preparation of a general statement of unsuitability for donation, which will not include falsified medical information.
The living organ donor has the right to request that family or loved ones be given the opportunity to discuss openly with the independent donor advocate team and the surgical team their concerns in a safe and non-threatening environment which does not include the recipient or any member of the recipient’s family.
Living Donor Ethics
The living organ donor has a right to know there are no uniform standard selection, evaluation, or discharge criteria for live donation (i.e., no standards for age, medical history, psychiatric history, or psychosocial background.)
The living organ donor has the right to know there is no uniform standard for informed consent for live organ donation.
The living organ donor has the right to know there has never been a public policy discussion on the ethics of live organ donation in the United States.
The living organ donor has the right to make a decision about donation in a setting free of coercion or pressure.
Living Donor Informed Consent
The living organ donor has the right to know that no regulatory body or registry currently tracks living organ donation nor long-term living donor morbidity and mortality in the United States.
The living organ donor has the right to informed consent based on clear information at each step of the evaluation and donation process. The consent for evaluation should be separate from the consent for surgery.
The living organ donor has the right to and is encouraged to obtain from doctors and other caregivers (nurses, transplant coordinators, social workers) appropriate, current, and understandable information about diagnosis, treatment, and prognosis. The living organ donor is entitled to discuss and request information about the specific procedures and/or treatments, the risks involved, and the length of recuperation.
The living organ donor has the right to know that there is potential for:
– Surgical complications, including the risk of donor death;
– Organ failure and the need for future organ transplant for the donor;
– Other medical complications, including long-term complications and complications currently unforeseen;
– Fatigue and abdominal or bowel symptoms such as bloating and nausea;
– Problems with body image;
– Transplant recipient death;
– Transplant recipient rejection and need for re-transplantation;
– Recurrent disease in a transplant recipient;
– Post surgery adjustment problems;
– Impact on the donor’s family or next of kin;
– Impact on the transplant recipient’s family or next of kin;
– Impact of donation on the donor’s lifestyle;
– Out of pocket expenses;
– Child care costs;
– Possible loss of employment;
– Impact on the ability to obtain future employment;
– Impact on the ability to obtain or afford health and life insurance.
(10A NCAC 13B. 5500 Supplemental Rules for Hospitals Providing Living Organ Donation Transplantation Services)
The living organ donor has the right to ask and be informed of business relationships among the hospital, educational institutions, other health care providers, or payers that may influence the donor’s treatment and care.
The living organ donor has the right to consent to, or decline, to take part in research studies affecting care and treatment or requiring direct patient involvement, and to have those studies fully explained prior to consent.
The living organ donor has the right to be fully informed of the risks, benefits, and alternative treatments available to his or her recipient.
The living organ donor has the right to information regarding candidate listing, multiple listing, and that in some regions deceased donor organs are more readily available with a shorter wait time.
The living organ donor has the right to expect that if, during the perioperative period, it is discovered that the donor organ is unsuitable in any way for the recipient or that removing it (or some portion of it) will put the donor at risk for previously unforeseen complications, the procedure will be aborted.
Living Donor Hospital Care
The living organ donor has the right to the same standard of care as his or her recipient.
The living donor has the right to ask for and receive surgeon and center-specific outcome data.
The living organ donor has the right to know the identity and credentials of the doctors, nurses, and practitioners involved in their care, as well as when those involved are students or other trainees.
The living organ donor has the right to know that there are no legal or professional standards for surgeon qualifications for kidney, lung, intestine or pancreas live donor surgeries. (Qualifications for live liver donor surgeons are limited to those certified by the OPTN or regulated by the states of New York and North Carolina.)
The living liver donor has the right to two liver transplant attending surgeons with demonstrated experience in live donor hepatectomy (15 procedures), demonstrated experience in major hepatobiliary resectional surgery (20 procedures) or surgical fellowship at an American Society of Transplant Surgeons (ASTS) approved transplant fellowship program with demonstrated experience (15 procedures) with live donor hepatectomy. Included is written verification by the fellowship program director or by the director of the supervising transplant program of hands-on training at an institution performing live donor hepatectomy. These two surgeons shall be present for the critical parts of the live donor surgery including the liver parenchymal transaction. (NYCRR Title 10, Section 405.22; 10A NCAC 13B. 5500 Supplemental Rules for Hospitals Providing Living Organ Donation Transplantation Services.)
The living kidney donor has the right to a primary surgeon who is a board-certified urologist or general surgeon with demonstrated and documented expertise in both open and laparoscopic live donor nephrectomy.
The living organ donor has the right to choose his/her surgeon.
The living kidney donor has the right to a primary surgeon who is not involved in the care of the recipient.
The living donor has the right to be followed by an internal medicine physician at least daily until discharge.
The living organ donor has the right to the standard of care for his or her surgery (and appropriate to the level of risk) were it not a living donation but done for the medical necessity of the donor.
The living organ donor has the right to be transferred from the operating room to a unit that is dedicated to the care of live organs donors and appropriate to the level of risk for the organ donated. The professional registered nursing ratio to patients on a post-operative surgical nursing division shall be at a minimum of 1:4 on all shifts.
The living donor has the right to 24-hour/seven days a week coverage by general surgery residents at the postgraduate year 2 level or higher or a transplant fellow and under the supervision of an Attending surgeon until safely discharged and during the follow-up period.
Other Living Donor Concerns
The living organ donor has the right to have an advance directive (such as a living will, health care proxy, or durable power of attorney for health care) and a designated surrogate decision-maker with the expectation that the hospital will honor the intent of that directive to the extent permitted by law and hospital policy. Health care institutions must tell patients of their rights under state law and hospital policy to make informed medical choices, ask if the patient has an advance directive, and include that information in patient records.
The living organ donor has the right, at any time during evaluation, inpatient care, or post-discharge, to designate additional physicians to receive medical updates.
The living organ donor has the right to expect discharge follow-up care for 24 months consistent with the mandatory OPTN data collection requirement (under section 121.11 (b) (2) of the OPTN final rule.)
The living organ donor has the right to timely attention to complications.
The living kidney donor has the right to full Medicare A and B coverage for evaluation, testing, hospital stay, and for any complications (medical or surgical) as established by statute in 1972 per Section 1881 of the Social Security Act.
The living non-renal organ donor has the right to the full medical coverage for testing, evaluation, hospital stay, and for any complications (medical or surgical) under the recipient’s health care benefit.
Living Organ Donor Privacy
The living organ donor has the right to every consideration of privacy. Case discussion, consultation, examination, and treatment should be conducted so as to protect each donor’s privacy.
The living organ donor has the right to expect that all communications and records related to his/her care will be treated as confidential. The living organ donor has the right to expect that the hospital will stress the confidentiality of this information when it releases it to any other parties entitled to review information in these records.
Living Organ Donor’s Right to Know
The living organ donor has the right to review the records about his/her care and to have the information explained or interpreted.
The living organ donor has the right to expect reasonable continuity of care when appropriate and to be informed by doctors and other caregivers of available and realistic care options when hospitalization is no longer appropriate.
The living organ donor has the right to be informed of hospital policies and practices that relate to patient care treatment and responsibilities.
The living organ donor has the right to be informed of available resources for resolving disputes, grievances, and conflicts, such as ethics committees, patient representatives, or other mechanisms available in the institution.
Copyright 2006 Rhonda Boone, Vickie Hurewitz, and Donna Luebke
Co-founder, The Live Organ Donor Education & Protection Project (LODEPP) Widow of Danny Boone, Live Liver Donor who died in 1999, 21 days after donating a portion of his liver to his brother in North Carolina
Co-founder, The Live Organ Donor Education & Protection Project (LODEPP)
Widow of Mike Hurewitz, Live Liver Donor who died in 2002, 3 days after donating 60% of his liver to his brother in New York
Donna L. Luebke, MSN, CNP Kidney donor to sister, 1994.
MetroHealth Medical Center/Case Western Reserve University
Donor advocate/nurse consultant, Living Organ Donor Advocate Program (www.lodap.com)
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Last updated: July 22, 2011