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Physician, health care provider guidelines to assure proper care of organ donors published in JAMA.

While there remain approximately 73,000 Americans on the waiting list for an organ, there has been sizeable (123%) increase in the number of living organ donors in the last 10 years. However, there have been no formal guidelines for physicians and health care providers to follow when dealing with these growing numbers of live donors.

This week, the December 13 issue of the Journal of the American Medical Assn. (JAMA) published a consensus statement on such guidelines--the result of a June conference in which four major transplant groups hammered out preliminary guidelines regarding donors of living organs.

"The person who gives consent to be a live organ donor should be competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, and fully informed of the risks, benefits, and alternative treatment available to the recipient," said the Consensus Statement on the Live Organ Donor.

The convening organizations at the June meeting included the National Kidney Foundation, and the American Society of Transplantation, American Society of Transplant Surgeons, and the American Society of Nephrology. Representatives from the United Network for Organ Sharing (UNOS), United Resource Networks and the National Institutes of Health also participated.

The need for a detailed consensus document was driven by three factors which have developed over the past 10 years:

(1) a 123% increase in the number of living organ donors;

(2) the relatively flat cadaveric donation (44.5% increase); and

(3) the growing disparity in the number of donors compared to people waiting for an organ

transplant, resulting partly from recent success in transplanting organs other than kidneys--portions of the liver and even the small intestine and pancreas - The number of patients in the US waiting for an organ transplant as of December 2 was 73,398, with about 30% being patients waiting for a liver, pancreas, pancreas-islet, kidney-pancreas or lung transplant, according to the UNOS.

"Solid organ transplantation from a live organ donor is an ethically acceptable and widely used practice," wrote the authors for the Live Organ Donor Consensus Group. "This approach to treatment affects not only the patient with end-stage organ failure, but also the healthy person who volunteers to donate and whose interests are equally important."

The consensus statement reviewed each of the components contained in the premise noted at the beginning of this article. Here is a thumbnail sketch of each with some explanatory information.

Informed Consent

*Understanding. ". . .donors must be able to assimilate accurate information regarding the risks and benefits to themselves. They must understand the benefits to the recipient, but also the alternative treatments available to the recipient. . .All donors should demonstrate capacity to understand the essential elements of providing consent to live donation, with information presented at a level of medical sophistication suitable for that individual.

*Disclosure. ". . .donors become special 'patients' beginning with the testing to determine whether they can donate. It is incumbent on the transplant center to provide full and accurate disclosure to potential donors of all pertinent information regarding risk and benefit to the donor and recipient .

The disclosure process should permit a 'cooling off period' between consent and the scheduled donor operation to provide the potential donor ample time to reconsider the decision to donate."

*Voluntary Nature. "The absence of reproducible health benefits for donors (e.g., a previously unknown medical condition that is discovered in the evaluation process) and the current legal restrictions against financial compensation are compelling reasons for the transplant team to verify the donor's freedom from coercion. . .An independent advocate for the donor should be identified whose only focus is the best interests of the donor."

*Documentation. "Core documents in living donor transplantation should include not only the usual informed consent releases but also documentation of the disclosure process, the donor's capacity to balance risk and benefit, freedom from coercion and that the donation is not conditioned on direct monetary compensation."

Medical Suitability

"A potential living organ donor should be healthy; however, the determination of medical suitability will differ according to the organ to be donated. Pregnancy is a contraindication to live donor organ donation until after delivery." The section includes guidelines to be followed for potential liver, and lung donors. The American Society of Transplantation is currently updating living kidney donation guidelines that will be available in 2001.

Psychosocial Suitability

"A psychosocial evaluation is necessary for each potential donor. The goals of such an evaluation are 3-fold: to evaluate psychological, emotional, and social stability to rule out unsuitable donors and enhance the donation process by identifying individual or donor-related factors that warrant appropriate intervention; to establish whether the potential donor is competent to give informed consent; and to assess the degree to which the decision to donate is being made freely, without undue pressure or coercion."

Live Organ Donor Source

"Whereas live organ donation was once restricted to those with a genetic link to the recipient, improvements in recipient immunosuppression have expanded the potential live donor pool to unrelated individuals who have an emotional relationship to the recipient and to donors who were strangers to their recipients before transplantation."

*Live-Donor Kidney Donation by Paired Exchange. The exchange of living donor kidneys between pairs of individuals with incompatible ABO blood types (and lymphocyte crossmatch) was considered by conference participants to be ethically acceptable. Such exchanges were not considered to be a form of commerce as suggested by some who are opposed to this approach.

*List-Paired Exchange of Kidneys. In list-paired exchange. "the incompatible living donor would provide an allograft to a patient on the cadaver waiting list in exchange for the cadaver donor pool providing a priority allograft (i.e., ABO compatible) to the donor's incompatible recipient." The participants recommended "any algorithm seeking to employ list-paired exchanges should be first applied within a limited area as a pilot study, under UNOS surveillance, with prospective monitoring of both beneficial and adverse consequences."

*Nondirected or Stranger Donation. "The criteria for ethical acceptability for nondirected live donor organ donation were considered by conference participants to be the same as those applied to directed donation, with careful attention to the psychosocial evaluation."

*Donating a second organ. "The conference participants considered it ethically acceptable for a person to donate more than 1 organ simultaneously or serially (e.g., the left lobe of a liver and a kidney) if the medical and psychosocial requirements for each organ donation were fulfilled."

*Minors as Live Organ Donors. Conditions where acceptable include: "When the potential donor and recipient are both highly likely to benefit (as in the case of identical twins); when the surgical risk for the donor is extremely low; when all other opportunities for transplantation have been exhausted, no potential adult living donor is available, and timely and/or effective transplantation from a cadaver donor is unlikely; and when the minor freely agrees to donate without coercion (established by the independent donor advocate.)"

*Financial Considerations in Live Organ Donation. "Living donors should not personally bear any costs associated with donation. In addition, guidelines should be established that are similar to those for short term disability to defray lost wages."

*Live Organ Donor Registry. "The conference endorsed the development of a living donor registry that would collect demographic, clinical, and outcome information on all living organ donors."

The Final Decision for Live Organ Donation

"While the autonomy of the potential donor must be respected, so also must the medical decision making of the transplant team be respected. Therefore, the team should never feel obliged to perform a transplant from a living donor if it believes that it will do more harm than good."

(Corresponding Author and Reprints: Francis L. Delmonico, MD, Harvard Medical School and Massachusetts General Hospital, White 505, Boston, MA 02114. E-mail:
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Title Annotation:Journal of the American Medical Association report
Comment:Physician, health care provider guidelines to assure proper care of organ donors published in JAMA.(Journal of the American Medical Association report)
Author:Warren, Jim
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Dec 15, 2000
Previous Article:MTF announces non-profit tissue processing alternative.
Next Article:Elements of Disclosure for Potential Living Donors.

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