OPTN, managed by UNOS, is charged with developing policy regarding living donation and living donors. They must announce and post all proposed policies for a public comment period before taking them back to various committees, voting and producing a final product (or policy).
In 2007, a policy for living donor evaluation was proposed.
In January 2007, the UNOS President sent a letter to all transplant programs that perform live donor transplants requesting copies of their informed consent, medical evaluation, and living donor follow-up protocols…The committee members reviewed and assessed all submitted protocols. Their evaluation revealed wide variation in the medical evaluation of potential living kidney donors. Some centers even lacked any formal guidelines for the medical evaluation of a living donor. (emphasis mine)
I think everyone can agree that this is not good, especially for the living donor. At that point, OPTN took the step of developing a policy* for the medical and psychosocial evaluation of the living donor based on two transplant-specific academic studies and from guidelines on the American College of Cardiology website, then throwing it out for public comment.
So what happened? Did OPTN pass an enforceable policy with teeth, requiring transplant centers to actually take care of their living donors? Nope. In the end, this is what we got*:
Since this resource is not considered OPTN or UNOS policy, it does not carry the monitoring or enforcement implications of policy. It is not an official guideline for clinical practice, and it is not intended to be clinically prescriptive or to define a standard of care. This resource will not be used to determine member compliance with policies or Bylaws; rather it is a resource being provided to the members for examples and amplification of the elements mentioned in the Bylaws. It is intended for members’ voluntary use.
The proposed policy included 7 goals of the psychosocial evaluation, and 8 necessary components. By comparison, the final ‘guidelines’ contain 8 bullet points and a non-concrete goal of “determining the presence of psychosocial problems that might complicate donation”.
More importantly, the proposed policy contained an appendix that includes a detailed rationale for interviewing a “Donor Support Person” (spouse, significant other, parent, friend, etc) during the living donor evaluation AND an inventory of questions for a POST-donation psychosocial interview of the living donor.
No such interviews of either type are routinely done by any US transplant center.
The proposed policy contained “Absolute Exclusion Criteria” (to donation) and a separate “Relative Contraindications” totaling 18 and 10 items, respectively. The adopted, voluntary guidelines have a 20-item list of “Possible Exclusion Criteria”
Proposed: Under 18 (absolute exclusion)
Final: Under 18 (possible exclusion)
Proposed: Age 18-21 years old; older age relative to the medical condition, aka recipient (relative contraindication)
Proposed: Obesity: BMI > 35kg/m2 (absolute exclusion)
Obesity (BMI 30-35) (Relative Contraindication)
Final: Morbid obesity (possible exclusion) -> Defintion of morbid obesity is BMI >40
Proposed: HIV, Hep B, Hep C (absolution exclusion)
Final: HIV, Hep B, Hep C (possible exclusion)
Proposed: kidney stones (Relative Contraindication)
The bigger question becomes, why did they bother? Why go through the time, energy and stress of putting together a detailed policy proposal only to adopt something so flimsy and without enforcement (especially when we, the taxpayers, are footing the bill)? What political processes occurred, leaving the public with something so average and meaningless? Did profit take priority over donor safety?
Edited to Add: In 2007, CMS (aka Medicare) released their Final Rule regarding the care and evaluation of living donors. It’s possible that OPTN was trying to ‘beat them to the punch’ so to speak, or to make it appear as if they were just as vested in protecting living donors. CMS regulations, while important, only affect providers and facilities that take Medicare/Medicaid patients. Not all do, CFR 42 doesn’t apply to everyone. UNOS/OPTN policies (their real ones, not the fake guidelines like above) affect ALL transplant centers in the US since they must all be ‘members’ of UNOS/OPTN in order to participate in the deceased organ system. Hence why the above is such a disappointment.
*I encourage a full and thorough reading.
ETA Nov. 2010: documents moved from UNOS’ server to OPTN’s so the proposed (failed) guidelines are now here.