Follow-Up Informed Consent Liver Donor Living Kidney Donor OPTN

Latest from OPTN’s Living Donor Committee

OPTN’s Living Donor sent their latest report to OPTN’s Board of Directors a couple of weeks ago. The following are noteworthy highlights:

1. After CMS (Medicare) published the Final Rule in 2007, requiring transplant centers to provide prospective living donors with an Independent Donor Advocate, OPTN followed suit by implementing a similar policy.

note: Yes, this is bureaucracy duplication at its finest, but necessary because some transplant centers may choose not to take Medicare/Medicaid patients, in which case, they would not have to abide by CMS policy. However, where it becomes a giant pain in the ass is where CMS requires one thing, eg. the IDA “must not be involved in transplantation activities on a routine basis” where OPTN simply says “not be involved with the potential recipient evaluation”. What policy do you think transplant centers will follow: the lesser of the two? Yeah).

UNOS started performing on-site reviews of living kidney donor transplant programs in January 2011. In April 2012, the Committee received a staff summary of findings and impressions on this first year of audits. The findings included the following observations:

– only 2 of 15 members surveyed were fully compliant with all IDA requirements and
– the benefit and need for post-donation follow-up was the most common element not documented by the IDA as being discussed with the potential donor.

This same report identified variability in member IDA protocols addressing training, qualifications, required documentation, IDA function in the evaluation process, and the use of individual IDAs versus donor advocate teams.
For the living donor site surveys completed in 2012, the Membership and Professional Standards Committee (MPSC) determined that 86% of these members had compliance issues related to IDA requirements.

You read that right: transplant centers are non-compliant with policies passed in 2007.

So the LD Committee wrote up a policy clarifying the role of the IDA and put it out for public comment in Spring 2013. After reading public comment, they revised the proposed policy and sent it to the Board of Directors in September. The BoD approved them and the new policies go into effect in February, 2014.
Note: unfortunately I don’t know the specifics of the revised proposal. The proposal that went up for public comment is available here:
2. The LD Committee wants all prospective living donors registered with the UNOS/OPTN database UNet before surgery. The proposal is up for public comment now:
3. The LD Committee has written a proposal for live liver donor follow-up, which is available for public comment now:
4. They also have proposed minimum requirements for living liver donor informed consent and medical evaluation. Some folks said (in essence): How those few other living organ donors? Shouldn’t they get protection too? So they’ve gone back to the drawing board to compose national standards of care for *all* living donors.
Note: Only took ’em nearly 60 years.
5. In case you’re not aware, living donor follow-up and data has been abyssmal, even though the Secretary of Health mandated it in 2000. SRTR, who collects and analyzes all transplant related data (transplant recipients have a 10-year govt funded registry), reported to OPTN’s LD Committee that they have a contractual obligation to report ‘adequacy of follow-up submission’, ‘adverse events’, and ‘laboratory results’ to the public. (Another FYI: OPTN and the transplant industry have very strenuously objected to *any* center-specific information be given to the public. It’s a symptom of the medical industry’s lack of transparency, which has given rise to numerous patients’ rights groups and pending legislation).

A subcommittee was assigned to work with the SRTR to recommend what metrics should be reported in the living donor program PSRs. The subcommittee ultimately recommended that the PSRs include “completeness” of living donor follow-up reporting, and adverse events to include re-hospitalization and type of complication. The subcommittee did not support reporting living donor deaths or organ failure for individual centers

Shock me, shock me that the subcommittee wouldn’t want the public to know if living donors died or experienced organ failure (Sorry about the sarcasm, but really, what motive would they have for withholding this information other than to A. protect their own butts and B. keep the flow of living donors going?)
5. And finally, they decided that living liver donors would *not* get wait list priority if they needed a liver transplant in the future. Nice, eh?

Read the full report to OPTN’s Board of Directors here:

One reply on “Latest from OPTN’s Living Donor Committee”

Clearly, independent education of living kidney donors is spotty at best. For the most part, potential problems of the nephrectomy, during and after the procedure, and in the future, are glossed over, if mentioned, at all. The drive to promote living donation is carried out by those who stand to gain the most from the donor, such as the ESRD patient, the transplant institution, the transplant surgeon and the drug companies that make the immunosuppressive drugs. On the other hand, the donor may get fifteen minutes of fame and a life time of health risks. Some have died due to the unwarrented nephrectomy. Imagine what any primary care physician would say if they discovered that their healthy patient has suddenly lost 50% of their renal function. The fact is they would be very concerned and begin batteries of test to evaluate your kidney function and overall wellness. Yes, people can live with one kidney. So, why do we have two? The fact is that all of us, as we grow older, steadily lose small amounts of renal function every year as we age. Having two kidneys helps our bodies compensate as well deal with problems like diabetes, hypertension, or other disease that come with age that might affect our kidneys. A person who gets into a car accident, or has any other physiological assualt to our bodies, will certainly recover better with two kidneys, instead of just one. The encouragement of living kidney donation has only one drive, which is financial, as there are not enough cadaver kidneys to address the need. Living kidney donation benefits everyone except the donor. In light of this, a national registry needs to be created to follow these brave individuals, who have stepped up in a very big way to help another person. As well, truth in advertising needs to be implemented, as only a polyanna story is being sold to the public, right now. The side effects of the immunosuppressive drugs are not fully being discussed with the receipients of all transplants. In other words, transplantation is sold to the public as a cure, as opposed as an option of treatment for ESRD. It’s time for transplant centers to clean up their acts and the media to understand that kidney transplantation is not a cure. As well, it’s time for everyone to understand the true risks involved when one volunteers to undergoe a nephrectomy. Somehow, calling kidney donation a nephrectomy (what it really is) kind of takes the romance out of the process.

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