Proposed OPTN Policies Living Donors Should Care About

I encourage everyone who’s invested in the way the US transplant system functions to review *all* the proposed policies and submit informed comments.

The following are the policies which affect living donors:

  • Revise Data Release Policy
  • Revise KPD Priority Points
  • Requirements for Therapeutic Organ Donation

All policies and the means to submit a public comment are available here.


More Proposed Policies From OPTN Up for Comment

Commenting period is until December 5, 2014. Yes, any member of the public can submit comment via their online form.

The first proposed policy is about informed consent for living kidney donors involved in a pair, swap, chain or bridge.

See them all here:

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:


Listen to OPTN’s Board of Directors Meeting, June 24

Remember all those proposed policies I’ve been haranguing y’all to submit public comment on? Well, the meeting to discuss the feedback on those policies and their adoption (or not) will be discussed at OPTN’s Board of Directors meeting on June 24-25.

You can listen via the web, for free:

And here’s the agenda:


BTW, if anyone is in the neighborhood and wants to attend in-person, I strongly suggest that too. And if you do, shoot me an email and let me know how it goes.

Advocacy Ethical Considerations Living Donor Protections Living Kidney Donor OPTN Organ Allocation

Proposed Kidney Allocation and Independent Donor Advocate Policies Detrimental to Living Donors

Today we have a guest post by Jane Zill, LICSW on OPTN’s proposed policies now up for public comment:


The Board of the OPTN will vote on new allocation principles for deceased donor kidneys in June. These allocation principles will definitely impact living organ donors. I am very concerned about this and believe that we should reach out to OPTN Board members immediately and to the Kidney Committee that sponsored this proposal. We don’t have much information about living donors who develop end stage renal disease. A few years ago it was thought to be only 56 but now a new tally is 324*. Because systematic data collection has never been required we do not have an accurate count or an understanding of the factors that led to organ failure in these people.


Also, public comment closes in June on a proposal for Independent Donor Advocacy. While the proposal represents hard work and good faith of the members of the Living Donor Committee, it falls far short of what is considered to be best practice. I believe that the wisest and safest route to go would be to ask HRSA to reverse its 2006 decision that gave the OPTN authority (thus the transplant surgical community) to make policy about living organ donation. The transplant surgical community has a conflict of interest regarding living donors that should preclude them from the ability to make their own policy about how they will care for living donors. Since 2006 their efforts have been very unproductive, while KPD [kidney paired donation] that requires the use of living donors, is gaining traction.


We need a National Center for the Independent Care and Advocacy for Living Organ Donors, which is totally apart from the purview of the OPTN or the transplant community. Public comment closes on the proposal about Independent Donor Advocacy in June.





Here is a .pdf of Jane’s public comment  at the OPTN Region 1 meeting in Worcester, MA. –   Public comment; Region 1, 4-13; IDA -1


(Check OPTN’s calendar; your regional meeting may be upcoming. They are open to the public)


Table that compares models of Independent Donor Advocacy: Best Practices, CMS Final Rule 2007 and OPTN’s current policy: Models of Independent Living Donor Advocacy


To submit your own public comment on the OPTN proposals:

Also, you can feel free to contact Jane directly, leave a comment here or email me if you’d like more information or to receive a template to submit to OPTN.



*note: I’ll be posting the most recent living kidney donors waitlisted numbers soon.