Living Kidney Donor Follow Up

[Donolenick]

Hello this is my first post.  I am a liver donor having donated in  2005 and, after some involvement in donor issues at my center I was nominated to serve on the Living Donor Committee (the "LDC") for UNOS on which I have been serving for 2 years.  I want to update the donor community on the status of a policy proposal requiring reporting on follow up status of living donors.  This past year the LDC approved 3 new policies envigorating the standards transplant centers must follow, including medical evaluation of living donors, informed consent and follow up reporting on living donors.  These policies were approved by LDC last winter and then underwent a public comment period and were reviewed by the Regional Committtees which approved them by a substantioal majoritiies.  I am focussing on the  the proposal on follow up of living donors because it has been the most controversial.  This new policy would require transplant centers to report to UNOS the status of living donors at 6 months, 1 year and 2 years from donoation.  The purpose is to encourage centers to keep track of the medical, social, employment and psychological status of donors and to develop data on the affect of donation.  The policy would require centers to report the following at  three intervals:

1.  Alive/Dead (Cause if known)
2. Hospital readmissions for donor related complications
3.  Need for dialysis (Yes/No)
4.  Development of post-donation diagnoses: hypertension, diabetes, cancer, other
5.  Loss of income or livelihood due to donation
6.  Loss of medical or life insurance due to donation
7.  Lab work-serum creatinine and urine protein

Initially the LDC voted to require centers to report these elements for 90% of donors, but after public comments raised concerns about centers being able to reach this target immediately, thus, at first centers are required to report on 75% of the donors increasing up to 90% after three years. The new policies were then sent to the Executive Board of UNOS for review and adoption.  However,  the UNOS Executive Board tabled these policy proposals due to various procedural and substantive objections by the representatives of the three main transplant medical societies.  By now the issues raised about the informed consent and medical evaluation policies have been virtually resolved and they will probably be adopted by the Board in November.  This is not true of the living donor follow up proposal.  The medical societies object to this new policy because of additional costs that will be incurred by transplant centers and claimed difficulty in keeping track of and obtaining the cooperation of donors.  Since there is opposition to any fixed requirement  of the percentage of donors that must be reported it is not clear what will happen to this policy.  The LDC will be having a discussion with the Societies on the follow up proposal tomorrow and this will be further discussed at the LDC meeing on September 10.  I would like to hear people's thoughts on this subject and provmise to update the Living Donation Forum on further developments regarding this policy as they arise. 

[elephant]

Dear Donolenick,

Thank you for your efforts on behalf of donors.  I agree that follow up is neglected.  I think that two years is actually too short.  Without adequate information regarding the longer term health of donors, how can informed consent be "informed"?  Why aren't the recipients/their insurers bearing some of the burden of the follow up care of donors?  Why don't some pharmaceutical manufacturers step up to help support better programs?  Seems to me the first are saving a bucket of money from the transplants, at least in the case of kidney recipients who go off dialysis?  And the second are making a bucket of money on the meds.  But what do I know?

Love, elephant

[livingdonor101]

Transplant recipients are put into a govt funded registry and followed for ten years. So the question becomes - if the true obstacle to living donor follow-up is money then why haven't UNOS/OPTN, NKF (who claims to care about LKDs) and the transplant industry (and/or its related membership organizations) lobbied Congress for equal funding for living donors?

In 2007, OPTN attempted to implement national standards of living donor evaluation, selection, treatment and follow-up (I have copies of the original proposals if anyone would like to see them). OPTN's membership overwhelmingly rejected these measures, so OPTN stripped them of their concreteness and teeth, and renamed them 'guidance documents'. It's only because of pressure from HRSA that OPTN is revisiting these issues (this is clearly spelled out in the current proposals themselves, if one takes the time to read the longer documents).

Transplant centers have been required to report at six-months and one-year since 2000, extended to two years in 2006. This is a federal mandate ordered by the Secretary of Health. Yet 30% of living donors are still reported 'lost' by one-year, OPTN's own LD data task force called the current database 'woefully inadequate' and 'useless' in 2009, and worst of all, not a single transplant center has been penalized for not complying with this requirement.

The transplant industry has had over a decade to implement this reporting requirement.  Instead, they're still bitching they have to do it at all. The only thing that changes in the current proposal is what is reported, not the reporting itself.

Two years is a joke. The living kidney donors wait-listed in need of their own kidney transplants are 13-20 years post-donation. And while we know that a 10% reduction in kidney function significantly increases one's risk of cardiovascular disease and death, we have no idea how many LKDs (who lose 20-30%) experience cardiac related issues, because no one tracks them for long enough.

Finally, notice that the follow-up proposal completely neglects psychological consequences. Sure, the transplant industry acknowledges that some living kidney donors experience depression, anxiety and PTSD post-donation, but what do they do to prevent or treat it (or pay for the necessary mental health services)? The answer is - nothing. The 2007 proposed standards contained a in-depth psychosocial evaluation, but like everything else, it was gutted.

So my thoughts are that the transplant industry has had repeated opportunities to do right by living donors, to treat us as equal in priority to transplant recipients, and every time they've failed to do so. As long as OPTN is in control of living donation and its membership is comprised of people and organizations that benefit from living donor transplants, the situation will probably not change. There's simply too much money in the status quo.

[CK]

I have to say...I do think they should do follow-up with donors, that seems like a no-brainer. I'm more than willing to go in for the first 2 years. But beyond that, I think it's my responsibility to take care of my health by seeing my PCP. I went into this voluntarily and it's my choice how I take care of myself afterward. For research purposes, it would nice if they did a brief follow-up so that we can have the statistics, but I don't think it's their job to hunt me down and make sure I get proper medical care.

IMO, there is no "transplant industry". Dialysis costs WAY more than transplant (that's why insurance pays for the donor) so really, if it were all about money, there would be a conspiracy to discourage donations so they can make the $72,000 a year or whatever they get for dialysis. Transplant saves the quality of life of people with kidney disease (and other diseases). Personally, I think you should be able to pay people for giving up an organ. We pay people for giving up sperm and eggs and no one questions whether that is good for the children brought into the world as a result. Recipients of transplants get better care because they are sicker and need it.

Sorry for the rant. I feel strongly about this misguided idea that hospitals use donors and take advantage of them to make money. There may be a need for better follow-up, but that doesn't equate to there being some sort of conspiracy to take people's organs maliciously.

[sherri]

CK,

I agree with you in that I don't think hospitals take people's organs maliciously. But it is not "hospitals", there are human beings, doctors, nurses, social workers etc who are all fallible. I think it must be hard to know how to deal with healthy patients when you see all the sick patients around you and are responsible to heal them. The healthy patients sometimes then are viewed as a "cure" for your patient. Yes, there are two teams who are supposed to represent the recipient and donor separately but essentially they all come together as a team when they discuss each case and work as one. In my case, the nurse coordinator started out by being in contact with both my brother and I together and then out of the blue said ok, from now on I am only your brother's nurse and someone else will be taking care of you. I felt very abandoned. I had been counting on her and I had given her all of my information. She knew all along she was representing my brother, got all my medical information, concluded that I was a possibility and then set up appointments for my lab work and left me. When I met with the nephrologist, I kept asking question after question on my list. I was very hesitant to do this, as I have another brother who I found out is also under the care of a nephrologist, and he said to me out of frustration, "well, you're healthy and your brother is sick". He wasn't my brother's doctor but he is a doctor who is trained to heal sick patients. Here I was a great treatment and he didn't want to let it go. The other issue is that there are no universal standards, no set protocols monitored by anyone. Every transplant center acts as they see fit. Some do certain tests, others don', some offer living donor advocates, some don't. We see it here on the forum, some donors have great treatment, support, follow up with their center and others feel abandoned.

In terms of diaylsis; that's a business too. Ask how many dialysis patients are even aware of living donor transplants? Are they on a waiting list for a transplant? Some nephrologists just don't even inform their patients because they think they aren't capable of managing their medications, don't have a support system etc. Some dialysis centers are owned by nephrologists and are a money maker for them. So unfortunately lots of things in medicine is a business. That's also what drives research and creates new medications and treatments for so many diseases. Double edged sword.

Look at the news recently about physicians who lost their licenses and hospitals in financial ruin because of cardiologists who used stents when not needed. I don't think physicians go into practice deciding "I think I'm going to commit malpractice." But I do think the lines get blurred and some decisions help one person but harm another or an entire process.

And yes, I have saved Medicare lots of money by having them not pay for another patient on dialysis. So as a donor, I should receive at least Medicare benefits to ensure my future health. Not necessarily a monetary payment but I believe donors should not fall through the health care cracks. And in terms of follow up, donors should be offered to be followed up for lifetime. Or if they do contact their center they should not be turned away to their PCP or told they are no longer required to give them care. No one can make someone keep an appointment. But I do not believe as some transplant centers claim, that donors are annoyed and do not want to come in for appointments. They don't have to come in for appointments. They can get their follow up, paid for by the transplant center, the same way they did when the transplant center needed them for the surgery, and have those results forwarded by their PCP to UNOS or OPTN. Physicians do it for recipients.

Ok, my rant is over. Glad that you had a great experience and hope both you and your recipient have many years of good health.

Sherri

[Donna Luebke]

I served on the OPTN/UNOS Board from 2003-2006.  Donor followup is not a new issue.  I appreciate that the LDC is keeping this a front and center topic.  As noted by livingdonor101, donor followup is a mandatory requirement. 

Let me explain:  as part of the OPTN Final Rule and since 1999, data submission requirements are mandatory (are 'recognized' by the Secretary.)  An OPTN policy has to be 'recognized' by the Secretary of the Department of Health & Human Services to make it mandatory--all other policies are voluntary but carry the weight of having a transplant hospital being declared "A Member Not in Good Standing."  If this occurs, the entire transplant hospital risks losing Medicare.  The Centers for Medicare and Medicaid Services 'regulates' transplantation and as a Condition of Participation (CoP) in Medicare mandates compliance with OPTN policies.  There is plenty of clout at the federal level to force compliance so has always puzzled me why the OPTN members get to debate this issue.  If mandatory--then have to be compliant.  No questions asked.  All other data submission requirements have a bar of 90% so why lower it for living donor followup.

I suggest reading the recent article published by Connie Davis, MD past Chair of the LDC.  Centers and surgeons argue donors do not want to be followed which Connie says is not true.  There are many ways to meet this data submission requirement.  Time to take it out of the hands of the OPTN and surgeons and let the donors and their health care providers submit.  This way, what I or my physician submit it truthful and accurate about my health & health issues.  OR make sure every living donor gets a LODN insurance policy. Not only does this include insurance but LODN will follow the donors.

There is and has never been a mechanism for donors to verify what is submitted to the OPTN about them.  Several years ago, I contacted UNOS as to what methods they use to verify accuracy and completeness of the donor data.  None.  It is well known that what has been submitted over the years or collected about donors is not comprehensive or reliable due to lack of quality checks & the high % of donors marked "lost to followup.'   Centers claim donor followup is unfunded mandate--I disagree.  Is tied to their CoP for Medicare--and due to the 1972 ESRD Kidney Act, there is a Medicare entitlement to kidney transplantation.  They get paid.

Thank you for sharing this information.  Is long overdue that DHHS and HRSA take a tough stance against the membership of the OPTN about this policy.  If after all these years, they have not developed mechanisms to collect reliable data then perhaps they should not be allowed to do live donor transplants and should be suspended from the Medicare payroll.  Is time to publicly display each centers compliance with this policy.  There is no excuse when hospitals have trauma registries, burn registries, tumor registries, etc.  We can only learn about patient populations we serve when we collect useful data about them.

A word of caution:  Ask for past OPTN Board and LDC minutes where donor data collection, medical evaluation, informed consent was discussed.  This is to avoid spinning your wheels and wasting time at meetings, etc.  None of this is new.  The OPTN is good at tying up agendas and getting nothing done.  Is time to get results and solid outcomes for donors. Not White Papers, consensus documents, or watered down policies.  We deserve better.  If I were an auditor for any certifying body and visiting a transplant center, the first thing I would request is their compliance with OPTN data submission requirements.  Lack of compliance would indicate lack of concern for the patients they serve and disrespect of the system which is supposed to be in place for patient safety.  Ironic how the OPTN keeps talking about donor safety, too, when they have not developed one policy in over 6 years that addresses safety.

Again, thank you.

[sloaner1982]

Oh my goodness! I can testify about the lack of followup care I recieved. Last time my center did any follow up was 9 months post. They are clearly in violation with the rules. 9 months is not two years. Yes,I agree that only colecting data for two years is not long enough to know what happens to living donors in the long term. If they donated at 30- how are they doing at 40, 50. 60? No one knows! It is a complete lie for centers to tell donors that studies show they can live along normal healthy life with one kidney. That is what I was told. I was lied to because they left out the part about donors only being followed for two years and that that information is not even complete or reliable. To give true informed consent. The centers need to be telling potential donors that they do not know how well living donors are doing longterm and we are all part of an experiment that does not have an answer yet. The risks to our future health are unknown. That is what we should be told.

[Fr Pat]

     I recall reading over the years that some countries in Europe have done long-term follow-up on living donors, but I don't recall which countries. Can anyone here offer some information on this? Not that this would be a substitute for the U.S. doing the same, but it would offer at least some informative long-term data.
    Fr. Pat