Living Donor Registry

I would not encourage people to be a living donor,” said Joyce Somsak, a spokeswoman for the division of the federal government that oversees organ transplants, the Health Resources and Services Administration (HRSA) in 2006 (63).

What is a Living Donor Registry?

A living donor registry is a national database of all people who present as potential living donors for the purpose of prospective study*. All potential living organ donors# would be entered into the database at the beginning of their living donor evaluation, and all aspects of their physical and psychosocial well-being would be tracked for the rest of their lives. Living donors would have access to their record within the registry for quality assurance and accuracy purposes; they would have the ability to self-report complications, issues or corrections.

The registry would be administered by an organization that does not profit or benefit from living donor transplants in order to prevent conflicts of interest and preserve the purity of the registry’s mission. Sanctions would be issued to non-compliant or underperforming transplant centers, such as fines, Medicare ineligibility or suspension of program certification.

A registry would provide a comprehensive and longitudinal database of living donors: demographics and risk factors at the time of donation, reasons why potential living donors are disqualified, post-op complications, mental health difficulties (anxiety, depression, PTSD), long-term health changes, financial and other psychosocial issues related to living donation (lost wages, inability to procure health insurance, job loss, etc). This data could be used to identify risk factors related to transplant outcome, donor psychosocial and physical complication rate, and the long-term ramifications of living donation on the donor. Ultimately, this information can be used to more thoroughly protect, evaluate, treat, and support living donors, minimizing risks and detrimental outcomes.

The Swiss organ living donor health registry was initiated in 1993. A donor registry has existed in the Netherlands since 1998. In Australia and New Zealand, the Anzdata Living Donor Kidney Registry was established in 1997. In 1997 the Norwegian National Hospital Donor Registry was established.(95)

FYI: Other patient populations, including transplant recipients, heart patients and those diagnosed with cancer, are currently kept in registries. In addition, persons with certain ‘implants’, such as pacemakers or artificial joints, are tracked in databases to study product safety, longevity and interactions.

#The inclusion of every individual who presents for living donor testing provides statistics regarding exclusion during evaluation, as well as insight into the preponderance and reasons for withdrawl during the evaluation process. The folks who qualify as living donors but choose not to donate can also be used as a comparison cohort for living donor research purposes.

“Long-term medical risk associated with donor nephrectomy [aka living kidney donation] cannot be accurately assessed in this country due to the patchwork access to health care afforded donors at this time.” (27)

Why is a Living Donor Registry Important?

1. Although the very first kidney transplant was between identical twins, living donors were never meant to be a prime source of transplantable organs. NOTA 1984 was intended to provide a national waiting list and database for deceased organ distribution. At the time, it was believed that if everyone became an organ donor and all viable organs were used, deceased organ donation could meet the needs of would-be recipients. Consequently, no public policies were ever developed for living donors/donation.

Then the number of would-be recipients increased due to the improvement of anti-rejection medications and the aging of the US population. Meanwhile, the transplant industry decided that a living donor kidney was ‘better’ for the recipient, so they turned their attention toward increasing living donation even though deceased organ donation was far from maximized. 

But they forgot to make sure the living, breathing people they were taking kidneys from were protected and cared for.

Living donation peaked in 2004. Since 2000, living donors have comprised 44-49% of all kidney donations. (see data). 

2. Past and current data collection is inadequate and incomplete.

There is NO long-term data on living donors’ health and well-being. No identifying information was collected on living donors until 1994 (136). We know nothing about any living donor prior to that year.  

Before 2013, a transplant center only had to report if a living donor was alive or dead to get credit for submitting follow-up. Even with that low standard, 1/3 were reported “lost” by one year.

However, following living donors for only two years (see below) provides no information on long-term consequences, such as hypertension, diabetes, cardiac disease and kidney dysfunction and failure. The living donors who have been added to the UNOS/OPTN waiting list since 1993 averaged 17 years post-donation when kidney failure occurred.

In addition, there is a paucity of research and knowledge regarding living donors’ psychological and emotional well-being. Current data collection policies do not require any mental health information.

From Shokeir in 2007:

There are deaths from open donor nephrectomy that have gone unreported…We can count at least 15 graft losses directly related to the surgical technique of Laparoscopic Live Donor Nephrectomy, [but] these losses were not emphasized, neither in recent review articles nor in the original articles.(134)

– According to a single-center study from 2000-2007, 12% of living donors reported not having seen a physician since postoperative follow-up; 7% had not had a blood pressure check, 29% had not had a urinalysis, and 20% reported not having had any blood tests. Records obtained from Primary Care Physicians of patients confirmed that of this cohort, 39% had not had a urinalysis and 14% had not had a creatinine measured. (58)

– Mr. Graham, then-Executive Director of UNOS, commented that the living donor data collected as of 2008 does not answer all of the questions on long-term complications, pre-donation issues, peri-operative conditions, and financial complications. (61)

– A survey of 27 liver donors reported only 60% of self-reported complications were documented in the medical records. This means 40% of complications were not in the living donors’ medical records (127). Meanwhile, LODN’s kidney donors self-reported higher complications rates (37.5%) than centers reported (28).

2a. But wait – haven’t transplant centers been required to report data on living donors’ health at the six-month and one-year post-surgery since 2000, extended to two-years in 2006?

Yes, and it’s mandatory, per the Secretary of Health (195).  However, at the November 2008 ACOT meeting, Dr. Cooper from OPTN reported that “For one in every five kidney donors in 2006, there were no forms submitted.“. (61) 

By 6 months, complications data on kidney donors are 17% incomplete; by 12 months, data is more than 50% incomplete. About one-third of kidney donors were reported as lost to follow-up during the first year post-transplant. (61)

By 6 months, complications data were less than 10% incomplete; by 12 months, data were less than 20% incomplete. A small fraction of liver donors were reported as lost to follow-up during the first year post-transplant. (61) 

The annual Utilization report issued on 1999-2008 (published in 2010), says: Of the 6732 living donors who donated an organ in 2006, more than 30% were lost to follow-up. (107)

According to OPTN (176):

– For those who donated between 7/1/07 and 6/30/08, only 56.4% of kidney donors had a valid status (alive or dead; not lost to follow-up) on their one-year living donor follow-up form, and only 31.4% had a valid serum creatinine lab value on their form. Using the same metrics for the same cohort, 69.6% of liver donors had a valid status (alive or dead; not lost to follow-up), and 52.2% had a valid bilirubin lab value on their form.

Only 29 transplant programs in that time period had ‘alive’ or ‘dead’ statuses on 100% of their living kidney donors (out of over 200). 15 programs had 0% follow-up. Meanwhile 14 liver donor programs had 100% compliance while 5 had 0%.  

– Of all living kidney donors from 7/1/2008 through 6/30/2009, only 63.5% were known to be either ALIVE OR DEAD one year after donation. This jumps to 66.8% for living liver donors.

There was evidence of a urine analysis in only 38.2% of ALL living kidney donors in that period, and a liver function test for only 50% of liver donors.(187)

– In 2009, OPTN’s own Living Donor Data Task Force determined OPTN’s database to be ‘woefully incomplete’ and ‘useless’ for analysis after the six-week post-donation mark. (136) This was confirmed in a 2011 OPTN proposed policy for improving living kidney donor data collection. (176)

– From 7/1/2009 through 6/30/2010, only 65.6% of kidney donors were known to be alive or dead one year post-donation, and only 40.7% had a relevant lab value. During that same time, 68.9% of liver donors were accounted for by one year, and 54.7% had a lab value (221).

In late 2013, under great pressure from HRSA, OPTN adopted a revised follow-up policy. In addition to the ‘status’ of alive or dead, the reports must now include a recent relevant lab report. Unfortunately, the center will be considered compliant if the have labs on only 70% of LKDs who donate after 2014. They are not required to know about 100% or even the statistically relevant 90% (227).

The actual risk of death in hepatic lobe donors for living donor liver transplantation (LDLT) is unknown because of the lack of a comprehensive database“. (120)

3. There were no standardized processes for evaluation, selection or treatment of living donors until 2013, and even now they’re very minimal.

Current law and policies give the 200-plus transplant programs in the U.S. great latitude in the evaluation, treatment and follow-up of their living donors (186). These differences will affect the validity and reliability of any future data, research or studies. Comparing apples to oranges, so to speak.

In addition, the transplant community has begun using what they call “Expanded Criteria” donors (older, lower pre-surgical GFR, obese, etc) on which no data has been collected.

A 30 year examination of living kidney donors at one large transplant center revealed that the average kidney donor was 3.38 years older each decade, had a .86 m/kg2 increase in BMI, and 1.49 ml/min decease in GFR. The authors concluded: This is an important epidemiological observation of potential future public health considering that the American population continues to age and increase in weight. (188)

In November 2012, OPTN’s Executive Committee finally implemented a minimum set of tests to be given during evaluation, but the policy is so open it requires any prospective living donor who was refused to be “informed that they could be evaluated by another transplant program that may have different selection criteria” (227). Also, the policies contain no consequences for noncompliance, so the transplant centers’ adherence and OPTN’s quality assurance remain to be seen.

Under current policy in the United States, living donor interests remain unprotected relative to current Western standards: risk cannot be quantitated (particularly among ethnic minorities), and Living Donors are not adequately shielded from financial and health consequences associated with nephrectomy. (38)

The Amsterdam Forum on Care of the Live Donor

4. Transplant centers are rated and compensated by their recipient outcomes and have no obligation (legal) or motivation (legal or financial) to provide their living donors with aftercare.

In fact, according a 2009 study, 78% of transplant centers prefer follow-up be done by the living donor’s primary care physician(13).

Dr. Matthew Cooper felt that centers do not report the donors with complications.  The centers may not know about complications or may minimize them. Living donors tend to be uncomfortable going back to their transplant center if they have a complication, which skewed the numbers. He felt that donors might be more honest if their responses did not go to the centers. (61)

Dr. Gil Thiel brought to attention the potential of underreporting donor complications because of the hesitation of the transplant physicians to reveal them either to the hospital center, future donors, or insurance carriers.(38)

The International Liver Transplantation Society’s 13th Annual International Congress (2007) states: “One of the key problems with examining living donor morbidity and mortality is the under-documentation or lack of direct reporting of complications by the transplant centers, leading to a dearth of hard data on which to base transplant decisions and to an to inability to provide potential donors with true informed consent.”

Because over 50% of Living Donor Registration forms were submitted by transplant centers less than 6 weeks after donation, complication rates are considered minimum estimates. Higher complications rates have been reported when donors themselves are the reporter.(84)

“Specialty societies may not have enough clout to regulate the actions of surgeons and transplantation programs.”(110) And right now, UNOS membership is made up primarily of transplant centers, surgeons, Organ Procurement Organizations, and Histocompatibility Laboratories (359/396 members). Who or what is keeping them in check?

5. Both short-term and long-term living donor studies are sporadic and rife with qualitative issues.

– Questionable conclusions may have resulted from small study samples and low response rates. Non-responders may have differed from responders, as highlighted in a study where some with adverse outcomes did not participate.

– The majority of living donor studies have been conducted retrospectively, and kidney and liver donors contacted many years after donation may have a biased recall. Having already gone through the experience, living donors may find it difficult to express negative feelings (7,26,4). Few studies collected data anonymously and living donors may have been less likely to report adversity if the studies were conducted by members of the transplant team.It is noteworthy that the few studies that did assess donors prospectively were more likely to report post-donation depression, poorer quality of life scores and psychological functioning. However, such assessments were often made shortly after surgery and whether such findings are persistent remains unclear.(17)

– Living donors must be compared to equally healthy non-donors, not the general population. Sometimes researchers use an incorrect comparison cohort, as appears to be the case for Ibrahim et al. as reported by Lin et al. which skews the results in favor of the researcher who wants to prove the safety of living kidney donation (222).

– The short and long-term health and social impacts of donor nephrectomy remain relatively undefined, owing in part to the paucity of long-term follow-up studies.(14,30,37).

6. The collection of mortality (death), morbidity, and complication data is ill-defined and non-standard.

– Uniform reporting of complications specific to the donor experience…is necessary…All reports of donor morbidity and mortality should explicitly state all minor and major complications. All morbidity reports should include all living donors without exception… Measurements should include economic and health related quality-of-life outcomes in addition to medical complications.  (124)

– There is a lack of regulation and uniformity in reporting of complications related to living donation as well as an absence of a national or international registry for tracking donor outcomes.(53)

– Standardized definitions of morbidity and better methods for observing and measuring outcomes are necessary to understand and potentially improve morbidity…Additionally, to improve outcomes, problems that donors experience must be understood. (124)  

Who has called for a Living Donor Registry?

Who hasn’t?

– Consensus Statement on the Live Organ Donor, 2000

“The rationale…includes concern for donor well-being, limitations of current knowledge regarding the long-term consequences of donation, the potential to evaluate the impact of in criteria for donor eligibility on the outcome of donors…” (65)

– Renz & Roberts. Long-term complications of living donor liver transplantation. Liver Transplantation Vol 6, No 6, Suppl 2 (Nov) 2000 pp: S73-S76

“The lack of precise morbidity and mortality data underscores the need for a worldwide database and information sharing among centers.” (122)

– Vastag, B. Living Donor Transplants Reexamined: Experts Cite Growing Concerns About Safety of Donors, 2003.

“DelMonico, who is also professor of surgery at Harvard Medical School, in Boston, said that lack of information about risk factors for living donors makes imperative a federal registry of living donor morbidity and mortality.”  (201)

– Jacobs SC, et al. “Laparoscopic donor nephrectomy: the University of Maryland 6-year experience”. J Urol. 2004 Jan;171(1):47-51.

“There should be a national data registry of donors to measure accurately the immediate impact and the long-term impact on donor health.”  (54) 

– International Forum on the Care of the Living Donor, Amsterdam 2005.

“Comprehensive national registries should be established to determine whether the incidence of medical risk factors and renal dysfunction is different from the general population.” (38)

– The International Liver Transplantation Society 13th Annual International Congress (2007) agreed that:

“One of the key problems with examining living donor morbidity and mortality is the under-documentation or lack of direct reporting of complications by the transplant centers, leading to a dearth of hard data on which to base transplant decisions and to an to inability to provide potential donors with true informed consent.”

– We Need a Registry of Living Kidney Donors: essay from Bioethics Forum after two studies revealed some living kidney donors end up on the transplant waiting list themselves.

Because of the high incidence of proteinuria and possible changes in bone metabolism inclusion of kidney donors in registries appears worthwhile. (73)

Lainie Friedman Ross (bioethicist, living donor researcher, UNOS committee member), Mark Siegler, and J. Richard Thistlethwaite, Jr., in 2007 after UNOS failed to pass a uniform living donor evaluation policy said in an essay published by The Hastings Center:

The lack of support for a prospective large-scale living donor registry is morally inexcusable.

Shokeir, AA in 2007:

We are in urgent need of a donor registry. We must know the combined experience with complications and long-term outcomes in live organ donors, rather than short-term reports from a single institution. (134)

Davis, C. in 2007:

How many more surveys will be conducted and donors donate before funding for a registry is established to follow the outcomes of living kidney donors? (203)

Emara, M. et al. in 2008:

The current donor registries are structured and are driven to expand donor pool. As living kidney donation is not without risks, more attention should be given to protect the donor health… We [see] a need to mandate the establishment of renal transplant donor registries at all transplanting programs as a prerequisite to protect the long-term well being of kidney donors. These registries can collect the database necessary to develop standards of practice and guidelines for future kidney donation. (95)

Barri, Y. et al. in 2010:

A registry including all kidney donors with regular follow-up updates may be the best way to alleviate anxiety about [long-term risks]. (169)

Ommen ES et al. 2011:

We argue that a national donor follow-up registry is essential to ensure transparency in ascertaining long-term health outcomes among all living donors and in providing assessments of quality assurance within transplant programs…We argue that the US government must provide funding to support a donor follow-up registry that can allow for meaningful and valid conclusions, in recognition of donors’ public service and to maintain trust in the system of living organ donation. (195)

Tong, et al. 2011:

Long-term, prospective cohort studies are needed in the living kidney donor population to assess physical and psychosocial outcomes after nephrectomy, and we suggest a living donor registry be mandated. (197)

Davis, 2012:

In summary, LD follow-up is not being performed as well as it should be in today’s transplant system model…In its purest form, the organization that evaluates and follows donors would be a nonprofit organization dedicated to only LDs and their needs, and would not be a part of the transplant hospital. It would be responsible for the evaluation and selection of donors, for communicating clearly to the donor operating team, for following LDs for their lifetime, for identifying donor’s medical and psychosocial complications, and for reporting donor outcomes to the appropriate agencies, the ultimate donor registry. (254)

Rodrigue, et al. 2015:

…we also strongly support establishing a national registry of patient-reported outcomes following living
kidney donation
. (253)

Why isn’t there a Living Donor Registry already?  

1. The original organ transplantation system was devised around deceased donor organs. Until 2006, no agency or organization had authority to oversee, or develop policies or procedures for living donation. Since the membership of OPTN benefits from living donor transplants, they have been resistant to implement any policy or standard that might reduce what they refer to as the ‘donor pool’ (See here for more).

2. There’s no profit in it. The deceased organ and tissue trade is a $2 Billion a year global industry, and transplant centers charge up to $500,000 for a transplant procedure (64). Living donors provide ~40% of organs transplanted, yet transplant centers and transplant-related organizations balk at the “expense” of a registry.

 This resistance is compounded by the Medicare’s performance metrics, which tie federal funding to recipient outcomes only. The more transplants performed, the bigger the profits (See #3 below).

FYI: transplant recipients are consistently and comprehensively followed for ten years, and bone marrow donors are followed until ‘no complication exists’ and then entered into a voluntary long-term registry.

3. Transplant centers and public policy organizations might fear what a registry will reveal. If anecdotal evidence are to be believed (that is, personal stories and small studies), there are far more consequences to living donation – physical and psychosocial – than anyone has ever acknowledged. If those risks and consequences are confirmed, the transplant community will have to stop using terms like “minimal risk” to describe living donation, take responsibility for their living donors by improving evaluation and aftercare procedures, and engage in more Informed Consent.

Conclusive data of harm to living donors could also reduce the number of people willing to become living donors, thereby reducing profit margins. (see #2)

**Despite some surgeons & published articles referring to a UNOS/OPTN ‘mandatory registry’, there is no such thing. ‘Woefully incomplete’ data that is ‘useless for research or analysis’ does not a registry make (136)**

Irony Alert: 
The Social Security Act in 1972, Section 1881, provides a Medicare benefit to living kidney donors. Two years later, the Director of SSA ordered transplant centers to bill the transplant recipient’s private insurance and/or filing all Living Kidney Donor charges under the recipient’s Medicare benefit, rather than giving the living kidney donor a benefit of their own.

If the law had been followed, the public and medical community would now have long-term data on approximately 120,000 living kidney donors. 

Instead, a review of all existing living donor research studies in 2006 found the accumulated literature to be ‘subject to selection bias’, rife with ‘small sample sizes’, ‘underpowered’, and containing a ‘paucity of data on cardiovascular risk factors’.

What To Do

– CMS (Medicare/Medicaid) is a government organization responsible to the public. So is HRSA, OPTN, DHHS, ACOT and myriad other acronyms. Each can be contacted privately via email, snail mail, telephone or fax. If one would like to make a more direct impact, their regularly scheduled meetings are open to the public. Attend and be heard. (See Public Policy Organizations page)

– Contact Federal Representatives and Senators, especially those on relevant committees.

Sample Letter

– Speak out. Use social media (twitter, facebook etc), personal blogs and otherwise to talk about these issues.

– Comment on message boards and forums, or respond to online articles which perpetuate myths, misunderstandings, or errors about living donation and living donors.

– Privately contact any reporter, blogger, etc. who author such articles or posts and politely and professionally correct them.

(*CA SB1395 is only establishes a list of healthy people willing to be living kidney donors in the same way one becomes a deceased organ donor. There is no funding, no follow-up, no way for non-unrelated living donors to join the list, and no mandatory reporting requirement by the transplant centers. This is NOT a registry in the true sense of the term.)

Last Updated: July 24, 2015