CMS - Medicare Ethical Considerations Informed Consent Liver Donor Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor OPTN

U.S. Transplant Centers’ Informed Consent Forms Are Deficient

The authors examined written informed consent forms from 148 U.S. transplant centers to assess their compliance with OPTN and CMS regulations passed in 2007.



 …most centers’ evaluation consent forms do not include all CMS and OPTN requirements. Multiple items balancing donor and recipient interests and confidentiality were omitted. In addition, information about payment for routine follow-up care, complications related to surgery and other health problems following surgery were highly variable and frequently ambiguous.


The authors identified 9 CMS (federal, Medicare) elements and 40 additional OPTN components.


For the most inclusive standard, a center received credit for addressing any aspect of an element, even if its consent form did not incorporate all the specified details. The moderately inclusive standard
generally required a consent form to address the element’s major subcomponents, even if it did not use language completely in line with the guideline. The least inclusive standard reflected a strict interpretation of each guideline. For these first three standards, centers that referred to other material or discussion for a cluster of elements (e.g. medical risks) or specific element (e.g. renal failure) were treated as though the relevant guideline(s) were fulfilled. In contrast, the fourth standard, least inclusive excluding other materials, required the consent form to contain the information, with an exception made for separate distribution of SRTR data.



Highlights of results using the “moderately inclusive” standard (any emphasis is mine):

  • 72% indicated that the decision to donate needed to be ‘‘voluntary,’’ ‘‘freely chosen’’ or ‘‘free from pressure or coercion.’’

[note: so the other 28% are okay with coercion??]

  • 98% of centers stated that the donors could withdraw from evaluation at any time, up to the start of surgery.
  • 64% of centers warned that it was illegal to receive compensation for donation, 19% noted that donors could not receive payment but did not say this was illegal and 17% did not address donor payment.

[note: how many recipients are told it’s illegal to pay for an organ? Serious question: is the burden of this illegality put on the person relinquishing the organ because of public sympathy toward the ‘sick’ recipient?]

  • Few centers (11%) required a formal ‘‘cooling off’’ period before the donor could proceed with surgery.
  • 75% indicated that an independent donor advocate would be assigned to safeguard the donor’s interests.
  • 92% addressed the confidentiality of donor health information.
  • Only 21% indicated that a new diagnosis could prompt mandatory public health authority notification.
  • Nearly all centers (98%) noted the need for a medical assessment;

[note:  Why not 100% – seriously??]

  • While 89% of centers mentioned psychosocial evaluations, only 46% explained their purpose.
  • 60% of centers offered details about the donor operation, often briefly describing a laparoscopic donor nephrectomy and noting that conversion to open might be required
  • Postoperative care was discussed extensively by 66% of programs. “The anticipated duration of hospitalization, pain management, Foley catheters and postoperative physical activity limitations were common topics.”
  • Only 54% stated that donation posed risks without the prospect of medical benefit.
  • Centers described satisfaction from helping another (34%) and possible discovery of a previously
    undiagnosed health problem (31%) as benefits to the donor.

[note: propaganda, propaganda, propaganda]

  • Although most centers (97%) discussed postdonation follow-up, only 65% said it was mandatory.

[note: and this is partially why we have no data]

  • Only 36% of centers told the donor who would pay for routine follow-up care.
  • Half the centers (55%) discussed who would pay for surgical complications.
  • Few centers (24%) provided or referenced national or center–specific living donor outcomes data.

[note: I’m actually surprised it’s that much]


NO CENTER INCLUDED ALL 40 OPTN-MANDATED ELEMENTS UNDER ANY STANDARD OF INCLUSIVENESS.  Applying the moderate standard, 68% of centers addressed half the components and 18% incorporated 30 items.


Under the moderately inclusive standard, only 40% of programs incorporated all nine federally mandated elements, although 83% discussed at least seven of them. Even under the most inclusive standard, 29% of centers did not address all CMS elements.


Make no mistake, not conforming to policies passed five years ago is more than problematic. It also underscores the imperative for potential living donors to embark on independent research and *not* rely on the transplant center to protect and care for them. (It *also* means that CMS and OPTN are doing a shoddy job in enforcing their own policies.)


Random note: of the 171 U.S. transplant centers with active living kidney donor transplant programs, *two*  had no written consent. FIVE YEARS after policy implementation and they still had NO WRITTEN CONSENT?! Someone should be publicly shaming those institutions.



Thiessen C, Kim YA, Formica R, Bia M, & Kulkarni S (2013). Written Informed Consent for Living Kidney Donors: Practices and Compliance With CMS and OPTN Requirements. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons PMID: 24020884

CMS - Medicare OPTN

OPTN Tries to Silence the Public’s Voice

OPTN was established by NOTA in 1984 as a membership organization to manage the US deceased organ transplant system. Living donors weren’t part of the equation until 2006 when UNOS’ Executive Director Walter Graham asked the Secretary of Health to allow OPTN to develop policies on living donation as well.

OPTN is considered a Public Policy Organization, which means it’s financially supported by the taxpayers and is obligated to represent and look out for the public’s well-being.


CMS (Centers for Medicare/Medicaid Services) Final Rule 2000, aka CFR 42 Part 121, establishes the makeup of OPTN’s Board of Directors, aka the Executive Committee:

(i) Approximately 50 percent transplant surgeons or transplant physicians;

(ii) At least 25 percent transplant candidates, transplant recipients, organ donors and family members. These members should represent the diversity of the population of transplant candidates, transplant recipients, organ donors and family members served by the OPTN including, to the extent practicable, the minority and gender diversity of this population. These members shall not be employees of, or have a similar relationship with OPOs, transplant centers, voluntary health organizations, transplant coordinators, histocompatibility experts, or other non-physician transplant professionals; however, the Board may waive this requirement for not more than 50 percent of these members; (emphasis mine)


OPTN’s Board of Directors consists of 45 people, but 2 are non-voting representatives of the feds. Based on the above, 10.75 of the BoD members should be ‘representative of the population’ served by OPTN, and ‘shall not be employees or, or have a similar relationship with OPOs, transplant centers, etc’.


But according to the Executive Summary (aka Meeting Notes) of OPTN’s last Board of Directors latest get-together in St. Louis:

The Board approved a waiver of the requirement regarding employment in the transplant community for not more than 50% of the Board members (and nominees) representing transplant candidates, recipients, organ donors, and family members.


So, we (the public) gets a whole 5/6 people on a 43/45 member Board to represent our interests. A whole 5/6 people who aren’t influenced or paid for by the profit-driven transplant industry.

Wow will I sleep better tonight.


I’ve no doubt that OPTN and its ilk will claim they couldn’t find qualified people to serve on the Board who aren’t also connected to the transplant industry. To that I say bull-honky. I have personal knowledge of multiple people who have applied (more than once) to serve on OPTN committees and been ignored. They weren’t even given an acknowledgement of their application, let alone an explanation for why they weren’t considered ‘qualified’. This waiver is nothing but the transplant industry’s continued attempt to control the direction of the transplant system in this country, to skew its policies and decisions in its favor.

It’s time for CMS and HRSA to step up and make sure that doesn’t happen.




CMS - Medicare Living Kidney Donor

Official Report of Toledo’s Thrown Away Living Donor Kidney

Read the full report here.

The following are excerpts from the report. Any and all emphasis is mine.


The clinical record review revealed Patient #9 was admitted to the facility on 08/10/12 with a diagnosis of kidney donation. A pre-operative progress note dated 08/10/12 stated the planned procedure was a right laproscopic donor nephrectomy. A review of the operative report for the procedure, dictated on 08/20/12, revealed after the kidney was removed, it was wrapped in a lap sponge and placed in a slush machine and covered with additional cold slush.

The report documented the circulating nurse, Nurse B and the scrub nurse, Staff B (the ‘scrub tech’ according to the case staff list) were informed the kidney was in the slush machine. The report stated, “As the skin was being closed it became apparent that the kidney was no longer in the slush machine”  and “investigation of this fact revealed that the circulating nurse had inadvertently discarded the kidney.”

Circulating Nurse A, who inadvertently disposed of the kidney, was interviewed on 08/16/12 at 12:45 PM. Nurse A stated that soon after the kidney was removed she was relieved for break by the relief circulating Nurse B. According to the facility’s investigation Nurse A left for lunch at 12:15 PM, after giving report to Nurse B and returned to the operating room after lunch at approximately 1:05 PM. Nurse A stated that because she was on break she wasn’t in the operating room when the surgeon announced the kidney was being placed in the slush machine.

Nurse A stated she took the contents of the slush machine, without realizing the kidney was within the slush, left the operating room, [went] down a hall and into a dirty utility room, and flushed [it] down a hopper.. Nurse A stated she thought the kidney was in the recipient’s room because that is what usually happens.


The tour [of the operating room] revealed Nurse A had to have walked one-half the square room’s perimeter and past Nurse B and Staff B to take the contents of the slush machine from one corner of the room to the only exit door, and then down the hall to the soiled utility room that contained the hopper.


Nurse B also stated that she never saw Nurse A leave the room with the contents of the slush machine.

Scrub technician Staff B said that she was responsible for the slush machine, but did not notice Nurse A take its contents, which included the kidney, out of the room.

Physician A, anesthesia resident, and Physician B, transplant surgeon, both stated that they did not notice Nurse A’s activity around the slush machine, or her leaving the operating room with its contents.

Staff C, administrative staff, said they have not yet figured out how circulating Nurse A could take the slush with the kidney in a 13-gallon size bag out of the room without Nurse B, Physician A and B, and Staff B not noticing anything out of the ordinary.



PS. What the report doesn’t say but the early media reports did is that no one noticed the kidney was missing for an hour. Standard procedure is for a donor kidney to be removed, rinsed and immediately taken the recipient’s OR. What was going on that the kidney was left unattended in the slush machine for an hour?

CMS - Medicare Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

Living Kidney Donors Still Can’t Obtain Health Insurance

The NY Times blog took some time to present yet another way we living living donors are being screwed by our own generosity: some of us can’t get health insurance.

(Read the article here)


What’s sad is that this problem isn’t new. NATCO (the self-proclaimed ‘organization for transplant offiicials’) issued a statement in May 2006, and the fact they felt compelled to do says the issue was pretty significant then.

And OPTN’s own Informed Consent guidance document recommends prospective living donors be informed they may have difficulty obtaining health or life insurance post-donation.


A provision in the Affordable Care Act, when it is implemented, will prohibit insurers from denying coverage based on pre-existing conditions. However, this will not stop insurance companies from pushing living kidney donors into the high-risk pool, forcing them to pay more for less coverage.


Some observations on the article itself (you know I had to):

– the writer uses the inflated wait list numbers instead of the ‘active’.


In Mr. Royer’s case, tests found a high creatinine level in his blood, which was interpreted to mean that Mr. Royer had kidney damage. Dr. Connaire told the Blue Cross panel that heard Mr. Royer’s second appeal that creatinine levels are high in most, if not all, kidney donors.


How many prospective living kidney donors are told their post-donation creatinine will be considered ‘high’? Conduct a random search on transplant centers’ website and tell me if it’s ever mentioned. I’ve spoken to quite a few LKDs (not to mention the survey takers) and it’s never come up. We’re all lead to believe we can lose 50% of nephrons and we’ll continue to be just as healthy as before.


“The literature says that if you have kidney problems you’ll have more heart disease, but taking a kidney out in a situation where everything is fine is a very different story,” said Dr. Connie L. Davis, who is chairwoman of the living donor committee of the Organ Procurement and Transplantation Network. “It does not have the same implications.”


Really? I’d like to see her proof of that, considering we have NO long-term comprehensive data on living donors at all.

Let’s see:

Garg’s study was Canadian where they have universal health care and different lifestyle than the US. And it only covered a decade as opposed to twenty years or more.

– Two published letters retorting Garg are less than flattering about his conclusions.


New research, not yet published, suggests the risk of developing kidney failure is even smaller for living kidney donors than for the general population, Ibrahim said.

This is the same Ibrahim that used an incorrect comparison cohort in single-center study which didn’t follow living kidney donors long-term, whose subjects were overwhelmingly white, and who sort of hid that only a tiny percentage of the entire sample underwent actual physicals?

Hm. I think we can see why I’m more than a little skeptical. After all, U of Minnesota makes big bucks from their living kidney donor transplant program.


And here’s my favorite:

…long-term studies have found donors live as long as other healthy people. One study reported that donors live even longer.


First off, the writer is referring to the Segev study, which is based on a ‘woefully inadequate’ and ‘useless’ database (that would be OPTN’s and the quoted terms are from OPTN’s own data task force in 2009). Secondly, NOT LONG-TERM. Thirdly, the abstract linked in the article has a small sample size, in a country where they have universal health care and a different lifestyle than the US. Not to mention, we have no idea how those LDs were evaluated and selected.


Meanwhile, Mjoen in 2011, who did follow his kidney donors into old-age, and used the correct comparison cohort, found that once living kidney donors hit their 60s and 70s, we started dying off at a faster rate than our two-kidneyed cohorts.


Do I think we should be discriminated against by insurance companies? Of course not. But do I think health insurance companies should operate on a for-profit paradigm? NO.


The ironic part of this entire discussion is that in the 1972 Social Security Act, Section 1881, wherein Congress created a Medicare benefit for those diagnosed with end-stage renal disease, they also granted benefits to their living donors. Of course, Congress (nor CMS) ever thought living donors would eventually compose nearly half the kidneys transplants every year. Consequently, they’ve kept that little gem under their proverbial hats.

So maybe what Mr. Royer needs to do, instead of talking to the NY Times, is contact a Medicare lawyer and fight not just for his benefit, but for the one owed to all living kidney donors.








CMS - Medicare Living Kidney Donor

‘Significant’ Problems at Hackensack University’s Kidney Transplant Program

The federal government found 28 “significant” deficiencies in the kidney transplant program at Hackensack University Medical Center before the hospital agreed to suspend it temporarily next month for an overhaul, according to Medicare documents.


Hackensack was threatened with closure LAST YEAR. Why was the public not informed of these deficiencies when they were found then?


…the survival rate after receiving a kidney transplant at Hackensack was 87.2 percent compared with the expected rate of 95.7 percent, and that the graft-survival rate,  or the survival of the kidney once transplanted in the recipient,  was 85.9 percent, compared with the expected rate of 92.6, for the 30 months ended 2010.

Only two patients died last year, and none in the last nine months, Flynn said (compliance officer).


Oh, only two? Well, pshaw.


Forty-nine kidney transplants were performed in the year ended last June 30, including 17 from living donors and 32 from deceased donors.

Ten patients died, compared with the expected rate of 3.53. Thirteen grafts failed, compared with the expected rate of 7.37. .”   <- I surmise this means within 30 months that ended in 2010, as indicated in a prior sentence.


And finally,

Twenty-seven of 800 organ transplant programs closed either temporarily or permanently last year



TWENTY SEVEN programs were closed at least part of the time last year. Where is the responsibility to the public? How many of those program closures, no matter how temporary, were reported in the media? UNOS, OPTN and Medicare are funded with tax money. Their first priority should be to the public, not protecting hospitals’ and surgeons’ reputations.


Full article here.