Advocacy Informed Consent OPTN

Guest Post- Living Kidney Donor Informed Consent

The proposed minimum requirements are based on recommendations from the Joint Society Work Group (AST, ASTS, and NATCO) to the OPTN Living Donor Committee. Where is the American Society of Nephrology, American College of Surgeons, American College of Physicians, Society of Laparoendoscopic Surgeons, American Society of Anesthesiologists, the National Institutes of Health, Uniformed Governors (attorneys), and independent donor advocates? It is dangerous to assume that the only experts are transplant industry insiders. The 2007 CMS Rules and Regulations for Transplant Programs mandated that donors must be fully informed of the medical, psychosocial, financial, and insurability risks. This proposal is not honest nor detailed enough to meet this requirement. This proposal’s background information starts in 2006 and is only a minimum requirement for consent. Therefore, I can only conclude that kidney donors have never been ‘fully’ informed of the risks or adverse events associated live donor nephrectomy? Thank you for this public disclosure.

According to Gail Agrawal, JD Dean of the KU Law School and past Chair of the Advisory Committee on Transplantation, state laws dictate informed consent and only the person doing the procedure can get the consent. This proposal does not include: legal expertise; language that is easily understood by ‘lay people’; document who is legally, morally, and ethically responsible for the consent of a live organ donor during a ‘process’—one that includes an ‘exhaustive and comprehensive’ medical evaluation and major surgery; the Living Organ Donor Network Insurance Policy; information about glomerular filtration rate, hyperfiltration or hypertrophy (if a do not know what kidneys do then not fully informed); an accurate and honest disclosure of the morbidity and mortality risks associated with general surgery including anesthesia risks; nor does it include non-donor (urological literature) and live donor nephrectomy risks separated out by surgical approach (open, hand-assisted or minimally invasive laparoscopic technique.)

This proposal is a blatant and purposeful attempt to minimize the risks associated with live donor nephrectomy when state that surgical risks include “scars, pain, and other consequences typical of any surgical procedure.” Donors deserve to know about the risks for a hernia, nerve damage/entrapment and chronic neuropathic pain, testicular swelling and infertility (ligating of gonadal veins), adrenal dysfunction (ligation of adrenal vein or direct injury to adrenal gland), chylous ascites, pancreatitis, small bowel obstruction, wound infection, reasons for reeoperations and readmissions, and the risk of dying. There is no magic fairy dust that protects us just because we are doing this noble, honorable, and self-less deed. For the laparoscopic procedure, surgeons must fully disclose the risks associated with pneumoperitoneum. Surgeons must fully disclose if they prescribe intraoperative Mannitol, Lasix, and Heparin and these risks.

What does it mean to lose 25-40% of your kidney function? Explain what “CKD” means. What does this mean for our long term cardiovascular health and wellness? Where are the non-transplant industry nephrologists? I want to hear from them (not a surgeon or a transplant nephrologist) what it means for us to have one kidney? Stop comparing us to the general population. Explain the allocation priority for living donors. Stop telling donors they will go to the ‘top of the list’ if develop ESRD.

Fully inform the potential donor that OPTN approved a Live Donor Kidney Program surgeon only has to do 2 open nephrectomies and 3 laparoscopic nephrectomies per year and they can be on any patient; not just a live donor even though a live donor procedure is technically more challenging. Disclose if the donor surgeon is a general surgeon OR board-certified urologist. Provide surgeon and center specific graft, recipient, and donor outcome data at 1, 5, and 10 years. One year outcome data is meaningless. Provide SRTR data as to the number of live donor nephrectomies at a particular program by year. Surgeons must fully disclose that we do not have a reliable and comprehensive live donor registry in the United States. Therefore, we cannot tell donors the procedure is ‘safe’, ‘minimal risk’ or ensure a valid consent.

Stop taking organs from the uninsured. Stop saying the recipient’s insurance covers ‘everything.’ Donors need to be fully informed of the recipient’s insurance coverage. Donors should be fully informed about Section 1881 of the Social Security Act which states that individuals who donate a kidney for transplantation are entitled to Medicare A and B. No donor should go to surgery without Medicare coverage. Medicare will pay for donor complications even years out from the donation (per Mark Horney, CMS). Medicare will cover all donors for at least 6 months.

Independent Donor Advocates: “The living donor recovery hospital must provide an independent donor advocate (IDA)…no thanks. Too many conflicts of interest if the IDA is paid by the transplant cost center and thus, not independent. According to CMS, this person ‘must not be involved in transplantation activities on a daily basis.” The donor should have the option of bringing their own IDA or IDA(T) whose sole interest is the well-being and safe passage of the donor. This person will ensure the donor has a thorough evaluation, informed consent process (will take names, get copies of all test results and any form the donor signs) and support the donor in withdrawing consent at any time. This is not a ‘contract’—it is an elective surgery.

Donna Luebke

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