OPTN Living Kidney Donor Informed Consent Checklist

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Living Kidney Donor
Informed Consent Checklist

OPTN policy changes for living donation, effective February 1, 2013, (with most recent revision February 1, 2014), created national standards for the evaluation and informed consent of all living kidney donors. Programs may use this checklist to review their donor evaluation process and determine if it contains all the required elements as specified in OPTN Policy 14.0. The ‘OPTN Reference’ column indicates throughout the checklist which specific policy section applies.

Living kidney donor consent    
   Written assurance by potential donor that he/she:
   Is willing to donate
   Is free from inducement and coercion
   Has been informed that he/she may decline to donate at any time
   Has been informed that transplant centers must:
   Offer donors an opportunity to discontinue the donor consent or evaluation process in a way that is protected and confidential
   Provide an independent living donor advocate (ILDA) to assist the potential donor during this process
   Instruction about all phases of the living donation process (teaching or instructional material can include any media, one-on-one or small group interaction)
   Consent
   Medical and psychosocial evaluations
   Pre and post operative care
   Required post operative follow up
   Presented in a language in which donor is able to engage in meaningful dialogue
   Disclosure that the recovery hospital will take all reasonable precautions to provide confidentiality for the donor/recipient
   Disclosure that it is a federal crime for any person to knowingly acquire, obtain or otherwise transfer any human organ for valuable consideration
   Disclosure that recovery hospital must provide an independent living donor advocate (ILDA)
   If the recovery hospital and recipient hospital are the same:
   Recovery hospital must provide the potential donor data from the most recent SRTR center-specific reports:
   National 1-year patient and graft survival rates
   Hospital’s 1-year patient and graft survival rates
   Notification about all CMS outcome requirements not being met by the transplant hospital
   If the recovery hospital is not the same AND the recipient hospital is known:
   Recovery hospital must provide the potential donor data from the most recent SRTR center-specific reports:
   National 1-year patient and graft survival rates
   Recipient hospital’s 1-year patient and graft survival rates
   Notification of all CMS outcome requirements not being met by the recipient hospital
   Education about expected post-donation kidney function and how chronic kidney disease and end-stage renal disease might potentially impact the donor in the future to include:
   On average, donors will have 25-35% permanent loss of kidney function at donation
   Baseline risk of ESRD does not exceed that of members of general population with same demographic profile
   Donor risks must be interpreted in light of known epidemiology of both CKD or ESRD
   CKD generally develops in midlife (40-50 years old)
   ESRD generally develops after age 60
   Medical evaluation of young potential donor cannot predict lifetime risk
   Donors may be at higher risk for CKD if they sustain damage to the remaining kidney. Development of CKD and progression to ESRD may be more rapid with only 1 kidney
   Dialysis is required when reaching ESRD
   Current practice prioritizes prior living kidney donors who became kidney transplant candILDAtes
   Disclosure of alternate procedures or courses of treatment for the recipient, including deceased donor transplant
   A deceased donor kidney may become available for the recipient before donor evaluation is complete or transplant occurs
   Any transplant candILDAte may have risk factors for increased morbidity or mortality that are not disclosed to the potential donor
   Disclosure that donor will receive a thorough medical and psychosocial evaluation
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"   Disclosure that health information obtained during the evaluation is subject to the same regulations as all records and could reveal conditions that must be reported to local, state, or federal public health authorities
   Disclosure that the recovery hospital is required to report living donor follow up information at 6 months, 1 year, and two years
   Potential donor must commit to post operative follow up testing coordinated by the recovery hospital
   Disclosure that any infectious disease or malignancy pertinent to acute recipient care discovered during the potential donor’s first two years of follow up care:
   Will be disclosed to the donor
   May need to be reported to local, state or federal public health authorities
   Will be disclosed to their recipient’s transplant center, and
   Will be reported through the OPTN Improving Patient Safety Portal

Living kidney donor evaluation consent   
   Written documentation that the potential donor was informed of the following:
   He/she must undergo a medical and psychosocial evaluation as required by Policy 14.4 and 14.5
   The transplant hospital may refuse the potential donor. He/she must be informed that he/she could be evaluated by another transplant program with different selection criteria
   The following are inherent risks associated with evaluation for living donation:
   Allergic reactions to contrast
   Discovery of reportable infections
   Discovery of serious medical conditions
   Discovery of adverse genetic findings unknown to the donor, discovery of certain abnormalities that will require more testing at the donor’s expense or create the need for unexpected decisions on the part of the transplant team
   Disclosure that these risks may be transient or permanent & include but are not limited to:
   Potential medical or surgical risks:
   Death
   Scars, pain, fatigue, and other consequences typical of any surgical procedure
   Decreased kidney function
   Abdominal or bowel symptoms such as bloating and nausea, and developing bowel obstruction
   Kidney failure and the need for dialysis or kidney transplant for the donor
   Impact of obesity, hypertension or other donor-specific medical conditions on morbidity and mortality of the potential donor
   Potential psychosocial risks:
   Problems with body image
   Post-surgery depression or anxiety
   Feelings of emotional distress or bereavement if recipient experiences any recurrent disease or in the event of the recipient’s death
   Impact of donation on the donor’s lifestyle
   Potential financial impacts:
   Personal expenses of travel, housing, child care, lost wages related to donation might not be reimbursed; however, resources may be available to defray some donation-related expenses
   Need for life-long follow up at the donor’s expense
   Loss of employment or income
   Negative impact on the ability to obtain future employment
   Negative impact on the ability to obtain, maintain, or afford health, disability, and life insurance
   Future health problems experienced by living donors following donation may not be covered by the recipient’s insurance

This checklist contains required elements found in OPTN Policy 14.0 that pertain to informed consent for the living donor patient. Use of this checklist is not required, nor does its use guarantee an assessment of compliance upon site survey. The checklist is meant to be used as a tool for members in the development of their site-specific templates, tools, and internal policies and procedures.  Use of this checklist does not replace the need to thoroughly document completion of all elements required by OPTN policy.
1/23/2014