In 2007, 57% of US centers presumed consent for candidate living kidney donor (CD) evaluation. Later that year, CMS and OPTN issued guidance for CD informed consent. We sought to evaluate how consent practices for CDs have changed over the last 5 years and compliance with CMS and OPTN regulations.
All US programs with >5 living kidney transplants (LKT) between 7/2010 and 6/2011 (184) were asked to share their CD evaluation consent forms. 13 sites were ineligible due to lack of living donor procurement. Two authors independently reviewed and coded all forms; discrepancies were resolved via discussion. Outcomes of interest were stratified by program volume, region, and year of consent revision. Standard statistics were applied to assess differences between the strata.
We received 131 consent forms and 17 checklists (87% of eligible sites). There were 6 (4%) decliners, 9 (5%) non-responders, and 8 (5%) sites without available forms. Decliners performed fewer LKTs than responders (mean 13 v. 35, p<0.0001); respondent groups were otherwise similar.
Most contacted sites (170, 99%) obtained consent for evaluation. However, 37 sites that provided a consent form (25%) addressed all CMS-mandated items. No site included all OPTN requirements; only 49 sites (37%) included at least 50% of the OPTN items. Sites in the lowest tertile for LKT (13% v. 30%, p=0.04) and total transplant volume (9% v. 32%, p=0.007) were less likely to discuss 75% or more of OPTN requirements.
Most frequently omitted were: donation could be stopped if the CD has a condition that might harm the intended recipient (IR) (117, 89%), disclosure of the IRs pre-existing life-threatening decisions (116, 89%), increased risk of over-the counter drugs (103, 79%), conditions found in evaluation could be reportable to the government (103, 76%), if the IR was on the deceased donor waiting list (100, 76%), and the CDs opt-out decision will not be shared without consent (98, 75%).
Practices for ensuring the informed consent of CDs have dramatically improved over the last 5 years. However, most sites do not include all CMS and OPTN requirements. Multiple items related to balancing CD and IR interests and confidentiality were omitted, suggesting that sites may not be comfortable with current guidance in this area. We propose that UNOS develop a uniform CD evaluation consent form to improve the consistency and efficiency of living donor consent.
To cite this abstract in AMA style:Thiessen C, Kim Y, Formica R, Bia M, Kulkarni S. Living Kidney Donor Consent: Compliance with CMS & OPTN Requirements [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/living-kidney-donor-consent-compliance-with-cms-optn-requirements/. Accessed September 23, 2017.
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