Living Donor Informed Consent Discussion Note

Date/Time: [Date and time of encounter]

Location: [clinic / hospital / telehealth] (If telehealth, include donor's state.)

Encounter Type: [in-person / phone / video]

Donor Name/MRN/DOB: [Per local policy]

Organ: [kidney / liver / other]

Donation Pathway: [directed / non-directed / paired exchange (KPD)]

Clinician(s) Present: [Name(s), role(s)]

Independent Living Donor Advocate: [participated / available / not present]

Others Present: [donor alone / support person(s) / intended recipient present] (If recipient or others present, document rationale and voluntariness protections taken. Document that donor had opportunity to speak privately.)

Interpreter/Accommodations: [Language and interpreter ID, or accessibility accommodations used] (Omit this line if not applicable.)

(This note documents the informed consent discussion and confirms required elements were reviewed. It does not substitute for signed surgical consent forms, which should be referenced separately.)

Decision-Making Capacity & Voluntariness

[Narrative confirming donor demonstrates capacity to understand, appreciate, and reason about donation, citing specific statements or behaviors reflecting understanding of risks, benefits, alternatives, and follow-up expectations.] [Statement of voluntariness with donor's affirmation that the decision is free from coercion or undue influence.] [Documentation that donor had opportunity to speak privately without the intended recipient or others who could influence the decision.] [Any concerns identified and mitigation steps taken, or plan for additional evaluation if uncertain.]

(Do not infer capacity from demeanor alone—document concrete evidence. If capacity is uncertain, document need for additional evaluation rather than proceeding.)

Confidentiality, Privacy & Right to Withdraw

• [Communications with transplant program are confidential per applicable laws]
• [Donor may decline or withdraw at any time without penalty]
• [Program can support withdrawal while protecting donor confidentiality, including assistance communicating with recipient if needed]
• [Certain findings may require disclosure to public health or recipient transplant team]

Pathway-Specific Counseling: [directed / paired exchange (KPD) / non-directed]

• [Directed: Donor preferences for information sharing with recipient]
• [Paired exchange/KPD: Program rules, timing dependencies, anonymity policies, logistical contingencies, right to withdraw]
• [Non-directed: Recipient selection process, anonymity policies, transport considerations]

(Include only applicable pathway; omit others.)

Process Overview

[Evaluation steps reviewed including medical testing, psychosocial assessment, and potential for incidental findings.] [Surgical course overview including pre-op preparation, expected hospital stay, pain management, convalescence, and activity restrictions.] [Post-donation follow-up expectations referenced.] [Statement that living donation provides no direct medical benefit to the donor.] [Any elements deferred: not discussed yet—to be reviewed at specified future visit.]

Risks of Living Donation Discussed

Medical/Surgical Risks

• [Anesthesia risks]
• [Bleeding and potential need for transfusion]
• [Infection]
• [Injury to surrounding structures]
• [Thromboembolism]
• [Pain and fatigue]
• [Wound complications]
• [Possibility of reoperation, readmission, or ICU care]
• [Mortality risk] (Include numeric estimates only if program-validated and current.)

Long-Term/Organ Function Risks

• [Potential long-term health impacts, some uncertain or not fully known]
• [Donor-specific factors that may increase risk] (Document as discussion points, not clearance determinations.)

Psychosocial Risks

• [Possible mood or anxiety symptoms post-donation]
• [Emotional impact if recipient outcome is poor]
• [Lifestyle disruptions, relationship stressors]
• [Body image concerns] (Include if applicable.)

Financial, Employment & Insurance Risks

• [Potential unreimbursed expenses including travel, lodging, childcare, lost wages]
• [Potential difficulty obtaining or affording health, life, or disability insurance]
• [Future donation-related health issues may not be covered by recipient insurance]
• [Resources reviewed and status] (Distinguish resources available vs. applied for vs. approved.)

Organ-Specific Risks

(Include only the subsection relevant to the organ being donated; omit others.)

Kidney Donation:

• [Expected permanent reduction in kidney function]
• [Increased vulnerability if remaining kidney is injured or develops disease]
• [Risk of CKD/ESRD over time; individual lifetime risk cannot be perfectly predicted]
• [Pregnancy-related considerations] (Include if applicable.)

Liver Donation:

• [Risk of acute liver failure with possible need for transplant]
• [Biliary complications]
• [Liver dysfunction and need for additional monitoring]
• [Higher transfusion risk]
• [Burden of additional testing from lab abnormalities]

Alternatives & Recipient Outcome Data

• [Alternatives for recipient reviewed: deceased donor transplant, medical management, dialysis, or not pursuing transplant]
• [Program determines candidacy using program criteria and clinical judgment]
• [Program outcome data for recipients and living donors offered or reviewed]
• [Materials provided or referenced]
• [Donor informed that some recipient information may not be disclosed due to confidentiality]

Legal & Regulatory Requirements Reviewed

• [Prohibition on exchanging organs for valuable consideration; permissible expense reimbursement distinguished]
• [Availability and role of Independent Living Donor Advocate]
• [Evaluation may reveal reportable conditions requiring disclosure]
• [Specimen storage and testing policies for donor-derived disease investigation]

Post-Donation Follow-Up Expectations

[Required follow-up schedule per program policy with timepoints.] [Follow-up components: labs, vitals, health status, psychosocial screening.] [Who coordinates follow-up and donor responsibilities.] [Cost responsibility: coverage by recipient insurance, donor insurance, program, or assistance resources.] [Recommendation for ongoing annual health maintenance relevant to donation and where this will occur.] [If plan not finalized: general expectations reviewed; specific plan to be provided prior to surgery.]

Donor Questions & Understanding

Donor Questions/Concerns: [Questions or concerns raised by donor] (Use donor's own words when feasible.)

Comprehension Check (Teach-Back): [Prompt used to assess understanding.] [Donor's summary of key points.] [Clarifications or additional education provided.] [Comprehension gaps identified and plan to reassess, if any.]

(Avoid conclusory statements such as "patient understands" without documenting how understanding was assessed.)

Decision & Next Steps

Donor Decision: [wishes to proceed with evaluation/donation planning / undecided and requests more time or counseling / declines or withdraws]

Next Steps: [Planned appointments, additional evaluations, referrals, materials to review]

If Withdrawal: [Confidentiality-protective communication plan] (Include only if donor declines or withdraws.)

Materials Provided

• [Program educational materials and handouts]
• [Outcome data materials]
• [Financial assistance resources or referrals]
• [Reference to signed consent forms executed today: form type, location filed, or planned signing date]

(If any required consent elements were not discussed during this encounter, document as "not discussed yet—to be reviewed at [visit type/timeframe]" rather than omitting. Keep eligibility and suitability determinations in a separate evaluation note.)