Format and points for assessment for Psychiatry fitness for organ donation

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Psychiatric Assessment for Fitness for Organ Donation

This covers both living donors (who require psychiatric clearance before donating) and transplant recipients (who need psychiatric fitness assessment for organ receipt). The assessment format is largely standardized across transplant psychiatry/consultation-liaison psychiatry.

I. Who Performs the Assessment

  • Consultation-liaison psychiatrist, transplant psychologist, or master's-level licensed clinical social worker (LICSW)
  • The donor must be seen independently (alone, without the recipient or recipient's family present) to allow free disclosure
  • An Independent Living Donor Advocate (ILDA) - separate from the transplant team - may also participate to protect the donor's interests

II. Standard Format of the Psychiatric Assessment

A. Pre-Assessment Preparation

  1. Review all available records: medical history, prior psychiatric records, substance use history, legal records
  2. Use standardized instruments alongside the clinical interview
  3. Standard tools include:
    • SIPAT (Stanford Integrated Psychosocial Assessment for Transplant) - most widely validated
    • PACT (Psychosocial Assessment of Candidates for Transplant)
    • TERS (Transplant Evaluation Rating Scale)
    • PHQ-9 / PHQ-2 for depression; GAD-7 / BAI for anxiety
    • MMSE or MoCA for cognitive screening
    • DAST (Drug Abuse Screening Test); CAGE-AID for substance use

B. Structure of the Interview

SectionCore Content
1. Identifying informationAge, occupation, relationships, support network
2. Reason for donation/transplantMotivation, voluntariness, understanding of organ failure
3. Psychiatric historyPast diagnoses, hospitalizations, suicidality, self-harm
4. Substance use historyAlcohol, illicit drugs, nicotine - first use, last use, treatment history
5. Medical historyComorbidities, medication adherence, prior surgeries
6. Social historySocial support, financial stability, employment, housing
7. Mental status examinationFull MSE including cognition, judgment, insight
8. Capacity/understandingUnderstands the procedure, risks, alternatives, voluntariness
9. Coping and adjustmentCoping style, response to illness/stress, prior losses
10. PsychoeducationPatient education regarding psychiatric risks of transplant/donation

III. Key Assessment Points (SIPAT Domains)

The SIPAT organizes assessment into four major domains. Each item is scored; a total score guides candidacy recommendation.

Domain A: Patient Readiness Level

ItemPoints Assessed
I. Knowledge and understanding of medical illness0 (excellent) - 4 (no understanding)
II. Understanding of transplant procedure and sequelae0 (excellent) - 4
IIa. Understanding of post-transplant lifestyle changes0-3
III. Willingness to undergo transplant / informed consent0-4

Domain B: Social Support System

ItemPoints Assessed
IV. Availability and stability of social support0-6
IVa. Appropriateness and quality of support network0-3
V. Living situation0-3

Domain C: Psychological Stability and Psychopathology

ItemPoints Assessed
VI. Psychiatric history (lifetime)0-4
VII. Current psychopathology (Axis I)0-6
VIIa. Assessment of depression (PHQ-9 / BDI)0-4
VIIb. Assessment of suicidality0-6
VIIc. Assessment of delirium/acute confusional state0-3
VIII. History of attempted suicide / self-harm0-6
IX. Anxiety (GAD-7 / BAI)0-3
X. Organic psychopathology / neurocognitive impairment (MoCA/MMSE)0-5
Xa. Current cognitive functioning0-2
XI. Personality traits vs. disorder0-6

Domain D: Lifestyle and Effect of Substance Use

ItemPoints Assessed
XII. Alcohol use/abuse (CAGE-AID, BAC)0-4
XIII. Alcohol dependence/recidivism risk0-4
XIV. Alcohol use - abstinence period0-4
XV. Illicit substance use0-4
XVI. Illicit substance dependence / recidivism risk0-4
XVII. Prescription substance abuse0-4
XVIII. Nicotine use/abuse/dependence0-5
XIX. Treatment compliance / adherence0-6

IV. SIPAT Score Interpretation

ScoreCategoryRecommendation
0-6Excellent candidateList without reservations
7-20Good candidateList; monitor identified risk factors
21-39Minimally acceptableConsider listing; risk factors must be addressed first
40-69Poor candidateDefer; risks must be satisfactorily addressed
≥70High-risk candidateSurgery NOT recommended while risk factors persist

V. Specific Points for Living Donor Assessment

These are additional (beyond the SIPAT) and are unique to the donation context:
  1. Voluntariness - donation must be free of coercion, guilt, financial pressure, or obligation
  2. Donor motivation - altruism vs. obligation vs. expectation of relationship change
  3. Understanding of risks and benefits - both for self and recipient; understand the permanent nature of donation
  4. Donor-recipient relationship - duration, closeness, nature; internet/social media only relationships require further evaluation
  5. Coercion screening - employer/employee, family pressure, faith community, past debts, financial dependency
  6. Ability to cope with major surgery - coping style, prior trauma, resilience
  7. Employment and family impact - financial readiness, time off work, care of dependents
  8. Post-operative support - availability of post-operative care, transportation, care at home
  9. Consistency with prior beliefs/behaviors - history of altruistic acts, values alignment
  10. Experience with grief and loss - in case the recipient dies; donor must be prepared for this possibility
  11. Ability to withdraw - must be reinforced that the donor can withdraw at any point up until anesthesia, without consequence

VI. Psychiatric Contraindications to Listing

Absolute Contraindications

  • Active suicidal or homicidal ideation
  • Active psychosis (untreated)
  • Dementia (severe/advanced)
  • Personality disorder severely impeding collaborative work with the transplant team
  • Persistent absence of adequate social support
  • Active illicit substance use with failure to engage in treatment
  • Active non-compliance with medical treatment (documented, sustained)

Relative Contraindications (may defer, not automatically exclude)

  • Recent substance use (typically require 6 months abstinence minimum, 2 years for alcohol-related organ failure at many centers)
  • Unstable psychiatric illness currently responding to treatment
  • Mild-moderate cognitive impairment
  • Moderate personality psychopathology with some treatment interfering traits
  • Inadequate social support with potential to be remediated

VII. Post-Assessment Recommendation Format

The written report should include:
  1. Patient identification and referral context
  2. Method (clinical interview, sources reviewed, instruments used with scores)
  3. Relevant history (psychiatric, substance use, medical, social, occupational)
  4. Mental status findings
  5. Formulation - synthesizing psychiatric risk and protective factors
  6. Psychiatric diagnoses (DSM-5 format, if applicable)
  7. Specific risk factors identified (SIPAT domains)
  8. Recommendation - one of:
    • Clear for listing
    • Conditional clearance (with specified conditions, e.g., sobriety contract, psychiatric treatment, re-evaluation date)
    • Deferral (with plan for re-evaluation)
    • Not a candidate at this time
  9. Treatment recommendations if psychiatric issues require management pre/post-transplant
  10. Follow-up plan

VIII. Special Populations / Additional Considerations

  • Substance use disorder (especially alcohol-related liver disease): Document sobriety period, substance use disorder treatment, relapse prevention plan, insight, and social supports. SALT score used for early liver transplant in alcoholic hepatitis.
  • Depression/anxiety: Assess severity, prior treatment response, current stability. Pre-transplant depression is a strong predictor of post-transplant non-adherence and mortality.
  • Personality disorders: Assess impact on capacity to collaborate with team, impulsivity, history of non-adherence.
  • Cognitive impairment: MoCA/MMSE. Mild impairment may be acceptable with adequate caregiving support; severe impairment is a contraindication.
  • Pediatric donors: Additional safeguards; assent and parental consent; best-interest standard.

Sources:
  • Kaplan & Sadock's Comprehensive Textbook of Psychiatry, Section 27.13 (Organ Transplantation), pp. 7366-7388
  • Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) - Maldonado et al., Psychosomatics 2012
  • Academy of Consultation-Liaison Psychiatry (ACLP) How-To Guide: Transplantation (Soeprono & Zimbrean, 2020)
  • Meyer et al., Comprehensive Assessment of Solid Organ Transplant Recipients - BWH/MGH CME 2025

Format for giving clearance as per Indian guidelines

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Psychiatric Clearance Certificate for Organ Donation - Indian Guidelines

Legal Basis (THOTA 1994, Amended 2011; Rules 2014)

Under the Transplantation of Human Organs and Tissues Act (THOTA), 1994 as amended in 2011, and the THOTA Rules, 2014 (notified 27 March 2014), psychiatric clearance is handled differently depending on the donor type:
Donor TypeForm RequiredPsychiatric Assessment Requirement
Near relative (blood relation)Form 1, Form 4Recommended; not always legally mandated by name
Spousal donorForm 2, Form 6Recommended; Authorisation Committee review
Unrelated/other living donorForm 3, Form 11Mandatory - Authorisation Committee must clear; psychiatrist clearance mandatory
Cadaveric (brain stem death)Form 8, Form 10Not applicable for donor; psychiatric role is family support
Key Legal Provision (Mohan Foundation / THOA Review Committee): "Psychiatrist clearance would be mandatory to certify the donor's mental condition, awareness, absence of any overt or latent psychiatric disease, and ability to give free consent." - This applies mandatorily for unrelated/other donors going before the Authorisation Committee (AC), and is strongly recommended for all living donors.

Format of the Psychiatric Clearance Certificate (India)

Based on the IPS (Indian Psychiatric Society) Guidelines - Sarkar, Grover & Chadda, 2022 (Indian Journal of Psychiatry 2022; 64:S308-S318) and the THOTA Rules 2014, the clearance certificate should be on the psychiatrist's letterhead and include:

PSYCHIATRIC FITNESS CERTIFICATE FOR ORGAN DONATION

[Hospital/Institution Letterhead]
Date: _______________
Ref. No.: _______________

To, The Authorisation Committee / Transplant Team, [Name of Hospital]

Subject: Psychiatric fitness certificate for organ donation

I. PATIENT IDENTIFICATION
Name of Donor
Age / Sex
Address
Identity Proof (Aadhaar/Passport No.)
Name of Recipient
Relationship to Recipient
Date of Assessment
Place of Assessment

II. INFORMANTS
  • Information obtained from: Donor (interview), family members (name), case records, treating physician's summary

III. ASSESSMENT CONDUCTED
(As per IPS guidelines, Table 5 checklist)
  1. Identity verification - Donor identity confirmed; relationship with recipient confirmed
  2. Competence assessment - Capacity to consent evaluated
  3. Understanding of procedure - Assessed for knowledge of:
    • The organ/tissue to be donated
    • The surgical procedure and its risks
    • Short-term and long-term implications for donor health
    • Alternatives to donation
  4. Motivation for donation - Assessed; nature of motivation documented (altruistic / familial / other)
  5. Voluntariness - Assessed for presence/absence of coercion, undue pressure, financial inducement
  6. Psychiatric history - Past and present
  7. Substance use history - Alcohol, tobacco, illicit substances
  8. Mental Status Examination (MSE) - Full MSE conducted
(Validated instruments applied if indicated: PHQ-9, AUDIT/CAGE, MMSE/MoCA, ASSIST)

IV. FINDINGS
A. Relevant Psychiatric/Medical History: [Brief narrative of any past psychiatric illness, substance use, hospitalizations, medications]
B. Mental Status Examination:
DomainFinding
Appearance and behaviour
Speech
Mood and Affect
Thought - form and content
Perceptions
Cognition (orientation, attention, memory)
Insight
Judgment
C. Capacity Assessment:
  • Understands the information: Yes / No
  • Retains the information: Yes / No
  • Weighs the information: Yes / No
  • Communicates a decision: Yes / No
D. Voluntariness Assessment:
  • Evidence of coercion: Present / Absent
  • Evidence of financial inducement: Present / Absent
  • Evidence of undue family/social pressure: Present / Absent
E. Motivation: [Document the stated reason for donation and the psychiatrist's impression of its authenticity]
F. Substance Use: [Document use/history with AUDIT score if applicable; abstinence period if relevant]

V. PSYCHIATRIC DIAGNOSIS (if any)
(DSM-5 / ICD-11)
  • Current diagnosis: _______________
  • Past diagnosis: _______________
  • On treatment: Yes / No - Medication: _______________

VI. OPINION AND RECOMMENDATION
Based on the above assessment, I am of the opinion that:
  1. The donor is / is not mentally competent to give informed consent for organ donation.
  2. The donor is / is not free from any overt or latent psychiatric illness that would preclude donation.
  3. The donor's consent is voluntary / not voluntary.
  4. The donor does / does not have any active substance use disorder.
  5. The donor is / is not psychiatrically fit to donate the organ in question.
Recommendation: [ ] Fit to donate - No psychiatric contraindication [ ] Fit to donate - Conditional (specify: _______________) [ ] Deferred - Psychiatric issue requires management first [ ] Not fit to donate at present

VII. SIGNATURE
Name of Psychiatrist: _______________________
Qualification: _______________________________
Registration No. (MCI/State Medical Council): ______________
Designation and Department: __________________
Hospital/Institution: _________________________
Seal: Date:

Key Points Required Under Indian Law (Mandatory Certification Points)

As required specifically by THOTA and THOA Review Committee guidelines, the psychiatrist's certificate must certify:
  1. Mental condition - Assessment of current and baseline mental state
  2. Awareness - The donor is aware of what they are consenting to
  3. Absence of overt psychiatric disease - No active psychosis, severe depression, mania, delirium
  4. Absence of latent psychiatric disease - No subclinical illness likely to impair capacity
  5. Ability to give free consent - No coercion, no cognitive impairment, no undue influence
These five points are the minimum legal requirements cited in the THOA Review Committee report and are non-negotiable for the Authorisation Committee.

Donor Categories and Who Goes Before the Authorisation Committee

ScenarioAC Approval Required?Psychiatrist Certificate
Near relative donor (Indian)No (if Form 4 + Form 19 complete)Recommended by IPS; many state ACs require it
Spousal donor (Indian)Yes (Form 6 submitted to AC)Mandatory in practice at most centres
Unrelated donor (Indian)Yes (Form 3 + Form 11 to AC)Legally mandatory
Foreign national donor or recipientYes (always)Mandatory
Minor as donorYes + Board of Medical ExpertsMandatory

IPS Recommended Instruments (Indian Context)

(From Sarkar et al., 2022 IPS Guidelines, Supplementary Table)
DomainInstrument
DepressionPHQ-9, HAMD, BDI, HADS
AnxietyGAD-7, HAMA, BAI
Cognitive screeningHMSE (Hindi MSE), MMSE, MoCA
Substance useAUDIT, CAGE-AID, ASSIST, DAST
General psychiatric screenMINI (Mini International Neuropsychiatric Interview), GHQ-12
PersonalityEPI, MMPI
CopingBrief COPE
Social supportSSQ (Social Support Questionnaire)

Practical Notes for Indian Psychiatrists

  • The certificate must be on hospital/institution letterhead, signed with MCI/state council registration number and official seal
  • For unrelated donors, the psychiatrist's certificate is submitted as part of Form 11 (Application for Approval of Transplantation from Living Donor) to the Hospital Authorisation Committee
  • The Authorisation Committee interviews the donor at least twice with a gap of time between interviews before approving unrelated donors
  • Psychiatric clearance is required before the AC meeting, not after
  • A short narrative format (not just check-boxes) is preferred by ACs to allow them to understand clinical reasoning
  • If there is any psychiatric disorder - even treated and stable - it must be declared and managed, not concealed; the opinion can still be "fit to donate" with appropriate qualification

Primary Sources:
  • Sarkar S, Grover S, Chadda RK. "Psychiatric assessment of persons for solid-organ transplant." Indian J Psychiatry 2022;64:S308-S318 (IPS guidelines, PMC9122170)
  • Transplantation of Human Organs and Tissues Act (THOTA), 1994 (as amended 2011); THOTA Rules, 2014
  • THOA Review Committee Report (Authorisation Committee conditions)
  • NOTTO Forms 1-11 (notto.mohfw.gov.in)
  • Anil Kumar BN, Mattoo SK. "Organ transplant & the psychiatrist: An overview." Indian J Med Res 2015;141:408-416
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