Establishing an Organ Donation Program at a Hospital

1. Understand the Two Types of Facilities

2. Legal and Regulatory Framework

Federal Requirements (USA)

• CMS Conditions of Participation (CoP) - 42 CFR §482.45 governs all Medicare/Medicaid participating hospitals
• 42 CFR Part 486 Subpart G - covers Organ Procurement Organizations (OPOs)
• NOTA (National Organ Transplant Act, 1984) - prohibits sale of organs, establishes the OPTN
• UAGA (Uniform Anatomical Gift Act) - state-level law governing donor consent

Accreditation Standards

• The Joint Commission (TJC) - requires written donation policies aligned with CMS CoPs
• DNV-NIAHO - similar accreditation standards
• ACHC (Accreditation Commission for Health Care) - alternate accreditor

Key March 2026 Update

3. Steps to Establish a Donor Hospital Program

Step 1 - Designate Leadership and a Transplant/Donation Coordinator

• Appoint a Donation Champion (typically an ICU physician or intensivist)
• Hire or designate a Hospital Donation Coordinator (HDC) - a trained RN or allied health professional
• Form a Donation Committee with representatives from ICU, neurology, ER, nursing, chaplaincy, social work, ethics, and administration

Step 2 - Enter a Memorandum of Agreement (MOA) with Your Regional OPO

• Every hospital with a ventilator AND an operating room must have a written agreement with its designated OPO (per 42 CFR §482.45 and §486.322)
• Find your designated OPO via the UNOS OPO directory
• The MOA must define:
  • What constitutes "timely referral" and "imminent death"
  • Responsibilities of hospital vs. OPO staff
  • Protocols for Donation After Brain Death (DBD) and Donation After Circulatory Death (DCD)

Step 3 - Develop Hospital Policies and Protocols

• Imminent death identification and referral - notify OPO within 60 minutes of imminent death triggers or cardiac death
• Brain Death/Death by Neurological Criteria (BD/DNC) determination - must be a separate, standalone policy (never combined with the donation policy)
• DCD protocol - for donation after circulatory death
• Family approach and consent - the OPO approaches the family; hospital staff should be supportive
• Withdrawal of life support - must precede any donation discussion with family
• Medical Examiner/Coroner cases - referral protocols even in forensic deaths
• Palliative sedation and organ viability management

Step 4 - Staff Training and Education

• Train ALL relevant staff (ICU nurses, ER physicians, charge nurses, social workers, chaplains)
• Topics: identifying clinical triggers, how to make the OPO referral call, sensitivity in family communication, legal and ethical obligations
• Accreditors (TJC, DNV) will audit staff education records during surveys

Step 5 - Agreements with Tissue and Eye Banks

• CMS CoPs require hospitals to have agreements with at least one tissue bank and at least one eye bank in addition to the OPO
• Many OPOs are also certified tissue/eye banks and can cover this requirement

Step 6 - Implement a Quality Assurance and Performance Improvement (QAPI) Program

• Track referral rates, conversion rates, and consent rates
• Conduct death record reviews with the OPO
• Review near-misses and missed referrals
• Report data to OPTN annually

4. Additional Steps to Become a Transplant Hospital

Step 1 - OPTN Membership

• Apply for membership in the Organ Procurement and Transplantation Network (OPTN), administered by UNOS
• Submit application at unos.org
• Membership is mandatory to be a transplant hospital

Step 2 - OPTN/UNOS Program Approval

• Apply for approval of each organ-specific transplant program (kidney, liver, heart, lung, etc.) separately
• Each program must meet minimum volume requirements (e.g., 10 transplants/year for some organs)
• Must designate a Transplant Program Director (physician with transplant fellowship training) and a Transplant Coordinator

Step 3 - Surgical and Facility Infrastructure

• Operating rooms equipped for multi-organ procurement and transplantation
• Dedicated transplant ICU beds
• 24/7 surgical coverage by qualified transplant surgeons
• HLA typing laboratory or contract with accredited lab
• Perfusion and organ preservation capabilities
• Blood bank with adequate stock of rare blood products

Step 4 - CMS Certification

• Apply for CMS transplant program certification (separate from general hospital CoPs)
• CMS conducts a survey before granting approval
• Ongoing compliance with 42 CFR Part 482 Subpart E (transplant-specific conditions)

Step 5 - Specialized Personnel

5. Ongoing Operational Requirements

• Timely OPO notifications - within 60 minutes of all deaths and imminent deaths
• Annual reporting to OPTN and CMS on donation and transplant outcomes
• QAPI data review with the OPO at least quarterly
• Policy updates - review donation and death determination policies annually
• CMS surveys - expect increased scrutiny per March 2026 CMS guidance
• State law compliance - some states (e.g., Virginia, West Virginia) have additional mandatory evaluation requirements

6. Key Organizations and Resources

Summary Checklist

• Appoint donation champion and hospital donation coordinator
• Execute MOA with designated regional OPO
• Execute agreements with tissue bank and eye bank
• Write and adopt mandatory donation policies (referral, BD/DNC, DCD, family approach)
• Train all relevant clinical and support staff
• Establish QAPI program with OPO
• (If transplant hospital) Apply for OPTN membership and CMS transplant certification
• (If transplant hospital) Recruit organ-specific transplant surgical team
• Implement 24/7 referral system to OPO
• Review and update all policies annually

Note: Regulations vary by country. The above reflects the US regulatory framework (CMS, OPTN/UNOS). If your hospital is outside the US, equivalent processes apply through your national transplant authority (e.g., NHS Blood and Transplant in the UK, Eurotransplant in Europe, NOTTO in India). Let me know your country and I can tailor this guidance further.