Establishing an Organ Donation Facility at a Hospital

• Track A - Donor Hospital: A hospital that identifies and refers potential donors to an Organ Procurement Organization (OPO). This applies to nearly all hospitals.
• Track B - Transplant Program: A hospital that actually performs transplant surgeries. This requires separate, more intensive CMS certification.

1. Understand the Legal and Regulatory Framework

Federal Laws

• National Organ Transplant Act (NOTA), 1984 - Established the OPTN and prohibits buying/selling organs.
• 42 CFR §482.45 - CMS Conditions of Participation (CoPs) requiring all hospitals to have written donation protocols and an OPO agreement.
• Uniform Anatomical Gift Act (UAGA) - Adopted in all 50 states; governs how organ donation consent is documented.
• Uniform Determination of Death Act (UDDA) - Defines brain death criteria used to declare donor eligibility.
• HIPAA (45 CFR §164.512(h)) - Permits sharing patient information with OPOs for donation purposes.

Accreditation Standards

• The Joint Commission, DNV-NIAHO, and ACHC all require hospitals to align with CMS CoPs on donation. Ensure your accreditation body's standards are met in parallel.

2. Enter into an Agreement with a Designated OPO

• Each geographic area has a designated OPO assigned by CMS. You must identify the OPO serving your Donation Service Area (DSA).
• Execute a formal Affiliation Agreement / Memorandum of Understanding (MOU) with the OPO, a tissue bank, and an eye bank. CMS requires written agreements with all three.
• The agreement must specify:
  • Timely notification procedures for imminent or actual patient deaths
  • OPO access to hospital records for donor suitability evaluation
  • OR space allocation for organ recovery procedures
  • Staff roles and OPO staff access to the facility
  • Protocols for donation after brain death (DBD) and donation after circulatory death (DCD)

3. Develop Hospital Policies and Protocols

4. Designate Key Staff Roles

• Donation Champion / Advocate: HRSA recommends every hospital with >100 beds appoint a clinical staff advocate specifically for organ and tissue donation.
• Designated Requestors: Staff trained and certified (via OPO-approved course) to approach donor families. They must complete a formal course designed jointly with tissue and eye bank communities.
• Medical Examiner / Legal Liaison: Coordinates cases where medicolegal concerns may affect donation.
• Intensive Care / Neurology Team: Trained in brain death declaration, donor management protocols.

5. Staff Training and Education

• Mandatory new hire orientation covering organ and tissue donation basics (HRSA Recommendation 11).
• Annual refresher training aligned with updated OPO protocols.
• Specific training modules for ICU nurses, emergency physicians, and intensivists.
• Training should include DCD protocols, family communication skills, and cultural/religious sensitivity.

6. Infrastructure and Physical Requirements

• Operating Room access: The OPO recovery team must have access to a sterile OR for organ procurement.
• ICU/Donor management area: Facilities to maintain hemodynamic stability in brain-dead donors pending procurement.
• Documentation systems: Interface with OPTN's UNet/DonorNet platform for tracking and data submission.
• Morgue / tissue recovery space: For tissue and eye recovery (less complex than organ OR).

7. Track B - Establishing a Transplant Program (Advanced)

• OPTN membership is required - apply through HRSA's OPTN Policies page.
• Organ-specific requirements: Each organ type (kidney, liver, heart, lung, pancreas, intestine) requires separate program approval.
  • A pancreas program requires a co-located Medicare-approved kidney program.
  • An intestinal program requires a co-located Medicare-approved liver program.
• Data submission and clinical experience minimums: Programs must meet outcome thresholds at §482.80 (e.g., minimum transplant volume) before initial Medicare approval.
• Transplant surgeon and physician credentialing: Must meet OPTN competency standards.
• Multidisciplinary transplant team: Surgeons, transplant coordinators, social workers, financial counselors, and dietitians.

8. Ongoing Compliance and Quality Improvement

• Death record reviews: Allow OPO access to retrospectively audit cases for missed donation opportunities.
• Performance metrics: Track referral rates, conversion rates, and organ yield per donor - CMS and OPTN both monitor these.
• CMS surveys: OPOs and transplant hospitals are subject to periodic CMS certification surveys (the latest guidance was issued March 2026, QSO-26-05).
• OPTN policy updates: Policies are updated regularly (most recently May 7, 2026). Assign a staff member to monitor HRSA OPTN policy updates.

9. Summary Checklist

• Identify your designated OPO (via CMS DSA map)
• Execute MOU/Affiliation Agreement with OPO, tissue bank, and eye bank
• Develop and adopt written donation protocols (42 CFR §482.45)
• Train and certify Designated Requestors
• Appoint a hospital donation advocate/champion
• Ensure OR, ICU, and documentation infrastructure are in place
• Integrate with OPTN DonorNet for data reporting
• If pursuing transplant program: apply for OPTN membership and CMS certification
• Establish ongoing QI and death record review process
• Maintain compliance with state UAGA and UDDA statutes

• CMS Organ Transplant Program page - certification requirements
• UNOS/OPTN - membership, organ matching policies
• HRSA Organ Donation - federal advisory recommendations
• Organ Donation Alliance DCD Guide - practical regulatory compliance guide