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OPTN Member Evaluation Plan expansion update; annual updates to monitoring and compliance documents

Published on: Tuesday, August 6, 2024

This news item was updated on Aug. 14, 2024.

The Organ Procurement and Transplantation Network (OPTN) Member Evaluation Plan documents how OPTN member transplant hospitals, organ procurement organizations, and histocompatibility labs are monitored and evaluated for compliance with OPTN policies and bylaws. Historically, this document has outlined expectations for compliance with membership requirements, performance thresholds, and site surveys. The OPTN Member Evaluation Plan is updated periodically to reflect the latest changes to policies and bylaws. In this update, which is effective Aug. 1, 2024, existing OPTN monitoring practices have been added to this document. None of these practices are new to the OPTN - they are now being codified to aid members in understanding how the OPTN monitors compliance with policies and bylaws.

Members are encouraged to review this information to stay up-to-date on OPTN monitoring and revise any compliance procedures as needed. To improve system performance, the OPTN Membership and Professional Standards Committee (MPSC) regularly shares information with the community about key topics and issues. Learn more on the MPSC member resources page.

In addition to the changes to the OPTN Member Evaluation plan, the OPTN has completed its annual review and update of the monitoring and compliance resource documents available on the OPTN website and linked below:

These documents are reviewed annually and updated to reflect any changes in OPTN processes or any relevant policy or bylaw implementations. Only minor changes have been made during this year’s update.

The changes made to the OPTN Member Evaluation Plan only reflect how the OPTN monitors members for compliance with OPTN Policies and Bylaws. No changes to OPTN Policies or Bylaws have been made.

All updates made to the OPTN Member Evaluation Plan have been outlined below. To review individual policies and bylaws in the OPTN Member Evaluation Plan, navigate to the plan from the Policy and Bylaws or Compliance and evaluation menus, and then click Evaluation plan. Once inside the PDF, click on the individual policy numbers from the table of contents to be taken to a specific policy’s page.

  • 1.4: Allocation of Organs during Emergencies
  • 5.4: Organ Offers
  • 5.4.B: Order of Allocation
  • 5.4.E: Allocation to Candidates Not on the Match Run
  • 5.9: Released Organs
  • 6.6: Heart Allocation Classifications and Rankings
  • 6.6.F: Allocation of Heart-Lungs
  • 7.3: Intestine Allocation Classifications and Rankings
  • 8.4: Kidney Allocation Classifications and Rankings
  • 8.5: Allocation of Both Kidneys from a Single Deceased Donor to a Single Candidate
  • 8.7: Allocation of Released Kidneys
  • 9.8: Liver Allocation, Classifications, and Rankings
  • 10.1: Lung Composite Allocation Score
  • 11.4: Pancreas, Kidney-Pancreas, and Islet Allocation Classifications and Rankings
  • 11.7: Allocation of Released Kidney-Pancreas, Pancreas, or Islets

  • 2.6.C: Reporting of Deceased Donor Blood Type and Subtype
  • 5.7: Organ Check-In
  • 5.8.A: Pre-Transplant Verification Prior to Organ Receipt
  • 5.8.B: Pre-Transplant Verification upon Organ Receipt
  • 14.7: Living Donor Pre-Recovery Verification
  • 14.11: Living Donor Pre-Transplant Verification
  • 16.2: Packaging and Labeling Responsibilities
  • 18.4.A: Reporting Requirements after Living Kidney Donation
  • 18.4.B: Reporting Requirements after Living Liver Donation
  • 18.5: Reporting of Patient Safety Events

  • 2.9: Required Deceased Donor Infectious Disease Testing
  • 3.3: Candidate Blood Type Determination and Reporting before Waiting List Registration
  • 3.4.C: Candidate Registrations
  • 5.1.A: Kidney Minimum Acceptance Criteria
  • 15.1: Patient Safety Contact
  • 15.7: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors
  • 16.6.A: Extra Vessels Use and Sharing
  • 16.6.B: Extra Vessels Storage
  • Appendices E.5, F.7, G.8, H.4, I.4: Transplant Programs that Register Candidates Less Than 18 Years Old
  • Appendix F.7.E: Emergency Membership Exceptions for Candidates Less than 18 Years Old
  • Appendix H.4.E: Emergency Membership Exceptions for Candidates Less than 18 Years Old

  • 15.2: Candidate Pre-Transplant Infectious Disease Reporting and Testing Requirements
  • 15.4: Host OPO Requirements for Reporting Post-Procurement Test Results and Discovery of Potential Disease Transmissions
  • 15.5.B: Transplant Program Requirements for Reporting Post-Transplant Discovery of Disease or Malignancy
  • 15.6: Living Donor Recovery Hospital Requirements for Reporting Post-Donation Discovery of Disease or Malignancy

Operational rules are developed by the MPSC to maintain their workload and allow for the efficient review of things that do not pose a threat to patient safety. Additional context on Operational Rules has been added to the OPTN Member Monitoring Processes.

  • 15.4: Host OPO Requirements for Reporting Post-Procurement Test Results and Discovery of Potential Disease Transmissions
  • 16.6.B: Extra Vessels Storage
  • Article 1.E: Member Compliance
  • Appendix D.8: Changes in Key Transplant Program Personnel
  • Appendix D.11: Review of Transplant Program Functional Activity
  • Appendix D.12.B: Patient Notification Requirements for Waiting List Inactivation

  • 1.3: Variances
  • 20: Travel Expense and Reimbursement
  • Article 1.E: Member Compliance
  • Appendix B.3: Quality Assessment and Performance Improvement (QAPI) Requirement
  • Appendix D.4: Quality Assessment and Performance Improvement (QAPI) Requirement

*The policies listed above only contain minor revisions.