Policies

OPTN policy

OPTN policies are rules that govern operation of all member transplant hospitals, organ procurement organizations (OPOs) and histocompatibility labs in the U.S.

OPTN policy

Updated 10/31/2024

Evaluation plan

The OPTN evaluation plan (PDF) provides guidance to member transplant centers, OPOs and histocompatibility labs on how to comply with OPTN policies and bylaws.

Evaluation Plan Updated 9/3/2024

Recent updates

The OPTN policies were last updated on 10/31/2024 with the implementation of changes related to the Refit Kidney Donor Profile Index Without Race and Hepatitis C Virus.

Update	Affected policies	Effective date
Refit Kidney Donor Profile Index without Race and Hepatitis C Virus	8.4.B: Deceased Donor Classifications	10/31/2024
Standardize Six-Minute Walk for Lung Allocation	10.1.A.1 Waitlist Survival Points for Candidates at least 12 Years Old 10.1.B.1 Post-Transplant Outcomes Points for Candidates at least 12 Years Old 10.3 Clinical Values and Update Schedule 10.3.B Lung Clinical Values That Must Be Updated Every Six Months 21.2.A Values Used in the Calculation of Lung Waiting List Survival 21.2.B.1 Coefficients Used in Calculating Lung Post-Transplant Outcomes	09/03/2024
Clarify Requirements for Pronouncement of Death	2.14.A: Conflicts of Interest 2.15.G Pronouncement of Death	07/25/2024
Modify Effect of Acceptance	5.6.D Effect of Acceptance	07/25/2024
Standardize the Patient Safety Contact and Reduce Duplicate Reporting	15.1 Patient Safety Contact	07/25/2024
Modify Organ Offer Acceptance Limit	5.6.C: Organ Offer Acceptance Limit	05/29/2024
Remove CPRA 99-100% Form for Highly Sensitized Candidates	5.1.A: Kidney Minimum Acceptance Criteria 8.4.F: Highly Sensitized Candidates	05/02/2024
Expedited Placement Variance	1.3.B: Creation of a Variance 1.3.C: Joining an Open Variance 1.3.D: Reporting Requirements for Variances 5.4.G: Open Variance for Expedited Placement	04/02/2024
Establish Member System Access, Security Framework, and Incident Management and Reporting Requirements	3.1: Access to the OPTN Computer Systems	03/19/2024
Require Reporting of Patient Safety Events	16.2: Packaging and Labelling Responsibilities 18.5: Reporting of Living Donor Events	01/10/2024
Update Data Collection for Lung Mortality Models	10.1.F: Lung Disease Diagnosis Groups 21.2.A: Values Used in the Calculation of Lung Waiting List Survival 21.2.B.1: Coefficients Used in Calculating Lung Post-Transplant Outcomes	12/13/2023
Establish Membership Requirements for Uterus Transplant Programs	1.2: Definitions 2.2: OPO Responsibilities 5.4.B: Order of Allocation 5.6.A: Receiving and Reviewing Organ Offers 18.1: Data Submission Requirements 18.2: Timely Collection of Data 18.3: Recording and Reporting the Outcomes of Organ Offers	12/5/2023
Modify Heart Policy for Intended Incompatible Blood Type (ABOi) Offers to Pediatric Candidates (PDF)	6.6.B.i: Eligibility for Intended Incompatible Blood Type Heart Offers 6.6.B.ii: Blood Type Matching Priority for Intended Incompatible Blood Type Hearts 6.6.B.iii: Reporting Requirements for Recipients of Intended Incompatible Blood Type Hearts 10.4.A: Eligibility for Intended Blood Group Incompatible Offers for Deceased Donor Lungs	11/30/2023
Establish Member System Access, Security Framework, and Incident Management and Reporting Requirement (PDF)	3.1.A: Security Requirements for Systems Accessing the OPTN Computer System	11/20/2023
Update Multi-Organ Allocation for Continuous Distribution of Lungs (PDF)	5.10.F: Allocation of Lung-Kidneys 5.10.G: Allocation of Heart-Liver and Lung-Liver	09/28/2023
Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation (PDF)	5.10.E: Other Multi-Organ Combinations 5.10.F: Allocation of Lung-Kidneys 5.10.G: Allocation of Heart-Liver and Lung-Liver 8.6.C: Kidney Allocation in Multi-Organ Combinations	09/28/2023
Expand Required Simultaneous Liver-Kidney Allocation (PDF)	9.9: Liver-Kidney Allocation	09/28/2023
Modify Lung Allocation by Blood Type (PDF)	10.1.C.1: Blood Type	09/27/2023
Programming VCA Allocation in UNet (PDF)	2.2: OPO Responsibilities 3.6.A: Waiting Time for Inactive Candidates 5.3.B: Infectious Disease Screening Criteria 5.4.B: Order of Allocation 5.6.A: Receiving and Reviewing Organ Offers 5.6.B: Time Limit for Review and Acceptance of Organ Offers 12.2: VCA Allocation 18.1.B: Timely Submission of Certain Data 18.3: Recording and Reporting the Outcomes of Organ Offers	09/14/2023
Modify Graft Failure Definition for VCA (PDF)	1.2: Definitions 12.1: Waiting Time 18.1: Data Submission Requirements	09/14/2023
Align OPTN Policy to Support Changes to Race and Ethnicity Data Collection (PDF)	2.11: Required Deceased Donor Information 5.4.A: Nondiscrimination in Organ Allocation 8.4.B: Deceased Donor Classifications 13.6.A: Requirements for Match Run Eligibility for Candidates 13.6.B: Requirements for Match Run Eligibility for Potential KPD Donors	9/14/2023
Ongoing Review of National Liver Review Board (NLRB) Diagnoses (PDF)	9.5.I.i: Initial Assessment and Requirements for HCC Exception Requests 9.5.I.ii: Eligible Candidates Definition of T2 Lesions 9.5.I.iii: Lesions Eligible for Downstaging Protocols 9.5.I.iv: Candidates with Alpha-fetoprotein (AFP) Levels Greater than 1000 Policy 9.5.I.v: Requirements for Dynamic Contrast-enhanced CT or MRI of the Liver 9.5.I.vi: Imaging Requirements for Class 5 Lesions 9.5.I.vii: Extensions of HCC Exceptions	07/13/2023
Improving Liver Allocation: MELD, PELD, Status 1A and Status 1B (PDF)	1.2: Definitions 9.1.B: Pediatric Status 1A Requirements 9.1.C: Pediatric Status 1B Requirements 9.1.D: MELD Score 9.1.E: PELD Score 9.1.F: Liver-Intestine Candidates 9.2: Status and Laboratory Values Update Schedule 9.7.C: Points Assigned by Diagnosis (New) 9.8.D: Sorting within Each Classification	07/13/2023
Update Kidney Paired Donation Policy	1.2: Definitions 13.3: Informed Consent for KPD Candidates 13.4: Informed Consent for KPD Donors 13.4.D: Additional Requirements for Non-Directed Donors 13.4.E: Additional Requirements for Bridge Donors 13.7.G: OPTN KPD Waiting Time Reinstatement 13.11: Receiving and Accepting KPD Match Offers 13.11.A: Requesting a Deadline Extension for a KPD Exchange	2/01/2023
Change Calculated Panel Reactive Antibody (CPRA) Calculation	1.2: Definitions 4.6: Calculated Panel Reactive Antibody (CPRA) Calculation 4.9: HLA Antigen Values and Split Equivalences 4.10.B: HLA Unacceptable Antigen Equivalences 5.3.A: Reporting Unacceptable Antigens for Calculated Panel Reactive Antibody (CPRA) 8.1: Calculated Panel Reactive Antibody (CPRA) 11.1: Calculated Panel Reactive Antibody (CPRA)	1/26/2023
Modify Waiting Time for Candidates Affected by Race-Inclusive eGFR Calculations	3.7.D	1/05/2023
Amend Status Extension Requirements in Adult Heart Allocation Policy	6.1.A.i: Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO) 6.1.A.ii: Non-dischargeable, Surgically Implanted, Non-Endovascular Biventricular Support Device 6.1.A.iii: Mechanical Circulatory Support Device (MCSD) with Life Threatening Ventricular Arrhythmia 6.1.C: Adult Heart Status 3 Requirements 6.1.C.iv: Mechanical Circulatory Support Device (MCSD) with Pump Thrombosis 6.1.C.v: Mechanical Circulatory Support Device (MCSD) with Right Heart Failure 6.1.C.vi: Mechanical Circulatory Support Device (MCSD) with Device Infection 6.1.C.xiii: Mechanical Circulatory Support Device (MCSD) with Life Threatening Ventricular Arrhythmia After 7 Days	10/27/2022
Establish Minimum Kidney Donor Criteria to Require Biopsy	2.11.A: Required Information for Deceased Kidney Donors	9/6/2022
Review of National Liver Review Board (NLRB) Diagnoses and Update to Alcohol Associated Diagnoses	9.5.I.i: Initial Assessment and Requirements for HCC Exception Requests 9.5.I.vii: Extensions of HCC Exceptions	8/30/2022
Align OPTN Policy with U.S. Public Health Service Guideline, 2020	1.2: Definitions 2.2: OPO Responsibilities 2.4: Deceased Donor Medical and Behavioral History 2.5: Hemodilution Assessment 2.7.A: Exceptions to HIV Screening Requirement 2.9: Required Deceased Donor Infections Disease Testing 13.11: Receiving and Accepting KPD Match Offers 14.1.A: Living Donor Psychosocial Evaluation Requirements 14.3: Informed Consent Requirements 14.4.A: Living Donor Medical Evaluation Requirements 14.8.B: Living Donor Specimen and Storage 14.9.B: Psychosocial and Medical Evaluation Requirements for Domino and Non-Domino Therapeutic Donors 15.2: Potential Candidate Screening Requirements 15.3.B: Donors with Risk Identified Pre-Transplant 15.3.C: Recipients of Organs from Donors with Increased Risk of Disease Transmission 16.3.D: Internal Labeling of Extra Vessels	8/30/2022
Modify Data Submission Policies	18.1: Data Submission Requirements 18.4: Data Submission Standards	8/30/2022
Update Human Leukocyte Antigen (HLA) Equivalency Tables	2.11.A: Required Information for Deceased Kidney Donors 2.11.B: Required Information for Deceased Liver Donors 2.11.C: Required Information for Deceased Heart Donors 2.11.D: Required Information for Deceased Lung Donors 2.11.E: Required Information for Deceased Pancreas Donors 4.3.A: Deceased Donor HLA Typing 4.10: Reference Tables of HLA Antigen Values and Split Equivalences 13.5.A: HLA Typing Requirements for OPTN KPD Candidates 13.5.C: HLA Typing Requirements for OPTN KPD Donors	8/30/2022
Establish OPTN Requirement for Race-Neutral eGFR Calculations	1.2: Definitions 3.6.B.i: Non-function of a Transplanted Kidney 8.4.A: Waiting Time for Candidates Registered at Age 18 Years or Older 8.5.G: Prioritization for Liver Recipients on the Kidney Waiting List 9.5.H: Requirements for Primary Hyperoxaluria MELD or PELD Score Exceptions 9.9.B: Liver-Kidney Candidate Eligibility for Candidates 18 Years or Older 13.7.G: OPTN KPD Waiting Time Renistatement	7/27/2022
Modify Living Donor Exclusion Criteria	14.4.E: Living Donor Exclusion Criteria	7/26/2022
Modify Heart Policy to Address Patient Safety Following Device Recall (PDF)	Policy 6.4: Adult and Pediatric Status Exceptions	7/14/2022
Pediatric Candidate Pre-Transplant HIV, HBV, and HCV Testing	15.2: Candidate Pre-Transplant Infectious Disease Reporting and Testing Requirements	7/1/2022
Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation	1.2: Definitions 9.4.A: MELD or PELD Score Exception Requests 9.4.C.ii: Other MELD or PELD Score Exception Extensions 9.4.D: Calculation of Median MELD or PELD at Transplant 9.5: Specific Standardized MELD or PELD Score Exceptions 9.5.A: Requirements for Cholangiocarcinoma (CCA) MELD or PELD Score Exceptions 9.5.B: Requirements for Cystic Fibrosis (CF) MELD or PELD Score Exceptions 9.5.C: Requirements for Familial Amyloid Polyneuropathy (FAP) MELD or PELD Score Exceptions 9.5.D: Requirements for Hepatic Artery Thrombosis (HAT) MELD or PELD Score Exceptions 9.5.E: Requirements for Hepatopulmonary Syndrome (HPS) MELD or PELD Score Exceptions 9.5.F: Requirements for Metabolic Disease MELD or PELD Score Exceptions 9.5.G: Requirements for Portopulmonary Hypertension MELD or PELD Score Exceptions 9.5.H: Requirements for Primary Hyperoxaluria MELD or PELD Score Exceptions 9.5.I: Requirements for Hepatocellular Carcinoma (HCC) MELD or PELD Score Exceptions 9.5.I.vii: Extension of HCC Exceptions 9.6.A: Waiting Time for Liver Candidates 9.8: Liver Allocation, Classifications and Rankings 9.8.D: Sorting Within Each Classification	06/28/2022
Reinstatement of Updates to Candidate Data During the COVID-19 Emergency	1.4.F: Updates to Candidate Data During COVID-19 Emergency	01/11/2022 Expired: 04/11/2022
Clarify Multi-Organ Allocation Policy	5.10.C: Allocation of Kidney-Pancreas 5.10.D: Allocation of Liver-Intestines 5.10.E: Other Multi-Organ Combinations 8.7: Kidney Allocation in Multi-Organ Combinations 9.9: Liver-Kidney Allocation	2/10/2022
Review of National Liver Review Board (NLRB) Diagnoses and Update to Alcohol Associated Diagnoses	9.5.I.i: Initial Assessment and Requirements for HCC Exception Requests 9.5.I.vii: Extensions of HCC Exceptions	02/01/2022
Administrative changes	1.1: Rules of Construction	12/06/2021
Updating NLRB Guidance and Policy Clarification	9.5.A: Requirements for Cholangiocarcinoma (CCA) MELD or PELD Exceptions	10/07/2021
Further Enhancements to the NLRB	Policy 9.5.G: Requirements for Portopulmonary Hypertension MELD or PELD score Exceptions	10/07/2021
Refine Lung Data Fields	10.1.E: LAS Values and Clinical Data Update Schedule for Candidates at Least 12 Years Old 10.1.F: The LAS Calculation	09/30/2021
Updated Cohort for Calculation of the LAS	10.1.E: LAS Values and Clinical Data Update Schedule for Candidates at Least 12 Years Old 10.1.F: The LAS Calculation 10.1.F.iii: Bilirubin in the LAS LAS 10.1.F.iv: Creatinine in the LAS LAS 10.5: Probability Data Used in the LAS Calculation	09/30/2021
Require Notification of Critical Human Leukocyte Antigen (HLA) Typing Changes	4.4: Resolving Discrepant Donor and Recipient HLA Typing Results 4.4.A: Requirement to Notify Transplant Programs and OPOs 4.4.A.i: Donor HLA Critical Discrepancies 4.4.A.ii: Candidate and Recipient HLA Critical Discrepancies 4.4.B: Requirement to Resolve Critical Discrepant Donor and Recipient HLA Typing Results	09/01/2021
Modify Living Donor Policy to Include Living VCA Donors	14.1.A: Living Donor Psychosocial Evaluation Requirements 14.2.A: ILDA Requirements for Living Donor Recovery Hospitals 14.3: Informed Consent Requirements 14.4.A: Living Donor Medical Evaluation Requirements 14.4.D Additional Requirements for the Medical Evaluation of Living Donors of Covered VCAs	09/01/2021
Repeal Policy 3.7.D: Applications for Modifications of Kidney Waiting Time during 2020 COVID-19 Emergency	3.7.D: Applications for Modifications of Kidney Waiting Time during 2020 COVID-19 Emergency	09/01/2021
Human Leukocyte Antigen (HLA) Equivalency Tables Update 2020 (Including Expedited Pathway for Future Updates)	4.9: HLA Antigen Values and Split Equivalences 4.10: Reference Tables of HLA Antigen Values and Split Equivalences	06/17/2021
National Heart Review Board for Pediatrics	6.4: Adult and Pediatric Status Exceptions 6.4.A: Review Board and Committee Review of Status Exceptions 6.4.A.i: Review Board Appeals 6.4.A.ii: Committee Appeals	06/15/2021
Clarification of Policies and Bylaws Specific to Vascularized Composite Allograft	1.2: Definitions 2.2: OPO Responsibilities 2.14.E: Deceased Donor Authorization Requirement Policy 5.4.B: Order of Allocation 5.6.A: Receiving and Reviewing Organ Offers 5.6.B: Time Limit for Review and Acceptance of Organ Offers 12: Allocation of Vascularized Composite Allografts (VCA) 12.1: Waiting Time 12.2: VCA Allocation 14.5.C: Reporting of Living Donor Blood Type and Subtype 15.4.A: Host OPO Requirements for Reporting Post-Procurement Donor Results and Discovery of Potential Disease Transmissions 18.1: Timely Submission of Certain Data 18.2 Timely Collection of Data 18.3: Recording and Reporting the Outcomes of Organ Offers	06/14/2021
List Covered Body Parts for VCA	1.2 Definitions	06/14/2021
Align OPTN Policy with US PHS Guideline 2020	14.8.B: Living Donor Specimen Collection and Storage 14.3: Informed Consent Requirements	06/01/2021
Lower Respiratory SARS-CoV-2 Testing for Lung Donors	1.2 - Definitions 2.9 - Required Deceased Donor Infectious Disease Testing	05/27/2021
Conclude Relaxation of Data Submission Requirements for Follow-Up Forms	18.1 - Data Submission Requirements 18.1.A - Retrospective Data Collection during COVID-19 Emergency 18.2 - Timely Collection of Data 18.5.A - Reporting Requirements after Living Kidney Donation 18.5.B - Reporting Requirements after Living Liver Donation	04/01/2021
Expedited Liver Placement	1.2 - Definitions 5.3.D - Liver Acceptance Criteria 5.6.B - Time Limit for Review and Acceptance of Organ Offers 9.10.A - Expedited Liver Placement Acceptance Criteria 9.10.B - Expedited Liver Offers	3/25/2021
Eliminate the use of DSA and Region in Pancreas Allocation Policy	1.2 - Definitions 11.4.A - Kidney-Pancreas Allocation Order 11.4.B - Pancreas Allocation When a Kidney is Unavailable 11.4.C - Organ Offer Limits 11.4.D - Islet Waiting Time Criteria 11.5 - Pancreas, Kidney-Pancreas, and Islet Allocation Classifications and Rankings 11.5.E - Sorting Within Each Classification 11.5.F - Deceased Donors 50 Years Old and Less with a BMI Less Then or Equal to 30 kg/m² 11.6 - Reallocation of Unsuitable Islets	03/15/2021
Eliminate the use of DSA and Region in Kidney Allocation Policy	5.1 - Minimum Acceptance Criteria 5.1.A - Kidney Minimum Acceptance Criteria 8.2 - Exceptions 8.2.A - Exceptions Due to Medical Urgency 8.3 - Kidney Allocation Points 8.5.F - Highly Sensitized Candidates 8.5.H - Allocation of Kidneys from Deceased Donors with KDPI Scores less than or equal to 20% 8.5.I - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 20% but less than 35% 8.5.J - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than or equal to 35% but less than or equal to 85% 8.5.K - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 85% 8.7 - Administrative Rules 8.7.A - Choice of Right versus Left Donor Kidney 8.7.B - National Kidney Offers	03/15/2021
Addressing Medically Urgent Candidates in New Kidney Allocation Policy	8.2.A - Exceptions Due to Medical Urgency 8.2.B - Deceased Donor Kidneys with Discrepant Human Leukocyte Antigen (HLA) Typings 8.4.C - Time at Medically Urgency Status 8.4.D - Waiting Time for Kidney Recipients 8.5.A - Candidate Classifications 8.5.C - Sorting within Each Classification 8.5.F - Highly Sensitized Candidates 8.5.H - Allocation of Kidneys from Deceased Donors with KDPI Scores less than or equal to 20% 8.5.I - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 20% but less than 35% 8.5.J - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than or equal to 35% but less than or equal to 85% 8.5.K - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 85% 8.7.A - Choice of Right Versus Left Donor Kidney	03/15/2021
Distribution of Kidneys and Pancreata from Alaska	8.7.D - Location of Donor Hospitals 11.8 - Administrative Rules 11.8A - Location of Donor Hospitals	03/15/2021
Modifications to Released Kidney and Pancreas Allocation	5.9 - Released Organs 8.3 - Kidney Allocation Score 8.5.H - Allocation of Kidneys from Deceased Donors with KDPI Scores less than or equal to 20% 8.5.I - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 20% but less than 35% 8.5.J - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than or equal to 35% but less than or equal to 85% 8.5.K - Allocation of Kidneys from Deceased Donors with KDPI Scores greater than 85% 8.8 - Allocation of Released Kidneys 11.4.A - Kidney-Pancreas Allocation Order 11.4.C - Organ Offer Limits 11.7 - Allocation of Released Kidney-Pancreas, Pancreas, or Islets	03/15/2021
Guidance and Policy Addressing Adult Heart Allocation	6.1.A.ii - Non-dischargeable, Surgically Implanted, NonEndovascular Biventricular Support Device 6.1.C.vi - Mechanical Circulatory Support Device (MCSD) with Device Infection 6.1.D.ii - Inotropes without Hemodynamic Monitoring	03/04/21