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 4/2/2024Evaluation 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 3/19/2024Recent updates
The OPTN policies were last updated on 4/2/2024 with the implementation of changes related to the Expedited Placement Variance proposal.
| Update | Affected policies | Effective date |
|---|---|---|
| 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 12.2: VCA Allocation 18.1.B: Timely Submission of Certain Data 18.3: Recording and Reporting the Outcomes of Organ |
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 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 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
|
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 |
7/1/2022 |
|
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 |
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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 |
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9.5.A: Requirements for Cholangiocarcinoma (CCA) MELD or PELD Exceptions |
10/07/2021 |
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Policy 9.5.G: Requirements for Portopulmonary Hypertension MELD or PELD score Exceptions |
10/07/2021 |
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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 |
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| 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 |
Explore other policy sections
Policy developmentThe OPTN policy development process uses community input to create evidence based rules about organ transplantation.
View notices of implemented policies & bylawsSummary of implemented policy and bylaws changes approved by the OPTN Board of Directors.
View notices of approved policies & bylawsSummary of approved policy and bylaws changes.
View the OPTN Evaluation PlanInformation about how UNOS assesses compliance with OPTN policies and bylaws.
If you have questions about these updates, please contact member.questions@unos.org.