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Policies

OPTN policy

OPTN policy icon

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 PDF link Updated 1/10/2024

Evaluation plan

OPTN evaluation plan icon

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 PDF link Updated 11/20/2023

Recent updates

The OPTN policies were last updated on 1/10/2024 with the implementation of changes related to Require Reporting of Patient Safety Events proposal.

Update Affected policies Effective date
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

Explore other policy sections

Policy development

The OPTN policy development process uses community input to create evidence based rules about organ transplantation.

View notices of implemented policies & bylaws

Summary of implemented policy and bylaws changes approved by the OPTN Board of Directors.

View notices of approved policies & bylaws

Summary of approved policy and bylaws changes.

View the OPTN Evaluation Plan

Information about how UNOS assesses compliance with OPTN policies and bylaws.

If you have questions about these updates, please contact member.questions@unos.org.