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Notices of implemented actions

Implemented

  • 1.2: Definitions
  • 1.4.F: Updates to Candidate Data during 2020 COVID-19 Emergency (Repealed as of 07/27/2021; Reinstated as of 1/11/2022; Expired 4/11/2022)
  • 2.9: Required Deceased Donor Infectious Disease Testing
  • 2.11: Required Deceased Donor Information
  • 3.7.D: Applications for Modification of Kidney Waiting Time during 2020 COVID-19 Emergency
  • 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

The table below shows Implemented policy notices with detailed Item name, board action date, and effective implementation date

Item Action Effective date
Expedited Placement Variance 03/2024 04/02/2024
Proposal to Address the Relationship of the OPTN and OPTN Contractor Board 03/2024 03/30/2024
Required Security Training for All OPTN Computer System Users 06/2023 03/19/2024
Recognizing Seasonal and Geographically Endemic Infections in Organ Donors: Considerations during Deceased and Living Donor Evaluation 12/2023 01/10/2024
Require Reporting of Patient Safety Events 12/2023 01/10/2024
Update Guidance on Optimizing VCA Recovery 12/2023 01/10/2024

Update Data Collection for Lung Mortality Models (PDF)

  • Updates to Waiting List & the Lung CAS Calculator on the OPTN site
12/2022

12/13/2023

Establish Membership Requirements for Uterus Transplant Programs (PDF)

12/2021 12/5/2023

Modify Heart Policy for Intended Incompatible Blood Type (ABOi) Offers to Pediatric Candidates (PDF)

06/2023 11/30/2023

Establish Member System Access, Security Framework, and Incident Management and Reporting Requirements (PDF)

  • Readiness assessment and annual attestations
06/2023 11/20/2023
Update Multi-Organ Allocation for Continuous Distribution of Lungs (PDF) 12/2022 09/28/2023
Establish Eligibility Criteria and Safety Net for Heart-Kidney and Lung-Kidney Allocation (PDF) 06/2022 09/28/2023
Expand Required Simultaneous Liver-Kidney Allocation (PDF) 06/2023 09/28/2023
Modify Lung Allocation by Blood Type (PDF) 09/2023 09/27/2023
Apply Transplant Notification Requirements for VCA Program Inactivation (PDF) 12/2022 09/14/2023
Data Collection to Evaluate Organ Logistics and Allocation (PDF) 12/2021 09/14/2023
Report Primary Graft Dysfunction in Heart Transplant Recipients (PDF) 12/2021 09/14/2023
Modifications to the Deceased Donor Registration (DDR) (PDF) 06/2021 09/14/2023
Update Data Collection to Align with U.S Public Health Service Guideline, 2020 (PDF) 12/2021 09/14/2023
Standardize Kidney Biopsy Reporting and Data Collection (PDF) 06/2022 09/14/2023

Programming VCA Allocation in UNet (PDF)

12/2020 09/14/2023

Modify Graft Failure Definition for VCA (PDF)

06/2022 09/14/2023
Update to VCA Transplant Outcomes Data Collection (PDF) 12/2020 09/14/2023

Align OPTN Policy to Support Changes to Race and Ethnicity Data Collection (PDF)

9/8/2023 Exec Comm Action 09/14/2023

Establish Member System Access, Security Framework, and Incident Management and Reporting Requirements (PDF)

  • Require Reporting of Security Incidents
06/2023 8/1/2023

Ongoing Review of National Liver Review Board (NLRB) Diagnoses (PDF)

06/2022 Board Action 07/13/2023

Improving Liver Allocation: MELD, PELD, Status 1A and Status 1B (PDF)

06/2022 Board Action 07/13/2023
Establish Continuous Distribution of Lungs (PDF) 12/2021 Board Action 03/09/2023
Revise Lung Review Board Guidelines, Guidance, and Policy for Continuous Distribution (PDF) 12/2022 Board action 03/09/2023

Update Multi-Organ Allocation for Continuous Distribution of Lungs (PDF)

  • 5.10.E: Other Multi-Organ Combinations
  • 6.6.F.i: Allocation of Heart-Lungs from Deceased Donors at Least 18 Years Old
  • 6.6.F.ii: Allocation of Heart-Lungs from Deceased Donors Less Than 18 Years Old
12/2022 Board action 03/09/2023

Update Kidney Paired Donation Policy (PDF)

12/2022 Board action 02/01/2023
Change Calculated Panel Reactive Antibody (CPRA) Calculation (PDF) 6/2022 Board action 1/26/2023
Continued Review of National Liver Review Board (NLRB) Guidance (PDF) 12/2022 Board action 1/05/2023
Modify Waiting Time for Candidates Affected by Race-Inclusive eGFR Calculations (PDF) 12/2022 Board action 1/05/2023
Transparency in Program Selection (PDF) 12/2022 Board action 1/05/2023
Amend Status Extension Requirements in Adult Heart Allocation Policy (PDF) 12/2021 Board Action 10/27/2022
Review of Liver and Intestine Variances in OPTN Policy (PDF) 10/2022 Executive Committee action 10/26/2022
Establish Minimum Kidney Donor Criteria to Require Biopsy (PDF) 6/2022 Board action 09/06/2022
Cross Organ Data Alignment (PDF) 6/2022 Board action 08/30/2022
Modify Data Submission Policies (PDF) 12/2019 Board action 08/30/2022
Update Human Leukocyte Antigen (HLA) Equivalency Tables (PDF) 12/2021 Board action 08/30/2022

Align OPTN Policy with US Public Health Service Guideline, 2020 (PDF)

  • Data collection for recipient HBV vaccination status
12/2020 Board action 08/30/2022

Further Enhancements to the National Liver Review Board (PDF)

  • Policy 9.5.I.i: Initial Assessment and Requirements for HCC Exception Requests
12/2020 Board action 08/30/2022

Review of National Liver Review Board (NLRB) Diagnoses and Update to Alcohol Associated Diagnoses (PDF)

  • Changes to Transplant Candidate Registration Form
    Changes to Transplant Recipient Registration Form

12/2021 Board Action

08/30/2022

Refine Lung Data Fields (PDF)

  • Data collection clarification for lung height and weight details
07/2021 Executive Committee action 08/30/2022
Establish OPTN Requirement for Race-Neutral Estimated Glomerular Filtration Rate (eGFR) Calculations (PDF) 6/2022 Board action 7/27/2022

Modify Living Donor Exclusion Criteria (PDF)

  • 14.4.E: Living Donor Exclusion Criteria
6/2022 Board action 7/26/2022

Ongoing Review of National Liver Review Board (NLRB) Diagnoses (PDF)

 Split implementation. Additional actions targeted for April 2023 implementation.

Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exceptions for Hepatocellular Carcinoma (HCC)

Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exceptions Review

6/2022 Board action 7/26/2022

Modify Heart Policy to Address Patient Safety Following Device Recall

7/2022 Executive Committee Action; 12/2022 Board action 7/14/2022

Enhance Transplant Program Performance Monitoring System, Phase 1 (July 2022) (PDF)

  • Inquiries related to post-transplant outcomes
6/2022 Board Action 7/14/2022
Pediatric Candidate Pre-Transplant HIV, HBV, and HCV Testing (PDF) 6/2022 Board Action 7/1/2022
Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation (PDF) 06/2021 Board Action 06/28/2022
Enhance Transplant Program Performance Monitoring System (PDF) 12/2021 Board Action Cohorts for pre- transplant metrics begin 1/1/2022

Clarify Multi-Organ Allocation Policy (PDF)

06/2021 Board action 02/10/2022
Guidance for Data Collection Regarding Classification of Citizenship Status (PDF) 12/2021 Board Action 02/01/2022
Ethical Considerations of Continuous Distribution in Organ Allocation (PDF) 12/2021 Board Action 02/01/2022

Review of National Liver Review Board (NLRB) Diagnoses and Update to Alcohol Associated Diagnoses (PDF)

  • 9.5.I.i: Initial Assessment and Requirements for HCC Exception Requests
  • 9.5.I.vii: Extensions of HCC Exceptions
  • Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exceptions for Hepatocellular Carcinoma (HCC)
  • Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exceptions Review

12/2021 Board Action 02/01/2022
Implemented policy items in 2021    
Extending Hawaii Puerto Rico Closed Blood Type Variance (PDF) 12/2020 Board action

12/6/2021

Extend HIV Organ Policy Equity (HOPE) Act Variance (PDF) 12/2020 Board action

12/6/2021

Lower Respiratory SARS-CoV-2 Testing for Lung Donors

4/26/2021 Executive Committee Action; 12/2021 Board action

5/27/2021

Update to Refusal Codes (PDF) 6/2021 Board action 12/2/2021

Further Enhancements to the NLRB

  • Policy 9.5.G: Requirements for Portopulmonary Hypertension MELD or PELD Score Exceptions
  • National Liver Review Board Operational Guidelines
  • Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exception Review
12/2020 Board action 10/07/2021

Updating National Liver Review Board Guidance and Policy Clarification (PDF)

  • Policy 9.5.A: Requirements for Cholangiocarcinoma (CCA) MELD or PELD Score Exceptions
06/2021 Board action

10/07/2021

Refine Lung Data Fields (PDF)

07/2021 Executive Committee Action

09/30/2021

Updated Cohort for Calculation of the LAS (PDF)

12/2020 Board action

09/30/2021

Require Notification of Critical Human Leukocyte Antigen (HLA) Typing Changes (PDF)

06/2021 Board action

09/01/2021

Modify Living Donor Policy to Include Living VCA Donors (PDF)

06/2021 Board action

09/01/2021

Updating National Liver Review Board Guidance and Policy Clarification (PDF)

  • Guidance to Liver Transplant Programs and the National Liver Review Board for Pediatric MELD or PELD Exception Review
  • Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exception Review
06/2021 Board action

07/15/2021

Human Leukocyte Antigen (HLA) Equivalency Tables Update 2020 (PDF)

06/2020 Board action

06/17/2021

National Heart Review Board for Pediatrics (PDF)

06/2020 Board action

06/15/2021

Clarification of Policies and Bylaws Specific to Vascularized Composite Allografts (PDF)

06/2021 Board action

06/14/2021

Combined Policy Notice for VCA Membership Requirements (2020) (PDF)

 

VCA - List Covered Body Parts - 1 of 2 (PDF)

  • Policy 1.2: Definitions
  • Bylaws Appendix D: Membership Requirements for Transplant Hospitals and Transplant Programs; Appendix J: Membership Requirements for Vascularized Composite Allograft (VCA) Transplant Programs; and Appendix M: Definitions

 

Align VCA program membership requirements with other programs (PDF)

 

Membership Requirements for VCA Transplant Programs (PDF)

06/2015, 06/2016, 06/2018 Board action

06/14/2021

Align OPTN Policy with US PHS Guideline 2020 (PDF)

  • Policy 14.3: Informed Consent Requirements
  • Policy 14.8.B: Living Donor Specimen Collection and Storage

12/2020 Board action

06/01/2021

Expedited Liver Placement (PDF)

12/2019 Board action 03/25/2021

Pancreas Removal of DSA (PDF)

12/2019 Board action 03/15/2021

Kidney Removal of DSA (PDF)

12/2019 Board action 03/15/2021

Addressing Medically Urgent Candidates in New Kidney Allocation Policy (PDF)

06/2020 Board action 03/15/2021

Distribution of Kidneys and Pancreata from Alaska (PDF)

06/2020 Board action 03/15/2021

Modifications to Released Kidney and Pancreas Allocation (PDF)

06/2020 Board action 03/15/2021

Guidance and Policy Addressing Adult Heart Allocation (PDF)

  • Policy 6.1.A.ii: Non-dischargeable, surgically implanted, non-endovascular biventricular support device: Effective March 4, 2021
  • Policy 6.1.C.vi: Mechanical Circulatory Support Devise (MCSD) with Device Infection: Effective March 4, 2021
  • Policy 6.1.D.ii: Inotropes without Hemodynamic Monitoring: Effective March 4, 2021
  • Guidance for Adult Heart Exceptions for
    Status 2 Candidates Experiencing Cardiogenic Shock: Effective February 9, 2021
12/2020 Board action 02/09/2021, 03/04/2021

Align OPTN Policy with US PHS Guideline 2020 (PDF)

Split implementation. Additional actions targeted for June 2021 implementation.

  • 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 Infectious Disease Testing
  • 13.11: Receiving and Accepting KPD Match Offers
  • 14.1.A: Living Donor Psychosocial Evaluation Requirements
  • 14.4.A: Living Donor Medical Evaluation Requirements
  • 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
12/2020 Board action 03/2021

Guidance Addressing the Use of Pediatric Heart Exceptions (PDF)

12/2020 Board action 02/09/2021
Further Enhancements to the National Liver Review Board (PDF)
  • Split implementation. Additional actions targeted for June 2021 implementation.
  • Guidance to Liver Transplant Programs and the National Liver Review Board for Adult MELD Exception Review
12/2020 Board action 02/09/2021
Implemented policy items in 2020    
Establish Pediatric Training and Experience (PDF) 12/2015 Board actions 12/07/2020
Revise Pediatric Emergency Membership Exception Pathway (PDF) 12/2017 Board action 12/07/2020
Incorporating COVID-19 Related Organ Failure In Candidate Listings (PDF) 10/2020 Board action 10/28/2020
Enhancements to the National Liver Review Board (PDF)
  • Policies 9.4.A: MELD or PELD Score Exception Requests and 9.4.D: Calculation of Median MELD or PELD at Transplant: Effective August 4, 2020
  • Operational Guidelines: Effective August 4, 2020
  • Operational Guidance: Effective August 4, 2020
  • Policies 9.4.C: MELD or PELD Score Exception Extensions and 9.5.I.vii: Extensions of HCC Exceptions: Effective September 10, 2020
06/2020 Board action 08/04/2020, 09/10/2020
Guidance and Policy Modifications Addressing Blood Type Determination (PDF)
  • Guidance: Effective June 8, 2020
  • Policy: Effective September 1, 2020
06/2020 Board action 06/08/2020,09/01/2020
Modify the Conflicts of Interests Bylaws (PDF) 06/2020 Board action 07/01/2020
Creation of OPTN Heart and Lung Committees (PDF) 03/2020 Board action 07/01/2020
Modify Lung TRF to Improve Post Transplant Lung Function Data 06/2018 Board action 06/30/2020
Eliminate the Use of Regions in VCA Distribution (PDF) 06/2019 Board action 06/18/2020
Modify HOPE Act Variance to Include Other Organs (PDF) 06/2019 Board action 05/21/2020
COVID-19 Emergency Policy Package (PDF) 04/2020 Executive Committee action 04/03/2020
Clarifications on Reporting Maintenance Dialysis (PDF) 06/2019 Board action 04/01/2020
Updates to Candidate Data During 2020 COVID-19 Emergency (PDF) 03/2020 Executive Committee action 03/17/2020
Variances Removal Policy Notice (PDF) 12/2019 Board action 03/01/2020
Clarification of Pre-Existing Liver Disease (PDF) 12/2019 Board action 03/01/2020
Addressing HLA Typing Errors 12/2018 Board action 02/27/2020
Access for Urgent Liver Candidates in Hawaii & Puerto Rico (PDF) 01/2020 Executive Committee action 02/18/2020
Liver and Intestine Distribution Using Distance from Donor Hospital (PDF) 12/2018 Board action 02/04/2020
Reduce Reporting Burdens and Clarify Policies on Extra Vessels (PDF)
  • Table 16.1: Required information on internal labels for extra vessels, number 7 (donor infectious disease results)
06/2018 Board action 01/29/2020
Update Transplant Hospital Definition (PDF) 12/2016 Board action 01/13/2020
Eliminate the Use of DSAs in Thoracic Organ Distribution (PDF) 06/2019 Board action 01/09/2020
Implemented policy items in 2019    
Adding DR Antigens and Equivalences (PDF) 12/2019 Board Action 12/04/2019
Hope Act Policy and Mini Brief (PDF) 12/2019 Board action 12/03/2019
Modify Appointment Process for the Histocompatibility Vice Chair (PDF) 12/2019 Board Action 12/03/2019
Aligning Units of Distribution in Closed Variance for Split Liver Transplantation (PDF) 12/2019 Board Action 12/03/2019
Split Liver Variance (PDF) 06/2019 Board action 12/03/2019
Revising Priority Points in Kidney Paired Donation Program (PDF) 12/2015 Board action;
10/2019 Executive Committee action
10/24/2019
Improving Dual Kidney Allocation 12/2017 Board action 9/2019
Improving en Bloc Kidney Allocation 12/2017 Board action 9/2019
Changes to Waiting Time Criteria for Kidney-Pancreas Candidates (PDF) 06/2018 Board action 7/11/2019
Guidance on Effective Practices in Organ Distribution 06/2019 Board action 6/10/2019
Ethical Implications of Multi-Organ Transplants White Paper 06/2019 Board action 6/10/2019
Revised National Liver Review Board Policies (PDF) 12/2018 Board action 5/14/2019
National Liver Review Board 06/2017 Board action 5/14/2019
Histocompatibility Bylaws Rewrite: General Supervisor (PDF) 06/2015 Board action 3/1/2018
Pancreas Program Functional Inactivity (PDF) 12/2018 Board action 4/8/2019
Addressing HLA Typing Errors (PDF)
  • Policy 2.2 (OPO responsibilities)
  • Bylaws C.2.D (OPO affiliation)
12/2018 Board action 3/1/2019
Amend CPRA Calculator (PDF) 01/2019 Executive Committee action 1/17/2019
Implemented policy items in 2018    
Change to Hospital-Based OPO Voting Privileges 12/2018 Board action 12/4/2018
Frameworks for Organ Distribution 12/2018 Board action 12/4/2018
Pediatric Transition and Transfer Guidance 12/2018 Board action 12/3/2018
Intestine Membership Bylaws Requirements 06/2015 Board action 11/20/2018
Modify Adult Heart Allocation 12/2016 Board action 10/18/2018
Clarification of Adult Heart Allocation 08/2017 Executive Committee action 10/18/2018
Review Board Guidance on HCM and RCM Exceptions 06/2018 Board action 10/18/2018
Modifications to the Distribution of Deceased Donor Lungs 06/2018 Board action 10/18/2018 (Policy 6.6.F)
06/12/2018 (Policies 1.2, 10.2.A, 10.4)
Clarify Informed Consent Policies for Transmittable Diseases 06/2018 Board action 09/01/2018
Reduce Reporting Burdens and Clarify Policies on Extra Vessels (PDF) 06/2018 Board action 09/01/2018 (except table 16.1)
VCA - List Covered Body Parts (2 0f 2) (PDF)
  • Bylaws Appendix J: Membership Requirements for Vascularized Composite Allograft (VCA) Transplant Programs: Effective September 1, 2018
  • Policy 1.2: Definitions: Target implementation date: December 2021
  • Bylaws Appendix D: Membership Requirements for Transplant Hospitals and Transplant Programs; Appendix J: Membership Requirements for Vascularized Composite Allograft (VCA) Transplant Programs; and Appendix M: Definitions: Target implementation date: December 2021
06/2016 Board action 09/01/2018
Improving the Efficiency of Organ Allocation (PDF) 12/2017 Board action 03/01/2018 (Policies 2.2, 2.11 and 2.12)
05/02/2018 (Policies 1.2 and 5.6.B)
06/12/2018 (Policies 2.11.A and 2.11.D)
06/13/2018 (Policy 5.6.C)
Revising OPTN Bylaws Appendix L (PDF) 06/2018 Board action 06/12/2018
Retrospective Review of Clerical Policy Changes (PDF) 06/2018 Executive Committee action 06/12/2018
Approved Transplant Fellowship Training Programs Bylaws (PDF) 12/2017 Board action 03/01/2018
Definition of Pancreas Graft Failure (PDF) 06/2015 Board action 2/28/2018
Modification to HCC Extension Criteria (PDF)   2/5/2018
Implemented policy items in 2017    
HCC Auto Approval Criteria Changes 12/2016 Board action
12/2017 Executive Committee action
12/12/2017
Lung Allocation Policy Modification (PDF) 11/2017 Executive Committee action 11/24/2017
Standardize Organ Coding and Tracking System 2/2017 Executive Committee action 11/01/2017
Improve the Categorization of Living Donor Events (PDF) 9/2017 executive committee action 10/18/2017
Add DQA-1 Equivalences Table 6/2016 Board action
6/2017 Executive Committee action
09/12/2017
Update HLA Equivalency Tables 12/2015 Board action
4/2017 Executive Committee action
09/12/2017
Personnel Procurement Requirements 12/2015 Board action 09/01/2017
Foreign Equivalent in Bylaws 12/2015 Board action 09/01/2017
Bylaws Rewrite 06/2017 Board action 09/01/2017
Primary Kidney Transplant Physician Update (PDF) 12/2016 Board action 09/01/2017
Clarification to Apply Kidney Minimum Acceptance Criteria to Highly Sensitized Candidates (PDF) 07/2017 Executive Committee action 09/01/2017
Simultaneous Liver-Kidney Allocation 06/2016 Board action 08/10/2017
Kidney: KAS Clarifications (part) 06/2016 Board action 06/29/2017
Retrospective Review of Clerical Changes to Policies (PDF) 06/2017 Executive committee action 06/29/2017
Informed Consent Changes - Potential Living Donors 12/2016 Board action 06/01/2017
Improving Post-Transplant Communication (part) 06/2016 Board action; Required toxoplasmosis testing of all donors 04/06/2017
Pediatric Lung Allocation Changes (PDF) 12/2015 Board action 03/30/2017
All Other KPD Guidelines to Policy (part) 06/2015 Board action 03/30/2017
Post-Implementation ABO Policy Changes (PDF) 12/2016 Board action 03/01/2017
Primary Transplant Surgeon Changes 12/2016 Board action 03/01/2017
Primary Transplant Physician Subspecialty Changes 12/2016 Board action 03/01/2017
Remove Donor Location from Required Procurement Log (PDF) 12/2016 Board action 03/01/2017
Changes to Imminent and Eligible Definitions (PDF) 12/2016 Board action 01/01/2017
Implemented policy items in 2016    
Retrospective Review of Clerical Changes to Policies (PDF) 12/2016 Executive committee action 11/10/2016
Registration Fee (PDF) 06/2016 Board action 10/01/2016
DTAC Policy Clarification (PDF) 06/2016 Executive Committee action 09/01/2016
OSC Policy Clarification (PDF) 08/2016 Executive Committee action 09/01/2016
HOPE Act (PDF) 06/2016 Board action 09/01/2016
Improving Post-Transplant Communication (part) 06/2016 Board action 09/01/2016
Kidney: KAS Clarifications (part) 06/2016 Board action 09/01/2016
Regional Councillor Vacancy (PDF) 06/2016 Board action 09/01/2017
Living Donor Candidate Registration (PDF) 04/2016 Executive Committee action 04/14/2016
Retrospective Review of Clerical Changes to Policies (PDF) 12/2016 Executive committee action 4/14/2016
Implemented policy items in 2015    
KPD Informed Consent (PDF) 06/2015 Board action 12/01/2015