Industry Literature

Public comment open from Jan. 21 through Mar. 23 2021

The winter 2021 public comment cycle opens Jan. 21 and will close March 23. The Organ Procurement and Transplantation Network (OPTN) is offering six proposals, two requests for feedback, and one white paper for public comment.

Comments and replies will be published here on the OPTN website to promote transparency and trust in the national transplant system. Visitors also have the option to share their posted comments to social media.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals and provide their valuable feedback to help shape U.S. organ transplant policy.

Items available for public comment:

  • 2021-2024 OPTN Strategic Plan
  • Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation
  • Clarify Multi-Organ Allocation Policy
  • Develop Measures for Primary Graft Dysfunction in Hearts
  • Modify the Deceased Donor Registration (DDR) Form
  • Require Notification of Human Leukocyte Antigen (HLA) Typing Changes
  • Revise General Considerations in Assessment for Transplant Candidacy
  • Update National Liver Review Board Guidance Documents and Policy Clarification
  • Update Transplant Program Key Personnel Training and Experience Requirements

Educational resources will be made available January 21 to provide multiple opportunities to learn more about the proposals.

All comments are reviewed and considered by the OPTN Board of Directors before they vote on the proposals to become policy. Learn more about the policy development process here.

Engage in public comment

 

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Saving lives together: Happy Holidays from the UNOS Organ Center

This holiday season, organ placement specialists are working around the clock in the UNOS Organ Center to help place lifesaving organs across the country. Here’s their holiday message for everyone touched by transplant. We wish you all a healthy and peaceful New Year!

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OPTN Board approves pediatric transplant program components, strategic planning, operational actions

Pediatric transplant program components

The Board of Directors of the Organ Procurement and Transplantation Network, at a virtual meeting held Dec. 7, approved pediatric components for 268 heart, kidney, liver, lung and pancreas transplant programs. Effective Dec. 8, any candidate younger than age 18 must be listed at one of these programs unless an exception is made for a very medically urgent heart or liver candidate. The searchable member directory on the OPTN website will display programs with a pediatric component.

“This is a key milestone in promoting the safety and efficiency of transplantation for children in need of a transplant,” said David Mulligan, M.D., president of the board. “The requirements were developed carefully to ensure that these programs have highly trained and experienced clinical staff and appropriate facilities to care for the specific needs of pediatric candidates and recipients. The application and review process took place in a staged fashion to allow programs interested in applying to take any needed steps to ensure they would qualify.”

Strategic planning

The board heard an overview of ongoing development of the OPTN Strategic Plan for 2021 through 2024. The OPTN Executive Committee will circulate a draft plan for public comment in January 2021, and a proposed final plan will be presented for board action in June 2021. As currently envisioned, there are four overall strategic goals:

  • Increase the number of transplants
  • Provide equity in access to transplants
  • Promote living donor and transplant recipient safety
  • Improve waitlisted patient, living donor, and transplant recipient outcomes

COVID-19 operational actions reviewed, will remain in effect

The board reviewed several operational actions adopted by the OPTN Executive Committee in March and April, 2020, to help members document COVID 19-issues affecting organ donation and transplantation and to help members focus needed resources on essential clinical services. The board agreed to make permanent a requirement for OPTN members to document COVID-19 testing for all potential deceased donors. The board resolved that the following measures will remain in effect, subject to ongoing Executive Committee review for their applicability and effectiveness:

  • Updates to transplant candidate data if a transplant hospital is unable to bring a candidate in for updated lab testing due to COVID-19 issues
  • Relaxation of certain data submission requirements for follow-up of transplant recipients and living donors
  • Modifications to reporting wait time initiation for kidney transplant candidates who are not on dialysis

Other actions

The board took additional actions as follows:

  • Approved new and amended OPTN policies to align with recently updated recommendations from the U.S. Public Health Service to assess organ donors and monitor transplant recipients for potential HIV, hepatitis B and hepatitis C infection
  • Endorsed a slate of nominees for election to open positions on the board for terms beginning July 1, 2021
  • Approved the programming into the UNetSM system of allocation policy for vascularized composite allografts (VCA)
  • Modified data collection requirements for living VCA donors
  • Accepted new guidance and updated policy regarding adult heart allocation, to standardize and streamline data reporting for candidates with certain clinical conditions
  • Adopted guidance addressing the use of exception requests for pediatric heart candidates
  • Approved additional updates to operational processes and guidance for the National Liver Review Board, to clarify guidance and better ensure expert review of exception requests
  • Updated the cohort of data used to calculate the lung allocation score
  • Amended the OPTN Bylaws to permit all members of the board to vote on the full slate of representatives to the OPTN Executive Committee

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Implementation notice: Waitlist℠ programming updates to local acceptance criteria for heart, lung, heart-lung, liver and intestine

Implementation date:

  • Dec. 3: Heart, lung, heart-lung, liver and intestine

At-a-glance

For heart, lung, heart-lung, liver and intestine programs, local donor acceptance criteria in Waitlist℠ have been updated in order to provide additional efficiency in organ allocation. Transplant programs should evaluate their current settings.

Summary of changes

With the transition away from donation service area (DSA) as a unit of allocation, a new framework has been developed to determine what type of offers would be screened using “local” acceptance criteria for a candidate. Because proximity to the donor hospital is a primary factor in the revised allocations, changes have been made to allow the location of the donor hospital in relation to the candidate to be considered when “local” acceptance criteria are applied.  Read additional background information here.

For each organ type, the following new local acceptance criteria will be used to include candidates on the match run:

  • Offers to candidates listed at transplant programs within the DSA and/or within 250 NM of the donor hospital:
    • Heart
    • Heart-lung
    • Lung
  • Offers to candidates listed at transplant programs within the DSA and/or within 150 NM of the donor hospital:
    • Liver
  • Offers to candidates listed at transplant programs within the DSA and/or within 500 NM of the donor hospital:
    • Intestine

Similar changes will be implemented for kidney and pancreas allocation on Dec. 15, when DSA and region are removed from distribution of those organs.

The inclusion of DSA in this definition does not impact the order of the match run as that is established and organized by distance-based allocation definitions within OPTN policy.

What you need to do

Transplant programs for all organ types should evaluate their current “local” acceptance criteria settings for candidates in Waitlist and determine if updates are appropriate based on the revised definition of “local” donor acceptance criteria.

Additional resources

Find professional education on UNOS Connect:

  • QLT103D Acceptance Criteria for Distance-based Allocation

In addition, DonorNet® online help documentation has been updated so that transplant programs will have access to the information about how local acceptance criteria is used for offers for all organ types.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 1-800-978-4334 from 8 a.m. to 7 p.m. EST.

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Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations

This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).

Innovating to strengthen the organ transplant system

illustration with binary 0s and 1s with icons of eye and growth

Innovation: FEATURE

UNOS Labs is a collaborative space where scientists, researchers and technology experts partner with donation and transplantation professionals to develop new solutions aimed at increasing efficiency in the national transplant system and saving more lives.

United Network for Organ Sharing’s core mission is to unite and strengthen the donation and transplant community to save lives. A major component that drives this mission is testing products, tools and methods aimed at improving the transplant system.

UNOS LabsSM , an experimental incubator created in 2018, fills a critical role in bridging resources and research expertise to make innovation happen and bring big ideas to life. It enables our researchers to develop solutions to continuously improve the national organ donation and transplant system and increase organ utilization.

“We’ve begun this endeavor of UNOS Labs to address some of the bigger questions in transplant and try to meet the community where they are, and try and capitalize on a lot of the innovations that are out in the medical space,” said program manager Casey Humphries.

UNOS Labs explores and validates concepts and technologies that may be deployed across the nation’s organ transplant system. It is a place to try out new ideas under the primary pillars of behavioral research, data science and technology through extensive testing and incremental development.

“The emphasis in Labs is that projects have an end goal,” Humphries said. “They’re not academic, they’re not something that we want to just publish on and then store under the pillow. The goal of Labs is to create something that can be used to benefit the system.”

Improving the transplant system through innovation

Among the new technologies UNOS researchers are leveraging is  natural language processing (NLP) to predict which deceased donor kidneys will experience placement difficulties and to forecast which will be accepted by transplant hospitals. Encouraged by the study findings, the UNOS team plans to conduct more research to better understand the potential to enhance existing predictive models.

Humphries said a unique process such as NLP is a great example of data science.

“We have data science, and that’s really looking at understanding data broadly and looking at innovative ways to approach big data,” she said. “We can derive insights from using data science techniques…something that we can’t do with typical statistics.”

UNOS researchers are also partnering with organ procurement organizations (OPOs) nationwide to better predict organ travel time. One of the biggest contributors to prolonged cold ischemic time is coordinating logistics for organ transport. Using data gathered from couriers and pilot OPOs, researchers are also studying the feasibility of real-time tracking of organs shipped via ground and air.

Other partnership projects involving UNOS researchers include developing a series of simulation models to study the impact of possible changes to the transplant ecosystem; measuring physicians’ attitudes and perceptions around predictive analytics; and developing a liver paired exchange pilot program.

Philanthropic support for research and analytics

The Mendez National Institute of Transplantation Foundation recently awarded UNOS a $100,000 grant toward better understanding of the role biopsies play in transplant outcomes. The research further aims to improve the tools that inform kidney offer acceptance decisions.

The F.M. Kirby Foundation has given UNOS $75,000 to help train clinicians in promoting organ donation and increase the number of organ transplants during the COVID-19 pandemic. And the Fresenius Medical Care Foundation awarded UNOS $106,000 to help improve transportation and logistics for organ donation.

“We are challenging ourselves to think more broadly about the technologies we could bring to the transplant system,” explained Humphries. “Grants make this research happen.”

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COVID-19 organ failure diagnosis codes for heart and lung candidate listings in UNet now available

Audience

  • Primary Data Coordinators, Physicians, Program Administrators and Surgeons at heart and lung programs
  • Transplant Program’s Clinical Coordinators, Administrators/Managers, Program Directors, Medical Directors and Surgical Directors at heart and lung programs
  • Please share this notice with anyone in your organization who would benefit from this information

Implementation date
Oct. 28, 2020

At-a-glance statement

The following changes to the diagnosis code drop down list in WaitlistSM and the Primary Diagnosis drop down list on TCR and TRR forms in TIEDI® are now available:

  • Lung candidates
    • COVID-19: ARDS
    • COVID-19: PULMONARY FIBROSIS
  • Heart candidates
    • COVID-19: DILATED MYOPATHY: ACTIVE MYOCARDITIS
    • COVID-19: DILATED MYOPATHY: HISTORY OF MYOCARDITIS
    • DILATED MYOPATHY: VIRAL changed to DILATED MYOPATHY: VIRAL (NOT COVID-19)
  • Conversion of of all actively listed Waitlist candidates with the inactive diagnosis to the new one. Removed candidates are not impacted.
  • For patients with the inactivated diagnosis on TIEDI forms, their Primary Diagnosis field are blank. Members entering forms in TIEDI need to select an appropriate code for their patients with viral Dilated Myopathy from one of the three new available codes.

What you need to do

  • Transplant hospitals should use the COVID-19 diagnosis codes as appropriate when listing lung and heart candidates or entering information on TCR and TRR TIEDI forms.
  • Transplant hospitals should also modify the diagnosis for any patient converted to the new Dilated Myopathy: Viral (Not COVID-19) code in Waitlist who should more accurately be assigned one of the COVID-19 heart diagnosis codes.

Additional details

The purpose of adding these options is to specify when COVID-19 related organ failure is the cause for lung and heart candidate listings.

The initial proposed action, addressing lung candidate diagnoses, was published for special public comment from Aug. 31 through Oct 1. During public comment, the OPTN Heart Transplantation Committee recommended that heart candidate diagnoses be added to those originally proposed for lung candidates. The OPTN Board of Directors approved the proposal during an Oct. 8 conference call.

Having these options available helps to identify trends in these patient populations that could inform future policy changes.  This is not expected to have any impact to the lung allocation score calculated for these lung candidates.

Education and resources

Read the policy notice on OPTN

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 800-978-4334 from 8 a.m. to 7 p.m. EDT.

For policy-related questions, contact member.questions@unos.org. 

The UNOS COVID-19 resources page is refreshed regularly with the most current updates and resources. Please check back frequently for updates.

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Using registries to improve outcomes and transplant management

in focus

Registries provide analysis and information to the transplant and healthcare community, improving the quality and safety of care.

The transplant community benefits from partnering with UNOS to create registries.

The transplant community benefits from partnering with UNOS to create registries.

Custom solutions

Contact us to learn more about Registries

The transplant community needs data warehouses that underlay new analytical tools and drive better outcomes and deeper insights. Registry-based studies make substantial contributions to the field of transplantation by optimizing the use of new data sources to understand outcomes and improve transplant management.

“UNOS’s registries enhance data collection and leverage our 35 years of transplant knowledge to analyze patient outcomes, study the effects of a new therapy, or combine various data sources to uncover new insights to transplant patient’s journey” says Wida Cherikh, principal research scientist at UNOS.

What is a registry?

At its core, a registry is a data capture system which merges similar data from various sources. UNOS’s secure registries focus on improving patient care, sharing collaborative knowledge, and advancing understanding in the field of organ transplantation. Data from registries addresses things such as treatment, quality improvement, benchmarking, and clinical research.

In UNOS’s clinical work, the data is structured, validated, and uses real-world patient populations. Registry-based studies are quicker and less expensive than clinical trials or prospective cohort studies and can provide answers to questions that may not be answerable from OPTN data alone. Our registries scale in a variety of ways spanning the months of a specific project or study, to decades which build the backbone of research in specific fields of medicine.

What are registries used for?

Registries are used by organ procurement organizations, transplant centers, academic research centers, medical device companies, pharmaceutical companies, biotech companies and pharmacy management to capture data, manage its use, and leverage the data for insights to include patient population trends and improved outcome measures.

The transplant community relies on UNOS to build and host registries and databases, including:

  • patient-level registries for large international societies
  • performance improvement and outcome registries for transplant programs
  • survey registries for submitting patient data
  • clinical registries using observational study methodology to collect uniform data and evaluate specified outcomes for a population

Build your registry studies effectively with UNOS Solutions

The UNOS Solutions team creates registry partnerships that optimize the use of new data sources to understand outcomes in transplantation. “TransMedics partnered exclusively with our trusted partners at UNOS to create the first Thoracic Organ Perfusion (TOP) Registry for our Organ Care System (OCS) technology,” said Dr. Waleed Hassanein, President and CEO at TransMedics, Inc. “ The UNOS team has provided a comprehensive platform that delivers the visibility and compliance that is necessary to conduct our registry.  Their team is world-class and provides an exceptional level of cooperation and partnership required for successful execution of these complex projects.”

Our team of research scientists, statisticians, and data analysts help you understand your data holistically, visualize your data, and give it context for analysis. You’ll be able to get reliable data, with an intuitive user interface, and receive real-time reports that allow you to see trends.

UNOS can help you find answers to your transplant-related challenges – we have the systems and people in place to create and implement registry-based studies for the transplant community.

Learn more about registries by contacting UNOS.

In focus

UNOS builds and hosts registries enabling OPOs and transplant centers to address issues such as treatment, payment, quality improvement, benchmarking and clinical research.

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Researchers say OPTN modified heart policy achieving stated goals

Preliminary results of the 2018 Organ Procurement and Transplantation Network modified adult heart allocation revision show the policy is achieving its intended goals.

United Network for Organ Sharing research led by research science manager Rebecca Goff, Ph.D., analyzed OPTN data, including early outcomes, geographical distribution, and waitlist and transplant characteristics, a year before, and a year after policy implementation.

“The manuscript revealed the benefit of the new six adult heart statuses that better stratify candidates and give broader access to the most medically urgent patients,” Goff said. “Thinking to the future, I am looking forward to the development of a sophisticated heart allocation score and, eventually, the move to the continuous distribution framework for heart allocation.”

Read more about the research into the effectiveness of the new adult heart allocation policy.

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Nicole Medwick from CORE discusses first national donor image sharing hub

As an organ procurement trainer at the Center for Organ Recovery and Education, Nicole Medwick is focused on making sure that the right organ reaches the right patient at the right time.

“At CORE we are always looking for new and innovative ways to improve our key processes,” she said.

So when CORE’s involvement in a medical imaging study sharing project led by United Network for Organ Sharing prompted a transplant team to accept a heart that they otherwise had planned to decline, Medwick felt proud of the work she had accomplished. “We were able to save an additional life that would not have been saved otherwise,” she said.

CORE is one of 13 organ procurement organizations (OPOs) across the country enrolled in UNet Image Sharing, a consistent, reliable and secure image sharing platform that provides OPOs and transplant hospitals universal access to high-quality medical imaging studies during the organ offer process. “UNet Image Sharing helps us share real-time images directly with transplant surgeons to help facilitate quicker decision making,” Medwick said.

Hear more about how UNet Image Sharing is helping to facilitate quicker decision making and improving efficiencies in the organ procurement process for Medwick and other members of the organ donation and transplant community.

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