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Author Topic: HRSA Announces Organ Procurement and Transplantation Network Modernization  (Read 252 times)

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Offline Clark

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https://www.hrsa.gov/about/news/press-releases/organ-procurement-transplantation-network-modernization-initiative

HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative
March 22, 2023

Initiative includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act

Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a Modernization Initiative https://www.hrsa.gov/organ-procurement-transplantation-modernization that includes several actions to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN):

Data dashboards detailing individual transplant center and organ procurement organization data on organ retrieval, waitlist outcomes, and transplants, and demographic data on organ donation and transplant;
Modernization of the OPTN IT system in line with industry-leading standards, improving OPTN governance, and increasing transparency and accountability in the system to better serve the needs of patients and families;
HRSA’s intent to issue contract solicitations for multiple awards to manage the OPTN in order to foster competition and ensure OPTN Board of Directors’ independence;
The President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million; and,
A request to Congress included in the Fiscal Year 2024 Budget to update the nearly 40-year-old National Organ Transplant Act to take actions such as:
Removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources, and
Expanding the pool of eligible contract entities to enhance performance and innovation through increased competition.

“Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network to save the lives of their loved ones who experience organ failure,” said Carole Johnson, HRSA Administrator. “At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less.”

Today, HRSA is posting on its website a new data dashboard https://data.hrsa.gov/topics/health-systems/organ-donation to share de-identified information on organ donors, organ procurement, transplant waitlists, and transplant recipients. Patients, families, clinicians, researchers, and others can use this data to inform decision-making as well as process improvements. Today’s launch is an initial data set, which HRSA intends to refine over time and update regularly.

This announcement also includes a plan to strengthen accountability, equity, and performance in the organ donation and transplantation system. This iterative plan will specifically focus on five key areas: technology; data transparency; governance; operations; and quality improvement and innovation. In implementing this plan, HRSA intends to issue contract solicitations for multiple awards to manage and improve the OPTN. HRSA also intends to further the OPTN Board of Directors’ independence through the contracting process and the use of multiple contracts. Ensuring robust competition in every industry is a key priority of the Biden-Harris Administration and will help meet the OPTN Modernization Initiative’s goals of promoting innovation and the best quality of service for patients.

Finally, the President’s Budget for Fiscal Year 2024 would more than double HRSA’s budget for organ-related work, including OPTN contracting and the implementation of the Modernization Initiative, to total $67 million. In addition, the Budget requests statutory changes to the National Organ Transplant Act to remove the decades-old ceiling on the amount of appropriated funding that can be awarded to the statutorily required vendor(s) for the OPTN.  It also requests that Congress expand the pool of eligible contract entities to enhance performance and innovation through increased competition, particularly with respect to information technology vendors. 

HRSA recognizes that while modernization work is complex, the integrity of the organ matching process is paramount and cannot be disrupted. That is why HRSA’s work will be guided by and centered around several key priorities, including the urgent needs of the more than 100,000 individuals and their families awaiting transplant; the 24/7 life-saving nature of the system; and patient safety and health. HRSA intends to engage with a wide and diverse group of stakeholders early and often to ensure a human-centered design approach that reflects pressing areas of need and ensuring experiences by system users like patients are addressed first. As a part of this commitment, HRSA has created an OPTN Modernization Website to keep stakeholders informed about the Modernization Initiative and provide regular progress updates.

https://www.hrsa.gov/organ-procurement-transplantation-modernization

HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative

On March 22, 2023, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), launched the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative to better serve the needs of patients and families. The Initiative will strengthen accountability, equity, and performance in the organ donation and transplantation system through a focus on five key areas: technology; data transparency; governance; operations; and quality improvement and innovation.

Background

Almost 40 years ago, the National Organ Transplant Act established the OPTN to coordinate and operate the nation’s organ procurement, allocation, and transplantation system and to increase access to donor organs for patients with end-stage organ failure.

Specifically, the statute charges the OPTN with operating a national list of individuals who need organs and a national computer system to match organs with individuals on the waiting list. The OPTN is governed by a Board of Directors and is charged with development and implementation of policies regarding organ allocation; assistance in the nationwide distribution of organs among transplant patients by operating a 24/7 system to match potential donors with individuals on the waiting list; actively working to increase the supply of donated organs; adoption and use of quality standards for collecting and transporting donated organs; providing information to physicians and other health professionals; collection, analysis, and publication of data on organ donation and transplants; and, conducts studies and demonstration projects to improve procedures for organ procurement and allocation.   

Today, the OPTN is comprised of nearly 400 member organizations and there are more than 104,000 adults and children on the waitlist.
 

Accountability efforts to date

Over the past two years, HRSA has taken steps to improve accountability in OPTN functions, including strengthening contract requirements and oversight.
Required Enhanced OPTN Security and Performance – In September of 2021, HRSA required the current OPTN contractor to take a series of actions to improve security and performance, including to increase security of the OPTN IT system, and improve the use of secure processes for system access and information exchange.
Sought Expert and Community Input on Ways to Improve Transparency, Accountability, and Performance in OPTN Operations – In April of 2022, HRSA published a formal Request for Information (RFI) on ways to improve patient and donor engagement, strengthen accountability throughout the system, and best leverage modern technology to support this lifesaving work. HRSA received responses from patient advocates, technology experts, OPTN members and other stakeholders. Responses focused on the need to modernize the OPTN system technology without compromising patient safety.
Convened a Conference with Patients and Families to Strengthen Performance Measures – In July 2022, HRSA created a forum for patients, families, and interested stakeholders to share their concerns and recommend future metrics for the transplantation system that support informed decision making for patients with organ failure, their families, and their health care teams. The Scientific Registry of Transplant Recipients is in the process of developing new metrics based on the conference feedback and recommendations.
Formally Engaged Technology Partners to Improve OPTN IT Systems – In July 2022, HRSA initiated ongoing engagement with the United States Digital Service (USDS)—which is dedicated to improving government services through technology modernization and data science—to leverage their expertise and advice as HRSA implements the OPTN Modernization Initiative.
Ongoing Collaboration with the Centers for Medicare & Medicaid Services (CMS) and other HHS Agencies – HRSA continues to collaborate with CMS and other HHS agencies on actions related to improving federal oversight, alignment and support of the organ donation and transplantation system.

OPTN Modernization Initiative

In response to the reform efforts to date, market research, RFI input, expert feedback, and engagement with USDS, HRSA concluded that achieving the agency’s objectives for enhanced accountability, equity, and performance required an iterative and modular modernization approach. Increasingly used by federal agencies and commercial organizations to modernize programs anchored by legacy technology and practices, iterative modernization approaches involve incorporating modularized components or processes that are developed, tested, and integrated, in parallel to the existing system over time, to maintain patient safety throughout the process while mitigating the risks involved in transforming a system that provides 24/7 life-saving services.

Leveraging this approach, HRSA is announcing a major new step in the agency’s reform efforts by embarking on a multi-year initiative to modernize the OPTN with the goal of increasing high-quality organ donation and transplantation. This initiative is designed in a way to meet the needs of:
Patients and families by further strengthening and providing equitable access to transplantation, improving safety and health outcomes, and empowering patients and providers with the data needed to make informed, shared decisions.
The organ donation, procurement, and transplantation community by supporting and facilitating the delivery of high-quality, equitable care and continuous improvement.
Researchers, scientists, and other stakeholders by investing in the advancement and innovation of the OPTN.
The public by providing transparency and accountability for delivering results in an efficient and effective manner.
To meet these needs, HRSA will focus on five key areas of reform as part of the Modernization Initiative in a manner the puts patients first, prioritizes information flow to clinicians, promotes innovation through continuous competition, and enhances transparency and accountability.
 

OPTN modernization aims

The OPTN Modernization Initiative will accelerate progress in five key areas to achieve the following aims:
Technology – The OPTN IT system is reliable, secure, patient-centered, user-friendly, and reflective of modern technology functionality. There is continuous focus on improved IT system functionality and security, while ensuring continuity of services, protecting patient safety, and accelerating innovation in line with industry-leading standards.
Data Transparency and Analytics – OPTN data is accessible, user-friendly, and patient-oriented. Modernization process provides easily accessible, high-quality, and timely data to make informed patient, donor, and clinical decisions; measure and evaluate program performance; inform oversight and compliance activities; and support the advancement of scientific research.
Governance – The OPTN Board of Directors is high-functioning and has greater independence; represents the diversity of communities; and delivers effective policy development.
Operations – The OPTN is effective and accountable in its implementation of organ policy, patient safety and compliance monitoring, organ transport, OPTN member support, and education of patients, families, and the public.
Quality Improvement and Innovation – The OPTN promotes a culture of quality improvement and innovation across the network by leveraging timely data and performance feedback, collaborative learning, and strategic partnerships.
 

Moving forward

For the first phase of the OPTN Modernization Initiative, initial steps include:
Making Data Available for Informed Decisions: To assist patients, clinicians, researchers, and others, today HRSA is publishing organ donation and transplantation data to improve decision-making as well as process improvements. Today’s launch is an initial data set, which HRSA intends to refine and update regularly over time.
Securing Support for Modernization:
As announced on March 9, the President’s FY 2024 Budget more than doubles the resources available to support HRSA’s organ transplantation programs, including the OPTN Modernization Initiative ($67 million).
The President’s Budget also includes legislative proposals critical to enhancing HRSA’s ability to achieve our modernization aims by updating the nearly 40-year-old National Organ Transplant Act, including removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources and expand the pool of entities that are eligible to compete for contracts to support the OPTN, in order to enhance performance and innovation through increased competition.
Building HRSA capacity for modernization: HRSA has procured program management support services to assist with its comprehensive approach for user-centered, wide stakeholder engagement on modernization design and implementation.
Ongoing consultation with USDS: HRSA will continue to consult with USDS as it works to create an agile approach to OPTN IT modernization.
Engaging Stakeholders: In late Spring, HRSA will continue its engagement with a diverse group of stakeholders early and often to identify and prioritize pressing areas of need for patients and clinicians.
Collaborating with Industry: In late Spring, HRSA will engage the IT community through Industry collaboration activities providing a high-level overview of the modernization efforts and forums for vendor participation in anticipation of future activities.
Soliciting Proposals for Modernization: HRSA intends to issue contract solicitations for multiple awards to manage and improve the OPTN. HRSA also intends to further the OPTN Board of Directors’ independence through the contracting process and the use of multiple contracts. Ensuring robust competition in every industry is a key priority of the Biden-Harris Administration and will help meet the OPTN Modernization Initiative’s goals of promoting innovation and the best quality of service for patients.

HRSA will keep stakeholders informed about the Modernization Initiative and provide regular progress updates on this website.

Unrelated directed kidney donor in 2003, recipient and I both well.
596 time blood and platelet donor since 1976 and still giving!
Elected to the OPTN/UNOS Boards of Directors & Executive, Kidney Transplantation, and Ad Hoc Public Solicitation of Organ Donors Committees, 2005-2011
Proud grandpa!

Offline Clark

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https://unos.org/news/unos-welcomes-competitive-bidding-process-for-next-optn-contract/

UNOS welcomes competitive bidding process for next OPTN contract

UNOS supports Health Resources and Services Administration’s (HRSA) plan to introduce additional reforms into the nation’s organ donation and transplantation system. We also stand united with HRSA in our shared goal to get as many donor organs as possible to patients in need while increasing accountability, transparency and oversight.
We welcome a competitive and open bidding process for the next Organ Procurement and Transplantation Network (OPTN) contract to advance our efforts to save as many lives as possible, as equitably as possible. We believe we have the experience and expertise required to best serve the nation’s patients and to help implement HRSA’s proposed initiatives.
Numerous components of HRSA’s plan also align with our new action agenda, which is a list of specific proposals we outlined earlier this year aimed at driving improvement across the system.
We are committed to working with HRSA, U.S. Department of Health and Human Services (HHS), Congress and others who care about this system so deeply to assist in carrying out these reforms and to do our part to improve how we serve America’s organ donors, transplant patients and their families.

Unrelated directed kidney donor in 2003, recipient and I both well.
596 time blood and platelet donor since 1976 and still giving!
Elected to the OPTN/UNOS Boards of Directors & Executive, Kidney Transplantation, and Ad Hoc Public Solicitation of Organ Donors Committees, 2005-2011
Proud grandpa!

 

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