ATTACH A - PWS (OPTN Operations) - Amend 0001.pdf

Title: OPTN Operations Transition IDIQ RFP No. 75R60224R00008 Attachment A – Performance Work Statement (PWS)

HRSA Organ Procurement and Transplantation Network Modernization Initiative

The Health Resources and Services Administration (HRSA) oversees the Organ Procurement and Transplantation Network (OPTN). The OPTN was established by Congress nearly four decades ago and consists of a comprehensive network of transplant professionals, community members, and others charged with increasing organ donation and operating and overseeing a fair and accountable system for allocating and transplanting organs in the United States.

Throughout the Biden-Harris Administration, HRSA has worked to strengthen the OPTN to better meet the urgent needs of the more than 100,000 people on the organ transplant waitlist and their families. In March 2023, HRSA launched the HRSA OPTN Modernization Initiative to strengthen OPTN accountability and performance by focusing on improving the organ procurement and transplant network’s governance, technology, and operations.

HRSA’s OPTN Modernization Initiative Across the nearly 40-year history of the OPTN, all functions of the OPTN have been managed by a single vendor and not competed separately based on technical expertise in areas like IT or operations. In 2023, Congress adopted HRSA’s proposal to update the decades-old statute, including by expressly authorizing HRSA to make multiple different awards to benefit from best-in-class vendors in different areas to improve performance and innovation. Congress also adopted HRSA’s proposal to require the OPTN Board of Directors to be independent from other OPTN contractors to strengthen OPTN accountability and oversight. The new law also requires that the award(s) to support the OPTN Board of Directors be distinct from the other awards made to support OPTN operations and eliminated the arbitrary appropriation cap to support this work. A key element of HRSA’s efforts to implement these important changes is 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.

As part of HRSA’s OPTN Modernization Initiative, HRSA has conducted extensive market research, assessed responses to a HRSA request for information seeking public input on reforms, hosted two industry days with over 300 participants each, and engaged in more than 800 conversations with community members. For the first time in the history of the program, HRSA is issuing a solicitation to support an independent OPTN Board of Directors and releasing multi-vendor solicitations for the OPTN informed by this market research and centered on improving outcomes for patients.

First Ever Multi-Vendor OPTN Solicitations These multi-vendor solicitations mark the first time OPTN support and services have been competitively bid by function. This is just phase 1 of the HRSA multi-vendor acquisition strategy. Later this year, HRSA intends to begin issuing solicitations for OPTN NextGen IT contracts to develop an agile, modern organ matching technology solution that is based on human-centered design, highly reliable, secure, and user-friendly, and informed by HRSA’s ongoing engagement with stakeholders and leading government technologists.

Phase 1: New OPTN Solicitations

OPTN Board of Directors Support Contractor [not included in the scope of this solicitation]:

HRSA is releasing a single-award Indefinite-Delivery-Indefinite-Quantity (IDIQ) solicitation to provide support and services for an independent OPTN Board of Directors. Services in this solicitation include:

• Establishing a transitional nominating committee and seeking public input to develop a slate of candidates for an independent OPTN Board of Directors.

• Conducting a special election/appointment to establish an independent OPTN Board of Directors.

• Reviewing and providing recommendations for modernizing OPTN bylaws and conflict of interest policy.

• Reviewing Board composition and structure and making recommendations for reforms to improve functionality and system outcomes.

• Supporting the Board of Directors in executing its management and functional responsibilities for OPTN organ matching policy and operations, OPTN membership standards, OPTN budget and financing, and other functions.

• Providing support to the Board for strategic planning, training, and performance evaluation.

• Collaborating with other OPTN contractors across the HRSA Modernization Initiative.

The OPTN Board Support Contractor will not be eligible for other HRSA OPTN contracts.

HRSA intends to award the Board Support IDIQ to a non-profit organizations and issue task orders f or services included in the performance work statement. The number and scope of task orders issued is contingent on final Fiscal Year 2024 appropriations.

OPTN Operations Transition Contractors: HRSA is releasing an IDIQ solicitation for multiple vendors to provide support for OPTN operations. Awards will support operations during the transition to and inform the development of a modernized OPTN, including implementing innovations and actionable reforms. The planned NextGen IT contracts, which will be released later this year, will build on this foundational work. Services in this solicitation include:

• Reviewing and mapping legacy OPTN operations approaches and identifying actionable reforms to improve patient outcomes, system functionality, and system accountability.

• Developing and implementing processes and metrics for monitoring and measuring OPTN member performance and compliance across all OPTN membership types and phases of the organ donation, procurement, waitlist, matching, transportation, and transplantation processes – with a focus on improving patient and donor/donor family experience.

• Updating the IT infrastructure to interface with the NextGen IT that will occur in a future IDIQ.

• Conducting reviews of current OPTN processes to identify and implement process improvements and change management strategies to improve system fairness, transparency and accountability.

• Providing strategic and administrative services – including improving transparency and increasing public input -- to support OPTN functions such as membership and professional standards, policy development, finance and auditing, network operations, and data.

• Analyzing and implementing approved recommendations to improve transplant program waitlist processes and acceptance criteria.

• Collaborating with other OPTN contractors across the HRSA Modernization Initiative.

Under the OPTN Operations Transition solicitation, HRSA intends to multiple IDIQ contracts to vendors and issue task orders for services included in the Performance Work Statement (PWS). The number and scope of task orders issued is contingent upon annual fiscal appropriations. It is intended that the terms of these awards will prohibit any member of the OPTN Board of Directors from serving as an officer or employee of any OPTN contractor.

I. PURPOSE

II. SCOPE

III. BACKGROUND

IV. PERIOD AND PLACE OF PERFORMANCE

V. DOMAINS

Domain 1 – Transformation Services Task 1.1 Functional and Process Improvement and Evaluation Task 1.2 Data Supplementation and Analyses Task 1.3 Coordination Among All Entities Supporting the OPTN Task 1.4 Transition Activities Task 1.5 General Requirements

1.5.1 OPTN Branding and Reporting

1.5.2 Use of Plain Language Guidelines & Other Government Laws and Regulations for all Products10 Task 1.6 Records Management Requirements (Reserved) Task 1.7 Security and Privacy Requirements (Reserved) Task 1.8 Section 508 Requirements (Reserved) Task 1.9 Other Requirements (Reserved) Domain 2 - OPTN Operations Task 2.1 Coordination and Support Services for OPTN Membership Committee Task 2.2 Coordination and Support Services for OPTN Network Operations Oversight Committee12 Task 2.3 Coordination and Support Services for OPTN Policy Committees Task 2.4 Coordination and Support Services for OPTN Data Collection, Oversight & Administration13 Task 2.5 Coordination and Support Services for Budget, Financial, and Audit Functions Task 2.6 Administrative and Coordination Services Task 2.7 Coordination and Support Services for Newly Established OPTN Committees Task 2.8 Services to Support the OPTN Organ Center Allocation and Placement Task 2.9 Coordination Among All Entities Supporting the OPTN Task 2.10 Transition Activities Task 2.11 General Requirements

2.11.1 OPTN Branding and Reporting

2.11.2 Use of Plain Language Guidelines & Other Government Laws and Regulations for Products 18 Task 2.12 Records Management Requirements (Reserved) Task 2.13 Security and Privacy Requirements (Reserved) Task 2.14 Section 508 Requirements (Reserved) Task 2.15 Other Requirements (Reserved) Domain 3 - Organ Allocation & Distribution (Matching) System, Information Technology, and Data19 Task 3.1 Services to Sustain and Improve the Organ Allocation and Distribution IT and Data Systems While the Modernized IT System is Built Task 3.2 Integration and Modernization Support Task 3.3 Coordination Among All Entities Supporting the OPTN Task 3.4 Transition Activities Task 3.5 General Requirements

3.5.1 OPTN Branding and Reporting

3.5.2 Use of Plain Language Guidelines & Other Government Laws and Regulations for all Products22 Task 3.6 Records Management Requirements (Reserved) Task 3.7 Security and Privacy Requirements (Reserved)

Task 3.8 Section 508 Requirements (Reserved) Task 3.9 Other Requirements (Reserved) Domain 4 – Communications Task 4.1 Communications Task 4.2 Coordination Among All Entities Supporting the OPTN Task 4.3 Transition Activities Task 4.4 General Requirements

4.4.1 OPTN Branding and Reporting

4.4.2 Use of Plain Language Guidelines & Other Government Laws and Regulations for all Products26 Task 4.5 Records Management Requirements (Reserved) Task 4.6 Security and Privacy Requirements (Reserved) Task 4.7 Section 508 Requirements (Reserved) Task 4.8 Other Requirements (Reserved)

Performance Work Statement (PWS) Title: Organ Procurement and Transplantation Network (OPTN) Operations Transition IDIQ

Date: 05/01/2024

I. PURPOSE

This Indefinite-Delivery-Indefinite-Quantity (IDIQ) contract vehicle supports the Health Resources and Services Administration’s (HRSA) Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. The OPTN is a comprehensive network of transplant professionals, community members, and others charged with increasing organ donation and operating and overseeing a fair and accountable system for allocating and transplanting organs. The OPTN operates under contracts issued and overseen by HRSA, with the OPTN Board of Directors providing governance and management of the OPTN. The contractors tasked under this Operations Transition IDIQ will provide strategic and administrative support services necessary to ensure OPTN functions operate effectively.

Functions supported through services and logistics to be delivered under this IDIQ include managing OPTN membership, IT network operations, including while new IT infrastructure is built, IT security and other functions related to privacy, budget, finance, policy, data, and administration. The OPTN Operations Transition contractors cannot also serve as the OPTN Board Support contractor and no member of the OPTN Board of Directors may be an officer or employee of an OPTN Operations Transition Contractor. Specific deliverables will be articulated at the task order level. All OPTN contractors are expected to work together to support the network that is the OPTN. The OPTN Operations Transition contractors will work closely with each other and other HRSA contractors (including the Board Support contractor and the Scientific Registry of Transplant Recipients contractor), and under the direction of HRSA in consultation with the OPTN Board of Directors, to effectively advance the mission of the OPTN.

II. SCOPE

The IDIQ contractor/s shall provide all services, qualified personnel, materials, equipment, and facilities needed to perform the tasks as listed in the Performance Work Statement, including the services necessary to enable the OPTN to carry out its statutory and regulatory requirements.

III. BACKGROUND

HRSA, an agency of the U.S. Department of Health and Human Services (HHS), oversees the OPTN, as authorized by the National Organ Transplant Act of 1984 (42 USC 273 et seq.) and recently amended by Public Law 118-14. (Also see the OPTN Final Rule at 42 CFR part 121). In March 2023, HRSA launched the HRSA Organ Procurement and Transplantation Network Modernization Initiative to strengthen accountability and performance in the organ donation and transplantation system by focusing on critical areas such as improved technology, governance, and operations. In 2023, Congress updated the nearly 40-year-old National Organ Transplant Act of 1984 to expressly authorize multiple awardees to support OPTN operations. See Public Law 118-14.. The OPTN includes an independent Board of Directors which will be directly supported by a separate OPTN Board Support Contractor, as well as operations functions to be supported by this IDIQ.

This IDIQ is one of the first contract vehicles with multi-vendor domains under the revised statute.

Multiple functions of the OPTN are to be reviewed, updated in consultation with the OPTN Board of https://www.hrsa.gov/optn-modernization

Directors and HRSA, and supported by this IDIQ. Examples include supporting the management of OPTN membership, which currently includes nearly 400 members from multiple areas such as transplant programs, organ procurement organizations and laboratories; supporting the management of the current OPTN IT network as a new more agile IT system is built, tested and deployed under a separate IDIQ; and supporting the management of the OPTN budget process.

IV. PERIOD AND PLACE OF PERFORMANCE

See section F.1 and F.2 of the contract.

V. DOMAINS

Domain 1 – Transformation Services This Domain encompasses business process re-engineering plans, business redesign recommendations, current state assessments, human-centered design projects, evaluations, audits, external data supplementation, special studies, and research across a wide range of organ donation, procurement, allocation, distribution, logistics, transportation, and transplantation topics, as well as OPTN functionality and processes, data, technology, and improving patient outcomes.

Task 1.1 Functional and Process Improvement and Evaluation

At the direction of the COR, the Contractor shall:

1. Provide business process re-engineering or redesign services. This includes reviewing and mapping historical operations approaches and making recommendations to HRSA for best practices to improve patient outcomes, system functionality, and system accountability. Support coordination of the implementation of findings as directed by HRSA. For example:

• Reviewing and mapping legacy OPTN operations approaches and identifying actionable reforms to improve patient outcomes, system functionality, and system accountability.

• Developing processes and metrics for monitoring and measuring OPTN member performance and compliance across all OPTN membership types and phases of the organ donation, procurement, waitlist, matching, transportation, and transplantation processes – with a focus on improving patient and donor/donor family experience.

2. Conduct reviews, evaluations, or assessments of current OPTN activities and functional processes. Identify process improvements and change management strategies to support quality improvement and to improve system accountability, including for data collection, policy development, compliance monitoring, quality improvement, and communications. Support coordination of the implementation of findings as directed by

HRSA.

3. Conduct studies and/or demonstration projects on topics and issues related to improving procedures, processes, and policies for organ donation, procurement, allocation, distribution, and transplantation, and improving patient outcomes. Support coordination of the implementation of findings as directed by HRSA.

4. Conduct assessments and/or evaluations of how data is captured, analyzed, coded, and shared within OPTN currently and identify opportunities and make recommendations to HRSA for how data usability, accessibility, security, privacy, and integrity can be improved. Support coordination of the implementation of findings as directed by

HRSA.

Task 1.2 Data Supplementation and Analyses

At the direction of the COR, the Contractor shall:

1. Obtain external data to supplement existing OPTN data, including potentially the creation of surveys and study instruments. All OPTN data is Federal data

Task 1.3 Coordination Among All Entities Supporting the OPTN

This subtask encompasses work and requirements to cooperate and collaborate with all entities supporting the OPTN while delivering the services necessary for the OPTN to meet its obligations.

At the direction of the COR, the Contractor shall:

1. Meet on a regular basis to be determined by HRSA to report on the status of deliverables and action items and shared metrics, conduct strategic planning, collaborate on innovative reforms, identify and address risks, and implement the HRSA OPTN Modernization Initiative.

2. Enter into data use agreements for OPTN data with other entities contracted to support the OPTN, as necessary and at the direction of HRSA, including implementing all appropriate privacy and security protections for OPTN-related materials, as outlined in the appendices and task orders.

3. Share all data and information necessary to enable OPTN and all entities supporting the OPTN to successfully perform. This includes assisting with access to OPTN data, process and procedure documentation, and other information necessary to complete OPTN activities. NOTE: Any potential restrictions on the part of contractors to sharing data and necessary information under a task order, including identification of proprietary information, must be stated in proposals at the time of task order solicitations.

4. Regularly meet with the COR, HRSA, the OPTN Board of Directors, and Board of Directors Committees on a basis to be determined by the COR and provide requested OPTN-related materials and updates as part of the OPTN Board of Director’s management and functional responsibilities.

5. Report to HRSA all data, information, and other requested OPTN-related materials to support HRSA’s oversight and congressional, statutory, regulatory, financial and other reporting requirements and oversight function.

6. Continually monitor, manage, and adjust processes, procedures, and functionality to integrate work with other entities supporting the OPTN.

7. Continually monitor, identify, and mitigate risks and proactively inform HRSA of any issues that prevent performance or successful implementation of efforts.

8. Conduct and participate in retrospectives to work collaboratively with other entities supporting the OPTN to identify issues and achievements, develop recommendations for improvement, and report on outcomes.

Task 1.4 Transition Activities

This subtask encompasses services required to enable the transition of any contract activities from incumbent contractors to other entities, including HRSA, the OPTN, HRSA contractors, and other entities supporting the OPTN. This includes both transition-in at the start of performance and transition-out at the end of performance.

At the direction of the COR, the Contractor shall:

1. Develop a transition plan for HRSA review and approval outlining the details of any transition (including applicable implementation roadmaps, risk management, privacy, back-up protocols, document transfer and processes) and implement approved plans to ensure successful transition.

2. Coordinate and implement the transition of any existing OPTN function or activity (including but not limited to processes, protocols, data collection or analyses, templates, systems) in such a way that ensures users have a seamless experience. This may include collaboration, coordinating, and training for multiple entities supporting the OPTN.

Task 1.5 General Requirements

1.5.1 OPTN Branding and Reporting

1.5.1.1 Branding

At the direction of the COR, all contractors shall brand all OPTN products produced under contracts associated with this IDIQ as OPTN products. OPTN contractor products shall be approved by a process established by the Board and/or HRSA. OPTN products can only contain OPTN branding. Contractors shall not brand any OPTN product as a product of the entity supporting the OPTN or as joint OPTN products. Additionally, no contractor shall brand any product not produced or approved to support the OPTN as an OPTN product.

1.5.1.2 Reporting

At the direction of the COR, all contractors shall contribute to the development of internal and external reports as necessary for the Board or HRSA to meet statutory and regulatory requirements, including information such as data and analyses on organ donation and transplantation, OPTN policies and policy development, OPTN system activities, and longitudinal analyses that describe trends over time in organ donation and transplantation.

1.5.2 Use of Plain Language Guidelines and Other Government Laws and Regulations f or all Products At the direction of the COR, the Contractor shall:

1. Follow the federal Plain Language Guidelines when developing products. The Plain Language Act of 2010 requires federal agencies to create communications that are clear and understandable to the public.

2. Ensure that all materials adhere to the Government Printing and Binding Regulations, including the prohibition on commercial advertising, “No Government publication or other Government printed matter, prepared or produced with either appropriated or nonappropriated funds or identified with an activity of the Government, shall contain any advertisement inserted by or for any private individual, firm, or corporation; or contain material which implies in any manner that the Government endorses or favors any specific commercial product, commodity, or service.” -- (Title III--General Provisions, 13. Advertisements, Commercial.)

3. Ensure that all materials do not contain any non-federal logos outside of the OPTN (since contractor logos are a form of institutional advertising); that materials do not contain contact information for non-federal organizations outside of the OPTN or OPTN affiliated individuals.

4. Ensure that all materials adhere to the prohibition against referring to lobbying in materials produced with appropriated funds.

Task 1.6 Records Management Requirements (Reserved)

This subtask encompasses work and requirements that apply across the domain that will be specified at the task order level. See Appendix A.

Task 1.7 Security and Privacy Requirements (Reserved) specified at the task order level. See Appendix B.

Task 1.8 Section 508 Requirements (Reserved) specified at the task order level. See Appendix C.

Task 1.9 Other Requirements (Reserved)

This subtask encompasses work and requirements that are applicable to any information technology (IT) development or modernization work specified at the task order level. See Appendix D.

Domain 2 - OPTN Operations

This Domain encompasses provision of the administrative, logistic, legal, management, research, analytic, and member technical support services necessary to ensure strong operations of the OPTN1. Services include coordinating and facilitating OPTN routine operations; providing full budget and accounting services; financial audits and planning; event management; OPTN member education; OPTN membership management, monitoring, quality improvement, and compliance activity; and OPTN member technical assistance. All OPTN operations activities shall be coordinated with the Board Support contractor through regular meetings and communications to facilitate Board of Directors management of or consultation on these OPTN functions.

Task 2.1 Coordination and Support Services for OPTN Membership Committee

This subtask encompasses services necessary for the OPTN Membership & Professional Standards Committee (MPSC) to carry out its functions, including those related to OPTN membership standards, compliance, monitoring, performance assessment and quality improvement.

At the direction of the COR, the Contractor shall:

1. Provide all services necessary to support MPSC operations and implement approved policies and procedures. This includes membership criteria and standards review and monitoring processes, Member performance metrics and compliance, alignment of MPSC criteria and policies with applicable federal laws and regulations, and membership applications processes.

2. Support the MPSC with drafting, revising, and updating OPTN membership criteria and standards, including support with developing and providing recommendations and reports to the Board of Directors.

3. Provide services to the MPSC to support their role in monitoring OPTN member compliance, performance, patient safety, and quality improvement.

4. Work with the MPSC to conduct ongoing review, monitoring, and improvement of transplant program waitlist processes and acceptance criteria.

5. Support the MPSC in conducting special reviews of OPTN members, coordinating medical peer reviews and site visits, and implementing the sanctions process. This includes supporting the MPSC with drafting of sanctions, member referrals to the Secretary, and enforcing OPTN approved sanctions and improvement plans.

6. Support the MPSC with providing technical assistance to OPTN members in identifying potential patient safety issues and developing corrective action plans to mitigate risk.

7. Develop and maintain real-time membership status reports for the MPSC and Board of Directors, and appropriate public reporting, documenting the membership and status of OPTN members.

1 The OPTN currently includes the Board of Directors, operating committees, policy committees, other standing committees defined in OPTN bylaws, subcommittees, ad hoc committee and groups, OPTN review boards, workgroups, OPTN regions, and OPTN members.

8. Provide services to ensure coordination between the OPTN and the Centers for Medicare and Medicaid Services (CMS). This includes managing ongoing OPTN and CMS coordination on activities to improving transplant system performance, waitlist processes, and acceptance criteria.

Task 2.2 Coordination and Support Services for OPTN Network Operations Oversight Committee

This subtask encompasses services necessary for the OPTN Network Operations Oversight Committee (NOOC) to carry out its functions and provide recommendations and reports to the Board of Directors, including those related to security of the OPTN IT systems. NOOC functions include review and recommendation to the Board of Directors on performance and availability metrics set by the government for entities supporting the OPTN, monitoring use and access to OPTN data, development of OPTN membership requirements for IT security and OPTN data use, monitoring and enforcing member compliance with requirements, performance assessment, and quality improvement.

1. Provide all services necessary to support NOOC operations and implement approved policies and procedures. This includes developing and monitoring OPTN matching function performance metrics, defining API development and use goals, system dashboards designs, security requirements and reporting processes, member data reporting and data access and use standards, and monitoring OPTN member IT compliance.

2. Develop and maintain real-time membership status reports for the NOOC and Board of Directors on OPTN member IT status, use of OPTN data, use of APIs, and other information as determined by NOOC for presentation in OPTN system dashboards on the OPTN website.

3. Work with the NOOC to refine security framework(s) for OPTN members based on the type of OPTN member organization, including development, testing and validation of member compliance with security requirements, and compliance with annual training requirements for OPTN member users and site administrators.

4. Support the NOOC in annually conducting a review of network operations and reporting finding to the OPTN Board and HRSA.

Task 2.3 Coordination and Support Services for OPTN Policy Committees

This subtask encompasses services necessary to support the OPTN Policy Oversight Committee (POC) and other OPTN committees, groups, and components that advise on policy to carry out their functions related to drafting and developing policy recommendations for consideration by the OPTN Board of Directors, strategic planning, policy evaluation, policy coordination and information sharing, variance processes, and metrics.

1. Provide all services necessary to support POC operations and implement approved policies and procedures. This includes supporting policy development committees, OPTN regions, variances, public comment, and policy metrics and performance monitoring.

2. Provide services and support for OPTN Policy development operations to meet, develop, document, maintain, monitor, and refine OPTN policy recommendations f or the OPTN Board of Directors and/or HRSA consideration.

3. Draft metrics to assess the timelines and effectiveness of the OPTN policy development and implementation process.

4. Draft OPTN processes for soliciting public comments on proposed OPTN policies, develop metrics to assess the OPTN public comment process, monitor the process, and make recommendations to revise/update the process.

5. Develop and manage processes to ensure the OPTN can receive, review, maintain, update, and implement OPTN policy variances in accordance with OPTN policies. This includes services to ensure policy variances align with applicable federal laws, OPTN policies, and contract requirements.

Task 2.4 Coordination and Support Services for OPTN Data Collection, Oversight, and Administration

This subtask encompasses services necessary for the OPTN Data Advisory Committee (DAC) to carry out its functions, including those related to monitoring and governing OPTN data collection and use to support OPTN policy development and evaluation, system outcome metrics, and information sharing.

1. Provide all services necessary to support DAC operations and implement approved policies and procedures. This includes drafting and recommending data policies, maintaining the OPTN Data Collection Principles and monitoring compliance with those principles, improving data elements, and supporting analytic work across the

OPTN.

2. Provide all services necessary to support the DAC in establishing and maintaining data governance and data standards for all OPTN data.

3. Provide all services necessary to ensure the DAC develops and monitors the processes to document, collect, and secure all data necessary for OPTN operations and that data is made available in timely and usable format to support policy and programmatic decision-making.

4. Coordinate the implementation of changes and updates to the OPTN public data dashboards as directed by OPTN Board of Directors and HRSA. Coordinate implementation of recommendations for continuous improvement to publicly available data.

5. Provide support for creating and implementing a process to ensure that all APIs are revised when OPTN data collection is updated.

6. Coordinate with other OPTN committees to identify and prioritize changes in OPTN data collection and OPTN data standards.

Task 2.5 Coordination and Support Services for Budget, Financial, and Audit Functions This subtask encompasses services necessary for the OPTN Finance Committee to carry out its functions, including those necessary to make recommendations to the OPTN Board of Directors for annual OPTN budgets and patient registration fees, as well as processes for determining and utilizing OPTN reserves collected through registration fees, and appropriate audits of entities supporting the OPTN.

1. Provide all services necessary to support OPTN Finance Committee operations and implement approved policies and procedures. This includes managing and monitoring revenue and expenses, budgeting, forecasting, investment and reserves strategies, OPTN registration fees, and making recommendations for improvements or changes.

2. Support management of OPTN accounting and finances including filing appropriate IRS documents, ensuring finances are audited consistent with laws and bylaws, issuing budget documents, tracking and monitoring registrations and expenditures, and conducting other associated functions for the network.

3. Coordinate with other OPTN committees and entities as needed to support the Finance Committee including coordinating development of annual OPTN budgets, registration fees, reserve components, use of OPTN reserve funds, and related justifications for OPTN Board of Directors consideration.

4. Develop and implement OPTN fee procedures to bill, collect, process, manage, and use OPTN registration fees and reserve fees (if applicable) in accordance with applicable federal laws, OPTN policies, and contract requirements.

5. Provide services to assist the OPTN Finance Committee with developing and implementing a system of OPTN internal controls for all entities supporting the OPTN for OPTN Board of Directors and HRSA approval.

6. Provide services necessary to perform internal audits, coordinate external audits, and report on the OPTN system of internal controls.

Task 2.6 Administrative and Coordination Services

This subtask encompasses providing administrative, logistic, management, training, subject matter expertise, and coordination services necessary for OPTN operations within committees, subcommittees, ad hoc groups, workgroups, and regions.

1. Develop process maps and checklists to assist the OPTN with documenting OPTN functions and activities, including but not limited to committee actions, policy recommendations to the OPTN Board of Directors, and task order deliverables. This includes documenting processes to ensure involvement of critical OPTN constituencies, HRSA, and other HHS Operating Divisions (when relevant), in OPTN functions and activities.

2. Provide virtual and in-person logistical services to committees, subcommittees, ad hoc groups, workgroups, OPTN review boards, and regions, including recommendations and implementation support for accessible in-person meeting venues, services related to registration, materials and documentation, audiovisual and web platform support, transcription, and facilitation. Processes shall be developed to allow public participation in all in-person and virtual committee, subcommittees, ad hoc groups, workgroups, and region meetings.

3. Provide education, training, and other services to ensure members of OPTN committees, regional member participants, and others involved in OPTN functions are educated about applicable federal laws and regulations, OPTN requirements, and HRSA contract requirements and can fulfill their responsibilities. This includes conflict of interest, confidentiality, and other compliance requirements.

4. Work with the OPTN, HRSA, and other entities supporting the OPTN to document current OPTN regional structures, evaluate processes, and determine future roles of regions in policy development and member education. This includes developing metrics to assess the effectiveness of the OPTN regional structure and process.

5. Provide research and analytic services to meet OPTN policy and functional needs across committees, subcommittees, ad hoc groups, workgroups, and regions.

6. Provide business process re-engineering or redesign services. This includes reviewing and mapping historical approaches of OPTN committee operations and recommending industry best practices to increase efficiency, transparency, fairness, accountability, and performance.

7. Establish, maintain, and enhance a web-based collaboration and document management platform that facilitates collaboration and document/artifact sharing across the OPTN.

Otherwise use systems provided by other OPTN entities. See Appendices for examples of potential security requirements at the task order level.

Task 2.7 Coordination and Support Services for Newly Established OPTN Committees

Per the OPTN Final Rule, the OPTN Board of Directors has authority to create and eliminate committees based on the strategic needs of the OPTN. This subtask encompasses services necessary for any new standing, ad hoc committees and/or workgroups established by the OPTN Board of Directors to carry out committee and workgroup functions needed to support the OPTN Board of Directors. All work will be completed at the direction of the COR.

Task 2.8 Services to Support the OPTN Organ Center Allocation and Placement

This subtask encompasses technical assistance, coordination, and facilitation of organ matching and transportation services on behalf of OPTN members when members are unable to complete these services independently, including serving as a backup for OPTN Members and assisting with placing hard to match organs.

At the direction of the COR, the Contractor shall:

1. Establish, operate, and maintain an organ center staffed with appropriately trained personnel to assist OPTN members in the allocation and transportation of donated organs and coordinate technical assistance with the Matching System.

Task 2.9 Coordination Among All Entities Supporting the OPTN This subtask encompasses work and requirements to cooperate and collaborate with all entities supporting the OPTN while delivering the services necessary for the OPTN to meet its obligations.

At the direction of the COR, the Contractor shall:

1. Meet on a regular basis to be determined by HRSA to report on the status of deliverables and action items and shared metrics, conduct strategic planning, collaborate on innovative reforms, identify and address risks, and implement the HRSA OPTN Modernization Initiative.

2. Enter into data use agreements for OPTN data with other entities contracted to support the OPTN, as necessary and at the direction of HRSA, including implementing all appropriate privacy and security protections for OPTN-related materials, as outlined in the appendices and task orders.

3. Share all data and information necessary to enable OPTN and all entities supporting the OPTN to successfully perform. This includes assisting with access to OPTN data, process and procedure documentation, and other information necessary to complete OPTN activities. NOTE: Any potential restrictions on the part of contractors to sharing data and necessary information under a task order, including identification of proprietary information, must be stated in proposals at the time of task order solicitations.

4. Regularly meet with the COR, HRSA, the OPTN Board of Directors, and OPTN Board of Directors Committees on a basis to be determined by the COR and provide requested OPTN-related materials and updates as part of the OPTN Board of Director’s management and functional responsibilities.

5. Report to HRSA all data, information, and other requested OPTN-related materials to support HRSA’s oversight and congressional, statutory, regulatory, financial and other reporting requirements and oversight function.

6. Continually monitor, manage, and adjust processes, procedures, and functionality to integrate work with other entities supporting the OPTN.

8. Conduct and participate in retrospectives to work collaboratively with other entities supporting the OPTN to identify issues and achievements, develop recommendations for improvement, and report on outcomes.

Task 2.10 Transition Activities

This subtask encompasses services required to enable the transition of any contract activities from incumbent contractors to other entities, including HRSA, the OPTN, HRSA contractors, and other entities supporting the OPTN. This includes both transition-in at the start of performance and transition-out at the end of performance.

1. Develop a transition plan for HRSA review and approval outlining the details of any transition (including applicable implementation roadmaps, risk management, privacy, back-up protocols, document transfer and processes) and implement approved plans to ensure successful transition.

2. Coordinate and implement the transition of any existing OPTN function or activity (including but not limited to processes, protocols, data collection or analyses, templates, systems) in such a way that ensures users have a seamless experience. This may include collaboration, coordinating, and training for multiple entities supporting the OPTN.

Task 2.11 General Requirements

2.11.1 OPTN Branding and Reporting

2.11.1.1 Branding

At the direction of the COR, all contractors shall brand all OPTN products produced under contracts associated with this IDIQ as OPTN products. OPTN contractor products shall be approved by a process established by the OPTN Board of Directors and/or HRSA. OPTN products can only contain OPTN branding. Contractors shall not brand any OPTN product as a product of the entity supporting the OPTN or as joint OPTN products. Additionally, no contractor shall brand any product not produced or approved to support the OPTN as an OPTN product.

2.11.1.2 Reporting

At the direction of the COR, all contractors shall contribute to the development of internal and external reports as necessary for the OPTN Board of Directors or HRSA to meet statutory and regulatory requirements, including information such as data and analyses on organ donation and transplantation, OPTN policies and policy development, OPTN system activities, and longitudinal analyses that describe trends over time in organ donation and transplantation.

2.11.2 Use of Plain Language Guidelines and Other Government Laws and Regulations f or

At the direction of the COR, the Contractor shall:

1. Follow the federal Plain Language Guidelines when developing products. The Plain Language Act of 2010 requires federal agencies to create communications that are clear and understandable to the public.

2. Ensure that all materials adhere to the Government Printing and Binding Regulations, including the prohibition on commercial advertising, “No Government publication or other Government printed matter, prepared or produced with either appropriated or nonappropriated funds or identified with an activity of the Government, shall contain any advertisement inserted by or for any private individual, firm, or corporation; or contain material which implies in any manner that the Government endorses or favors any specific commercial product, commodity, or service.” -- (Title III--General Provisions, 13. Advertisements, Commercial.)

3. Ensure that all materials do not contain any non-federal logos outside of the OPTN (since contractor logos are a form of institutional advertising); that materials do not contain contact information for non-federal organizations outside of the OPTN or OPTN affiliated individuals.

4. Ensure that all materials adhere to the prohibition against referring to lobbying in materials produced with appropriated funds.

Task 2.12 Records Management Requirements (Reserved) specified at the task order level. See Appendix A.

Task 2.13 Security and Privacy Requirements (Reserved) specified at the task order level. See Appendix B.

Task 2.14 Section 508 Requirements (Reserved) specified at the task order level. See Appendix C.

Task 2.15 Other Requirements (Reserved)

This subtask encompasses work and requirements that are applicable to any information

Domain 3 - Organ Allocation and Distribution (Matching) System, Information Technology, and Data This Domain encompasses operation and limited enhancement of the legacy OPTN Organ Allocation and Distribution (Matching) System, services required for the OPTN Kidney Paired Donation pilot program (KPDPP), and services necessary for other information technology and data aspects of the OPTN. This includes infrastructure management, security, data collection, storage, validation, reporting, incident response, responding to data requests, meeting service uptime targets, and integration with modern, modular architecture and services.

Task 3.1 Services to Sustain and Improve the Organ Allocation and Distribution IT and Data Systems While the Modernized IT System is Built

This subtask encompasses services necessary to maintain the Matching System and management of OPTN data, as the modernized OPTN IT Matching System is built. The OPTN information systems have been determined to be at the Federal Information Security Modernization Act of 2014 (FISMA) – High level, ensuring commitment to data security and compliance with federal information security standards. All OPTN data is Federal data.

At the direction of the COR, the Contractor shall:

1. Provide the services necessary for the OPTN to maintain a national list of individuals awaiting an organ transplant at OPTN member transplant programs. The matching system must be available 24/7, as required by NOTA.

2. Provide the services necessary to match and allocate organs from deceased donors to individuals on the national waiting list based on organ allocation policies approved by the OPTN Board of Directors.

3. Provide the services necessary to receive all necessary data and information on donated organs from all appropriate sources in a timely manner.

4. Provide technical assistance to OPTN members to support OPTN member reviews, monitoring of IT security issues on their local systems, and development of corrective action plans to mitigate risk.

5. Securely manage patient and donor data consistent with federal standards, accommodate multiple electronic platforms and Internet browsers, and meet data entry, modification, and transmittal requirements identified in task orders.

6. Provide all services necessary for the OPTN to collect and retain all official OPTN data in accordance with applicable federal laws and regulations. This includes using the Paperwork Reduction Act process, providing the information necessary for Information Collection Request (ICR) packages, following all privacy and security requirements for the protection of PHI and PII, meeting applicable System of Records Notice (SORN) requirements, and ensuring collection and access to data is maintained.

7. Maintain, perform and report on regular audits and quality checks on OPTN data at a frequency determined by HRSA to ensure security, privacy, and accuracy of the data.

Make OPTN data securely available and accessible to HRSA and others, as directed by

HRSA.

8. Ensure continuous system uptime, reliability, and functionality, meeting or exceeding government-defined service level agreements and performance metrics. This includes proactive management of system resources, regular monitoring of system performance, and rapid response to any issues affecting system availability or integrity.

9. Develop and maintain APIs and other interfaces required to interact and securely exchange information among entities supporting the OPTN, OPTN members and other entities receiving OPTN data, modules, systems or other functionality ensuring cohesive functioning of all systems facilitating the organ procurement and transplantation process.

Task 3.2 Integration and Modernization Support

This subtask is centered on the integration of advanced technologies and systems that have been identified, developed, and validated through other OPTN contracts such as NextGen IT.

The focus is on seamlessly incorporating modern, modular architecture while maintaining system functionality and reliability during the process, and enhancing operational efficiency through these technological advancements.

At the direction of the COR, the Contractor shall:

1. Meet, collaborate with, and provide necessary training and support to entities developing new modular functionalities that may replace parts of the existing OPTN IT system, ensuring successful transition of the relevant part of the OPTN IT system.

2. Conduct a detailed analysis of the current OPTN Matching System to transition its functionalities into cloud-based, modular services, ensuring compliance with all relevant legal and regulatory standards.

3. Accept new modules built through NexGen IT. This includes updating system code for compatibility with new components and APIs, and conducting thorough testing to ensure consistent, uninterrupted operation in line with NextGen IT and other OPTN initiatives.

4. Develop and maintain updated components/modules, and external-facing APIs for robust and secure integration with third-party services, adhering to data security and privacy standards.

5. In the course of performing the responsibilities of task, maintain strict adherence to predefined performance and availability metrics set by the government. This responsibility encompasses rigorous testing and validation of prescribed changes, new modules and APIs, continuous monitoring of system performance during the integration phase, and ensuring minimal disruption to system availability and functionality.

6. Provide subject matter expertise to other HRSA and other OPTN contractors during various phases of the system development lifecycle, focusing on discovery, design, prototyping and integration of current or new functionalities. Additionally, the contractor will be responsible for the ongoing operations and maintenance of integrated modernized components, ensuring and validating performance, security, and compliance with HRSA and OPTN Standards.

7. Provide research, analytic, and business process re-engineering services to meet the policy and functional needs of the OPTN across its processes and systems. This includes operations process discovery and mapping and identifying and recommending industry best practices. These effort efforts aim to enhance efficiency, fairness, transparency, accountability, and performance in OPTN operations.

Task 3.3 Coordination Among All Entities Supporting the OPTN supporting the OPTN while delivering the services necessary for the OPTN to meet its obligations.

At the direction of the COR, the Contractor shall: