R410--Accelerating VA Innovation and Learning (AVAIL)

Request for Information (RFI) Accelerating VA Innovation and Learning (AVAIL) The Department of Veterans Affairs (VA) is issuing this RFI in accordance with FAR 15.201(e). The agency does not intend to award a contract but rather gather information on capability, delivery and other market information pertinent for acquisition planning. The result of this market research will contribute to determining the method of procurement and identify parties having an interest in and the resources to support this requirement for the following: SECTION 1 - TASKS Task 6.1 Advanced Manufacturing in Healthcare The contractor shall participate in the design, development, testing, and/or evaluation of new, personalized medical devices and solutions utilizing advanced manufacturing techniques (e.g. 3D printing, injection molding, milling). These actions will focus on new solutions across 5 major lanes of effort pertaining to the use of advanced manufacturing in VA: (1) anatomical model for pre-surgical planning; (2) personalized prosthetics, orthotics, and surgical instruments (3) personalized dental devices or equipment; (4) personalized assistive technology; and (5) bio-fabrication. In general, medical device product development innovation tasks shall include the following steps: Initiation: assessment of product idea, opportunity, and impact. Planning: detailed scoping and planning of user needs, product requirements, financing, product risks, testing, and transfer to manufacturing. Development: product specifications, risk analysis, design and process development activities including bench testing, Design of Experiment, process development, installation of needed equipment, quality control requirements, and establishment and documentation of all processes necessary for product realization. Validation: authorship, execution, and validation report of design and process validation requirements per the master validation plan; submission of regulatory filings to FDA for market clearance (if applicable). Transfer: scaling of product and process and transfer from product development to manufacturing; manufacturing operator and user training modules or programs; product awareness campaign strategy and collateral. Products, product lines or solutions shall be limited to the five aforementioned lanes of efforts and include, for example, design of a patient-matched surgical cutting guide, design and production of customized lower limb sockets or other prosthetics, or a suite of dental devices. The VHA will determine product or product lines based on shifting organizational or market priorities (i.e. production of nasal testing swabs due to limited market supply) or Veteran need. Deliverables for this task shall take the form of monthly progress reports, which shall serve as documentation to capture progress in product or product line manufacturing as well as lessons learned, and a design file of the product or product line. To note, a design file is not intended to represent a finished product or solution that is ready for broad scale use in clinical care, as products or product lines may require human subject and/or clinical trials for broader clinical use. Should this be the case, the design file and solution or product would be handed off to VHA DEAN and contractual responsibilities around product or solution advancement would cease. This task is also not intended nor is a contractual obligation for large scale manufacturing of the product or product line. Additionally, the government reserves the right to determine feasibility, scalability, and value assessment of a specific product or product line every three months to determine whether such a product should continue to be manufactured or pursued. Lastly, cost of materials or supplies should be factored into the overall cost of the deliverable(s). Deliverables: Advanced Manufacturing in Healthcare Product Monthly Progress Report to include labor categories/hours worked and what was accomplished. Advanced Manufacturing in Healthcare Product Design File (e.g. STL file) (per product) Task 6.2 Data Transformation Subtask 6.2.1 Advanced Clinical Decision Support Solutions The contractor shall participate in the design, development, testing, and/or evaluation of new, advanced clinical decision support tools spanning a wide range of clinical areas. Specific work shall focus on augmenting highly reliable, precise, and data driven clinical care delivery amongst the following lanes of effort: (1) chronic disease management (i.e. diabetes, brain health, chronic kidney disease, heart failure, long COVID, amongst others); (2) high risk, high utilizer patient populations (i.e. multiple chronic conditions, cancer, frequent utilization of emergency or urgent care); (3) vulnerable or underserved patient populations (i.e. homeless, food insecurity); (4) acute conditions such as sepsis. Solutions must take advantage of the existing suite of VA data and analytic platforms (i.e. BI - business intelligence, VA Arches, VA Common Operating Platform, MDClone, amongst others), VA FHIR-based APIs, and VA data sets (i.e. Patient-Generated Health Data, Corporate Data Warehouse, VINCI, Financial Services Center resource and claims date, amongst others). Specific features must include integration into existing VA workflows and/or existing product lines utilizing software-as-a-service, mobile applications, and existing clinical information systems where possible. Solution development must follow a human centered design methodology and also include objective methods to measure the impact of use of the CDS tool on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in CDS implementation as well as lessons learned, and a design file of the advanced CDS tool. The government reserves the right to determine feasibility, scalability, and value assessment of a specific CDS tool every three months to determine whether such a product should continue to be utilized or pursued. Deliverables: Advanced Clinical Decision Support Tool Monthly Progress Report Advanced Clinical Decision Support Tool Design File Subtask 6.2.2 Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP) and Neural Networks (NN) Solutions The contractor shall participate in the design, development, testing, and/or evaluation of new artificial intelligence (AI), machine learning (ML), natural language processing (NLP) or neural networks (NN) solutions across a wide range of clinical and administrative areas. Specific work shall focus on augmenting highly reliable, data driven clinical care delivery amongst the following lanes of effort: (1) chronic disease management (i.e. diabetes, brain health, chronic kidney disease, heart failure, long COVID, amongst others); (2) high risk, high utilizer patient populations (i.e. multiple chronic conditions, frequent utilization of emergency or urgent care); and (3) vulnerable or underserved patient populations (i.e. homeless, food insecurity); (4) acute conditions such as sepsis; and (5) administrative task automation within the clinical workflow. Solutions must take advantage of the existing suite of VA data and analytic platforms (i.e. BI - business intelligence, VA Arches/MDClone, VA Common Operating Platform, Rockies, amongst others), VA FHIR-based APIs, and VA data sets (i.e. Patient-Generated Health Data, Corporate Data Warehouse, VistA data, Cerner, Community Care Data, Financial Services Center resource and claims date, Social Determinants of Health Data amongst others). Specific features must include integration into existing VA workflows and/or existing product lines utilizing software-as-a-service, mobile applications, and existing clinical information systems where possible. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the clinical decision support (CDS) or operational efficiency tool on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the solution set(s) including any algorithms or code related to solutions developed. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued or whether the effort should be decommissioned to focus on other solutions sets with more value for government. Specific to Optional Task 6.6.1, the Contractor shall possess a deep knowledge of the use of AI in clinical care, emerging FDA regulations and policies surrounding this technology, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. Deliverables: Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP) and Neural Networks (NN) Solutions Monthly Progress Report Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP) and Neural Networks (NN) Solutions Artificial Intelligence (Machine Learning/Natural Language Processing/Neural Networks) Solution Design File Subtask 6.2.3 Application Program Interfaces (API) Solutions The contractor shall participate in the design, development, testing, and/or evaluation of new healthcare API solutions across a wide range of clinical and administrative areas. Specific work shall focus on augmenting highly reliable, data driven clinical care delivery amongst the following lanes of effort: (1) solution interoperability; (2) health record and patient information exchange; (3) automation of administrative task (i.e. patient scheduling, insurance capture and billing); (4) capture and integration of remote patient monitoring data into existing workflows; and (5) capture and integration of patient reported outcomes into existing workflows. Solutions must take advantage of the existing suite of VA data and analytic platforms (i.e. BI - business intelligence, VA Arches/MDClone, VA Common Operating Platform, Rockies, amongst others), VA FHIR-based APIs, and VA data sets (i.e. Patient-Generated Health Data, Corporate Data Warehouse, VistA data, Cerner, Community Care Data, Financial Services Center resource and claims date, Social Determinants of Health Data amongst others). Specific features must include integration into existing VA workflows and/or existing product lines utilizing software-as-a-service, mobile applications, and existing clinical information systems where possible. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the API solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the synthetic data solution set(s) including any algorithms or code related to solutions developed. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued or whether the effort should be decommissioned to focus on other solutions sets with more value for government. APIs must conform to current VA standards (FHIR API), utilizing the VA Lighthouse initiative and guidance to be sure of VA-wide interoperability. Specific to Optional Task 6.6.2, The Contractor shall possess a deep knowledge of the use of APIs in clinical care with VA FHIR APIs, as well as a knowledge of ONC standards regarding data interoperability and standards, existing and those that need to be developed. Deliverables: Application Program Interfaces (API) Solution Progress Report to include labor categories/hours worked and what was accomplished. Application Program Interfaces (API) Solution Design File Subtask 6.2.4 Synthetic Data Solutions The contractor shall participate in the design, development, testing, and/or evaluation of new, synthetic data solutions spanning a wide range of clinical areas for quality improvement efforts. Specific work shall focus on augmenting highly reliable, data driven clinical care delivery amongst the following lanes of effort: (1) chronic disease management (i.e. diabetes, mental health, chronic kidney disease, heart failure, long COVID, amongst others); (2) high risk, high utilizer patient populations (i.e. multiple chronic conditions, frequent utilization of emergency or urgent care); and (3) vulnerable or underserved patient populations (i.e. homeless, food insecurity); and (4) acute conditions such as sepsis. Solutions must take advantage of the existing suite of VA data and analytic platforms (i.e. BI - business intelligence, VA Arches/MDClone, VA Common Operating Platform, Rockies, amongst others), VA FHIR-based APIs, and VA data sets (i.e. Patient-Generated Health Data, Corporate Data Warehouse, VistA data, Cerner, Community Care Data, Financial Services Center resource and claims date, Social Determinants of Health Data amongst others). Specific features must include integration into existing VA workflows and/or existing product lines utilizing software-as-a-service, mobile applications, and existing clinical information systems where possible. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the developed solution or operational efficiency tool on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the synthetic data solution set(s) including any algorithms or code related to solutions developed. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued or whether the effort should be decommissioned to focus on other solutions sets with more value for government. Deliverables: Synthetic Data Solution Progress Report Synthetic Data Solution Design File Task 6.3 Digital Health Innovation Subtask 6.3.1 Digital Care Solutions The contractor shall participate in the design, development, testing, and/or evaluation of new, digital care solutions spanning a wide range of clinical areas for quality improvement efforts. Specific work shall focus on augmenting highly reliable, data driven clinical care delivery amongst the following lanes of effort: (1) chronic disease management (i.e. diabetes, mental health, chronic kidney disease, heart failure, long COVID, amongst others); (2) high risk, high utilizer patient populations (i.e. multiple chronic conditions, frequent utilization of emergency or urgent care); and (3) vulnerable or underserved patient populations (i.e. homeless, food insecurity); and (4) acute conditions such as sepsis. Solutions must take advantage of the existing suite of VA data and analytic platforms (i.e. BI - business intelligence, VA Arches/MDClone, VA Common Operating Platform, Rockies, amongst others), VA FHIR-based APIs, and VA data sets (i.e. Patient-Generated Health Data, Corporate Data Warehouse, VistA data, Cerner, Community Care Data, Financial Services Center resource and claims date, Social Determinants of Health Data amongst others). Specific features must include integration into existing VA workflows and/or existing product lines utilizing software-as-a-service, mobile applications, and existing clinical information systems where possible. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the developed solution or operational efficiency tool on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the synthetic data solution set. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Specific to subtask 6.3.1, the contractor shall possess a deep knowledge of the use of immersive technology platforms and systems integration in clinical care, emerging FDA regulations and policies surrounding digital health, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. Deliverables: Digital Health Innovation Progress Report Digital Health Innovation Design File Subtask 6.3.2 Digital Twin Solutions The contractor shall participate in the design, development, testing, and/or evaluation of digital twin solutions specific to: (1) architectural blueprints of construction for planned and/or future clinical spaces (i.e. exam room, operating room) and facilities (i.e. VA Medical Center); (2) integration and adoption processes of a new, emerging technology (i.e. 3D-Printing) into clinical care delivery. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Furthermore, digital twin solutions should be designed in such as way as to leverage the use of extended reality modalities (i.e. Virtual Reality, Augmented Reality) and possess the capability for simulation and modeling to predict future clinician and operational workflows to enabling resource forecasting. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the digital twin solution. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Deliverables: Digital Twin Solution Progress Report Digital Twin Design File Subtask 6.3.3 5G Technology Solutions The contractor shall participate in the design, development, testing, and/or evaluation of 5G enabled or augmented technology solutions spanning several lanes of effort which promised to be transformed by greater connectivity of the internet of things and advances in mobile edge computing. Specific task will focus on: (1) real-time remote and/or virtual care delivery; (2) patient wearable devices; (3) advanced computer spatial technology utilizing augmented reality for clinical care delivery (i.e. AR-guided surgical navigation); (4) deployment of analytics for digital health information transformation; (5) and advances in extended reality (i.e. Augmented Reality, Virtual Reality) for clinical care delivery and training. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the 5G-solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the digital twin solution. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Specific to optional task #.#, the contractor shall possess a deep knowledge of the use of 5G technology platforms and systems integration in clinical care, emerging FDA regulations and policies surrounding this technology, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. Deliverables: 5G Technology Solution Progress Report to include labor categories/hours worked and what was accomplished. 5G Technology Solution Design File Subtask 6.3.4 Blockchain in Healthcare Project(s) The contractor shall participate in the design, development, testing, and/or evaluation of blockchain solutions spanning several lanes of effort. Specific task will focus on: (1) secure data sharing across institutions; (2) supply chain optimization; (3) quality management and product tracking; and (4) optimization of clinically required administrative task such and provider credentialling and privileging. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the blockchain solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the blockchain solution. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Deliverables: Block Chain in Healthcare Solution Progress Report to include labor categories/hours worked and what was accomplished. Block Chain in Healthcare Solution Design File Task 6.4 Immersive and Simulation Technology Subtask 6.4.1 Extended Reality Solutions The contractor shall participate in the design, development, testing, and/or evaluation of immersive training solutions leveraging extended reality modalities (i.e. Augmented Reality, Virtual Reality) that span a wide range of clinical areas. Specific work shall focus on: (1) alternative therapies for mental health disorders; (2) clinical procedural training (i.e. patient intubation, central line placement); (3) virtual individual and/or group clinical visits; and (4) virtual rehabilitation across clinical conditions such as post-operative care, traumatic brain injury, poly-trauma, amongst others. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the synthetic data solution set. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Specific to task #.#, the contractor shall possess a deep knowledge of the use of immersive technology platforms and systems integration in clinical care, emerging FDA regulations and policies surrounding this technology, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. Deliverables: Immersive Technology Solution Progress Report Immersive Technology Solution Design File Subtask 6.4.2 Clinical Simulation Solutions The contractor shall participate in the design, development, testing, and/or evaluation of clinical simulation solution that will enable the delivery of high value care through better adoption and integration of emerging technology and workflow optimization utilizing clinical simulation. Specific task will focus on: (1) early-stage evaluation and testing of emerging technologies (i.e. augmented reality, digital health innovations for remote patient monitoring, and virtual health, amongst others); (2) clinical-care workflow optimization (i.e. clinical resuscitation in the acute care setting, patient triaging and registration, amongst others); (3) full end-to-end clinical and functional workflow review for operational assessments of health information systems; and (4) enhanced adoption and integration of emerging technologies (i.e. 3D-printing) through simulation-based training. Solution development must follow a human centered design methodology and include objective methods to measure the impact of use of the blockchain solution on Veteran-centered outcomes, including clinical, financial, and operational impact. Deliverables shall take the form of monthly progress reports, which shall serve as documentation to capture both progress in implementation as well as lessons learned, and a design file of the clinical simulation solution. When applicable, solutions should leverage the use of extended-reality modalities (i.e. augmented and virtual reality) and existing VHA-training platforms which will enable solutions to be delivered at scale without geographical limitations. The government reserves the right to determine feasibility, scalability, and value assessment of the specific solution every three months to determine whether such a product should continue to be utilized or pursued. Deliverable: Clinical Simulation Solution Monthly Progress Report Clinical Simulation Solution Design File Task 6.5 Clinical and Business Model Innovation The contractor shall assist VA in the exploration, design, modeling, and analysis of innovative clinical and business models to advance high value or value-based care that incorporate such payment modalities like bundled payment, direct contracting, shared savings, and/or other value-based approaches. Strategies and approaches should aim to reduce expenditures for the Department while preserving or enhancing the quality of care furnished by the VA to improve veteran's access to care and services and improve quality, timeliness, and patient satisfaction. Strategic areas of interest include, but are not limited to, chronic disease management, ED-based care coordination, and at-home/virtual care. The Contractor shall explore and assess opportunities to enhance or streamline existing VHA processes, systems, and standards to improve Veteran health outcomes, innovation, and research, promote health equity and create discretionary cost savings for the Department. This may include targeting new adjacencies, platforms, and break-away capabilities, conducting market research and value-assessments, synthesizing case studies to determine success and failure factors and developing reports and recommendations based on identified parameters of interest. Potential areas for exploration include, but are not limited to, the existing Veterans Equitable Resource Allocation (VERA) system, MISSION Act wait times/distance standards, and authorizations for care in the community. The contractor shall leverage advanced analytics, VA and non-VA data sets, and existing published research to inform the design and direction of care and payment models. Models shall be designed in such a way that their impact and effectiveness are accurately measurable. The contractor may also be required to provide subject matter expertise around innovative business model that could lead to self-sustaining of revenue generating service lines through the capture of VA's intellectual property. This would be specific to all the above the deliverables and leverage current legal structures such as Cooperative Research and Development Agreements. Deliverables will take the form of monthly reports submitted to the to include a summary of work performed and any work products produced in support of work efforts related to this task and a final design file of the proposed innovation. Deliverables: Clinical and Business Model Innovation Monthly Progress Report Clinical and Business Model Innovation Design File Task 6.6 Strategic Planning and Project Scheduling The Contractor shall provide strategic planning services, which involve planning, implementation, monitoring, and evaluation for a results-based accountability system. Strategic planning is an iterative process and includes examination of historical artifacts and changing contexts (internal and external), creating the vision, mission statements, goals (long and short range), performance measurements, and lessons learned for VA'S innovation, programs, or projects. The Contractor shall also develop program/project road maps that define the current, near-term, and future states of healthcare innovation. Additionally, the Contractor shall provide program and project scheduling support services to define how all program/project elements integrate and demonstrate an effective program/project plan. Scheduling support shall include the development of a network of program/project tasks linked to each program/project's start and finish, documenting the intra and interdependencies for each program/project phase. The Contractor shall define the program/project's critical path, as well as those tasks/activities and series of tasks that lead to major interim events or deliverables. Each program/project's performance measurement baseline will be used to track progress, forecasts, and changes throughout execution. Deliverables will take the form of monthly reports to include and work-related documents or materials - such as strategic planning documents, project roadmaps and schedules - related to the efforts described above. Deliverables: Monthly Progress Report Strategic Planning Documents and Project Schedules Task 6.7 Programmatic Support Subtask 6.7.1 Project/Pilot Implementation Support The Contractor shall provide comprehensive programmatic, project and/or pilot implementation support to assist in planning, monitoring, and controlling innovation and development efforts throughout each project phase, ensuring that projects are delivered on time, on budget, and with high quality results. The Contractor shall assist in program-level integration and planning activities for the VA innovation portfolio and develop strategies to increase success of innovation activities across the VA health care provider and Veteran communities. The Contractor shall track, coordinate, facilitate, and evaluate program, project, and release activities and provide recommendations for VA decision-making as well as identifying/presenting ideas and approaches to solving program/project issues that have impacts to scope, cost, and schedule. The Contractor shall actively seek information from innovation leadership regarding risks, issues, requirements, designs, or solutions in support of project and VA-wide dependencies. The Contractor shall support programmatic and project/pilot implementation support such as: Agile process management and coordination Requirement's elicitation, management, and analysis Meeting facilitation and internal communications Research and analysis Lifecycle price/cost estimation Process improvement and workflow assessment Risk and change management Performance and knowledge management Reporting and documentation Monitoring and governance Internal and external stakeholder coordination Authority to Operate (ATO) coordination and documentation development when applicable Deliverables will take the form of monthly progress reports to include and any sub-task related documents or materials - such as project dashboards, key performance indicator tracking sheets, synthesis of research and analysis - related to the numbered items above. Deliverables: Monthly Progress Report Subtask 6.7.2 Replication...