SOURCES SOUGHT
R -- *UPDATED* VA DEAN Innovation Research and Simulation Support
- Notice Date
- 6/8/2021 6:48:26 AM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- SAC FREDERICK (36C10X) FREDERICK MD 21703 USA
- ZIP Code
- 21703
- Solicitation Number
- 36C10X21Q0136
- Response Due
- 5/20/2021 2:00:00 PM
- Archive Date
- 07/12/2021
- Point of Contact
- David S Rupert, Contracting Specialist, Phone: (202) 536-9972
- E-Mail Address
-
David.Rupert@va.gov
(David.Rupert@va.gov)
- Awardee
- null
- Description
- Request for Information (RFI) 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: Task 1. Emerging Technology to Transform Clinical Care Delivery and Service The pace at which healthcare is changing, which has only been accelerated by the COVID-19 pandemic, represents new challenges and opportunities for the Veterans Health Administration. The emergence of new technologies in clinical care delivery, such as 3-dimensional printing and virtual reality, represent foundational shifts in health care delivery. To realize the full value of these solutions in an effort to advance clinical care writ large, rapid prototyping, testing, evaluation and integration in the clinical workflow of proven solutions will need to occur more seamlessly, and rapidly, than ever before. This change and success will ensure VHA can continue to deliver world class care and service for our nation�s Veterans. To accomplish this, the Veterans Health Administration will require subject matter expertise, both clinical and scientific, across various disciplines. The contractor will be responsible for assisting the government with end-to-end design and clinical integration of the below topic areas. Specific task will include initial discovery work and solution ideation, evaluation and testing of a minimum viable product, evaluation and assessment of real world impact of a proposed solution, replication testing and large-scale integration in the clinical and operational workflow. Task for each CLIN will be broken up into three month �sprints�, to allow for necessary measurement and evaluation of impact, course correction or cancelling a specific initiative. Specific knowledge and requirements listed within each category below: Advanced Manufacturing for Clinical Care ����������� Contractor will support VHA in advancing the adoption and application of advanced manufacturing (i.e. 3-dimensional printing and 3-dimensional bio-printing) for clinical care delivery. Such work could include advances in pre-surgical planning through anatomic modeling, development of custom orthotics and prosthetics, or use of additive manufacturing for design and development of surgical implants. Contractor must possess subject matter expertise in medical device design, testing and production, with additional subject matter expertise in Food and Drug Administration (FDA) regulations as well as the necessary implementation of a Quality Record and Management System for medical device production. Additionally, the contractor must possess both bio-medical and clinical expertise in the use of advanced manufacturing across multiple clinical disciplines as well as a sound appreciation for business and financial modeling for in-hospital manufacturing services. Advanced 3D Nano Printing ����������� Contractor shall support VHA in advancing the fabrication of surfaces and structures to produce bioengineering devices and chips.� Contractor must possess subject matter expertise in scanning probe lithographic technology for direct writing of soft materials such as biopolymer and organic molecules.� Contractor shall offer consultative service in the design of bio-functional devices and surfaces.� Contractor shall produce such devices and surfaces in the nano- to micro-scale range or higher.� Additionally, contractor is expected to provide guidance in developing clinical -grade constructs and in obtaining FDA approvals. Advanced Manufacturing for Drugs and Biologics Contractor will support VHA in advancing the adoption and application of advanced design and manufacturing of drugs and biologics for clinical care delivery. Such work could include advances in computer-aided design, development of custom panels of small molecules and biologics, and development of advanced screening assays. Contractor must possess subject matter expertise in medicinal chemistry, design, testing and production, with additional subject matter expertise in Food and Drug Administration (FDA) regulations as well as the necessary implementation of a Quality Record and Management System for drugs and biologics production. Additionally, the contractor must possess both bio-medical and clinical expertise in the use of advanced manufacturing across multiple clinical disciplines as well as a sound appreciation for business and financial modeling for in-hospital services. Microarray and Chip Development Contractor will support VHA in advancing the adoption and application of advanced design and implementation of microarrays for clinical care delivery. Such work could include development of custom arrays and chips for genetic sequencing and studying molecular interactions such as, but not limited to, protein-protein, protein-gene, and gene-gene interactions. Contractor must possess subject matter expertise in biochemistry, design, testing and production, with additional subject matter expertise in the necessary implementation of a Quality Record and Management System for microarray development. Additionally, the contractor must possess both bio-medical and clinical expertise in the use of microarrays across multiple clinical areas, data measurement and evaluation and clinical integration of new protocols. � Robotic Process Automation (RPA) ����������� Contractor will support VHA in advancing the use of Robotic Process Automation (RPA) for clinical care delivery and service optimization. Use cases could include using RPA to automate collection of patient data during clinical visits, patient scheduling and automate administrative functions to enhance the clinical workflow and free providers to spend more time directly with Veterans. Contractor must possess subject matter expertise in clinical workflow optimization, deployment and adoption of automated solutions into the clinical workflow, as well as a deep knowledge of clinical informatics and software design. � � Immersive Technologies ����������� The role of extended realities � such as virtual and augmented reality � hold promise for the treatment of various conditions as well as enhancing the practice of medicine. The contractor will assist the VHA in the design, testing and deployment of various immersive technologies in the clinical care delivery setting. Examples include the use of Virtual Reality for the treatment of Post-Traumatic Stress Disorder (PTSD), or the use of Augmented Reality for surgical navigation in the Operating Room. The contractor must possess a deep knowledge of the use of immersive technology 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Precision Medicine Precision medicine is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease. This may also be called personalized medicine.� The contractor will assist the VHA in the design, testing and deployment of various precision medicine capabilities in the clinical care delivery setting. Examples include the use of precision medicine to treat lung cancer, melanoma (skin cancer), colon cancer, and pancreatic cancer. It can also help with some rare childhood illnesses, cystic fibrosis, and human immunodeficiency virus (HIV).� The contractor must possess a deep knowledge of the use of precision medicine in clinical care, emerging FDA regulations and policies surrounding this capability, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Remote Care Remote care programs use telehealth technology to facilitate clinically driven, remote monitoring, care, and education of patients and are an absolute necessity for providers and payers striving to implement an effective population health management strategy.� Remote Care is a telemedicine service, which allows constant monitoring of the patient's condition and performance of preventive and control check-ups outside medical facilities. This form of care is made possible by the use of mobile devices which measure vital signs.� The contractor will assist the VHA in the design, testing and deployment of various remote care technologies in the clinical care delivery setting. Examples include the use of telemedicine for the digital transmission of medical imaging, remote medical diagnosis and evaluations, and video consultations with specialists. The contractor must possess a deep knowledge of the use of remote care 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Artificial Intelligence (Machine Learning/Natural Language Processing/Neural Networks) Artificial intelligence (AI) refers to the simulation of human intelligence in machines that are programmed to think like humans and mimic their actions. The term may also be applied to any machine that exhibits traits associated with a human mind such as learning and problem-solving.� The basic objective of AI (also called heuristic programming, machine intelligence, or the simulation of cognitive behavior) is to enable computers to perform such intellectual tasks as decision making, problem solving, perception, understanding human communication (in any language, and translate among them).� There are four types of artificial intelligence: reactive machines, limited memory, theory of mind and self-awareness.� The contractor will assist the VHA in the design, testing and deployment of various AI technologies in the clinical care delivery setting. Examples include the common use of artificial intelligence in healthcare involving NLP applications that can understand and classify clinical documentation. NLP systems can analyze unstructured clinical notes on patients, giving incredible insight into understanding quality, improving methods, and better results for patients.� The contractor must 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Application Program Interfaces (API) An application programing interface (API) is a set of standards that govern how software applications talk to each other. APIs play an increasingly important role in healthcare data exchange, whether for data analytics, medical research, or creating innovate ways to access the EHR.� The contractor will assist the VHA in the design, testing and deployment of various API technologies in the clinical care delivery setting. Examples include using an application on mobile device, the application connects to the Internet and sends data to a server. The server then retrieves that data, interprets it, performs the necessary actions and sends it back to the mobile device.� The contractor must possess a deep knowledge of the use of APIs 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. Edge Computing Edge computing is a distributed, open IT architecture that features decentralized processing power, enabling mobile computing and Internet of Things (IoT) technologies. In edge computing, data is processed by the device itself or by a local computer or server, rather than being transmitted to a data center.� Edge computing optimizes Internet devices and web applications by bringing computing closer to the source of the data.� The contractor will assist the VHA in the design, testing and deployment of edge computing in the clinical care delivery setting. Examples include Edge computing as an enabler for doctors to deliver care to remote areas where connectivity may not be great and skilled healthcare personnel may not be available.� Furthermore, healthcare providers can use edge computing and analytics to convert data into new insights to help improve patient outcomes while delivering financial and operational value.� The contractor must possess a deep knowledge of the use of edge computing 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � 5G Technology 5G is the 5th generation mobile network. It is a new global�wireless�standard after 1G, 2G, 3G, and 4G networks. 5G enables a new kind of network that is designed to connect virtually everyone and everything together including machines, objects, and devices.� Like other cellular networks, 5G networks use a system of cell sites that divide their territory into sectors and send encoded data through radio waves. Each cell site must be connected to a network backbone, whether through a wired or wireless backhaul connection.� The contractor will assist the VHA in the design, testing and deployment of 5G in the clinical care delivery setting. Examples include 5G-enabled wearable devices, whereby healthcare providers can monitor patients remotely and gather real-time data for preventative care and other individually tailored healthcare provisions.� The contractor must possess a deep knowledge of the use of 5G 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. This effort is an RFI to gather information for the Innovations office. This is not an effort to gather any information regarding any OIT wireless or infrastructure services contracts. Any information gathered will not be on the VA�s internal network.� Block Chain in Healthcare Blockchain in healthcare is emerging as novel methodology that can enable the VHA to implement both fine grained supply chain tracking and data sharing systems that can improve business processes by providing tracking of both physical and digital assets internal and external to the VHA. The contractor will assist the VHA in the design, testing and deployment of blockchain technology within the context of healthcare delivery. The contractor must also possess a knowledge of cybersecurity, privacy, and supply chain/logistics management. Innovative solutions for biospecimen collection and processing Contractor will support VHA in innovative mechanisms for collection of various biospecimens, including home-based, self-collection in support of precision medicine and genomic epidemiology. The solutions(s) must ensure adequate yields of DNA, RNA, proteins and/or metabolites as needed. The contractor must possess subject matter expertise and experience in biospecimen collection and processing technologies. Task 2. Advanced Clinical Decision Support and Data-Driven Decision Making in Healthcare Data-driven decision-making (DDDM) is defined as using facts, metrics, and data to guide strategic business decisions that align with VHA goals, objectives, and initiatives. VHA needs to make data-driven decision-making the norm�creating a culture that encourages critical thinking and curiosity.� To realize the full value of these solutions in an effort to advance clinical care writ large, data-driven decision-making integration in the clinical workflow of proven solutions will need to occur more seamlessly, and rapidly, than ever before. This change and success will ensure VHA can continue to deliver world class care and service for our nation�s Veterans. To accomplish this, the Veterans Health Administration will require subject matter expertise, both clinical and scientific, in the areas such as clinical informatics, data science, and artificial intelligence. The contractor will be responsible for providing subject matter expertise across a wide variety of data analytics platforms and well as provide necessary development and clinical integration expertise for custom developed solutions. Specific knowledge and requirements listed within each category below: Synthetic Data Synthetic healthcare data are generated to meet specific needs or certain conditions that may not be found in the original, real data. This can be useful when designing any type of system because the synthetic data are used as a theoretical value, situation.� Synthetic data is information that's artificially manufactured rather than generated by real-world events. Synthetic healthcare data is created algorithmically, and it is used as a stand-in for test datasets of production or operational data, to validate mathematical models and, increasingly, to train healthcare machine learning models.� The contractor will assist the VHA in the design, testing and deployment of various synthetic data technologies in the clinical care delivery setting. Examples include synthetic healthcare data sets that provide a vast amount of synthetic medical data (i.e. genomic data), various measurements, financial data, statistical data, demographics of specific populations, and insurance data.� The contractor must possess a deep knowledge of the use of synthetic data 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. Secure Model Operations AI Platform to Discover, Deploy, Manage & Govern Machine Learning at Scale Through algorithmic analysis of healthcare data, AIOps helps VHA�s clinical teams work smarter and faster, so they can detect digital-healthcare service issues earlier and resolve them quickly before business operations and customers are impacted.� AIOps is short for artificial intelligence for IT operations. It refers to multi-layered technology platforms that automate and enhance IT operations through analytics and machine learning (ML). The contractor will assist the VHA in the design, testing and deployment of various AIOps technologies in the clinical care delivery setting. Examples include digital transformation, as a natural place for AIOps within service management as a means to automate processes and automatically spot and react to issues in real-time.� The contractor must possess a deep knowledge of the use of AIOps 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Data Platforms and Systems Integrator A data platform is an integrated technology solution that allows data located in database(s) to be governed, accessed, and delivered to users, data applications, or other technologies for strategic business purposes. Systems Integration is the process of creating a complex information system that may include designing or building a customized architecture or application, integrating it with new or existing hardware, packaged and custom software, and communications.� The contractor will assist the VHA in the design, testing and deployment of various data platforms and systems integration technologies in the clinical care delivery setting. Examples include VHA�s Electronic Health Record Modernization (EHRM) effort or Cerner implementation.� The contractor must possess a deep knowledge of the use of data 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. � Internet of Things (IoT) and Wearables The Internet of things (IoT) describes the network of physical objects�a.k.a. ""things""�that are embedded with sensors, software, and other technologies for the purpose of connecting and exchanging data with other devices and systems over the Internet.� The contractor will assist the VHA in the design, testing and deployment of IoT technologies in the clinical care delivery setting. Examples include connected appliances, smart security systems, autonomous equipment, wearable health monitors, smart equipment, ultra-high-speed wireless internet and biometric scanners.� The contractor must possess a deep knowledge of the use of IoT 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. Genomic Epidemiology Genetic epidemiology is the study of the role of genetic factors in determining health and disease in families and in populations, and the interplay of such genetic factors with environmental factors. Genetic epidemiology seeks to derive a statistical and quantitative analysis of how genetics work in large groups.� The contractor will assist the VHA in the design, testing and deployment of genetic epidemiology technologies and or studies in the clinical care delivery setting. Examples include epidemiological technologies or studies that measure the risk of illness or death in an exposed population compared to that risk in an identical, unexposed population (a population the same age, sex, race and social status as the exposed population). The contractor must possess a deep knowledge of the use of genomic epidemiology 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. Clinical Trial Development A clinical trial is a research study conducted in human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective.� The contractor will assist the VHA in the design, testing and deployment of clinical trials in the clinical care or virtual delivery setting. Examples include new drugs, medical devices, biologicals, vaccines, surgical and other medical treatments and procedures, psycho-therapeutic and behavioral therapies help service changes, preventative care strategies and educational.� The contractor must possess a deep knowledge of conducting clinical trials including any emerging FDA regulations and policies surrounding emerging capabilities and/or subsequent technologies, as well as a knowledge of clinical effectiveness studies and/or evaluation across multiple clinical settings. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation, including biostatistics, trial monitoring and clinical integration of new protocols. 5.2.X Clinical Trials In Silico The ability to conduct clinical trials using existing clinical datasets has advanced dramatically in the past decade. Clinical trials in silico are now used to examine the safety and effectiveness of existing treatments for new indications.� The contractor will assist the VHA in the design, and conduct of clinical trials in silico. Examples include new drugs, genomic data, biologicals, vaccines, surgical and other medical treatments and procedures, psycho-therapeutic and behavioral therapies help service changes, preventative care strategies and educational.� The contractor must possess a deep knowledge of conducting clinical trials in silico including any emerging FDA regulations and policies surrounding emerging capabilities �and/or subsequent technologies, as well as a knowledge of clinical effectiveness studies, drug-device pairs, and/or evaluation across multiple clinical settings.� Translating VA Discoveries to Clinical Care The VA supports a robust discovery research program but often investigators do not have the knowledge and skills needed to take discoveries from laboratory research to�pre-clinical and�clinical�research and licensing.�This includes drugs, biologics, biomarkers, and devices, each area involving different pathways and regulatory issues. The contractor will assist VHA in evaluating discoveries, developing a de-risking plan to facilitate�regulatory filing, conducting needed�regulatory-compliant�studies, and assisting with licensing efforts.�For the devices-related research, the contractor must have deep knowledge of the FDA's�regulation for in vitro diagnostic (IVD)products and a track record of supporting successful approval of IVD devices. For the�drugs and biologics-related research, the contractor must have demonstrated experience of conducting pre-clinical animal studies, relevant bioanalytical studies to support Pharmacokinetics/Pharmacodynamics (including but not limited to the development, validation and implementation of applicable bioanalytical technologies, such as quantification of drugs, biomarkers. Proteomics, RNA seq, DNA sequencing, Mass Spectroscopy, Imaging, etc.); where needed, the contractor must be capable of producing drug entireties in cGMP facilities.�Overall, the contractor must have knowledgeable and experienced scientific and technical staff and suitable infrastructure for conducting the studies, knowledge of technology transfer processes, efficient project management, open communication, timely data analysis and reporting, and a track record of dealing with FDA and successful regulatory findings. � Biostatistical Support Contractor will support VHA in providing biostatistical support for a range of biostatistical needs that include but are not limited to design of clinical trials and other research studies, analysis of the results of clinical trial and other research studies, genomic analysis, proteomic analysis and microbiome analysis. Contractor must possess subject matter expertise in biostatistical analysis for clinical and biomedical applications as well as a knowledge of potential regulatory issues that would be important in translating findings to clinical applications. � Digital Twins A digital twin is a virtual representation that serves as the real-time digital counterpart of a physical object or process. A digital twin is, in essence, a computer program that uses real world data to create simulations that can predict how a product or process will perform. These programs can integrate the internet of things, artificial intelligence and software analytics to enhance the output.� The contractor will assist the VHA in the design, testing and deployment of digital twins in the clinical care delivery setting. Examples include digital twins used to optimize machines with the maintenance of healthcare equipment such as biomedical appliances, where the combination and integration of the three digital twins Product, Production, and Performance evolve together to create the digital thread. Another example of digital twins is the use of 3D modeling to create digital companions for the physical objects.� The contractor must possess a deep knowledge of the use of digital twins 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. The contractor must also possess a knowledge of clinical protocol design and subsequent deployment, design, data measurement and evaluation and clinical integration of new protocols. Task 3. Clinical Simulation Training The contractor shall support SimLEARN in its mission to advance clinical training through healthcare simulation by providing subject matter expertise to design, implement and further advance pre-defined and limited (by the government) healthcare simulation courses or modules. Successful completion of this task will require subject matter expertise in clinical care delivery, healthcare education and training, healthcare simulation, simulation and curriculum design, healthcare informatics as well as research methods for analysis of learning objective and impact. Courses will be determined by SimLEARN leadership under the direction of clinical leads, both in medicine and nursing. Training and curriculum plans shall include comprehensive design of the simulated scenarios, necessary educational materials, and competency assessments developed independently by the contractor or in support of the larger SimLEARN Learning consultants using the Analysis, Design, Development, Implementation, and Evaluation (ADDIE) model. The contractors will provide the necessary subject matters experts for in-person training modules as well coordinate amongst necessary government subject matter experts, other federal agencies (e.g. Department of Defense) and industry partners (e.g. Cerner Corporation) when such coordination for successful design and execution of a simulation course is necessary. Contract support would bolster this effort through the lifecycle of course design and implementation. Number of courses for which the contractor will support will be limited to 4 for the duration of 12 months. Contractor will be responsible for submitting monthly status reports on efforts towards training and curriculum development. Task 4. Clinical Simulation and Training to Enhance Adoption of Emerging Technology in Clinical Care Delivery The contractor shall assist in the development of up to 4, for the duration of 12 months, simulation and workflow analysis ...
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