C01 Redacted Curapatient Justification.pdf

Control Number: VA-20-00081347

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for award of a firm-fixed price (FFP) contract to Curapatient Inc. (Curapatient) located at 100 Spectrum Center Dr. Ste 250, Irvine CA 92618-4964 for software licenses and support services.

3. Description of Supplies or Services: VA National Artificial Intelligence Institute (NAII) has a requirement for Curapatient Commercial-Off-the-Shelf (COTS), hosted, cloud-based, COVID-19 Care Plan Management solution, which utilizes Artificial Intelligence (AI) techniques and technologies, and Software as a Service (SaaS) delivery model for VA Medical Center (VAMC) locations in Washington, DC and Long Beach, CA for a total of approximately 700 patients and 10 clinicians at each site. This solution shall assist clinicians and patients in managing complex health conditions, specifically for COVID-19 monitoring and management, and promoting social distancing. The SaaS solution shall include a web-based, patient-facing component, along with a web-based, clinician facing component compatible with MS

Windows. This COTS solution shall also provide VA NAII with quantitative and qualitative data to support its ongoing mission. Furthermore, the proposed action requires support services from the Original Software Developer (OSD), which include training and remote (virtual) support, as well as additional support services to obtain the required Federal Risk and Authorization Management Program (FedRAMP) and VA Authority to Operate (ATO). The period of performance (PoP) of this proposed effort shall be 12-months from date of award, with up to one subsequent 12-month option period, if exercised. The total PoP shall not exceed 24 months.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition

Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: Based on Market Research as outlined in section 8 of this Justification, no other source, other than the proposed source, Curapatient, can meet all of the technical and functional requirements.

The NAII seeks to develop AI research and development capabilities in VA as a means to support Veterans, their families, survivors, and caregivers. The NAII is dedicated to advancing AI research and development for real-world impact and outcomes to ensure Veteran health and well-being. As such, NAII recognized that VA’s care plan management, hospital readmissions, and the outpatient management of complex health conditions could be better managed with the assistance of AI.

Curapatient software licenses and support services Control Number: VA-20-00081347

Further, the use of AI in care plan management enables unique opportunities to advance research into the use of AI to train models relevant to care plan management and complex conditions. With the arrival of COVID-19 as a public health emergency, the same principles of care plan management, with the additional complications of social distancing, tracking large panels of potentially at-risk patients, and monitoring a condition that can rapidly accelerate towards hospitalization or death, the need for an AI-driven care plan management solution became even more evident and the proposed scope of the project shifted to focus on AI driven solutions for COVID care plan management at home. As such, VA identified the requirement for the proposed action.

The Market Research indicates that no other solution currently offers an already developed, AI-driven, COTS care plan management capability that is able to meet the Government’s requirements for integrating into patient care workflows, clinical settings, and patient at home settings, and therefore does not meet the

Government’s timeliness requirements. Given the increased strain on hospitals during this pandemic, and patients being required to self-quarantine at home and maintain social distancing, a solution is required in the short term which utilizes AI and machine learning (ML) to monitor patients’ complex health conditions and care management. As such, there currently is no other COTS solution with this AI capability developed and integrated, and therefore, there are no other sources, other than the proposed, that can meet VA’s timeliness requirements due to the existing pandemic. Any other solution would have to be developed and successfully tested prior to even beginning the process to obtain the required FedRAMP compliance/VA ATO. Only then could it be used to provide care and monitoring. VA estimates that this could take an additional three to six months.

Additionally, VA is actively seeking to leverage the AI and ML inherent in this solution into clinical care in order to provide the ability to identify and reconcile medications virtually to allow medication in pill form to be identified in real-world situations through images (or video), and use natural language processing to identify sentiment, and variations within it, when interacting with patients to determine if in-person intervention is needed. VA also requires the capability to utilize AI to include unsupervised learning to perform cluster analysis and provide easily understood dashboards that clinicians can use to manage large clusters of patients who are isolating at home. The proposed solution will ultimately provide data from the AI model to VA researchers, which can be used for training purposes and will accelerate future Research and Development (R&D) efforts into integrating AI in healthcare, ultimately providing better patient care to the Veteran. No solution, other than the proposed, currently exists which has these AI capabilities integrated into patient care plan workflows for clinical settings and at home settings.

Further, no source, other than the proposed, can meet the requirements set forth in the Performance Work Statement related to VA’s functional requirement to provide an activity feed and stratified roles. These functional requirements ensure changes in patient status are communicated at the appropriate level to clinical providers who

Curapatient software licenses and support services Control Number: VA-20-00081347 can intervene or escalate the information in a timely manner by providing a real time metric. For example, the Curapatient solution provides AI functionality to interpret changes in patient vitals in terms of direction and magnitude and not just standard deviations. This allows for contextual decision making by VA’s clinicians.

Additionally, the proposed support services to be performed under this effort must be provided by the OSD. While other developer and professional groups may be able to provide base functions such as routine maintenance or helpdesk services, activities such as obtaining the required ATO or FedRAMP approval, and certain maintenance activities will require access to the source code. As such, only the OSD has access to this information.

Therefore, based on the above, only the proposed source, Curapatient, can satisfy all of the Government’s requirements detailed above. To prevent loss of life and catastrophic degradation in patient care, VA must have the capacity to integrate new technologies into its healthcare workflows and practices. Not procuring as proposed, will significantly impact VA’s clinicians ability to perform its mission of providing care to the Veteran, specifically in identifying, documenting, and intervening in patient outcomes, as well as decrease the burden on the tracking of patient data which could lead to clinician burnout.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201.

Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: VA performed Market Research via release of a sources sought/request for information (RFI) announcement published on the Contracting Opportunities Page (36C10B21Q0524) on September 16, 2020. Nine responses were received and reviewed by VA and its technical experts. Based on this review and analysis, the VA’s subject matter experts determined that only Curapatient can meet the Government’s requirement as noted in section 5 of this Justification.

Additionally, VA confirmed that the Curapatient software licenses are proprietary software products of Curapatient Inc. and that Curapatient is the sole authorized source to provide the technical support services. Based on the market research and review of the Curapatient Inc.’s capability statement, the Government’s technical experts have determined that Curapatient Inc. is the only source that could meet all of the Government’s requirements.

9. Other Facts: None.