JA-NCI-Extension_for_Digital_Health_Solutions_for_COVID-19.pdf

Justification and Approval for Other than Full and Open

Competition

"Source Selection Information - see FAR 2.101 and 3.104"

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS/National Institutes of Health/National Cancer Institute (NCI)

b. Sponsoring organization.

National Institutes of Health/National Cancer Institute (NCI) and National Institute of Biomedical Imaging and Engineering (NIBIB)

c. Program Manager information.

• Program Manager's name: Andrew Kurtz

• Mailing address: 31 Center Drive, Room 1 0A33, Bethesda, MD 20892-2580

• E-mail address: kurtza@mail.nih.gov

• Telephone number: 301-640-1065

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

To modify Contract No: 75N91020C00038 and extend the period of performance of the contract titled, "Digital Health Solutions for COVID-19' COVID Community Action and Research Engagement (COVID-CARE", by an additional 3 months. The new period of performance will be from September 14, 2020 to December 13, 2021. This action will not require any funding. Contract No: 75N91020C00038 has sufficient funds. This extension will allow sufficient time for completion of ongoing studies and analysis of the data collected as part of these studies.

b. Project background.

The proposed project is a continuation of an ongoing contract to Vignet, Inc. under Contract No: 75N91020C00038. The original contract was awarded under a special initiative as part of NCl's and NIBIB's congressionally supported response to COVI D-19. The original period of performance was September 14, 2020 through September 13, 2021. The total dollar amount obligated to date is $4,025,915. The initial award to Vignet Inc. was made under Other Than Full and Open Competition Limited Source, per FAR 6.302-2 - Unusual and Compelling Urgency, and the proposed acquisition is necessary to satisfy the original technical requirements of the project.

Vignet has leveraged its Vibrent Digital Health Solutions Platform (DHSP) to implement large-scale validation of this technology among diverse user groups (e.g., race, ethnicity, age, socioeconomic and health status) to support individual, organizational, community and societal-level decision-making in the COVID-19 pandemic response. The current contract involves two studies designed to evaluate whether combining symptom screening with at-home COVID-19 testing can improve testing accuracy, as compared to at-home testing alone. Vignet is performing an evaluation to establish the effectiveness of symptom screening and at-home testing for a study population of 600 participants (Study 1), and they are also performing a separate study to demonstrate generalizability and acceptability of this testing strategy in an underrepresented population of 250 participants (Study 2).

As of 8/13/2021, the enrollment for Study 1 was 53% complete (319 enrolled out of 600 planned), and the enrollment for Study 2 was 47% complete (118 enrolled out of 250 planned). Patient enrollment was slower than anticipated during the spring and early summer 2021, in part due to the substantial increase in COVID-19 vaccinations and corresponding decrease in infections across the US, including the catchment area for Vignet’s studies. Subsequently, the emergence of the COVID-19 Delta variant in July 2021 led to a new wave of COVID-19 infections. This re-emergence of new infections has contributed to a recent increase in enrollment for Vignet’s two studies. The contract is still within the current period of performance; however, due to the enrollment delays during the spring and early summer 2021, it is requested that the contract be extended for an additional 3 months to complete Studies 1 and 2. Current trends in COVID-19 positivity in the regions that this study is engaged support a very high likelihood that this time is necessary and sufficient to fulfill recruitment goals and yield sufficient statistical rigor for the intended analyses. If recruitment falls short for any other reason at this point, it is unlikely that allowing for more time will resolve those issues.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Digital Health Solutions for COVID-19; COVID Community Action and Research Engagement (COVID-CARE)

b. Project description. See attached Statement of Work

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment

Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.:

New requirement Follow-on Other (specify): Bilateral Modification for a No-Cost

Extension

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. 75N91020C00038

c. Total estimated dollar value and performance/delivery period.

$4,025,915; No additional funds are required for this action.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(i)(a).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Vignet Inc.

3811 Wheatgrain Lane Fairfax, VA 22033-2168

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Vignet has the unique qualifications to provide the services for this requirement and is the only organization that can complete the specific work at this time. Vignet was responsible for conceiving, designing, and implementing the two studies underway, in addition to providing a novel technology platform necessary for the study design, and therefore has specialized knowledge and experience in meeting the remaining requirement. The specific innovation developed under this contract involves a proprietary, Artificial Intelligence (AI)-powered COVID-19 screening and testing tool. The development and validation of this tool required one year of intensive data collection, algorithm development, and continuous refinement. Importantly, to successfully deploy this new tool to address the COVID-19 pandemic, Vignet integrated the tool with its existing Digital Health Solutions Platform (DHSP), which has been under development for several years. Additionally, Vignet spent significant time establishing the necessary infrastructure to support the ongoing studies, including securing research collaborations and developing sophisticated recruitment strategies, which could not be easily replicated by another source within an acceptable timeframe.

Considering the complexity of the study design, the advanced stage of development of Vibrent’s existing DHSP platform, and the costs and timeframes associated with the specific tool developed under the current award, we estimate it would take another vendor approximately 1-2 years to get up to speed at a cost of $3M. Transferring the ongoing studies and data to another contractor is not realistically feasible at this stage in the project.

It will be critically important for Studies 1 and 2 to reach their total enrollment targets to realize the full value of these studies. Vignet has been performing the studies and has collected the data required for analysis of the full data set. In the near term, full participant enrollment will generate additional data that will help the NIH to better understand the benefits of combining symptom screening with at-home COVID-19 testing. Full participant enrollment is necessary to provide sufficient statistical strength for the proposed analyses and decision model being developed. Without this extension, recruitment is unlikely to exceed ~50% and would thereby lack scientific rigor. Longer term, the additional data obtained under this acquisition will provide a more robust data set that can be publicly accessed (via a centralized Data Hub) to support future research studies on COVID-19 and future pandemics. This modification does not require additional funding, as Vignet has sufficient funding to complete the final deliverables.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A pre-solicitation notice of the Government’s intent to Sole Source for a three-month no-cost extension was posted to SAM.gov on August 25, 2021. No responses were received by the notice closing date of 3:00 PM EDT, August 30, 2021. A Justification and Approval notice will be posted to SAM.gov within 14 days of any resultant contract modification being executed.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

This J&A is at no additional cost to the Government - the modification will not obligate funds or increase the contract value. Cost/price reasonableness was conducted for the original award, and a determination of fair and reasonableness price is documented in the award file. There have been no modifications that have changed the contract value.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

For the initial award, the National Cancer Institute conducted market research by publishing a Request For Information (RFI) on the Government Point of Entry, beta.sam.gov on May 26, 2020. The RFI was also provided to the Small Business Innovation Research (SBIR) office and the NIH Office of Small Disadvantaged Business Utilization for dissemination to the small business community and posted on the NCI website. This special notice provided the objectives of this requirement and invited interested vendors to participate in an informational web conference hosted by NCI and NIBIB. The conference was held on May 29, 2020 pursuant to the market research technique as stated in FAR 10.002(b)(2)(v) for an interchange meeting to give industry an opportunity to communicate with acquisition personnel and program staff. The interested vendors were asked to submit capability statements following the web conference to NCI by 5:00PM on June 5, 2020. The capability statements were evaluated by a team of experts from NCI and NIBIB.

Eleven organizations were identified as likely to be capable to provide a solution to the Government’s research needs with unique capabilities offered by each vendor. Of the 11 proposals submitted, only 7 were found Technically Acceptable by a peer review technical evaluation panel, and awards were negotiated with those 7 vendors. Each of these 7 awards represented a unique project in its response to the Broad Agency Announcement solicitation’s research objectives.

NIH Project Officers have remained abreast of technology developments in the marketplace since the COVID-19 outbreak and the award of this initial contract, and no capability statements, proposals, or communications among the scientific community have indicated that there are substantially similar technology platforms that have achieved the technical objectives set forth in the research and development and supporting clinical studies undertaken by Vignet. It would also not be feasible to substitute in a different vendor to complete the research and development project designed by this vendor due to intellectual property issues with a proprietary technology platform, as well as clinical study protocol complexities which would unreasonably delay the achievement of research objectives critical to responding to an ongoing pandemic.

9. Any other facts supporting the use of other than full and open competition.

The COVID-19 pandemic has evolved rapidly since it began in early 2020 and is continuing to evolve in real time. During the last 11 months, Vignet has demonstrated the ability to meet these changing demands while remaining focused on the core activities and deliverables under this contract. Seeking a follow-on contract from any other source would result in unacceptable delays in fulfilling NIH’s requirements, as this would require another organization to spend several months to a few years building the knowledge, skills, technical competencies, and infrastructure necessary to complete the work. COVID-19 infection rates are presently at 65% of their peak in January 2021 and are rising fast due to the spread of the COVID-19 delta variant. There is an urgent need to complete the two studies initiated by Vignet, so that the benefits of their testing approach can be fully leveraged within a matter of months to address the ongoing pandemic. Selecting another vendor would delay critical results that would hamper our ability to reduce COVID-19 infections (and save lives) over the next 6-12 months. Additionally, Vignet retains patent rights, copyrights, and other proprietary processes that are likely to delay the Government’s ability to obtain these services from another source.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed interest.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

No further acquisitions of this nature are anticipated. This requirement will not be recompeted.