S02 - Redacted_SS JA - DataFax2.pdf

FORCE Number VA-23-00036295

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: This proposed action is for a 12-month firm-fixed price sole source contract with one option period and optional tasks to DF/Net Research, Inc., 140 Lakeside Ave Ste 310, Seattle, Washington 98122, a Woman-Owned Small Business (WOSB) for the renewal of DFdiscover (also known as DataFax or iDataFax) software server licenses, maintenance, support and user seats in support of the Cooperative Studies Program Coordinating Centers (CSPCC).

3. Description of Supplies or Services: VA, Office of Information and Technology, CSPCC has a requirement for the renewal of 100 existing DFdiscover software server licenses, maintenance, support and user seats for VA to distribute as needed for use within the Cooperative Studies Program to allow CSPCC to continue to collect and conduct multi-site research and clinical studies. CSPCC requires full feature electronic data capture tools that will provide data collection and data analysis management in a single comprehensive software. These multi-site research and clinical studies follow strict scientific/regulatory guidelines comparing different treatment methods to determine cost benefits of treatment, efficacy of treatments, and determine new standards of care/treatment for Veterans. The software allows the centers to collect clinical data for current ongoing multisite clinical trials by electronic data entry. In addition, CSPCC requires a rich, programmable edit check language to detect problems, display warnings, request corrections when filling out forms and remote site monitoring capabilities. The maintenance and support include unlimited phone and email technical support, on-line self-help, software patches and updates for the software.

The period of performance is a 12-month base period from March 9, 2023 through March 8, 2024, along with technical support above the included maintenance, live or computer based training, and a separate randomization software module validation as optional tasks to be exercised anytime within the base period of performance.

There is one 12-month option period with the before mentioned optional tasks (to be exercised anytime within the option period of performance) for continued maintenance and support. The total estimated value of the proposed action is

, inclusive of option period and optional tasks.

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.”

DFdiscover Software Servers Licenses, Maintenance, Support and User Seats

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is DF/Net Research, Inc. DF/Net Research, Inc., is the sole provider of the CSPCC’s required DFdiscover software, as detailed in section 8 below. DF/Net Research, Inc., owns all proprietary program language and the intellectual property of all software products under the DFdiscover umbrella. As determined by market research, other software products exist with similar capabilities, but these products do not satisfy the CSPCC’s requirements for execution of research and clinical study trial management nor does any other license allow use of the proprietary DFdiscover implementation that CSPCC’s system was built on. Further, the data stored on the DFdiscover platform at CSPCC contains research and clinical data that is critical to the VA’s research and development mission, and no other third-party software providers can provide access to, or integrate with, the DFdiscover platform, and would render the research data inaccessible and the studies inoperable, causing serious disruptions to studies which improve VA’s ability to care for its patients. To ensure that safety events are reported within regulatory guidelines and minimize the risk of non-compliance of regulations, automated alerting is the standard. Only the DFdiscover software can provide customized real-time automated alerts as outlined per study protocol. These automated alerts are implemented through an extensive proprietary edit check language that is also used for customizable data cleaning capability, Serious Adverse Event (SAE) alerting and electronic Data Capture (eDC) capabilities and support. The customizable edit check capabilities listed previously allow for automation of highly complex protocols to ensure the integrity of the clinical trial protocol by taking the human error factor out of the mix.

Additionally, DF/Net Research’s DFdiscover software is the only product option that can satisfy VA CSPCC’s requirement for eDC capabilities with the support included.

If any other vendor’s solution were to be utilized, even if there were another software capable of meeting VA’s functional requirements, a full-scale replacement of the CSPCC’s data management system would be necessary. A full-scale replacement of the CSPCC’s data management system, inclusive of custom processes built around the current system including SQL Databases, data processing scripts and SAS Programs, would come at a significant duplicative estimated cost of approximately $850,000.00, take a minimum of a year to deploy, validate the new system, and recreate all existing data. During this time, the aforementioned studies would be disrupted. These estimates of cost and time are based on previous acquisition history and would not be recovered through competition. To introduce another software product would also require halting all data collection while CSPCC engages in a complete re-design of the existing clinical studies running on DFdiscover, recreation of collected data, re-training of study and site staff and validation of new system. Disruption in service would have a severe negative effect on ongoing trials and the Veterans enrolled in these studies.

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

DFdiscover Software Servers Licenses, Maintenance, Support and User Seats 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: The Government's technical expert conducted web-based market research in October 2022. Specifically, the Government's technical expert reviewed alternative solutions from DataLabs and MediData (Large Businesses).

Based on reviews of their products, the Government’s technical expert determined they could not satisfy VA CSPCC requirements for electronic data capture customization capabilities and support. It was found that no other entity has the capability to deliver a license for the DFdiscover software suite. Only the DFdiscover system provides electronic data capture, a robust edit check language, and electronic data export tools for managing, analyzing, and visualizing collected clinical data. VA Subject Matter Experts regularly review industry trade publications and conduct internet research efforts, the Government’s technical expert determined that only DF/Net DFdiscover software can meet all of VA’s functional requirements and avoid the duplication of time and cost as outlined in Section 5 of this justification.

The Contract Specialist (CS) conducted market research in January 2023 by using National Aeronautics and Space Administration Solutions for Enterprise- Wide Procurement V Governmentwide Acquisition Contract Market Research Tool and Provider Look-up Tool in February 2023 to determine if any Service- Disabled Veteran-Owned Small Business (SDVOSB) contract holders can provide the full requirement. Based on the market research, the CS found zero SDVOSBs capable of meeting the full requirement. The CS contacted DF/Net Research Inc by email, and received a sole source letter dated February 9, 2023, stating they do not have any authorized resellers of the DFdiscover software. The letter has been placed in the contract file. Based on this market research, the Government does not expect to receive two or more offers from SDVOSBs.

Based on this market research, it was also determined that there is no similar software product that provide all the required functionality, as discussed above.

The software and software maintenance required for this effort was not developed by a SDVOSB and will be acquired as a sole source basis from DF/Net Research Inc. This requirement shall be issued as a sole source to a

WOSB.

9. Other Facts: None.