P03 - JA Informed Consent Web ICW - Final_Redacted.pdf

Informed Consent Web (ICW) CONTROL NUMBER VA-24-00101146 competed. To promote competition VA is adjusting the requirement. Based on market research, as detailed in Section 8 of this justification, no other source can immediately provide the required continuation of the fully implemented and integrated ICW solution, software licenses and maintenance.

Taylor provides the only solution that is compatible with VA’s existing systems, including VistA, Computerized Patient Record System (CPRS), EHR, and current VHA business processes. Any disruption of service or maintenance would negatively affect VA’s ability to provide the ongoing documenting of patients’ signature and informed consent for over 2,400 treatments/procedures, capturing information for individual treatments/procedures required on multiple VA Forms. Without consent software, the VA’s mission to provide healthcare services to Veterans would be impacted. The VA would lose access to the critical software that captures patient consent on medical procedures performed throughout the VA enterprise. Losing access to this software, even for one day, would impact the Veterans who receive treatment daily throughout the VA.

Taylor is the only source with immediate access to a database of the medical content and VA Forms required to document signature informed consent. Without this functionality, the VA will lose the ability and the functionality for electronic signature informed consent, and patient education documents for all medical specialties, stored in the VA electronic patient health record, with a single sign on capability using a Personal Identification Verification (PIV) card. It is operationally infeasible to go back to paper. If a contract is not in place to continue support and services, the project will be unable to operate, sustain and maintain the vital Informed Consent system. The Informed Consent software is used by VA Providers and their Veteran patients to complete more than 3.3 million consent forms each year for treatments and procedures (e.g., colonoscopies, transfusions, and opioids prescriptions.

In addition, Taylor is the only source with proprietary rights to the source code necessary to deliver the software and database access, as well as provide the software maintenance and technical support required by VA. Specifically, no other source has access to Taylor’s proprietary source code to deliver, configure, test, and integrate with the existing brand name Taylor ICW application. Taylor is the Original Software Developer and Intellectual Property (IP) Owner of the ICW application and does not authorize any other source to modify its proprietary code.

Taylor is the only source with access to the necessary proprietary data elements, systems, and ICW software and source code. Without authorized access to Taylor’s IP and source code, any other developed source code or configuration would cause bugs, errors and/or security breaches to the ICW application. No other source has access to the proprietary source code necessary to provide software maintenance. Additionally, due to these proprietary constraints no alternative software is interoperable with the existing brand name Taylor ICW application. Due to the proprietary constraints, the use of any other vendor capture documentation software would require the replacement of the existing brand-name Taylor ICW application in place. This would result in an estimated amount of M in duplication of cost based on procurement history and an estimated minimum of 12 months to implement an alternative solution.

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: No barriers to future competition are anticipated.

VA anticipates issuing a competitive solicitation by 2nd Quarter of FY2025 and all future acquisitions will be awarded on a competitive basis.

8. Market Research: The Government’s technical experts conducted market research from June 2023 through July 2024 to ascertain if other sources could meet VA’s functionality requirements, including web searches. Specifically, technical experts reviewed Agile Modern Secure (AMS) Networks and Automated Resources Technology & Training (ARTTRA) and determined that the solutions are not interoperable and compatible with Vista and EHR.

Market research was also conducted by the CS confirming with Taylor that the software is proprietary, and no resellers exist. Taylor confirmed this information on August 30, 2024. Due to the proprietary restrictions, no other vendor can access the software code or work with the existing database. The government’s technical experts have determined that Taylor Communications, Inc. is the only source that can meet all of the VA’s requirements.

9. Other Facts: None.

10. Technical/Requirements Certification I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Date

11. Fair and Reasonable Cost Determination I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on price analysis to include comparison of proposed prices to the Independent Government Cost Estimate (IGCE) and historical pricing.

12. Contracting Officer Certification/Approval I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve with the acquisition of an Enterprise COTS, cloud-based, signature informed consent solution, pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.