P03 SOLE SOURCE JUSTIFICATION 1_Redacted.pdf

Caymus iRIS Limited Enterprise TAC: VA-22-00071865

SOLE SOURCE JUSTIFICATION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center-Division G 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for a Firm-Fixed-Price contract to obtain iRIS (a subsidiary of Cayuse) software licensing and supporting services of the Caymus iRIS Limited Enterprise (formally called the iMedRIS Research Suite) to support the Loma Linda VA Healthcare System at 11201 Benton Street, Loma Linda, CA 92357.

3. Description of the Supplies or Services: The proposed action is to provide an integrated software suite of products and services that will support Animal Management Solutions (e.g., Institutional animal Care and Use Committee (IACUC) & Applied Research Center (ARC)), Human Subjects (e.g., Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Scientific Review Board (SRB) etc.), Grants Administration (e.g., Pre/Post Award), Conflict of Interest, and other administrative solutions for the research community. The period of performance is August 14, 2022, through August 13, 2023, with four 12-month option periods.

4. Statutory Authority: In accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i), “Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available…” for purchases not exceeding the simplified acquisition threshold.

5. Rationale Supporting Use of Authority Cited Above: The Caymus iRIS Limited Enterprise software licensing and supporting services delivers a focused suite of research compliance and administration software. This product is used in the study, design, development, enhancement, implementation, and supports various aspects of research information and data. Based upon market research, as described in section 8 of this justification, it was determined that only the subject software has the capability to satisfy the department of Veterans Affairs Loma Linda Healthcare System (VALLHCS) requirement for the continuous use of a single suite product to document and maintain research continuity. iRIS has been in place and significantly embedded in the VALLHCS research environment for long-term research studies that require continued monitoring in, and outside the VALLHCS environment. No other source is capable of sending the information through the layered approval process required for the integration of committee approval. Acquisition of a new or different research data integration system or product would result in substantial reduplication of costs.

VALLHCS Office of Research Development is using iRis software for Protocol Compliance of all approved Research Basic and Clinical Studies. This service helps to manage compliance and streamline the documentation review and evaluation process.

The purpose of this contract is to continue to use iRis until IRBNet, the VA’s National Protocol Compliance Contract is operational and active at VALLHCS. Only the iRis software system can provide the necessary software updates because of the proprietary source code required to develop and implement software updates. No other source is compatible or interoperable with the existing iRis infrastructure that meets the government’s unique functional needs. To incorporate a new software could result in the facility losing access to in Veterans Equitable Resource Allocation (VERA) dollars, which could not be recouped, Additionally, it would require VA to purchase an entirely new product and invest resources to convert existing data into a new platform rather than expand on the existing infrastructure.

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. 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: The Government’s technical experts conducted market research during FY2022 that included reviewing similar software products such as Research Gate, Zotero, and Idea Rover to ascertain if other brands could meet VA’s functionality requirements. The evaluation of these systems and IRBNET have found that the functionality provided is similar to a docushare system and does not provide the same functionality as the iRis software that is currently in use. Specifically, the other software options do not meet the requirements as they do not provide the ability for projects to go through multiple levels of review concurrently through various committees while maintaining source document validity. Additional web-based research was conducted that did not identify any other products that could meet the minimum needs of compliance with research committee reviews, document integrity, and compliance with research regulations for human subjects, animals and biosafety nor can others offer a seamless migration of existing research records and products. VA networking Subject Matter Experts regularly review industry trade publications and conduct internet research to ascertain if any other branded or industry standard software product is available that meets the requirements of the agency. Based on all of these market research efforts, the Government’s technical experts have determined that only the aforementioned iRis software licensing and supporting services can meet all of the VA’s needs.

The Contract Specialist (CS) conducted market research in June 2022 by using the NASA SEWP V GWAC and General Services Administration (GSA) Federal Supply Schedule Research and Provider Lookup tools to determine what vendors are capable of meeting the requirement. Based on this market research, the CS was unable to locate any resellers of this software capable of meeting the full requirement.

9. Technical and Requirements Certification: None