REDACTED_JA_VISN 23 HTM-Biomed Data Innovations Support.pdf

VISN 23 HTM/Biomed Data Innovations Support CONTROL NUMBER VA-26-00019720

LIMITED-SOURCES JUSTIFICATION

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 action is for a sole source, firm-fixed-price (FFP) contract with a 12 month base period and three (3) 12-month option periods to Data Innovations, LLC, 463 Mountain View Drive, Suite 305, Colchester, Vermont 05446- 5952 for the annual license renewal of brand name Data Innovations, LLC’s Instrument Manager, to include maintenance and regular software support for the production and test systems at all eight (8) VISN 23 locations. This effort is being conducted under the authority of the Multiple Award Schedule (MAS) Program; the proposed effort will be awarded under the General Services Administration (GSA) Federal Supply Schedule

GS-35F-389DA.

3. Description of the Supplies or Services: VA, Veterans Health Administration, Veterans Integrated Service Network (VISN) 23, Pathology and Laboratory Medicine has a requirement for the annual license renewal of brand name Data Innovations, LLC’s Instrument Manager, to include maintenance and regular software support for production and test systems which includes software, maintenance, support and hardware. The Data Innovations, LLC’s Instrument Manager is VA’s Laboratory Information System (LIS). It is the link between the lab analyzers and the Veterans Health Information System Technology Architecture (VistA) Computerized Patient Record System (CPRS). This system uses the Information and Technology platform at all eight (8) VISN 23 laboratory locations for instrumentation management. The VISN 23 locations utilize the brand name Data Innovations, LLC’s Instrument Manager middleware for the process of getting the clinical laboratory analyzer results into VistA CPRS. VA requires a Health Level Seven (HL7) capable product that is compatible with VistA to ensure that laboratory tests could be downloaded to the VistA computer system without any operator intervention. The sustainment and support services allow for HL7 messaging, development of rules, which is necessary for auto-verification of patient test results and data pulls, support of the auto-verification capabilities within the DI middleware system, installation, and configuration support for DI IM software license on middleware systems (Production, Shadow, Test, and Reports Manager)In order to remain functional, the brand name Data Innovations, LLC’s Instrument Manager software requires annual license renewal, to include maintenance and regular software support to assure timely and accurate data flow to support patient care. The Data Innovations, LLC’s Instrument Manager software license sustainment and support services are required in order to provide continued support to the licenses, which allows for non-emergency telephone support from 9 am to 8 pm Eastern Standard Time, 24x7x365 emergency support, software patches/updates, enhancements and new release versions, individual login credentials for accessing Customer Web Portal to submit and track requests for support, availability of online knowledge base, driver download web page for new and updated drivers, language locale web page for new and updated language locale files, with notifications and IMLink (a device relationship management service). The sustainment and support services are part of the procurement and inclusive of the purchase. It is critical to patient care that these results are timely and accurate.

The period of performance shall include one (1) 12-month base period and three (3) 12-month option periods to be exercised at the Government’s discretion. The total estimated value of the requirement is , inclusive of all option periods.

4. Authority: This acquisition is conducted under the authority of the Multiple Award Schedule Program. The specific authority providing for a limited source award is Federal Acquisition Regulation (FAR) Overhaul VA Deviation 8.401(b), General Services Acquisition Manual/Regulation (GSAM/R) Section 538.7104-4 “Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source is Data Innovation, LLC, 463 Mountain View DR STE 305, Colchester, Vermont 05446-5952.

Based on market research it was determined that Data Innovation, LLC is the only source capable of satisfying VA’s requirements.

All VISN 23 Pathology and Laboratory Medicine Services exclusively use Data Innovation, LLC’s Instrument Manager as the middleware software to interface laboratory testing analyzers to the electronic health care record maintained through VistA. Data Innovation, LLC’s Instrument Manager is also the middleware software that supports auto-validation of laboratory results from the laboratory instruments to VistA and is the only middleware fully approved on VA’s Technical Reference Model to interface high complexity laboratory equipment to VA’s network. It is a highly specialized software that can interface laboratory instruments and integrate with the National VistA Laboratory Universal Interface for auto-validation and lab result reporting. This requirement is needed to ensure laboratory data can pass between the lab instruments and the medical record, in accordance with College of American Pathology and Joint Commission standards.

Data Innovations, LLC is the original equipment manufacturer (OEM) of the Instrument Manager software and the only vendor with the technical staff that has the specialized experience sufficient to meet Joint Commission Laboratory accreditation through Clinical Laboratory Improvement Amendments to provide support to the Government for Data Innovation, LLC’s Instrument Manager in accordance with accreditation standards.

Additionally, as the OEM, Data Innovations, LLC is the only vendor who has proprietary access to the source code for their brand name Instrument Manager. Veteran patient care would be greatly impacted negatively by laboratory result reporting delays and potential manual entry errors, which would also impact the clinical staff’s ability to diagnose and treat patients if there were any delay in fulfilling this requirement. If another source was sought, conversion of the systems would require replacement of not only software, but interfacing hardware and training, plus a new solution would have to be created to interface with VistA. With eight (8) locations in VISN 23 ,the estimated duplicated cost to change to a different software for the same required outcome would be approximately , to acquire and install new hardware then integrate and configure all data to flow between the new solution and VAs infrastructure as well as configure and integrate numerous analyzers vendor contracts with the new potential solution. This estimate is based on previous efforts to create the existing infrastructure.

In addition, the aforementioned redesign of the infrastructure would result in extensive delivery delays of 8 to 10 years. VISN 23 has used (VistA) for over 35 years as part of the national VA infrastructure. Data Innovations, Inc’s Instrument Manger software, maintenance and regular software support has been in use as middleware for the VISN 23 Pathology and Laboratory Medicine Services Labs for over a decade. VISN 23 will start transitioning to Oracle next year and requires this contract for a duration of four (4) years until the Oracle platform completely replaces the VistA legacy system. A redesign would not be feasible in the middle of the modernization effort VA wide to move from VistA to Oracle. It is critical that VA prioritizes the implementation of reliable software to guarantee accurate and timely results for Veterans. If the necessary software maintenance is not secured, the Data Innovation, LLC’s Instrument Manager software used by VISN 23 would cease to function resulting in serious risk to patient safety.

Consequently, only Data Innovation, LLC, can satisfy these requirements because it holds the proprietary code and owns the intellectual property rights to manage and configure its own software. Due to the software being proprietary, access to the software code is required for creating updates and patches. Without this access, modifying the software code as required for necessary updates and patches would not be possible. Data Innovation, LLC is the only vendor capable of satisfying VA’s requirements discussed above without VA experiencing significant negative impact to Veterans and a substantial duplication of the cost that would not be recovered through competition.

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. In accordance with FAR Overhaul VA Deviation 8.401(b) and GSAM/R 538.7104-3(b)(i) the justification will be made publicly available within 14 days of award.

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. Specifically, the Government will continue to monitor the marketplace to determine whether other brand name software could integrate into VA's existing infrastructure.

8. Market Research: Market Research was conducted beginning April 01, 2025 to October 01, 2026 by the Government’s Subject Matter Experts (SMEs) via web based research. The software products CliniSys and Orchard software were reviewed by the SMEs. While these products possesses some similar capabilities to perform the proposed effort, it does not possess the HL7 middleware that is compatible with VistA.

Data Innovation, LLC owns all intellectual property rights in their products and does not support third-party technical services no other vendor has access to this code. Without access to the proprietary code, no other provider can provide the requisite services.

Data Innovation, LLC has confirmed to the government that they own all intellectual property rights for their products and they are the only ones that are authorized to provide the required services. There is no competition expected for this effort nor is there the possibility that this proposed action can be set aside due to proprietary reasons.

The Government posted a notice of intent to negotiate a FFP, sole source contract with Data Innovations LLC located at 463 Mountain View Drive, Colchester, Vermont 05446 under their GSA MAS contract, GS-35F-389DA, for brand name Data Innovations LLC’s Instrument Manager Maintenance and Support. This notice of intent to sole source, issued as RFI 1794257, closed on February 7, 2026, and no alternative proposals were received.

9. Other Facts: None