C01. Single Source Justfication - 36C25626P0118 _Signed_Redacted.pdf

Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 6 Revision: 03 Effective Date: 04/15/24 Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

1. Contracting Activity:

Network Contracting Office 16 (NCO 16), located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 in support of the Fayetteville VA Medical Center 1100 North College Avenue Fayetteville, AR 72703-1944.

2. Nature and/or Description of the Action Being Processed:

The Veterans Health Care System of the Ozarks (VHSO) requires a new firm-fixed-price contract to Data Innovations (DI) for the procurement and implementation of Laboratory Result Auto-Verification Software, including integration, configuration, and support services.

This is a new contract action, not a modification to an existing DI contract, as the total cost of the Auto-Verification software exceeds the Simplified Acquisition Threshold (SAT). The new contract will ensure seamless integration with the existing Data Innovations Instrument Manager (IM) software currently in use at VHSO for all laboratory data management.

Type of Contract: Firm-Fixed-Price (FFP)

Base Period of Performance: January 1, 2026 – December 31, 2026 Option Period 1: January 1, 2027 – December 31, 2027 Option Period 2: January 1, 2028 – December 31, 2028 Estimated Award Date: 01-01-2026

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

VHSO requires Auto-Verification (AV) Software from Data Innovations (DI) to automate the validation of laboratory test results and improve operational efficiency, accuracy, and patient safety.

The AV software integrates directly with DI’s existing Instrument Manager (IM) system to automate the verification process for laboratory test results. Using predefined rules and algorithms within the Laboratory Information System (LIS), the software automatically validates results that meet normal parameters, while flagging abnormal or critical results for manual review. This automation reduces turnaround time, minimizes human error, and enhances workflow efficiency.

The DI Auto-Verification software will integrate seamlessly into the existing DI IM infrastructure, ensuring data consistency, validated interoperability, and uninterrupted laboratory operations.

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The Technical Reference Model (TRM) and Enterprise Risk Assessment (ERA) approvals are already established for this system, and a Business Associate Agreement (BAA) will be executed post-award to ensure compliance with HIPAA and VA data security requirements.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Data Innovations (DI) is the sole manufacturer and provider of the Instrument Manager (IM) system currently implemented at VHSO and at multiple VA laboratories nationwide. DI also provides exclusive licensing, updates, and technical support for all IM-related products and modules.

The requested Auto-Verification software is a proprietary add-on module designed specifically for DI’s IM architecture. Integration with any other vendor’s product would require:

Full replacement of the existing IM software, Reconfiguration of all laboratory analyzer interfaces, Redevelopment of data communication pathways to the VA’s LIS (VistA), and Extensive retesting and revalidation of system connections and results accuracy.

Such actions would result in substantial duplication of cost to the Government that could not reasonably be recovered through competition and unacceptable delays in meeting laboratory reporting requirements essential to patient care.

DI’s system uniquely supports the VA’s current laboratory data workflow, and no other vendor can provide software that integrates directly with the existing infrastructure.

Accordingly, Data Innovations is the only firm capable of providing the required supplies and services without the Veterans Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Efforts were conducted by database queries to the Electronic Contract Management System (eCMS), General Services Administration (GSA) eLibrary, Dynamic Small Business Search (DSBS), Veteran Small Business Certification (VetCert), AbilityOne, and System for Award Management (SAM). A review of available sources and the VetCert database in accordance with VAAR 810.001-70 revealed that no verified SDVOSBs or VOSBs are capable of providing or supporting the proprietary DI Auto-Verification software or a comparable solution compatible with the existing IM system.

Based on the market research conducted, there is no reasonable expectation that quotations will be received from two or more certified VetCert listed SDVOSB/VOSBs and award can be made at a fair and reasonable price that offers the best value to the Government.

Data Innovations LLC is a Small Buiness and due to the unique requirement and based on market research findings, Data Innovations LLC appears to be qualified and capable of Single Source procurement.

Due to the proprietary design of DI’s software, no other vendors are authorized to sell, distribute, or integrate DI modules. Therefore, the publication of a Sources Sought Notice was not deemed practical, as market research confirmed only one responsible source.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The Contracting Officer will determine that the anticipated cost of is fair and reasonable based on:

Comparison to pricing for similar DI software modules under existing VA and government-wide contracts, Verification against DI’s published price lists and GSA catalog rates, and Independent Government Cost Estimate (IGCE) evaluation.

The Contracting Officer will ensure that the final negotiated price aligns with market norms for comparable proprietary software and integration services.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Efforts were conducted by database queries to the Electronic Contract Management System (eCMS), General Services Administration (GSA) eLibrary, Dynamic Small Business Search (DSBS), Veteran Small Business Certification (VetCert), AbilityOne, and System for Award Management (SAM). A review of available sources and the VetCert database in accordance with VAAR 810.001-70 revealed that no verified SDVOSBs or VOSBs are capable of providing or supporting the proprietary DI Auto-Verification software or a comparable solution compatible with the existing IM system.

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Based on the market research conducted, there is no reasonable expectation that quotations will be received from two or more certified VetCert listed SDVOSB/VOSBs and award can be made at a fair and reasonable price that offers the best value to the Government.

Data Innovations LLC is a Small Buiness and due to the unique requirement and based on market research findings, Data Innovations LLC appears to be qualified and capable of Single Source procurement.

Due to the proprietary design of DI’s software, no other vendors are authorized to sell, distribute, or integrate DI modules. Therefore, the publication of a Sources Sought Notice was not deemed practical, as market research confirmed only one responsible source.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Replacement of the existing DI IM software would incur significant additional costs and operational downtime.

Laboratory data integrity and patient care rely on continuous use of the DI-managed system.

Standardizing on the existing DI platform promotes compatibility and cost efficiency across VA laboratory operations.

This acquisition maintains compliance with VA enterprise IT and data management policies.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Data Innovations LLC

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The VA will continue to monitor future advancements in laboratory information management technologies and evaluate whether open-architecture systems may be compatible with the

VA LIS.

However, due to the proprietary nature of DI’s IM software and the need for interoperability with VA’s established systems, full and open competition is not feasible at this time.

Future modernization of the LIS or laboratory systems may present opportunities for competitive acquisitions.

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12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.