S02. Brand Name Justification_Redacted.pdf

Brand Name Justification >SAT

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and workflow standards. The performance period covers the delivery and installation timeframe required to integrate the drawers into active pharmacy infrastructure, and installation must be coordinated with Pharmacy, OIT, and Biomedical Engineering as outlined in the previously approved Statement of Work

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

The acquisition requires the use of a brand-name justification because BD Pyxis Cubie Drawers are highly specialized, proprietary components that integrate directly with the BD Pyxis MedStation ES medication dispensing platform. These drawers use BD-specific firmware, calibration protocols, and security features that no third-party product can replicate or integrate with.

Any attempt to use non-BD components would compromise system certification, void warranties, and require expensive revalidation and reprogramming of the entire automated dispensing system, resulting in significant delays and duplication of cost.

Additionally, the Pyxis ES platform is a closed, FDA-regulated system in which alternative components are not validated or supported; therefore, only brand-name BD drawers satisfy the clinical, cybersecurity, and operational requirements. The drawers also support VHA Directive 1195 by providing controlled single-compartment access, secure medication segregation, and automated audit trails, which are essential for high-alert drug management.

No other product meets these mandatory features, and no alternative manufacturer offers a compatible or substitutable solution. As such, while the procurement will be competed among authorized SDVOSB distributors, the brand-name restriction is essential to meeting the Government's requirements.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

Efforts were made to maximize competition to the extent practicable. A Notice of Intent (NOI) to sole source was posted on the Governmentwide Point of Entry, Contract Opportunities, from July 15 through July 18, 2025. The NOI sought industry feedback from any capable vendor that could provide the required BD Pyxis Cubie Drawers. No responses were received during the NOI period, which initially suggested that only one responsible source existed.

However, during the subsequent solicitation phase, multiple SDVOSB firms submitted quotations for the requirement. The manufacturer later confirmed that these firms were authorized distributors of BD Pyxis capital equipment. As a result, rather than awarding a sole source contract, the acquisition was transitioned to a

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competitive SDVOSB set-aside, ensuring that as many potential sources as feasible could participate. Additional market research was conducted through eCMS, GSA eLibrary, DSBS, VetCert, AbilityOne, and SAM, with no evidence of any non-BD manufacturer capable of offering equivalent or compatible items.

These actions demonstrate that the Government took steps to identify competitive sources and ultimately obtained multiple viable SDVOSB quotes consistent with VA’s small business priorities.

6. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable:

The Contracting Officer has determined that the anticipated cost for this acquisition will be fair and reasonable based on several factors. First, multiple SDVOSB firms submitted competitive quotes for the same BD brand-name items, providing adequate pricing competition within the authorized distributor network. Second, the estimated value of $302,544.00 is consistent with previous procurement history for this equipment and aligns with BD’s established pricing for federal customers.

Third, any awarded contractor must be an authorized distributor, ensuring pricing reflects genuine, authorized product sources and not inflated or reseller-inflated rates. Cost and price analysis will include comparison of competing quotes, verification of authorized distributor status, evaluation against historical pricing, and assessment of price reasonableness for installation services. Certified cost or pricing data is not required due to the competitive nature of the SDVOSB set-aside and the firm-fixed-price structure of the procurement.

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

Market research complied with RFQ Part 10 and VAAR 810.001-70. Searches of VetCert identified hundreds of SDVOSBs under NAICS 339112, but only three were identified by the manufacturer as authorized distributors of BD Pyxis drawers.1 Additional searches of AbilityOne, DSBS, and GSA eLibrary identified zero alternative manufacturers or equivalent products capable of meeting VA’s needs. An NOI was posted and received no responses. However, during the formal solicitation, multiple SDVOSBs submitted quotes and the manufacturer independently confirmed their authorized status. This established the VA “Rule of Two,” supporting an SDVOSB set-aside. Market research also confirmed that BD is the sole manufacturer of the required drawers, that no equivalent products exist, and that a brand-name justification is required.

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

The use of a brand-name restriction is justified because BD Pyxis Cubie Drawers are the only products compatible with the VA’s existing BD Pyxis MedStation ES

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system. The Government cannot develop generic specifications because the BD Pyxis ecosystem operates on proprietary software and firmware not accessible to third-party manufacturers.1 Introducing non-BD hardware would void system warranties, compromise security safeguards, and violate compliance requirements associated with medication storage and high-alert drug management. The VA has made significant capital investments in the BD Pyxis ecosystem, and replacing it to support third-party hardware would cause significant delays and duplicative costs.

No domestic or foreign equivalent exists, and competitive market research confirmed that no alternative products are technically capable or clinically acceptable.

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

Multiple SDVOSBs expressed interest by submitting quotations in response to the solicitation following the NOI period. These firms demonstrated capability by providing authorized distributor letters validated by the manufacturer. Consistent with your instructions, vendor names are not listed individually, but all interested firms were verified as SDVOSB-certified and authorized to distribute BD Pyxis equipment.

10. 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:

For future acquisitions, the VA will continue to reassess the market to determine whether additional authorized distributors emerge or whether product lines evolve to allow broader compatibility. Market research will be refreshed prior to any subsequent procurement to ensure compliance with VA priority sourcing requirements. Given that BD Pyxis drawers remain proprietary components with no alternatives, there are currently no actions that can remove the brand-name restriction without replacing the entire BD Pyxis medication management infrastructure—an approach that would be cost-prohibitive and detrimental to patient safety. Because competition among authorized SDVOSB distributors is now available, the VA will continue to utilize SDVOSB set-aside procedures for future buys when two or more capable SDVOSBs are identified. No additional barriers to competition exist beyond the inherent proprietary nature of the system.

11. 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

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supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. 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.