P03. Single Source Justification MPT to SAT_Signed_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 4 Acquisition ID# 36C256-25-AP-3817

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) (Brand Name)

Acquisition Plan Action ID: 36C256-25-AP-3817

1. Contracting Activity: Department of Veterans Affairs, Veterans Health

Administration, Network Contracting Office 16, in support of Department of Veterans Affairs, VISN 16, G.V. “Sonny” Montgomery VA Medical Center, Pharmacy, 1500 E.

Woodrow Wilson Drive, Jackson, MS 39216

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Department of Veterans Affairs, G.V. (Sonny) Montgomery VA Medical Center (GVSM VAMC), Pharmacy Service, has an immediate and mission-critical requirement to procure and install twelve (12) BD Pyxis Cubie Drawer HH 20-20-0 units (Product #120242-02). These drawers will replace outdated Matrix-style drawers currently installed in BD Pyxis MedStation ES systems located in the facility’s Outpatient Clinics and Community-Based Outpatient Clinics (CBOCs). The upgrade is essential to meeting the enhanced medication safety requirements of the forthcoming VHA Directive 1195, which mandates improved handling, access controls, and documentation procedures for High Alert Medications.

BD Pyxis Cubie Drawers offer modular, compartmentalized storage with automated, secure, and auditable access features. They are specifically designed to mitigate the risk of dosing errors, diversion, and improper access—issues that are more prevalent with the Matrix drawer design. The drawers allow only one medication compartment to be accessed at a time, significantly reducing the chance of clinicians selecting the wrong drug or dose, which is critical for high-alert drug classes (e.g., opioids, anticoagulants, insulin, etc.).

This acquisition is not a standalone upgrade—it is a key component in maintaining interoperability and continuity with the existing BD Pyxis Medication Management System. GVSM VAMC has standardized its infrastructure across the following tightly integrated BD platforms:

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BD Pyxis ES MedStations – main automated dispensing cabinets used in inpatient and outpatient areas

BD Pyxis Refrigerators – for temperature-sensitive drugs, integrated with Pyxis software

BD HealthSight – central visibility platform for medication inventory and compliance

BD Knowledge Portal – analytics platform providing real-time medication usage and risk indicators

BD CII Safe – controlled substance management BD IV Prep – (to be implemented) sterile compounding solution with integration to Pyxis workflow

Each of these systems contributes to a comprehensive closed-loop medication management model that supports the VA’s commitment to patient safety, regulatory compliance, and operational efficiency.

The estimated value of this procurement is which includes product cost, shipping, configuration, and professional installation by authorized BD technicians.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

This procurement is limited to brand-name BD Pyxis Cubie Drawers and is not open to third-party alternatives due to the following critical, non-substitutable characteristics:

System Compatibility with BD Pyxis MedStation ES:

The BD Pyxis Cubie drawers are proprietary hardware modules that integrate directly with the BD Pyxis MedStation ES platform. They operate using BD’s embedded firmware and configuration protocols, enabling automatic recognition, compartment calibration, security integration, and seamless interaction with other BD medication management software. Third-party drawers are incompatible and unsupported within this closed and FDA-regulated system. Integrating non-BD hardware would require reprogramming or replacing the entire MedStation, which would result in significant downtime, revalidation costs, and loss of system certification.

Designed for Compliance with VHA Directive 1195:

VHA Directive 1195 requires segregated, secure, and auditable storage for high-alert medications. Cubie drawers are the only drawer type validated by BD for use within their Pyxis ES system that meets these storage, access, and alert standards.

Features such as single-drawer access, tamper-evident design, and automatic usage logging are built into the Cubie configuration. Matrix drawers, by contrast, lack these safeguards, and third-party alternatives are not certified for use with the BD ecosystem or VHA mandates.

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Warranty, Cybersecurity, and Support Considerations:

The Pyxis ES platform and its components are protected by an enterprise support and security agreement with BD. Installing third-party drawers would void warranty protection, compromise cybersecurity safeguards, and disconnect the unit from BD’s software update and audit trails. In a healthcare environment governed by strict data protection laws (e.g., HIPAA, FISMA), this would pose an unacceptable risk.

Follow-On Requirement for an Existing Enterprise System:

GVSM VAMC has made a long-term capital investment in the BD Pyxis ecosystem (originally developed by CareFusion, acquired by BD in 2015). This request is a follow-on acquisition necessary to upgrade and modernize existing BD hardware to align with VA clinical priorities. Attempting to integrate third-party components would require replacing the entire system—an approach that would result in significant cost duplication, extended project delays, and training disruptions for medical staff.

4. Description of market research conducted and results or statement why it was not conducted:

Notice of intent to sole source number 36C25625Q1192 was posted on the Governmentwide Point of Entry (GPE) known as Contract Opportunities on July 15 and closed on July 18, 2025. The intent of the notice was to allow vendors the opportunity to identify their interest and capabilities. Any interested party that believed they were capable of fulfilling the requirement was encouraged to respond.

Upon closing of the intent to sole source notice, no companies responded.

Database searches were conducted across the following federal acquisition resources:

• Electronic Contract Management System (eCMS)

• General Services Administration (GSA) eLibrary

• System for Award Management (SAM)

• Dynamic Small Business Search (DSBS)

• Veteran Small Business Certification (VetCert)

• AbilityOne These searches yielded no evidence of additional SDVOSBs, VOSBs, or other large businesses authorized to provide Pyxis Cubie Drawers. No alternative sources were identified offering functionally equivalent systems that could meet the clinical, technical, and patient safety requirements outlined by the requesting service line.

Based on this research, there is no reasonable expectation that quotations would be received from two or more SDVOSBs/VOSBs. Award to Carefusion Solutions LLC.

represents the best value and lowest risk to the government.

5. 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;

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( ) (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;

6.Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.