Brand Name Justification Pyxis Medstations CO Signed redacted_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 7

REVISION: 01

Acquisition ID#: 36C255-25-AP-0932

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C25525AP0932 Profile Upgrade for Pyxis Medstation

1. Contracting Activity: Department of Veterans Affairs, VISN 15, Harry S. Truman Memorial Veternas’ Hospital on Columbia, MO 65201-5275 2237: 589-25-1-5622-0549

2. Nature and/or Description of the Action Being Processed: This procurement is for a new, one time, firm-fixed price supply contract for software profile upgrades on five (5) Pyxis Mestations for the Columbia VA Medical Hopital in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of

FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The total estimated value of this procurement is . This acquisition is for profile upgrades to the Pyxis Medstations. These upgrades will enable the Medstations to match the profiling capabilities of existing machines, thereby enhancing medication safety by ensuring that medication cannot be removed without a pharmacist-verified prescription order. In addition, this upgrade must be BD/Carefusion brand due to the need to connect to additional Pixus equipment owned by the Columbia VA Hospital. However, the equipment may be purchased through the manufacurer or through one of 3 SDVOSB distributors. The contractor shall deliver and install the upgrade immediate upon award and no later than May 30, 2025.

Produce ID Product Name QTY 13529-01 135291-01 5 Profile Upgrade for Medstation

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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Acquisition ID#: 36C255-25-AP-0932

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Unique features, compatibility, cost effectiveness, support and warranty, market research and alternatives, risk and mitigations and support for SDVOSBs. This document provides a compelling justification for the selection of a specific brand under FAR 6.303, which mandates that there is only one brand capable of meeting the agency’s unique needs.

Major System or Highly Specialized Equipment:

BD/Carefusion is the original equipment manufacturer (OEM) for the Pyxis Medstations proprietary software.

The Pyxis Medstations and their associated software upgrades are classified as highly specialized equipment crucial for the automation of medication dispensing within the Columbia VA Medical Hospital. These systems are an integral component of a robust medication management framework, designed to optimize safety, accuracy, and efficiency in medication distribution and administration.

Rationale for Single Source Procurement:

1. Substantial Duplication of Cost:

Procuring alternative medication dispensing systems other than BD/Carefusion’s Pyxis Medstations would result in substantial duplication of costs that would not be recovered through competition. The existing infrastructure, including the Pyxis Enterprise System, is already in place and tailored to the specific needs and operational workflows of the hospital. Transitioning to a different system would require significant investments in new hardware, software, integration services, staff training, and potential system downtime. Such expenses would far exceed the cost of upgrading the existing Pyxis devices.

2. Unacceptable Delays:

Switching to a different medication dispensing system would introduce unacceptable delays in fulfilling the agency’s requirements. The process of selecting a new vendor, conducting compatibility assessments, system integration, and user training would take considerable time, during which the hospital would face operational disruptions. These delays could compromise the standard of care provided to patients, particularly those requiring timely administration of high-risk and high-value medications. It is imperative to maintain continuity in medication management processes to ensure the safety and well-being of patients.

Conclusion:

Given the reasons outlined above, BD/Carefusion is the only responsible source capable of providing the required software profile upgrade for the existing Pyxis Medstations without incurring prohibitive costs and operational delays. The Pyxis Medstations are critical to the hospital's medication management system, ensuring patient safety and adherence to regulatory standards. Therefore, a brand-specific procurement for BD/Carefusion’s proprietary software upgrade is justified and necessary for the continued effective operation of the hospital’s medication dispensing system.

BD/Carefusion does have authorized Service-Disabled Veteran-Owned Small Business (SDVOSB) distributors capable of providing the necessary software profile upgrade for the Pyxis Medstations, further justifying the brand-specific requirement to comply with procurement regulations and support veteran-owned businesses. This approach also aligns with the VA's commitment to supporting veteran-owned enterprises.

Thus, BD/Carefusion is the only brand that can fulfill this specific requirement effectively, ensuring compatibility, safety, and regulatory compliance.

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Acquisition ID#: 36C255-25-AP-0932

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

Market Research: A thorough market analysis was conducted to identify potential manufacturers and suppliers capable of meeting the VA’s requirements. This research confirmed BD/Carefusion as the only manufacturer whose equipment meets all necessary specifications and compatibility requirements.

Sources Sought Notice: A Sources Sought Notice was issued on February 19, 2025, under synopsis number 36C25525Q0209. The purpose of the synopsis was to identify potential sources capable of providing the proprietary software profile upgrade for the existing Pyxis Medstations at the Columbia VA Medical Hospital and to ensure competition.

Responses Received: One response was received from , an SDVOSB. Upon thorough evaluation, it was determined that could meet the necessary specifications as an authorized distributor of BD/Carefusion products, thus confirming the capability to provide the required software profile upgrade.

Outreach to Vendors: The Contracting Specialist (CS) reached out to various manufacturers and suppliers to explore potential alternatives. However, none were able to meet the seamless integration, compatibility, and operational benchmarks set by the Pyxis Medstation. These benchmarks are critical for maintaining the efficiency and safety standards of the existing system.

Engagement with SDVOSBs: The CS ensured that the procurement process engaged SDVOSBs, aligning with federal procurement policies and the VA’s commitment to supporting veteran-owned businesses. The CS reached out to two other SDVOSB distributors to obtain their capability statements.

(SDVOSB) replied with their capability statement and authorized distribution letter from BD/Carefusion.

By incorporating these efforts, the VA remains diligent in its procurement strategy, ensuring that the chosen solution (Pyxis Medstation) not only meets its specialized needs but also supports the broader effort to engage a diverse range of suppliers.

Conclusion: The Pyxis Medstation is indispensable for the VA’s pharmacy medication dispensing system due to its unparalleled compatibility, risk mitigation, operational efficiency, and support services. Investing in BD/Carefusion and its authorized SDVOSB distributors aligns with the VA’s strategic objectives, ensuring that the pharmacy operations remain efficient, reliable, and cost-effective.

This comprehensive approach, integrating meticulous market research, a broad-reaching Sources Sought Notice, outreach to vendors, and engagement with SDVOSBs, underscores the VA's commitment to a diligent procurement strategy. The unique capabilities of BD/Carefusion's proprietary system and its authorized distributors ensure the seamless fulfillment of the VA's specialized requirements in medication management.

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

As the Contracting Officer (CO), I have determined that the anticipated cost of for the software profile upgrade of the five Pyxis Medstations is fair and reasonable. Market research revealed there is adequate competition in the marketplace and that a fair and reasonable price is available. A technical evaluation will be conducted on all quotes received.

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Acquisition ID#: 36C255-25-AP-0932

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

Market research was conducted in accordance with FAR Part 10, and VAAR Part 810 The results are summarized below:

Vendor Information Pages (VIP) Database: To comply with the VA Rule of Two, an inquiry was conducted in the Vendor Information Pages (VIP) database to identify service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) that could potentially meet the requirements for the software profile upgrade for Pyxis Medstations. The contracting officer (CO) reviewed the VIP database to determine if two or more SDVOSBs or VOSBs were listed as verified in the appropriate NAICS code. The following steps were taken:

1. Search Query: The CO performed a detailed search in the VIP database using the NAICS code 513210 (Software Publishers) to find qualified vendors.

2. Results: The search identified three SDVOSB firms capable of meeting the requirements. However, manual follow-up and detailed evaluations confirmed that two SDVOSB, , and had the necessary authorization from BD/Carefusion to supply the proprietary software upgrade.

The results of this search were printed and included in the solicitation file as required by VAAR 810.002.

Market Research Efforts:

1. Sources Sought Notice: A Sources Sought Notice was issued on February 19, 2025, under synopsis number 36C25525Q0209 to identify potential sources capable of providing the proprietary software profile upgrade. The synopsis advised the industry of the pending acquisition and solicited inquiries from interested parties.

2. Responses Received: One response was received from (SDVOSB). This response was scrutinized to ensure compliance with the technical and functional requirements.

, an authorized distributor of BD/Carefusion products, was capable of providing the needed software upgrade.

3. Outreach to Vendors: Apart from the sources sought notice, the CO reached out to various manufacturers and suppliers to explore potential alternatives. These efforts included consultations with both national and local vendors to determine their capability to meet the specified requirements. None of the contacted vendors could provide a solution that met the seamless integration, compatibility, and operational benchmarks set by the Pyxis Medstation.

4. Engagement with SDVOSBs: The CO ensured active engagement with SDVOSBs to adhere to federal procurement policies and support veteran-owned businesses. The CO contacted two additional SDVOSB distributors to obtain their capability statements. However, these vendors could not provide the required proprietary software upgrades because they lacked authorization from BD/Carefusion.

BAA/TAA Considerations: Considerations relative to Buy American Act (BAA) and Trade Agreements Act (TAA) were reviewed, ensuring compliance with FAR 25. The relevant clauses were included in the solicitation to ensure that all federal procurement regulations were met.

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Acquisition ID#: 36C255-25-AP-0932

Conclusion:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. The thorough market analysis and VIP search confirm that BD/Carefusion, through its authorized SDVOSB distributors or

, are the only responsible sources that can provide the required software profile upgrade for the Pyxis Medstations. The unique nature of the proprietary software and its critical role in maintaining medication safety and operational efficiency at the Columbia VA Medical Hospital justify an SDVOSB set-aside procurement. This approach aligns with the VA’s commitment to ensure compatibility, safety, and support for veteran-owned businesses within the procurement process.

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

Proprietary Technology and Compatibility:

The Pyxis Medstations and the associated software upgrades required for the Columbia VA Medical Hospital include proprietary technology developed and maintained exclusively by BD/Carefusion. This proprietary nature ensures that only BD/Carefusion or its authorized distributors can provide the necessary software upgrades compatible with the existing Pyxis Enterprise System. Given the high degree of customization and integration required, no other vendor can develop or provide a product that would seamlessly integrate with the existing systems without extensive modifications and risk to system integrity and functionality.

Specifications and Engineering Descriptions:

The specific requirements for the software profile upgrade are tailored to the Pyxis Medstations' proprietary architecture. Generic specifications or engineering descriptions are not feasible because the upgrade involves detailed, proprietary software algorithms and configurations designed exclusively for BD/Carefusion’s Pyxis system. Developing alternative specifications would not be achievable without full access to BD/Carefusion’s proprietary information, which is not available to other vendors.

Operational Efficiency and Risk Mitigation:

Maintaining consistency with the existing medication management system is crucial for operational efficiency and risk mitigation. Altering the medication dispensing system could introduce unacceptable risks and delays, as discussed in previous sections. Transitioning to a different software system that is not specifically designed for the Pyxis Medstations would require significant reconfiguration, retraining, and could potentially compromise patient safety due to incompatibility issues.

Engineering and Security Requirements:

The BD/Carefusion Pyxis Medstations and the associated software have been built with specific engineering and security requirements integral to the VA’s operations. These requirements are engineered to ensure not just functionality but also compliance with stringent VA and federal security standards. Any alternative solutions would require extensive vetting, validation, and possibly new certifications to meet these strict standards, which is both time-consuming and resource-intensive.

BD/Carefusion’s Authorized Distributors:

BD/Carefusion works with authorized distributors, including SDVOSBs, to provide their products and services.

These distributors are vetted and trained by BD/Carefusion to ensure they meet the high standards necessary

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Acquisition ID#: 36C255-25-AP-0932 for supporting VA operations. Engaging these distributors supports federal and VA policies aimed at promoting veteran-owned small businesses and ensures compliance with acquisition regulations.

Justification for Brand Name and SDVOSB Set-aside:

Given the proprietary nature, specific compatibility requirements, and operational necessity of the Pyxis Medstations’ software profile upgrade, a brand name, SDVOSB set-aside acquisition from BD/Carefusion and its authorized SDVOSB distributors, or , is justified. There are no other suppliers capable of providing the required proprietary software upgrade while maintaining the required compatibility, safety, and operational efficiency.

Non-domestic End Items:

If the item is a non-domestic end item, the Contracting Officer (CO) will complete the appropriate Individual Nonavailability Determination & Findings (D&F) in accordance with FAR 25.103(b)(2). This ensures compliance with the Buy American Act (BAA) and Trade Agreements Act (TAA) where applicable and justifies the nonavailability of domestic items that meet the agency’s requirements.

In conclusion, BD/Carefusion’s proprietary technology, the critical need for compatibility, the high risk associated with deviations, and the support for authorized SDVOSB distributors comprehensively justify the use of other than full and open competition for this acquisition. The brand name procurement strategy ensures the continuity, safety, and efficacy of the VA’s medication management system.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: The following sources expressed their interest in the acquisition for the software profile upgrade for the Pyxis Medstations at the Columbia VA Medical Hospital:

1. (SDVOSB)

a. Contact Information:

Address:

Point of Contact:

Email:

Phone:

b. Description: is an authorized distributor of BD/Carefusion products and has confirmed their ability to provide the necessary proprietary software profile upgrade.

2. (SDVOSB)

a. Contact Information:

Address:

Point of Contact:

Email:

Phone: (

b. Description: is an authoirzed distribtor of BD/Carefusion products and has confirmed their ability to provide the necessar proprietary software profile upgrade.

This list includes all entities that formally expressed interest in writing following the issuance of the Sources Sought Notice and subsequent outreach by the Contracting Specialist.

No other vendors or suppliers responded with written interest or capability statements that met the specific requirements for the Pyxis Medstations’ software profile upgrade. As described in Section 6 above, extensive