SS Justification_CAREFUSION_MSU_Redacted.pdf

Becton, Dickinson and Company (BD), formerly CareFusion, is the original equipment manufacturer (OEM) and sole proprietary provider authorized to provide software licensing, maintenance, upgrades, repairs, and technical support for the Pyxis medication dispensing system currently installed at the Mescalero Indian Health Service Ambulatory Clinic.

The Pyxis system utilizes proprietary hardware, software, firmware, interfaces, and system architecture that are exclusively owned and controlled by BD. No third-party vendor is authorized to provide the required proprietary software updates, firmware patches, system integrity, cybersecurity compliance, and manufacturer warranty.

Replacement of the existing Pyxis system with an alternate medication dispensing platform would result in substantial duplication of costs to the Government, including but not limited to procurement of replacement equipment, system configuration, interface redevelopment, employee retraining, workflow disruption, downtime risks, and potential interruption to patient care operations.

Additionally, transition to another system would create unacceptable operational delays and risks associated with medication dispensing, inventory accountability, patient safety, and continuity of healthcare services.

requirements.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts:

This acquisition is

The Mescalero IHS Ambulatory Clinic currently relies on the existing Pyxis ES medication dispensing infrastructure for secure medication storage, dispensing, inventory management, and pharmacy workflow operations. An interruption in support services would create unacceptable risk to patient care operations, medication accountability, and pharmacy functionality.

Transition to another contractor during this interim period is not feasible because BD/CareFusion is the original equipment manufacturer and sole authorized provider of proprietary Pyxis software licensing, firmware updates, maintenance, and technical support services.

6. Actions to Increase Competition:

a. A Synopsis Was / Was Not Published: A synopsis was not published pursuant to applicable FAR and HHS acquisition procedures because the Government determined that only one responsible source is reasonably available to satisfy agency requirements.

b. Responses Were / Were Not Received: Not applicable

c. Sources Expressing Interest: No other sources capable of providing proprietary OEM-authorized Pyxis software licensing, maintenance, and support services have expressed interest or been identified.

d. Actions to Foster Competition for Future, Similar Requirements: The Government will continue to evaluate available technologies and alternatives during future acquisition planning cycles. However, due to the proprietary nature of the existing Pyxis system, only BD is currently capable of providing the required OEM-authorized support and maintenance services. Should future replacement or modernization initiatives become feasible and fiscally advantageous, the Government will evaluate competitive alternatives at that time.

7. Market Research: Market research was conducted through review of available vendor information, prior procurement history, internet-based research, discussions with technical personnel, and review of manufacturer support requirements for the installed Pyxis system.

The market research confirmed that:

BD/CareFusion is the original manufacturer and sole proprietary owner of the Pyxis medication dispensing system;

Proprietary software licensing, firmware updates, and system support are only available directly through BD;

Third-party vendors are not authorized to provide manufacturer-certified support or proprietary software access;

Use of non-authorized support providers could compromise system functionality, cybersecurity compliance, interoperability, patient safety, and warranty coverage.

Based on the results of market research, the Government concluded that no other responsible source is capable of fulfilling the requirement.

8. Procurement history: Add as many prior awards as necessary to provide a thorough understanding of the procurement history.

Contractor: Becton, Dickinson and Company (BD) / CareFusion

(2) If only one response is received, include a statement of price reasonableness in the contract file. The contracting officer may base the statement on

(i) Market research.

(ii) Comparison of proposed price with prices found reasonable on previous purchases.

(iii) Current price lists, catalogs, or advertisements. However, inclusion of a price in a price list, catalog, or advertisement does not, in and of itself, establish fairness and reasonableness.

(iv) A comparison with similar items in a related industry.

(vi) Comparison to an independent Government estimate.

(vii) Any other reasonable basis, as follows:

proposed pricing and compare it against historical pricing, current maintenance agreements, market indicators, and the independent Government estimate to ensure the proposed price is fair and reasonable.

13. Contracting Officer (CO) Certification and Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. [Always required; CO approval authority is limited to $900 thousand.]

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(The following Reviews and Approvals will ordinarily be provided on a separate page at the end of the justification to allow for minor, administrative changes to be made during the review process; delete any individual reviews/approvals not applicable.)

ELEVATED REVIEWS & APPROVALS

14. Insert Division Advocate for Competition (AfC) Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition. [Division AfC approval authority is limited to $20 million.]

X Right-Click "Signature Setup"

Typed Name Title Signature & Date:

15. Insert Division Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports a sole source acquisition. [HCA approval authority is limited to $90 million.]

Head of the Contracting Activity Signature & Date:

16. HHS Office of General Counsel Review and Concurrence: I reviewed this justification and concur that it adequately supports a sole source acquisition. [Mandatory when SPE approval is required, unless otherwise waived in writing by the SPE.]

Title Signature & Date:

17. HHS Advocate for Competition (AfC) Review and Concurrence: I reviewed this justification and concur that it adequately supports a sole source acquisition. [Mandatory when SPE approval is required.]

HHS Advocate for Competition Signature & Date:

FINAL APPROVAL

18. HHS Senior Procurement Executive Approval: Based on the foregoing, I hereby approve this sole source justification pursuant to the authority cited in section 4 above. [Required if the total award value, including all options and FAR 52.217-8 value, exceeds $90 million.]

HHS Senior Procurement Executive Signature & Date: