Notice of Intent to Sole Source HT941026N014 v2_Redacted.pdf

CUI

Control Number: FY26-0502

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division-West CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Tracy Robinson, tracy.m.robinson18.civ@health.mil

Source Selection Information - See FAR 2.101 and 3.104-4

NOV 2024

Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold

1. Identification of the Agency and Contracting Activity: Orthopedics Department, Naval Medical Center San Diego (NMCSD), Healthcare Contracting Division – West (HCD-W), Defense Health Agency Contracting Activity (DHACA).

2. Description of Action:

New Requirement Purchase Order Blanket Purchase Agreement (BPA) Order against BPA # Click or tap here to enter text.

Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract # Click or tap here to enter text.

Order against Single Award IDIQ Contract # Click or tap here to enter text.

Order against Federal Supply Schedule Contract # Click or tap here to enter text.

Follow-on Requirement to Contract/Order # Click or tap here to enter text.

Modification against existing Contract/Order and Modification # Click or tap here to enter text.

Contract Type Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid Click or tap here to enter text.

3. Description of Services or Supplies and Estimated Value: The requirement is to procure Precise System used to lengthening a leg from a gunshot wound for NMCSD from Globus Medical Inc.

NOV 2024

For the upcoming case on January 16, 2026, these items are essential for a patient who sustained a gunshot wound during a training exercise, resulting in a complete sciatic nerve injury and leg shortening. As mentioned, Precise technologies, owned by Globus Medical, is the only responsible source that can meet the minimal requirements for lengthening the patient's leg.

Currently, the patient is unable to walk until his leg is lengthened.

6. Market Research: The Precise System from Globus Medical is utilized in limb lengthening procedures for patients with discrepancies in limb length. Market research conducted by technical experts in December 2024 and December 2025 involved reviewing similar past procurements, searching for open market contractors, and examining mandatory sources. The search utilized platforms such as SAM.gov, FPDS-NG, Federal Prison Industries (FPI), AbilityOne, GSA Advantage, and the VA to identify potential sources capable of meeting the Government's requirements.

In December 2024, these items were included in the ECAT system, and a not-to-exceed (NTE) was issued on December 12, 2024. However, on December 18, 2024, an attempt to process the invoice revealed that the items were not appearing in ECAT. Following Globus Medical's acquisition of NuVasive in January 2025, the items were removed from the ECAT contract. The department has been collaborating with Globus to reinstate these items into ECAT, but this has not yet occurred, and there is no timeline for their return.

Additionally, there is another case scheduled for January 16, 2026, and Globus requires confirmation of payment for the previous items before proceeding with this case.

The upcoming case on January 16, 2026, involves a trauma patient who sustained a gunshot wound during a training exercise, resulting in a complete sciatic nerve injury and leg shortening.

Globus Medical is the only responsible source capable of meeting the minimal requirements for lengthening the patient's leg to restore the ability to walk.

A Notice of Intent (HT941026N0014) was posted from January 6 to January 8, 2026, and no responses were received. A Sole Source Justification for this procurement is currently pending.

Furthermore, a DD2579 Small Business Coordination Record will be submitted to the DHA OSBP for approval to utilize Novartis Pharmaceuticals Corporation for this requirement.

7. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes

(2) If 7.a.(1) is No, was the action just prior to this one competed? Not Applicable

NOV 2024

(3) If 7.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable

b. Additional Information: None

8. Technical Certification:

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

9. Fair and Reasonable Cost Determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5. The required equipment is commercially available and has been previously procured, which establishes current and historical information that will be used in price analysis as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.4031(b)(3)

10. Contracting Officer Determination: I certify this justification is accurate and complete to the best of my knowledge and belief.