26-007002 - Sole Source Justification.docx

Justification for a Sole Source Acquisition FAR Subpart 13.501

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Department of Health and Human Services, Assistant Secretary for Administration, Office of Acquisition Management Services

b. Requiring activity.

One-time purchase of mechanical ventilator

2. Nature and/or description of the action being approved This request is for the one-time purchase of a mechanical ventilator. Includes Hamilton-C6 Ventilator Package, Hamilton-C6 Neonatal Application, and Hamilton-C6 nCPAP-PS Application. The purchase is necessary to the NIH, Critical Care Medicine Department (CCMD), Critical Care Therapy and Respiratory Care Section to maintain the ability to provide invasive mechanical ventilation in the ICU on adult and pediatric patients within the Clinical Center.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Hamilton-C6

b. Project description.

The Critical Care Medicine Department routinely provides invasive mechanical ventilation in the ICU on adult and pediatric patients within the Clinical Center. The Hamilton-C6 allows advanced informatics and customized patient monitoring cells during invasive support of all patients regardless of size or age. By utilizing the Hamilton-C6, we can increase diagnostics and decrease ICU census by utilizing the features.

c. Proposed contract/order type.

Firm, fixed price for one-time purchase

d. Total estimated dollar value and performance/delivery period.

Total Estimated Dollar Value: $47,650.06

Period of Performance: Delivery expected July 2026-December 2026

e. Name and address of the proposed contractor.

Hamilton Medical, Inc.

201 Edison Way Reno, NV 89502

4. Identification of the statutory authority permitting a sole source.

This sole source acquisition is being conducted using the procedures of FAR Part 12 and FAR Subpart 13.5 in accordance with 41.U.S.C 1901 for a commercial item not exceeding $7.5 million. Acquisitions conducted under simplified acquisition procedures are exempt from the requirements in Part 6. In accordance with FAR 13.106-1(b) and FAR 13.501(a) contracting officers may conduct sole source acquisitions if the need to do so is justified in writing.

This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR subpart 13.5 were used.

5. Proposed contractor’s unique qualifications or nature of the acquisition requires use of the authority cited.

The contracting officer has determined that only one source is reasonably available because the requested equipment must integrate with existing NIH-owned electronic medical record using the already established interface. The manufacturer utilizes proprietary hardware/software interfaces and data protocols that are not available from other sources. Use of an alternate product would require significant system modification, revalidation, retraining, and could adversely affect continuity of operations and data comparability. The manufacturer sells directly and is the only source capable of providing equipment that meets the Government's compatibility requirements.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by FAR subpart 5.2 and, if not, which exception under 5.202 applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

9. Any other facts supporting the justification.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

12. Requiring Activity certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Head of the Sponsoring Program Office

13. Contracting Officer certification and approval.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

OPDIV Competition Advocate