HHS_SSJ-WRSU MiniBox_CO Signed.pdf

Sole Source Justification (SSJ) RFO - FAR 12.102(b) & 12.201-1

1. Acquisition Title Acquisition of PulmOne MiniBox+ Pulmonary Diagnostic System

Division: Indian Health Service (IHS)

Contracting Activity: Department of Health and Human Services, Indian Health Service/Phoenix Area Office

Author: Tami Bonebrake

Basis for approval: Individual

2. Nature and/or Description of the Action being Approved The Indian Health Service requests a firm-fixed-price purchase order with PulmOne for the acquisition of the PulmOne MiniBox+ pulmonary diagnostic system. The Government projects award in FY 2026 using appropriated funds.

Contractor: PulmOne Performance Period: One-time delivery and installation Estimated Total Dollar Value:

Original Contract Value: Not applicable New Contract Value:

3. Description of Supplies and/or Services The PulmOne MiniBox+ is a pulmonary diagnostic system necessary to support the new performs spirometry, Diffusion Capacity of the Lung for Carbon Monoxide (DLCO), and lung volume measurements using gasless, cabinless plethysmography-equivalent technology without requiring a traditional body box.

Unlike competing systems that require nitrogen washout techniques or closed chamber body plethysmography, the PulmOne MiniBox+ provides accurate and efficient lung volume measurement in a compact, portable configuration suitable for facilities with limited space.

The system is uniquely capable of accommodating obese, wheelchair-bound, non-ambulatory, and claustrophobic patients.

Additional operational and technical advantages include:

-friendly interface suitable for clinical or administrative staff

The acquisition supports IHS strategic goals to improve access to comprehensive respiratory diagnostic services while optimizing operational efficiency.

4. Statutory Authority Cited and Rationale This sole source acquisition is being conducted under RFO FAR 12.201-1 simplified procedures for covered actions greater than the simplified acquisition threshold and less than or equal to $9 million pursuant to 41 U.S.C. 1901.

The contracting officer has determined that only one source is reasonably available based on the following rationale:

PulmOne is the only known vendor capable of providing a pulmonary diagnostic system with gasless, cabinless lung volume measurement technology offering plethysmography-equivalent accuracy without the need for a traditional body box. Competing systems utilize gas dilution methods and require enclosed body plethysmography chambers that are

-bound, and claustrophobic patients

No other known alternative currently available in the marketplace meets all required salient characteristics.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts Not applicable. This is a new equipment acquisition and not a bridge contract or extension.

6. Actions to Increase Competition Not available for competition.

7. Market Research Market research was conducted through review of commercially available pulmonary function testing systems and consultation with clinical personnel regarding operational requirements. Research determined that competing systems rely on nitrogen washout or portability, and patient accessibility requirements.

The PulmOne MiniBox+ was identified as the only commercially available system capable of providing gasless, cabinless lung volume measurements with plethysmography-equivalent accuracy while supporting all required patient accessibility and integration requirements.

8. Procurement History Not applicable. This is a new acquisition for the facility and not a follow-on procurement.

9. Additional Information or Other Facts This system will require access to or communication through the Federal IHS Domain or IHS-controlled network devices and therefore must comply with all applicable IHS, HHS, and DHS cybersecurity and security compliance requirements. Any vendor access to IHS network-controlled devices or systems must meet all applicable security requirements.

10. Technical or Requirements Program Management Certification I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: ______________________

Title: ____________________________

Signature & Date: __________________

12. Fair and Reasonable Price Determination As the contracting officer, I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based upon:

Market research

Comparison of proposed price with prices found reasonable on previous purchases

Comparison to an independent Government estimate

Other: __________________________

13. Contracting Officer Certification and Approval I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: _Jeremy Steel_____________________

Contracting Officer

Signature & Date: __________________

14. Division Advocate for Competition Review and Approval Typed Name: ______________________

Title: ____________________________

Signature & Date: __________________