HT941025N0137 Sole Source Justification_Okinawa.pdf

CUI

Control Number: FY25-0358

Controlled by: Defense Health Agency Controlled by: Healthcare Contracting Division – West (HCD-W) CUI Category: Source Selection Limited Dissemination Control: FEDCON POC: Cha-on Gordon Email: cha-on.p.gordon2.civ@health.mil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

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

1. Identification of the Agency and Contracting Activity: This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), to meet the requirements of the 18th Operational Medical Readiness Squadron (OMRS) for Neonatal Intensive Care Unit (NICU) at U.S. Naval Hospital Okinawa (USNHO), Japan, Unit 5268 FM5270 McKennon Ave. Bldg 3154 Kadena AB Okinawa-City, Okinawa Japan 904-0203.

2. Description of Action:

☒ New Requirement ☒ Purchase Order ☐ Blanket Purchase Agreement (BPA) ☐ Order against BPA # ☐ Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract # ☐ Order against Single Award IDIQ Contract # ☐ Order against Federal Supply Schedule Contract #

☐ Follow-on Requirement to Contract/Order # N6264519P0026 and N6264517P2027 ☐ Modification against existing Contract/Order and Modification #

Contract Type ☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

3. Description of Services or Supplies and Estimated Value: The 18th Operational Medical Readiness Squadron (OMRS) for Neonatal Intensive Care Unit (NICU) at U.S. Naval Hospital Okinawa (USNHO), Japan, has a requirement for four (4) time-cycled pressure-limited high-frequency jet ventilators with passive exhalation. Each ventilator must have independently adjustable PIP, Rate, and Inspiratory Time (Ti). Each ventilator shall operate in tandem with a conventional ventilator (CV) using the LifePort ETT Adapter (LPA).request the purchase of LifePulse High-Frequency Jet Ventilation (HFJV) Ventilators.

Based on market research, Bunnell Incorporated is the Original Equipment Manufacturer (OEM) for subject requirement. Bunnell Incorporated will provide all required equipment and supplies.

Name of Proposed contractor and address:

Bunnel, Incorporated

UEI: P6N5XM5Y34W3

330 Cutler DR North Salt Lake, Utah 84054-2955, United States

Control Number: FY25-0226

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Base Items Required Delivery Date Type of Funding Unit Unit Price Total Price

LifePulse High Frequency Jet Ventilator – Model 204 Part #204 6 -8 weeks from time of award O&M EA $45,800 $183,200

Extra Whisper Jet Patient Box Model 314 6 -8 weeks from time of award

O&M EA $2,910 $11,640

Pole Stand Cart Part #605 6 -8 weeks from time of award

O&M EA $1,450 $5,800

Bracket – hanger for blender on pole stand cart Part #606 6 -8 weeks from time of award

O&M EA $120 $480

Durable Shipping Case Part #700 6 -8 weeks from time of award

O&M EA $910 $1,820

Shipping 6 -8 weeks from time of award

O&M EA $6,400 $6,400

TOTAL PRICE $209,340

4. Authority: Procurement is conducted under Federal Acquisition Regulations (FAR) Subpart 13.5, in accordance with 41 U.S.C. 1901, Simplified Acquisition Procedures for commercial items.

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold, only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization).

5. Reason for Authority Cited: According to market research, Bunnel, Incorporated is the OEM for LifePulse High-Frequency Jet Ventilation and is the only vendor capable of meeting all the Government's minimum requirements. There are not authorized resellers of these products. Bunnell’s High-Frequency Jet Ventilator provides superior physiologic impacts and unique therapeutic flexibility.The LifePulse®, also known as the Jet, is a time-cycled pressure-limited ventilator with passive exhalation. It hasindependently adjustable PIP, Rate, and Inspiratory Time (Ti). The Jet operates in tandem with a conventionalventilator (CV) through the use of the LifePort ETT Adapter (LPA). The CV provides PEEP and intermittent orsustained lung recruitment maneuvers when indicated. The use of both ventilators allows clinicians the ability toseparate the management of ventilation from oxygenation. Unique characteristics of the Jet set it apart from otherforms of high frequency ventilation. Exceptionally short inspiratory times result in extremely small tidal volumes (VT)leading to significant pressure attenuation at the alveoli. Adjustable respiratory rates and inspiratory times createvariable I:E ratios which may benefit various complex pathophysiologies. Passive exhalation during HFJV providesthe ability to use lower mean airway pressures without increasing the risk of airway collapse or capillary compression.

6. Market Research: Market research was conducted by technical experts in August 2025 and included mandatory source searches (AbilityOne, Unicor, and ECAT); vendor capability searches on SAM.gov, SBA Dynamic Search, and GSA Advantage; review of commercial off-the-shelf (COTS) surgical planning tools; and consultation with other DoD training centers currently using virtual surgical planning (VSP) software. The NICU at USNHO utilizes LifePulse High-Frequency Jet Ventilation (HFJV) and requires replacement units for High-Frequency Jet Ventilators which has reached its end-of-life cycle and needs to be replaced for the safety and continued care of patients. Results confirmed that LifePulse High- Frequency Jet Ventilators are only sold by the OEM Bunnell Incorporated and is the only authorized distributor. A Notice of Intent (NOI) to sole source was posted on sam.gov from 14 August 2025 to 18 August 2025 no other vendor capable of providing the equipment submitted a response. A DD2579 Small Business Coordination Record will be sent to DHA OSBP for approval for this sole source requirement.

Market research has determined that this requirement will sole sourced Bunnell Incorporated, UEI:

P6N5XM5Y34W3 CAGE: 3T551.

7. Other Facts:

Control Number: FY25-0226

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

a. Procurement History:

(1) Is this a new requirement? No

(2) If 7.a.(1) is No, was the action just prior to this one competed? No

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

b. Additional Information: The Department of the Navy awarded N6264519P0026 on 10 April 2019 and contract N6264517P2027 on 7 September 2017 as a sole source contract to Bunnell Incorporated for LifePulse High-Frequency Jet Ventilators.

8. Technical/Requirement 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.

TSgt Kerraine R. Govia, USAF Section Chief, Service Contract Management 18th Medical Support Squadron, PACAF Kadena AB, Okinawa, Japan

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).

Mariangela J. Monsalve Contracting Officer

DHACA, HCD-W

10. Contracting Officer Determination:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Mariangela Monsalve Contracting Officer

DHACA, HCD-W