4.2 Sole Source Justification Form FY25 _SCIREQ (Scientific Respiratory Equipment Inc).pdf
PDF 307 KB Posted
- Attached to
- FlexiVent System Purchase Federal contract opportunity
- Solicitation number
- N3239825Q4703
About this file
This document is a Justification and Approval (J&A) for Other Than Full and Open Competition for the Naval Medical Research Command (NMRC). The document details a sole-source procurement of one (1) FlexiVent FX system from SCIREQ (Scientific Respiratory Equipment Inc.) in Montreal, Canada, for specialized pulmonary function testing research. The system is a proprietary instrument designed for use in small laboratory animals like rats and mice, with capabilities including computer-controlled mechanical ventilation, pressure and flow transducers, data acquisition software, and respiratory mechanics assessment tools.
The J&A justifies the sole-source procurement under 10 U.S.C. 2304(c)(1) and FAR 6.302-1, citing SCIREQ as the exclusive manufacturer and distributor of this specialized platform. The anticipated cost is deemed fair and reasonable, reflecting the equipment's advanced software, precision instrumentation, and unique technical specifications. The procurement will support the Navy Expeditionary Medical Research requirements, specifically enabling precise, reproducible measurement of respiratory mechanics for military-relevant inhalation toxicology studies with enhanced scientific rigor.
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JUSTIFICATION AND APPROVAL
OTHER THAN FULL AND OPEN COMPETITION
1. Identification of the agency and the contracting activity.
This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.
2. Nature and/or description of the action.
3. Description of Supplies or Services.
4. Identification of the statutory exceptions permitting other than full and open competition.
The statutory exception permitting other than full and open competition for this acquisition is
5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.
6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.
Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the government point of entry in accordance with FAR 5.202.
7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.
8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.
9. Other facts supporting the use of other than full and open competition.
Not applicable
10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.
Not applicable
11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.
For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements are feasible.
12. Point of Contact:
The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.
TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED
BY NAVSUP 4200.83 series
I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.
Technical POC
Phone Date Name Title Department/Command
Department Head
Phone Date Name Title Department/Command
CONTRACTING OFFICER CERTIFICATION
I certify that this justification is accurate and complete to the best of my knowledge.
Contracting Officer Phone Date
Technical Cognizance
| Phone: 937-904-9459 |
| Date: 08May2025 |
| Name_2: |
| 0: |
| 0: Karen Mumy |
Director
EHEL/NAMRU-D
| 1: |
| 0: Nathan Gargas |
Research Biologist/Lab Manager
EHEL/NAMRU-D
| 2025-05-08T09:21:43-0400 | |
| GARGAS.NATHAN.MICHAEL.1407338649 |
| Phone_2: 937-904-9474 |
| Date_2: 12 MAY 2025 |
| Text2: The SCIREQ is the sole manufacturer and supplier of the FlexiVent system, which remains the only commercially available platform that offers fully integrated hardware and software for precision lung function testing in rodent models. No other vendors were identified that provide an equivalent system capable of achieving the same level of standardization, reproducibility, and compatibility with NAMRU-D’s existing equipment and ongoing research protocols. Based on these findings, full and open competition would not yield alternative sources that meet the specific technical and operational requirements of this acquisition. |
| Text3: The anticipated cost for the FlexiVent system is fair and reasonable. SCIREQ is the sole manufacturer and distributor of the FlexiVent platform, and the pricing structure reflects the specialized nature of the equipment, including advanced software, precision instrumentation, and post-sale support. |
| Text4: The FlexiVent system is a proprietary instrument developed and manufactured solely by SCIREQ (Scientific Respiratory Equipment Inc.), which holds exclusive rights to its design, components, and supporting software. SCIREQ is the only known source capable of providing the complete, fully integrated system along with necessary maintenance, calibration tools, and technical support. Compatibility with NAMRU-D’s existing FlexiVent infrastructure is essential for standardization of data, consistency across studies, and operational efficiency. No other vendor offers an equivalent system with the same precision in measuring lung function parameters using the forced oscillation technique in small animal models |
| Text5: To procure one (1) FlexiVent system from SCIREQ (Scientific Respiratory Equipment Inc., Montreal, QC, Canada) to support toxic inhalation exposure studies conducted by the Naval Medical Research Unit Dayton (NAMRU-D). The FlexiVent is a specialized computer-controlled mechanical ventilator system designed for preclinical research in small animal models, enabling precise, reproducible measurement of respiratory mechanics including airway resistance, compliance, and tissue elastance. This procurement will expand NAMRU-D’s capacity for high-throughput, high-precision lung function testing in support of multiple ongoing and upcoming DoD funded studies. The requirement is being processed under other than full and open competition due to the proprietary and specialized nature of the equipment, which is uniquely manufactured and supported by SCIREQ. |
| Text1: The supplies to be acquired include one (1) FlexiVent FX system from SCIREQ, a specialized pulmonary function testing platform designed for use in small laboratory animals such as rats and mice. The system includes a computer-controlled mechanical ventilator, pressure and flow transducers, software for data acquisition and analysis, and associated hardware required to perform high-resolution respiratory mechanics assessments using the forced oscillation technique. The equipment will be used to assess airway resistance, lung compliance, and tissue elastance in rodent models exposed to airborne toxicants, enabling NAMRU-D to conduct military-relevant inhalation toxicology studies with greater throughput, precision, and scientific rigor. |
| Phone_3: |
| Date_3: 13 June 2025 |
| Text6: Use one of the following in both sections, then delete those not used: |
10 U.S.C. 2304(c)(1), Only one responsible source.
10 U.S.C. 2304(c)(2), Unusual and compelling urgency.
10 U.S.C. 2304(c)(3), Industrial mobilization; engineering, developmental, or research capability; or expert services.
10 U.S.C. 2304(c)(4), International agreement.
10 U.S.C. 2304(c)(5), Authorized or required by statute.
10 U.S.C. 2304(c)(6), National Security.)
Be sure to include the FAR cite as well. See attached FAR explanation sheet for J&A references
FAR Part 13 FAR 13.106-1(b)(1) <$150K FAR 6.302-1, Only One Source (>$150K) FAR 6.302-2, Unusual and Compelling
| Text7: 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions or FAR 13.106-1(b)(1) soliciting from a single source. | |
| 2025-05-12T14:57:00-0400 | |
| MUMY.KAREN.LYNN.1383751884 |
| 2025-06-13T10:58:24-0400 | |
| PONCZEK.MICHAEL.JOSEPH.1098624054 |
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