4.2 Sole Source Justification Form-TSE Systems KO signed 12.23.25.pdf
PDF 521 KB Posted
- Attached to
- Stellar Implantable Transmitters Federal contract opportunity
- Solicitation number
- N3239826Q8631
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). NAMRU Dayton seeks to sole-source purchase telemetric implants from TSE Systems for a currently funded study on the autonomic and overt toxicity of aircraft deicing fluid. The specific telemeters must be compatible with an existing TSE Stellar telemetry receiver, suitable for implantation into a rat model, able to sample blood pressure at >500 Hz, and have a battery life allowing data collection for over 3 months. The contract is valued under $150,000, and the government anticipates negotiating a discounted price from the commercial price list. Market research confirmed TSE Systems as the sole worldwide supplier of compatible telemeters, justifying the sole-source procurement under FAR 6.302-1 and 10 U.S.C. 2304(c)(1) exceptions.
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Text version
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: 20Nov2025 |
| Name_2: |
| 0: |
| 0: Dr. Karen L. Mumy |
Director, EHEL
EHEL/NAMRU-D
| 1: |
| 0: Nathan M. Gargas |
Research Biologist/Lab Manager
EHEL/NAMRU-D
| 2025-11-20T14:54:41-0500 | |
| GARGAS.NATHAN.MICHAEL.1407338649 |
| Phone_2: 937-904-9474 |
| Date_2: 20 NOV 2025 |
| Text2: The data were obtained from the Internet and through email. Information was obtained through google and GSA searches. There are no other implants commercially available other than through TSE Systems that are compatible with a TSE receiver. Email communication with the company confirmed that the telemeters are of appropriate size for implantation into a rat model, able to sample blood pressure at >500 Hz, and have a battery life allowing data collection for > 3 months. Further, they confirmed that they are the sole worldwide supplier of TSE telemeters. |
| Text3: The Contracting Officer shall determine the anticipated cost to the Government of the software covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is mage. In addition, the Government anticipated that the negotiated contract price will reflect a discount from the commercial price list and will be determined fair and reasonable. |
| Text4: NAMRU Dayton requests this purchase be solely sourced to TSE systems. Telemetric implants compatible with the already owned TSE receiver are exclusively sold by TSE Systems. |
| Text5: NAMRU Dayton presently owns a TSE Stellar telemetry receiver. A currently funded study (Autonomic and overt toxicity of aircraft deicing fluid) needs to acquire intravascular telemetric blood pressure transducers. These telemeters will allow longitudinal collection of arterial blood pressure to derive measures of autonomic blood pressure regulation. Without these implants the study will not be able to provide required data to the sponsor. |
| Text1: Supplies: |
The telemeters are compatible with a TSE receiver, appropriate size for implantation into a rat model, able to sample blood pressure at >500 Hz, and have a battery life allowing data collection for > 3 months.
| Phone_3: |
| Date_3: |
| 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.
Be sure to include the FAR cite as well. See attached FAR explanation sheet for J&A references
FAR 13.106-1(b)(1) <$150K
| 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. | |
| 2025-11-20T14:58:17-0500 | |
| MUMY.KAREN.LYNN.1383751884 |
| 2025-12-23T13:52:22-0500 | |
| JOHNSON.NATAKI.SHIDONA.1515567492 |
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