JA W81K0025QA082 Redacted_Redacted.pdf

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Volumetric Diffusive Respirators (VDRs)
Solicitation number
W81K0025QA082
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This document is a Justification Review Document for a Sole Source acquisition under FAR Part 13.501 for the Medical Readiness Contracting Office West (MRCO-W). The procurement is for eight (8) Volumetric Diffusive Respirators (VDR-4) from Sentec, Inc. for the USAISR Respiratory Therapy Department at Brooke Army Medical Center, Joint Base San Antonio, Fort Sam Houston, Texas. The VDR-4 is an adult intensive care flow-regulated ventilator specifically designed for burn patients, which includes an air and oxygen blender, Monitron II, and video graphics array for real-time wave form analysis and patient alarms.

The sole source justification is based on Sentec, Inc. being the exclusive manufacturer, sales organization, and authorized service center for these specialized medical devices in the U.S. Market research was conducted across multiple platforms including SAM.gov, FPDS-NG, and small business databases, with no alternative sources identified. A special notice was published on sam.gov on 6 May 2025 inviting potential vendors to submit capability statements, but no responses were received. The procurement will use FY25 Defense Health Program (DHP) funds, with a purchase request number of HT085350995297. The contract will be a Firm Fixed Price arrangement, and MRCO-W will continue to evaluate the market for potential alternative sources in future procurements.

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CUI//SP-SSEL

Control Number: 25-MRCO-WEST-169

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

2 JUN 2023

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office West (MRCO-W)

2. Description of Action: MRCO-W intends to issue a sole source, Firm Fixed Price contract to Sentec, Inc for the procurement of eight (8) Volumetric Diffusive Respirators for USAISR Respiratory Therapy Department, Brooke Army Medical Center, Fort Sam Houston, TX.

Purchase Request: HT085350995297. FY25 Defense Health Program (DHP) funds.

3. Description of Supplies/Services: This requirement is for eight (8) Volumetric Diffusive Respirators, model K00008-1, VDR-4 with Monitron II, Stand & VGA includes x 1: A50075- VDR VDR® Stan, A50060 Lubetube, Xiameter Pmx-200, Silicone Fluid .16 oz, A50117 Mounting block Assembly, Ring, A50123 Test Lung Assembly, Neonatal, Nitrile, MON- WHTVGA White Medical Grade Monitor provided by Sentec. The VDR-4 is an adult intensive care flow-regulated and time-cycled ventilator which provides high frequency percussive ventilation, specifically for burn patients. It includes air and oxygen blender with stand for patient transport and Monitron II and video graphics array for real time wave form analysis and audible patient alarms. The USAISR Respiratory Therapy Department, Brooke Army Medical Center, Fort Sam Houston, TX, currently uses the VDR.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name), under the authority of the simplified procedures for certain commercial items

5. Reason for Authority Cited: In accordance with FAR 13.501(a)(1), there is only one responsible source, and no other supplies or services will satisfy the specific agency requirements. This sole source (including brand name) justification satisfies the format the Contracting Officer must use under FAR 6.303-2 to reflect the procedures in FAR Subpart 13.5, used in accordance with 41 U.S.C. 1901 and/or the authority of 41 U.S.C. 1903. Sentec, Inc is the sole provider of all Sentec VDRs and supplies related to use in the U.S. Sentec Inc is both the manufacturer and the direct sales organization for these products. Additionally, it operates as the sole authorized service center for the product lines in the U. S. No other vendors are authorized to distribute, sell, or service these products or supplies within the U.S.

The department currently have supplies and accessories for the Sentec VDRs. These supplies and accessories are only compatible with Sectec VDRs.

6. Efforts to Obtain Competition: A special notice of intent to sole source this requirement to Sentec was published on sam.gov on 6 May 2025, inviting interested vendors to submit their capability statements proposal or quote not later than 12 May 2025. No responses were received.

Based on market research and the results of the notice published, competition is not anticipated for this requirement. Sentec provided a signed letter stating they are the sole provider of all Sentec VDRs. Due to the nature of this requirement, subcontracting opportunities are not available.

CUI//SP-SSEL

Control Number: 25-MRCO-WEST-169

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

3 JUN 2023

7. Actions to Increase Competition: After contract award, this justification will be available on sam.gov Contracting Opportunities. If in the future, other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings.

8. Market Research: In accordance with FAR Part 10, market research was completed by both the Requiring Activity and conducted by MRCO-W.

a. A thorough search was conducted via the internet sites for AbiltyOne, UNICOR, System for Award Management (SAM), the Federal Procurement Data System – Next Generation (FPDS-NG), General Services Administration’s (GSA) Acquisition Gateway, Federal Supply Schedule contracts , as well as https://www.vendorportal.ecms.va.gov/NAC/MedSurg/List, to identify any potential contractor capable of providing Sentec VDRs. No sources were identified that could satisfy the needs of this requirement.

b. A search of the Small Business Administration’s Dynamic Small Business Search

(DSBS) database was conducted utilizing NAICS code 339112 and the key word “ventilator” to identify vendors capable of meeting the needs of this requirement, identify small business vendors, and determine potential set-asides or subcontracting possibilities. No sources were identified.

c. The VDRs are not available through the DLA Prime Vendor Program.

9. Interested Sources: A notice of intent to sole source this requirement to Sentec was published on sam.gov on 6 May 2025, inviting interested vendors to submit their capability statements proposal or quote not later than 12 May 2025. No responses were received.

10. Other Facts:

a. Procurement history. This is the first time MRCO-W is procuring VDRs for the USAISR Respiratory Therapy Department, Brooke Army Medical Center, Fort Sam Houston, TX

b. Other facts. N/A

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