SSJ Digital Transcutaneous Blood Gas Monitoring System_Redacted.pdf

Revision: 02 Page 1 of 6 Effective Date: 12/30/2025 Acquisition ID# 36C261-26-AP-1773

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12.201-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID: 36C261-26-AP-1773 JOFOC Tracking Number:

1. Contracting Activity:

Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Regional Procurement Office (RPO) West, Network Contracting Office 21 (NCO 21), in support of Veterans Integrated Service Network 21 (VISN 21), Northern California Health Care System (VANCHCS), 10535 Hospital Way, Mather, CA 95655.

Purchase Request Number: 612-26-1-145-0099

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The VA Northern California Health Care System (VANCHCS) has requested the procurement of 2 new Digital Transcutaneous Blood Gas Monitoring Systems. There is a strong need for transcutaneous monitoring in the management of Veterans on non-invasive respiratory support (particularly biPAP and high-flow nasal) at VANCHCS. Current trends show that carbon dioxide levels play a growing role in ventilation, outcomes, and cost management in hospitals. A Transcutaneous Blood Gas Monitoring System ensures proactive, real-time clinical decision-making for Veterans without the need for a more invasive Arterial Blood Gas Test.

This will be a Firm-Fixed-Price Purchase Order for the procurement of 2 Digital Transcutaneous Blood Gas Monitoring Systems.

All Items are Brand Name or Equal Manufacturer Part

Number Description Quantity Unit

101342 V-Sign Sensor VS-A/P/N [1/PK] 2 Each 104255 tCOM+ Hospital USA 2 Each

GCX-RS

Roll Stand GCX RS-0006-64 [1/PK]

**Must order with plate** 2 Each tCOM-GCX-MP tCOM+ Vesa Mounting Plate GCX FLP-

0001-17 [1/PK]

2 Each

Total Estimated Value:

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Acquisition ID# 36C261-26-AP-1773

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Sentec tCOM+ Hospital Monitor in conjunction with the V-Sign Sensor 2 and accessories is a portable stand-alone Transcutaneous Blood Gas Monitoring System intended for continuous and noninvasive patient monitoring of carbon dioxide partial pressure, oxygen partial pressure, functional oxygen saturation, and pulse rate. The system is appropriate for use in adult, pediatric, and neonatal populations; it is both reusable and waterproof.

Given the market research conducted, there are no known Transcutaneous Blood Gas Monitoring Systems available for sale within the United States, outside of the Sentec tCOM+ Hospital USA Monitor with V-Sign Sensor and applicable accessories.

There are also no authorized distributors for Sentec Transcutaneous Blood Gas Monitoring Systems, with the exception of the Original Equipment Manufacturer (OEM) – Sentec, Inc.

(JCYVNVQZ2RX4).

In addition, there are no known or existing national contracts under the Federal Supply Schedule (FSS), the General Services Administration (GSA) or the Department of Veterans Affairs (VA) that offer Transcutaneous Blood Gas Monitoring systems.

Finally, there are no known Transcutaneous Blood Gas Monitoring Systems capable of meeting this requirement, that are also manufactured in the United States of America.

4. Description of market research conducted and results or statement why it was not conducted:

The Nonmanufacturing Rule (NMR) does not apply. According to the NMR Class Waiver Database (June 2022), there is an active waiver in effect for NAICS Code 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing.

The Buy American Statute applies. According to the Original Equipment Manufacturer (OEM), Sentec, Inc. (JCYVNVQZ2RX4), the items are manufactured in Switzerland

. An Individual Buy American Act Waiver is required.

The Food and Drug Administration (FDA) regulates medical devices sold in the United States to assure their safety and effectiveness. Items purchased for use at the Department of Veterans Affairs must be FDA approved.

The Sentec tCOM+ Hospital Monitor in conjunction with the V-Sign Sensor 2 and accessories are FDA approved.

Used the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) to identify certified capable Service Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB).

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Conducted a search of SBA’s DSBS utilizing NAICS 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing and filters for SDVOSB / VOSB vendors only, which resulted in the identification of 468 SDVOSB / VOSB vendors potentially capable of meeting the Government’s need.

Conducted a search of suggested vendor, Sentec, Inc. (JCYVNVQZ2RX4). Sentec, Inc. is a Small Business. Sentec, Inc. is not an SDVOSB / VOSB.

According to a letter dated 11/25/2025, signed by , Sentec, Inc. Director of Customer Operations, and provided by , Sentec, Inc. Sr. Territory Manager & Natl Field Sales Trainer, on 12/17/2025, “Sentec, Inc…is the sole provider of all Sentec Transcutaneous CO2 Monitoring Systems (TCM), Intrapulmonary Percussive Ventilation (IPV), Volumetric Diffusive Respirator (VDR), and supplies related to use in the United States. Sentec, Inc. is both the manufacturer and the direct sales organization for these products…No other vendors are authorized to distribute, sell, or service these products or supplies within the U.S. [United States]”. Additionally, and according to , these items are manufactured in Switzerland

A search of the VA National Acquisition Center (NAC) was conducted utilizing keyword(s):

• Transcutaneous Blood Gas Monitor – No results returned.

• Transcutaneous Hospital Monitor – No results returned.

• tCOM+ Hospital Monitor – No results returned.

• V-Sign Sensor 2 – No results returned.

• Digital Monitoring System – No results returned.

• Digital Monitoring System & 334510 - No results returned.

A search of the VA Supply Chain Master Catalog (SCMC) was conducted utilizing keyword(s):

• Transcutaneous Blood Gas Monitor – No results returned.

• Transcutaneous Hospital Monitor – No results returned.

• tCOM+ Hospital Monitor – No results returned.

• V-Sign Sensor 2 – No results returned.

• Digital Monitoring System – No applicable results returned.

o 47 items total, 36 for various types of hospital mattresses.

o 10 results for various types of patient monitoring systems and accessories (EKG

(electrocardiogram) Monitor, Blood Glucose Monitor, Cuff-link Monitoring Systems, Miscellaneous Cables, Sleep Apnea Monitoring, and BIS (Bispectral Index) Module Monitoring).

• Digital Monitoring System & 334510 - No results returned.

A search of General Services Administration (GSA) Advantage was conducted utilizing keyword(s):

• Transcutaneous Blood Gas Monitor – No applicable results returned.

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Acquisition ID# 36C261-26-AP-1773 o 6 items total to include Cholesterol Analyzers, Blood Bank Freezers, and Mobile Medical Clinics.

• Transcutaneous Hospital Monitor – No results returned.

• tCOM+ Hospital Monitor – No results returned.

• V-Sign Sensor 2 – No results returned.

• Digital Monitoring System – No applicable results returned.

o 13,849 results returned to include Digital Signage, Televisions, Fire Alarms, Air Monitoring Systems, Boat Monitoring Systems, Security Systems, and other Miscellaneous Monitoring Systems and Products.

• Digital Monitoring System & 334510 - No results returned.

A search of the Federal Procurement Data System (FPDS) was conducted utilizing keyword(s):

• Transcutaneous Blood Gas Monitor – No results returned.

• Transcutaneous Hospital Monitor – No results returned.

• tCOM+ Hospital Monitor – No results returned.

• V-Sign Sensor 2 – 1 result from 08/31/2015.

o 08/31/2015 | VA24815P5054 | Sovereign Medical, Inc. | $24,665.10 | Digital Monitor w/VSTATS and V-Sign Sensor | Small Business Set-Aside | 2 Offers Received | Purchase Order.

• Digital Monitoring System – 292 results returned.

o Results range from 09/2025 to 09/2003 and include procurements for Security

Systems, Environmental Control, Computing Infrastructure, and other Miscellaneous items. Results narrowed with the addition of the NAICS Code (334510) below.

• Digital Monitoring System & 334510 - 10 results returned.

o Results range from 09/2025 to 02/2013.

o All results from 09/2025 to 08/2021 appear to be Purchase Orders from the

Department of Veterans Affairs to Sentec, Inc.

A search of bing.com was conducted utilizing keyword(s):

• Transcutaneous Blood Gas Monitor – about 6,360 results returned, with the first page of results reviewed for purposes of this market research.

o Two Transcutaneous Blood Gas Monitoring Systems found – Sentec Transcutaneous C02 Monitoring (TCM) and Radiometer America Transcutaneous Monitoring Solutions; all other results appear to be publications discussing the use of and/or research into the technology.

o The Sentec Transcutaneous Monitoring System (or equal) is the subject of this procurement.

o The Radiometer America Transcutaneous Monitoring Systems appear to be “or equal” products. Radiometer America did not respond to the published Sources Sought Notice, nor did any other vendor with authority to distribute Radiometer America products.

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7:18AM – CLSS Studio, LLC ( ) confirmed their interest in the opportunity and stated they would provide the Brand Name Sentec Brand Hospital Monitors. Following this telephone conversation, emailed a capability statement which outlined the same – CLSS Studio will provide Brand Name Sentec Products through Authorized Distribution. As per the manufacturer however, there are no authorized distributors for Sentec Transcutaneous Blood Gas Monitoring Systems, with the exception of the Original Equipment Manufacturer (OEM) – Sentec, Inc. (JCYVNVQZ2RX4).

5. Contracting Officer's Certification: Purchase is approved in accordance with RFO 12.201-1. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer