36C24726Q0435_1.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799

POINT OF CONTACT*

Contracting Officer Darius Crane darius.crane@va.gov

(843) 577-5011

PLACE OF PERFORMANCE

Birmingham VAMC

NCO 07

700 19th Street S

Birmingham AL

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. The Department of Veterans Affairs, Birmingham VAMC – Birmingham, AL 32599-1927 has a requirement to procure a Non-Invasive Ventilation System for the Birmingham VA Healthcare System.

This solicitation is issued as a Small business set aside Brand Name or Equal RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01 effective 03/13/2026.

Note: Interested offerors must be registered in SAM.gov to be considered for Award.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 employees.

The FSC/PSC is 6515.

Vendor shall provide Brand Name or Equal equipment to meet or exceed the NKV-330 Ventilator supplied by Nihon Kohden that will satisfy the below listed salient characteristics.

Specifications/salient characteristics:

The ventilator system offered must be equal in features, performance, and functionality to the Nihon Kohden NKV‑330 and must meet the following minimum salient characteristics:

1. Patient Safety & Filtration

• Must have integrated dual HEPA filtration.

• Must not be under any current FDA recall.

2. Monitoring Capabilities

• Must have integrated EtCO₂ and SpO₂ monitoring.

• Must support continuous CO₂ and SpO₂ monitoring, including while in Standby mode.

• Must support continuous CO₂ monitoring during NPPV therapy.

3. Ventilation & Therapy Modes

• Must support multiple non‑invasive ventilation modes suitable for ER, ICU, and intra‑hospital transport use.

• Must include high‑flow oxygen therapy capability as a standard, non‑optional feature.

4. Data Storage & Clinical Information

• Must provide full disclosure of at least 72 hours of continuous waveform data.

• Must be able to communicate/interface with CPRS, Clinicomp, and Cerner systems.

5. Alarm & Safety Features

• Must have clearly visible visual alarms and audible alarms for critical events.

• Must include a dual-speaker alarm system, ensuring alarm audibility even if one speaker fails.

• Must allow uninterrupted operation during power loss via:

– Hot‑swappable main battery

– Internal backup battery

6. Operational Flexibility

• Must be suitable for use across the continuum of care, including:

– Emergency Department

– Intensive Care

– Recovery / step‑down

– Intra-hospital transport

7. Interface & Sensor Integration

• Must incorporate a modular or smart‑cable connection system that automatically detects attached CO₂ or SpO₂ sensors and updates the display accordingly.

• Must allow real‑time monitoring and display updates without manual reconfiguration.

8. Patient Comfort (Applicable Accessory Requirement)

• If a non-invasive mask is included, it must be designed to fit a wide range of facial shapes while minimizing skin pressure and discomfort.

All interested Vendors shall provide quotations for the below items:

ITEM INFORMATION

COMPREHENSIVE NKV330,

TROLLEY, ACCESSORIES 2IN

MANUFACTURER PART NUMBER (MPN):

LOCAL STOCK NUMBER: NKV330-COMP-T

T/ZA

NKV-330 ANNUAL EXTENDED WARRANTY

MANUFACTURER PART NUMBER (MPN):

LOCAL STOCK NUMBER: #EW-NKV330

NKV-330 BIOMED TRAINING

MANUFACTURER PART NUMBER (MPN):

LOCAL STOCK NUMBER: #330-BMD TRAINING

Delivery shall be provided no later than 30 days after receipt of order (ARO).

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services” Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

3. 52.225-2 Buy American Certificate.

Buy American Certificate (Oct 2022)

(a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(b) Foreign End Products:

(b)[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No. ___

[List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision)

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items”

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” The following subparagraphs of FAR 52.212-5 are applicable:

FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

Commercial products shall comply with 52.225-1 Buy American-Supplies FAR 52.225-1 Buy American-Supplies

(a) Definitions. As used in this clause— Commercially available off-the-shelf (COTS) item—

(1) Means any item of supply (including construction material) that is–

(i) A commercial product (as defined in paragraph (1) of the definition of “commercial product” at Federal Acquisition Regulation (FAR) 2.101);

(ii) Sold in substantial quantities in the commercial marketplace; and

(iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and

(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products.

Component means an article, material, or supply incorporated directly into an end product.

Cost of components means—

(1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or

(2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product.

Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at FAR 25.105 .

Domestic end product means—

(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both-

(i) An unmanufactured end product mined or produced in the United States;

(ii) An end product manufactured in the United States, if-

(A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic. Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or

(B) The end product is a COTS item; or

(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of "cost of components".

End product means those articles, materials, and supplies to be acquired under the contract for public use.

Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws.

Foreign end product means an end product other than a domestic end product.

Foreign iron and steel means iron or steel products not produced in the United States. Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign.

Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the product and a good faith estimate of the cost of iron or steel components excluding COTS fasteners.

Steel means an alloy that includes at least 50 percent iron, between 0.02 and 2 percent carbon, and may include other elements.

United States means the 50 States, the District of Columbia, and outlying areas.

(b) 41 U.S.C. chapter 83, Buy American, provides a preference for domestic end products for supplies acquired for use in the United States. In accordance with 41 U.S.C. 1907, the domestic content test of the Buy American statute is waived for an end product that is a COTS item, except that for an end product that consists wholly or predominantly of iron or steel or a combination of both, the domestic content test is applied only to the iron and steel content of the end product, excluding COTS fasteners.

(c) Offerors may obtain from the Contracting Officer a list of foreign articles that the Contracting Officer will treat as domestic for this contract.

(d) The Contractor shall deliver only domestic end products except to the extent that it specified delivery of foreign end products in the provision of the solicitation entitled "Buy American Certificate."

(End of clause)

All quotes shall be sent to the Contracting Officer, Darius Crane at darius.crane@va.gov Award will be based upon Contracting Officer decision for the quote most favorable to the Government.

The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions.

All quoters shall submit the following to be considered acceptable for award:

· Documentation that confirms the company/employee are manufacturer authorized resellers/distributors and installers of the quoted items.

· If you are quoting/offering “or equal” items, the offeror must clearly identify the exact make, model, manufacturer, and item description for each line item to be considered. Quotes/offerors that do not provide an adequate description of how the “equal” product meets or exceeds the requested item(s) will not be considered for award. This is not applicable to offerors that are quoting “EXACT MATCH” items.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Instruction to Offerors All quoters shall submit your Quotes no later than April 29, 2026, at 12:00PM (EST), via email to darius.crane@va.gov . Please place in “ATTENTION: 36C24726Q0435 NON-INVASIVE VENTILATORS” in the subject line of your email. All offers must include the solicitation number. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail no later than April 27, 2026, at 9:00AM (EST), via the same email address. Please place in “ATTENTION: 36C24726Q0435 NON-INVASIVE VENTILATORS” in the subject line of your email. Questions received later than this time/date may not receive a response.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Combined Synopsis/Solicitation Notice