HT941027N0010 NOI BDAACH Reagent for BioFire system.pdf

Notice of Intent to Sole Source HT941027N0010

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SUPPLY CONTRACT

AND IS NOT A REQUEST FOR COMPETITIVE QUOTES.

The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division– San Diego (HCD-SD), intends to award a firm-fixed-price purchase order for panels for the BioFire System. This procurement supports the operational requirements of Brian D. Allgood Army Community Hospital (BDAACH), Camp Humphreys, Republic of Korea. In accordance with (RFO) 12.102(b), this acquisition of commercial products and services will be conducted on a sole-source basis because only one source is available to meet the Government’s needs:

BioFire Defense, LLC 79 W. 4500 S., Suite 14 Salt Lake City, UT 84107-2663

UEI: NHMDGM122546

CAGE Code: 088J2

The North American Industry Classification System (NAICS) code for this requirement is 325413, In-Vitro Diagnostic Substance Manufacturing, with a small business size standard of 1,300 employees. The Product Service Code (PSC) is 6640, Laboratory Equipment and Supplies.

Brian D. Allgood Army Community Hospital (BDAACH), Camp Humphreys, Republic of Korea, currently owns and operates BioFire diagnostic systems manufactured by BioFire Diagnostics, LLC. The hospital’s existing BioFire systems require BioFire system-specific reagent panels; panels manufactured by other vendors are not compatible with the installed equipment.

BDAACH requires BioFire Gastrointestinal Panel IVD and Respiratory Panel 2.1 IVD, 30 tests, to support ongoing diagnostic testing requirements. The Respiratory Panel 2.1 IVD enables the laboratory to detect multiple respiratory pathogens commonly associated with the cold and influenza season. The Gastrointestinal Panel IVD supports molecular stool testing by simultaneously detecting multiple bacteria, viruses, and parasites associated with gastrointestinal infections.

BioFire Defense, LLC is the sole-source provider of BioFire systems and system-specific reagents to the Department of War (DoW), including the BioFire FilmArray 2.0, BioFire FilmArray Torch, and BioFire SpotFire systems, as well as associated service, maintenance, extended warranties, software, and system-specific reagents. Because the required panels must be compatible with BDAACH’s existing BioFire equipment, no other source can provide interchangeable panels that will meet the hospital’s minimum requirements without replacing the installed systems.

Replacing the existing BioFire equipment to accommodate another manufacturer’s testing panels would result in additional costs to the Government, including the procurement, installation, validation, and implementation of replacement equipment. Replacement would also require training laboratory personnel and Biomedical Equipment Technician (BMET) personnel on the operation and maintenance of the new equipment. BDAACH BMET personnel are already trained to maintain the existing BioFire systems. Transitioning to a different system could disrupt laboratory operations and adversely affect the timely delivery of patient diagnostic services.

Accordingly, BioFire Defense, LLC is the only responsible source capable of providing the required BioFire Gastrointestinal Panel IVD and Respiratory Panel 2.1 IVD for use with BDAACH’s existing BioFire diagnostic systems.

Items required:

CLIN 0001: Gastrointestinal Panel IVD, 30 Tests – Base Quantity: 12 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea Mailing / APO Address: Unit 15245 APO, AP 96271 Delivery Period: 03/01/2027-09/30/2027

CLIN 0002: Respirtory panel 2.1 IVD, 30 Tests – Base Quantity: 35 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea Mailing / APO Address: Unit 15245 APO, AP 96271 Delivery Period: 03/01/2027-09/30/2027

CLIN 1001: Gastrointestinal Panel IVD, 30 Tests – Base Quantity: 20 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea Mailing / APO Address: Unit 15245 APO, AP 96271 Delivery Period: 09/01/2027-09/30/2028

CLIN 1002: Respirtory panel 2.1 IVD, 30 Tests – Base Quantity: 60 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea

Delivery Period: 09/01/2027-09/30/2028

CLIN 2001: Gastrointestinal Panel IVD, 30 Tests – Base

Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea Mailing / APO Address: Unit 15245 APO, AP 96271 Delivery Period: 09/01/2028-09/30/2029

CLIN 2002: Respirtory panel 2.1 IVD, 30 Tests – Base Quantity: 60 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea

Delivery Period: 09/01/2028-09/30/2029

CLIN 3001: Gastrointestinal Panel IVD, 30 Tests – Base

Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea Mailing / APO Address: Unit 15245 APO, AP 96271 Delivery Period: 09/01/2029-09/30/2030

CLIN 3002: Respirtory panel 2.1 IVD, 30 Tests – Base Quantity: 60 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea

Delivery Period: 09/01/2029-09/30/2030

CLIN 3001: Gastrointestinal Panel IVD, 30 Tests – Base

Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea

Delivery Period: 09/01/2030-09/30/2031

CLIN 3002: Respirtory panel 2.1 IVD, 30 Tests – Base Quantity: 60 Unit of Issue: EA Physical Location: Buildings 3030 and 3031, Indianhead Avenue, USAG Humphreys, South Korea

Delivery Period: 09/01/2030-09/30/2031

This notice of intent is not a request for competitive proposals, and no formal solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement. Submissions must include management, technical, and cost data in sufficient detail accompanied by convincing evidence to clearly demonstrate the capability to provide the required equipment and preventive maintenance. Capability statements shall not exceed four (4) pages (8.5" x 11" format) using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. Requests for documentation, inquiries for additional information, or submissions consisting solely of questions will not be considered affirmative responses. A determination by the Government not to compete this requirement based on responses to this notice is solely within the discretion of the Government. Information received will be considered exclusively for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole-source purchase order.

Response Instructions:

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to:

• Cha-on Gordon at cha-on.p.gordon2.civ@health.mil

• Susan Fujita at susan.m.fujita.civ@health.mil

The closing date for challenges is no later than 1000 Pacific Daylight Time, Monday 23 November 2026

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.

https://www.google.com/url?q=mailto%3Acha-on.p.gordon2.civ%40health.mil mailto:susan.m.fujita.civ@health.mil