Notice of Intent to Sole Source - Rev 1.pdf

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Notice of Intent to Sole Source - Rapid fFN Products - Hologic Sales and Services, LLC
Solicitation number
HT941026Q2062
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This is a Notice of Intent to Sole Source a commercial product procurement. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division (HCD-W), San Diego intends to award a firm-fixed-price contract to Hologic Sales and Service, LLC for the supply of medical diagnostic products for the U.S. Naval Hospital Okinawa, Japan. The required items are three Rapid fFN Control Kits (Product No. 01166), three boxes of fFN Cassettes (26 per box), and three Specimen Collection Kits (25 per kit). These products are compatible with the Hologic TLiIQ Analyzer. The delivery period extends from October 1, 2026 through September 30, 2029, with deliveries scheduled for October 2nd, February 1st, and June 1st annually. The contract is structured as a base period with two option years.

The sole source justification is based on Hologic Sales and Service, LLC being the sole proprietary manufacturer of the Rapid fFN test for the TLiIQ System and the sole domestic distributor authorized by parent company Hologic, Inc. The NAICS code is 325413 (In-Vitro Diagnostic Substance Manufacturing) with a business size standard of 1,250 employees, and the Product Service Code is 6550 (In-Vitro Diagnostic Substances, Reagents, Test Kits, and Sets). Interested vendors may challenge the sole source basis by submitting a capability statement (maximum eight 8.5 x 11 inch pages, 10-point font minimum) to Eddie L. "Franc" Franklin Jr. at eddie.l.franklin.civ@health.mil by August 28, 2026 at 5:00 AM Pacific Daylight Time. The Government will consider all responses to determine whether to conduct a competitive procurement or proceed with the sole source award. Telephone requests will not be accepted.

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Notice of Intent to Sole Source

HT941026N0112

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE COMMERCIAL PRODUCT PROCUREMENT

and IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. The Defense Health Agency Contracting

Activity (DHACA), Healthcare Contracting Division (HCD-W), San Diego, intends to award a firm-fixed-price contract for the supply of three (3) Rapid fFN Control Kits (Product No. 01166), three (3) boxes of fFN Cassettes

(26 per box), and three (3) Specimen Collection Kits (25 per kit) for the U.S. Naval Hospital Okinawa, Japan. This action is being conducted per the procedures in Federal Acquisition Regulation (FAR) Subpart 12.102(a), which permits acquisitions from a single source when it is determined that only one source is reasonably available to meet the agency’s requirements:

HOLOGIC SALES AND SERVICE, LLC

250 CAMPUS DRIVE

MARLBOROUGH, MA 01752

Delivery Period – 1 October 2026 through 30 September 2029

Hologic Sales and services, LLC shall deliver one each of the products described above on October 2nd, February 1st, and June 1st for the duration of the contract. The delivery/ship to address is: DoDAAC: HT0720 Country Code: JPN

COMMANDING OFFICER, USNH OKINAWA 111 FUTENMABARU, GINOWAN CITY OKINAWA, 901-

2202 JAPAN

The North American Industry Classification System (NAICS) code for this requirement is 325413 – In-Vitro

Diagnostic Substance Manufacturing; the business size standard is 1,250 employees. The Product Service Code

(PSC) is 6550 – In-Vitro Diagnostic Substances, Reagents, Test Kits, and Sets.

The objective of this sole source award is to procure supplies for the U.S. Naval Hospital Okinawa (USNHO)

Laboratory Department. USNHO requires the annual supply of Hologic fFN Rapid Cassettes and Control Kits compatible with the Hologic TLiIQ Analyzer. The anticipated period of performance is for a base period with two

(2) option years.

Hologic Sales and Service, LLC is the sole proprietary manufacturer of the Rapid fFN® test for the TLiIQ® System.

In addition, Hologic, Inc., as the ultimate parent company, has authorized Hologic Sales and Service, LLC to be the sole domestic distributor for the Rapid fFN test for the TLiIQ System. Hologic, Inc., and Hologic Sales and Service, LLC are collectively referred to herein as “Hologic.” The Rapid fFN test is performed using immunodiagnostic products that are solely manufactured by Hologic. Hologic does not sell through dealers or distributors in the U.S.;

sales are made directly to the end user only.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management, technical data, and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required supplies for United States Naval Hospital Okinawa.

Capability statements shall not exceed six (8.5 x 11 inch) pages 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. A request for documentation, additional information, or submissions that only ask questions will not be considered an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or

Adobe PDF attachment to Eddie L. “Franc” Franklin Jr. at eddie.l.franklin.civ@health.mil. The closing date for challenges is no later than 5:00 AM Pacific Daylight Time, 28 August 2026.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.

mailto:eddie.l.franklin.civ@health.mil

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