SAM #HT941026N0107

Sole Source Procurement of Amicus Apheresis Reagents and Consumables for Naval Hospital Okinawa

This procurement opportunity is for Amicus Apheresis reagents and consumables to support the Naval Hospital Okinawa's blood platelet processing and pathogen reduction requirements. - Government Buyer: - Defense Health Agency Contracting Activity (DHACA) - Healthcare Contracting Division West (HCD-W) - OEM Highlight: - Fenwal, Inc. is the sole manufacturer and provider for the required products - Products/Services Requested: - Amicus Apheresis reagents for cell separator systems - Intercept platelet small volume processing sets - Platelet dual storage containers - All products are used for pathogen reduction in blood platelets, as required by FDA standards - Notable Requirements: - Products must be compatible with the Amicus cell separator and Intercept pathogen reducing equipment - Delivery is to be drop-shipped to the Cardinal Health MPS Distribution Center in Ontario, CA - Procurement is under NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing) and PSC 6550 (In-Vitro Diagnostic Substances, Reagents, Test Kits and Sets) - No specific part numbers or quantities are provided in the notice - Sole source justification: Only Fenwal, Inc. can meet the technical and regulatory requirements for these consumables

Description

Notice of Intent to Sole Source HT941026N0107

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 – West (HCD-W), intends to award a firm-fixed-price purchase order for Drop Shipment of FDA Fenwal Amicus Apheresis Reagents (Manufacturer: Fenwal, Inc.). This procurement supports the operational requirements of Naval Hospital Okinawa, Japan, and is conducted in accordance with Federal Acquisition Regulation (FAR) 12.102(a), this acquisition of commercial products and services is being executed as a sole source, as the Contracting Officer does not have a reasonable expectation that two or more offers will be received.

FENWAL, INC., 3 CORPORATE DR STE 300, LAKE ZURICH, IL 60047-8930, United States

UEI: E9UHXHZCGJV5

CAGE: 4Q7Q2

The North American Industry Classification System (NAICS) code for this requirement is 325413, In-Vitro Diagnostic Substance Manufacturing, which has a business size standard of 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 Amicus Apheresis reagents for the cell separator for Naval Hospital Okinawa, located at Bldg 960, Tarawa Road, Camp Foster, Okinawa, Japan.

The requested Intecept platelet small volume processing set and platelet dual storage containers are used in the Intercept pathogen reducing equipment. These items are vital in the collection, treatment and sustainment of adequate inventory of blood platelets products for routine and emergent patient care and mission requirement. Pathogen reduction of donated blood platelet products reduces the transmission of viruses and infections upon transfusion. US Naval Hospital Okinawa PACOM Armed Services Blood Bank Center (ASBBC) is mandated by FDA to conduct pathogen reduction process for all collected blood platelets. Supplies of the platelet sets are historically sustained thru a drop shipment contract. The suggested vendor is the sole manufacturer and provider of the platelet sets.

Fenwal, Inc., is the only source capable of meeting the government’s minimum requirements.

Delivery Period: 1 October 2026 through 30 September 2027

Delivery Location: MAB, DLA TROOP SUPPORT XDOCK WEST PROJECT, C/O CARDINAL HEALTH MPS DISTRIBUTION CENTER, 4551 EAST PHILADELPHIA STREET, ONTARIO CA 91761

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:

Mariangela Monsalve at mariangela.j.monsalve.civ@health.mil Bobbie Dobberstein at bobbie.s.dobberstein.ctr@health.mil

The closing date for challenges is no later than 1000 Pacific Daylight Time, Friday, August 28, 2026.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.

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