NOI Abbott Alinity Reagents and Consumables

Notice of Intent to Sole Source

HT941025N0067

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE NON-PERSONAL SERVICES CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to negotiate and award a firm fixed price contract for Abbott Alinity Reagents and Consumables, in accordance with Federal Acquisition Regulation FAR 13.501(a), only one source being available to meet the Government’s needs, to:

Abbott Laboratories Inc.

100 Abbott Park Road

BLDG. AP6D; Dept. 32L

Abbott Park, IL 60064-3500

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 (# of 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 Reagents and Consumables compatible to support one (1) Abbott Alinity S Series Instrument, laboratory, immunoassay, chemiluminescent Sterilizer for U.S. Naval Hospital Okinawa Japan (USNHOJ).

1. Reagents and Consumables shall be capable of supporting high volume donor-specific, fully automated InVitro diagnostic testing for blood donor screening for anti-HBC, anti-HBsAg, anti-HIV 1/2, anti-HTLV I/II, anti-HCV, and Chagas. Reagents to be used with system shall not require staff preparation before use in the analyzer.


2. Reagents and Consumables, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The reagents and consumables manufacture, and usage shall support compliance with the Occupational Safety and Health Administration (OSHA) requirements.


3. Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed Alinity reagents and consumables such that use of the reagents and consumables will not void the OEM warranty.

Based on market research, Abbott Laboratories Inc. is the only source that can meet the Government’s minimum requirement for the Abbott Alinity Sterilizer compatible reagents and consumables in support of USNHOJ.

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 and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required supplies validated by Abbott Laboratories Inc. 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 or additional information or submissions that only ask questions will not be considered as 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 Gilberto Esteves at gilberto.a.esteves.civ@health.mil. The closing date for challenges is no later than 0800 Pacific Time, 07 April 2024.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.