NOI Abbott Alinity Reagents and Consumables
Closed Pre-Solicitation Posted
- Solicitation number
- HT941025N0067
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Japan
Notice details come from SAM.gov. Updated .
About this opportunity
The Defense Health Agency Contracting Activity (DHACA) intends to sole source a firm fixed price contract to Abbott Laboratories Inc. for Abbott Alinity Reagents and Consumables to support the U.S. Naval Hospital Okinawa Japan. The procurement involves acquiring reagents and consumables compatible with an Abbott Alinity S Series Instrument for high-volume, automated in-vitro diagnostic blood donor screening. Specific testing requirements include screening for anti-HBC, anti-HBsAg, anti-HIV 1/2, anti-HTLV I/II, anti-HCV, and Chagas. The government will evaluate capability statements that demonstrate the ability to provide validated supplies, with submissions limited to eight pages and due by 0800 Pacific Time on April 7, 2024. Interested vendors must submit detailed management, technical, and cost information demonstrating compliance with FDA and OSHA requirements.
The contract opportunity is not set aside for any specific business category and falls under NAICS code 325413 with a business size standard of 1,250 employees. Abbott Laboratories is considered the sole source based on market research, as they are the only supplier capable of meeting the government's minimum requirements for the Alinity Sterilizer compatible reagents and consumables. The contractor must be an Original Equipment Manufacturer authorized dealer, distributor, or reseller, and the reagents must not require staff preparation before use in the analyzer. Submissions will be considered solely to determine whether to proceed with a competitive procurement or a sole source purchase order. Vendors wanting to challenge the basis of the requirement must submit capability statements electronically to the designated contact, Gilberto Esteves, by the specified deadline.
Notice text
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).
- 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.
- 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.
- 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.
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