USNH Okinawa Supply Requirement for Reagents and Consumables to support 1 analyzer, laboratory, immunoassay, chemiluminescent Abbott Alinity

DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENT The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis 10 U.S.C. 2304(c)(1) and FAR 13.501(a)(1)(i), soliciting from a single source. The proposed source is Abbott Laboratories, Inc. of 200 Abbott Park Road, Abbott Park, IL. 60064 USA. The U.S. Pacific Command Armed Services Blood Bank Center (ASBBC) in Naval Hospital Okinawa has a supply requirement for reagents and consumables to support one (1) analyzer, laboratory, immunoassay, chemiluminescent [17-916] (Analyzer) for the U.S. Naval Hospital (USNH) Okinawa. The analyzer, procured via a separate action, shall be capable of blood donor screening for anti-HBC, anti-HBsAg, anti-HIV 1/2, anti-HTLV I/II, anti-HCV, and Chagas. The analyzer shall be Food and Drug Administration (FDA) approved for each of the listed tests. Reagents shall not require staff preparation before use in the analyzer. The analyzer using these reagents shall be capable of continuous loading of reagents and supplies. The analyzer shall be able to accommodate a minimum throughput of 600 tests per hour. The vendor shall provide quality control, reagents, and consumables as outlined in the Statement of Work (SOW) for a base year and up to four option periods. The reagents and consumables for the Abbott system, 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 when delivery is requested outside of the United States of America. The system shall be installed in 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 equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. If interim storage is required, the vendor shall make arrangements for the storage. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516. This notice of intent is not a request for competitive proposals. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. 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. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Mr. Philmore Crichlow at philmore.h.crichlow.civ@mail.mil. Closing date for challenges is no later than 1:00 PM ET on 29 August 2021. No phone calls will be accepted.