Cepheid-Xpert Xpress SARS-CoV2   3

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part FAR

8.405-(6)(b)(1) only one source is capable of responding). The proposed source is Cepheid of 904 Caribbean Dr., Sunnyvale, CA 94089-1189. The requirement for one (1) analyzer, laboratory, molecular assay, infectious microorganism [20-802], for United States Naval Hospital (USNH) Guam.

This requirement is part of Federal Supply Schedule (FSS) procurement. Only one award will be made as a result

of this synopsis. The majority of the items required for the unit are available on Cepheid's contract

(GS-07F-0597T). However, the following component is not available via their schedule: Xpert Xpress SARS-CoV2.

The analyzer, 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 analyzer 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 analyzer such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the analyzer shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the analyzer, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. 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 American Industry Classification System (NAICS) 334516. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. 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.

Submit email capability statements (using PDF, MS Word, Excel attachments) to Kerry McKean at kerry.a.mckean.civ@mail.mil. Statements are due no later than 1000 ET 12 August 2020. No phone calls will be accepted.