This is a combined Sole Source Synopsis / Solicitation published for informational purposes only. This proposed action is for the procurement of Roche Diagnostics Immunoassay and CTNG reagents for testing clinical and infectious disease patient samples for the U.S. Air Force School of Aerospace Medicine, Epidemiology Laboratory Service Division (USAFSAM/PHE) located at Wright-Patterson Air Force Base. See Attachment 1, Statement of Work.

The Government intends to solicit and negotiate with only one source under the authority of FAR 8.405-6(a)(1)(i)(B).

This proposed procurement will be a Sole Source under North American Industry Classification System Code (NAICS) 325413: In-Vitro Diagnostic Substance Manufacturing. Business size standard for NAICS 325413 is 1,250 employees. PSC/FSC code: 6550: In vitro Diagnostic Substances, Reagents, Test Kits.

The proposed source is Roche Diagnostics, located at 9115 Hague Rd, Indianapolis, IN, 46256. A determination by the Government not to compete this proposed contract based upon 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. This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation or exception to the intent to purchase on a sole source basis, which shall be considered by the Government, if received by Thursday, 5 September 2019, 2:00 P.M. EST. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

In order to comply with FAR 5.207(c)(15), the reason for lack of competition is as follows: The Government requires instrumentation, reagents, consumables, and support to perform chemistry, immunology, and molecular assays to provide timely clinical diagnostic testing and patient care for the U.S. Air Force School of Aerospace Medicine, Epidemiology Laboratory Service Division (USAFSAM/PHE) located at Wright-Patterson Air Force Base. PHE requires supporting reagents that meet College of American Pathologists (CAP), Food and Drug Administration (FDA), and the Center for Disease Control and Prevention (CDC) standards and methodology. The proposed sole source, Roche Diagnostics, is the only known source able to provide the specific reagents that are required to function IAW Federal FDA regulations and in an integrated platform with a single point of entry.

Delivery Destination: USAFSAM/PHE
2510 Fifth Street, Area B
Facility 20840
Wright-Patterson AFB, OH 45433-7913

Delivery Type: FOB Destination (As defined in FAR 2.101 - Definitions, the seller or consignor is responsible for the cost of shipping and risk of loss.)

Inspection and Acceptance: Both inspection and acceptance will be by the Government at Destination.

Important Notice to Contractors: All prospective awardees are required to register at the System for Award Management (SAM) and to maintain active registration during the life of the contract. SAM can be accessed at https://www.sam.gov. For a detailed description of the applicable SAM requirements and payment information, please review the clauses included in the attached solicitation.
Any information should be e-mailed to both [email protected] and [email protected] no later than Thursday, 5 September 2019, 2:00 P.M. EST. Only inquiries/information received through e-mail by this date will be considered.

Please be advised that all correspondence sent via e-mail shall contain a subject line that reads "Roche Diagnostics Immunoassay Reagents" Note that e-mail filters at Wright-Patterson AFB are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e., .exe, or .zip files). Therefore, if this subject line is not included, the e-mail may not get through the e-mail filters. Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the e-mail filters at Wright-Patterson Air Force Base. If sending attachments with e-mail ensure only .PDF, .doc, or .xls documents are sent. The e-mail filter may delete any other form of attachments.