6550--South Texas VA Health Care System Strep A PCR Reagents

Special Notice Notice of Intent to Award a Sole Source Procurement

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract/order to Cepheid for procurement of the following items and services:

Scope

The STVHCS has a need for the Xpert Xpress Strep A Reagents compatible with current leased Cepheid Gene Xpert Instrumentation. No other types of substitute or third-party reagents will fit the need of the STVHCS for the reasons notated. The Strep A test is an automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes DNA. The test is used to diagnose pharyngitis caused by the Group A Streptococcus (GAS) earlier to allow for proper antibiotic therapy. This is crucial in order to reduce the changes of GAS complication such as Rheumatic Fever and Glomerulonephritis.

Contractor must be able to offer the following Brand Name reagents, no substitutions:

Provide ready to use.

Item#

Description/Part Number

Qty

XPRSTREPA-10

Kit, Xpress, STREPA, US-IVD,10 Test

Bead1, Bead 2, Bead 3 (freeze dried) 1 each per cartridge

Lysis Reagent (Guanidinium Thiocyanate) 1.5mL per cartridge

Sodium Hydroxide 1.5 mL per cartridge

Elution Reagent 2.0mL per cartridge

Disposable transfer pipettes 1 per kit

90

480 CFA

ESWAB, Liquid Amies, Flocked, COPAN, 480 CFA

18

The Contractor is required to provide a continuously stocked inventory of Cepheid Strep A reagents and supplies, and any other materials required to properly perform Cepheid Strep A testing such that Core Laboratory operations are not interrupted. These items shall be of the highest quality, to assure precision and accuracy. Expiration date must be clearly marked all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s Core Laboratory equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Location

These reagents and supplies will be used in the Microbiology laboratory located in the Pathology and Laboratory Medicine Service s San Antonio Laboratories of the STVHCS.

Period of Performance

Five One-Year Ordering Periods

Deliverables/Supplies

Supplies for Strep A testing on the Cepheid Gene Xpert Instrumentation in the Microbiology Laboratory.

Government Inherent Functions:

Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

Be professionally competent to handle required duties.

Work with staff to ensure safety measures are in place and documented.

Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran s Healthcare System and VHA Handbook 1106.1.

Information Systems Officer, Information Protection:Â Â Â

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.Â

Privacy Officer:Â

The contractor will not have access to Patient Health Information (PHI), nor will they have the capability of accessing patient information during the services provided to the VA.

Records Manager:Â

There will be no federal records created, maintained, used, or dispositioned with this contract;Â regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].

Anticipated Period of Performance: 1 March 2022 through 28 February 2027

The proposed sole source procurement will be made by an IDIQ with Cepheid.

The requesting activity has submitted a sole source justification request that states that vendor Cepheid is the only vendor that can provide the necessary required supplies. Market research did not find an alternate approved vendor that can provide the required supplies.

This notice is not to be considered a request for quotations or proposals. No contract will be awarded on the basis of offers received in response to this notice; however, all responsible sources may submit a capability statement, proposal or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 5 business days from the publication of this notice, a contract will be issued to Cepheid without any further notice.

The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.