36C25723Q0502.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Robyn Nussbaum Contracting Officer robyn.nussbaum@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

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AGENCY CONTACT’S EMAIL ADDRESS

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DESCRIPTION

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 to GenMark Diagnostics, Inc. for procurement of the following requirement:

Scope The STVHCS has a continued need for reagent test kits and supplies as needed to perform HCVg Molecular Diagnostic testing on the Government owned GenMark XT-8 analyzers located in the San Antonio Laboratory of Pathology & Laboratory Medicine Service at STVHCS. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers.

The Contractor is required to provide a continuously stocked inventory of eSensor HCVg reagents and supplies and any other materials required to properly perform HCV testing such that the Molecular 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 GenMark XT-8 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 Molecular 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 on the GenMark XT-8 analyzers located in the Molecular Laboratory in the Pathology and Laboratory Medicine Service of the STVHCS.

Period of Performance IDIQ contract with five one-year ordering periods.

Deliverables/Supplies As needed Cost Per Test Reagents and Supplies for HCVg Molecular Diagnostic Testing.

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:

1. Be professionally competent to handle required duties.

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

1. 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:

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.

Privacy Officer:

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:

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

The proposed sole source procurement will be made by an open market pricing agreement with GenMark Diagnostics, Inc.

The requesting activity has submitted a sole source justification request that states that vendor GenMark Diagnostics, Inc. is the only vendor that can fulfill the requirement. Market research did not find an alternate approved vendor that can provide all of the required supplies for the requirement.

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 days from the publication of this notice, a contract will be issued to GenMark Diagnostics, Inc. without any further notice.

The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. §1901 as implemented in FAR 13.501., Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Special Notice