36C25726Q0719.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Ognian D. Ivanov ognian.ivanov@va.gov 210-694-6302

ADDITIONAL INFORMATION

AGENCY’S URL

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AGENCY CONTACT’S EMAIL ADDRESS

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DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

Network Contracting Office 17 (NCO 17) VISN 17 – Center of Excellence for Research on Returning War Veterans Central Texas Veterans Health Care System

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT

Pursuant to FAR 13.106-1(b)

VISN 17 Center of Excellence for Research on Returning War Veterans Central Texas Veterans Health Care System 4800 Memorial Drive, Waco, TX 76711

1. Description of Requirement The Department of Veterans Affairs (VA), Network Contracting Office 17 (NCO 17), on behalf of the VISN 17 Center of Excellence for Research on Returning War Veterans, intends to award a sole source purchase order to Fisher Scientific Company LLC (Thermo Fisher Scientific), 300 Industry Drive, Pittsburgh, PA 15275, for the procurement of the Applied Biosystems quant Studio 7 Pro Real-Time PCR (qPCR) System and associated accessories and service agreements, as identified below:

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing PSC Code: 6640 – Laboratory Equipment and Supplies Place of Performance: VISN 17 Center of Excellence for Research on Returning War Veterans, 4800 Memorial Drive, Building 93, Waco, TX 76711 Period of Performance: One-time purchase (instrument/accessories) with four optional annual service agreement years following installation.

2. Authority for Sole Source Acquisition This requirement is for a commercial product. The acquisition is being conducted in accordance with FAR Part 12, Acquisition of Commercial Products and Commercial Services, using RFO-to-FAR guidance and applicable agency implementation memorandums. The notice is issued to provide public notice of the Government’s intent to make a noncompetitive award to a single responsible source for a commercial product requirement using simplified acquisition methods consistent with current RFO implementation practices.

This notice intentionally avoids reliance on FAR Part 13 as the primary substantive authority for the commercial nature of the acquisition, because current RFO guidance distinguishes commercial acquisitions from non-commercial simplified acquisition procedures. The supporting contract file shall include the applicable sole source rationale, commercial item basis, price reasonableness support, and any agency-required approvals or determinations.

3. Basis for Sole Source Determination Fisher Scientific Company LLC (Thermo Fisher Scientific) is the manufacturer and the sole authorized supplier of the Applied Biosystems Quant Studio 7 Pro Real-Time PCR System. No third-party vendors are authorized to produce, sell, or service this system. The quant Studio 7 Pro incorporates proprietary components, software, optical systems, and integrated workflow tools that are not available from any other manufacturer.

Market research was conducted to evaluate alternative qPCR platforms from Bio-Rad, Agilent, Roche, Qiagen, and Eppendorf. No alternative system was found to simultaneously provide: (1) TaqMan Array Card (TAC) block compatibility with ultra-low-volume (~1.5 µL) fixed-content assays; (2) direct integration with the Thermo Scientific Orbitor RS2 Microplate Mover for automated high-throughput plate loading; (3) six independently controlled VeriFlex™ Peltier temperature zones; (4) 21-filter OptiFlex™ optical system enabling six-target multiplexing; and (5) built-in Security, Audit, and e-Signature (SAE) features designed to support 21 CFR Part 11 compliance.

Additionally, the Center of Excellence currently operates Thermo Fisher Scientific qPCR instruments, assays (TaqMan), plastics (MicroAmp), and Connect Platform workflows. Transitioning to an alternate vendor system would require full re-validation of all existing assays and would jeopardize reproducibility and continuity of long-term, multi-year Veteran-focused research programs.

4. Response Instructions This notice is NOT a request for competitive proposals. However, any firm that believes it can provide the required supplies and services that meet all specifications described herein may submit a capability statement and/or quotation to the Contracting Officer no later than the response deadline identified above.

Responses must be submitted in writing via email to the Contracting Officer at the address below. Telephone inquiries will not be accepted. The Government will evaluate all responses received and determine whether competitive procurement is appropriate. If no capable alternative sources are identified within the 10-day response period, award will be made to Fisher Scientific Company LLC as a sole source.

Capability statements shall address, at minimum, the ability to provide all specifications listed in Section 1, including TAC block compatibility, Orbitor RS2 automation integration, 21-filter multiplexing optics, 21 CFR Part 11 SAE features, and full backward compatibility with existing Applied Biosystems TaqMan assays and MicroAmp consumables. Incomplete responses will not be considered.

5. Contract Structure The contract schedule is structured as a base period plus four option years using VA line item numbering conventions. Base CLINs are numbered 0001 through 0008. Option Year One begins with 1001, Option Year Two begins with 2001, Option Year Three begins with 3001, and Option Year Four begins with 4001. The base period covers the one-time purchase of the instrument, included accessories, and training. The option periods cover annual preventive maintenance service only.

6. Contracting Officer Point of Contact

Network Contracting Office 17 (NCO 17) Lab Support Team

7. Set-Aside Status This acquisition is not set aside for small business. The intended awardee, Fisher Scientific Company LLC (Thermo Fisher Scientific), is a large business. A small business set-aside was determined to be impracticable because the required system is proprietary and available only through the manufacturer or its authorized distributors.

8. Contracting Officer Statement This notice is prepared for posting in support of a proposed sole source commercial product acquisition and is intended to reflect the acquisition approach in a manner consistent with FAR, RFO-to-FAR guidance, and applicable VA implementation memorandums. The Government reserves the right to cancel this notice or revise the acquisition approach based on responses received or further review of the acquisition file.

This notice is posted in accordance with F Commercial Product Acquisition Using FAR Part 12 and RFO Guidance . The Government reserves the right to cancel this notice and/or proceed with competitive acquisition at any time.

Special Notice