JOFOC NCO19 Biofire Reagents HCA Approved Final to Post.pdf

GSAR 538.7104-3 Sole Source Justification Page 1 of 5 Acquisition ID#: 36C259-26-AP-2785

SOLE SOURCE JUSTIFICATION

ORDER >SAT

General Services Administration Acquisition Regulation (GSAR) 538.7104-3

Acquisition Plan Action ID: 36C259-26-AP-2785 Tracking Number: FY26- NCO 19 - 2224

(1) Contracting Activity:

Department of Veterans Affairs (VA) Network Contracting Office 19 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111

Organizational Activity:

Department of Veterans Affairs VA Medical Centers listed below:

Name Address

Cheyenne VA Medical Center 2360 East Pershing Blvd., Cheyenne, WY 82001 Sheridan VA Medical Center 1898 Fort Rd., Sheridan, WY 82801 Grand Junction VA Medical Center 2121 North Ave., Grand Junction, CO 81501 Eastern Oklahoma (Muskogee) VA Medical Center

1011 Honor Heights Drive, Muskogee, OK 74401

James Mountain Inhofe VA Medical Center

440 S. Houston St., Tulsa, OK 74127

Salt Lake City VA Medical Center 500 Foothill Drive Salt Lake City, UT 84148

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

The action under review is a sole-source justification to award a five-year, Federal Supply Schedule (FSS) Blanket Purchase Agreement (BPA) to BioMérieux, Inc. for BioFire TORCH system reagents and essential maintenance services.

Order against: FSS Contract Number: 36F79724D0020

GSAR 538.7104-3 Sole Source Justification Page 2 of 5

Name of Proposed Contractor: BioMérieux, Inc.

Street Address: 515 South Colorow Drive City, State, Zip: Salt Lake City, UT 84108

(3) Description of Supplies or Services:

The estimated value of the proposed action is $6,023,246.25

The Government requires BioFire reagents specifically designed for the Government-owned BioFire TORCH instruments (manufactured by BioMérieux) to accurately test veteran patients for infectious diseases, blood culture identification, and gastrointestinal health. In addition, ongoing maintenance services for these BioFire TORCH systems are essential to ensure reliable performance and operational readiness throughout the five-year period.

Estimated Period of Performance: 09/30/2026 – 09/29/2031

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

Only one source: Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized; GSAR 538.7104-3(b)(ii).

The BioFire TORCH systems are manufactured by BioMérieux and owned by the Government.

The Contracting Officer confirmed with BioMérieux that only BioMérieux-manufactured reagents will work on their laboratory analyzers, and only BioMérieux technicians can service the instruments. BioMérieux does not have any authorized resellers or distributors for their reagents, so no third-party reagents are available as an alternative.

The BioFire TORCH is a single, Food and Drug Administration (FDA) cleared platform that tests

Replacing it would require four separate systems from four different companies to match this single system's capabilities, with cascading costs at every stage of the transition.

GSAR 538.7104-3 Sole Source Justification Page 3 of 5

Based on the above, it is in the Government's best interest to continue using the BioFire TORCH systems already installed and operating in the medical center labs departments, and to award a sole-source FSS BPA to BioMérieux for BioFire TORCH reagents and maintenance.

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7104-3 to aid the contracting officer in making this best value determination:

FSS pricing for these items has already been negotiated and discounted; however, the Contracting Officer will further negotiate with BioMérieux to secure additional discounts on the reagents.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

The Contracting Officer confirmed through written correspondence with BioMérieux, Inc. on July 13 that the company is the sole distributor of BioFire TORCH system reagents and that only BioMérieux-authorized technicians are permitted to service the instruments. The Government currently owns BioMérieux-manufactured BioFire TORCH analyzers

These systems support critical clinical functions, including infectious disease testing, blood culture identification, and gastrointestinal health diagnostics.

BioMérieux further verified that it has no authorized distributors or resellers, including Service- Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), small business, or other large-business partners. The company does not engage with any third-party distributors for these products or services. In this same correspondence, BioMérieux confirmed that its reagents are available under FSS contract 36F79724D0020, while maintenance services are only offered on the open market.

(7) Any Other Facts Supporting the Justification: There are no additional supporting facts to include in this section of justification.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

The Government-owned BioFire TORCH systems have an estimated five years of remaining useful life before reaching end-of-life status. When that point approaches, the Government will reassess the operational needs of each medical center and conduct a full evaluation to determine the best