36C24126Q0413.docx

Special Notice Special Notice

GENERAL INFORMATION

VAMC White River Junction

215 North Main Street White River Junction, VT 05009

POINT OF CONTACT*

Contract Specialist Sarah Ballentine Sarah.Ballentine@va.gov 802-295-9363 ext. 5725

ADDITIONAL INFORMATION

DESCRIPTION

NOTICE OF INTENT TO SOLICIT SOLE SOURCE- BioMerieux BioFire; Film Array test panels and reagents for the BioMerieux BioFire® FilmArray® Torch System.

Response Due Date: May 8, by 4:30PM (EST)

Requirement:

The Department of Veterans Affairs, VISN 1, Pathology and Laboratory Medicine Service (P&LMS) requires a 5-Year BPA for the BioMerieux BioFire; Film Array test panels and reagents for the BioMerieux BioFire® FilmArray® Torch System. This shall include equipment, as well as all necessary supplies, reagents, network connection, service, maintenance, and parts needed to produce a patient result. Contractor shall provide BioMerieux BioFire, Film Array test panels, reagents, and all necessary pieces.

Period of Performance: 08/18/2026 – 08/17/2031

The authority for this action is FAR 6.302.1-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

The intent is to procure the referenced services on a sole source basis. No solicitation will be posted to Contract Opportunities.

The North American Industry Classification System code (NAICS) for this requirement is 325413. All responsible sources that feel they should be considered qualified to provide the above-mentioned products may submit a response to this notice (by the response due date shown above) to Sarah.Ballentine@va.gov.

The information provided shall include detailed (and relevant) documentation to allow the government to perform adequate market research and make a proper determination. A determination by the government not to compete this proposed requirement 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 IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION

AVAILABLE AT THIS TIME. REQUESTS FOR A SOLICITATION WILL NOT RECEIVE A

RESPONSE.

Statement of Work

Background: Veterans Integrated Service Network (VISN) 1, Network Consolidated Laboratory is requesting a 5-year BPA for test kits required for the use on the BioFire® FilmArray® Torch System.

Scope:

The Film Array test panels are a Food and Drug Administration (FDA) approved moderately complex Polymerase Chain Reaction (PCR) assays for the detection of infectious agents. The FilmArray instrument integrates sample preparation, amplification, detection, and analysis into one simple system that requires 2 minutes of hands-on time and has a total run time of about 45 minutes. The FilmArray software automatically generates a result for each target in a single report.

The BioFire RP2.1 Panel includes 22 targets and offers an unprecedented run time of about 45 minutes, enabling higher efficiency and throughput on the BioFire® FilmArray® Torch Systems. All panels use a syndromic approach to accurately detect and identify the pathogens most commonly associated with respiratory infections. Fast and comprehensive, the BioFire Respiratory Panels offer Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, co-hording, and additional diagnostic testing.

The BioFire FilmArray Blood Culture Identification (BCID) Panel tests for a comprehensive set of 27 targets and the Blood Culture Identification 2 (BCID2) Panel tests for a comprehensive set of 43 targets (33gram-positive, gram-negative, and yeast pathogens and 10 antibiotic resistance genes) associated with bloodstream infections. The BioFire BCID and BCID2 Panels detect and identify the most common causes of bloodstream infections in about one hour.

TEST PANEL KITS REQUIRED

The Government reserves the right to add additional testing kits during the life of this agreement.

1. The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

2. All reagents should have the longest outdates possible, preferably 6 months before expiration when received on-site.

3. SDS – Safety Data Sheets are required. Any product formulation changes must be accompanied with an updated SDS.

4. BioFire Diagnostics will supply a quarterly report to the Contracting Officer’s Representative (COR) that indicates the products and quantities purchased each month. The report will consist of a breakdown which includes: the facility name, products obtained under this agreement, and the volume per month.

5. All pricing includes FOB destination with 2-day shipping upon order.

6. In the event of a recall, BioFire must comply with all applicable rules and regulations regarding notice to customers. BioFire shall reimburse customer for any costs actually incurred by Customer to comply with recall instructions and processes provided by Contractor to sequester, package and return the affected products, as applicable.

7. In the case of a company merger and/or acquisition, BioFire Diagnostics, LLC will immediately notify the Contracting Officer for this BPA and provide a contingency plan of services to assure that no break in services is experienced by the participating facilities.

8. The test kits will be shipped and replenished in quantities as requested by the individual site laboratory. The laboratory departments will request the kits on an as-needed basis.

9. Each site will be invoiced for their own delivery orders. The Contractor will provide direct delivery to the requesting lab at the contractor’s expense. The Laboratory department will order using their usual procedures and referencing the purchase agreement pricing. They will be invoiced for their own orders. Each laboratory may order any of the reagent kits listed in this contract.

All VISN 1 sites may order from this agreement:

The Government reserves the right to add additional VISN 1 Lab sites and testing kits during the life of this agreement.

VA Connecticut Healthcare System West Haven Campus 950 Campbell Avenue West Haven, CT 06516 VA Connecticut Healthcare System Newington Campus 555 Willard Ave.

Newington, CT 06111

VA White River Junction 215 North Main Street White River Junction, VT 05009-001 VA Manchester 718 Smyth Road Manchester, NH 03104

VA Providence 830 Chalkstone Avenue Providence, RI 02908 VA Maine 1 VA Center Augusta, ME 04330

VA Boston Healthcare System West Roxbury Campus 1400 VFW Parkway West Roxbury, MA 02132 VA Central Western Massachusetts Healthcare System Northampton Campus 421 North Main Street Leeds, MA 01053

VA Boston Healthcare System Brockton Campus 940 Belmont Street Brockton, MA 02301 VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730

VA Boston Healthcare System Jamaica Plain Campus 150 S. Huntington Avenue Boston, MA 02130

Special Notice