6550--Notice of Intent to Sole Source Biomerieux / Biofire Film Array Torch PCR

The Department of Veterans Affairs on behalf of the VA Veterans Integrated Service Network (VISN) 2 Medical Centers intends to award a sole source action to:

Name of Contractor:

Biomerieux, Inc

Street Address:

515 S. Colorow Drive

City, State, Zip:

Salt Lake City, Utah 84108-1248

The Department of Veteran Affairs (VA) Veterans Integrated Service Network (VISN) 2, NCO 2, proposes to accomplish an open market, firm fixed price, Indefinite Delivery, Indefinite Quantity (ID/IQ) contract with a base period of one (1) year to include four (4) one (1) year option periods. All option periods will be priced and evaluated for fair and reasonableness prior to contract award.

VISN 2 Medical Centers have a requirement for reagent rental agreements for Polymerase Chain Reaction (PCR) testing for Respiratory, Gastrointestinal, Blood Culture Identification, and Meningitis Encephalitis. The reagent rental agreement is inclusive of the following units: Film Array Analyzers, Film Array 2.0 computer kits and terminals, Film Array printer kits, Film Array Duo Racks, one (1) for each Laboratory, consumables, reagents, preventive maintenance training, insurance, service repairs, test kits required to produce patient testing results and a two (2) year extended warranty for each facility. Chargeable monthly testing kits:

ITEM #

ITEM #

QTY

423742

BIOFIRE RP2.1 PANEL, 30 TESTS

223

RFIT-ASY-0116

KIT GI PANEL IVD 30 TESTS

59

RFIT-ASY-0147

Blood Culture Identification 2 (BCID2)

72

RFIT-ASY-0118

Meningitis/Encephalitis (ME) Panel

2

RFIT-ASY-0144

Pneumonia (PN) Panel

3

RFIT-ASY-0138

Joint Infection (JI) Panel

12

423753

Verification Panel, RP2.1

1

423640

Verification Panel, BCID2 Zeptometrix

1

FLM1-ASY-130

Verification panel GI

1

The Film Array Test Panels are an FDA approved closed PCR system for the detection of infectious agents. The Film Array instrument integrates sample preparation, amplification, detection, and analysis into one simple system. The Film Array Respiratory Panel tests for a comprehensive panel of twenty respiratory viruses and bacteria. The Film Array Blood Culture Panel tests for a comprehensive list of twenty-four pathogens and three antibiotic resistant genes associated with difficult to treat blood culture infections and high mortality rates. b. The diagnostic uses of the microbiology testing reagents or assays are based on methods, reference ranges, and physician input. Due to the transport and treatment of the patients in various facilities within the VISN 2 Region it is imperative that the methods and reference ranges be identical to meet the Standard of Care requirements of the Joint Commission. Biomerieux / BioFire Diagnostics is able to meet the capacity needs of the VISN 2 Medical Center Laboratories. BioFire Diagnostics also meets the National Patient Safety Goals and Joint Commission requirements to reduce whole blood volume as much as possible on all lab testing.

Justification to restrict competition: The Film Array System Analyzer is proprietary from the manufacturer Biomerieux / BioFire Diagnostics. Biomerieux / BioFire Diagnostics has provided documentation verifying that they are the only manufacturer of the Film Array System Analyzer. BioFire Diagnostics is the only manufacturer of the FilmArray system, and it is also the only manufacturer of the Blood Culture Identification Kit for the FilmArray System. The Biomerieux / BioFire Diagnostic Reagents are the only reagents that can be utilized on the FilmArray Analyzer.

Market research has been completed in accordance with FAR Part 10 and has concluded the required equipment and associated line items are manufactured by a single vendor, Biomerieux / Biofire. A search of firms manufacturing/distributing similar items/products identified two (2) additional vendors. Further research identified the two (2) manufacturer s Nanosphere and Accelerate do not manufacture/produce a product capable of sufficiently meeting the Government s requirement. Per the BioFire Diagnostics, Accounts Representative, there are no veteran owned or small businesses authorized to distribute their products(s).

This notice of intent to sole source with justification for brand name only satisfies the public posting requirements of the FAR.

Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer s intended distribution channels.

This notice is not a request for quotes; however, all responsible sources may submit a capability statement which shall be considered by the Government. All capability statements must be received by no later than 12:00 PM Eastern Standard Time on April 25, 2023. Responses to be submitted to Lindsay Goldsmith, Contracting Officer at lindsay.goldsmith@va.gov. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.