Biofire Torch SSJ signed_Redacted.pdf

BioFire FilmArray Torch System and Reagents 36C255-23-AP-2352

Attachment 7: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 4 of 7 Revision: 01 Effective Date: 04/01/23

Meningitis/Encephalitis (ME) tests with 14 targets/results, all with only one (1) blood draw.

These test results will allow providers to have a quick determination of a patient’s viral status to decide if a patient can be released to a home quarantine or need to be admitted. The ability to perform Viral and Bacterial tests simultaneously and to provide results within one hour to diagnose a patient for Respiratory ailments are unique benefits of this system.

The other FDA approved manufacturers who provide PCR instruments are Luminex and Cepheid. The VA does utilize the Cepheid PCR instrument; however, it is used for different test panels as outlined below and does not offer the required tests for this requirement:

BioFire FilmArray Torch Cepheid GeneXpert Luminex Verigene Respiratory panel, blood culture identification panel, gastrointestinal panel, meningitis-encephalitis panel, mycoplasma pneumoniae panel, Joint Infection panel

Carba-R, C. difficile, C.

difficile/Epi, MRSA, MRSA/SA BC, MRSA/SA

SSTI, Norovirus, SA Nasal Complete, vanA, Ebola (emergency use authorization), EV, Flu, Flu/RSV XC, MTB/RIF, CT-NG, GBS, GBS LB, TV, FII & FV

Gram-positive blood culture, Gram-negative blood culture, C. difficile, enteric pathogens, respiratory pathogens flex

Additionally, the BioFire Respiratory Panel has 22 targets, while the other instruments only have 4 targets and do not offer the required GI, BCID, or joint fluid panels. The Torch can run 4 to 13 specimens at the same time depending upon the configuration without the need for additional space, which is limited in VA laboratories.

Accordingly, BioFire Diagnostics, LLC is the only firm capable of providing the required system and reagents described in Section III above. BioFire Diagnostics, LLC confirmed they are the only one responsible source because their equipment, reagents and verification kits are proprietary and must be compatible for usage. There are no authorized distributors.

Since the maintenance and reagents are proprietary to BioFire, the Contracting Officer (CO) did not determine separate contracts for the maintenance and reagents.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The BioFire Diagnostics, LLC Government representative was contacted to inquire if third party reagents and verification kits can be used on BioFire systems. BioFire Diagnostics, LLC confirmed that only BioFire manufactured reagents and verification kits can be used on the BioFire FilmArray Torch System. They also confirmed that BioFire Diagnostics, LLC is the sole distributor of their reagents and verification kits.

VHAPG Part 806.3 OFOC Page 5 of 7 Revision: 01 Effective Date: 04/01/23

This is aligned with industry standards in Pathology and Laboratory testing, wherein vendor manufactured reagents and kits are solely to be used on vendor manufactured instrumentation and vice versa.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost to the Government is considered to be fair and reasonable. While this acquisition will be open-market, BioFire Diagnostics has a Federal Supply Schedule contract on GSA. Some, but not all of the reagents are on the Federal Supply Schedule. Additionally, the Torch system is not available. Also, a comparison of pricing provided to a single site versus this VISN-wide acquisition showed an increase in the discount percentages for the reagents and verification kits. Additional price analysis can be compared to other VISN contracts for the same items procured from BioFire Diagnostics. While this item is over the threshold for certified cost and pricing data, the exemption for commercial products and services will apply since this system is offered to all healthcare providers, laboratories, universities, and research labs.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The contracting office searched contract opportunities for posted J&As related to BioFire, as well as a review of FPDS-NG and VetCert. VetCert listed 192 SDVOSB and VOSB with NAICS code 334516; however, due to the proprietary nature of the BioFire FilmArray Torch system and reagents, none are authorized distributors or service providers. Market Research was minimal and focused on verifying the sole-source letter provided by the contractor stating BioFire reagents were only available through the manufacturer and no other distributors were authorized to provided products to the BioFire provided equipment.

A search of Contract Opportunities found two Sole-Source Justifications for Biofire Instruments and Reagents. One was awarded by NCO-19 with an estimated value of $4.7M over five years under AP 36C259-21-AP-1179; and the other was awarded by NCO-1, with an estimated value of $1.02M for one-year, under AP VA241-20-AP-2312.

Additional search was conducted on FPDS-NG for BioFire contracts under the Department of Veterans Affairs. Since 2012, there have been 665 basic contract actions awarded to five different entities:

BIOFIRE DIAGNOSTICS LLC (593 actions) BIOFIRE DEFENSE LLC (5 actions) BIOFIRE DIAGNOSTICS INC. (55 actions) BIOMERIEUX, INC. (11 actions)* GOVERNMENT SCIENTIFIC SOURCE INC. (1 action in 2018) *BioMerieux is the parent company of BioFire Diagnostics and BioFire Defense.

The one contract for Government Scientific source was for $82,360 and later de-obligated by $57,652. Government Scientific is a small business distributor of scientific type supplies.

Their on-line catalog does not list any of the required BioFire reagents or instruments.

VHAPG Part 806.3 OFOC Page 6 of 7 Revision: 01 Effective Date: 04/01/23

Market research has shown that there are no other vendors that offer this specific testing product. BioFire Diagnostics, LLC is the sole manufacturer and distributor of the FilmArray Torch system and reagents.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

No other facts were considered.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

None

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The agency will continue to survey the market to see if conditions have changed and new products have become available. Additionally, the using activities routinely attend trade shows and review medical and trade journals to stay on the cutting edge of technological advancements. New technology would have to be developed by other companies to overcome barriers to competition.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

04/05/2023

Name: Zaida Rivera Date Title: VISN 15 Regional Laboratory Manager Facility: Kansas City, VAMC