Biomerieux Spotfire JA_v2.pdf

Justification and Approval for Other Than Full and Open ompetition

1. Agency/Contracting Activity:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number-

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

Phone:

3. Des ription of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is

BIOMÉRIEUX, INC.

515 Colorow Dr Salt Lake City, Utah 84108 Amy.McCourt@biomerieux.com Mobile: +1 (385) 271-8399

102,100.00

Requesting state of the art, Biomerieux VC-SPOTFIRE 4 - 4707799 for respiratory testing. This is a "FDA approved CLIA Waived Polymerase Chain Reaction (PCR) system". Other systems available are currently under FDA Emergency Use Authorization only. The Biomerieux VC-SPOTFIRE can differentiate between COVID-19, Influenza A, Influenza B, Respiratory syncytial virus (RSV), and Rhinovirus in 16 minutes, with one sample collection. A 15 panel respiratory target test kit is also available if indicated, with the same 16 minute turn-around testing time, with no additional sample required. The correct management depends on the accurate diagnosis of each pathogen. Like the flu, SARS-CoV-2 (the virus that causes COVID-19) may have peak seasonality in the fall/winter/spring. Clinical signs and symptoms of respiratory viral infection for SARS-CoV-2, flu and RSV, and rhinovirus can be similar. Multiplex-testing for SARS-CoV-2, flu, RSV, and rhinovirus will be critical to detect and differentiate between disease states, enabling accurate patient diagnosis and treatment in a timely manner.

This allows better service to patients during busy respiratory seasons. PCR tests are the “gold standard” for COVID-19 and other respiratory test. This system allows for greater efficiency of determining respiratory illnesses to rule out COVID-19 within 16 minutes, while also screening for 4 other respiratory targets. This includes SPOTFIRE® RSP Pos & Neg Controls - M425, Spotfire Respiratory Panel Mini, OCC 31034 item 424589 and Spotfire Respiratory Panel OCC 31034 item 424461

DHHS/IHS/Pawnee

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C. 253(c)(1)

4. Authority and Rationale: Identify the statutory authority, FAR title, and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Biomerieux is the manufacturer of the V-Spotfire system and owns proprietary to this equipment. This system is only available through Biomerieux.

The Biomerieux VC-SPOTFIRE is the only FDA approved CLIA Waived supplier that can perform a combo test that will differentiate SARS-CoV-2, flu, RSV and rhinovirus using one sample collection. It is also the only supplier with a 15 respiratory target test kit that is FDA approved and CLIA Waived. Due to the increase in respiratory diseases in our patient population, this combo test is beneficial and necessary for direct patient care.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 253(c)(5)

Other (See FAR Subpart 6.3 for additional authority):

5. Bridge Contracts

6. Actions to Increase Competition:

Not applicable

There are no other vendors that can provide this equipment as Biomerieux is the manufacturer and has sole propriety. There are no approved third party distributors.

7. Market Research:

8. Procurement History:

Previous Purchase Order(s) or Contract(s): Yes No

If “Yes”, for each purchase order or contract provide:

Purchase order or contract number:

Was action competed? Yes No

Research was performed on other systems in the market with CLIA waived multi-test capability that includes Combo Flu, COVID, RSV and rhinovirus.

-Roche Cobas Liat System has a combo Flu and COVID test that does not include RSV.

-Luminex provides a respiratory panel that is not CLIA Waived.

-Quidel Corporation provides a FLU and SARS combo that does not include RSV -Abbott ID NOW COVID-19 2.0 has individual COVID test. Must test for each test individually with multiple samples.

The only instrument on the market that provides this capability using only one patient sample is the Biomerieux VC-SPOTFIRE. The one sample method reduces patient discomfort as well as provides a better quality of sampling. This analyzer and tests panels are CLIA Waived which allows for a more flexible QC program which decreases tech time providing a more efficient and effective laboratory program.

This analyzer is FDA approved for all the tests above.

75H71123P00237

Yes, a sole source notice was posted on Sam.gov.

Program Manager

Name:

Position Title:

Email address:

Phone:

(No signature required)

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

11. Fair and Reasonable Price Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

12. Contracting Officer’s Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Additional Information to support the justification.

Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this J&A is accurate and complete.

Providers will be able to quickly differentiate between 4-15 respiratory diseases which may require different treatments, thus better serving our patients in a more timely fashion. The Emergency Use Authorization issued by FDA will expire at some point for current applications and labs that are not prepared will no longer be able to use the current testing system until the method is FDA approved and whether or not

John Brown

Laboratory Supervisor

John.Brown2@ihs.gov

918-762-6682

Terry Burris

CEO

Terry.burris@ihs.gov

Terry L. Burris -S Digitally signed by Terry L. Burris - S Date: 2024.06.28 10:57:40 -05'00'

Based on market research, pricing was determined fair and reasonable by comparing pricing to similar laboratory testing systems.

Sean L. Long -S Digitally signed by Sean L. Long -S Date: 2024.06.28 11:27:06 -05'00'

Sean Long

Chief Contracting Officer

6/28/24