A02-JA FINAL REDACTED.pdf

CUI

Control Number: FY25-0230

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

NOV 2024

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21702.

2. Description of Action: This requirement is for a new Firm Fixed Price contract for a base year and four option years for the Naval Medical Center San Diego (NMCSD).

Funding for this effort will utilize Fiscal Year 2025 Operations & Maintenance Funding.

3. Description of Supplies/Services: The NMCSD has a requirement for supplies and consumables, and antimicrobial susceptibility testing (AST) cards for the government owned Biomerieux, Inc. Vitek 2XL Matrix-Assisted Laser Desorption/Ionization-Time of Flight (MALDI-TOF) Mass Spectrometer. The Biomerieux, Inc. Vitek 2 supplies and antimicrobial susceptibility cards are the only brand capable of running on the Vitek 2XL MALDI-TOF Mass Spectrometer. The Vitek 2XL is the only MALDI-TOF mass spectrometer on the market with approval by the U.S. Food and Drug Administration for rapid (same-day) identification of molds and mycobacteria.

Period of Performance: 01 October 2025 - 31 March 2030 (Base Year plus 4 Option Years)

Period Period of Performance

Base Period 1 Oct 2025-30 Sep 2026

Option Period 1 1 Oct 2026-30 Sep 2027

Option Period 2 1 Oct 2027-30 Sep 2028

Option Period 3 1 Oct 2028-30 Sep 2029

Option Period 4 1 Oct 2029-30 Sep 2030

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FED Only POC: Christopher L. Cook

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Rationale Justifying Use of Authority Cited: The NMCSD microbiology laboratory currently uses the Biomerieux, Inc. Vitek 2XL, manufactured by Biomerieux, Inc., Inc.

No other vendor’s antimicrobial susceptibility testing panels will run on this microbiology analyzer. Therefore Biomerieux, Inc., is the only vendor who can satisfy this part of the requirement. Bruker and Biomerieux, Inc., are the only manufacturer of the MALDI-TOF mass spectrometers that have U.S. FDA approval for rapid organism identification.

However, only the MALDI-TOF mass spectrometer from Biomerieux, Inc., Inc has FDA approval for molds and mycobacteria. The Bruker model does not satisfy this part of the requirement. Lastly, Biomerieux, Inc., is the sole distributer of their own supplies; they do not allow third party wholesalers or distributors and continuing to use the existing government-owned analyzer is the most cost-effective solution.

6. Efforts to Obtain Competition: A thorough internet search indicated that the Beckman Coulter DXM Microscan Walkaway, Becton Dickenson Phoenix, ThermoFisher Scientific Sensititre offer antibiotic susceptibility testing and the Bruker Biotyper that offers organism identification by MALDI-TOF. The first three companies do not offer AST panels that can run on our government-owned Vitek 2XL manufactured by Biomerieux, Inc. Bruker does not offer a MALDI-TOF that has FDA-approved organism identification databases for mold or mycobacteria. As such, the only vendor that meets our requirements is Biomerieux, Inc., Inc.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: A Notice of Intent to sole source was posted to SAM.gov for 15 days. No responses were received. It is likely that at some future date, Bruker will obtain FDA approval for molds and mycobacteria. At that time, it will be in the government’s best interest to compete this part of the requirement in a future contract requirement.

8. Market Research: Market research was conducted in March and April 2025. The webpages of the competing vendors for MALDI-TOF (Bruker) and for antimicrobial susceptibility testing (ThermoFisher Scientific, Becton Dickenson Co, and Beckman Coulter) and reputable medical supply distributors were surveyed for information. In some cases, vendors were contacted by email inquiry. None of the other vendors satisfy the requirements as listed. Biomerieux, Inc. does not have any authorized distributors of their brand name products. Bruker’s MALDI-TOF mass spectrometer does not have FDA approval for mold or mycobacteria, as required in the SOW. ThermoFisher, Becton Dickinson and Beckman Coulter manufacture competing AST panels, but none are capable of running on the government-owned Vitek 2XL. As such, Biomerieux, Inc. is the only vendor who can satisfy all aspects of the requirements. No effective competition is anticipated.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

9. Other Facts:

a. Procurement history:

(1) Contract Number: N6264520D5017 Date of Award: 30-Sep-2025

(2) Previously competed: Sole Source

(3) Previous authority for less than Full & Open Competition: FAR 13.106- 1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

(4) Biomerieux, Inc. is the Original Equipment Manufacturer (OEM) and is the only authorized party to provide Vitek 2 supplies.

(5) No previous contract was awarded using full and open competition

(6) No unusual patterns have been revealed during the procurement of N6264520D5017.

(7) There have not been any significant changes since the award of N6264520D5017.

10. Interested Sources: A Notice of Intent to award a Sole Source will be posted on the Federal Business Opportunities website for 15 days to afford the public an opportunity to respond with a Capability Statement. No responses are expected.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

11. Technical Certification: I certify 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.

12. Requirements Certification: I certify 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.

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable in accordance with the Federal Acquisition Regulation (FAR) 15.404, Proposal Analysis. Techniques to be used will be comparison with the Independent Government Estimate and historical pricing on previous purchases. As part of this basis, Certified Cost and Pricing Data IS NOT required in accordance with FAR 15.403-1(b)(3).

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Concurrence

Courtney A. Piar Contracting Officer

USMARAA