Justification and Approval - Bio-Plex 200 (Brand name)_Redacted.pdf

CUI

Justification and Approval for Other Than Full and Open Competition Justification FAR Subpart 13.106-1(b) – Soliciting from a Single Source (including Brand Name)

1. Identification of the agency and contracting activity:

Defense Health Agency, Southern Markets Contracting Division (SM-CD) 7800 IH-10 West Ste 235 San Antonio, TX 78230

2. Nature and/or Description of Action being approved: Approval is being requested for a new firm fixed price contract using FY 22 Operations and Maintenance (O&M) funds for the procurement of the Bio-Plex 200 with high-throughput fluidics (HTF), multiplex array system with an annual repair/maintenance place that provides complete support.

3. Description of Supplies/Services: The Uniformed Services University of the Health Sciences’ (USUHS) Department of Medicine requires the Bio-Rad Bio-Plex 200 with HTF that permits the analysis of up to 100 biomolecules in a single sample. The device is an automated immunoassay multiplex array system that provides a wide range of biomarker assessments, including cytokines, chemokines, growth factors, soluble receptors, hormones, and gene expression analyses.

Table 1 – Bio-Rad™ Bio-Plex™ 200 with HTF

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition:

41 U.S.C. 1902 Simplified Acquisition Procedures as implemented in FAR Subpart 13.106-1(b)

– Soliciting from a Single Source (including Brand Name)

Controlled By: DHA Controlled By: SM-CD CUI Category: PROCURE Limited Dissemination Control: FEDCON POC: Adam Foret, 726-203-0016

5. Rationale Justifying Use of the Statutory Authority Cited:

The Bio-Rad Bio-Plex 200 System with HTF offers best performing suspension array system that permits the analysis of up to 100 biomolecules in a single sample at an affordable price.

There is no other supplier on the market that offers a suspension array system with similar of better performing methods. The High-thoughput fluidics (HTF) delivers up to 20 L of sheath fluid without user intervention. This system will replace current 10 year old equipment that has a proven reliability and allows for the continuity of the data being obtained.

Bio-Plex 100/200 is the only multiplex array system that meets all of the requirements below:

a) An array reader that combines 2 lasers, high-throughput fluidics, and real-time digital signal processing to distinguish up to 100 different color-coded bead sets, each representing a different assay.

b) A microplate platform that automates the reading of 96-well plates, yielding up to 9,600 data points in about 35 min.

c) Instrument control software with integrated data analysis package. No export to third party software necessary for data reduction.

d) Automated maintenance feature for commonly used functions such as start-up, calibration, washing, and shutdown.

e) Multiple analyte report table option; allowing users to easily compare data across samples for the entire data set, option to hide any one or multiple columns.

6. Efforts to Obtain Competition:

The Government’s market research identified Bio-Rad as the sole manufacturer of the Bio-Plex 200 with HTF. Additionally, the Government uncovered the Bio-Plex is distributed by companies other than Bio-Rad. This acquisition will be competed amongst authorized distributors of Bio-Plex equipment.

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

8. Market Research: Market research was completed 1 September and covered DHA Inventory, GSAXcess, Federal Prison Industries, Ability One, VA.gov, GSA Advantage and DLA Inventory, which yielded no results for the Bio-Plex 200 with HTF. Further internet search was done seeking potential sources. After conducting a thorough analysis sources other than Bio-Rad provide the Bio-Plex 200.

9. Other Facts: Based on the above noted market research it is clear the Bio-Plex 200 with HTF and 100/200 annual maintenance complete support plan meets the USUHS requirement for the replacement of aged current equipment.

10. Interested Sources:

11. Actions to overcome barriers: The Bio-Plex 200 with HTF is the required equipment to meet USUHS ability to research protein and nucleic acid. Market research has shown that no other piece of equipment offers a product that meets the Government's needs, but the government will consider any offer for a comparable product meeting the Government's needs.

COORDINATION:

12. Technical/ Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

Title: Principle Investigator

13. Requirements Certification:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

14. Fair and Reasonable Cost Determination:

The cost to the Government will be determined fair and reasonable based on competition amongst authorized resellers and market research.

15. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

16. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A).

I certify that this justification is accurate and complete to the best of my knowledge and belief.