Sole Source Justification.pdf

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United States Department of Agriculture Justification for Other than Full and Open Competition

Commercial Supplies/Services Exceeding $7.5 Million, and Non-Commercial Supplies/Services Exceeding the Simplified Acquisition Threshold

FAR 6.3

1. Identification of the agency and the contracting activity.

USDA Food Safety and Inspection Service (FSIS).

Dr. Glenn Tillman, glenn.tillman@usda.gov, 706-206-2011

2. The nature and/or description of the action being approved.

The USDA FSIS proposes to enter into a contract on a basis other than full and open competition and negotiate a sole source justification with bioMérieux to create and maintain a subtyping method for whole genome sequencing (WGS) data, as permitted by FAR authority 6.302-1.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Food pathogen subtypes are reported to establishments and to the public, where they can be used to detect repetitive subtypes over time. FSIS determined that the Centers for Disease Control and Prevention (CDC) WGS typing method for Campylobacter is unsuitable for reporting isolates from FSIS surveillance program. Therefore, the government needs a suitable typing method that could be generated efficiently and is comparable to other typing methods developed for other foodborne pathogens like Salmonella. BioMérieux will provide expertise and intellectual property necessary to develop a suitable typing method, train FSIS on the use of this method, and provide technical assistance. The estimated value will not exceed $95,000.

4. The statutory authority permitting other than full and open competition.

41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements."

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

BioMérieux will provide a typing method that is compatible with FSIS’ current needs for reporting to meet the needs of the federal government. This vendor is the only one capable of meeting the federal government needs, by producing a code compatible with CDC PulseNet. While other vendors are capable of producing a product, none appear positioned to meet the federal government’s needs to produce a code compatible with the current system in place with CDC PulseNet. Previously, the company has worked with CDC to develop typing methods used by FSIS for foodborne pathogens other than Campylobacter. In addition, bioMérieux would use existing data generated by CDC to develop and evaluate a Campylobacter allele code for mailto:glenn.tillman@usda.gov

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FSIS. Therefore, the method of meeting the requirement avoids the need to develop a completely new data stream, avoiding additional costs and incompatibility with existing typing methods used by FSIS and CDC. BioMérieux has access to data generated by the CDC PulseNet Calculation Engine, as they were the company that created the algorithms.

6. Description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

The FSIS Laboratory System provided the same eight questions to three different vendors engaged in WGS data analyses (Qiagen, bioMérieux, and IHRC, Inc). Two vendors (Qiagen and bioMérieux) responded to the inquiry.

7. Description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

The FSIS Laboratory System drafted eight technical questions as part of market research to understand what capabilities exist in the open market. The questions were intended to better understand how existing systems could fit into current workflows and how adaptable the systems are to FSIS reporting structures. The FSIS Laboratory System provided the same eight questions to three different vendors engaged in WGS data analyses for input. FSIS determined that bioMérieux can use existing data generated by CDC to evaluate and develop a Campylobacter typing method that is (1) suitable for use with FSIS isolates and (2) uses existing data compatible with subtypes for other foodborne pathogens reported by FSIS. BioMérieux has unique access to the data generated by CDC as they were the developers of the system. Their data analyses are compatible with the current FSIS reporting structures unlike the other company that replied to the technical questions.

8. Any other facts supporting the use of other than full and open competition.

None

9. Listing of the sources, if any, that expressed a written interest in the acquisition.

bioMérieux Inc 100 Rodolphe St.

Durham, NC 27712

QIAGEN

1001 Marshall Street Redwood City, CA 94063

10. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

To overcome barriers to competition, FSIS will perform market research based on an assessment of the government’s needs. In this situation, FSIS analysts determined that most compatible and cost-efficient solution was to work with the same company that had already developed typing systems for the other foodborne pathogens and was capable of using existing Campylobacter sequence data.

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11. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

We will compare project costs (labor, materials) to CDC’s costs for a similar project from the same vendor.

Certifications & Approvals

☒ The information provided for this justification has been reviewed and certified accurate and complete by __Glenn Tillman_____________ (Insert Name), Program/Technical Personnel.

Contracting Officer (not exceeding $750,000). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☒ Approved.

☐ Reviewed and forwarding to the Procuring Activity Advocate (MASCO or Delegate).

George D. Baptist III Contracting Officer

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