A16_Single_Source_Justification_1.pdf

FWS Form 3-0034 (Rev. 10/2020) U.S. Fish and Wildlife Service

1. Description of Need

3. Other Capable Sources

2. Market Research Conducted

Pursuant to FAR subpart 13.106-1(b)(1)(i) and (ii), for purchases not exceeding the Simplified Acquisition Threshold (SAT), Contracting Officers may solicit from only one source if the circumstances deem only one source is reasonably available (e.g., urgency, exclusive licensing agreements, brand name, or industrial mobilization).

Instructions: The information in the text boxes are provided as sample language or to indicate a needed fill-in. Sample language should be removed from the final document. All text boxes require information and shall not be left blank.

SINGLE SOURCE JUSTIFICATION

(UNDER SAT)

JOINT ADMINISTRATIVE OPERATIONS

Acquisitions Operations

4. Barriers to Competition

5. Contractor's Qualifications

6. Determination of Fair and Reasonable Cost

7. Recommendation and Certification by Program Office

Based on the above justification, I recommend this acquisition to be conducted using sole source acquisition procedures. I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

Program / Project Officer

8. Contracting Officer Certification and Approval: Under SAT

Based on the above justification, I hereby certify and approve the use of sole source acquisition procedures under FAR Part 13 for this purchase.

Contracting Officer

Text3: No other capable sources were identified. While several vendors supply general laboratory consumables, none offer the validated, platform‑specific kits and reagents that meet the laboratory’s DNA extraction, lysis, and enzymatic digestion workflow requirements.

Alternative sources lack:

QIAGEN‑specific buffer formulations required for consistent DNA extraction performance.

Validated column and basket formats compatible with established protocols.

Reagent quality guarantees that meet federal assay sensitivity standards.

Using alternative brands would invalidate current protocols, disrupt longitudinal datasets, and increase the risk of failed assays, contamination events, and sample loss.

Text2: Market research was conducted by reviewing alternative manufacturers and suppliers of DNA extraction kits, lysis baskets, and molecular‑grade enzymes. The review determined that QIAGEN is the only manufacturer offering the exact formulations, spin‑column specifications, and reagent chemistries validated for compatibility with existing laboratory workflows. Substitution with competitor brands would require revalidation of extraction performance, introduce variability in DNA yield and purity, and compromise comparability with historical dataset baselines.

Additionally, the proprietary chemistry of QIAGEN’s DNeasy extraction system—including silica‑membrane column design, buffer formulations, and protocol‑specific reagent concentrations—cannot be replicated with alternative brands without significant workflow disruption.

The QIAGEN product line requested — specifically DNeasy kits, Investigator Lyse&Spin Baskets, Proteinase K, and collection tubes — match established workflows and platform requirements. No alternate manufacturer provides direct substitutes that fulfill all compatibility, chemical, and performance needs

Text6: Pricing was evaluated using the QIAGEN quotation (Quote #260417US02063580AC, valid 04/17/2026–12/31/2026). QIAGEN provides standardized commercial pricing, and quoted costs align with previous procurement history and federal purchasing expectations for molecular biology consumables.

Based on price comparison with historical QIAGEN purchases and the lack of viable equivalent competitors, the pricing is considered fair and reasonable and compliant with federal procurement regulations.

Text5: QIAGEN LLC is a longstanding, reputable supplier of molecular biology reagents, consumables, and extraction systems used globally in environmental genetics and regulatory monitoring. They are the original manufacturer of all items included in this procurement and maintain validated performance specifications, quality assurances, and technical support for their extraction workflows.