A16_Justifications___Sole_Source_v2_1.pdf

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

1. Description of Need

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

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

3. Other Capable Sources

4. Barriers to Competition

All laboratory reagents for the carp eDNA monitoring program go through a strict validation process to ensure a high degree of reproducibility of qPCR results from one case to the next, and one year to the next. WGL staff conduct these reagent validations to ensure the best performing reagents are used by the laboratory. The qPCR markers developed and used in the WGL have been optimized with the Taqman Environmental Master Mix to be as efficient, reproducible, and sensitive as possible to deliver the highest standard of reliability of laboratory results. It is expensive and time consuming to conduct these validations, and in the history of the USFWS carp eDNA monitoring program, there has never been a comparable reagent that performs as well as TaqMan Environmental Master Mix in terms of reproducibility and reliability with the QAPP multiplex qPCR markers.

WGL staff also have to ensure that there is no inhibition of the qPCR tests being run attributable to inhibitors in the environmental samples. This is accomplished by running inhibition controls during the reagent validation. Taqman Environmental Master Mix is the reagent that most effectively reduced false negatives in our qPCR assays during quality assurance validations based on the multiple validations conducted in the laboratory since 2013.

The TaqMan Environmental Master Mix ordered will need to meet the following specifications:

1. All 75 x 20 ml aliquots of reagents must be from a single production lot that is good for use for one calendar year to correspond with our annual monitoring schedule (Expiration December 2023 or later) and to meet reagent quality assurance protocol.

2. Reagent must be in 20 ml aliquots to meet the needs of the laboratory where multiple 384 well qPCR plates are set up robotically due to the high throughput nature of workflow.

3. Reagent must demonstrate a reproducible DNA amplification from crude environmental water samples greater than or equal to the Taqman Environmental Master Mix in the presence of IPC (internal positive controls for inhibitors).

4. We need this order to be received no earlier than September 1, 2022 and no later than October 1, 2022 due to concerns about reagent expiration and so that we can continue to process samples.