A11_J_A_Bio_Rad_Hunter_Signed_redacted.pdf

SOLE SOURCE JUSTIFICATION AND APPROVAL FOR ACQUISITION UNDER

THE SIMPLIFIED ACQUISTION THRESHOLD

1. Contracting Agency and Activity. The Department of the Interior, United States Geological Survey, plans to contract on a sole source basis. This document sets forth the justification and approval as required by FAR 13.106-1(b)(1).

2. Nature of Action Being Approved. The U.S. Geological Survey, Wetland and Aquatic Research Center, requests the award of supplies and consumables for the QX200 Droplet Digital PCR System.

3. Description of Supplies or Services.

In FY14, the U.S. Geological Survey, Wetland and Aquatic Research Center Conservation Genetics Lab acquired a Bio-Rad QX200 Droplet Digital PCR System in order to absolutely quantify number of DNA copies in a sample. Additionally, in FY18, our Lab also acquired a Bio Rad Automated Droplet Generator (AutoDG) for use with the System to improve efficiency and precision. To run the Droplet Digital PCR System, many supplies and consumables are needed, for which Bio-Rad is the sole proprietor. These include:

ddPCRsupermix for probes with no dUTP (500 rxn) – master mix for use in sample preparation for droplet generation in the QX200 Droplet Digital PCR System.

ddPCR Buffer Control for Probes – Electrophoresis buffers, reagents, and acrylamide are available as individual reagents or premixed buffers and solutions. Products include loading buffers for protein or nucleic acid samples, detergents, ampholytes, and gel‐casting buffers.

DG8 Cartridges and Gaskets - for use with the QX200 Manual Droplet Generator

DG32 Automated Droplet Generator cartridges – specific trays for use with the Automated Droplet Generator in the QX200 Droplet Digital PCR System.

Automated Droplet Generation Oil for probes - for the AutoDG to create sample-in-oil droplets required for Droplet Digital PCR

Pipet tips for AutoDG system – pipet tips made specifically to fit the Automated Droplet Generator in the QX200 Droplet Digital PCR System.

Pipet waste bins for AutoDG system – waste bins to collect and dispose of above pipet tips made specifically to fit the Automated Droplet Generator in the QX200 Droplet Digital PCR System.

Droplet reader oil – oil required by the droplet reader in the QX200 Droplet Digital PCR System.

Droplet generation oil – oil required for droplet generation in the QX200 Droplet Digital PCR System.

Prime PCR probe assay - Digital PCR assay for use in the QX200 Droplet Digital PCR System required for providing an absolute quantification of target DNA molecules.

Prime PCR Template for Probe Assay - Gene-specific synthetic DNA template designed to give a positive result when used with the corresponding probe assay for use in the QX200 Droplet Digital PCR System.

ddPCR 96-well Plate - ddPCR 96-Well Plates optimized for maximum ddPCR performance in the QX200 Droplet Digital PCR System and designed specifically for use with Pierceable Foil Heat Seals and the PX1 PCR Plate Sealer.

PCR Plate Heat Seal, foil, pierceable - foil seals for PCR and QX200 Droplet Digital PCR System applications, for use with PX1 PCR Plate Sealer

4. Estimated Dollar Value. $16,000.00

5. Statutory Authority. The proposed action may be awarded on a sole source basis under the authority of FAR 13.106-1(b)(1) – only one source reasonably available.

6. Rationale Supporting Use of Citation in No. 5. The Government requires Digital Droplet PCR technology for analysis of environmental DNA (eDNA) research. Environmental DNA detects minute amounts of DNA from environmental samples, such as water or soil. This method is used to detect rare and hard to detect imperiled (manatees) and invasive (pythons, Asian Carp, snakehead fish, caiman) species to aid management and natural resource decisions. Digital Droplet PCR technology is superior to the more traditional quantitative PCR due to the absolute DNA quantification, increased precision and sensitivity, and reduced inhibition due to environmental contaminants. As a result, the Government purchased a QX200 Droplet Digital PCR system from Bio-Rad Laboratories for our eDNA analyses for a price of $81,545.00. Consumables are required for the Bio-Rad system. Purchasing another system just to compete the consumables is not in the best interest of the taxpayer as the original investment in the Bio-Rad system will be lost.

In order to run samples on the QX200 Droplet Digital PCR System, many reagents and consumables are required. Currently, these are only manufactured and sold by the manufacturer of the QX200 Droplet Digital PCR System, Bio-Rad laboratories.

7. Other Information. No additional information.

8. The Efforts to Identify Additional Sources Including the Market Research Conducted.

No other sources are known to manufacture reagents and supplies designed for the QX200 Droplet Digital PCR System. This capability is not currently available with any other contractor or vendor at this time, based on our market research. Our market research includes internet searches for the products we require, conversations with colleagues, and calling the company directly. The company confirmed they are the only place to purchase these reagents and supplies. They have no resellers of the items and there are no generic versions manufactured by other companies available. The recommendation of the USGS WARC in support of this noncompetitive justification is made in recognition of the fact that the competition must be obtained where at all possible.

9. Future Plans to Permit Competition. USGS Wetland and Aquatic Research Center is continually searching for more competitive ways to conduct its research that would retain the integrity of the research through networking with professional societies and reading of professional literature. Future requirements will be competed if other companies start manufacturing supplies to use with the QX200 Droplet Digital PCR System.

10. Recommendation and Certification from Program Office

Based on the above, I recommend this acquisition be conducted on a sole source basis and certify the above statements are true and accurate.

Margaret Hunter, Research Geneticist Date

11. Certifications from the Contracting Officer:

a. The order represents a fair and reasonable price based upon previous purchases, such as G16PX01556, G17PX01386, 140G0118P0359, and 140G0119P0336

b. This justification is accurate and complete to the best of my knowledge and belief.

12. Approvals

Daniel Galvin, Contracting Officer, Chief RAB Date

Jennifer Kelley, Bureau Competition Advocate Date

MARGARET

HUNTER

Digitally signed by MARGARET

HUNTER

Date: 2021.08.11 14:21:55 -04'00'

DANIEL

GALVIN

Digitally signed by

DANIEL GALVIN

Date: 2021.08.13 13:39:30 -04'00'