SSJ.143041-25-0009-1_Redacted.pdf

Version 2.0

SINGLE SOURCE DETERMINATION USING

SIMPLIFIED ACQUISITION PROCEDURES (SAP)

FOR AN ACTION NOT EXCEEDING THE SIMPLIFIED ACQUISITION THRESHOLD

(AUTHORITY: FAR 13.106-1(b)(1))

143041-25-0009

1. Agency and contracting activity. Department of Commerce, NOAA Acquisition and Grants Office (AGO), Western Acquisition Division, Seattle SAP Branch and Northwest Fisheries Science Center, Seattle, WA.

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

NWFSC’s Genetics and Evolution Program requires a KingFisher Apex bead-based nucleic acid isolation and purification instrument (ThermoFisher Scientific / dba Life Technologies Corp) to support the growing needs of NWFSC’s Molecular Genetics Laboratory for precision processing of environmental DNA (eDNA) samples. NWFSC’s laboratory employs a wide array of molecular genetic approaches to support a diverse project portfolio and requires an instrument that supports automated magnetic bead-based purification of DNA, RNA and cells. This instrument is needed to support both ongoing work and projects directly supported by Inflation Reduction Act funding. The automated system must be compatible with existing validated protocols and reagents, must be capable of processing 96 samples per run and have customizable protocols and must include an instrument parts and service warranty (1 year) to avoid interruption of service. Life Technologies is the only vendor with the capability to perform the required service with OEM parts and technicians certified to service the KingFisher Apex.

The estimated cost of the KingFisher Apex instrument, associated parts and service agreements is

3. Identification of the single source or the brand name to be solicited.

ThermoFisher Scientific / dba Life Technologies Corp 5781 Van Allen Way Carlsbad, CA 92008

4. Supporting rationale. Only one source or brand name is reasonably available as detailed below:

Brand Name – This particular brand name is essential to the requirement and market research indicates similar products do not meet or cannot be modified to meet agency needs. The KingFisher Apex instrument was the only instrument found to meet the following Government requirements:

Technical specifications

96 place magnetic head for 96 samples for volumes 20-200 l and total working volumes up to 5000ul

96PCR magnetic head for 96 samples for volumes 20- 100 l

Instrument utilizes permanent earth magnetic rods which are covered with disposable plastic tip comb during processing to ensure sterility and avoid sample contamination

Magnetic particles are collected in the very end of the tip during process which enables release of particles in very small volumes (50ul)

Instrument can be used for nucleic acid, protein and cell purification applications Small bench-top instrument with footprint (99 x 77.5 x 83.5 cm) User interchangeable magnetic heads User interface for customer protocol modification Open system compatible with user selectable magnetic particle-based reagents Heating/cooling capability from +4°C to +100°C Fast protocol run times, typically 30-60 min depending on the applications

Compatibility to existing systems or equipment - The required service must be compatible in all aspects (form, fit, and function) with existing systems or equipment, and the source is uniquely qualified to meet the requirement. The KingFisher Apex is a proprietary instrument of ThermoFisher Scientific dba/ Life Technologies Corp. In addition, Life Technologies is the only provider with technicians certified to perform the required service with Original Equipment Manufacturer (OEM) parts, and technicians certified to service the KingFisher Apex. This automated magnetic bead-based system and its parts are critical to the operation of the instrument, and the OEM Part can only be serviced by certified Life Technologies engineers.

Life Technologies (ThermoFisher) is the only service provider that has access to Original Equipment Manufacturer Parts, and is the only service provider with technicians certified in the most up-to-date parts & techniques that the instruments require to optimally perform. The Life Technologies (ThermoFisher) 3500 Genetic Analyzer was improved from older genetic analyzer models with the addition of a single-line 505 nm, solid-state long-life laser. This laser is critical to the operation of the instrument and the Original Equipment Manufacturer Part can only be serviced by certified Life Technologies engineers. Our forensic genetic results and calibrations need to conform to industry standards, quality and legal service for acceptance in the courtroom. For these reasons other service providers do not have the capability to provide the required parts and service needed to fulfill this request.

Furthermore, the KingFisher Apex has been demonstrated compatibility with existing systems, consumables and protocols currently employed in the lab and continuity of these protocols is necessary to meet the needs of existing, validated protocols. For these reasons, other service providers do not have the capability to provide the required parts and services to fulfill this request.

Exclusive Licensing Agreement/Restrictive Rights/Authorized Reseller - The source has one or more of the following: an established exclusive licensing agreement, proprietary data, limited rights in data, patent rights, OEM required certifications or OEM authorized reseller, copyrights, or secret processes with regard to the supplies or services required.

Life Technologies Corporation is the only company that legally holds the intellectual property

(IP) license for the instrument’s Collection Software and Sequencing Analysis. All non-authorized third party service providers are prohibited from accessing, using, or installing Genetic Analyzer software.

Life Technologies Corporation is the only company currently offering service contracts for the QuantStudio 6 Flex real time PCR system

Life Technologies is the authorized distributor of the KingFisher Apex and the sole provider authorized to service the instrument using OEM parts and certified service personnel, as indicated by the notice provided by the parent company, ThermoFisher Scientific, within the contract file.

5. Market Research. Comprehensive market research was conducte to explore all potential sources available on the open market for this very specialized instrument. Market research included an in-depth internet search for companies that manufacture automated bead-based DNA extraction instruments and found several companies, including Opentrons (Opentrons) and Roche (MagNA Pure 96), however, only the KingFisher Apex meets all of our stringent, yet flexible needs and standards for sterile, customizable workspaces with a high degree of precision & accuracy.

This justification informs, confirms, and certifies that ThermoScientific dba Life Technologies and the KingFisher Apex purification instrument is, according to our best knowledge, the only purification instrument with the above feature combination and, therefore, a proprietary item of Life Technologies Corp.

6. Technical/Requirements Representative Certification

I certify that this requirement constitutes the Government’s minimum needs and the supporting data provided herein is accurate and complete to the best of my knowledge and belief.

Date

Molecular Genetics Team Lead Northwest Fisheries Science Center

7. Determination

I hereby determine that the circumstances of this action deem only one source is reasonably available. This determination is accurate and complete to the best of my knowledge and belief.

Sandra Caswell Date Contracting Officer

Digitally signed by

CASWELL.SANDRA.ANN.1073426363

Date: 2024.11.13 14:22:16 -10'00'