A16_Single_Source_Justification_1.pdf
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- OR-CLARK R BAVIN FWO-DNA KITS AND SUPPLI
- Solicitation number
- 140FS123P0288
About this file
This document is a single source justification for a sole source procurement of DNA extraction kits and other consumables from Qiagen, LLC. The National Fish and Wildlife Forensic Laboratory requires these products to complement their existing Qiagen QIAsymphony robotic DNA extraction platform and 3500xL genetic analyzer, which have been validated for use in forensic casework under ISO 17025. Qiagen is the only supplier that can provide products compatible with and validated for the laboratory's existing instrumentation. No other vendors offer a comparable integrated solution. The solicitation number is 140FS123P0288 from the Department of the Interior Fish and Wildlife Service for an anticipated award to Qiagen, LLC for an indefinite delivery/indefinite quantity contract. The justification was certified and approved on September 11, 2023.
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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: The products we require from QIAgen are compatible with our existing laboratory equipment and protocols, ensuring seamless integration into our workflow. Using these products will save both time and money as they have been validated for use in our specific application and no other vendor offers a comparable solution, and any other extraction kits would not 1) be compatible with the QIAsymphony or 2) be validated for use in forensic casework. |
| Text2: QIAgen is the only company that produces DNA extraction kits that the QIAsymphony robotics platform already in use at the NFWFL can utilize. Additionally, the QIAgen kits and other consumable plastics listed in the attached quotes have all been validated for forensic casework in the NFWFL Genetics section and any other consumables would need to go through costly validation procedures before being used in forensic casework. |
| Text1: The Qiagen symphony consumables for DNA extraction is being purchased to complement existing instrumentation in the Genetics Laboratory at the OLE National Fish and Wildlife Forensic Laboratory (NFWFL). |
The Big Dye Terminator (BDT V3.1) chemistry is used daily for sequencing of forensic casework of species identification, additionally, the POP-7 and the Anode and Cathode buffers are integral in the routine process of species ID, individual matching, and all other aspects of our daily casework. The items listed in this quote are vital to our casework, and are specific to our existing Genetic Analyzer 3500xL equipment. This equipment and the consumables have been validated for use in wildlife forensic casework. The use of validated protocols and reagents and the ability to maintain consistency between procedures is crucial to forensic genetic analyses, and is required under the guidelines of our Accreditation under ISO 170
| Text4: There does not exist another entity that could provide the needed products with the same specifications for the existing QIAgen robotic instrumentation already in use at the NFWFL. The listed products are the only products that may used on this robotics platform. | |
| Text6: Their products are designed to streamline workflows, reduce processing times, and minimize the need for repeat experiments, ultimately leading to faster and more cost-effective research outcomes. No other competitor produces the DNA extraction kits, and other consumables that are designed to work in the instrumentation already in place at the NFWFL. IAW FAR part 13.5 basis for award using Simplified Acquisition Procedures the proposed price is determined to be fair and reasonable based on the following comparison of the proposed price with purchase found reasonable on previous purchases 140F0522P0250 & 140F0621P0020 IAW FAR 13.106-3(a)(2)(ii))). Therefore, after having weighed all facts and circumstances, the anticipated award to Qiagen, LLC. is fair and reasonable. | |
| 2023-03-29T11:39:04-0700 | |
| TAMARA MILAGRES |
| 2023-09-11T09:55:15-0700 | |
| OSCAR OROZCO |
Text5: Qiagen has extensive experience in developing and producing high-quality molecular biology and genetic testing products. Qiagen's products required have been validated for use in our specific instrumentation, and is essential for the success of our mission. The use of validated protocols and reagents and the ability to maintain consistency between procedures is crucial to forensic genetic analyses, and is required under the guidelines of our Accreditation under ISO 17025. They are the only unique and qualified source capable of providing these items.
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