LSJ --Fisher COVID 19.pdf

LIMITED-SOURCES JUSTIFICATION

(LSJ)

1 Defense Logistics Agency (DLA) Troop Support, Medical Supplier Operations, Electronic Catalog (ECAT) Division, is the contracting activity.

2 This justification is for the acquisition of the Thermo Fisher COVID-19 Equipment. These items are currently available under Fisher’s Electronic Catalog (ECAT) contract number SPE2DE19D0007, which expires on May 10, 2024.

3 The Government has the following requirements for various Thermo Fisher part numbers (P/N) for COVID-19 Equipment. These are Department of Health and Human Services (HHS) requirements under their Operation Warp Speed (OWS) Program. OWS is a program to accelerate the development, manufacturing, and distribution of COVID 19 vaccines, therapeutics, and diagnostics. The associated part numbers are listed below:

Item Description: KingFisher™ Flex Purification System, KingFisher with 96 Deep-well Head (P/N 5400630) QuantStudio 7 Flex Real-Time PCR (P/N 4485701) IQOQ Studio7Flex system (P/N 4487008)

4 This action is being conducted under the authority of the ECAT Multiple Award Schedule

Program. The authority waiving the competition requirements is FAR 8.405-6(a)(1)(i)(A) – An urgent and compelling need exists, and following the procedures would result in unacceptable delays. As explained below, the Government’s need for this equipment is extremely time sensitive.

COVID-19 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus. In order to provide support in response to President Donald Trump’s March 13, 2020 Emergency Declaration, access to COVID- 19 Equipment is urgently needed. To support the critical OWS mission, the requirement is needed by August 10, 2020 for expanding testing capabilities within the United States at commercial laboratories. The subject items are the only equipment immediately available and within the required timeframe. The Thermo Fisher lab testing equipment is the only equipment available at this time in inventory to meet the needs in the United States.

The KingFisher™ Flex Purification System, KingFisher with 96 Deep-well Head (P/N 5400630), is a flexible solution for different types of sample processing needs. It includes 24 magnet heads that allow users to raise the processing volume up to 5 mL, resulting in increased yield of the purified product. Ninety-six (96) samples can be processed with the King Fisher 96 magnet head in less than 20 minutes. This is a fully automated system that yields high-speed purification of nucleic acids, proteins and cells. It is an open and flexible system that allows users to use any magnetic particle based kit to meet the application demands.

The QuantStudio 7 Flex Real-Time PCR and IQOQ Studio7Flex system has increased application versatility through the accommodation of 4 different block types that is compatible with over 8 million assays for gene expression, genetic variation, gene regulation or protein expression experiments. The design of the platform, combined with the Applied Biosystems, provides responsive touch-screen automation capabilities and block exchange without the need for any tools.

The Fisher COVID-19 Equipment is intended for use by laboratory personnel who have received specific training on the use of the devices. The Fisher COVID-19 Equipment is authorized and approved under the Food and Drug Administration’s Emergency Use Authorization.

Two delivery orders are anticipated to be issued in a short time-frame for HHS requirements, upon approval of this LSJ. Delivery is needed by Monday, August 10, 2020.

5 This acquisition represents the best value to the Government consistent with FAR 8.404(d).

6 Market research was performed by the DLA Contracting Officer in August, 2020. The subject items are the only equipment immediately available within the subject timeframe available in the commercial marketplace. The Fisher COVID 19 equipment is the only equipment available at this time to meet the time sensitive needs of these testing sites.

7 There are no other facts supporting the use of this authority.

8 ECAT vendors have the opportunity to add products that fall within scope of the ECAT contract at any time, thereby increasing competition. DLA Troop Support will continue to attempt to locate other acceptable sources for the ECAT program for future requirements of the Government as they arise. However, due to the urgent and compelling nature of this acquisition, competitive procedures cannot be followed.

9 As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.