P03 -Final JA Sole Source - Palo Alto Pkg 22 - CO 7.7.20 - Copy_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C261-20-AP-0656

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC)in support of VA Palo Alto Research and VMU. Purchase Request Number 640-20-1-522-0022.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is an individual J&A for approval of a Sole Source Justification in accordance with FAR 13.106-1(b) soliciting competition; soliciting from a single source (including brand name), where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

The new Palo Alto Research facility requires an Applied Biosystems: QuantStudio7 Flex Real-Time Polymerase Chain Reaction (PCR) system for research purposes.

Studying the gene expression of cells or tissue is crucial for better understanding of health and disease, and it allows us to better understand how the body reacts to stress or challenges. Research allows us to understand how the body responds to pathogens like viruses, medication, and so on. One of the most reliable and robust ways to study gene expression is by utilizing Polymerase Chain Reaction (PCR) - a method used to rapidly make millions to billions of copies of a specific DNA sample, allowing us to take a very small sample of DNA and amplify it to a large enough amount to study in detail. The PCR reaction takes place in an instrument called a thermocycler that uses multipole cycles to amplify the DNA of interest. The PCR process generally consists of a series of temperature changes that is repeated 25–50 times.

The ThermoFisher Quant Studio 7 (QS7), is an instrument that is carried out in a thermal cycler with the capacity to illuminate each sample with a beam of light with six (6) different specified wavelengths, and detects the fluorescence emitted with an average run time of 30 minutes. This thermal cycler is also able to rapidly heat and chill samples. ThermoFisher also carries a large selection of validated probes designed to work in their instruments; thus, allowing users to buy probes that can be used for absolute quantification assay immediately. This reduces time and money spent on trying to manually design and validate probes for genes of interest. Moreover, this instrument not only uses six (6) lasers, it also supports 21 different filter options allowing for large scale multiplexing: detecting multipole probes from the same sample, that is crucial when trying to study samples from human patients where the amount of available sample is very limted.

The instrument has the ability to switch between 384 well format to 96 well format. The ability to use 384 well plate will allow us to use a test format that utilizes a small amount of sample volume, helping to reduce the amount of sample needed from patients. The ability to use 96 well format will allow us to minimize sample transfer form tissue culture or form a cell sorter. This helps in reducing sample loss.

The other alternative would be to use two (2) different instruments: one (1) for 96 well plates and one

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 2 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

(1) for 384 wells plates. Only this instrument has the ability to switch between the two (2) different platforms; saving time, space, and costs.

The Contracting Officer has determined a Firm-Fixed Price (FFP) purchase order is appropriate for this acquisition. The total estimated cost/price of the purchase order is $76,963.80.

CLIN Description/Part Number* QTY Price 0001 ThermoFisher Scientific’s Applied Biosystems

QuantStudio 7 Flex

0002 Applied Biosystems Block Upgrade Kit for Quant Studio7.

Estimated Total

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The ThermoFisher Quant Studio 7 (QS7), is an instrument that is carried out in a thermal cycler with the capacity to illuminate each sample with a beam of light with six (6) different specified wavelengths, and detects the fluorescence emitted with an average run time of 30 minutes. This thermal cycler is also able to rapidly heat and chill samples. ThermoFisher also carries a large selection of validated probes designed to work in their instruments; thus allowing users to buy probes that can be used for absolute quantification assay immediately. This reduces time and money spent on trying to manually design and validate probes for genes of interest. Moreover, this instrument not only uses six (6) lasers, it also supports 21 different filter options allowing for large scale multiplexing: detecting multipole probes from the same sample, that is crucial when trying to study samples from human patients where the amount of available sample is very limited.

4. Description of market research conducted and results or statement why it was not conducted:

In accordance with FAR Part 10, the facility conducted market research for this acquisition by looking at other brands: Bio-Rad, Roche, PerkinElmer, Agilent, Cole Parmer and more. Search terms included: size, number of lasers and filters, reading speed, TaqMan assay support, touch screen for operations, software for data analysis, supported plate platform (48/96/384), and ability to switch between plate platforms minimum reaction volume.

The only other instrument that offers this plate format flexibility is the Roche LightCycler 480. However, the Roche instrument only offers five (5) lasers and the instrument requires a computer for operation.

Also, it is much larger than the QS7 with a longer run time when compared to the QS7.

Based on these market research efforts, the Government’s technical experts have determined that only the QS7 system can meet the VA’s needs.

The Contract Specialist (CS) completed additional market research that is documented in the contract file and verified that the ThermoFisher Scientific QS7 is the only system that will meet the VA’s needs.

Thermo is an other than small business manufacturer as verified in SAM.

The (CS) contacted the Manufacturer “ThermoFisher Scientific” and was informed that this system can only be purchased through one (1) source: ThermoFisher Scientific or Fisher Scientific Product. Thermo Fisher does not offer this equipment through authorized dealers.