S02- ATTACHMNET 5 - Partial Brand Name JA - LiCOR Pearl - Palo Alto Pkg 10 - CO 10.6.20.doc

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

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: 36C261-19-AP-5174

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC) in support of VA Palo Alto Research and VMU. Purchase Request #640-20-1-522-0010

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

This is an individual J&A for approval of a partial Brand Name 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 VAPAHCS’s mission is to provide exceptional health care to all Veterans. The Research Department embraces continuous learning and improvements to the care we provide and views research as fundamental to our ongoing success. With more than 100 Principal Investigators, the VA Research Laboratory (working in conjunction with faculty and staff from Stanford University) includes both clinical studies as well as basic scientific research investigating fundamental mechanisms in the laboratory. Specific conditions, especially prevalent in veterans, include Post-Traumatic stress disorder (PTSD), traumatic brain injury (TBI), geriatric medicine and polytrauma, orthopedic and cardiovascular conditions, as well as other general public health issues. Providing veteran-centered care and engaging in continuous improvements are the guiding principles that shape the overall approach to how we will deliver outstanding health care.

To perform the required live animal testing for research purposes, VA Palo Alto requires the delivery and installation of the LI-COR Pearl Trilogy Small Animal Imaging System for the new research facility.

The Pearl Trilogy Infrared Small animal imaging system with Anesthesia Suite is the only instrument on the market that provides both whole animal and far-red spectrum imaging.

Box; Smartflow Anesthesia Suite (120V)

Model #9430-03

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

Having the LiCOR Pearl Imaging System will add to the imaging capabilities of live animals at the Research Veterinary Medical Unit (VMU) at the Veterans Affairs Palo Alto facility. Having live animal imaging that can use the far-red spectrum means that we can now “see” what’s going on in the brain without killing the mice and not worrying about the blocking procedure as we will have very low background noise. Using this system also will reduce the number of animals used.

Having this instrument also allows the researchers to use multiple colors. This can be useful to study a tumor model that will have color one (1), and then use a drug that will try to kill/treat the tumor which would be tagged with color two (2), and so on.

The LiCOR Pearl Trilogy is the only instrument on the market that provides both whole animal and far-red spectrum imaging. This is patented technology exclusively owned by LiCOR.

The mission of the VA Palo Alto Health Care System (VAPAHCS) is to provide exceptional health care to all Veterans we serve. We embrace continuous learning, improvement, and research as fundamental to our ongoing success. With more than 250 Principal Investigators, the VA Research Program includes not only clinical research, but also basic science investigating disease mechanisms in the laboratory. The Research Program addresses health challenges especially prevalent in Veterans, including post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), geriatric medicine and polytrauma, cardiovascular, orthopedic as well as other public health issues. Providing Veteran-Centered Care and engaging in continuous improvement are the guiding principles that shape our overall approach to how we will deliver outstanding health care. Innovative research is a key engine in advancing Veteran and public health.

A common way to study disease and health is by conducting animal studies. Since rodents can be genetically manipulated, researchers have the ability to induce diseases in a controlled manner, allowing for scientific inquiry into the efficacy of treatments; as well as gain fundamental scientific knowledge about how a disease develops. By using animal models, medical researchers can learn what causes diseases, and how to prevent, treat, or cure them. Although the use of animals in modern medicine and biology is essential, researchers are actively working to reduce the numbers used and improve upon how they are used. The ability to use non-invasive techniques, such as whole live animal imaging, is an essential tool in ongoing efforts for replacement, refinement, and reduction of animal use.

The LiCOR Pearl Trilogy system provides sensitive and consistent near infrared and bioluminescent imaging in-vivo in mice, as well as ex-vivo imaging of tissues and organs. This instrument provides uniform illumination of the entire animal in a single image. Along with uniform illumination, the LiCOR Pearl Trilogy also provides a uniquely wide dynamic range and high sensitivity. The consistent illumination makes it easy to assess biodistribution and clearance of an optical probe throughout an animal, or within multiple organs imaged at the same time. A probe is a molecule of interest that carries a dye that can be visualized and tracked. A probe could be any protein or a tag that emits a florescent light. These probes can be proteins such as those found in jelly fish and fireflies (Green/Yellow/Red Fluorescent Protein- GFP/RFP/YFP or luciferase) or synthetic tags.

The LiCOR Pearl Trilogy has the ability to visualize far-red fluorescent probes. These probes are extremely useful as they are synthetic and cannot be found in the body, where some tissues and organs (such as fat and bones) naturally produce fluorescent light. The ability to overcome this limitation allows researchers to decrease the incidence of animal imaging while increasing the quality of the data and information obtained. The LiCOR Pearl offers a wide six (6)-log dynamic range, enabling capture of consistent images throughout a longitudinal study, without saturation, changing lenses, or camera settings. Most importantly, the LiCOR Pearl Trilogy has a high signal-to-noise ratio allowing researchers to image targets deep inside an animal with minimal interference from background noise. This is essential for applications such as those characterizing the specificity of an optical probe and probes in the far-red spectrum. Finally, the LiCOR Pearl Trilogy is easy to operate and can capture images quickly, making it simple to integrate into a busy imaging facility.

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

In accordance with FAR Part 10, market research has been conducted for this acquisition. Market research was conducted by the facility by reviewing other similar equipment and by contacting vendors (LiCOR, Azure, VWR, ThermoFisher, Bioad, Ivis). Review of these products is based on the systems capability for tissue imaging, live mice imaging, WB imaging, In-Cell Western, far-red imaging, software size, reliability and support services. Based on these market research efforts, the Government’s technical experts have determined that only the Li-Cor Pearl Trilogy imaging system can meet the VA’s needs.

The Contract Specialist (CS) conducted additional market research that is documented in the contract file and includes the posting of a Notice of Intent to Sole Source (Brand Name). No other vendors or manufacturers responded to the Notice of Intent offering a different brand solution with similar capabilities. The CO determined there are no other systems on the market that can offer the functions the LiCOR Pearl Imaging System provides. Further, LiCOR’s proprietary software is essential to the Government’s requirement and there is no known software on the market that can offer a comparable solution.

The CS contacted LiCOR to determine if the manufacturer worked with any small business concerns and was informed the purchase can only be made through LiCOR or their sole small business authorized dealer, Government Scientific Source.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Michelle Rhodes Date

Contracting Officer VHAPM Part 813.106

Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020