P03 Sole Source Justification - Over SAT 36C249-23-AP-1914 Signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-23-AP-1914

1. Contracting Activity: Department of Veterans Affairs, VISN 9, Tennessee Valley Healthcare System

Nashville Medical Center, 1310 24th Avenue South, Nashville, TN 37212. 626-23-2-2150-0031

2. Nature and/or Description of the Action Being Processed: This is a Brand Name procurement for purchase of mIRage-LS sub-micron IR Multimodal Microscope – Base System with 785nm Visible Probe in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, 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 requirement will result in a new Firm Fixed-Price contract with a value of $553,660.00.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: TVHS Nasvhille (VISN 9) is seeking a multi-modal spectroscopy microscope with spatial resolution of several microns for the Research & Development service. This equipment will enhance the research capabilities of VA investigators working on projects to improve the health of Veterans. Approval is requested to specifically purchase the mIRage-LS sub-micron IR Multimodal Microscope – Base System (MIRAGE- LS-IR-BASE) with 785 nm Visible Probe and Raman spectrometer (RAMAN-785-LS) as well as with epi-fluorescence camera (UP-WFEF-A) from PHOTOTHERMAL SPECTROSCOPY CORP (PCS), the only manufacturer of this equipment. PCS holds the patent on the Optical Photothermal Infrared (O- PTIR) technology that enables the non-destructive, spatial assessment of physiochemical properties of tissues and cells. There is no other microscope on the market that acquires both infrared (IR) and complementary Raman spectra from the same region of interest and does so with minimal sample presentation. These spectra are analyzed to quantify the physiochemical properties of tissues and can be used to generate images of compositional characteristics of tissues such as bone.

Item

Description/Part Number*

Qty

1 mIRage-LS sub-micron IR Multimodal Microscope 1 2 mIRage Automated (Motorized) Stage - MIRAGE-MS-LS 1 3 mIRage Hyperspectral & O-PTIR Imaging - MIRAGE-HSI 1 mIRage HYPERspectra QCL with Wide Range QCL (1800- 800cm-1) - LS-QCL 1

5 Rigid Optical Table (900 mm x 1200 mm) - ROT-3x4 1 6 4 Days of Installation and Training - IN-4 1 mIRage/Raman Spectrometer and Integration, 785nm with Single Grating -

RAMAN-785-LS

Wide Field Epi-fluorescence Camera, Illuminator, Light source, and Filter Cubes - UP-WFEF-A

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9 Filter Cube & Housing – Blue FLT-BLUE-A 1 10 Filter Cube & Housing – Green FLT-GREEN-A 1 11 Filter Cube & Housing – Red FLT-RED-A 1

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

a. Only One Responsible Source (FAR 6.302-1): PHOTOTHERMAL SPECTROSCOPY CORP (PCS) provides support and services for a wide array of applications for internal and external customers doing research. The areas of research include medical science, chemical engineering, chemistry, material science, and environmental science.

The purchase of a new Infrared Spectroscopy Microscope system provides capability that does not exist at our VA station. Similar systems are diffraction limited, typically >20 micron spatial resolution, thus limiting their ability to study smaller features of interest in biomedical research.

In addition, samples are typically prepared as thin sections for transmission to give best quality data and for comparison to spectral libraries. Histoglogical preparation of these thin sections is inherently destructive. In some cases, to improve spatial resolution or minimize sample preparation (in other words, avoid thin sectioning by histolgoy), manufacturers of infrared (IR) spectroscopy equipment incorporate the use of various attenuated total reflectance (ATR) objectives. Although this technique improves resolution to <10 micron and minimizes sample preparation, this technique contributes to artifacts in the spectra including photometric differences and spectral wavelength changes in the spectra when compared to traditional transmission IR spectra. ATR objectives require contact with sample which in some cases can cause damage to the samples or spread cross contamination as the sample is moved from one location to the next. ATR objectives can be damaged during use and are expensive to replace.

The desired equipment (major system) is highly specialized offering multivariate capability not previously available in one spectroscopy instrument. The major system can fulfill multiple types of analysis on the same microscope (instrument) and the same spatial resolution. Specifically, the major system uniquely enables the simultaneous collection of IR and Raman hyperspectral images at the same spatial resolution. No other instrument in the marketplace can do this. The

Effective Date: 02/01/2022 Page 3 of 5 major system also includes widefield epi-fluorescence imaging so that molecular specificity guides the selection of areas of chemical interrogation by IR spectroscopy on the same system without moving the sample or changing optics.

The new, highly specialized technique called Optical Photothermal Infrared (O-PTIR) has unique advantages over traditional FTIR or direct Quantum Cascade Laser (QCL)-based Microscopy as follows: sub-micron spatial resolution, less sample preparation (non-destructive), no contact with tissue samples or cells, and less prone to artifacts than traditional FTIR microscopy.

The O-PTIR technique is configured to offer simultaneous collection of IR and Raman spectroscopy on the same sample, at the same time, and with the same spatial resolution. For these reasons, we have chosen to purchase the mIRage Laser Spectroscopy (LS) microscope from the only company that produces O-PTIR microscope system (Photothermal Spectroscopy Corporation or PSC). The O-PTIR technique is patent protected (PCS owns the IP), and as such, cannot be offered by other IR microscope vendors.

The mIRage LS microscope will be uniquely configured to offer co-located fluorescence microscopy that uses the highly specific fluorescence camera to indicate and guide O-PTIR chemical measurements. This fully integrated fluorescence microscopy unit will provide high molecular specificity for bio-molecular structures. In other words, the integrated fluorescence camera enables identification of fluorescent tags for the acquisition of IR information.

The system will incorporate a counter-propagating mode that provides IR spatially resolved resolution below 500 nm. mIRage-LS sub-500 nm IR multimodal microscope and spectroscopy system uniquely combines multimodal capabilities into one system. In a combined platform, the mIRage-LS supports both optical photothermal spectroscopy (O-PTIR) with simultaneous Raman and with co-located Fluorescence Microscopy. Additionally, a major innovation, O-PTIR counter propagating mode, has improved the IR spatial resolution to sub 500 nm.

Contracting another company to build such a highly specialized piece of equipment would be cost prohibited, would violate the patent help PSC and would take at least a year to build.

The highly specialized microscope being sought is essential to the VA-funded research being done at TVHS Nashville. It will enhance the ability to characterize tissues and cells from studies of disease that affect Veterans.

Accordingly, Photothermal Spectroscopy Corporation (PCS) is the only firm capable of providing the services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As previously stated, PCS holds the patent on the O-PTIR technology that enables the simultaneous acquisition of infrared and Raman spectral data at sub-micron spatial resolution. An Intent to Sole Source (36C24923Q0371) was posted on sam.gov 7/17 through 7/26 and no inquires were revied in association with public notice. Therefore, it is not possible to solicit other sources for a similar highly specialized instrument.

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7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The costs are anticipated to be fair and reasonable based on comparison of the quote to the Independent Government Cost Estimate (IGCE), comparative evaluation of quote received from PSC and a fair and reasonable determination will be documented prior to award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research was conducted and as it appears the requested vendor is the only source to provide and install the requested products.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

PHOTOTHERMAL SPECTROSCOPY CORP

325 Chapala Street, Santa Barbara, CA. 93101, USA

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Department of Veterans Affairs will continue to seek vendors capable of providing medical equipment in future procurements. However, at the presenttime, based on available market research, there are no other vendors that are fully capable of providing the required supplies other than PHOTOTHERMAL SPECTROSCOPY CORP.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

_UNIQUE A. WILLIAMS___________ _02/27/2023_______________

Name Date Title: Budget Analyst Facility: Tennessee Valley Healthcare System – VA Nashville

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Scott Dickey Date Contracting Officer, NCO 09

08/07/2023 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

Effective Date: 02/01/2022 Page 5 of 5

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

John McComas Date Supply East Branch Chief – NCO 09