P03 - JOFOC_Redacted.pdf

VHAPM Part 813.106 Simplif ied Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justif ication for SAP under the SAT

VHAPM Part 813.106 Page 1 of 2 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: 36C252-22-AP-0553

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Edward Hines, Jr. VA

Hospital, Great Lakes Acquisition Center, 578-22-1-969-0012.

2. Brief description of supplies/services required and the intended use/estimated amount:

This is a brand name only justif ication for a Clarif i Microvascular Assessment Tool manufactured by Modulated Imaging, Inc. (“ModulIM”).

CLIN Item Description Qty Unit

0001 1504

Clarif i Imaging system includes Clarif i imaging head, mobile cart, integrated tablet computer, calibration card, and Rev H software which provides the following: SFDI (comprised of NIR, visible light, and sophisticated algorithms) acquisition of five (5) perfusion and oxygenation biomarker maps and values including;

StO2, HbT1, HbT2, HbR, and HbO2. Cloud data transfer capabilities, reporting function for up to six (6) localized tissue regions of interest (ROI), data and image comparison mode.

1 EA

1702-

Clarif i Imaging Protection+ Three Year Warranty: Includes battery replacement and software updates

1 EA

0003 1704 Instrument Shipping and Handling 1 EA

Estimated amount:

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

Clarif i imaging technology is a COVID-19 procurement and VA Video Connect (VVC) eligible because it has high potential to impact the care of Veterans by assessing microcirculation (non-invasively/no-contact) in the lower limbs. Clarif i will initially, be used in a post procedure, follow-up exam application. The Clarif i is lightweight and portable which can be ideal when using in the Emergency Room or other venues requiring immediate circulation determination.

Because of these characteristics Surgery Service Lines can deploy it at Community-Based Outpatient Clinics and allow it to be used during a provider VVC patient exam.

Amputations due to diabetes-related complications are a major issue for the Edward Hines, Jr. VA Hospital and the VA healthcare system which is why the Prevention of Amputation in Veterans Everywhere (PAVE) Program was established. Microvascular complications and peripheral arterial disease (PAD), when combined, increase the risk of amputation by 22.7-fold. The Clarif i imaging system can provide timely wound-prevention insight to microvascular status and PAD in a rapid and non-contact manner.

Hospitals and other VAs use Clarif i imaging system to help manage patients during the pandemic who’s amputations have increased during COVID due to reduction in visi ts and

VHAPM Part 813.106 Simplif ied Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justif ication for SAP under the SAT

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 precautions over virus spread. The Clarifi technology is well-suited for these patient concerns and Hines’s continued movement towards VVC, digital health and tele-medicine. A technician can perform microvascular assessment using Clarif i and the images can be externally reviewed by an expert physician. The Clarif i Imaging System will enable us to get the best care to our patients while minimizing COVID exposure. A non-contact-Microvascular assessment (Clarif i) can also help minimize unnecessary clinic visits by allowing clinical staff to determine which patients urgently need to visit the clinic. This VVC plan will get best care to patients when they need it.

From a clinical and patient safety vantage, Clarif i can investigate severity of microvascular changes in patients that have COVID-19. Deadly cases of COVID-19 are associated with amplifying the effect of comorbidities like diabetes and cardiovascular disease on oxygen delivery to key organs. Microvascular changes during the progression of the d isease may be lead indicators of complication severity. The facility strongly believes that microvascular assessment could play a role in understanding and helping mitigate these acute changes.

Finally, Clarif i imaging system and its ability to perform microvascular assessment can also be deployed to other surgical services including wound services, plastics, and vascular surgery.

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

A VIP search was conducted with NAICS 334510 and keywords, “microvascular,” “spatial frequency,” “tissue oxygen,” “oxygenation,” or “Clarif i” (brand name). Zero results were returned.

A search for “microvascular” on GSA Advantage, NAC MedSurg, ICD, and SCMC produced zero results.

The CO sent an e-mail to the manufacturer to determine if uses any small business distributors, including VOSBs or SDVOSBs. It replied that it does not have any relationships.

This justif ication is to be provided with an Intent to Sole Source or Award notif ication.

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.

Jim Hedman

Contracting Officer

11/19/2021