6515--Notice of Award Scout Wound Imaging Device and Software

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22 Page 1 of 9

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

PR/IFACP:

JOFOC Tracker#:

Contracting Activity: Department of Veterans Affairs, Network Contracting Office 19, located at 6162 South Willow Drive, Suite 300, Greenwood Village, Colorado 80111.

Organizational Activity: VISN 19 Eastern Colorado Health Care System at 1700 N. Wheeling Street, Aurora, CO 80045.

Nature and/or Description of the Action Being Processed: This proposed sole source requirement is for five (5) Scout wound imaging cameras, one (1) cloud based subscription license to Scout Software, setup, configuration and testing of the Scout Software, clinical training at each end user s location, and a Scout Protection Plan for support. This purchase is required to expand the capabilities of Wound Care Services at ECHCS and allow clinicians to image and treat Veteran s with wounds. This requirement is requesting one 12-month base year, plus four (4) option periods as follows:

Base Year: 08/01/2023 07/31/2024

OPT YR 1: 08/01/2024 07/31/2025

OPT YR 2: 08/01/2025 07/31/2026

OPT YR 3: 08/01/2026 07/31/2027

OPT YR 4: 08/01/2027 07/31/2028

Total estimated contract value: $252,500.00

Description of Supplies/Services Required to Meet the Agency s Needs: ECHCS is requesting five (5) dual-function wound imaging devices to enhance care of Veterans within the health care system. These devices will be used at multiple clinics within the healthcare system including inpatient and outpatient clinics. In addition to the wound imaging devices, the requirement will include an annual license to Scout Software, project management that includes setup, configuration and testing of the software, clinical training, and an annual protection plan for each system. The dual functioning standard and infrared imaging of the devices provides photographic and thermographic imaging for wound assessment and treatment. Software will enable clinicians to objectively and quantitatively measure skin temperature changes, while documenting physiological changes over the course of the patient s length of stay.

Statutory Authority Permitting Restricted Competition:Â

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

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Wound Vision, LLC is the sole distributor and manufacturer of Scout Wound Imaging Devices. The Scout Wound Imaging device and associated software is the only technology available on the market that offers the dual function of photographic and thermographic imaging in wound care treatment. Scout Wound Imaging devices are FDA approved for use in the United States. The system must support DICOM modality worklist, DICOM image storage to multiple send destinations, DICOM structured reporting for PowerScribe 360. In addition, the Scout Imaging Device supports image annotation and measurements.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted for equal to products with zero results. Other products on the market either do not offer the dual functionality of photographic and thermographic imaging or do not offer VA approved technology. Nicholas McMurray, Vice President Wound Vision, confirmed via letter dated 03/15/2023, that the SCA200, SSL100-SHS, SSL100-SHS-PM, SSL100-EMR, SSL100-PM, SCT100, and SPP200 product codes related to the Scout solution is a sole source product, manufactured, sold and distributed exclusively by WoundVision, LLC. No division of WoundVision, LLC, nor any other company, makes similar or competing products.

These products must be purchased directly from WoundVision, LLC. There are no agents or dealers authorized to represent this product. Sole source letter in AP Briefcase as P03.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This device was purchased by the San Antonio VA Health Care System in FY22 (36C25722P0558). The price of this acquisition is comparable to acquisition history as the overall amount was $262,500.00. The independent government cost estimate for this acquisition is $252,500.00, which is less than the amount of a prior award for the same items. Additional price analysis, if required, will be conducted by the CO to ensure the price remains fair and reasonable prior to award.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted using SAM.gov, FPDS.gov, GSA eLibrary, and VA Vendor Information Pages and found the small business Wound Vision, LLC is the sole distributor and manufacturer of the required devices and software.

Vendor Information Pages search using NAICS 334510, and keyword Wound Imaging System yielded 46 search results. VIP Query in AP Briefcase as P02.1. Sources sought sent to VIP query and no responses were received confirming an equal to solution. 36C25923Q0304 posted to contract opportunities also yielding zero results for a potential equal to solution.

SAM.gov Wound Imaging System search results: RFQ-23-PHX-005 (Musculoskeletal Ultrasound), 36C24E23Q0032 (Live Cell Analysis Research), and HHS-NIH-NIDA-OA-19-010401-CSS (Laser Holographic Microscopy Instrument). Results in AP Briefcase as P02.

A search of SCMC, ECAT, and SEWP for part# SCA200, and wound imaging system, did not yield any results.

Any Other Facts Supporting the Use of Other than Full and Open Competition: Similar technology currently available on the market could not be found. Market research indicates the Scout Imaging Device from Wound Vision, LLC is the only VA approved technology currently available to meet the unique clinical need. The Nonmanufacturer rule applies to this sole source procurement over SAT to small business WoundVision LLC, and can be met. VAAR 852.219-76 Limitations on subcontracting also applies and can be met.

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

Wound Vision, LLC Small Business

10585 N. Meridian St. Ste 101

Indianapolis, IN 46290

Sales Representative: Blair Kyle, 317-800-0011, blair.kyle@woundvision.com

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 Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

_____________________________ ________________________

Leslie Miller Date

Acquisition Utilization Specialist

Supply Chain Management Service

Eastern Colorado Health Care System

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

_____________________________ ________________________

P. Matt Zorch Date

Contracting Officer, Supply 1

Network Contracting Office 19 (NCO 19)

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.

_____________________________ ________________________

Sarilynn Thomas Date

Branch Chief, Supply 1 Branch

Network Contracting Office 19 (NCO 19) Awarded contract 36C25923P0732 to WOUNDVISION, LLC for 98500.00000000 on 2023-05-09.