FAR 13.5 Sole Source Justification Redacted.pdf

Effective Date: 11/15/24 Page 1 of 4

REVISION: 01

Acquisition ID#: 36C260-25-AP-2199

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C260-25-AP-2199

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West, Network Contracting Office 20 on behalf of Portland VA Medical Center. Funding for this procurement action is through 2237 648-25-2-9961-0105.

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm fixed price commodities contract for the upgrade of the Synaptive Modus V robotic digital microscope to the Modus X version 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. This will be a firm fixed price for the parts needed to upgrade the microscope.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Portland VA Medical Center requires an contract to ensure that all Synaptive Modus V robotic digital microscope has the necessary upgrades to the new requirement Modus X.

Modus X Salient characteristics:

Upgradeable from current platform (Modus V) 3D through entire zoom range

27x magnification 4k cameras

Fluorescence visualization (blue, yellow, and IR modules) Continuous auto-focus

Snap focus with single function foot pedal Voice controlled optics Supports the use of long pointer instrumentation Capable of controlling the monitor from the Modus X Video clip recording and playback

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:

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

Effective Date: 11/15/24 Page 2 of 4

Acquisition ID#: 36C260-25-AP-2199

( 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):

The Synaptive products are highly specialized, including proprietary software. These products can only be serviced by Original Equipment Manufacturer (OEM) authorized Technicians utilizing OEM replacement parts distributed by OEM authorized distributors IAW VAAR Clause 852.212-71.

This equipment is relied upon during surgical procedures, and as such has critical requirements for support: the availability of 24- hour telephone technical support, on-site support, troubleshooting support within 30 minutes, and planned maintenance & software updates performed per the Original Equipment Manufacturer (OEM) specifications. Fidelis Sustainability Distribution LLC has the ability, and authorization from the OEM, to ensure that these necessary services are provided.

Due to the need for OEM replacement parts award is required to include VAAR Clause 852.212-71 prohibiting grey market products. Therefore, only contractors providing documentation as an OEM authorized distributor can be considered for award. Only OEM authorized distributors can provide clinical applications support for the OR team. These services are only available through their sole authorized distributor, Fidelis Sustainability Distribution, LLC.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Government wide databases were searched for possible contract vehicles and sources of supply. FPDS was searched to for acquisition history and reveals that historically this service and equipment has been awarded sole source to Fidelis. There are no existing contract vehicles for this equipment. A statement of proprietary ownership has been provided and is in the contract file. Fidelis is the only authorized company to provide maintenance and support of the of this system.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: IAW FAR 13.106-3(a)(2)(ii) the pricing provided by Fidelis, based on comparison to pricing provided in past purchase for similar services and the prior contracts for this same item. The prices are the eCAT pricing but facilities cannot purchase over the SAT.

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 to satisfy the requirementsof the FAR 10.002(b) collaboratively with NCO 20 Contracting and the Portland VAHCS Biomedical Engineering Department. Searches conducted of the commercial marketplace conclude that this requirement can only be met by the original equipment manufacturer’s authorized distributor for the required parts and services. A search of the VIP database identified 404 certified contractors for NAICS code 334510. However, Effective Date: 11/15/24 Page 3 of 4

Acquisition ID#: 36C260-25-AP-2199 due to the proprietary nature of the requirement and the OEM letter identifying Fidelis Sustainability Distribution, LLC, a registered SDVOSB, as the ONLY authorized distributor for this requirement, there is no reasonable expectation that any other vendors will be able to meet the requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

RFI 36C26025Q0319 was posted and only the OEM distributor Fidelis responded. The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. Reviewing the market for similar maintenance indicates that retaining rights to this type of system is common within the industry.

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

Fidelis Sustainability Distribution, LLC

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:

None at this time. The OEM retains sole rights to maintain and supply parts for their equipment, with only one authorized distributor.

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.

Gordon P. Hosoda Date Chief, HTM Portland

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.

Gregory Watson Date Contracting Officer

NCO 20

3/12/2025

GORDON

HOSODA

Digitally signed by

GORDON HOSODA

Date: 2025.03.12 06:49:06 -07'00'

GREGORY WATSON

Digitally signed by GREGORY

WATSON

Date: 2025.03.12 07:06:05 -07'00'

Effective Date: 11/15/24 Page 4 of 4

REVISION: 01

Acquisition ID#: 36C260-25-AP-2199

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.

Date

Krystal Weeks Branch Chief, Medical Equipment

NCO20

KRYSTAL WEEKS

Digitally signed by KRYSTAL

WEEKS

Date: 2025.03.12 11:20:55 -07'00'