P03. JnA Sole Source - Clinical Imaging Equipment CO BC 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: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C262-26-AP-0360

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C262-26-AP-0360

1. Contracting Activity: Department of Veterans Affairs, NCO 22, VA Loma Linda Healthcare System;

605-26-1-027-0011

2. Nature and/or Description of the Action Being Processed: This procurement VA Loma Linda Healthcare System (VALLHCS) need to maintain and service its AGFA imaging and visualization devices and systems. This is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, when 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 is a new, 12 month firm-fixed price maintenance and service agreement. The maintenance and service agreement includes all labor, supervision, parts, and transportation to service and maintain the equipment/systems as provided for in the contract agreement. Preventative Maintenance (PM) will be accomplished in accordance with the Original Equipment Manufacturer (OEM) recommendations. The contractor must use OEM certified parts and service engineer/technicians must be OEM trained on all equipment to ensure functionality.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The maintenance and service agreement supporting VALLHCS AGFA equipment and systems is required from October 4, 2025 to October 3, 2026. Total value for this acquisition is $594,240.91.

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

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C262-26-AP-0360

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): AGFA Healthcare Corporation is the OEM and only source certified to maintain and service VALLHCSs AGFA Devices and Software.

These systems are subject to Food and Drug Administration (FDA) accreditation and regulation. The minimum requirement to be accredited by FDA and other regulating agencies is to meet OEM operating specifications AGFA are the only authorized technicians granted access to proprietary software/hardware upgrades to guarantee VALLHCSs equipment can meet these standards.

Additionally, replacing Clinical Imaging System Devices and Software to meet competition requirements is not feasible, and would cause unnecessary interruptions and potential delays to veteran care.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: IAW FAR 13.106-501(a)(1)(iii), Special Documentation Requirements, Contracting Officer will make justifications required by FAR 6.305(a) publicly available within 14 days after contract award. The VA will continue to conduct market research for the maintenance of Clinical Imaging System Devices and Software. However, AGFA Healthcare Corporation. is the only capable firm of providing services for VALLHCS at this time.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Fair and reasonable pricing will be determined IAW FAR 13.106-3(a)(2). Pricing will be evaluated to be fair and reasonable based on comparison of the proposed prices found reasonable on previous purchases, a comparison with similar items in a related industry, and a comparison to the Independent Government Estimate (IGE).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A mandatory review of the Vendor Information Pages database found 320 verified SDVOSB and VOSB entities under NAICS 811210. Market Research was then restricted to AGFA Healthcare Corporation who provided a sole-source letter dated, January 10, 2025 stating that only their Field Service Engineers (FSEs) and authorized representatives are allowed to install proprietary software and hardware updates/upgrades on equipment subject to FDA accreditation and regulation.

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: AGFA Healthcare

Corporation; UEI KV19ND1TM3Z9; 10 S ACADEMY ST, GREENVILLE, SC 29601 USA; Andrea Morningstar, 519-572-2151, andrea.morningstar@agfa.com.

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 VA will continue to conduct market research for the maintenance of Clinical Imaging System Devices and Software. However, AGFA Healthcare Corporation. is the only capable firm of providing services for VALLHCS at this time.

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C262-26-AP-0360

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.

Jonathan McGalliard Date Chief Biomedical Engineer VA Loma Linda Healthcare System

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.

Norman Napper-Rogers Date Contracting Officer

NCO 22

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.

Mayte Diaz Date Branch Chief

NCO 22

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