P03_FAR 16 Exception to Fair Opportunity AGFA MJC CO_Redacted.pdf

Effective Date: 03/15/2023 Page 1 of 3 Revision: 02 Acquisition ID#: 36C241-26-AP-0913

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID: 36C241-26-AP-0913

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Northampton Medical Center, 421

North Main Street, Leeds, MA 01053.

2. Description of Action: The proposed sole source task order against IDIQ VA797H-17-D-0004 is for a base plus two (2) firm fixed price annual maintenance and support agreement.

3. Description of Services: Annual service maintenance agreement for Worcester Belmont Street

Campus on the 1 AGFA DR 400 Detector System. This agreement includes 24/7/365 help desk support to address questions and problems, remote technical support available during normal business hours Monday through Friday, preventative maintenance services and priority onsite response coverage during downtime events.

Estimated Amount:

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i):

( ) FAR 16.505(b)(2)(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

( X ) FAR 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

( ) FAR 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

( ) FAR 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee.

( ) FAR 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source”. The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business

(VOSB).

Effective Date: 03/15/2023 Page 2 of 3

Acquisition ID#: 36C241-26-AP-0913

Rationale Supporting Use of Authority Cited Above: Only LB OEM AGFA US Corp field service engineers are authorized to provide preventive maintenance and repairs on this equipment and support for the related software due to the highly specialized and proprietary nature of the hardware and software. OEM AGFA US Corp has provided a sole source letter (see attached).

Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that could meet the Government’s requirements. There is no competition anticipated for this acquisition. An intent to sole source will be posted on Sam.gov and the justification will be made publicly available.

Actions to Increase Competition: 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.

Market Research: Searches were conducted on DSBS and Sam.gov with NAICS and keyword AGFA. Only one SDVOSB was listed as a result, Sustainment Technologies. A further search on GSA Advantage was conducted with keyword AGFA and no relevant results were displayed. Contact was made to LB OEM AGFA US Corp Service Contract Sales Rep Melissa Cooper. It was confirmed that only AGFA field engineers are authorized to perform service and maintenance due to the highly specialized and proprietary nature of the hardware and software, and a sole source letter was provided and on file.

Other Facts: AGFA, the manufacturer of the imaging equipment, is responsible for all system information security certifications, testing and on-going (IA) and security updates and patches.

Accordingly, only Agfa can maintain the critical security status of the imaging equipment on an on-going basis. Imaging equipment are FDA approved medical devices, and updates and patches must be thoroughly tested by the manufacturer prior to being applied to a medical system; therefore, only Agfa can do this.

Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Name Date Title Facility

11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable: All items are currently on AGFA US Corp’s IDIQ contract VA797H-17-D-0004 and have previously been determined fair and reasonable at time of award.

CONOR OLEJARZ

Digitally signed by CONOR

OLEJARZ

Date: 2025.12.04 12:35:52 -05'00'

Effective Date: 03/15/2023 Page 3 of 3

Acquisition ID#: 36C241-26-AP-0913

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

Manasés Cabrera Date Contracting Officer

MANASES CABRERA Digitally signed by MANASES CABRERA Date: 2025.12.04 11:17:53 -05'00'

Agfa US Corporation 611 River Drive, Center 3 Elmwood Park, NJ 07407

December 2, 2025

VAMC Worchester 403 Belmont Street Worchester, MA 01604

RE: Sole Source Letter, AGFA DR 400 System

To Whom It May Concern, Agfa US Corp is the only vendor who is able to perform maintenance services on Agfa US Corp’s Imaging equipment in the DoD and VA environments and ensure the installed systems' performance in accordance with the terms and conditions of the contract the equipment was initially purchased under.

The proprietary software used in Agfa's imaging equipment requires licenses; therefore, only Agfa can provide licenses for the software updates that are covered under a warranty. Updates and upgrades to system software can only be provided by Agfa as these are FDA regulated medical devices. These updates / upgrades are essential to maintain the imaging equipment.

Per contract requirements, all imaging equipment must meet VA and DoD Cybersecurity requirements and individual Military Service Information Assurance (IA) requirements. Vendors are also required to continuously update system software and services in response to nation assurance security threats and alerts. Agfa the manufacturer of the imaging equipment is responsible for all system information security certifications, testing and on-going (IA) and security updates and patches. Accordingly, only Agfa can maintain the critical security status of the imaging equipment on an on- going basis. Imaging equipment are FDA approved medical devices, and updates and patches must be thoroughly tested by the manufacturer prior to being applied to a medical system;

therefore, only Agfa can do this.

Please let me know if you need any further information regarding this matter.

Sincerely, Charles Clawson Charles Clawson Government Contract Specialist, AGFA US Corp