Justification and Approval 36C10X26D0011_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

Sole Source Justification under Simplified Procedures Part 12

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Sole Source Justification for Other Than Full and Open Competition."

This Sole source Justification for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC), on behalf of Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Equipment Life Cycle Management (ELCM) Program.

(2) Nature and/or description of the action being approved.

The VA intends to negotiate a non-competitive, sole-source award to Veterans Healthcare Supply Solutions (VHSS) (UEI: TLTXKMLQEYU9), a certified Service- Disabled Veteran-Owned Small Business (SDVOSB), for the procurement of commercially available EXALT™ Model D Duodenoscope Image Controllers, manufactured by Boston Scientific. This acquisition will be issued as a VA-wide, single-award requirements contract in accordance with FAR 12.102(b). VHSS is the only authorized distributor of these products, making them the sole source capable of meeting the Government’s needs.

The proposed action will result in the award of a new, firm-fixed-price requirements contract to ensure continuity of care and timely delivery of critical medical equipment for Veterans.

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The EXALT Model D Duodenoscope Image Controller is essential for operating Model D single use duodenoscopes during endoscopic procedures, such as diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography. The Image Controller serves as the processing and control unit that:

Converts signals from the duodenoscope into live, viewable images for clinicians.

Controls illumination at the scope tip for proper visualization.

Interfaces with external image capture systems for documentation.

Without this controller, the Government-owned duodenoscopes cannot function, making it a mission-critical component for continued clinical operations and patient care.

The total estimated value of this procurement, inclusive of one 12-month base period, plus four 12-month option periods, is

(4) An identification of the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. 1901 –Simplified Acquisition Procedures.

(5) A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The EXALT Model D Duodenoscope Image Controller is a proprietary device manufactured exclusively by Boston Scientific and is technically required for operation of the EXALT Model D single use duodenoscopes currently available under VA contract 36C24123A0008. The controller and scope function as an integrated system, utilizing proprietary hardware connections, firmware, image processing algorithms, and light-source control protocols that are not disclosed or licensed for third-party use.

No other manufacturer produces a controller that is compatible, interoperable, or configurable with the EXALT Model D duodenoscope. Third-party video processors cannot recognize, power, illuminate, or process video signals from the EXALT Model D scope due to closed system architecture and proprietary signal pathways. As a result, substitution of another controller is technically infeasible and would render the scopes inoperable.

The Government maintains an existing inventory of EXALT Model D single-use duodenoscopes that cannot be utilized without the EXALT Image Controller, making the controller a mission-critical component for continued clinical operations. Replacement of the controller with a non-compatible system would require full replacement of the existing scope inventory, resulting in significant additional cost, workflow disruption, retraining requirements, and procedural delays, none of which represent a reasonable alternative.

The EXALT Image Controller provides unique and essential functionality, including:

Proprietary real-time video processing optimized for the EXALT Model D imaging sensor.

Integrated illumination control specifically calibrated to the scope’s distal LED system.

Native compatibility with existing endoscopy suite video capture and documentation systems.

Reliable performance during ERCP and related high-risk gastrointestinal procedures, where visualization quality and system reliability directly impact patient safety and clinical outcomes.

Because the controller is solely manufactured by Boston Scientific, is not interchangeable with any other product, and is required to operate Government-owned EXALT Model D duodenoscopes, only Boston Scientific possesses the unique qualifications and technical capability to meet the Government’s minimum requirements.

Accordingly, this acquisition meets the criteria for other than full and open competition under the cited authority, as no other product can satisfy the Government’s operational, technical, or clinical needs.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by FAR Part 5 and, if not, which exception under 5 applies.

Efforts were made to identify as many potential sources as practicable. A Request for Information (RFI) notice was posted by the Contracting Officer on SAM.gov under notice number 36C10G26Q0041 on January 14, 2026, with a closing date on January 29, 2026, the results of which will be discussed in Section 8, below. The purpose of this RFI was to determine if sources capable of satisfying the agency’s requirement for compatible Duodenoscope Image Controllers exist. The RFI remained open for 15 days to allow maximum opportunity for Service-Disabled Veteran-Owned Small Businesses (SDVOSBs), Veteran-Owned Small Businesses (VOSBs), and all other small business concerns to respond before a solicitation is released.

The proposed action will be synopsized on SAM.gov in accordance with FAR 5.101.

Any proposals received will be evaluated in accordance with the solicitation provisions.

The Government will continue to conduct market research to ascertain whether changes in the marketplace enable future competitive actions; however, all future requirements will be handled on a case-by-case basis.

Any proposals that are received shall receive consideration and will be evaluated in accordance with the solicitation provisions.

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions (if available), and other information as made available.

(8) A description of the market research conducted (see part 10), and the results or a statement of the reason market research was not conducted.

Pursuant to the information obtained from market research, the required devices are not readily available on existing purchasing vehicles, such as Government-Wide Acquisition Contract (GWAC), Internal Indefinite Delivery Indefinite Quantity (IDIQ) contract, Government-Wide Acquisition Contract (GSA) Federal Supply Schedule (FSS), etc.

In accordance with VAAR 810.001-70, the Small Business Administration (SBA) Certification Database was queried. A search was conducted utilizing North American Industry Classification System (NAICS) 339112, which resulted in 15 potential sources.

In order to obtain a better picture of industry capabilities, the contracting officer published Sources Sought Number 36C10G26Q0041 on January 14, 2026, with a closing date of January 29, 2026. The sources sought closed without any responses.

On February 6, 2026, the Contracting Officer contacted the manufacturer, Boston Scientific, requesting information as to whether it would respond to a solicitation for this requirement and whether there are any authorized distributors of this product.

Boston Scientific responded, stating that it would not respond to a solicitation and that Veterans Healthcare Supply Solutions (VHSS) is their sole authorized distributor for this equipment. VHSS then responded declaring its interest in this requirement and providing its authorized distributor letter.

Based on the foregoing, the Contracting Officer has determined it’s in the best interest of the Government to negotiate a non-competitive sole source requirements contract with VHSS, in accordance with FAR Part 12.102(b).

(9) Any other facts supporting the use of other than full and open competition.

Boston Scientific is the original equipment manufacturer (OEM) and has confirmed that Veterans Healthcare Supply Solutions (VHSS) is its sole authorized nationwide distributor for the EXALT™ Image Controller. No other entities hold distribution rights, leaving VHSS as the only source capable of meeting the Government’s requirements.

To maintain continuity of patient care and prevent disruption of critical endoscopic procedures, the VA intends to negotiate and award a single-award, firm-fixed-price contract to VHSS in accordance with the procedures outlined in FAR Part 12.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Only VHSS has expressed interest in this acquisition in writing. VA is not aware of any other firm except VHSS (address: 2615 Port Industrial DR, Unit 405 Jacksonville, FL 32226-5601).

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition 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. All future requirements will be handled on a case-by-case basis to determine any future acquisition strategy

(12) Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

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.

Signature: ________________

Annette Holland, Deputy Program Manager Life Cycle Management Office of Supply Chain (19OSC)

(13) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer ’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief. Furthermore, I determine that the anticipated price to the Government for this action will result in fair and reasonable prices paid based on the rationale provided herein.

Signature: _________ _

Anthony Zibolski Contracting Officer Strategic Acquisition Center

Approval

Based on the foregoing justification, I hereby approve this acquisition on an “other than full and open competition” basis pursuant to the statutory authority cited in paragraph four above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition. As this action does not exceed $20M, the certification below required by FAR 6.104-2 serves as approval.

Signature: _______

Efrain J. Fernandez Director of Contracts Procuring Activity Advocate for Competition (SAC Frederick) Strategic Acquisition Center

FERNANDEZ