SPYGLASS DISCOVER PACKAGE BRAND NAME ONLY

Form / Attachment / Pricing Sheet

This document is the "Buy American Certificate" provision (FAR 52.225-2, Oct 2022). It requires offerors to certify the origin of end products and their components, specifically addressing domestic content and the use of critical components.

• Certification of End Products: Offerors must certify that each end product is a domestic end product, unless listed otherwise.
• Foreign End Products: Offerors must list any foreign end products, indicating their country of origin. For foreign end products not made of iron or steel, offerors must also specify if they exceed 55% domestic content (unless they are COTS items) or if the domestic content percentage is unknown.
• Domestic End Products with Critical Components: Offerors must separately list domestic end products that contain a critical component.
• Definitions: Key terms such as "commercially available off-the-shelf (COTS) item," "critical component," "domestic end product," "end product," and "foreign end product" are defined in the "Buy American-Supplies" clause.

This certificate is crucial for bidders to complete accurately. It directly impacts the evaluation of offers under the Buy American Act policies and procedures outlined in FAR Part 25. Failure to complete this certification correctly may affect proposal evaluation and compliance.

Form / Attachment / Pricing Sheet

This document is a Justification for Single Source Awards, prepared in accordance with FAR 13.106-1 for purchases over the Micro-Purchase Threshold but not exceeding the SAT. It outlines the rationale for a single-source award for the Spyglass Discover Endoscopic System.

• Contracting Activity: Department of Veterans Affairs, VISN 23, Iowa City VA Medical Center.
• Supplies/Services: Spyglass Discover Endoscopic System.
• Reason for Single Source: The Spyglass Endoscope System is described as the only FDA-cleared, single-operator cholangio-pancreatoscopy platform providing high-resolution, direct visualization of the biliary and pancreatic ducts with dedicated therapeutic accessories. No other manufacturer offers a functionally equivalent system. Additionally, providers are currently trained on this specific system.
• Market Research: Searches on GSA eLibrary and NAC for "Spyglass endescope" yielded no results. Searches for "like" items identified Boston Scientific and Veterans Healthcare Supply Solutions. A search for small businesses (VOSB and SDVOSB) under NAICS Code 339112 was conducted. The "rule of 2" was not met during market research.
• Contracting Officer's Certification: The purchase is approved in accordance with FAR 13.106-1(b), certifying the justification's accuracy.

This document indicates a potential single-source award for a specific medical device. Bidders offering alternative or competing systems may find this justification relevant for understanding the government's rationale and potentially challenging the single-source determination if they believe their product meets the stated unique requirements.

Solicitation / RFP / RFQ

This is a Request for Quotation (RFQ) for a "Spyglass Discover Package" for the Department of Veterans Affairs, Iowa City VA Medical Center. The acquisition is being conducted as "Brand Name Only" and is "Full and Open" (unrestricted). The government intends to award a single, Firm Fixed Price contract.

The core requirement is for a "Spyglass Discover Package" which includes:

• 1 each Discover Digital Controller
• 1 each Autolith Touch EHL Generator
• 18 each Discover T/A Catheter

Detailed functional and performance specifications are provided for the Digital Controller and Autolith EHL Generator, focusing on capabilities for diagnostic and therapeutic applications, high-resolution imaging, irrigation, and stone fragmentation.

• Contract Type: Firm Fixed Price

• Period of Performance: Delivery is FOB Destination, 60 days ARO or before.

• Award Anticipated: 02/25/2026

• Questions Due: February 17, 2026, by 10:00 AM CST.

• Offers Due: February 20, 2026, by 10:00 AM CST.

• Submission Method: All questions and offers must be emailed to Becky.delossantos@va.gov. The subject line for emails must include "RFQ 36C26326Q0359".

• Offerors are recommended to use and submit the SF 1449 form. Partial offers are not accepted.

• Evaluation: The government intends to evaluate all line items on a group basis and make a single award. The evaluation will consider Technical Acceptability (including a signed Buy American Certificate) and Price. Past performance will also be considered.

• This acquisition is unrestricted (Full and Open).

• Offerors are required to be registered in SAM.gov.

• A "Buy American Certificate" must be completed and signed.

• The solicitation is issued under FAR 12 Commercial & FAR 13 Simplified Acquisition Procedures.

• Offerors must agree to the terms and conditions or explain any disagreements.

• Invoices must be submitted electronically within 30 days of receipt and acceptance.