SAM #36C24826Q0912

Sole Source Intent: Medtronic Situate Detection System for VA VISN 8 Medical Centers

This opportunity is for the Department of Veterans Affairs VISN 8 medical centers to acquire, install, and maintain the Medtronic Situate Detection System X for surgical safety. - Sole source contract intended for Covidien Sales LLC (Medtronic) as the OEM - Products include: - Situate Console X - Body Scanner Lite - Room Scanner X - Complete Care Service Plan - Services required: - Installation and user training for clinical and technical staff - Onsite clinical support during initial use - Preventive maintenance, technical support, and warranty services - System must provide integrated RF scanning for retained surgical item detection, workflow guidance, scan verification, and documentation - Contract features a 12-month base period with four 12-month option periods for ongoing service plan coverage - Other vendors may submit capability statements if they can meet all technical, regulatory, and maintenance requirements - Estimated contract value likely in the low to mid six figures, depending on scope and number of medical centers served - Medtronic is the only identified OEM, but competitors with similar FDA-cleared surgical safety systems may be considered if they meet all requirements

Description

Notice of Intent to Award as Sole Source: The Department of Veterans Affairs, NCO 8, intends to award a Sole Source, Firm-Fixed Price contract to Covidien Sales LLC for the for the acquisition, installation, training, and annual maintenance of the Medtronic Situate Detection System X, including the Situate Console X, Body Scanner Lite, Room Scanner X, and Complete Care Service Plan for VISN 8 medical centers. The anticipated contract shall consist of one (1) twelve-month base period with four (4) twelve-month option periods for continued Complete Care Service Plan coverage. The Government requires an integrated retained surgical item detection system capable of: automated non-handheld under-patient RF scanning; handheld environmental RF scanning; workflow guidance supporting standardized clinical use; scan verification; documentation supporting the patient's medical record; and manufacturer-supported maintenance, software support, and/or technical assistance.

The Government conducted market research to identify commercially available retained surgical item prevention technologies capable of satisfying its minimum operational requirements. The Government recognizes that multiple manufacturers offer retained surgical item prevention products. However, no other commercially available system was identified that simultaneously satisfies all of the Government's minimum operational requirements without requiring revision of those requirements. Accordingly, the Government intends to negotiate with Covidien Sales LLC as the only responsible source identified during market research capable of meeting the Government's minimum needs. Any responsible source believing it can satisfy the Government's minimum requirements is encouraged to submit a capability statement. Capability statements shall clearly demonstrate, with supporting technical documentation, how the proposed system satisfies each minimum requirement identified in the Statement of Need. Capability statements will be evaluated solely to determine whether competition is appropriate for this acquisition General marketing literature or unsupported assertions of equivalency will not be considered sufficient. Capability statements should include: detailed technical specifications; FDA clearance or authorization, if applicable; description of patient-scanning methodology; description of environmental scanning capability; workflow guidance and scan verification functionality; installation and training approach; preventive maintenance and software support capabilities; warranty information; and evidence of compliance with applicable trade requirements, if required by the solicitation

This announcement is being issued for information purposes only and does not constitute a a Request for Quotations (RFQ) or Request for Proposals (RFP). Responsible sources that oppose this decision may identify their interest by submitting their capability information meeting the salient characteristics and/or an OEM Authorization Letter to provide both the Situate Console X Body Scanner Lite system and the Complete Care Service Plan The Government will not be responsible for any costs associated with the preparation of responses to this notification. Telephone inquiries will not be accepted. All inquiries and submittals must be sent via email to Todd Pappas, Contracting Officer, at todd.pappas@va.gov. by 12PM EST, on Friday July 24, 2026.

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