436 0 SOW Statement Of Work Stereotactic Navigation- Updated 2.22.24.docx

STATEMENT OF WORK (SOW)

1.1 SCOPE

The Department of Veterans Affairs (VA) Fort Harrison Montana in VSIN 19 is expanding services to include ENT surgery. The station requires a Stereotactic Navigation system that provides the ENT surgeon three dimensional imagine guided endoscopic approach to sinus surgery. This allows for maximum safety while navigating between sinus cavities and the cranial vault. The vendor will:

a. Navigation System’s features help provide real-time visual confirmation from beginning to end:

· Planning points help identify drainage pathways, challenging anatomy and structural anomalies. Planning points also function as beacons, which alert the user when a navigated surgical device approaches the point.

· The user must be able to place an unlimited number of virtual cameras in areas of interest. A virtual camera provides a True View of the area, allowing the user to see beyond the endoscope.

· System must have fast-anatomical real-time imaging tool that documents surgical changes to the anatomy.

· Must allow automatic merging between the CT scan and an MR scan. The surgeon can control the blending level between both scans, while simultaneously navigating on both scans using the navigated tools.

· Must be capable of connecting to the facility’s PACS server and easily load scans directly from the network.

· Must have artificial intelligence to apply automatic segmentation to pre-defined anatomical structures.

· Must be able to calculate and present the shortest, valid path between 2 points specified by the physician. A valid path is defined as a path that doesn’t cross bone and finds the optimal route in air (if available) or in tissue other than bone tissue.

1.2 LABOR AND MATERIAL REQUIREMENTS

a. Vendor Service:

· Provide surgical team at least 1 in-service onsite on operation, cleaning, and basic maintenance with surgeon present.

· Provide additional education as needed for software updates and changing practices.

· Provide annual competencies as requested by the facility.

· Provide physician support in surgical cases for the first two weeks of operation.

· Fort Harrison is requesting firm fixed price contract for one (1) ENT Navigation system, accessories, associated software, manufacturer’s warranty and maintenance for a base year plus three additional option years.

1.3 PRIVACY STATEMENT

a. Information Security: The C&A requirements do not apply, a Security Accreditation Package is not required. Incidental exposure to protected health information may occur from accessing the work site. Staff will follow all Privacy & Security policies and procedures.

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