Description
Veterans Health Affairs, Network Contracting Office 1, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide Warranty, Interface License, and Enterprise Design for the recently purchased Carl Zeiss Clarus 700 as described below and will not interrupt the continuum of care. ALL RESPONSES TO THIS INTENT TO SOLE SOURCE ARE DUE 9/8/2021 2:00 PM EST Statement of Work (SOW) Performance Work Statement Introduction The VA Maine HCS has purchase three Clarus 700 from Zeiss for the Eye clinic. The service that is required for this procurement is the 1-Year Warranty, forum-Dicom Interface License and the Enterprise Architecture Design for each the 3 purchased units. Background -Units have already been delivered Ultra-widefield cameras of the CLARUS 700 from ZEISS allows for better visualization of the peripheral retina, aiding in monitoring any changes in areas that we were not previously able to photograph. Widefield fluorescein angiography allows for better evaluation of the entire posterior pole and identifies vascular changes in the many diabetic veterans we manage. This new camera will allow for efficient diagnosis of potentially blinding or life-threatening conditions that may have been missed with a narrower field camera. High quality fundus autofluorescence with allow for earlier detection of possible macular toxicity in veterans on hydroxychloroquine a standard of care test for these veterans. The camera is highly compatible with FORUM software already used in the clinic. The Clarus 700 is an ultra-widefield retinal camera Fundus Photography/ Retinal Imaging Unit that allows clinicians to use color to their diagnostic advantage. Color fundus imaging can aid in the diagnosis and documentation of ocular disease, pathology, ensuring confidence when evaluating the retina, optic disc, nevi and lesions where color is important and Fluorescein Angiography Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor s performance responsibilities). This project will provide three State of the Art Clarus 700 from Zeiss for the Eye Clinic department. The Clarus 700 is an ultra-widefield retinal camera Fundus Photography/ Retinal Imaging Unit that allows clinicians to use color to their diagnostic advantage. Color fundus imaging can aid in the diagnosis and documentation of ocular disease, pathology, ensuring confidence when evaluating the retina, optic disc, nevi and lesions where color is important and Fluorescein Angiography. This is the standard of care outside the VA and with essential features as. Ultra-wide field of view True Color imaging from broad spectrum LED scans Exceptional resolution Fluorescein Angiography (FA) Advanced imaging features 3D Stereo Model for Optical Nerve Head Analysis. External eye image (ocular surface), External Photos Non-Myd 2.5 mm (ability to capture images on patients with a pupil measurement down to 2.5mm) 27 Megapixel Camera 7-micron resolution Compensation for ametropia - 24 D to + 20 D continuous Automatic Operations Auto-focus Auto-gain, Auto-Montage, Auto-laterality Acquisition Speed Live IR Preview, 10 frames/second Image Capture, 0.2 seconds True Clinical Color with RGB separation and images in the following below including Green Autofluorescence, as well as Blue Autofluorescence-Blue Ultra widefield capturing the following degrees 133° with one capture shot 200° (2 capture shots) images, 267° montage images Broad Line Fundus Imaging (BLFI), Capturing the image with a broad rectangle of light sweeps across retina and detected using monochromatic camera. True Color Images generated through sequential illumination by broad-spectrum RGB LEDs (light-emitting diodes). Broad spectrum LEDs gives true, natural-looking fundus as seen via direct observation. The CLARUS 700 from ZEISS shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing diagnostic information. This includes all log files, error traps, screen capture images and database query results used to aid Technical and Installation in their troubleshooting activities. Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions). The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system. Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks). The VA Maine HCS has purchase three Clarus 700 from Zeiss for the Eye clinic. The service that is required for this procurement is the 1-Year Warranty, forum-Dicom Interface License and the Enterprise Architecture Design for each the 3 purchased units. Deliverables (List all data required to manage or monitor contractor performance). The VA Maine HCS has purchase three Clarus 700 from Zeiss for the Eye clinic. The service that is required for this procurement is the 1-Year Warranty, forum-Dicom Interface License and the Enterprise Architecture Design for each the 3 purchased units.