6540--Simulation Eyesi Surgical Complete System

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT/RFI DESCRIPTION This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 33915 (size standard of 1,000 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. The Department of Veterans Affairs (VA) is seeking sources capable of providing Haag-Sterit Simulation Eyesi Surgical Complete System or equivalent Eye Surgical Complete System. STATEMENT OF WORK GENERAL: VA Phoenix Healthcare System Ophthalmology Department located at 650 E Indian School Rd, Phoenix, AZ 85012 is looking for Haag-Sterit Simulation Eyesi Surgical Complete System or equivalent Eye Surgical Complete System with following required salient characteristics. This will be used as a high fidelity surgical simulator which allows trainees in Ophthalmology to learn the essential steps of cataract and retina surgery The Eye Clinic is expanding its Ophthalmology Department and will be providing a new service to our Cataract Veteran population. SCOPE: VA Phoenix Healthcare System Ophthalmology is looking to establish a Firm Fixed-Price contract to purchase Haag-Sterit Simulation Eyesi Surgical Complete System or equivalent Eye Surgical Complete System. The contractor is required to provide brand name or equal equipment that meets or exceed the physical, functional, and performance of the listed salient characteristics in this section. PHYSICAL/SALIENT CHARACTERSITICS: Equivalent Eye Surgical Complete System must have the following physical salient characteristics and the contractor is required to provide proofs: The simulator must be a PC based. The simulator must provide all steps of cataract and retina surgery to competency. The simulator must use high resolution of OLEN screens in the microscope dynamic surgical scenarios in 3D. The simulator must have a patient head on a bed so the surgeon can hold surgical instruments to perform operations. The simulator must be allow surgeons to conduct a virtual reality surgical experience the cataract surgery. The simulator must provide training modules on Capsularhexis, Phaco chop, Hydro Dissection, Irrigation & Aspiration, ILM Peeling, Retinal Detachment, Epiretinal membrane, Endolaser, and Posterior Hyaloid at minimum. The simulator must provide real-world possibilities of complications or sub optimal results if technique is poor. Detailed training data must be exportable from the simulator so that the attending surgeons can objectively monitor and assess the skills level of individual trainees over time. The simulator must permit a one-on-one training environment. The simulator must have dedicated patient interface for cataract and retina surgery. The simulator must have quad camera optical tracking system in order to capture fine details. The simulator must have hand activated forceps for cataract and retina surgery. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide functional and performance capability as listed above section. WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. The government does not accept extended warranties, which require advance payment. PLACE OF PERFORMANCE: VA Phoenix Healthcare System 650 East Indian School Road, Phoenix, AZ 85012 PRIVACY AND CONFIDENTIALITY STATEMENT: In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment included in this contractor does not involve connection of IT devices to a VA network. Therefore, C&A, SAP, & the following from App C apply In reference to VHA Handbook 6500.6 Appendix A, Block 7, the equipment does not involve storing, generating, transmitting, or exchanging VA sensitive information. Therefore, the following from App C apply. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract. During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data; to provide services, install, train, maintain or repair equipment. VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training will be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on VA TMS website at: https://www.tms.va.gov/SecureAuth35/. Contractor will provide evidence of training to the Program Office, upon request. The list of Eye Surgical Complete System s characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required. If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses to this notice shall be submitted via email to contact@example.gov. Telephone responses will not be accepted. Responses must be received no later than Tuesday, July 23, 2024 by 10:00 AM Pacific Local Time. All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.