6540--Carl Zeiss Lumera 700 Microscope System with OCT

THIS IS A SOURCES SOUGHT NOTICE ONLY: This announcement seeks information from the industry, which will be used for preliminary planning purposes for procurement. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS. THIS IS STRICTLY MARKET RESEARCH. Carl Zeiss Lumera 700 Microscope System with OCT The purpose of this synopsis is to gain knowledge of interest, capabilities, and qualifications of various members of industry, who have the capability to provide Carl Zeiss Lumera 700 Microscope System with OCT. All interested firms must be registered in SAM (System for Award Management) to be eligible for the award of Government contracts. Interested parties responding to this Sources Sought request shall submit the following information at a minimum: (1) Company name and address point of contact with phone number and SAM UEI. (2) Documentation relating to performance capability, current point of contact, and phone number). (3) Socio-economic status to identify the business class as a large business, SDVOSB, VOSB, small business, Woman Owned, etc. (4) Place of manufacture (5) Any other pertinent company documentation prior to submission of offers to a solicitation. Any SD/VOSB firms responding to this Sources Sought Notice must also provide proof of registration in the SBA Vet Cert prior to submitting offers to a solicitation. This market research is for informational and planning purposes. This is not a solicitation and does not obligate the Government to issue a solicitation. Please be advised that the government will not pay any costs for responses and information submitted. All submissions are acceptable via contact@example.gov RESULTS INFORMATION: Respondents will not be notified of the results, and it is at the discretion of the Government to utilize results. Firms responding to this Sources Sought announcement, who fail to meet all requirements as stated above, and who fail to provide ALL the required information requested, will not be used to help the Government make the acquisition decision, which is the intent of this sources sought announcement. STATEMENT OF WORK (SOW) February 2025 1. Objective The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded Contractor in relation to the provision, installation, integration, and implementation of the Carl Zeiss Lumera 700 Microscope System with OCT. This document highlights the technical specifications and services being requested by the White River Junction VAMC for consideration towards the purchase. Vendors under this proposal shall provide all equipment, accessories, applicable training, and manuals. Product delivery will be the responsibility of the Vendors working with the White River Junction VAMC project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices. 2. Background Cataract surgery removes the cloudy lens (cataract) from the eye and replaces it with a clear new artificial lens (intraocular lens). Ophthalmic surgery allows Veterans to improve their vision and quality of life. Patient safety and outcomes during surgery depend upon the ability of the ophthalmologist (eye surgeon) to visualize the structures of the eye. The enhanced visualization and intraoperative guidance provided by this Zeiss microscope will improve the safety and quality of ophthalmic surgery at the White River Junction VA by allowing eye surgeons to better visualize the structures of the eye. This supports the ophthalmology clinic mission to prevent blindness and promote eye health in rural New England. The ability to utilize intraoperative OCT in cases of poor visualization and align astigmatism correcting intraocular lenses (toric IOLs) with intraoperative guidance supports the VA Core Value of Excellence. These technologies allow the surgeon to prevent complications by utilizing OCT to image structures in complex cases and improve patient outcomes by aligning toric IOLs more accurately. The Contractor is responsible for the set-up of the equipment. VA Staff in Clinical Engineering is responsible for connecting any approved equipment to the VA network. 3. Scope Buy the Carl Zeiss Lumera 700 Microscope System with OCT. This solution shall, must, and will be approved for use on the VA network. 4. Specific Tasks Equipment: All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements for allowable operating system platforms. System Equipment Set-up monitors or modules [If applicable] Software for Integration and Connectivity to Network (if applicable and desired) Other (2) User Manuals (2) Service Manuals (2) Reprocessing Manuals [If applicable] Information on disposable procurement Services Training Installation Task 1 Provide Software and Licensing 5.1.1 Subtask 1 Software and Licensing Provide all software and licensing for Carl Zeiss Lumera 700 Microscope System with OCT Task 2 Provide Hardware 5.2.1 Subtask 1 Provide Hardware Task 3 Provide Installation Subtask 1 Provide Installation Delivery of equipment to POC space on desired day and time of VA preference Provide installation of microscope and hardware Provide loading and configuration of all software Conduct performance verification testing Task 4 Provide Onsite Training Subtask 1 Provide onsite go-live support and training Provide onsite go-live support Provide onsite technical training Provide all service passwords for all system components Provide Operators and Service Manuals Task 5 Provide Warranty Subtask 1 Warranty Provide at least one year of product warranty for hardware/software Task 7 General Information 5.7.1 Subtask 1 Hours of Operation Normal hours of operation are Monday through Friday from 7:00 am to 4:30 pm Central Standard Time, excluding national holidays. All onsite service/repairs will be performed during normal hours. Task 8 General Information 5.8.1 Subtask 2 Costs Any charges for travel, lodging, services, manuals, tools, software, or licenses are included within this contract, and it s agreed upon price, unless specifically stated in writing to the Contracting Officer. 5.8.2 Subtask 3 Protocol the Contractor shall physically sign into (and out of) the facility and obtain a visitor s badge upon every visit. Contractor shall physically check in and out with the COR or designee while on campus. 6. Training Vendor will be required to provide two user manuals for the Carl Zeiss Lumera 700 Microscope System with OCT. Vendor will be required to provide an on-station in-service on the proper use and setup of the Carl Zeiss Lumera 700 Microscope System with OCT. Vendor will be required to provide the cleaning methods/guidelines for Carl Zeiss Lumera 700 Microscope System with OCT and other accessories. All employees who will be utilizing Carl Zeiss Lumera 700 Microscope System with OCT, including Physicians/Surgeons, Technicians, Bio/Clinical Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative by Carl Zeiss prior to using the System. No charge on a mutually agreeable date and time. 7. Installation Contractor s Responsibilities: Based on approved deployment work schedule, the Contractor shall provide all labor necessary to install, deploy and configure the requirements of WRJ VAMC Contractor shall receive and place equipment in the pre-arranged designated areas at the WRJ VAMC The Contractor shall unpack and install all equipment in the designated area and dispose of all trash. Disposing of the trash is the responsibility of the Contractor. Contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure product is fully operational in accordance with manufacture operating standards Vendor will coordinate all site visits with the Biomed staff at least 24 hours in advance. The vendor will provide at-least a 1-year manufacturer warranty on the device from the date of installation. Medical Center s Responsibilities: Providing access to patient care spaces, hallways, and equipment rooms during normal business hours for implementation of the general system installation requirements. Providing a single point of contact to work with in planning and implementing the services described. Assign additional clinical staff during the transitions Responsible for any structural changes (cabinets, desks, etc.). On-site assembly and installation of items and performance of services identified in this document will take place during hours defined as: 0730 to 1500 (i.e.: 7:30 am to 3:00 pm ET), Saturday or Sunday, excluding Federal Holidays High risk clinical areas may require after hours install. The Contractor is required to provide all tools, labor, and materials to complete assembly and installation of the items detailed in this document. The Contractor shall have an on-site representative for the duration of assembly and installation to serve as the primary interface with the WRJ VAMC staff. The WRJ VA will provide a staging area for the equipment to be staged before deployed 8. Performance Monitoring The COR shall monitor the performance of this contract. This shall be accomplished by monitoring the component upgrade as well as final performance verification. 9. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) None 10. Other Pertinent Information or Special Considerations Packaging, Packing and Shipping Instructions Shipping costs shall be included in the terms of this contract. Shipping address: The System will be delivered directly to the White River Junction VA Medical Center. Primary POC will be shipping POC. 11. Place of Performance White River Junction VAMC 215 N Main Street White River Junction VT 05009-0001 12. Delivery Schedule The Contractor shall have 120 days to perform all tasks and resolve all issues. Longer if agreed upon by COR. 13. Period of Performance The Contractor shall have 120 days to perform all tasks and resolve all issues. Longer if agreed upon by COR. 14. Additional Requirement: The device we require must meet the following requirements upon delivery: Product will be delivered during normal working hours, between 7:30am and 4:30pm Monday through Friday. Documentation which includes a statement acknowledging the invoice and receipt of delivery. Carl Zeiss will provide labor to install product and test it to ensure functionality before Pharmacy Service will accept delivery. Carl Zeiss will continue to provide service and support on this product as required in contract. 15. Records Management The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.