6540--Intent to Sole Source Ophthalmology Microscope Opmi Lumera System

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by FAR 6.302-1(a)(2) and 6.301-1(c), only one responsible source and no other supplies or services will satisfy agency requirements and brand-name descriptions.

The Department of Veterans Affairs Medical Center located at 215 North Main Street, White River Junction, VT 05009-0001, has a requirement for a Carl Zeiss Lumera 700 Microscope System with OCT.

The Government intends to award a firm-fixed-price sole source contract.

A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. this notice of intent is not a request for competitive proposals. This is a written notice to inform the public of the Governments intent to award on a sole source basis.

Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government.

Please contact Manases Cabrera, Contracting Specialist, with the responses or questions regarding this requirement at manases.cabrera@va.gov.

This notice will close on March 28, 2025, at 4:30 PM Eastern Standard Time (EST)

STATEMENT OF WORK (SOW)

1. Objective

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the awarded Contractor 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 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 vendors will be responsible for coordinating and performing the devices' delivery, implementation, and training.

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 ophthalmologist's (eye surgeon's) ability 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 visualize the structures of the eye better. This supports the ophthalmology clinic's 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.