S20 Intent to Sole Source - Alcon UNITY Cataract System 1-9-26.pdf

INTENT TO SOLE SOURCE

THIS IS NOT A SOLICITATION OR REQUEST FOR OFFERS. NO SOLICITATION PACKAGE IS

AVAILABLE AND TELEPHONE REQUESTS WILL NOT BE HONORED AND NO SOLICITATION WILL

BE POSTED TO CONTRACT OPPORTUNITIES.

PROCUREMENT TITLE: Alcon UNITY® Vitreoretinal Cataract System

INTENT TO AWARD: The Department of Veterans Affairs, VAMC 163 Veterans Drive, White River Junction VT 05009, intends to award one (1) to O. R. ELDER INC., for the Alcon UNITY® Vitreoretinal Cataract System, for use during phacoemulsification cataract surgery.

BACKGROUND AND DESCRIPTION: The Alcon UNITY® Vitreoretinal Cataract System is designed to enable precision control, safety, and efficiency for doctors during phacoemulsification cataract surgery.

The system includes VCS Console, Remote, Laser, Large Tray, VCS 6 button footswitch, CS 4 button footswitch, Laser footswitch, BSS Rack, 2 UNITY 4D Phaco handpieces, Ozil Frag handpiece, installation, maintenance, and training (see enclosed SOW).

NAICS: 339112 – Surgical and Medical Instrument Manufacturing, Size Standard 1,000 Employee.

PSC: 6515 – Medical and Surgical Instruments, Equipment, and Supplies

AUTHORITY: The authority for this procurement will be via FAR Part 12 - Acquisition of Commercial Products and Commercial Services. A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

INTERESTED PARTIES: However, any Contractor who believes that they have experience and capability to provide equipment and perform installation on equipment described in the enclosed Statement of Work (SOW) may express interest by submitting a written capability statement or letter of interest to pearl.wray@va.gov by 14:00 EST, by 1/16/2026. Any questions related to this notice can be sent to pearl.wray@va.gov

STATEMENT OF WORK

UNITY® Vitreoretinal Cataract System

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 of ALCON UNITY. This document highlights the technical specifications and services requested by the White River Junction VAMC for consideration regarding the purchase of the systems. Vendors under this proposal shall provide all equipment, accessories, applicable training, and manuals.

mailto:pearl.wray@va.gov

Project Management / Equipment Implementation

Product delivery will be the responsibility of the Vendors working with the White River Junction VAHCS project management POC, the Vendor will be responsible for coordinating and performing the delivery, implementation, and training for the devices.

Background/Justification/

The objective of this project is to enhance the quality of clinical care provided to our veterans by procuring the Alcon Unity system. The system provides a next-generation platform for phacoemulsification cataract surgery with improved efficiency and safety for Veterans. By incorporating Alcon Unity, we aim to improve the safety and outcomes of cataract surgery at the White River Junction VAHCS. This initiative will involve the procurement of Alcon Unity system, comprehensive training for medical and technical staff on operation and maintenance, and the seamless integration of this machine into our current surgical workflow. This addition reflects our ongoing commitment to equipping our healthcare facilities with cutting-edge technology to provide the best possible care for our veterans.

This enhancement aligns with our commitment to providing state-of-the-art care and improving patient outcomes for our Veterans.

Equipment Specifications

Equipment: All equipment must be new, state-of-the-art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements including vendor supported operating systems.

1. System Equipment

a. Set-up of System

b. Other

i. (1) User Manuals

ii. (1) Service Manuals

iii. (1) Cleaning instructions

2. Services

a. Training

b. Installation [See below]

Training Provided / Training Materials

1. Vendors will be required to provide 1 user manual.

2. Vendors will be required to provide 1 service manual.

3. Vendors will be required to provide an on-station in-service on the proper use and setup.

4. Vendors will be required to provide cleaning methods/guidelines for equipment.

5. All employees who will be utilizing the equipment, including Providers, Technicians, Healthcare

Technology Management (HTM) Engineering, and Clinic staff members ("Trainees"), must be trained by an authorized representative prior to using the System.

6. No charge on a mutually agreeable date and time.

Installation

1. Contractor’s Responsibilities:

a. Based on approved deployment work schedule, the Contractor shall provide all labor necessary to install, deploy and configure the requirements of WRJ VAHCS

b. The contractor shall receive and place equipment in the pre-arranged designated area at the WRJ VAHCS

c. 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.

d. The contractor shall perform all installation and configuration necessary to complete the work, plus perform technical service checks to ensure the product is fully operational in accordance with manufacture operating standards.

e. Vendors will coordinate all site visits with the HTM staff at least 24 hours in advance.

f. The vendor will provide at least a 1-year manufacturer warranty on the device from the date of installation.

2. Medical Center’s Responsibilities:

a. Providing access to patient care spaces, hallways, and equipment rooms during normal business hours for implementation of the general system installation requirements.

b. Providing a single point of contact to work with in planning and implementing the services described.

3. 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), Monday to Friday, excluding Federal Holidays o High risk clinical areas may require after-hour installation.

4. The Contractor is required to provide all tools, labor, and materials to complete assembly and installation of the items detailed in this document.

5. The Contractor shall have an on-site representative for the duration of assembly and installation to serve as the primary interface with the WRJ VAHCS staff.

Delivery Location

The contractor shall deliver all equipment to the:

White River Junction VA Medical Center 163 Veterans Dr.

White River Junction, VT 05009 ATTN: Operating Room and Molly Riche (Operating Room Nurse Manager)

Records Management

1. The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

2. 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.

3. 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.

4. 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.

5. The contractor shall not retain, use, sell, or disseminate copies of any deliverables that contain information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

6. The contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

7. The Government Agency owns the rights to all data/records produced as part of this contract.

8. 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. Contractors must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

9. The 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.].

10. 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.

11. 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.

12. The A&A (Assessment and Authorization) requirements do not apply, and a Security Accreditation

Package is not required.

End of SOW and Notice