Anterior Segment OCT Platform_SOW_20240925.docx

Hunter Holmes VA Medical Center, Richmond Fredericksburg Health Care Center Initial Outfitting, Transition & Activation Project

General Conditions and Statement of Work Anterion Platform Camera and accessories for Anterior Segment Eye Evaluations

Introduction The Central VA Medical System has a requirement to purchase a new high-resolution swept-source OCT imaging platform for anterior segment examinations at the newly constructed Fredericksburg HCC. This VA will work with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. This requirement is in support of a brand name or equal requirement in accordance with the FAR. See attachments for salient characteristics. This requirement is in support of the activation of the new Fredericksburg Health Care Center. Item(s) are to be delivered to the location specified in section V.

Make/Model

QTY

Site Location Site Address The address for delivery is listed below. Additional information on delivery can be found in section IV.

Fredericksburg HCC 10432 Patriot Highway Fredericksburg, VA 22408

Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

Table 2 – Anticipated Building Outfitting Schedule

Schedule and Order Management The above delivery schedule is based upon the current construction schedule, which is subject to change. The vendor shall not increase prices for a change in delivery date for up to 90 days due to construction delays. The awardees actual delivery dates will be confirmed by VA upon award. Post-award the vendor will coordinate delivery prior to beginning any work (see section IV). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the VA POC and the vendor. Schedule changes that are beyond the dates specified in the contract will require approval by the Contracting Officer and a contract modification.

Delivery and Receiving Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided by the VA POC post-award. Delivery must be coordinated with Activation Project Management team POC- Zoe Moyer at zoe.moyer@va.gov prior to any attempts at delivery. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company.

☒ Fredericksburg Health Care Center Fredericksburg HCC 10432 Patriot Highway Fredericksburg, VA 22408

· Delivery shall be freight on board (FOB) – Destination.

On-Site Delivery:

· The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

· The delivery of items identified in this document shall take place during normal business hours which are defined as: 0800 to 1630 (i.e.: 8:00am to 4:30pm Central Time), Monday through Friday, and excluding Federal Holidays.

· Delivery trucks will not be permitted to remain at the loading dock. Trucks shall be unloaded by the vendor, moved from the dock, and then brought back to the dock if required to haul out any waste, tools, or excess materials.

· Labeling of delivered items shall include the awarded contract number and VA purchase order number for identification and reference upon receipt of product.

Clean Up and Disposal There are no dumpsters available for vendor use. The removal of waste and/or excess material shall be conducted through the loading dock area. Delivery trucks and/or other vendor vehicles will not be permitted to remain at the loading dock. Vehicles will need to be brought back to the dock if required to remove any waste, tools, or excess materials.

Deliverables The vendor shall provide CAD drawings (including shop drawings) and specifications for site prep for their product as required. AutoCad or Revit drawings are not a requirement of this SOW. The vendor shall provide a completed VA Form 6550 (newly updated as of 10/01/2023) with submittal documents for any and all item(s) that may connect to the VA network and medical devices that store sensitive patient information. The C&A requirements do not apply, and a Security Accreditation Package is not required.

Assembly and Installation [ ☒ is ☐ is not required] The vendor is required to manage and coordinate installation at the Fredericksburg HCC with the COR or his representative IOT&A POC directly. Do not reach out to schedule installation with any clinical end-users.

On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 8:00 AM to 4:30 PM EST, Monday through Friday, and excluding Federal Holidays.

Proposed installation date will occur after delivery of equipment. See current delivery schedule above.

The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

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

The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur because of the vendor’s (or associated sub-contractors) installation.

During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and the IOT&A team, IRIS Solutions and the Richmond VAMC POC. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

Training [ ☒ is ☐ is not required] The vendor is required to provide live clinical training on set up, operation, shut down, and troubleshooting procedures to facility staff.

The vendor shall coordinate training dates with the on-site Project Manager. Post-award, these dates will be confirmed with the vendor to meet the clinical schedule. Proposed training date will occur after installation of equipment.

Current timeframe of training is November 2024.

The vendor shall provide documentation and/or certification to each staff member that has successfully completed the training.

Security and Confidentiality VA Network Connection: ☒ is ☐ is not required

· If checked above, this equipment does connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, block 6, the C&A requirements do apply to this requirement, and a Security Accreditation Package is required.

· This equipment does hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist block 7, Appendix B and C provisions apply.

· Appendix B: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

· Appendix C: VA will own this equipment. If vendor needs access during delivery, assembly, install or repair, the contractor shall be escorted by a VA employee to ensure there is no exposure to VA sensitive information. If the contractor is required to be on site for more than two consecutive days, VHA Privacy Training, TMS Course , is required and available at the linked website (Click Here). The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.

Standard Warranty

· The products shall be covered by vendor’s standard warranty terms and provisions. Vendors to provide their standard warranty information in their quotes. It should be noted however that the warranty coverage shall be no less than 1 YEAR.

· The vendor shall extend such warranty directly to the customer as if such customer had purchased the Products directly from the vendor;

Use of Premises

· If during the performance of this contract, work will be carried out at the Fredericksburg HCC premises, the vendor shall perform all work in such a manner that will cause a minimum interference with facility operations and the operations of other contractors on the premises.

· The vendor shall communicate through the IOT&A POC and VA POC any required coordination requirements with the General Construction contractor prior to and during delivery and installation activities.

· The project may be an active construction site during delivery and installation. The vendor shall take all necessary precautions to protect the premises and all persons and property therein from damage or injury. The vendor shall assume responsibility for taking precautions for the vendor's (and associated subcontractors’) employees, agents, licensees, and permittees. The vendor shall abide by any safety requirements imposed by the GC (e.g. hard hats, safety vests).

· The vendors shall abide by all rules and regulations set forth by the Richmond VAMC, Fredericksburg HCC and/or state and federal governments due to the Coronavirus (COVID-19) and have their own personal protective equipment (PPE) in use for the time they are on the campus grounds, if required.

SALIENT CHARACTERISTICS:

CLIN 1: Anterior Segment OCT Imaging Platform

Total Quantity: 1 X Network Required if Checked X Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked X End User Training Required if Checked

Basis of Design: Anterion Multimodel OCT Imaging Platform

Salient Characteristics:

· OCT imager that performs high-resolution anterior segment examinations and measurement in one unit

· Exams to include biometry/axial length, cornea exams, anterior segment imaging, and analyzes all data.

· Images and system use the Software Heyex 2 and provided workstation to transmit information to HER.

· Laser wavelength range 1200-1400 nm

· OCT Imaging parameters: A-scan rate at 50,000 Hz, Resolution (in tissue) <10 μm axially x 30 μm laterally

· Upgradeable package to include table top unit, mobile table, isolation transformer and PC

· Dimensions/Camera: 472mmH x 317mmW x 496mmD

· Power: 100-240V, 50/60 Hz, 120 VA

CLIN 2: Cornea application software

Total Quantity: 1 X Network Required if Checked X Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked X End User Training Required if Checked

Basis of Design: ANTERION Cornea App #88091

Salient Characteristics:

· Software for CLIN 1 performance.

· Software must provide a comprehensive diagnostic solution to assess a patient’s individual corneal geometry.

· Is used to diagnose or monitor corneal alterations and enhance the planning and evaluation of refractive surgery.

· Provide a combination of high-resolution OCT images and corneal measurements for a thorough assessment, including curvature and elevation maps of the anterior and posterior corneal surfaces.

CLIN 3: Cataract application software

Total Quantity: 1 X Network Required if Checked X Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked X End User Training Required if Checked

Basis of Design: ANTERION Cataract App #88092

Salient Characteristics:

· Software for CLIN 1 performance.

· Software must be included that combines key measurements for cataract surgery planning: corneal analysis, anterior chamber depth, lens thickness, and axial length.

· The swept-source OCT technology must allow for accurate measurements and visual confirmation with high-resolution images even through dense cataracts.

CLIN 4: Software for metrics application

Total Quantity: 1 X Network Required if Checked X Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked X End User Training Required if Checked

Basis of Design: ANTERION Metrics App #88093

Salient Characteristics:

· Software for CLIN 1 performance.

· Software that features exceptionally clear swept-source OCT images with the anterior chamber displayed in a radial view.

image1.jpg