S02-ATTACHMENT 1- SOW 014 - M6050 - Retinal Imaging System Fluoroscein Indocyanine.docx

FY22Q1-014 l JSN: M6050 l Retinal Imaging System, Fluoroscein/Indocyanine

Phoenix VA Health Care System Initial Outfitting, Transition & Activation Statement of Work Retinal Imaging System, Fluoroscein/Indocyanine (JSN: M6050)

Phoenix VA Health Care System Phoenix VA Clinic – 32nd Street Project 400 North 32nd St.

Phoenix, AZ 85008 Introduction The Phoenix Veteran Affairs Health Care System has a requirement to purchase Retinal Imaging System, Fluoroscein/Indocyanine (JSN: M6050) with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See salient characteristics below. This is a Brand Name or Equal Requirement. This requirement is in support of the activation of Phoenix VA Clinic – 32nd Street Project. The new Outpatient Clinic has the need for Three (3) Retinal Imaging Systems to be used for tele-retinal examinations. These Fundus digital cameras will be used to provide state of the art eye examinations that are crucial for maintaining the health of the patient’s vision. This equipment will allow the doctor to examine the retina. Topcon is the basis of design.

Table 1 – Package Items Summary

(1ea) Stool OS-100 and OS-400 – Brand or Equal

Additional Item Requirements The vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA IT Operations Department.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

General Conditions Site Address The address of the Phoenix VA Clinic – 32nd Street is provided below.

400 North 32nd St.

Phoenix, AZ 85008

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

Delivery and Receiving

2.4.1 Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award.

☒ Phoenix VA Clinic – 32nd Street (Direct Delivery to address detailed in paragraph 2.1)

2.4.6 NOTE: Due to the COVID19 situation, the vendor must follow CDC guidelines when on VA property. Any individuals who need to enter the building for installation &/or training will be required to be screened by the site staff prior to entry. Please allow time for this in your schedule.

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.

Assembly, Installation, and Calibration Required (Yes ☒ No ☐) The vendor is required to manage and coordinate installation at the Phoenix VA Clinic – 32nd Street with the COR or his representative IOT&A POC.

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 Arizona Time, Monday through Friday, and excluding Federal Holidays.

Proposed installation date will occur after delivery of equipment. Current timeframe of delivery is February 21, 2022 – March 21, 2022.

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 Phoenix VA Clinic – 32nd Street. 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 Required (Yes ☒ No ☐) The vendor is required to provide live clinical training on set up, operation, shut down, and troubleshooting procedures to nursing 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 March 2022.

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

Confidentiality and Non-Disclosure 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 do 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 VA10203, is required and available at https://www.tms.va.gov/SecureAuth35/. 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.

Salient characteristics Retinal Imaging System, Fluoroscein/Indocyanine (JSN: M6050)

Total Quantity: 3 ☒ Network Required if Checked ☒ Manufacturer Certified Installation Required if Checked ☒ BMET Training Required if Checked ☒ End User Training Required if Checked

Basis of Design is Topcon Healthcare TRC-NW8, MFG P/N: TRC-NW8 Imaging System w/EZ Lite 2 w/ OS-100 and OS-400 Stools; AIT-250W Wheelchair accessible instrument table Brand Name or Equal Requirement Salient Characteristics:

· Non-Mydriatic retinal camera with auto focus and auto capture capabilities

· Stereo photography capable of capturing stereoscopic images

· Right and left eye auto detection

· Digital camera capable of capturing high-resolution pictures (14 megapixels or greater) with a 45-degree field of view and true color photography

· Network ready to be able to connect to an image filing system

· Integrated color monitor, LCD or equivalent, to allow the preview of images

· Capable of performing both color and red-free photography and observation

· Small pupil detection and observation of pupils 3.5mm or larger in diameter

· Illuminated operation panel

· Electric chinrest adjustment for proper patient positioning

· Each unit shall include two (2) stools - one for the patient and one for the operator

· Each stool shall be height adjustable (up to 6 inches)

· One stool must include a back rest and a minimum of two (2) locking casters; the other stool must be without back rest and include a minimum of four (4) non-locking casters

· Includes ADA compliant wheelchair accessible table. Each table must include:

· Minimum Motorized Height range: 25”-27”

· Maximum Motorized Height range: 37”-40”

· Integrated electrical power strip

· Minimum load capacity of 300lbs

· Minimum table dimensions: 36” W x 24” D

· Maximum table dimensions: 38” W x 26” D

· Electrical requirement of 100-120 VAC or comparable

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