Attachment A _ SOW with Salient Characteristics_Specifications.docx

STATEMENT OF WORK

Green Laser System (36C26224Q1777)

1.0 Scope of Work (Purpose)

The purpose of this statement of work is to procure a ZEISS VISULAS GREEN LASER SYSTEM OR EQUAL for the Surgical Service Department at the Phoenix VA Healthcare System. We have started an operative ophthalmology program at the Phoenix VA, and we need to invest in the equipment to properly diagnose and best treat the veteran population. Most of the use of this system is for cataract, glaucoma, diabetes, and macular degeneration laser procedures. Over 50% of patients with diabetic macular edema require laser treatment in addition to their medications, justifying the benefits of adding retina laser treatment to our current clinical capabilities. Laser continues to be the treatment of choice for proliferative diabetic retinopathy and serves as an adjuvant treatment for macular edema. This instrument streamlines the clinical routine for convenient and efficient treatment experiences for the Veteran.

The contractor shall provide the equipment in accordance with this description of specifications and other requirements of this request.

2.0 Specifications & Equipment Description:

2.1 Device Description

The VISULAS LASER is a multi-workflow system with premium slit lamp microscope to view the eye, optimized coaxial illumination for the laser treatment area, and multi-spot pulse pattern to speed up the treatment and reduce pain for the patient.

One of the key benefits of ZEISS VISULAS Green is the connection to the FORUM data management solution. This allows the users to seamlessly integrate laser therapy into the ZEISS Retina Workflow ensuring high level of flexibility and efficiency throughout the entire process. The treating clinical team will be able to access and review patient’s data prior to examination, treatment, and follow-up all in one place.

The appropriate true-to-color physician’s safety ClearView safety filter remains active to ensure a safe treatment for the operator. With the ability to monitor important treatment settings directly in the eyepiece, the InsightView display allows the physician to stay focused on the patient’s treatment without looking away to adjust setting therefore improving efficiency and safety.

2.2 Technical Specifications (Salient Physical and Functional Characteristics) Must-Haves:

1. 532 nm wavelength laser beam

2. Spot features: Single pulse and multiple pulse (multiple spot) feature

3. Pulse duration range: 10 to 2,500 millisecond (ms) continuous wave (cw) operation

4. Adjustable pulse interval: 10 to 6,000 ms

5. LASER source: Frequency doubled Nd: YVO, diode pumped, continuous wave laser source

6. LED Illumination intensity: 5.6 V, 2 W brightness continuously adjustable

7. Aiming beam: Diode, 620 to 650 nm, maximum (1mW at the cornea)

8. Inter-pupillary distance range: 55 to 78mm

9. Refractive error range for adjustment of observer oculars: -5 to +5 diopters (D)

10. Magnification: 5x/8x/12x/20x/32x

11. Laser Class 4 in accordance with International Electrotechnical (IEC) 60825-1 safety standards

12. Device class 2 in accordance with ISO (International Organization for Standardization) 15004-2

13. 1,500 mW maximum power

14. Laser beam guidance: Dual laser ports for slit lamp and indirect laser beam guidance

15. Integrated settings display

16. Zeiss Forum compatible pdf output to CPRS electronic health record

17. Built-in electrical power supply

18. Application range: Glaucoma and Retina

19. Must be 100% compatible with existing equipment

2.3 Justification

The Zeiss VISULAS LASER workstation is specifically being requested to integrate with our current clinical equipment, imaging, and data management system, minimizing the need and financial costs of adding on additional machines, instruments and devices to achieve the same multiple functions. Integration with the current documentation of clinical findings allows for thorough review of patient history for accurate clinical decisions and treatment choices.

3.0 Delivery and Shipping Information. The contractor shall provide the following for shipment and delivery of equipment:

3.1 The Contractor shall ship the procurement/item to 650 E. Indian School Road, Room 1153, Phoenix, AZ 85012.

3.2 The Contractor shall be responsible for assessing the facility for all requirement cabling and other equipment needed for installation.

3.3 The contractor will assemble the laser, uncrate, and set up the new machine in place, and assemble the new unit, and make all internal connections.

3.4 The contractor will re-connect the new unit to the existing utilities and perform the start-up check to ensure proper function.

3.5 The Contractor will consult and coordinate with the in-house engineering group to gain access to restricted areas.

3.6 All installation plans will be reviewed and signed off on by the project VA POC and engineering representative.

4.0 System Documentation:

4.1 The contractor’s offer shall provide a complete set of unabridged operators manual, service manuals, electronic schematics, troubleshooting guides, and parts lists for each piece of equipment which is part of the system procured.

4.2 The contractor’s offer shall provide a complete set of manufacturer’s cleaning guidelines/instruction for each system component that is used.

5.0 Warranty:

5.1 The contractor shall provide the standard 12 months warranty; with options to purchase extended warranties upon request.

6.0 Period and Place of Performance:

The system must ship within 30 days of the award's effective date as this is an essential piece of equipment for the facility. Installation and implementation requirements shall be coordinated with the VA POC and engineering within 14 days of the award effective date.

Department of Veterans Affairs VA Phoenix Healthcare System 650 E. Indian School Rd.

Phoenix, AZ 85012

7.0 Operating Constraints:

7.1 All installation and implementation work may be completed after regular business hours and on weekends due to the impedance of patient care. The hours for installation will be coordinated/agreed upon before installation.

7.2 PVAHCS must have the discretion to defer/hold any installations if locations are not accessible for the installation process.

8.0 Security Requirements:

8.1 In reference to VHA Handbook 6500.6 Appendix A, blocks 6 and 7, the equipment included in this contract does not capture and process ePHI over the hospital network.

8.2 In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract may involve connection of IT devices to a VA network. Networking of the data from the unit may be facilitated by the installer, but is the responsibility of IT people at VA.

8.3 The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract.

8.4 During install, training, warranty repair and/or maintenance provided by the contractor, they may have physical administrative access to the equipment included in this contract that capture and process ePHI. If warranty repair is done off-site, all hard drives or other data storage devices will be retained by VA and will not be released to contractor.

8.5 Privacy and HIPAA Focused Training Web-Based (WBT): VA Course No.

VA10203 is the official privacy training for VA employees, contractors, and volunteers who have access to facilities, equipment, or information. All contracted employees will complete this training prior to accessing the facility or subject equipment, or to the data therein. The training is available on the VA TMS website at: https://www.tms.va.gov/secureauth35 . Contractor will provide evidence of training to the VA POC, if requested.

(End of SOW)