Attachment 1 - Statement of Work.pdf

Statement Work Statement and Specification Warm Springs Service Unit Optometry

Optical Coherence Tomography Angiography & Table Installation, Calibration, & On-Site Training Services

1. Introduction:

The Portland Area Indian Health Service provides access to health care for an estimated 150, 000 American Indian/Alaska Native residents of Oregon, Washington, and Idaho.

The Portland Area Indian Health Service operates four Federal Health Facilities in five Tribal Communities and one at Chemawa Indian School. The Health Centers provide a wide range of clinical services and are open 40 hours each week.

The WSSU requires the procurement of a Topcon Maestro2 with Optical Coherence Tomography Angiography (OCTA) for the optometry department.

2. Background:

At Warm Springs Service Unit (WSSU) Optometry Department is requesting for new optical coherence tomography angiography equipment with table, as existing equipment is at its end-of-life and beyond repair. Warm Springs Service Unit will need to purchase new up-to-date OCTA to continue provide direct patient care for community and visitors.

This purchase will require contract to provide equipment, warranty, software & upgrades, support services, installation, calibration, and provide on-stie training at WSSU.

The OCTA is used to scan for and diagnose conditions in the retina and vascular structures of the eye. This camera will enhance diagnostic accuracy and clinical efficiency, it offers non-invasive, high resolution imaging of retinal and optic nerve structures enabling early detection and monitoring of ocular disease.

3. Scope:

The contractor will provide one (1) Maestro2 OCTA with table equipment, software & upgrades, 24/7 support services, installation & calibration services, and on-site training to WSSU staff. The contractor shall provide all labor, supervision, materials, equipment, tools, supplies, and transportation to successfully deliver OCTA with table, install and calibrate and provide on-site training for staff. Contractor and employees are to be mindful of HIPAA compliance.

The contractor will provide the following:

1. Remove and dispose of existing OCTA equipment at WSSU.

2. Install brand new Maestro2 OCTA with table.

3. Provide software and upgrades, if applicable.

4. Provide warranty coverage and user manual guide for OCTA.

5. Provide 24/7 support services, if applicable.

6. Calibrate equipment for proper functions (troubleshoot, etc.)

7. Provide on-site training for (estimate of 3 personnel) of Optometry Staff.

8. Acquisition of a fully functional FDA approved OCT-A system capable of high resolution retinal imaging and angiography.

9. Delivery and set up at the designated WSSU optometry clinic.

10. On-site installation and calibration with a the qualified vendor.

11. Initial staff training on system operation, workflow integration, and basic troubleshooting.

12. Optional service contract coverage.

13. Optional connectivity integration with the clinics HER/PACS.

4. Specific Tasks or Specification.

Observation & photography of the fundus Type of photography Color: Red-free (Note 1) & IR (Note 3) Picture angle for photography: 45° ± 5% or less 30° or equivalent (digital zoom) Operating distance: 34.8 ± 0.1mm (when taking a picture of fundus) Photographable diameter of pupil:

Normal pupil diameter: ø4.0mm or more.

Small pupil diameter: ø3.3mm or more

Fundus image resolution (on fundus):

Center: 60 lines/mm or more Middle (r/2): 40 lines/mm or more Middle (r): 25 lines/mm or more IR photography: Center: 5 lines/mm or more (Note 3)

Observation & photographing of the fundus tomogram Scan range (on fundus):

Horizontal direction 3 – 12mm ± 5% or less Vertical direction 3 – 9mm ± 5% or less

Scan pattern:

3D scan (horizontal/vertical) Linear scan (Line-scan/Cross-scan/Radial-scan)

Scan speed: 50,000 A-Scans per second Lateral resolution: 20µm or less In-depth resolution: 6µm or less Pixel spacing: 2.6µm ± 2% Photographable diameter of pupil: ø2.5mm or more

Observation & photographing of the fundus image/fundus tomogram Fixation target

Internal fixation target:

Dot matrix type organic EL display.

The display position can be changed and adjusted.

The displaying method can be changed.

Peripheral fixation target:

This is displayed according to the internal fixation target displayed position.

External fixation target

Observation & photographing of anterior segment Type of photography: Color & IR (Note 3) Operating distance: 62.6 ± 0.1mm (when taking a picture of anterior segment) (Note 2)

Observation & photographing of the anterior segment tomogram Operating distance: 62.6 ± 0.1mm (when taking a picture of anterior segment) (Note 2) Scan range (on cornea) (Note 2):

Horizontal direction 3 – 6mm ± 5% or less Vertical direction 3 – 6mm ± 5% or less

Scan pattern: Linear scan (Line-scan/Radial-scan) Scan speed: 50,000 A-Scans per second Fixation target: External fixation target

(Note 1) Digital Red-free photography that processes a color image and displays it in pseudo-red-free condition.

(Note 2) When the attachment for anterior segment is included in the system configuration.

(Note 3) This is used only for recording the position where a tomogram is captured.

6. Security Requirements.

6.1 Facility Access:

All contractor personal shall check in daily as “visitors” with front desk administration office. Sign in and front desk will page Department to notify personals arrival. Contractor personal shall comply with all facility security protocols.

6.2 Information Security:

Maestro2 OCTA comes with an all-in-one computer, it can store images on the machine or be added to the local D1 network for uploading into the electronic health record, this will require the use of a personal identification verification (PIV) card and/or temporary access card provided by the requesting service unit.

Only trained and authorized personnel is to have access to the equipment.

7. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work.

Software updates.

b. Identification of Potential Conflicts of Interest (COI).

No known conflicts of interest are associated.

e. Inspection and Acceptance Criteria.

Sensory inspection to take place at time of delivery by COR or receiving personnel.

However, installation, training and testing of this equipment will occur on site with Contractor and the Government. At that time the COR will be available for communication with the contractor and department shall any equipment failures, missing parts, damage, or defects be found. The COR and Program will work with the contractor to remedy the noted issues within a reasonable timeframe.

Contractor shall provide final inspection and testing report once equipment is installed, calibrated, on-site training is complete.

8. Government Furnished Property/ Government Furnished Equipment:

The Government will provide the following furnished equipment and/or property:

a. Access to the network infrastructure for system software set up, license, and system configuration verifications.

b. The Government will not provide furnished equipment, such as: laptops, desktops, monitors, etc.

9. Risk Control

Pre-Installation site assessment to reduce physical integration issues.

Redundancy in imaging documentation in case of device failure.

Defined contact with vendor support to ensure minimal downtime.

10. Place of Performance / Delivery Address.

Warm Springs Health & Wellness Center Optometry Department ATTN: Dr. Ian Cheslock 1270 Kot-Num Road Warm Springs OR, 97761

11. Period of Performance:

The period of performance will be date of award through 1 year for warranty coverage, helpdesk support services, and software support.