6540--Optos Silverstone Retinal OCT (Brand Name Only)

VA Pittsburgh Healthcare System (VAPHS)

SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR OPTOS SILVERSTONE RETINAL CAMERA

Background VAPHS currently has an older model Optos Monaco for Retinal Screening that keeps failing and out of warranty. With the repair cost of the system this requires to upgrade to the newer model Optos Silverstone.

Project Scope

VAPHS needs an Optos Silverstone Retinal screen camera. This is used to retinal screening and diagnosing diseases.

Specifications

Combined UWF (200d) fundus imaging and image-guided, Swept Source OCT

Single image captures 82% of the retina (927 mm2)

Single capture covers 200d of the internal surface of the retina

Single capture image reaches beyond the equator showing vortex vessels and ampullae

Ultra-widefield (200d) image capture in less than ½ second

Montage image shows up to 97% of the retina (1166 mm2)

Ellipsoidal mirror with virtual point technology enables maximum imaging field of view

Clinically validated color imaging proven equivalent to color fundus photography for pathology detection(1)

Multiple wavelength color imaging provides: color, red-free, choroidal, and true-color views with a single capture

Ease of use validated in multi-site clinical studies(2)

Proven to enhance clinic flow(3)

Proprietary software presents images in a consistent geometry that accurately represents anatomical features across the retina and allows for accurate measurements across the retina

Auto-capture capability

Non-mydriatic, cSLO technology images through 2 mm pupil

cSLO technology images through most cataracts

Light source wavelengths: red 635 nm, green 532 nm, blue 488 nm, IR 802 nm

DICOM compliant as per the DICOM Conformance Statement

System is listed on the VA s VistA Imaging Approved DICOM Modality Interfaces list found at: http://www.va.gov/HEALTH/imaging/docs/VistA_Imaging_DICOM_Modality_Interfaces.pdf

Able to perform fundus autofluorescence (AF) with green laser

Able to perform fluorescein angiography (FA)

Able to perform indocyanine green angiography (ICGA)

All functions (color photo, red-free photo, choroidal imaging, AF imaging, FA, and ICGA) are included in a single compact system

Includes alignment software to ensure that pictures are taken in the same place each time and that images in the same place taken with different modalities and/or on different dates can be accurately overlaid for clinical comparison

Includes image overlay software for accurate comparison of images from different days and in different modes

Includes HIPAA compliant, browser-based image review software

Includes image measurement tools

Capable of stereo disc imaging

Capable of combined FA and ICGA capture

System includes an automatic, wheelchair accessible table

Powered via connection to standard AC outlet (100 to 240 V)

System requires minimum maintenance

System is field serviceable and can be routinely maintained by VAHCS engineering personnel

Warranty included

Delivery Location

Attn: Andrea Thomas or Joshua Olexa 2A118

VA Pittsburgh Healthcare System

University Drive C

Building 1

Pittsburgh, PA 15240-1001

Prior to delivery, Contracting Officer Representative and/or Business Manager shall receive shipping information from Contractor and forward to Logistics and Biomed using the emails listed above.

The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

Safety Data Sheet (SDS)

Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without SDS sheets. All instructions for use shall be followed. Products will not be used until SDS's are submitted to the COR.

The contractor shall maintain a current, green in color, loose-leaf notebook on the job site at all times, which is readily available for viewing by the COR or VA Safety Officer.

Delivery Coordination

Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number

Additional Charges

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. There will be no additional charges for time spent assembling the bladder scanners. There will be no additional charges for any time spent on-site provided training to either clinical or technical staff. There will be no additional charges with the waste management protocol listed in section 8.

Packaging Waste management

Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash.

Estimates

In the quotes, vendors will indicate whether their solution has MET, NOT MET or MET WITH QUALIFICATIONS for each line item in this document (MET WITH QUALIFICATIONS will require a detailed listing of non-compliance). In addition, vendors will complete the Instructions to Offertory s (ITO) and respond in detail to each question. Vendors are required to respond to each item individually in both documents. Include the specification/question number and text in your response document to facilitate review.

10. Influenza Vaccination

VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

- Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

- Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192.

11. Tuberculosis Prevention

Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

RUBELLA TESTING: Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.

Please provide a signed memo stating that:

(number of assigned Key Personnel) assigned to VA Contract #___________ have tested negative for tuberculosis within the past 365 days.

(number of assigned Key Personnel) assigned to VA Contract #___________ have been immunized for measles, mumps, rubella or a rubella titer of 1.8 or greater.

12. HIPAA Training Certificates

If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract.

13. Tobacco

All VA Pittsburgh property is tobacco free. Contractor personnel will comply with VA Pittsburgh tobacco and smoking policies. Violations will result in a warning and possible citation.

14. COVID-19 Related Policies

Upon entering VAPHS, per CDC and federal regulations, all personnel must wear the required PPE while on-site; at a minimum this includes a cloth mask. PPE will not be provided by VAPHS.

All individuals are required to enter through the main entrance for temperature screening. If Contractor s temperature exceeds the designated threshold, they will be asked to leave. In the event of an FSE being forced to vacate the premises, they shall notify the necessary Biomedical Engineering staff and provide a contact for a replacement.