Attachment 1 SON.docx

VA Pittsburgh Healthcare System (VAPHS)

SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR MELLING MEDICAL, LUMENIS DIGITAL DUET (PART NUMBER: GAS910000DIG)

1. Background VA Pittsburgh requires a replacement for failing equipment in the Ophthalmology Clinic to avoid delays or cancellations in Veteran care. Respectfully requesting the procurement of the Melling Medical, Lumenis Digital Duet (Part Number: GAS910000DIG) for an emergency procurement that aligns with Unusual and Compelling Urgency to avoid Veterans not receiving needed Eye care. The Digital Duet is an “all-in-one” anterior segment laser platform, that includes both Selective Laser Trabeculoplasty (SLT) and Yttrium-Aluminum Garnet (YAG) capabilities for Veteran Eye care needs.

2. Specifications

· System includes HD digital camera to capture image/record, one pair of safety spectacles, operator manual on a USB drive, laser safety sign

· Two legs table-Americans with Disabilities (ADA) compliant SLT/YAG system that allows for true wheelchair accessibility with convenient control features.

· Local service for the SLT/YAG laser with rapid service with more than 50 field services engineers available across the United States that local or beyond field service engineers can be on-site in response to the warranty and Biomedical Engineering needs of VA Pittsburgh

· Must feature highly accurate Super Gaussian beam profile to achieve optical breakdown or photo disruption, while simultaneously offering the lowest possible energy levels

· Equipment automatically runs internal tests to ensure that every laser pulse meets the exact power requirements

· Installation, calibration, and on-site training that is included within the written quote and to be performed on-site by experts of the equipment

· Onsite-services available Monday-Friday, 0800 to 1700, dependent on availability

· Vendor will coordinate shipping and handling

· The vendor warrants that equipment will be free from defects in materials and workmanship and will conform in all material respects to technical specifications

· At minimum, 15-month warranty on equipment

· Vendor representative available to assist with initially putting equipment in service

Equipment needed

To be published with the awarded Vendor’s submission.

3. Delivery Location Attn: Joshua Olexa 2A118 VA Pittsburgh Healthcare System University Drive C Building 1 Pittsburgh, PA 15240-1001

Delivery should be coordinated with the COR of the contract prior to shipping of any equipment

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.

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

4. Training

Any training scheduled should be coordinated with the COR and VA staff.

5. 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.

6. 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.

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 follows VHA Directive 1192.

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

0. 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.

0. 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.