STATEMENT OF WORK.docx

STATEMENT OF WORK

Background:

The Northern Indiana Health Care System (NIHS) Veterans Affairs Medical Center (VAMC) currently has laser systems that are outdated and do not meet the latest technological advancements. In compliance with VA procurement and medical equipment standards outlined in the Subcommittee on Research Safety’s (SRS) SRS-011 - Laser Safety Policy, and Veterans Health Administration (VHA) Directive 1121(2) - VHA Eye and Vision Care, NIHS VAMC has authorized the purchase of a new CO2 laser system. The acquisition of the new system will address technological gaps, ensuring better treatment options and safety for patients.

Scope of Work:

To improve surgical capabilities and patient outcomes, the scope of work includes the procurement, delivery, installation, and initial training of staff on the use and maintenance of the new laser system. This system and training will be used for various medical procedures, providing precision and efficiency in surgical interventions.

· Procurement. The Government will award a one-time firm fixed price contract and issue a purchase order to the Contractor offering the best value to the Government for the acquisition of the laser system (including delivery and installation), associated accessories, and staff training.

· Delivery and Installation.

· Contractor will deliver equipment to the NIHS VAMC Warehouse within 45 days after receipt of order (ARO).

· NIHS VAMC Biomedical Engineering and Supply Chain Management staff will be available within three (3) business days of delivery to inspect and accept the equipment.

· If accepted, the equipment will be processed and entered into the inventory management system for facility tracking purposes. The equipment will then be delivered to the operating room.

· If the equipment is not accepted, the Contractor will be contacted to address and correct any defects and/or concerns found. The Government will not be responsible for any additional shipping cost required to return unacceptable equipment.

· The Contractor must provide the expected lead time and equipment delivery date to the NIHS VAMC point of contact (POC) within two (2) weeks ARO. POC information will be provided to the Contractor at the time of award.

· Any unexpected shipping delays must be reported in writing to the POC and Contracting Officer.

· The Contractor will provide tracking information to the POC when the equipment is shipped.

· The POC will track shipping and delivery via email and telephone correspondence.

· Professional installation by the Contractor will be coordinated with the NIHS VAMC POC within 15 days of delivery, inspection and acceptance of the equipment. Installation is expected to be completed within 60 days after delivery and acceptance.

· The installation site will not require prep work or pre installation meetings.

· The Contractor will confirm successful completion of installation and provide written reports for required installation corrections (if needed).

· Acceptance Criteria. The laser system will be considered acceptable when:

· The system is delivered and installed as per the equipment manufacturer’s specifications.

· The system passes all functional tests performed by the NIHS VAMC Biomedical Engineering staff.

· Training and Technical Assistance.

· The Contractor will provide training for staff (up to 15 to include nurses, doctors, and technicians) on the effective operation and maintenance of the laser system within 60 days of equipment delivery.

· Training dates and times will be coordinated with the facility POC. The POC will ensure staff availability for training.

· Training will be conducted at the Fort Wayne VAMC Surgery Department.

· The Contractor will provide certificates of completion to participants at the conclusion of training sessions.

· The Contractor will provide immediate virtual support and onsite support within 2 business days upon request.

Deliverables:

Equipment, supplies, and services will include:

· CO2 Laser – Quantity of 1 Each

· 125MM Handpiece Set for Laser – Quantity of 1 Each

· Laser Glasses – Quantity of 6 Each

· Laser Safety Officer Certification Course – Quantity of 2 Each

· Online Laser Education Portal for Staff – Quantity of 1 Each

· Laser System Shipping and Installation Charges – Quantity of 1 Each Delivery is FOB Destination. Hours of operation are Monday – Friday, 6:00AM – 3PM EST. No deliveries are accepted on the following Federal holidays:

· New Year’s Day – January 1

· Martin Luther King, Jr.’s birthday – 3rd Monday in January

· President’s Day – 3rd Monday in February

· Memorial Day - Last Monday in May

· Juneteenth National Independence Day - June 19

· Independence Day - July 4

· Labor Day - 1st Monday in September

· Columbus Day (Indigenous People’s Day) - 2nd Monday in October

· Veterans Day - November 11

· Thanksgiving Day - 4th Thursday in November

· Christmas Day – December 25th

The President of the United States of America may declare additional days as a federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

Equipment Technical Specifications:

· Wavelength: 1.2 pm

· Emission Modes: CW, Pulsed, and SP

· Super Pulse Power: 0.5 to 15W

· Peak Power: 30W

· Arm Reach: 45 inches

· Cooling: Self-contained air cooled

· Minimum Spot Diameter: .10mm (50mm handpiece), .25mm (125mm handpiece)

· Aiming Beam: 5mW Diode, adjustable Equipment Dimensions:

· Height: 85 inches (216 cm)

· Width: 13.5 inches (50 cm)

· Depth: 20 inches (62.5 cm)

· Weight: 280 pounds (127 kg) Environment:

· A minimum of 20 inches from walls to allow for ventilation

· An enclosed environment in accordance with the ANSI Standard

· Maximum allowable humidity: 90%

· Room Temperature Range: 10-25 degrees Celsius (50-77 Fahrenheit) Facility Power Requirements: A dedicated powerline: The powerline should not be shared with other heavy variable loads such as elevators, air conditioning systems, large motors, etc.

· Total FX

· 120 Volts AC (+/- 10%)

· 20 Amps

· 50-60 Hz single phase

· Recommended Power Outlet: NEMA 5-20R

· Alpha

· 220 Volts AC (+/- 10%)

· 20 Amps

· 50-60 Hz single phase

· Power Outlet: NEMA L6-20R Place of Performance:

All work will be performed at the NIHS VAMC, 2121 Lake Avenue, Fort Wayne, IN 46805-5100

Security:

The Contractor will not have access to any personally identifiable information/protected health information (PHI/PII) during the performance of services as described within this requirement. The certification and accreditation (C&A) requirements do not apply. A Security Accreditation Package is not required.