EYESI Scope of Work.docx

STATEMENT OF WORK

LT CHARLES S. KETTLES VA MEDICAL CENTER

EYESI SURGUICAL SIMULATOR

1.0 Introduction

This Statement of Work (SOW) defines the requirements of the Department of Veterans Affairs (VA) in establishing a fixed-price purchase order for EyeSi Surgical Simulator.

1.1 Background

VA Ann Arbor Healthcare System requires an EyeSi Surgical Simulator to provide our ophthalmology residents the ability to learn the essential steps of cataract surgery. This is a key step in preparing trainees before performing real live surgery in a patient. The challenge with the current crisis created by the COVID-19 pandemic poses a scenario of a longer interruption of service and surgeries. Also, the new guidelines for the AGCME accreditation requirements now mandate to have a formal wet-lab or surgical simulator as part of the resident training. As of today, 80% of the Ophthalmology Residency Programs own a simulator. 36 of all the EyeSi simulators are located at a Veterans Administration Hospital Facility. Within VSN 8, Gainesville VAMC, VA SimLearn VA National Training Center Orlando, Orlando VAMC and Miami VAMC already have a simulator to assist in resident training. Also, there are peer review studies that validate the impact in quality of care by improving phacoemulsification surgery skills along with reductions in complications. Due to these reasons, we believe acquiring an EyeSi will improve the quality and safety of care delivered to our veterans while improving our capability of training residents.

1.2 Scope

The scope of this purchase order is to provide Ann Arbor VAMC with the EYESI Surgical System, for delivery to 2215 Fuller Rd Ann Arbor VAMC location. Contractors shall furnish the simulator and provide training to the VA Ophthalmology Attending Staff and Residents.

2.0 General Requirement

The contractor shall deliver the following item:

Item No. Description Quantity

Including access to VRmNet during validity period.

An EyeSi Simulator provides a virtual environment that allow Ophthalmology Trainees to learn basic surgery steps in a safely manner prior to performing live surgery in a patient.

All equipment to be supplied under the specifications shall be the newest and the most current model of a standard product of a manufacturer of record. A manufacturer of record is defined as a company whose main occupation is the manufacture for sale of the items of equipment and which:

a. Maintains a factory production line.

b. Maintains a stock of replacement parts for the item.

c. Maintains engineering drawings, specifications, operating manuals and maintenance manuals.

d. Has published and distributed descriptive literature and equipment specifications on the equipment.

Key Features:

1. Cataract Surgery Simulator platform that includes Cataract Surgery Interface Hardware and Software. Also, a spare Cataract Instrument Set is included.

2. Highly realistic simulation of cataract surgery that increases trainees’ microsurgical skills without risk for patients.

3. Cataract Surgery Module includes training for capsulorhexis, hydro dissection, phacoemulsification, irrigation/aspiration, IOL insertion as well as complication management.

4. The Pre-installed Simulator Curriculum permits repetitive practice of microsurgical skills that would not be accomplishable in a wet lab setting. Courseware leads trainees’ step by step to proficiency in cataract surgery.

5. Assessment and Performance Comparison is provided through feedback on surgical efficiency. Trainees’ are scored and ranked among each other which fosters proficiency and consistency.

6. Effectiveness of the EyeSi Surgical System has been validated through numerous studies.

3.0 Period of Performance

This requirement shall be effective from the date of award: 45 days ARO.

4.0 Installation

The contractor shall be responsible for the installation, performance verification and validation of the equipment with a Ophthalmology Clinic Staff member who will accept the equipment.

Contractor shall train Ophthalmology Clinic Staff and assist with competency validation.

All work and installation shall be coordinated with the COR and Biomedical Engineering groups. The installation shall occur at the discretion of the COR and be coordinated with the site. All requested products shall be completely manufactured as specified and delivered to the respective delivery locations as described above.

5.0 Warranty and Support:

Warranty of the equipment shall be provided for at least one year upon receipt and acceptance of the equipment. The Chief Biomedical Engineer shall sign off on acceptance before the warranty cycle begins.

Key Terms for warranty support:

· One year of warranty upon initial receipt and acceptance signature

· On-site support during period of warranty.

· Remote Support during normal Ann Arbor VA working hours.

· Warranty includes repair and replacement parts

VA Engineering will have full access to the hardware that constitute the system. The Contractor shall provide one (1) set of user manuals and technical manuals to VA Engineering.

A copy of the service report shall be provided to both the using Service and Biomedical Engineering.

The contractor shall verify to Engineering that the system meets all requirements stated on this contract through demonstration and validation. Warranty period will start upon sign off and acceptance signature from COR and using services.

6.0 Sign-in Procedures:

All Contractor workers are required to sign in and out at the at the corresponding locations as directed by the COR or designee at this facility. All contractor employees are required to wear the assigned VA badge always.

7.0 Work Hours:

Normal business hours are 7:00AM to 3:30 PM Monday thru Friday excluding Federal Holidays. Work completed outside this time shall be requested through the COR.

Requests for afterhours work shall be submitted in writing to the COR two (2) weeks prior to work. The VA requires that information submitted shall contain extent of work, workers involved, the affected areas, and the estimated times of operation.