J065--Energy Generator Software Salt Lake City VA Medical Center Pharmacy

STATEMENT OF WORK (SOW)

Service Contract Agreement

Salt Lake City Utah V.A. Medical Center (SLCVA)

500 Foothill Drive Salt Lake City, UT 84148-0001

The George E. Wahlen VA Medical Center, SLCVA Biomedical Engineering Department has a requirement for a service maintenance contract for a Barrx Flex RFA Energy Generator. The contractor shall provide all labor, transportation, recertification, materials, equipment, tools, software, and disposal necessary for performing preventative maintenance (PM) and onsite repairs as required on this device.

Background

The SLCVA acquired this device in 2017 and the warranty has since expired. This is an energy generator used for tissue ablation in the GI clinic. Issues with software on this device cannot be repaired in-house by biomed. Additionally, there are no backup units at the facility. Therefore, a service contract is required to keep the uptime of this device as high as possible.

Service agreement Period of Performance:

Base year: 4/1/2026 to 3/31/2027

Option year 1: 4/1/2027 to 3/31/2028

Option year 2: 4/1/2028 to 3/31/2029

The coverage on the listed equipment shall include the generator, generator software, footswitch, and output cable.

Devices

The following devices will be supported by this service contract.

EE #

Manufacturer

Equipment Name

Model

Serial

82732

Covidien

Radiofrequency Therapy Systems: Tissue Ablation

Barrx Flex RFA Generator

FE3350X

Scope of Services

The contractor agrees to provide the following during the Period of Performance (POP) of this contract:

Contractor shall provide full-service coverage of this equipment, including both corrective and preventative maintenance. The Contractor shall not charge additional money for any shipping, parts, labor, or travel to repair or replace this equipment.

Contractor shall provide functionally equivalent loaner equipment at the Customer s request at no additional charge while the customer s equipment is being repaired or serviced.

Contractor shall provide all software version upgrades for this equipment to Customer at no additional charge.

Documentation

The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the specifications each ESR must, at a minimum, document the following data legibly and in complete detail:

Name of contractor and contract number

Purchase order number

Contractor service ESR number/log number

Date, time (starting and ending), equipment downtime and hours on-site for service call.

Description of problems reported by the COR/user (if applicable)

Identification of equipment to be serviced: Inventory ID number

Manufacturer s name, device name, model number and serial number

Any other manufacturer s identification numbers

Itemized description of service performed (incl., if applicable, costs associated with after normal working hour services) including:

Labor and travel

Parts (with part numbers)

Materials and circuit location of problem/corrective action

Total cost to be billed

Signatures, as needed

FSE performing services described

Authorized VA Employee who witnessed service described

Reporting Requirements

The contractor shall check in with Biomedical Engineering Department prior to performing any service or maintenance. When the service is completed, the FSE shall document services rendered on a legible ESR. The FSE shall log out with the Biomedical Engineering Department and submit the ESR(s) to the COR and Biomedical Engineering Department.

Quality Assurance

According to the Inspection of Services clause (FAR 52.246-4 Inspection of Services Fixed Price, Aug 1996) the government will evaluate the contractor s performance under this contract. For those tasks listed on the Performance Requirement Table (PRT) in this SOW, the COR will follow the methods of surveillance specified in this contract. When a required service in the PRT indicates defective performance, the COR will require the contract manager or representative to document the service or repair performed. Government surveillance of tasks not listed in the PRT may occur during the performance period of this contract. Such surveillance will be done by the method of surveillance identified in the PRT. Any action taken by the contracting officer as result of surveillance will be in accordance with the terms of this contract.

Hours of Coverage

Telephone support

Support Monday-Friday 0800-1700 local time

Response within 24 business hours

Facility hours

Normal hours of coverage are Monday through Friday from 8am to 5pm local time (Mountain), excluding federal holidays listed as follows:

New Year s Day

Memorial Day

Columbus Day

Christmas Day

Dr. Martin Luther King Jr s Birthday

Independence Day

Veteran s Day

Presidents Day

Labor Day

Thanksgiving Day

Any other day specifically declared a National Holiday by the President of the United States

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday the preceding Friday is observed as a holiday by US Government Agencies.

Infection Control

Contractor shall conform to the infection control measures as specified in the work area.

Preventative Maintenance Service will normally be performed in the surgical suite, unless otherwise directed by facilities staff.

Facility Security

Contractors, contractor personnel, subcontractors, shall be subjected to the same Federal Laws, Regulations, Standards, VA Directives and Policies regarding information system and physical security as VA personnel

Contractor shall comply with all VAMC facility security requirements. Weapons prohibited: enclosed containers, toolboxes, vehicles, and personal property are subject to searches at the discretion of the VAMC police.

Contractors, contractor personnel, subcontractors, shall park in designated parking areas. Biomedical Engineering will provide instruction on approved areas.

END OF SOW