SOW NeuWave Ablation.docx

STATEMENT OF WORK – Neuwave Ablation System Maintenance

1.0 SCOPE

The contractor shall furnish labor, parts, supplies and equipment necessary to provide scheduled and unscheduled maintenance, and periodic preventive maintenance inspections for the equipment listed below. Equipment is located at the Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045.

1.1 Period of Performance

Base: 9/30/2026 to 9/29/2027 Option Year One: 9/30/2027 to 9/29/2028 Option Year Two: 9/30/2028 to 9/29/2029 Option Year Three: 9/30/2029 to 9/29/2030 Option Year Four: 9/30/2030 to 9/29/2031

1.2 Equipment Covered

1.2.1 NeuWave Ablation System

Model: CERTUS 140 Serial No: NM17NEA00560 EE/MX Number: MX1602425

1.2.2 NeuWave Ablation System

Model: CERTUS 140 Serial No: NM15NEA00332 EE/MX Number: EE82207

2.0 HOURS OF COVERAGE

2.1 Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding the federal holidays listed as follows:

Federal Holidays:

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

2.2 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.

3.0 PARTS

3.1 The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled preventive and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance), by the contractor during the period of the medical equipment being covered. Only new OEM-authorized or OEM-approved parts shall be furnished to maintain equipment in accordance with manufacturer specifications.

4.0 SERVICE MANUALS/TOOLS/EQUIPMENT

4.1 The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request.

5.0 SCHEDULED MAINTENANCE

5.1 The Contractor shall perform PM Service to ensure that the equipment listed performs in accordance with the original manufacturer’s specifications. Annual PM Service must be completed by December 31st of each year. An outline of the PM schedule and procedures shall be provided to the Biomedical Engineer.

The contractor shall provide a written description of the Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

a. Cleaning of equipment.

b. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer's specifications.

c. Calibrating and lubricating the equipment.

d. Performing remedial, non-emergent maintenance.

e. Testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn.

f. Inspection and replacement of worn or frayed electrical wiring and cables.

g. Returning the equipment to the operating condition and mode

h. Providing documentation of services performed.

5.2 All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. The only exception is hardware/software update/upgrade installations which shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the Biomedical Engineer). The contractor shall provide applicable OEM-authorized software and hardware updates included within the purchased service coverage at no additional charge.

5.3 All exceptions to the PM schedule shall be arranged and approved in advance with the Point of Contact, or Biomedical Engineer. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the Point of Contact at the completion of the PM.

5.4 Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

6.0 UNSCHEDULED MAINTENANCE

6.1 The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

6.2 Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the CO has the authority to approve/request an unscheduled maintenance service call to the contractor.

6.3 The contractor shall provide remote technical support and determine whether on-site service is required. If on-site service is required following remote diagnostics, the contractor shall provide a Field Service Engineer on site within two business days. Parts required to complete repairs shall be provided in accordance with the purchased service coverage and OEM availability.

6.4 There shall be no additional hourly charge to the Government for covered unscheduled maintenance performed during normal hours of coverage. Work performed outside normal hours of coverage at the request of the Biomedical Engineer, Point of Contact, or Contracting Officer Representative shall be separately authorized before performance and may be billed separately if not included under the purchased service coverage. Any additional charges must be approved by the Contracting Officer or COR before the work is performed.

7.0 DOCUMENTATION/REPORTS

7.1 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 Engineer Service Report (ESR) must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor and contract number

b. Name of FSE who performed services

c. Contractor service ESR number/log number

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

e. VA purchase order number(s) covering the call if outside normal working hours.

f. Description of problems reported by the POC/user (if applicable).

g. Identification of equipment to be serviced:

· Inventory ID number,

· Manufacturer's name, device name, model number & serial number,

· Any other manufacturer's identification numbers.

h. Itemized Description of Service Performed (including, 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 (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

i. Signatures:

· FSE performing services described.

· Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or CO before service is completed

7.2 The Contractor shall log in with Biomedical Engineering prior to performing any services. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log out with Biomedical Engineering and submit the ESR(s) to the Biomedical Engineer, or Point of Contact. All ESRs shall be submitted to the equipment user for an “acceptance signature” and then to the POC for an “authorization signature”. If the POC is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR).

8.0 ADDITIONAL CHARGES

8.1 There shall be no additional charge for time spent at the site awaiting the arrival of additional Field Service Engineers and/or delivery of parts when such time is included under the purchased service coverage. Any charges not included under the purchased service coverage must be approved by the Contracting Officer or COR before performance.

9.0 REPORTING REQUIRED SERVICES BEYOND SERVICE SCOPE

9.1 The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in, or repairs required, to the scheduled equipment which, the contractor does not consider his/her responsibility due to “abuse” or “damage” to the equipment. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

10.0 ACCEPTANCE OF CONDITION OF EQUIPMENT

10.1 The contractor accepts responsibility for the covered equipment in an “as is” condition. Inspection of the equipment by the contractor shall be completed prior to coverage if required by the contractor.

11.0 COMPETENCY AND CERTIFICATION OF PERSONNEL SERVICING EQUIPMENT

11.1 Each respondent must have an established business, with an office and full time staff. The staff shall include a fully qualified FSE and fully qualified alternate FSE.

11.2 “Fully Qualified” is based on successful completion of OEM-authorized training and experience servicing the equipment identified in this SOW. Field Service Engineers shall be authorized by NeuWave Medical, or by NeuWave Medical’s contracted service partner operating under NeuWave’s OEM authority and oversight, to perform scheduled and unscheduled maintenance on the covered equipment.

11.3 All work shall be performed by OEM-authorized, fully qualified, competent Field Service Engineers. The contractor shall provide documentation of OEM authorization, training, or certification upon request for personnel performing work on the covered equipment. The contractor shall provide copies of all factory certificates for FSEs showing types of equipment and dates of training for all equipment identified to be covered. When deemed appropriate, the COR or Contracting Office Representative reserve the right to prohibit contractor personnel from working on VAMC equipment.

12.0 CONTRACTOR TEST EQUIPMENT

12.1 The contractor shall ensure all contractor supplied test equipment is properly calibrated, and certified. If requested by the COR or POC, the contract shall be able to supply any certificates tied to the quality of the test equipment. Test equipment calibration shall be traceable to a national standard.