SOW Trophon Maintenance.docx

Statement of Work Nanosonics Trophon Maintenance

1. Purpose and Background The Department of Veterans Affairs, VA Eastern Colorado Health Care System, requires scheduled and unscheduled maintenance for two Nanosonics trophon units at Rocky Mountain Regional VA Medical Center.

The services are required to maintain the equipment in accordance with the original manufacturer's specifications.

2. Scope of Work 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.

The contractor shall furnish all labor, supervision, personnel, parts, supplies, tools, test equipment, materials, travel, coordination, documentation, and incidentals necessary to perform the services described in this SOW.

The contractor shall provide preventive maintenance, out-of-warranty repair, replacement parts, applicable hardware and software updates, 5,000-cycle major service, loaners during depot service, and transportation as described in this SOW.

The contractor shall provide all services, parts, support, documentation, and transportation required by this SOW and the resulting contract.

3. Services, Systems, Equipment, and Minimum Requirements The contractor shall provide preventive maintenance and repair services for the two Nanosonics trophon units identified below at Rocky Mountain Regional VA Medical Center, 1700 N. Wheeling Street, Aurora, CO 80045.

Service coverage includes:

The contractor shall provide corrective maintenance and repair services during the awarded base period and each exercised option period.

The contractor shall supply original manufacturer replacement parts required for covered maintenance and repairs.

The contractor shall perform preventive maintenance annually in accordance with manufacturer requirements and this SOW.

The contractor shall perform major service at each 5,000-cycle interval in accordance with manufacturer requirements.

When a covered unit requires depot service, the contractor shall provide a compatible, fully operational loaner at no additional charge for the full duration of service. The loaner shall remain available until the serviced unit has been returned to VA.

The contractor shall arrange and pay for ground transportation of both the VA device and the loaner in both directions, including shipment to the service center and return to VA. Shipping shall be included in the service coverage at no additional charge. Biomedical Engineering shall coordinate equipment handoff with the contractor.

The contractor shall provide on-site service at the identified facility and depot service as needed to perform the maintenance and repairs required by this SOW. On-site response shall meet the Response Requirements section.

Covered equipment/systems/services include:

MX 3545842

Rocky Mountain Regional VA Medical Center

MX 3019977

Rocky Mountain Regional VA Medical Center

The contractor is responsible only for equipment, systems, or services identified in the resulting contract or order.

Equipment, systems, serial numbers, asset numbers, locations, or coverage may not be added, removed, or substituted without written authorization from the Contracting Officer.

4. Period of Performance Coverage will be for one (1) twelve (12) month term, with four (4) possible option years to be exercised by the government.

5. Place of Performance Performance shall take place at:

Department of Veterans Affairs VA Eastern Colorado Health Care System Rocky Mountain Regional VA Medical Center 1700 N. Wheeling Street Aurora, CO 80045 Specific work areas, departments, rooms, clinics, or remote locations shall be coordinated with the Government point of contact before work begins.Hours of Performance / Coverage Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m. (MST), excluding the federal holidays listed as follows:

Federal Holidays:

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.

Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government to be determined by the COR or designated representatives.

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 software/hardware updates at no charge.

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.

After-hours, weekend, emergency, or on-call services that result in additional charges require prior written authorization from the Contracting Officer. Requests or scheduling approval by Biomedical Engineering, the point of contact, or COR do not authorize additional charges.

6. Contractor Qualifications The contractor shall provide qualified personnel who are trained, experienced, and capable of performing the services required by this SOW.

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.

“Fully Qualified” is based on successful completion of factory training and experience in the field. For training, the FSE shall have successfully completed a formalized training program for the equipment identified in the schedule. For field experience, the FSE(s) shall have a minimum of two years of experience (with the exception of equipment on the market less than two years) with respect to scheduled and unscheduled preventive and remedial maintenance, on the covered equipment.

The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by fully qualified competent FSEs. 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.

It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event.

Service Manuals Tools and Equipment 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.

Contractor Test Equipment 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.

7. Required Services and Performance Outcomes Summary The contractor shall provide the following services and meet the required outcomes:

Requirement 1: Service Documentation and Reports The contractor shall provide electronic service documentation for each scheduled or unscheduled service event. Documentation shall identify the service performed, equipment serviced, work completed, parts used, test results, corrective action, downtime, and VA acceptance, as applicable.

Requirement 2: Preventive Maintenance The contractor shall perform scheduled preventive maintenance, inspection, testing, calibration, and related service in accordance with manufacturer requirements and this SOW.

Requirement 3: Unscheduled Corrective Maintenance The contractor shall provide unscheduled corrective maintenance, troubleshooting, repair, adjustment, calibration, parts replacement, remote support, or on-site support to restore covered equipment or systems to operational condition.

Requirement 4: Response Requirements The contractor shall meet the required response times for covered service requests and provide a service-call number, estimated arrival time, status update, or other required communication when a service request is accepted.

Requirement 5: Covered Parts, Support, and Software The contractor shall provide covered labor, travel, parts, software support, remote support, and technical support when included in the awarded service coverage.

8. Service Documentation and Reports 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:

The contractor shall provide a legible electronic service report for every scheduled or unscheduled service event.

1. Name of contractor and contract number

2. Name of FSE who performed services

3. Contractor service ESR number/log number

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

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

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

7. Identification of equipment to be serviced:

8. Inventory ID number

9. Manufacturer's name, device name, model number & serial number

10. Any other manufacturer's identification numbers.

11. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including:

a. Labor and Travel

b. Parts (with part numbers),

c. Materials and Circuit Location of problem/corrective action.

d. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

12. Signatures:

a. FSE performing services described.

b. Authorized VA Employee who witnessed service described.

Any additional charges claimed must receive prior written approval from the Contracting Officer before chargeable work is performed.

The Contractor shall log-in and sign-in with Biomedical Engineering prior to performing any services. The Contractor shall submit any mobile media devices that would be used on a system to Biomedical Engineering for a virus scan prior to beginning work. If the Contractor does not have a VA provided contractor badge, the Contractor will obtain a temporary guest badge from Biomedical Engineering prior to beginning work on-site. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log-out and sign-out with Biomedical Engineering, return the guest badge, 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).

The contractor shall provide service history, preventive maintenance status, uptime data, and open service-call reports to the COR upon request. Records shall be submitted in an accessible electronic format.

9. Scheduled Services / Preventive Maintenance 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.

Within 30 calendar days after award, the contractor shall provide the COR and Biomedical Engineering a preventive maintenance schedule for the performance period. Updated schedules shall be provided within 30 calendar days after each exercised option period.

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:

Cleaning of equipment.

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

Calibrating and lubricating the equipment.

Performing remedial, non-emergent maintenance.

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

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

Returning the equipment to the operating condition and mode Providing documentation of services performed.

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.

The contractor shall use manufacturer procedures and record actual test values for work that requires testing or measurement.

10. Unscheduled Services / Corrective Maintenance 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.

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.

There shall be no hourly charge to the Government for unscheduled maintenance performed within normal coverage hours, 8:00 a.m. MST to 5:00 p.m. MST. Separately chargeable work outside normal coverage hours, including work extending beyond coverage hours because of a Government-caused delay, requires a purchase order and prior written Contracting Officer authorization before chargeable service is performed.

Additional Charges There will be no additional charge for time spent at the site (during or after the normal coverage areas) awaiting the arrival of additional FSE and/or delivery of parts Reporting Required Services Beyond Service Scope 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.

Chargeable work shall not begin unless authorized in writing by the Contracting Officer.

11. Response Requirements The contractor shall meet the response times and service requirements specified in this SOW.

Response requirements are as follows:

The contractor's FSE shall respond on-site within twenty-four (24) hours after receipt of request for service. The contractor shall provide parts, if required to effect repair, within 24 hours of diagnosing the problem.

Response requirements apply during normal hours of coverage unless after-hours, weekend, emergency, or on-call support is expressly included in the resulting contract or order.

The contractor shall provide the COR, service point of contact, or other designated Government representative a service-call number, estimated arrival time, status update, or other required communication when the service request is accepted.

Unscheduled maintenance visits shall be requested or authorized only by the COR, service point of contact, Contracting Officer, or other Government representative designated for the requirement.

When a required part is not immediately available, the contractor shall notify the COR or Government point of contact of the estimated delivery date and the interim plan to restore service.

12. Covered Parts, Support, and Software 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 standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

The covered service includes the loaner and ground transportation requirements stated in Services, Systems, Equipment, and Minimum Requirements. The contractor shall provide applicable hardware and software updates at no charge and schedule installations as stated in Hours of Performance / Coverage.

Coverage includes the following:

a. Labor and travel for covered scheduled and unscheduled service.

b. Covered replacement parts.

c. Remote technical support.

d. Software support, safety updates, performance updates, reliability updates, cybersecurity updates, or other manufacturer-provided updates.

e. Technical escalation support.

f. Annual preventive maintenance, 5,000-cycle major service, compatible loaner equipment for depot service, and ground transportation for serviced and loaner equipment in both directions.

Acceptance of Condition of Equipment The contractor accepts responsibility for the equipment covered under this equipment in an “as is” condition. Inspection of the equipment by the contractor shall be done prior to coverage, if required by the contractor.

Chargeable work shall not begin unless authorized in writing by the Contracting Officer.

13. Inspection and Acceptance The COR or designated Government point of contact will inspect completed services by reviewing the service report, confirming completion of required testing, and verifying that the equipment, system, or service has been returned to the required operating condition.

VA signature on a service report documents receipt and initial acceptance of the service performed.

A service-report signature documents the work and technical acceptance; it does not authorize additional charges or changes to contract scope, price, or period of performance.

14. Facility Access and Safety Contractor employees shall wear visible identification at all times when on premises of the VAMC.

Contractor personnel are responsible for parking in appropriate designated personnel. The VA will not be responsible for parking violation incurred by the contractor. Information on parking is available from the VA police station.

Smoking is prohibited inside any VA facility.

Possession of firearms is prohibited. Enclosed containers, including tool boxes, may be subject to search at the discretion of the VAMC.

Contractor personnel shall comply with VA identification, parking, smoking, safety, infection-control, and facility-access requirements. Personnel shall wear visible identification while on VA property.

15. Warranty, End-of-Life, and Equipment Changes Coverage for equipment that remains under manufacturer warranty shall begin only after the warranty expires unless concurrent coverage is specifically required and approved.

Known warranty, end-of-life, or end-of-support information includes:

MX 3545842

MX 3019977

The contractor shall notify the COR and Contracting Officer at least 90 days before covered equipment becomes unsupported during the period of performance.

Equipment additions, removals, replacements, coverage changes, or price adjustments require a written contract modification issued by the Contracting Officer before they take effect.

Nanosonics trophon Service and Maintenance