P02 SOW PROCEPT AQUABEAM SERVICE PLAN.pdf

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STATEMENT OF WORK (SOW)

Title: PROCEPT BioRobotics AquaBeam Robotic System Service Plan Agreement

General: The contractor shall provide full-service support for the PROCEPT BioRobotics AquaBeam Robotic System located at the VA Connecticut Healthcare System. The PROCEPT AquaBeam Robotic System is an image-guided, surgical robotic system designed to provide robot-assisted aquablation therapy and create personalized treatment planning to optimize patient outcomes. This system is utilized to advance prostate care that the veteran population receives at VA Connecticut Healthcare System.

Description of Work: The contractor shall provide all required service including emergency service, repairs, preventative and corrective maintenance, labor, travel, original equipment manufacturer (OEM) replacement and repair parts, technical support, application support, and factory authorized updates/modifications/upgrades for the VA AquaBeam Robotic System. All services performed shall be in accordance with the (OEM) specifications. Field service engineers must be licensed or contracted with the original manufacturer in order to work on the equipment. All parts and software must be certified new from the original manufacturer. Reference below for equipment type and the required service:

Summary of Service & Equipment Description: Service Coverage for PROCEPT BioRobotics AquaBeam System including but not limited to the below model names and serial numbers:

• AQUABEAM Robotics System/Device – EE: 137338 (SN: 23C01689) – 1-Year Contract o All-in-one equipment coverage to include all system probes and accessories:

AQUABEAM SC2000 Scopes:

• EE: 137375 (SN: $7221/S0017)

• EE: 137376 (SN: $7221/S0018)

• EE: 137377 (SN: $7221/S0020)

• EE: 137378 (SN: S0022)

o Service coverage for corrective maintenance and repair services to include:

OEM replacement parts Labor and travel Natural wear and tear coverage Service performed by manufacturer-trained field service engineers o Preventative Maintenance provided per OEM (PROCEPT) recommended schedules o Equipment and software updates for continued optimal reliability and performance o On-site service by field service engineers with 3 to 5 business day response time o Technical support call center representatives for remote assistance o Loaner product availability for extended service periods o On-site hardware and software setup and testing by manufacturer-trained individuals o On-site in-service training for clinical staff by manufacturer-trained education specialists

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Place of Performance:

Department of Veterans Affairs VA Connecticut Healthcare System West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516

Anticipated Period of Performance: Date of Service: 11/28/2025 – 11/27/2026

Hours of Performance: Normal hours of coverage are Monday through Friday 8:00 AM to 6:00 PM EST excluding federal holidays.

A. All service/repairs will be performed during normal hours of coverage unless requested or approved by the VA’s Contracting Officer’s Representative (COR) or Program Manager.

B. Preventative periodic maintenance will be performed Monday through Friday 8:00 AM to 6:00 PM EST or as agreed to by the user and the COR in accordance with manufacturer’s recommendations.

C. There will be 24/7 telephone support.

NOTE: Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR or designated representatives. Government provides software/hardware upgrade/update. There shall be no additional charge for time spent at the site during or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

Conformance Standards: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer’s technical performance specifications.

Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract.

Operational Uptime – Requirements: The medical equipment/system shall be operable and available for use 98% of the normal operating hours of the equipment. Downtime will be computed from notification of problem during normal work hours.

Guaranteed Response Time: The OEM certified Field Service Engineer (FSE) will use commercially reasonable efforts to respond to Customer’s requests within 24 hours of notification to the vendor’s service support team.

Live Phone Support: Service shall include phone support with vendor technical support engineers 24 hours, 7 days a week.

After Hours Phone Support: Service for after hour phone support shall include 24 hours, 7 days a week, and 365 days a year for technical assistance when required.

Software Enhancements: Periodic software enhancements shall be provided as part of the firm fixed price contract and shall be considered within scope.

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Preventative Maintenance: Perform system scheduled maintenance inspections as outlined in the user’s manual developed by the manufacturer.

Parts Exchange: All parts required for the repair of the system (excludes instruments and accessories) are covered.

Part Protection: Preferred pricing on repairs or replacement due to accidental damage.

Labor & Travel Expenses: All labor and travel conducted during normal business hours: Monday through Friday, 8:00 AM to 6:00PM EST (excludes vendor company holidays) are covered.

Certified Trained Technicians and Key Personnel: The scheduled maintenance and service calls shall be performed by OEM trained personnel in accordance with the agreement. Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE’s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the 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.

Unscheduled Maintenance (Emergency Repair Service):

A. Contractor shall maintain the equipment in accordance with the manufacturer’s specifications.

The Contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. The VA’s COR or PM are authorized to request and approve service calls from the Contractor.

C. Response Time: Contractor's FSE must respond with a phone call to the COR or designated representative within 1 hour after receipt of telephoned notification during normal hours of coverage.

Scheduled Maintenance: All labor and travel conducted during normal business hours: Monday through Friday, 8:00 AM to 6:00PM EST (excludes vendor company holidays) are covered.

Parts: All needed parts for wear and tear, repairs, and maintenance conducted are covered.

Service Manuals/Tools/Equipment: All required manuals, tools, and equipment for repairs and maintenance conducted are covered and are the responsibility of the vendor.

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Check in Requirements: The Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins.

Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department.

Documentation: Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information:

• Identification of equipment to be serviced:

o VA EE Number o Vendor Inventory ID number o Manufacturer Name o Device Name o Model Number o Serial Number o System ID

• Name of contractor and contract number

• Name of FSE who performed services

• Contractor service ESR number/log number

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

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

• Total time spent performing maintenance.

• Detailed narrative and itemized description of the services required and performed including:

o Labor and travel o Parts (with part numbers) o Materials o Location o Corrective Action

• Copies of all test reports

• Complete list of parts replaced (when applicable)

• Date and time the repair/support was completed

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

• Signatures:

o FSE performing services described o Authorized VA employee who witnessed service described

P a g e 5 | 6 o NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed!

The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs.

Reporting Requirements: The Contractor may be required to report to the Clinical Engineering Department to log in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user.

Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the Contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work and hold the Contractor in default.

Reporting Required Services Beyond the Contract Scope: The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the VA’s COR or designated Program Manager (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish to the COR or PM a written estimate of the cost to make necessary repairs.

Condition of Equipment: The Contractor shall accept responsibility for the equipment.

Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

Test Equipment: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to the Original Equipment Manufacture’s standard.

Compliance with OSHA Bloodborne Pathogens Standard: The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard.

The Contractor shall:

a. Have methods by which all employees are educated as to risks associated with

b. bloodborne pathogens.

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c. Have policies and procedures which reduce the risk of employee exposure to bloodborne pathogens.

d. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

e. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

Contractor Personnel Security Requirements: Security Requirements: All contractor personnel may be required obtain a short-term identification badge issued by the VA. Such badge shall be worn by the individual and prominently always displayed while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. To obtain a short-term identification badge, contractor personnel shall present to the COR a valid (non-expired) photo identification issued by a US federal, state, or local government agency. Escort will be provided as required in sensitive work areas. The C&A requirements do not apply, and the security accreditation package is not required. The identified Sole Source Vendor shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in standard acquisition guidelines. Per the VA handbook 6500.6, no VA sensitive information will be transferred, shared, or stored with vendor. As such, no additional mechanisms will be needed to ensure the protection of information.