Statement of Work - Scope and Probe Maintenance - 05-21-2026.docx

Statement of Work (SOW)

General: The contractor shall provide all parts, materials, labor, tools, supervision, shipping, and related expenses necessary to provide scheduled and unscheduled maintenance, and periodic preventive maintenance inspections for the Equipment List below in Appendix A. Equipment is located at Eastern Colorado Healthcare VA, Aurora, CO, and any associated Community-Based Outpatient Clinics (CBOCs). All services shall be performed in accordance with original equipment manufacturer (OEM) specifications and applicable VA, VHA, and national standards for reusable medical devices.

Parts: 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 scheduled 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.

Equipment List: A list of makes and models of equipment to be covered is provided in Appendix A. This list includes: flexible GI and pulmonary endoscopes, flexible and rigid surgical endoscopes, ultrasound probes (e.g., linear, convex, phased-array), and TEE probes. The list may only be updated by the Contracting Officer (CO) during the period of performance via a modification.

Scheduled Maintenance:

· The Contractor shall perform Preventative Maintenance (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. PM services shall include, but need not be limited to, the following:

· Leak testing and sealing of relevant components

· Repair or replacement of insertion tubes, umbilicals, bending sections, and strain reliefs

· Repair or replacement of light guides, lenses, distal tips, and optical assemblies

· Articulation mechanism repair and alignment

· Probe cable repair, jacket replacement, and connector repair

· Scan head relensing and housing repair for probes

· Correction of electrical and signal issues

· Cosmetic restoration of housings where required to meet OEM-equivalent safety standards

· 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.

· 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.

· 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.

Unscheduled 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. 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.

· The contractor shall respond on site within four (4) hours after receipt of request for service. The contractor shall provide parts, if required to effect repair, within 24 hours of diagnosing the problem.

· Unscheduled maintenance shall be invoiced under a Not‑to‑Exceed (NTE) CLIN established in the contract. The contractor shall not exceed the total NTE amount without prior written approval from the Contracting Officer.

Hours of Performance:

Delivery shall occur Monday through Friday 8:00 AM to 5:00 PM MST for all issues requiring corrective maintenance, and Monday through Friday 8:00 AM to 5:00 PM MST for all periodic maintenance. There will be Monday through Friday 8:00 AM to 5:00 PM MST telephone support. This excludes federal holidays or as otherwise arranged with the Contracting Officer’s Representative (COR).

The contractor shall have a process to initiate a repair either via a preferred secure web-based tracking portal, email, or phone. Work orders and shipping labels shall generally be provided within one (1) business day of request.

Check in Requirements (If On-Site Work Is Required): 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. Biomedical Engineering can be reached at 720-723-6852.

Contractor Qualifications: The contractor shall have demonstrable experience performing depot-level repairs on flexible and rigid endoscopes and ultrasound/TEE probes at scale, including servicing for large hospital systems. The contractor shall maintain relevant quality and regulatory certifications for its repair facilities (e.g., ISO 13485 or equivalent; applicable FDA/UL requirements).

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:

· Type, model, System ID, and serial number (s) of all equipment on which maintenance was performed

· Total time spent performing maintenance

· Purpose of service (scheduled or unscheduled)

· Detailed narrative description of the services required

· Description of defect and corrective action taken

· Start date/time and completion date/time

· Copies of all test reports

· Complete list of parts replaced and costs (when applicable)

· Name of service technician

· Date and time the repair/support was 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.

Appendix A