DRAFT PWS for RFI Medtronic O-ARM.docx

Department of Defense Defense Health Agency Performance Work Statement

O-arm Maintenance Services for ER Department

15/APR/2026

Naval Medical Readiness Training Center Portsmouth, VA (NMRTC) Materials Management Department

PART 1

1.0 GENERAL INFORMATION

1.1. Description of Service/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide calibration support for the items listed and all support items / components as defined in this PWS except for those items specified as government furnished property and services for DFA BioMed located at NMRTC Portsmouth, Building #250, Portsmouth, VA 23708. The contractor shall perform to the standards in this contract.

1.2. Background: The Main Operating Room at Naval Medical Center Portsmouth (NMCP) has a need for a maintenance and service plan for the following pieces of equipment: O-Arm surgical imaging system. In the past this equipment was serviced through contract.

1.3. Period of Performance (PoP): 01 June 2026 – 31 May 2029

1.4. Objectives: Provide preventative maintenance and identify any potential repairs that may be needed for Medtronic O-Arm Surgical Imaging System.

1.5. Scope: An annual service contract is required. Which includes technical services support by phone including remote support, preventative maintenance every 12 months, full coverage on parts/travel/labor charges, full coverage on replacement parts, hardware or software upgrade and all software maintenance/updates.

1.6. Federal Regulations: Not Applicable.

1.7. Geographical Location: Not Applicable.

1.8. Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services.

1.9. Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the Contracting Officer (CO) and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.10. Contractor Identification: Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company.

1.10.1. The contractor shall report to DFA Biomed at NMCP for service maintenance before any services are performed under this contract.

1.10.2. After services are completed, the contractor shall report to DFA Biomed at NMCP that will verify the work has been completed before departure.

PART 2

2.0 SPECIFIC TASK

2.1 Service Agreement for Annual Preventative Maintenance and Corrective Maintenance This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, normal working hour coverage; emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Preventative maintenance and corrective repairs, if needed, shall be done prior to the 15th of March each fiscal year to the main component and all subcomponents listed below.

2.1.1 Preventive Maintenance: Shall be performed once a year in accordance with the Original Equipment Manufacturers (OEM) recommendations. The contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and throughout contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. In the event that a sub-contractor is used for this requirement, the sub-contractor must be a Certified Agent of the OEM. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM( original equipment Manufactures) as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally, contractor must have ready access to parts inventory of OEM replacement parts.

2.1.2 The contractor shall make the best effort to schedule and complete annual preventive maintenance services prior to the 15th of March, but no later than the last day of the month. Vendor shall report to Biomedical Engineering Bldg. 250 1st floor located at 54 Lewis Minor St. Portsmouth, VA 23708. The contact number is 757-953-5336. The FSE shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, contractor FSE’s shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor).

2.1.3 The contractor shall provide BME a Field Service Report (FSR) within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents/sub-contractor’s are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally, contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed. FSR will be emailed to BME distribution email at usn.hampton-roads.nmrtc-portsmouth-va.list.nmcp-dfabiomed@health.mil.

2.1.4 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission (JC) Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

2.1.5 The contractor shall provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance.

2.1.6 The contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. The contractor points of contact (POC). Service calls shall be placed 24 hours a day, 7 days a week by calling a vendor supplied toll free response center. Qualified service reps are required to make a “best effort” to call back within 4-hours during normal business hours (8:00am – 4:30pm EST Monday – Friday excluding Federal Holidays) to schedule service visit.

2.2 Corrective Maintenance: Normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 4 hours after receipt of trouble call and make a best effort to provide on-site service within 48 hours of call and a best effort to have all equipment operational within 72 hours of initial on-site response.

2.2.1 In the event that emergency services outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates, and negotiated and approved by a Contracting Officer prior to services rendered. Government request for corrective maintenance will be placed by BME, to the contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract.

2.3.3 Contractor’s pricing shall be inclusive of all costs including parts, labor, travel and shipping, unless otherwise indicated.

2.8.1 The contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the onset of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start whichever occurs first. All non-apparent / hidden discrepancies must be identified no later than the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor’s normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without corrective maintenance. The contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects are either a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

2.8.2 The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of contractor supplies, materials, or for the personal belongings brought onto Government property by contractor’s personnel.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Utilities, and Materials and determined:

3.1. Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below: provide [Insert within the blank lines shown below what Services the Government will provide for the contractor staff to provide the support outlined in the PWS.]

3.2. Utilities: The Government:

☐ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below: All utilities in the facility, including electricity and water, will be available for the contractor’s use in performance of tasks outlined in this PWS.

3.3. Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below: [Insert in the blank lines shown below what Materials will be provided, i.e., Standard Operating Procedures and Policies]

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1. Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below: The contractor shall provide all services as described in Part 2 of this PWS.

4.2. General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 2 of this PWS.

4.3. Secret Facility Clearance: Not Applicable

4.4. Materials: The contractor shall furnish all materials, supplies, and replacement parts necessary to meet the requirements under this PWS.

4.5. Equipment: The contractor shall furnish all tools, diagnostic equipment, test phantoms, and any other equipment necessary to meet the requirements under this PWS.

4.6. Facilities: Not Applicable

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 2)

Performance Requirements Summary (PRS) # 1.

Annual Preventive Maintenance: The contractor shall perform scheduled preventive maintenance annually.

PRS # 3

Reporting: The contractor shall provide a Field Service Report (FSR) after service is performed.

DHA PWS, FEB 2024

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