Medtronic Fusion PWS - KO reviewed.docx

Department of Defense Defense Health Agency Naval Medical Readiness Training Command Portsmouth

Performance Work Statement Medtronic Fusion Stereotactic Neuro Surgical Service Contract

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Medtronic Fusion stereotactic neuro surgical service contract.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Medtronic Fusion stereotactic neuro surgical Preventative and corrective maintenance as defined in this Performance Work Statement (PWS).

1.1.2 Background: The Mental Health department of Naval Medical Readiness Training Command (NMRTC) Portsmouth in Portsmouth, VA has a requirement for a service and maintenance plan for the Medtronic Fusion stereotactic neuro surgical units and their components.

1.1.3 Scope: Annual preventative maintenance of unit and corrective maintenance of the unit as needed. Services include the use of Original Equipment Manufacturers (OEM) parts. The contractor shall accomplish all preventative maintenance and corrective maintenance of the unit within manufacturer’s specifications.

1.1.4 Period of Performance (PoP):

Base Year: 22 October 2026 – 21 October 2027 Option Year I: 22 October 2027 – 21 October 2028 Option Year II: 22 October 2028 – 21 October 2029 Option Year III: 22 October 2029 – 21 October 2030 Option Year IV: 22 October 2030 – 21 October 2031

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at Naval Medical Readiness Training Command Portsmouth, 620 John Paul Jones Circle Portsmouth, VA 23708 Main Operating Room.

1.2.2 Recognized Federal holidays: Is not required to perform services on holidays.

New Year’s Day Martin Luther King Jr.’s Birthday President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

1.2.3 Hours of operation: The contractor is responsible for conducting business 8:00 A.M. to 4:00 P.M Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.2.4 Emergency Services: N/A

1.3 Contractor Identification

1.3.1 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. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Governemnt understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1. Service Agreement for Annual Preventative Maintenance and Corrective Maintenance

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 manufactuers) 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. 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, if an FSE is in the geographic area. Normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); 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 June each fiscal year to all equipment listed under section 2.10 and its subcomponents.

2.1.3 The contractor shall provide to 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. If one is available in the geographic area.

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 (8am – 5pm 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 no later than the close of business (4:30 pm) on the next business day. Vendor is to make a best effort to have all equipment operational within 72 hours of initial on-site response. If there is a FSE in the geographic area. If not, a loaner shall be provided and the unit that needs service shall be sent in for depo level maintenance.

2.2.1 In the event that emergency service 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 Base Access. Vendors and contractors will apply for, and maintain, base access. This can be done at https://dbids-global.dmdc.mil/home/. Vendors and contractors will also complete form SECNAV 5512/1 and submit to BME points of contacts Mr. Benjamin Lee benjamin.c.lee8.civ@health.mil and Mr. Dennis Christin dennis.e.christin.civ@health.mil for processing.

2.3.1 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 either are a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

2.3.2 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.

2.4 Replacement Parts: The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, Joint Commission (JC), manufacturer’s certifications or any other certifications as they apply.

2.4.1 The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items.

2.4.2 Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

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

2.4.4 Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the contractor.

2.5 Software: The contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

2.6 Removal of Government Property: Whenever the repair of equipment cannot be performed at the Government site as determined by the contractor, the contractor shall notify BME who will make arrangements for the contractor to remove the item to the contractor’s designated site. The contractor may be required to sign a Government form accepting responsibility for the Government equipment. The contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

2.6.1 All charges resulting from a contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the contractor.

2.7 Equipment Modification Upgrades: The contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the contractor installation of any modification, alteration, or upgrades.

2.7.1 The contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

2.7.2 The Government shall not alter the system without prior notification to the contractor.

2.7.3 The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

2.8 Service beyond the Scope of the Contract: The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the contractor considers they are not responsible for under the terms of this contract.

2.8.1 At the same time of the notification, the contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

2.9 Special Qualifications: The Contractor must be an OEM-certified service provider. Contractors must verify that an individual whom they plan to employ or continue to employ in the performance of this contract is authorized to accept employment in the United States. Individuals such as those who have been admitted as permanent residents, granted asylum or refugee status, or admitted in work-related nonimmigrant classifications may have employment authorization as a direct result of their immigration status

2.9.1 When using education/certification in conjunction with labor categories, the COR in coordination with the CO must establish a review process of contractor personnel to ensure labor category requirements are met.

2.10. Equipment List:

3.0 Qualifications/Considerations

3.1 Special Qualifications/Considerations: The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

4.0 Points of Contact

4.1 Points of Contact: TBD