P01 SOW Full Coverage Service Contract 636-25-4-2301-0279 MEDTRONIC O-ARM.doc

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

636-25-4-2301-0279

1. Scope of Work:

1.1. The contractor will furnish all labor, transportation, parts, test equipment, tools, and expertise necessary to maintain the Medtronic O-ARM located at the Omaha VA Medical Center. The vendor shall provide the following coverages on the system. Corrective Maintenance: provide diagnostics, labor, and repair of the system should the product fail to function within Medtronic (the manufacturer of the system) published specifications. The vendor shall provide, at no cost to the government, all replacement parts necessary to return the covered unit to good working order. Standard overnight shipping will be used for replacement parts. Planned Maintenance: At a mutually agreed upon time during normal coverage hours, the vendor shall provide all necessary planned maintenance as defined in the system technical manual. Software Coverage: provide all software maintenance releases as deemed necessary by equipment manufacturer. Provide software upgrade releases when available at no charge. The vendor shall provide all coverages and benefits normally given in their commercial service and support agreements to include factory training opportunities for the clinicians. All work done by the vendor shall ensure the equipment maintains it Food and Drug Administration (FDA) certification.

1.2. This contract is effective for 1 year starting 18 Aug 2025 plus 4 one-year options that may be exercised by the VA.

1.3. Normal service requirements under this contract consist of scheduled preventive maintenance inspections, adjustments and repairs, as specified herein, along with scheduled contractor maintenance in response to service calls made by VA Omaha to the contractor due to a partial or complete system or subsystem failure which requires the contractor to respond within a specified time frame to make needed repairs/adjustments to the system.

1.4. The equipment under contract does store ephi and electronically transmit to VA VISTA Imaging via the VA network.

2. Equipment:

2.1. The equipment to be serviced/maintained includes:

Medtronic O-ARM O2, serial number C2240

3. Definitions/Acronyms:

3.1. NWIHCS - Nebraska Western Iowa Health Care System. Consists of 3 main campuses: Omaha 4101 Woolworth Ave, Omaha NE 68105 (ph 402.995.3040); Grand Island 2201 N Broadwell Ave, Grand Island NE 68803 (308-382-3660 ext 2491); and Lincoln 600 South 70th, Lincoln NE 68510 (ph 402.489.3802 ext 6437)

3.2. CO – Contracting Officer.

3.3. COR – Contracting Officer’s Representative.

3.4. IAW – In Accordance With

3.5. PM – Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

3.6. FSE – Field Service Engineer. A person who is authorized by the contractor

3.7. FSR – Field Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

3.8. Acceptance Signature – Signature of VA Omaha employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

3.9. Authorization Signature – COR’s signature; indicates COR accepts work status as stated in ESR.

3.10. OSHA – Occupational Safety and Health Administration.

3.11. First Look / CO-OP – type of service contract coverage were the VA BESS attempts to solve minor problems or makes easily completed repairs with parts provided by the vendor. May also include the VA BESS accomplishing scheduled maintenance (PM) instead of the vendor performing it. This type of coverage normally results in a cost savings to the government.

3.12. BESS — Biomedical Equipment Support Specialist. VA employee responsible vendor coordination of maintenance for VA owned medical equipment.

4. Conformance Standards:

4.1. Contract service shall ensure that the equipment/system functions in conformance with the latest published edition of NFPA-99, OSHA, manufacturer’s Network Equipment/System upgrades/updates shall be installed in strict accordance with manufacturer’s specifications and must operate within manufacturer’s specifications and must operate within manufacturer’s specified parameters.

5. Hours of Coverage:

5.1. The contractor will respond by phone at no additional charge, within the normal business hours (7:00 AM to 4:00 PM (CST) M-F).

5.2. All scheduled service/repairs shall be performed during these normal hours of coverage unless one of the following conditions exist:

5.2.1 The contractor wishes to perform such maintenance at a time that is outside of the normal hours of coverage, at no additional cost to the Government, and the contractor submits a request to the COR prior to the proposed start of the maintenance and the request is approved by the COR before work is begun.

5.2.1.1 The COR directs that the scheduled maintenance be performed at a time that is outside the normal hours of coverage and the additional cost is recommended by the COR and authorized by the CO.

5.3. Scheduled maintenance shall be performed in accordance at the manufacturer’s recommended intervals and should be scheduled/completed during the month the VA requests. Changes in this periodicity will occur only when approval is granted by the COR and CO.

5.4. Scheduling for unscheduled maintenance requirements outside of normal hours shall be coordinated with and require the approval of the COR.

5.6. Federal holidays observed by VA Omaha are:

New Years Day

Labor Day

Martin Luther King Day

Columbus Day

President’s Day

Veteran’s Day

Memorial Day

Thanksgiving Day

Independence Day

Christmas Day and any other day specifically designated by the President of the United States.

6. Unscheduled Maintenance:

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

6.2. The contractor shall provide repair service, which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and installing parts.

6.3. All parts will be covered in this agreement.

6.4. The Contracting Officer, COR and designated Alternate have the authority to approve/request a service call from the contractor.

6.5. Response time:

6.5.1. Contractor’s FSE shall respond by phone during normal business hours or within (2) hours after normal business hours.

6.5.2. If the problem cannot be corrected by phone or by remote diagnostics the contractor will dispatch a technician to arrive not later than the next business day after the call is placed.

7. Scheduled Maintenance:

7.1. Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with the manufacturers recommendations as published in the Manufacturer’s Maintenance Manuals for the system.

7.2. Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM.

7.3. PM services shall include, but need not be limited to, the following:

7.3.1. Cleaning of equipment to include filters, gearing, and other parts.

7.3.2. Reviewing operating system software diagnostics to ensure that the system is operating as specified by the manufacturer’s specifications.

7.3.3. Calibrating and lubricating the equipment.

7.3.4. Performing remedial maintenance of non-emergent nature.

7.3.5. Performing electrical safety inspection IAW NFPA 99.

8. Parts:

8.1 The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer.

8.2 Parts may be repaired or replaced, as the contractor deems appropriate. No used parts will be used to repair this equipment.

9. Service Manuals:

9.1. VA will not provide service manuals of service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSEs all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary the meet the performance requirements of this contract.

9.2. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the Contracting Officer upon request.

10. Documentation/Reports:

10.1. Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices required to maintain the equipment in accordance with manufacturer specifications.

10.2. Any additional charges claimed will be approved by the CO via the COR before service is completed.

11. Reporting Requirements:

11.1. Upon arrival at VA Omaha the contractor shall be required to log in with Biomed in room B556 in Omaha, room C09 in Grand Island or room 7-3-LN in Lincoln. This log in is mandatory as well as wearing the contractor badge issued upon log in. Contractor’s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name. In addition, the contractor shall submit fingerprints through the VA police for issuance of a VA identification badge that shall be worn at all time while working at a VA facility.

11.2. When service is completed, the FSE shall document services rendered on a legible ESR(s) and submit to the BESS who set-up the service. The ESR can be submitted when logging out with Biomed, via an internet web site or e-mail. ESRs should be submitted not later than 5 business days after service is complete. Preferred method of delivery is via email to NWIHCSBiomedicalStaff@va.gov

11.3. In those cases when the Biomed office is closed, contractor personnel will log in and/or out via the VA police and after hours service shall be prearranged with the BESS.

12. Services Beyond the Contract Scope:

12.1. Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence of 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.

12.2. Contactor shall furnish the COR with a written estimate of the cost to make necessary repairs.

13. Condition of Equipment:

13.1. The contractor accepts responsibility for the equipment described in “as is” condition.

13.2. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract.

14. Test Equipment:

14.1. Test equipment calibration shall be traceable to National Institutes of Standard Technology standards. Each service report shall list test equipment used and date calibration to NIST is due. Test equipment out of calibration shall not be used.

15. Identification, Parking, Smoking, and VA Regulations:

15.1. Contractor’s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

15.2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from VA Police Service. VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

15.3. Smoking is prohibited inside all VA buildings.

15.4. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

15.5. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state or municipal court.

16. Contractor Qualifications:

16.2. “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 solicitation as required by the Original Equipment Manufacturer (OEM) and equal to what the manufacturer provides their own field service personnel.

16.3. Contractor must provide, upon request, evidence of appropriate training of any FSE(s) providing services under terms of the contract. Subcontracting of any ensuing award of this solicitation will not be allowed without written permission of the Contracting Officer.

16.4. Contractor must have access to all OEM proprietary information due to the critical nature of these services. Examples of this information would be software updates and factory service bulletins that describe updates/modifications needed to make the equipment under this contract safe for use.

17. Quality Assurance Surveillance Plan

No more than 1 COR write-up per quarter. Repeat complaints/ discrepancies for the same area/ facility will result in an unacceptable rating for the month.

Reporting Requirements