SOW_-_St_Jude_Ensite.pdf

STATEMENT OF WORK

MAINTENANCE OF ST. JUDE MEDICAL CARDIAC ELECTROPHYSIOLOGY

EQUIPMENT

at the 60th Medical Group, David Grant Medical Center, Travis Air Force Base, California

29 Mar 2019

1. DESCRIPTION OF SERVICES

1.1. The Contractor shall provide non-personal services consisting of management, labor, tools, supplies, material, transportation, parts, and replacement parts, diagnostic equipment and other equipment necessary to maintain and provide preventive and corrective maintenance service for the St. Jude Medical Cardiac Electrophysiology Equipment located at the 60th Medical Group, David Grant Medical Center, Travis Air Force Base, California. Contractor travel to perform preventative maintenance services, unscheduled/corrective or repair services, and any necessary parts replacement shall be included in the contract and at no additional cost to the Government.

The Contractor shall submit reports and documentation as identified throughout this Statement of

Work (SOW).

1.2. All work under this contract shall be performed in compliance with Joint Commission on

Accreditation of Healthcare Organizations (JCAHO), Federal Drug Administration (FDA) standards, Health Insurance Portability and Accountability Act (HIPPA) in accordance with

45CFR 160 and 164, National Fire Protection Association Standard NFPA 99 (Electrical

Equipment in Healthcare Facilities), Original Equipment Manufacturer (OEM) specifications as required.

1.3. The Contractor shall be authorized/qualified by the OEM in the repair of all equipment listed under this contract. Contractor shall maintain authorization/qualifications throughout entire contract period. Qualification includes but not limited to the certification of all repairpersons and repair facilities by the OEM as being authorized/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. Only OEM authorized/OEM trained personnel shall perform services under this contract.

1.4. Equipment covered under the contract. Equipment listed in this contract will be maintained to meet the OEM's specifications. Appendix A: Equipment List provides the location, quantity and other pertinent information of the St. Jude Medical Cardiac Electrophysiology

Equipment.

1.5. Scheduled Maintenance Inspections. The Contractor shall provide one scheduled preventive maintenance inspection per year performed by OEM authorized/OEM trained personnel. The Contractor shall complete scheduled maintenance to the current published OEM specifications. Service shall consist of: review of system operation, inspection, and functional testing checks of all equipment in accordance with the latest OEM established service procedures.

1.5.1. Per mutually agreed upon schedule between the Contractor, the contracting officer, and the

Medical Equipment Repair Center (MERC). Schedules shall be developed and approved within

60 days after contract award. Contractor shall finalize the date and time of preventive maintenance services with MERC at least two weeks prior to performing services. All services shall be performed during normal duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal holidays as listed in paragraph 2.4.1. The Contractor shall check in at the

MERC both upon arrival and upon completion of on-site work in accordance with paragraph 2.5 of this SOW.

1.6. Unscheduled/Corrective/Repair Services. The Contractor shall provide unlimited on-site corrective services per year performed by OEM-trained and authorized technicians. The

Contractor shall complete corrective maintenance to the current published OEM specifications in order to return the equipment/system to fully operational status within current OEM specifications. Government request for corrective maintenance will be placed by MERC, to the

Contractor's POC. The Contractor OEM authorized/OEM trained personnel shall respond immediately on central 24x7-manned telephone support line for clinical issues, provide telephone technical support within two (1) hour, and schedule on-site support within 24 hours when necessary. All corrective maintenance service shall be accomplished during normal duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal Holidays unless first coordinated with the MERC. Emergency after-hours travel and labor is included at no additional cost to the Government. The Contractor will coordinate corrective maintenance visits with the

MERC prior to arrival on site. The Contractor shall check in at the MERC both upon arrival and upon completion of on-site work in accordance with paragraph 2.5 of this SOW.

1.7. Telephone Support. The Contractor shall provide 24x7 access to OEM telephone support in accordance with OEM specifications and standards.

1.8. Software Support. The Contractor shall provide software updates, patches, and field corrections in accordance with the OEM’s latest established service procedures. The Contractor shall receive advance approval for the installation of all software updates and revisions from the

Government and shall be coordinated though MERC. Defective software shall be replaced at no additional cost to the Government.

1.9. Service Reports. A service report is required for any maintenance service performed at any time. The original service report must be presented to the MERC upon completion of the work prior to departure or must be emailed to the MERC at usaf.travis.60-mdg.mbx.60-mdg-sgslb-merc@mail.mil within five (5) business days. The service report must include the following as a minimum:

Date and time of service.

Company and service representative names.

Contract number.

A detailed description of any services performed including labor and any parts used.

OEM PM/Calibration checklists with results may serve as the service report.

1.10. OEM Replacement Parts. The Contractor shall provide all replacement parts, excluding consumables, necessary for scheduled and corrective services. The Contractor shall have ready access to all OEM replacement parts. All parts supplied shall be compatible with the existing system. All parts must be either new OEM parts or parts refurbished by the OEM of the covered medical equipment. 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. Parts used during scheduled and corrective services shall become the property of the Government. Replaced parts shall become the property of the Contractor and shall be removed from the hospital and disposed of at no additional cost to the Government.

mailto:usaf.travis.60-mdg.mbx.60-mdg-sgslb-merc@mail.mil mailto:usaf.travis.60-mdg.mbx.60-mdg-sgslb-merc@mail.mil

1.11. Whenever the repair of equipment cannot be performed at the Government site as determined by the Contractor, the Contractor shall notify MERC who will make arrangements for the Contractor to remove the item to the Contractor's designated site. The Contractor shall be required to sign a Government form accepting responsibility for the Government equipment. The

Contractor shall provide a detailed description of removed items including as a minimum the manufacturer serial numbers of all equipment/items removed.

1.12. 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. 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.

ECN Manufacturer/

Model

Description Model Serial # Location

60559

ST JUDE

MEDICAL INC

STEREOTACTIC

SYSTEM, IMAGE-

GUIDED, CARDIAC

MAPPING/ABLATION

ENSITE 17307019 Bldg. 777, Cath Lab

061857 ST JUDE

MEDICAL INC

CARDIAC ABLATION

PROCESSOR,

CONTACT FORCE

DISPLAY

TACTISYS

QUARTZ

32842 Bldg. 777, Cath Lab

061856 ST JUDE

MEDICAL INC

STIMULATOR,

ELECTRICAL,

CARDIAC,

DIAGNOSTIC

EP-4 14193184 Bldg. 777, Cath Lab

57228 NEUROTHERM

INC

RADIOFREQUENCY

THERAPY SYSTEM,

TISSUE ABLATION,

NERVE FIBER

NT2000 3665-15 Bldg.

Anesthesia

60593 ST JUDE

MEDICAL INC

PUMP, IRRIGATION,

CATHETER

COOL POINT 03972 Bldg. 777, Cath Lab

60591 ST JUDE

MEDICAL INC

RADIOFREQUENCY

THERAPY SYSTEM,

TISSUE ABLATION,

CARDIAC

AMPERE

GENERATOR

17218570 Bldg. 777, Cath Lab

2. GENERAL INFORMATION:

2.1. The Contractor shall not accept any instructions issued by any person employed by the US

Government, other than: the Contracting Officer (CO), or MERC, all acting within the limits of their authority. The CO is the only authorized individual who has the authority to modify or make changes to performance under this contract.

2.2. The Contractor Point of Contact (POC). The Contractor shall provide in writing the name and telephone number of a primary and alternate individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government.

2.3. The Contractor shall be responsible for the repair/replacement of damaged Government owned equipment and property due to the negligence of the Contractor or his representatives. All such replacement or repair shall be at the Contractor's expense and shall be inspected to the satisfaction of the CO or appointed representative.

2.4 Hours of Operation. Contractor Personnel shall be readily available five (5) days a week to work during normal business hours 8:00 AM - 5:00 PM, Monday through Friday. The Contractor is not required to provide preventative, routine or corrective services on the ten (10) Federal

Holidays or weekends.

2.4.1. Federal holidays are as follows:

New Year's Day - 1 January

Martin Luther King Day - 3rd Monday in January

Washington's Birthday - 3rd Monday in February

Memorial Day - last Monday in May

Independence Day - 4 July

Labor Day - 1st Monday in September

Columbus Day - 2nd Monday in October

Veteran's Day - 11 November

Thanksgiving Day - 4th Thursday in November

Christmas Day - 25 December

If a scheduled service falls on an observed Federal Holiday, service will be performed on the next workday, (i.e., if a holiday falls on Monday, service will be provided on Tuesday). Due to mission requirements, work will be scheduled in advance.

2.5. Arrival at Government facility. Contractor personnel shall check-in with the MERC upon arrival at the Government site and again prior to departure to sign in/out on the visitor-tracking log sheet. (MERC located in Building 777, 1st floor; 707-423-3948). The Contractor personnel shall personally notify MERC of problems that result in the equipment being left disabled upon their departure.

2.6. The Contractor 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. 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.

2.7. 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.

2.8. During the final month 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.

Appendix A

Equipment List