SOW Teruma BCT Trima Maintenance FY20.pdf

STATEMENT OF WORK

TRIMA PLATELET MACHINE SERVICE MAINTENANCE

GENERAL REQUIREMENTS: The effort required hereunder shall be performed in accordance with this Statement of Work and with all other terms and conditions set forth herein.

SCOPE: The contractor is required to provide all services, materials and equipment necessary for the repair/preventive maintenance of Trima Accel Automated Blood Collection systems and seal safe Machines: (CaridianBCT Model 81000, Serial Number 1T09852, ECN 153784;

CaridianBCT Model 81000, Serial Number 1T09853, ECN 153787; CaridianBCT Model 81000, Serial Number 1T09854, ECN 153786; CaridianBCT Model 81000, Serial Number 1T09855, ECN 153785; CaridianBCT Model 81000, Serial Number 1T03628, ECN 041892; CaridianBCT Model 71251, Serial Number 7207SAN, Trima Seal Safe; CaridianBCT Model 71251, Serial Number 7209SAN, Trima Seal Safe; CaridianBCT Model 71251, Serial Number 2485, Trima Seal Safe CaridianBCT Model 71251, Serial Number 7210SAN CaridianBCT Model 71251, Serial Number 7211SAN ) located in the Blood Donor Center Department at Naval Medical Center, San Diego (NMCSD) to ensure dependable and reliable equipment operation.

The scope of work performed under these specifications includes the furnishing of all labor, and parts to perform all repairs on equipment listed, to assure continued operation at their designed efficiency and capacity. The preventative maintenance procedure must consist of each procedure as outlined in manufacturer’s preventative maintenance checklist. The manufactures preventative maintenance checklist consists of the following:

Mechanical Inspection and Cleansing

• Display arm

• IV pole

• Display console

• Valves

• Pump rotors

• General inspection

• Leak detector

• Gear shroud

• Centrifuge arm

• Filler latch inspection

• Filler latch cleaning

• Filler latch lubrication

• Lower hex holder

• Brake system

• Pump panel cleaning

• Door springs

• Door and panel

• Door arm screws

• Door arm bumper

• Fan grate cleaning

Seal Safe Checks

• Seal Safe installed?

• Seal Safe RF unit serial number

• Seal Safe head serial number

• Sealer head cable

• Sealer head cleaning

• Sealer head alignment

• Sealer head splash guard and spring

Device and Software Information

• Machine on time

• Number of runs

• Trima Accel system software version

• STS software version (≥ 3.5)

• Download DLOGs

System Checks and Calibrations

• Fans

• Stop and Pause buttons

• Alarm LEDs

• Cassette plate down

• Reservoir level sensors

Touch Screen, Pressure and RBC Calibrations

• Touch screen

• Access pressure sensor

• Zero pressure (-20 mmHg to +20 mmHg)

• +330 mmHg (+290 mmHg to +370 mmHg)

• -250 mmHg (-220 mmHg to -280 mmHg)

• +550 mmHg (+500 mmHg to +600 mmHg)

Centrifuge pressure sensor

• +500 mmHg (+450 mmHg to +550 mmHg)

• +1,300 mmHg (+1,170 mmHg to +1,430 mmHg)

• RBC detector

• Calibration file installation

Pump Rotor Occlusion

• AC, inlet, and return occlusion

• Plasma and platelet occlusion

System Autotest and V7 Watchdog

• System Autotest

• V7 watchdog

Electrical Safety and Power

• Grounding straps

• Ground wire resistance (≤ 0.3 Ω)

• Protective Earth Leakage Current

• Normal condition with neutral closed (NC)

• AC power voltages ≤ 165 V AC (≤ 300 µA Closed neutral-reverse)

• AC power voltages > 165 V AC (≤ 500 µA Closed neutral-forward)

• Single Fault Condition (SFC) with neutral open

• AC Power voltages ≤ 165 V AC (>35 µA to ≤ 600 µA Open neutral-reverse)

• AC Power voltages > 165 V AC (>35 µA to ≤ 1,000 µA Open neutral-forward)

Fluid Run

• AC sensor

• Draw pressure too low function

• Return pressure too high function

• Centrifuge pressure high function

• Power fail recovery function

• End of fluid run

• Seal check

• Next procedure

End of Preventive Maintenance

• Documentation

• Verify all entries

LOCATION: Blood Donor Center, Material Management BIOMED Repair Department, Building 1, Ground Floor, Room GD-18H, Naval Medical Center San Diego, 34800 BOB

WILSON DRIVE, SAN DIEGO, CA. 92134-5000.

NMCSD PREVENTIVE MAINTENANCE REQUIREMENTS:

a. Perform service repair/preventive maintenance to industry standards.

b. Ensure that only FULLY QUALIFIED FIELD ENGINEERS and TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third party service schools for the above-mentioned equipment, shall be employed in the performance of any and all work performed under this contract. Upon request, contractor shall provide training certificates (or notarized copies) to the Material Management Department BIOMED division for verification.

c. Make repairs to the extent necessary (as determined by inspection tests or disassembly) to ensure a functional system that will efficiently serve its intended purpose.

NMCSD CORRECTIVE MAINTENANCE REQUIREMENTS:

a. Correct inoperable condition in a timely manner. Immediately upon contract award, the contractor will provide Material Management Department BIOMED division, Naval Medical

Center San Diego, an emergency telephone number. Contractor will respond no later than two

(2) hours after telephone notification Monday-Friday, hours of 0800–1700.

b. Provide only the work necessary to restore the equipment to a serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts replacements are not necessary.

c. Equipment improvements/modifications shall be made only upon Material Management Department, Biomed Repair Department written approval and direction.

d. Notify the Material Management Department, Naval Medical Center San Diego, Biomed Repair Department immediately upon receipt of OEM or replacement parts/equipment safety recalls notices.

e. Insure that original design and functional capabilities will not be changed, modified, or altered unless the Material Management Department, Biomed Repair Department, Naval Medical Center, San Diego authorizes such changes in writing.

f. Provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made.

g. Furnish manufacturer OEM approved lubricants and lubricate wear points within the equipment.

h. Extend to the Government all commercial warranties on replacement parts, consistent with standard industry inventory.

TRAVEL AND RELATED EXPENSES: Contractor shall be responsible for its service related trip expenses including round trip travel, mileage, and overnight living expenses.

RESPONSE TIME: Contractor shall use commercially reasonable efforts to:

a. Respond by telephone to any report of a malfunction requiring repair within two (2) hours of notification by NMCSD Monday – Friday, 0800-1700.

b. Provide on-site support within one (1) business day of notification by NMCSD personnel.

TITLE TO EQUIPMENT: Contractor shall not assume possession or control of any part of the equipment. The government retains ownership to title thereof.

LIABILITY: The Contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief or acts of God.

UTILITIES: The Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) that are available and required for any service performed under this contract. The building engineer, to ensure compatibility with the Naval Medical Center's electrical wiring and equipment, must approve contractor electrical equipment.

SHIPMENT: The contractor shall not exceed two (2) business days of shipment for all equipment coming from and going to Material Management Department, Biomed Repair Department, Naval Medical Center San Diego.

ACCESS TO EQUIPMENT: Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment.

GOVERNMENT PERSONNEL: NMCSD employees will not perform maintenance or attempt repairs to equipment while such equipment is under the purview of this contract unless agreed to in writing by the contractor.

PARTS AVAILABILITY: To ensure minimal equipment downtime, contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and materials within two (2) business days.

LABOR: All compensation for labor from the hours of 0800-1700. Local PST Time is included in the contract price. Any labor performed outside of this timeframe is not included in the contract pricing. If service becomes necessary to be performed between 1700-0800, NMCSD Biomedical Repair Division shall be notified prior to performance. Parts and materials: All compensation for parts and materials is included in contract price.

PARTS/SUPPLIES QUALITY: Parts and Supplies provided under this contract shall be new.

SECURITY REQUIREMENTS: Contractor will be required to contact the Medical Repair Branch at (619) 532-8010 to submit the required information to complete the NMCSD Security Pass Form by 1400 the day prior to the scheduled visit. In the case of emergent repairs/service, the contractor will wait at the main gate for an escort from Medical Repair Branch personnel.

CONTRACTOR CHECK-IN/CHECK-OUT: Contractor is required to report to the Material Management Department, Biomed Repair Department, Build 1, Ground Floor, Room GD-18H1 Naval Medical Center San Diego, for Visitor Badges during the hours of 0800-1600, Monday through Friday, prior to and upon completion of any service/repair performed.

FIELD SERVICE REPORTS: Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at:

Naval Medical Center, San Diego Bio Medical Repair Building 1, Ground Floor, Room GD-18H1 Phone: 619-532-8010 Fax: 619-532-8013

Or electronically at: usn.nmcsd-contractadministrator@mail.mil

The contractor, or his representative, shall complete the vendor supplied Field Service Report to include the following:

Contractor Name Technician’s Printed Name, Telephone Number and Signature Date and Time of Arrival

ECN (Equipment Code Number) and Serial Number Time Expended Repairing/Service; Labor Hours, Rate and Materials Summary of Work Performed and Accepted by End-User (Government Representative’s Printed Name and Signature) All Field Service Reports shall be submitted within 72 hours of completion of service.

Completed Field Service Reports are Required Prior to Acceptance of any Invoice.

PREVENTIVE MAINTENANCE AND REPAIR SERVICE SCHEDULES

SERVICES SHALL BE REQUIRED BASED UPON THE FOLLOWING AGREED

SCHEDULES:

PREVENTIVE MAINTENANCE: (Check One)

___ __ One (1) time per fiscal year _________________________________

___X__ Two (2) times per fiscal year MARCH / SEPTEMBER

___ ___ Four (4) times per fiscal year: December/March/June/September

REPAIR: (Check One)

___X___ Monday - Friday, 0800-1700

_______ Seven (7) days per week, 24-hour coverage