Preventative maintenance on Impella AIC Console System

Notice Type: Combine Solicitation

Posted Date: 16-MAY-19

Office Address: Department of the Navy; Bureau of Medicine and Surgery; Naval Medical Center San Diego; Bldg 134800 Bob Wilson Drive San Diego CA 92134-5000

Subject: Preventative maintenance on Impella AIC Console System

Classification Code: J - Maintenance, repair & rebuilding of equipment

Solicitation Number: N0025919N0057

Contact: ZHAO LI, Contract Specialist, Phone 6195329583, Email [email protected]

Setaside: N/AN/A

Place of Performance (address): 34800 Bob Wilson Dr.SAN DIEGO, CA

Place of Performance (zipcode): 92134

Place of Performance Country: US

Description: Department of the Navy

Bureau of Medicine and Surgery

Naval Medical Center San Diego

Notice of Intent to Sole Source

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference#: N0025919N0057. Naval Medical Center San Diego (NMCSD) intends to award a firm fixed price sole source contract under the authority of FAR 13.106-1(b)(1)(i), only one source being available to meet the Government's needs, to:

ABIOMED, INC.

22 Cherry Hill Dr.

Danvers, MA, 01923-2575

The North American Industry Classification System (NAICS) code for this requirement is 811219; the business size standard is $20,500,000.

The objective of this sole source award is to procure preventative maintenance on Impella AIC Console System at Naval Medical Center San Diego, in accordance with the statement of work includes all parts, support, and labor charges for the equipment as listed below:

Impella AIC Console System

ECN: 145754

S/N: IC5951

ABIOMED, INC. is the only source that can perform preventative maintenance on Impella AIC Console System due to the proprietary nature of this equipment, no other company was found that has authorized third-party service providers.

Additionally, parts utilized in repairs are Original Equipment Manufacturer (OEM) parts/components in order to ensure maximal function and that liability and warranty on devices are intact.

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work and are able to provide valid certification to provide service validated by ABIOMED, INC. Capability statements shall not exceed 6 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

Capability statements are due by Thursday 07:00 AM Pacific Time, May 24, 2019. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected]. The email subject line shall state, "Naval Medical Center San Diego, Special Notice Number N0025919N0057."

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED

STATEMENT OF WORK

IMPELLA CIRULATORY ASSIST REPAIR/REPLACE AND MAINTENANCE SERVICE

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

SCOPE: The contract dates will be effective immediately upon contract approval for the remainder of Fiscal Year 2019; base year will begin from 10 Jun 19 to 09 Jun 20, with 4 option years. The contractor is required to provide all services, materials and equipment necessary for the repair/replace and preventive maintenance of our IMPELLA CIRCULATORY ASSIST: ECN: 145754, SN: IC5951 located in the Cardiology Catherization Laboratory 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.

"Repair" means any (a) modification, adjustment, or replacement of the hardware that corrects a malfunction by bringing the hardware into material conformity with the technical specifications for the hardware or (b) a procedure or routine that, when observed in the regular operation of the hardware, avoids the material adverse effect of the applicable nonconformity.

"Replace" means a one for one replacement to provide a substitute of equal or greater value in the place of a damage or defective item for pay back, return, or refund of entire equipment.

"Preventive maintenance: (PM) refers to the care and servicing by personnel for the purpose of maintaining equipment and facilities in satisfactory operating condition by providing for systematic inspection, detection, and correction of incipient failures either before they occur or before they develop into major defects. Maintenance, including tests, measurements, adjustments, and parts replacement, performed specifically to prevent faults from occurring.

Hours of Work. Work required in the performance of this contract shall be performed during NMCSD Cardiology Clinic Normal Operating Hours, Monday thru Friday 0800 -1600 excluding NMCSD Holidays.

Location: Cardiology Clinic, Building 1, 2nd deck, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego CA 92134. # 619.532.7843

NMCSD PREVENTIVE MAINTENANCE REQUIREMENTS:

* a. Perform service repair/replace and 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 0800-1600.

* 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, 0800-1600.

* b. Provide on-site support within two (2) business days 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 0800-1600. 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 1600-0800, 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

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: FEBRUARY and AUGUST

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

REPAIR: (Check One)

___X___ Monday - Friday, 0800-1600

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

End of Statement of Work

Link/URL: https://www.fbo.gov/spg/DON/BUMED/N00259/N0025919N0057/listing.html