SOW-BIOSENSEWEBSTER.pdf

DESCRIPTION-SPECIFICATION-WORK STATEMENT

(Biosense Webster CARTO® and SMARTABLATE® System Maintenance Contract)**

1. Statement of Work.

This contract shall provide on-site preventive maintenance inspections and repairs on "Department of Defense Owned Equipment" located (WRNMMCB) Walter Reed at Bethesda, formerly National Naval Medical Center, (CARDIOLOGY), 8901 Wisconsin Ave, Bethesda, MD 20889. The contract is required for Base and one option year.

1. CARTO 3 SYSTEM SN:12057 ECN: 147288

2. SMARTABLATE GENERATOR SN:G4C-2327 ECN: 182684

3. IRRIGATION PUMP SN:G4CP-2326 ECN: 182686

4. REMOTE CONTROL SN:G4RC-2346

5. CARTO 3 SYSTEM SN:29085 ECN: 166952

6. SMARTABLATE GENERATOR SN:G4C-0768

7. IRRIGATION PUMP SN:G4CP-0791 ECN: 201482

8. REMOTE CONTROL SN:G4RC-0738

1.a. General

1.b. The Contractor shall comply with Federal, State, Local laws, and Federal Regulations as applicable to the performance of this contract.

1.c. The Contractor shall not accept instructions issued by any person employed by the U.S. Government, other than: the Contracting Officer (KO), or Bio-Medical Repair (BMR), all acting within the limits of their authority.

2. Scope of Work

2.a. The Accelerated Solutions Agreement (ASA) Purchase Order shall provide preventive maintenance service on the CARTO® 3 and SMARTABLATE® systems at Walter Reed National Military Medical Center. Additionally, it provides corrective maintenance on the system if it shall be malfunctioning or inoperable at a mutually agreeable time and loaner equipment, when deemed necessary by the Contractor. Training materials shall be provided for base software upgrades that affect user operation of the base software. The ASA shall also provide new Equipment Upgrades or Software Upgrades.

For the duration of the Agreement, the Government will be eligible to acquire at no additional charge, a single unit of each new hardware or software product upgrade, if any, that Contractor makes commercially available for purchase in the United States on or after January 1, 2022 (hereinafter, these products shall collectively be referred to as “Equipment Upgrades/Software Upgrades”).

Government elects to reference the Purchase Order for shipment of all eligible Equipment Upgrades/Software Upgrades upon availability.

The Contractor shall determine, in its sole discretion, what hardware and software made generally available for purchase in the US after January 1, 2022 shall be deemed Equipment Upgrades or Software Upgrades eligible for purchase or license under this agreement. Neither any item that the Contractor deems to be a disposable product including, but not limited to, any form of catheter, nor any new version of the CARTO® System shall be considered Equipment Upgrades or Software Upgrades. The Contractor reserves the right to make changes to Company-branded equipment built and/or sold at any time without incurring any obligation to make the same or similar changes on equipment previously built or sold.

The Government acknowledges and agrees that in the event of any return of any item received under this Agreement, the Contractor shall have no obligation to credit or refund any monetary amounts paid by the Government pursuant to this Agreement.

2.b. 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 Preventative Maintenance (PM), Calibration (CAL), Safety testing (ST).

2.c. 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.

2.d. Equipment listed in this contract will be maintained to meet the original equipment manufacturers’ (OEM's) specifications.

2.e. Equipment and associated components shall be serviced as listed on: SF Form 1449, "Solicitation/Contract/Order for Commercial Items".

2.f. "Contractor's Point-of-Contact" (POC). The Contractor shall provide in writing; the name and the telephone number of the primary and alternate English-speaking individual to act as their representative for the scheduling and coordination of service calls, and shall be responsible for the coordination of the contract with the Government.

2.g. The Contracting Officer (KO) and Bio-Medical Repair (BMR) shall immediately be notified, in writing, whenever changes are made to the contract.

3. Identification of Contractor Personnel.

3.a. The Government (SECURITY-PASS AND ID) will provide 'Identification Badges' to the Contractor. The ID badge must be worn during the performance of services at the Government site.

4. Government Furnished Property, Materials and Services.

4.a. The Government certifies that the equipment to be maintained 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 the need for remedial maintenance. The Contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the last month of this contract, the Government shall make an equipment inspection, and any correction or deficiencies noted during this inspection, shall be resolved prior to contract end.

4.b. If applicable, the Government will furnish expendable supplies consumed during procedural sequence and necessary for the completion of the required maintenance/ services.

4.c. The Contractor shall not be responsible for delays encountered due to the non-availability of Government furnished property.

4.d. The Government will be responsible for maintaining the proper environment, utilities, and site requirements necessary for the equipment to function properly as specified by the OEM.

4.e. The Government will operate the equipment in accordance with the instruction provided in the OEM manual.

4.f. During a service visit, the Government will not be responsible for damage or loss due to fire, theft, accident, or other disasters to contractor's supplies, materials, or personal belongings.

5. Contractor Furnished Property and Material.

5.a. Unless otherwise stated, the Government shall furnish supplies/material referenced in section 4.b; the Contractor shall furnish replacement parts required during the performance of this contract, unless stated in 10.g.

5.b. The Contractor shall provide all test equipment, service literature, reference publications, laptop computers, and diagnostic software to be used by the contractor service technicians, as required for the completion of the services in accordance with this contract.

6. Replacement Parts.

6.a. The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system.

6.b. The Contractor shall replace all worn or defective parts, unless stated in 10.g, necessary to restore the equipment to an operational condition as specified by the OEM.

6.c. Contractor installed replacement parts shall become the property of Government and malfunctioning parts shall become the property of the Contractor.

6.d. 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.

6.e. The Contractor shall use only new or warranted replacement parts, where the quality is equal-to, or better than, the OEM's original part.

6.f. The Contractor must include software revisions and upgrades (field service changes) required due to a manufacturer announced safety-hazard and FDA recall as part of the contract, at no additional cost to the Government.

7. Specific Tasks.

7.a. Contractor Report Requirements.

7.b. During normal duty hours, Contractor personnel shall check-in with Bio- Medical Repair (BMR), located in Bldg. 5, upon arrival at the Government site and again prior to departure. The Bio-Medical Repair shop can be reached on:

301-295-5515. The Contractor's FSEs shall personally notify (BMR) of problems that result in the equipment being left disabled upon their departure. During other than normal duty hours, Contractor FSEs shall notify the equipment operator designated by (BMR).

7.c. The Contractor shall provide a full-service report upon departure or within two (2) days after completion of all service rendered. Please provide Safdar Hussain, Biomed Contract Manager, a copy of the service report(s) (Safdar.hussain.civ@mail.mil).

The service report shall include, but not be limited to: contractor’s work order number, detailed description of the services(s) performed, replacement part(s) information (part number, nomenclature and serial number (if applicable)). Also, the completion date and the name of the technician performing the service shall be noted.

8. Contractor Responsibility.

8.a. The Contractor shall be responsible for all government equipment listed on SF Form 1449 during the period listed in this contract and under his control.

8.b. The Contractor shall be responsible for any damages to Government owned equipment/property and shall replace or repair any property damaged due to the fault of the Contractor or his representatives. All such replacement or repairs shall be at the Contractor's expense and contract officer’s approval.

8.c. The Contractor shall ensure all areas where equipment is serviced, on-site, shall be left in a clean, neat, safe and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart upon Contractor departure from the work site. Equipment being repaired shall be safely secured at all times.

8.d. The Contractor is not responsible for service required due to Government misuse, abuse, or damage to the system or its components when it has been determined that the damage resulted from an act of God. The Contractor will use commercially reasonable efforts to expedite this determination and submit it to (BMR) for resolution as quickly as possible.

9. Preventative Maintenance Services.

9.a. The Contractor shall, as a minimum, perform all preventative maintenance services in accordance with the OEMs suggested service intervals, unless otherwise stated in 9.b. And the contractor shall supply all parts, unless stated in 10.g, required to successfully complete the preventive maintenance process at no additional charge to the government.

9.b. The Government is requesting the preventative maintenance be performed every (12) months in the month requested by the BIOMEDICAL Maintenance Department on Carto 3 units SN: 12057& SN: 29085. Preventive Maintenance on GENERATOR AND PUMP is done every twelve (12) months.

*Note* The Contractor shall schedule and complete PM upon mutually agreed date.

*PM INSPECTION STICKERS*

Upon PM completion, contractor shall apply inspection stickers and REMOVE ALL OUTDATED stickers from contract supported equipment. Contractor may supply own inspection stickers or request stickers from Bio-medical Repair Shop prior to preventive maintenance visit. Please call: 301-295-3812/5515.

mailto:@navy.mil

9.d. The Contractor shall confirm scheduled dates with (BMR) at least five working days prior to performing preventative maintenance services.

9.e. The Contractor shall schedule preventative maintenance for other than peak patient examination times determined by (BMR) at each site.

9.f. The Contractor shall, at a minimum, perform all preventative maintenance services as prescribed by the OEM using a detailed services checklist. The completed checklist shall be provided to the Government with the Contractor's service report.

9.g. All test equipment used in the performance of this contract will be routinely calibrated and the calibration shall be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards.

9.h. Electrical safety inspections will be performed to determine an equipment item's conformance with the current leakage values as specified in the most recent edition of ANSI/AAMI Standard ES1. Electrical safety inspections will be performed as part of the scheduled maintenance program. Additionally, electrical safety inspections will be performed prior to issue of new or repaired equipment.

10. Remedial Repairs.

10.a. reserved

10.b. EMERGENCY SERVICE (repair requests) Contractor will use commercially reasonable efforts to respond to the emergency call (request for repair) within (4) four hours of receiving a call. If an emergency service call shall fall within one month of the next normally schedule maintenance call, then the emergency service rendered, coupled with any additional work that would be performed during a normally schedule service call, will fulfill Contractor’s obligation for that regularly scheduled call.

10.c. (x) Normal Working Hour Maintenance Coverage The contractor shall respond Monday thru Friday, between 7:00 a.m. to 5:00 p.m.

The contractor shall use commercially reasonable efforts to telephonically respond within (4) business hours after receipt of notification of equipment failure, and provide on-site *see emergency call reference.

10.d. All requests for remedial repair, (requests for service), shall be placed by Bio-medical Repair (BMR) personnel. And Bio-medical personnel will contact the Contractor. Remedial Maintenance shall be performed during normal duty hours, unless otherwise indicated above.

10.e. The contractor shall assign a unique log number (reference #) whenever the government requests remedial repairs.

10.f. The Contractor's response to requests for repairs may include telephone consultation between the equipment user/operator and a contractor's field service engineer. The purpose of this telephone consultation shall be:

1) to provide instruction in determining operator error;

2) to determine the most likely cause of the problem;

3) to determine if resolution of the problem requires the dispatch of a field service engineer; and

4) to identify replacement parts likely to be required in order to return the equipment to operational condition as specified by the OEM.

10. g. unless otherwise indicated, each level of service shall include all parts furnished by the Contractor at no additional cost to the Government.

Exclusions from this contract are listed as follows: There are specific parts excluded from both the Carto and Smart Ablate System and ALL customers agree to this.

SmartAblate Part Exclusions:

(a) Pole Clamp

(b) Hardware Enhancements

(c) Tubing

Carto Part Exclusions:

(a) Pre-Shipment cables for installation

(b) Pre-shipment cables for relocations 10.h. The Contractor shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

11. Removal of Government Property.

11.a. When the repair of equipment cannot be performed at the Government site, as determined by the Contractor, the Contractor shall notify (BMR) 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, Optional Form 7 (Property Pass) accepting responsibility for the Government equipment.

11.b. 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.

12. Equipment Modification Upgrades.

12.a. The Contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from the (BMR) prior to the Contractor installation of any modification, alteration, or upgrades.

12.b. The Contractor shall perform all OEM field modifications and safety inspections without charge to the Government.

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

12.d. The Government shall not alter the system without prior notification to the Contractor.

12.e. The service agreement does not include free software upgrades.

13. Service Beyond the Scope of the Contract.

13.a. The Contractor shall use commercially reasonable efforts to immediately, notify (BMR) of the existence or the development of any defects in/or repair required to the scheduled equipment that the contractor considers they are not responsible for under the terms of this contract.

13.b. At the same time of the notification, the Contractor shall furnish (BMR) with a 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.

14. Equipment Warranties: The Contractor warrants that the Equipment Upgrades / or Software Upgrades shall meet the specifications in the Contractor-approved documents delivered with the Equipment Upgrades / or Software Upgrades on the date of shipment and for 12 months thereafter (the “Warranty Period”). This warranty covers the cost of parts and labor required to correct any malfunction of the Equipment Upgrades / or Software Upgrades but excludes expendables and consumables. Any parts provided under this warranty (including the replacement of an entire piece of Equipment Upgrade / or Software Upgrade) shall be covered by this warranty for the balance of the original Warranty Period applicable to that Equipment Upgrade / or Software Upgrade.

15. Enhancement Software Warranty: If Enhancement Software fails to perform the Contractor’s sole obligation, and the Government’s sole remedy, shall be for the Contractor to repair or replace the affected software at its reasonable discretion. This warranty does not cover any software not manufactured by or for the Contractor. This warranty excludes damage due to incorrect use or misuse, damage or faulty operation due to unauthorized or inexpert repair, use of incorrect power supply, and use of non-conforming software, attachments or devices not provided by the Contractor in connection with the Equipment Upgrade / or Software Upgrade or Enhancement Software.

16. General Product Warranty: Any warranties provided by either the Contractor or any affiliate, as applicable, with respect to a given Product shall be as described above and in the labeling of that Product on purchase. THERE SHALL BE

NO WARRANTIES THAT EXTEND BEYOND THE FOREGOING DESCRIPTION INCLUDING, BUT NOT

LIMITED TO, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

17. Baseline Software License: Subject to the terms of this Agreement, the Contractor grants the Government a perpetual, non-transferable license to use the Baseline Software installed on a piece of Equipment Upgrade / or Software Upgrade purchased under this Agreement, but only on the piece of Equipment Upgrade / or Software Upgrade on which it shall be originally installed. The Government must not modify or change the Baseline Software as installed, nor may the Government decompile, disassemble or otherwise reverse engineer the Baseline Software. The Government must not copy the Baseline Software or user documentation.

18. Enhancement Software License: Subject to the terms of this Agreement, the Contractor grants the Government a perpetual, nontransferable, non-exclusive license to use Enhancement Software purchased under this Agreement with the Baseline Software installed on the Equipment Upgrades / or Software Upgrades indicated on this Agreement. The Government must not modify or change the Enhancement Software, nor may the Government decompile, disassemble or otherwise reverse engineer the Enhancement Software. The Government must not copy the Enhancement Software or user documentation. The Government shall operate, maintain and care for the Enhancement Software in accordance with the instructions in the user documentation and in this Agreement. If the Government breaches any obligation under this Agreement, or does not pay any amount due with respect to Enhancement Software, upon request, the Government shall return all copies of the Enhancement Software and user documentation to the Contractor.

19. Proprietary Rights: The Contractor owns all copyright, trade secret, patent, trademark and other proprietary rights in the baseline software included with Equipment purchased by the Government (“Baseline Software”) and software enhancements (“Enhancement Software”), including all modifications and improvements thereto. Title to any Baseline Software and Enhancement Software shall not pass to the Government but shall be licensed to the Government as described in this Agreement.