SOW DRAFT.pdf

Farapulse Boston Scientific

SERVICE

EQUIPMENT IDENTIFICATION AND COVERAGE

A. Support, Services, & Maintenance for:

1) Premium support for the following serial numbers:

108973480

104382335

B. Service means the following with respect to the Equipment.

1) On-site field service preventive maintenance visit, which includes a thorough inspection/performance test per year to ensure the Equipment meets specifications.

2) Working hours 7 A.M to 5 P.M Monday through Friday

3) All labor, parts, materials, travel expenses and ancillary costs required for the Equipment

Service are included.

GENERAL REQUIREMENT

Michael E. DeBakey Medical Center is requesting for a contractor to provide support services including on-site repairs, telephone support, preventive maintenance, and updates for the

FARAPULSE System located at 2002 Holcombe Blvd, Houston, TX 77030. The contractor will maintain the FARAPULSE System at an optimal performance level. Upgrade and updates shall be performed as necessary per manufacturer’s specifications. The Contractor shall furnish all labor, materials, parts, equipment, tools to service and perform yearly preventative maintenance on the FARAPULSE System identified in the Equipment Identification and Coverage Section.

DEFINITIONS/ACRONYMS

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer's Representative

D. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

DRAFT

E. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

F. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency

Repair has been accomplished or is still in a pending status.

G. Authorization Signature - COR's signature; indicates COR accepts work status as stated in

ESR.

H. NFPA - National Fire Protection Association.

I. CDRH - Center for Devices and Radiological Health.

J. MEDVAMC – Michael E. DeBakey Veterans Affairs Medical Center

K. VAH - Department of Veterans Affairs Hospital

L. OEM - Original Equipment Manufacture

HOURS OF COVERAGE

A. Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee.

B. Any necessary hardware/software update/upgrade installations as deemed by the OEM will be scheduled at least three (3) days in advance and shall be performed at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR).

C. Work performed outside the normal hours of coverage at the request of COR or designee will be billed at the price listed in Vendor Contract. Billing will include service time and exclude parts, as they are included in this contract. The COR or designee will provide a credit card purchase order to cover charges outside of the scope of this contract. PO# must be included on invoice for payment. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

D. Federal Holidays observed by the VAMC are:

New Years' Day

Martin Luther King Day

Presidents' Day

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans' Day

Thanksgiving Day

Christmas Day

In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute

Any other day designated by Executive Order

Any other day designated by the President’s Proclamation

E. Preventive maintenance will be performed yearly.

UNSCHEDULED MAINTENANCE (Emergency Repair Service)

A. Contractor shall maintain the equipment in accordance with the manufacturer's latest specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. The CO, COR or designee has the authority to approve/request a service call from the

Contractor.

C. Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within immediately after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work on-site no later than 2 days after notification of equipment malfunction. This requirement for response time shall be the same for both services calls during the VA normal business hours and after-hour service calls.

D. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete unscheduled maintenance are included within this contract unless specifically stated in writing otherwise and approved by the COR.

E. Contractor shall provide mandatory safety and performance-related updates to covered equipment and software.

F. The Contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment.

SCHEDULED MAINTENANCE

A. The Contractor shall perform PM service to ensure that the FARAPULSE System will perform in optimum working conditions. Preventive maintenance inspections shall be scheduled at least three (3) days in advance with the Contracting Officer Representative (COR). The PM must be done in accordance with the latest OEM maintenance procedures and protocols. (An outline of the PM procedures and schedule shall be provided to the COR). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR at the completion of the PM. The contractor shall provide written description of

Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

1) Cleaning of equipment.

2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications.

3) Calibrating and lubricating the equipment.

4) Performing remedial maintenance of non-emergent nature.

5) Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

6) Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

7) Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

8) Returning the equipment to the operating condition defined in "Conformance Standards"

Section.

9) Providing documentation of services performed.

10) Inspecting and calibrating the hard copy image device.

B. PM services shall be performed in accordance with, and during the hours defined in the

"Hours of Coverage" section and the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

C. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR.

PARTS & TRAVEL

Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or service for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No re-manufactures or gray market items will be acceptable. Any retrofitted parts shall be approved by the COR prior to installation and shall also be approved by the OEM prior to installation.

The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the

Contractor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA facility upon discovery of such items.

The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications.

The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the

COR. (The Contractor shall also list any excluded parts under the service contract).

Travel for any and all service and preventative maintenance covered within this contract shall be covered by the Contractor and shall not be reimbursed by the CO, VAMC, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances.

SERVICE MANUALS/TOOLS/EQUIPMENT

The MEDVAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract.

TEST EQUIPMENT

Should the COR request it, prior to commencement of work on this contract, the Contractor shall provide the MEDVAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the MEDVAMC. Test equipment calibration shall be traceable to a national standard.

CONDITION OF EQUIPMENT

The Contractor accepts responsibility for the FARAPULSE System in "as is" condition. Failure to inspect the systems prior to contract award will not relieve the Contractor from performance of the requirements of this contract. Following the completion of any service performed by the contractor, the contractor shall show to the COR that the required system components are in place and fully functional prior to COR acceptance explained in the Reporting Requirements

REMOVAL OF EQUIPMENT

Should a piece of equipment require repair at the Contractor’s plant, the Contractor shall coordinate with the COR the removal of equipment. Government property cannot be removed from the station without a signed Property Pass. This Property Pass may be obtained from

Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge

ONSITE REPORTING REQUIREMENTS

The Contractor shall be required to report to Biomedical Engineering to log in. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR OR designee for an "authorization signature" unless otherwise stated by the COR. If the COR is unavailable, a hard copy or an electronic version of the FSR must also be submitted to the COR within 5 days after the service day. A signed, authorized copy of the ESR will be returned to the

Contractor after the work can be reviewed (if requested or noted on the ESR).

VA Biomedical Contact Persons: Daniel Clesi, Tekia Chess, Andrew Chi, Alyiah Hilton, Abron

Kid, Christie Pascua

Location (Building/Room Number): BA-200

Telephone Number & Extension(s): 713-791-1414 x227270

DOCUMENTATION/REPORTS

The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices

(for outside normal working hour services) required to maintain the equipment in accordance with the "Conformance Standards" section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The electronic engineering service report (ESR) will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order numbers covering the call if outside normal working hours.

F. Description of problem reported by COR.

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name,

4) Model number,

5) Serial number,

6) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Parts (with part numbers),

3) Materials and Circuit Location of problem/corrective action.

REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or 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. The Contractor shall furnish the CO and

COR with a written estimate of the cost to make necessary repairs.

COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

A. Each respondent must have an established business, with an office and full-time staff.

The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "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 and is OEM

Certified. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on the covered equipment listed in the “Equipment Identification”

C. The FSEs shall be authorized by the OEM to perform the maintenance services. All work shall be performed by "Fully Qualified", OEM Certified competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC prior to award.

The COR may authenticate the training requirements, request locations, training certificates or credentials, and technician location from the Contractor at any time for any personnel who are servicing or installing any equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment if evidence is not provided when requested.

D. If subcontractor(s) are used, they must be approved by the COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

SOFTWARE UPGRADES & UPDATES

Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract.

The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

IDENTIFICATION, PARKING, SMOKING AND VA REGULATIONS

The Contractor's FSEs shall always wear visible identification while on the premises of the

VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

Smoking is prohibited on the VA medical center campus. Possession of weapons is prohibited.

Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

NOTE: - The Contractor must submit with technical proposal unique or unusual conditions to suit specific situation(s) should the above clause not be entirely applicable.

SAFETY REQUIREMENTS

In the performance of this contract, the Contractor shall take such safety precautions as the

Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

The MEDVAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence.

OTHER REQUIREMENTS

a) The Contractor shall require his employees to comply with all VA rules and regulations pertaining to the conduct of his employees while on station. Particular attention is drawn to the fact that the VAMC is a NO SMOKING Facility. Smoking is not permitted in any building and is only permitted in designated smoking shelters on the VA campus.

b) Contractor shall have use of station telephones to make business calls related to Medical

Center’s equipment. Misuse of this privilege will necessitate the need to require the contractor to use public telephones.

UNAUTHORIZED USE OF GOVERNMENT EQUIPMENT

(1). The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call.

(2). The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

PRIVACY/SECURITY

The contractor will not have electronic connectivity to the VA network. The Vendor will only have access to patient databases and PHI when physically troubleshooting.

Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the

ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

INSURANCE

A. Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.

B. General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

C. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.

PAYMENT

All invoices shall be submitted in arrears, properly prepared in accordance with FAR 52.212-4, contain sufficient details, and match with the service tickets for the work rendered.

A. Invoices

Invoices shall be properly prepared and sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. Invoices shall be sent in arrears at the beginning of the first month of each quarter following the quarter in which the services were rendered and billed for. At a minimum, all invoices shall include the following details:

Ø Contract No.

Ø Purchase Order No. Correct purchase order number which will be issued by the Contracting

Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor.

Ø Item(s) covered (to include serial #'s)

Ø Description of the services rendered

Ø Billing period in which the services were rendered

Ø Invoice number and date

Payments will be made in accordance with the prompt payment act out of the Government annual appropriated funds obligated in a purchase order which will be issued after the contract is awarded.

ADDITIONAL CHARGES

There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

In any case, the VA shall be explicitly notified in advance that additional charges will be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform service, a separate purchase order will be issued to the Contractor for the work. Any service required which the Contractor believes to be in excess of the contract provisions and require additional payment (e.g., work beyond normal work hours) shall not be performed without prior authorization from the BIOMED COR, who will arrange a separate purchase order to pay for the additional service if desired by the VA.

The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc., on straight time or overtime work.

GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT

After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

END OF SERVICE PERIOD

No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer.

Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date to the COR. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the

Contractor’s repairman shall report their arrival and departure to the COR.