632-21-1-454-0053 GE Anesthesia SOW.docx

STATEMENT OF WORK

SERVICE/MAINTENANCE OF EQUIPMENT

DATEX-OHMEDA ANESTHESIA SYSTEM located at the:

Northport VAMC, 79 Middleville Road, Northport, New York 11768.

I. REQUIREMENTS:

A. Furnish all necessary labor, equipment, tools, materials, repair service, software updates, parts, etc., for On-Site Maintenance Services as specified below in accordance with the terms, conditions and schedule of this agreement.

B. Service/maintenance during normal hours of coverage:

C. COVERAGE PERIOD:

Date of Award through and including four option years.

II. EQUIPMENT: Equipment to be serviced/maintained includes:

A. ANESTHESIA SYSTEM LOCATED IN BUILDING 200, OPERATING ROOM SUITE, 1ST FLOOR:

FULL SERVICE, INCLUDING ALL PARTS, EMERGENCY REPAIRS AND TWO (2) PREVENTATIVE MAINTENANCE INSPECTIONS/YEAR:

B. OPERATING ROOM TRACE GAS ANALYSIS, QTY 7 ROOMS, ANALYSIS TO BE PERFORMED TWICE ANNUALLY

III. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Chief or designee, Building 11, Room 1, phone # (631) 261-4400 extension 7429.

B. CO - Contracting Officer.

C. COR - Contracting Officer Technical Representative (Biomedical Engineering)

D. PMI - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

E. ESI – Electrical Safety Inspection.

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

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

H. Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR.

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

J. NFPA - National Fire Protection Association.

K. CDRH - Center for Devices and Radiological Health.

L. VAMC - Department of Veterans Affairs Medical Center

M. OSHA - Occupational Safety and Health Agency.

N. OEM - Original Equipment Manufacturer.

O. AQL – Acceptable Quality Level

IV. CONFORMANCE STANDARDS:

The contractor shall ensure that the equipment (hardware and software) functions in conformance with the latest FDA (medical device regulations (including but not limited to Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates.

V. SECURITY

A. All vendors/contractors will sign-in at the Biomedical Engineering Administrative Office building 11 room 1, before reporting to their respective work site. Each vendor/contractor will be issued a temporary identification badge that must be worn at all times above the waist, in front, with the face of the card visible.

B. If removable media (i.e. USB or DVD/CD Device) is required to service, troubleshoot or install/update software, then it must be scanned with an anti-virus program. The removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device at the scanning workstation located in Biomedical Engineering. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

C. All items covered by the manufacturer's warranty, contractor service of any devices, systems, or other equipment containing media (hard drives, optical disks, etc.) with VA sensitive information must not be removed / returned to the vendor at the end of life, for trade-in, or other purposes.

D. Upon completion of the scheduled work, the vendor/contractor will return to the Biomedical Engineering Administrative Office building 11 room 1, to sign-out, return the temporary identification badge, and leave any Field Service Reports if necessary.

E. All medical device workstations and servers must be in compliance with MDIA (Medical Device Infrastructure Architecture) as well as comply with all FDA regulations.

VI. HOURS OF COVERAGE:

A. Normal business hours of coverage are [Monday through Friday] from [8:00 am to 5:00 pm EST], excluding federal holidays. All service/repairs will be performed during normal business hours of coverage unless requested and approved by [COR].

B. Covered work performed outside the normal hours of coverage at the request of [COR] will be billed at the Time & Materials Basis, Billing will include service time, and exclude parts and travel time as they are included in Section I. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

C. Federal Holidays observed by the VAMC are:

And any other day specifically declared by the President of the United States to be a national holiday.

VII. UNSCHEDULED MAINTENANCE:

A. UNSCHEDULED EMERGENCY CORRECTIVE MAINTENANCE RELATING TO HARDWARE OR SOFTWARE PROBLEMS are NOT COVERED by this contract but SHALL BE MADE AVAILABLE ON A TIME & MATERIALS BASIS.

B. Only, the CO, COR or designated alternate has the authority to approve/request a non-covered service call from the contractor.

VIII. SCHEDULED MAINTENANCE (PLANNED MAINTENANCE):

A. The contractor shall perform Preventive Maintenance Inspection (PMI) services to ensure that equipment listed in the schedule performs in accordance with, Conformance Standards Section. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMIs and a PMI checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM.

PMI 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 to 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 which are likely to become faulty, fail or become worn.

6. Measuring and adjusting and calibrating as necessary for optimal performance, output or image quality.

7. Inspecting electrical wiring and cables for wear and fraying.

8. Inspecting all mechanical components including, but not limited to: 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.

9. Performing any Electrical Safety Inspections required by NFPA-99 as they may apply to this class of equipment and its application.

10. Returning the equipment to the operating condition as defined in, Conformance Standards Section.

11. Providing documentation of services performed.

12. Preventive Maintenance Inspections shall be scheduled and performed as follows:

Items requiring 2 visits [semi-annual PM inspections] shall be inspected in the months of [December and June]

Items requiring 1 visit [annual PM inspection]: shall be inspected in the month of September

B. All exceptions to the PMI schedule shall be arranged and approved in advance with the COR.

C. All parts, services, manuals, tools, or software required to successfully complete scheduled PMI are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.

D. Upon completion of the preventive maintenance and any required electrical safety inspection, the FSE must tag the equipment with an inspection tag, label or sticker which provides the following information: date inspected, date of expiration of inspection, and initials of FSE. VA Biomedical Engineering Labels will be provided to the FSE upon request when reporting (signing-in) to Biomedical Engineering.

IX. PARTS:

The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall INCLUDE all routine preventative maintenance parts, but it shall NOT INCLUDE major repair parts or consumables. The contractor shall use OEM new or re-built parts. New parts shall be furnished by the contractor and guaranteed against defects and/or failure for a period of 1 year from the date of completed installation of the component. Used parts, those removed from another similar system shall not be installed without approval by the COR.

X. MISCELLANEOUS SERVICES, COVERAGE AND TERMS:

A. VA shall notify contractor immediately of any equipment failure which may require corrective action to resolve in order to schedule repairs and provide Purchase Card information or Purchase Order Number.

B. Contractor shall be responsible for all preventative (planned) maintenance service-related travel expenses including overnight living expenses.

C. VA shall notify contractor 24 hours in advance of a scheduled service visit if equipment will be unavailable for PM.

D. Telephone Technical Support and any applicable remote diagnostics shall be available from the contractor on a 24-hours by seven-days- per-week basis.

E. Software “Updates” ARE INCLUDED and shall consist of any modification, update, improvement or error corrections and shall be performed during normal business hours. Updates do not include separately licensed software modules which provide additional functionality relating to an application or feature for the hardware or software.

F. Software “Upgrades” that consist of separately licensed software modules providing additional functionality relating to an application or feature for the hardware or software are NOT INCLUDED and shall require a separate Purchase Order.

G. Clinical Applications Support by telephone shall be available M-F, 8AM – 5PM Central Standard Time to contractor-trained VA personnel who use the covered equipment and the COR.

XI. SERVICE MANUALS:

The VAMC shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all 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. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

XII. DOCUMENTATION/REPORTS:

The documentation will include legible detailed descriptions of the scheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards Section. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor.

B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, time (starting and ending), and Hours-On-Site for service call.

E. VA Purchase Order (PO) #(s) covering the call, if outside normal working hours.

F. Description of Problem reported by COR/User.

G. Identification of Equipment to be serviced:

VA Inventory Entry # (if available), manufacturer, model#, serial#, and any other manufacturer's ID#’s.

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

a. Labor and travel hours, parts replaced (with part #s), location of problem (equipment assembly, circuit, etc.) and Corrective Action.

I. Total Cost to be billed.

J. Signatures:

1. FSE performing services described.

2. VA Employee who is notified and accepts that repair /service has been completed.

K. A “Log Book” to be left with the supervisor at the equipment site for entering arrival and departure times and maintaining a PM and Repair records.

XIII. REPORTING REQUIREMENTS:

A. The contractor shall be required to report to Biomedical Engineering, Building 11, Basement level, Room 1 to log in during Normal Business Hours. Outside of Normal Business hours, FSE may report directly to area Supervisor at equipment site. When the service is completed, the FSE shall document services rendered on a legible ESR(s). All ESRs require an acceptance signature from the Area Supervisor. The FSE shall be required to log out either by contacting/meeting the COR to provide him with the ESR(s) or at Biomedical Engineering. Outside of Normal Business Hours, FSR(s) may be left in the Biomedical lock-box located at the entrance to Biomedical Engineering (Building 11, Basement Level, Room 1). Detailed FSR(s) must be received within five (5) business days after completion of work electronically (e-mailed to COR, Kelly.Orourke@va.gov), by fax to (631) 266-6010, or by mail (VA Medical Center, 79 Middleville Road, Chief Biomedical Engineering (138A), Northport, NY 11768).

XIV. PAYMENT:

A. Purchase Order Payment Procedures:

Payments will be made QUARTERLY in arrears upon receipt of properly prepared, certified invoices which must show reference to the purchase order number and contract number issued upon the award of this contract. Each invoice must include the Service Reports (ESR's) for work performed during that quarter. OTHERWISE, THE INVOICE WILL INDICATE, “NO SERVICE REQUESTED NOR PROVIDED, INVOICE IS FOR PAYMENT ONLY”.

B. For invoicing: These are the instructions on where to send your bills:

http://www.tungsten-network.com/us/en/veterans-affairs-us/

Contacts: Please contact the OB10 team at,

C. Please contact the Department of Veteran Affairs, Financial Service Center at: 1-877-353-9791 (http://www.fsc.va.gov/einvoice.asp)

XV. ADDITIONAL CHARGES:

A. There will be no additional charge to the Government 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.

XVI. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

A. The Contractor shall immediately, but not later than 24 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.

XVII. QUALIFICATIONS:

A. Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

XVIII. CONDITION OF EQUIPMENT:

A. The contractor accepts responsibility for the equipment described in Section, II, in "as is" condition.

B. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

XIX. 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 comparable to that identified in the Section B schedule. For field experience, the FSE(s) has a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on covered equipment.

C. The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs who are authorized and certified by the OEM. The contractor shall be able to furnish upon request written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model of equipment the contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment.

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

XX. TEST EQUIPMENT:

A. Contractor is required to utilize testing equipment for calibration which has been certified to be accurate, with accuracy traceable to a national standard. Certification certificates shall be made available to COR upon demand

XXI. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

A. The contractor's FSE's shall wear visible company identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Smoking is prohibited inside any buildings at the VAMC or near entranceways. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to police search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court.