Statement of Work Full Service Abbott EnSite Service and Support.docx

STATEMENT OF WORK – Abbott Ensite, Ampere, ViewMate Maintenance

1. The contractor shall furnish labor, parts, supplies and equipment necessary to provide scheduled and unscheduled maintenance, and periodic preventive maintenance inspections for the equipment listed below. Equipment is located at the Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045.

SPECIFIC SERVICE FOR

a. EnSite X EP Mapping System

i. Serial Number: 19464668

ii. MX Number: 3855227

b. Ampere Generator

i. Serial Number: 15716533

ii. MX Number: 465662

c. Cool Point Irrigation Pump

i. Serial Number: 2139

d. TactiSys Quartz System

i. Serial Number: 31313

e. ViewMate ICE Ultrasound Console

i. Serial Number: NW4-4C000827

ii. MX Number: 3786336

f. SP5-1SVMM Transducer

i. Serial Number: NT5J4B133559

ii. MX Number: 3787236

g. L9-3S VMM Transducer

i. Serial Number: NT5L48039481

ii. MX Number: 3787243

SERVICE COVERAGE INCLUDES:

a. EnSite X EP Mapping System & Peripherals

· Extended Product Warranty: Parts Replacement Coverage

· Software Upgrades/Revisions

· Universal Coverage to include 1 each of Ampere RF ablation generator, Cool Point irrigation pump, TactiSys Quartz system

· Annual Preventative Maintenance

· After Hour Preventative Maintenance

· On-Site Service, Priority Response Level 1 (within one business day)

· Shipping Level 1: Frist Overnight for down systems; for non-down systems, Priority Next Business-Day morning (by 10:30AM MST)

· 24/7/365 Telephone Technical Support: 1-800-381-4447, Option 3

· Remote System Diagnostics and Maintenance (as applicable; requires network connection and client set-up)

· Loaner Systems / Components / Modules

· Technical User Training Course Credits

· Advanced Training Package

· 20% Parts and Services Discount

· Most Up-to-Date Commercially Available Hardware Upgrades / Revisions

· Commercially Available Software Expansion Modules

· Technology Performance Package: replacement coverage for select normal wear-and-tear items

b. Ampere Generator

· Hardware Upgrades / Revisions

c. Cool Point Irrigation Pump

· Annual Preventative Maintenance

· Corrective Maintenance

· Hardware Upgrades/Revisions

· Software Upgrades/Revisions

d. TactiSys Quartz System

· Annual Preventative Maintenance

· Corrective Maintenance

· Hardware Upgrades/Revisions

· Software Upgrades/Revisions

e. ViewMate ICE Ultrasound Console

· Extended Product Warranty: Parts Replacement Coverage

· Software Upgrades/Revisions

· Component Hardware Upgrades / Revision

· Annual Preventative Maintenance

· After Hour Preventative Maintenance

· On-Site Service, Priority Response Level 1 (within one business day)

· Shipping Level 1: Frist Overnight for down systems; for non-down systems, Priority Next Business-Day morning (by 10:30AM MST)

· 24/7/365 Telephone Technical Support: 1-800-381-4447, Option 3

· Remote System Diagnostics and Maintenance (as applicable; requires network connection and client set-up)

· Loaner Systems / Components / Modules

· Technical User Training Course Credits

· Advanced Training Package

· 20% Parts and Services Discount

· Most Up-to-Date Commercially Available Hardware Upgrades / Revisions

· Commercially Available Software Expansion Modules

· Technology Performance Package: replacement coverage for select normal wear-and-tear items b.

f. SP5-1SVMM Transducer

· Annual Preventative Maintenance

· Corrective Maintenance

· Hardware Upgrades/Revisions

· Software Upgrades/Revisions

g. L9-3S VMM Transducer

· Annual Preventative Maintenance

· Corrective Maintenance

· Hardware Upgrades/Revisions

· Software Upgrades/Revisions

2. HOURS OF COVERAGE

a. Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m.(MST), excluding the federal holidays listed as follows:

Federal Holidays:

Any other day specifically declared a National Holiday by the President of the United States

b. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

c. Hardware/software update/upgrade installations will be scheduled and performed at a mutually agreed upon time at no additional charge to the Government to be determined by the COR or designated representatives.

3. PARTS

a. The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled preventive, and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance), by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

4. SERVICE MANUALS/TOOLS/EQUIPMENT

a. The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. 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) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request.

5. SCHEDULED MAINTENANCE

a. The Contractor shall perform PM Service to ensure that the equipment listed performs in accordance with the original manufacturer’s specifications. Annual PM Service must be completed by December 31st of each year. An outline of the PM schedule and procedures shall be provided to the Biomedical Engineer.

b. The contractor shall provide a written description of the 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:

i. Cleaning of equipment.

ii. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer's specifications.

iii. Calibrating and lubricating the equipment.

iv. Performing remedial, non-emergent maintenance.

v. Testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn.

vi. Inspection and replacement of worn or frayed electrical wiring and cables.

vii. Returning the equipment to the operating condition and mode

viii. Providing documentation of services performed.

c. All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. The only exception is hardware/software update/upgrade installations which shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the Biomedical Engineer). The contractor shall provide software/hardware updates at no charge.

d. All exceptions to the PM schedule shall be arranged and approved in advance with the Point of Contact, or Biomedical Engineer. 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 Point of Contact at the completion of the PM.

e. Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

6. UNSCHEDULED MAINTENANCE

a. The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

b. Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the CO has the authority to approve/request an unscheduled maintenance service call to the contractor.

c. The contractor's FSE shall respond on-site within twenty-four (24) hours after receipt of request for service. The contractor shall provide parts, if required to effect repair, within 24 hours of diagnosing the problem.

d. There shall be no hourly charge to the Government for unscheduled maintenance performed within the normal hours of coverage, 8:00am MST to 5:00pm MST. Work performed outside the normal hours of coverage, at the request of the Biomedical Engineer, Point of Contact, or Contracting Office Representative, shall be invoiced separately and shall not have service rendered until Purchase Order is obtained. In the event of a Government caused delay, the VA will pay hourly labor charges for unscheduled service the inadvertently extends beyond the specified normal hours of coverage.

7. DOCUMENTATION/REPORTS

a. The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the specifications. Each Engineer Service Report (ESR) must, at a minimum, document the following data legibly and in complete detail:

i. Name of contractor and contract number

ii. Name of FSE who performed services

iii. Contractor service ESR number/log number

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

v. VA purchase order number(s) covering the call if outside normal working hours.

vi. Description of problems reported by the POC/user (if applicable).

vii. Identification of equipment to be serviced:

viii. Inventory ID number

ix. Manufacturer's name, device name, model number & serial number

x. Any other manufacturer's identification numbers.

xi. 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.

4. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

xii. Signatures:

1. FSE performing services described.

2. Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or CO before service is completed

b. The Contractor shall log-in and sign-in with Biomedical Engineering prior to performing any services. The Contractor shall submit any mobile media devices that would be used on a system to Biomedical Engineering for a virus scan prior to beginning work. If the Contractor does not have a VA provided contractor badge, the Contractor will obtain a temporary guest badge from Biomedical Engineering prior to beginning work on-site. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log-out and sign-out with Biomedical Engineering, return the guest badge, and submit the ESR(s) to the Biomedical Engineer or Point of Contact. All ESRs shall be submitted to the equipment user for an “acceptance signature” and then to the POC for an “authorization signature”. If the POC is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR).

8. OPERATIONAL UPTIME & DOWNTIME – REQUIREMENTS

a. The equipment shall be operable and available for use 95% of the normal hours of coverage as defined under “HOURS OF COVERAGE”. Downtime will be computed from notification of problem during normal coverage hours. Operational uptime will be calculated using month as the basis of calculation. Downtime and Uptime can also be provided based on the equipment record within Biomedical Engineering’s computerized maintenance management system (CMMS).

b. If a product fails to meet the contractor’s uptime commitment identified on the product schedule during any year of the agreement, the contractor will provide the applicable remedy listed below.

Remedy

Reduction in the amount of the then-current annual charge for the affected product during the following contract year, at the following amounts:

% Less than Uptime Commitment:

.1%-5% 5.1%-10% >10%

Reduction %:

5% 10% 15%

c. Uptime is calculated as follows: (Uptime-downtime)/uptime, with uptime measured as the coverage hours identified on the product schedule (hours per days x days per week x 52 weeks). Downtime is measured as the number of hours the product is inoperable and out of service.

d. Product is considered in service if the customer fails to give the contractor immediate and unencumbered access to it or continues to obtain scans from it after notifying the contractor of product failure. Products are considered out of service if it is unavailable for scanning patients and diagnosing images on the display console or operator’s console.

e. Peripheral equipment (e.g. remote console, magnetic tape drive, hard copy devices, multi-format, laser cameras) are excluded. Services required for anything other than product failure, and damage or inoperability beyond the contractor’s control, are excluded. The customer is responsible for tracking and calculating uptime. To be eligible for the remedy, the customer must maintain a performance log that includes data required to calculate downtime.

9. REPORTING REQUIRED SERVICES BEYOND SERVICE SCOPE

a. The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in, or repairs required, to the scheduled equipment which, the contractor does not consider his/her responsibility due to “abuse” or “damage” to the equipment. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

10. ACCEPTANCE OF CONDITION OF EQUIPMENT

a. The contractor accepts responsibility for the equipment covered under this equipment in an “as is” condition. Inspection of the equipment by the contractor shall be done prior to coverage, if required by the contractor.

11. COMPETENCY AND CERTIFICATION OF PERSONNEL SERVICING EQUIPMENT

a. Each respondent must have an established business, with an office and full-time staff. The staff shall include a fully qualified FSE and fully qualified alternate FSE.

b. “Fully Qualified” is based on successful completion of factory training and experience in the field. For training, the FSE shall have successfully completed a formalized training program for the equipment identified in the schedule. For field experience, the FSE(s) shall have a minimum of two years of experience (with the exception of equipment on the market less than two years) with respect to scheduled and unscheduled preventive and remedial maintenance, on the 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. The contractor shall provide copies of all factory certificates for FSEs showing types of equipment and dates of training for all equipment identified to be covered. When deemed appropriate, the COR or Contracting Office Representative reserve the right to prohibit contractor personnel from working on VAMC equipment.

d. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device- system, at the time of the maintenance event.

12. CONTRACTOR TEST EQUIPMENT

a. The contractor shall ensure all contractor supplied test equipment is properly calibrated, and certified. If requested by the COR or POC, the contract shall be able to supply any certificates tied to the quality of the test equipment. Test equipment calibration shall be traceable to a national standard.