36C245-24-AP-3550 Statement of Work ABIOMEDICAL.docx

Statement of Work

PROJECT NAME: Abiomed Impella AIC System Support Contract

A. GENERAL

Scope of Services:

The purpose of this requirement is to provide support for the AIC Impella systems at Washington DC VAMC. The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform service and maintenance.

Location: Washington DC VA Medical Center, 50 Irving Street NW, Washington, DC 20422

B. WORK HOURS

a. Hours of Operation: Normal business hours are Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays. Should the Contractor require work afterhours, the Contractor shall arrange in advance with the Contracting Officer’s Representative (COR).

b. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays.

c. National Holidays: The holidays observed by the Federal Government are: New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday. Contractor may work on holidays with prior communication and coordination.

C. PERIOD OF PERFORMANCE

D. EQUIPMENT

EE 1296068/

SN IC2630

E. SPECIFICATIONS

a. Preventative Maintenance

i. This contract shall include all preventative maintenance of the equipment according to manufacturer’s recommendations/procedures in the equipment manual.

ii. All tasks in the manufacturer’s procedures shall be completed at the manufacturer’s listed frequencies.

iii. The maintenance shall include:

1. Thorough exterior inspection

2. Power alarms

3. Data transfer

4. Keypad functions

5. Data and time check

6. Purge cassette

7. Purge driver

8. Purse pressure sensor/display

9. Short circuit simulation

10. Phase cut simulation

11. Signal cut simulation

12. Pump change

13. Emergency stop

14. Battery test

15. Power charge test

16. Battery check/ Fan check/ Power fail alarm

17. Data transfer/ SW update

18. Software / Firmware/ Hardware version

iv. PMs will be accomplished in accordance with the Original Equipment Manufacturer (OEM) recommendations.

b. Corrective Maintenance

i. The contract shall include all on-site corrective (unplanned) maintenance/repair of the equipment in accordance with the manufacturer’s manual.

ii. Recalls & Alerts-- Contractor shall perform all remediation actions needed for product alerts and recalls issued for the equipment.

iii. The contractor will perform unlimited corrective services on equipment/systems under full coverage agreement from OEM.

c. Parts/Materials/Tools/Labor

i. All parts and materials to complete the maintenance shall be included as a part of this contract

ii. Contractor shall provide their own tools to complete the maintenance.

iii. All labor (including travel) to complete the maintenance is included in the contract.

iv. Contractor must use OEM certified parts and service. Use of refurbished parts have to be approved in writing by Biomedical Engineering prior to use.

v. Engineer/technicians must be OEM trained on all equipment included in agreement. Proof of competency to be provided upon request.

d. Updates/Patching

i. Contractor shall complete available updates to the software at the discretion of Biomedical Engineering.

ii. Contractor shall complete all patching according to manufacturer’s specifications.

e. Response Time

i. Contractor shall respond to trouble phone calls within thirty minutes.

ii. The minimum standard response time for dispatch will be no later than the following workday after notification of equipment malfunction.

iii. Service agreement service call priority with OEM under active coverage.

f. Check in/Out

i. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

ii. Contractor personnel shall sign in using the department’s vendor sign in sheet, filling out all required information.

iii. Contractor personnel’s tool bags are subject to inspection by the Biomedical Engineering department upon arrival and upon departure.

iv. Contractor personnel shall sign out upon completion of visit.

v. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the Biomedical Engineering department, especially noting if the system is still down or not fully repaired.

vi. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

vii. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

g. Reporting

i. Within 5 business days of award, must provide validation of equipment active coverage with OEM to certify service agreement in place.

ii. Contractor shall provide a copy of the service report, complete with test data, to the VHAWASHTM@VA.GOV within three business days after completion of any services.

iii. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided.

h. Remote Support

i. The Contractor shall provide a telephone line available 24/7/365 for technical support. Contractor shall also provide a phone number for VA staff to call to dispatch Contractor field service engineers/technicians.

ii. If remote support via site-to-site virtual private network (VPN) is required, Contractor shall work with the COR and the facility Information Security Officer (ISO) to meet the requirements prior to connection. A National Site to Site MOU/ISA is the preferred way to complete this connection.

i. Patient Health Information

i. The Contractor shall safeguard patient health information.

ii. The Contractor shall report to the Biomedical Engineering Department any issues with disclosed or unsecure patient health information.

iii. Contractor shall note remove any hard drives, storage devices, or anything containing patient health information from the site.

j. Contractor Requirements

i. All Contractor personnel performing services on the equipment shall have factory training and experience in the maintenance and repair of the equipment.

ii. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government.

iii. Waste Removal: The contractor is responsible to remove and properly dispose of all waste related to the services provide on-site.

k. Safety and Security

i. Contractor shall follow all Occupational Safety and Health Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact.

ii. Contractor shall follow all local procedures concerning infection control. Should the Contractor be unsure of the requirements, the COR can provide the specific information and procedures.

iii. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

iv. Property Damage

1. The contractor shall take all necessary precautions to prevent damage to any Government property.

2. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken.

3. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer.

v. Chemical Use

1. Prior to performance of any work, the Contractor will be required to furnish the Contracting Officer with the trade names (if any) and chemical names of all chemicals to be used, along with a label showing contents, the use strength of the chemical as applied, and the antidote thereto.

2. Contractor shall furnish the same information each time a change is made to the chemicals or products used in the performance of this contract.

3. This information is required for emergency treatment in the event of ingestion or and/or contact with the material by humans.

F. QUALITY ASSURANCE

a. End-users, Biomedical Engineering, and/or the contract COR shall perform system verification tests to ensure the system is fully functional following service/repairs.

b. Issues with the quality of the Contractor’s work will be communicated through the Contracting Officer to the Contractor point of contact for resolution.

c. Documentation with be completed in the Government systems.

G. Invoicing/Payment

a. Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer.

b. Payment: Payment will be made in arrears, and upon receipt of a properly prepared invoice. Any invoice that is not properly prepared may get refused and sent back for correction. An invoice must include the following criteria to be considered “properly prepared”:

i. Contract period of performance and monthly period of performance when the service was completed.

ii. Equipment SN and model name serviced.

iii. Contract number

iv. Purchase order number

v. Correct payment address H. GUARANTEE: The contractor will guarantee workmanship and all parts furnished by the contractor for a period of not less than 90 days.

I. PRIOR INSPECTION OF EQUIPMENT: Potential contractors may, at their own expense, inspect equipment covered by this solicitation (ref 52.237-1 SITE VISIT). Arrangements must be made in advance with Biomedical Engineering.

J. Failure to carry out the above procedures will be considered as a failure to document the service visit and will constitute a failure to perform.

ORIGINAL EQUIPMENT MANUFACTURER (OEM) LETTER

image1.png