Combined SoW 2-2-2023.pdf

STATEMENT OF WORK

The contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items necessary to provide full-service maintenance (preventive and corrective maintenance), remotely and on site for the Impella® Heart Pumps located at the VA Medical

Centers, in Wilkes-Barre, PA 18711 and Pittsburgh, PA 15240 and as defined in this Statement of Work (SoW).

WORK TO BE PERFORMED:

Service Agreement Coverage (Includes AIC Console and Cart)

1. All Preventive and Corrective Maintenance as required

2. All factory qualified parts

3. Service loaners as needed if covered equipment not available for clinical use due to service-related issue

4. Includes all labor, round trip shipping via FedEx Priority, packaging material (average PM turnaround time 1-2 days)

5. Ensures compliance to Regulatory requirements.

6. 24 Hour expert phone support

7. Equipment history, including service reports and data sheets provided

8. Factory revisions implementing up-to-date quality improvements installed during preventive maintenance

9. One free rental, up to 5 days, per contract year for each covered system

Equipment:

Item Qty Model S/N Location

1 1 AIC IC2457 Pittsburgh

2 1 AIC IC2621 Pittsburgh

3 1 AIC IC9872 Pittsburgh

4 1 AIC IC6350 Wilkes-Barre

5 1 AIC IC6351 Wilkes-Barre

SPECIAL WORK REQUIREMENTS:

Documentation

At the completion of each service call or scheduled maintenance, the contractor shall provide a written service report to the designated points of contact at the corresponding medical centers. This report will clearly indicate the following:

1. Date of Service

2. Name of Vendor Service Technician/Engineer

3. Type of Service Performed

4. Model

5. Serial Number

6. VA Barcode (EE Number) of the Component of the System

7. Description of the Service Completed

8. List of Any Parts Replaced

9. Obligation Number (693-CXXXXX (see schedule)).

The contractor’s name and obligation number are to be listed in the subject line. Failure to provide complete and legible documentation as described may result in payment delays or nonpayment.

Calibration and Documentation of Contractor's Test Equipment:

Test and measuring equipment used by the contractor during performance of this contract must be calibrated within twelve months to a traceable national or international standard, such as

National Institute of Standards and Technology (NIST). Each service instance, where the contractor’s test and/or measuring equipment is used to calibrate, maintain or repair the medical equipment identified in the equipment list; the contractor must track the specific equipment used.

This equipment should be uniquely identified on the service documentation provided to the facility at the completion of the service instance. The identification should be traceable back to the specific test and measuring equipment used. Upon request, the contractor is required to provide the technical points of contact with documentation verifying the calibration of the equipment. This documentation should, at a minimum, include the following:

1. Unique identifier for the test and measuring equipment. This should match the identifier on the service documentation.

2. Testing interval.

3. Test date.

4. Next test due date.

5. “As Received” and “As Returned” status of the equipment being tested (e.g., was equipment in tolerance or not when received for testing? and was equipment in tolerance or not when returned?).

6. Calibration results.

7. Identification of the device used to test equipment.

8. Statement of traceability to the national or international standard used in the testing and calibration of the equipment. The national or international standard will be specified on the certificate.

9. Reference to the testing procedure used.

10. Calibration company identification information including company name,

11. address, phone number and name of specific representative completing

12. performance testing and calibration service.

The contractor is required to respond to all repair requests during normal business hours, via phone call within one hour of receipt of request, or within 4 hours if responding in person.

The contractor shall notify the designated point of contact and the police service when they arrive on site. The contractor will schedule all preventative maintenance with the proper individuals at each medical center.

Performance Period:

The period of Performance will be a Base Period of one (1) year from the date of award, followed by four, one-year options to be awarded consecutively.

Modifications:

In Accordance with FAR 43.102, Only contracting officers acting within the scope of their authority are empowered to execute contract modifications on behalf of the Government. Other

Government personnel shall not-execute contract modifications; act in such a manner as to cause the contractor to believe that they have authority to bind the Government; or direct or encourage the contractor to perform work that should be the subject of a contract modification.

Contract modifications, including changes that could be issued unilaterally, shall be priced before their execution if this can be done without adversely affecting the interest of the

Government. If a significant cost increase could result from a contract modification and time does not permit negotiation of a price, at least a ceiling price shall be negotiated unless impractical. Copies of each contract modification executed will be kept in a project folder along with all other products of the project. Contractors who incur costs through the actions of parties other than a warranted Contracting Officer shall be borne by the contractor.

Travel:

Travel expenses are the responsibility of the contractor.

Contractor Personnel Security Requirements

The Equipment is not part of the medical center’s network and does not store PHI/PII.