CARTO Mapping ABLATION

Statement of Work CARTO 3 ABLATION UPGRADE GENERAL INFORMATION 1.0 Scope of Work: The objective of this project is to acquire an upgrade kit and a new generator for the existing CARTO 3 Mapping Ablation System at Harry S. Truman VA Medical Center (HSTVA) located at 800 Hospital Dr, Columbia, MO. This upgrade aims to enhance the system's performance, ensuring improved accuracy, safety, and efficiency in cardiac electrophysiology procedures.

2.0 Background: The Harry S. Truman VA Medical Center utilizes the CARTO 3 Mapping Ablation System for cardiac electrophysiology procedures. Over time, the existing generator and system modules have become outdated, impacting the effectiveness of the system and the quality of patient care. Given the critical role of precise mapping in treating arrhythmias, this upgrade is essential to maintain high standards of care. Supply Chain Management will conduct an incoming inspection upon delivery, and the Biomedical Engineering (Biomed) team will perform necessary checks to ensure proper functionality.

CONTRACTOR REQUIREMENTS 3.0 Technical Requirements/Tasks: The contractor must provide and deliver the following:

An upgrade kit suitable for the CARTO 3 Mapping Ablation System, including all necessary software and modules. A new, compatible generator specifically designed for the CARTO 3 System. Complete technical documentation and installation guides for both the upgrade kit and generator. Tasks to be performed by the contractor: Supply and deliver the specified upgrade kit and generator to the Harry S. Truman VA Medical Center. Provide support and training resources as needed for the proper installation and operation of the upgraded system components. Ensure all equipment and provided software/middleware meet the current standards and specifications for the CARTO 3 Mapping Ablation System.

Note: The contractor is expected to perform these services independently without direct supervision. Approval of key personnel may be needed but not on an individual-task basis. Clear, detailed documentation must be provided to enable VA personnel to execute installation without further oversight.

4.0 Government Furnished: The government will furnish the necessary environment and facilities to house and utilize the upgraded CARTO 3 System. The Harry S. Truman VA Medical Center, located at 800 Hospital Dr, Columbia, MO, will be the designated location for delivery. The COR (Tyler Wells, Tyler.Wells2@va.gov) is responsible for reviewing and approving reports and final products generated under the contract. Federal holidays and facility access limitations will be communicated as needed upon agreement.

5.0 Deliverables / Schedule:

Reporting Requirements: The contractor is required to provide status reports on the progress of procurement, delivery, and any encountered issues. This should be done on a bi-weekly basis, starting immediately after contract award.

6.0 Travel: Any required travel must be discussed and pre-approved by the Contracting Officer (CO) or Contracting Officer Representative (COR). All travel expenses will be reimbursed in accordance with Federal/agency travel regulations.

7.0 Contractor’s Key Personnel: Key personnel should have relevant experience in medical device delivery, installation, and customer support. Resumes may be required upon request to verify qualifications pertinent to the SOW requirements.

8.0 Security Requirements: No specific security clearances are required for delivery personnel; however, adherence to facility security protocols during delivery and setup is mandatory.

9.0 Data Rights: Any data produced, furnished, or used in meeting the contract requirements remains the property of the government. The contractor must ensure confidentiality and proper handling of any sensitive information. 10.0 Section 508 – Electronic and Information Technology Standards: All software and technology provided must comply with Section 508 requirements to ensure accessibility for individuals with disabilities.