6525--Brand Name or Equal - Medrad Intego PET Infusion System

B. 2 – DRAFT - Statement of Work ___________________________________________________ BACKGROUND Iowa City VA Health Care System, Nuclear Medicine Dept., has a requirement for Medrad Intego PET Infusion System. The purpose of this requirement is to procure an automated F18 FDG infusion system for the Iowa City VA Health Care System. The procurement shall include all parts, materials, labor, travel, and training to complete the full installation of the F18 FDG infusion system at the location. SALIENT CHARACTERISTICS Specifications – Brand Name OR Equal - Medrad Intego PET Infusion System Minimum Specific Requirements: Infusion System must have cleared indications for use for delivery of FDG and NaF in the United States. Technical Requirements The procurement is for a quantity of 1 Medrad® Intego PET Infusion System by Bayer Radiology Solutions. The automated F18 FDG infusion system will be installed for use in the Iowa City VA Medical Center Nuclear Medicine Hot Lab, 2W23A. The infusion system will arrive with the following items to ensure device start-up: 3 Vial shields 1 Case Source Administration Sets 1 Case Patient Administration Sets 1 Power cord 1 Power retainer cable 1 Operating manual Contractor will ensure radiation shielding and safety features are compliant with Nuclear Regulatory Commission (NRC) and Food and Drug Administration (FDA) standards Cleaning/Sterilization Requirements The device shall be able to be cleaned with common hospital cleaning products. The contractor shall provide cleaning instructions (Instructions for use – IFU); electronic versions are acceptable. Delivery Requirements Delivery is required 90 days from award of the contract. Large deliveries are to be coordinated in advance with the COR to ensure necessary planning takes place. Contractor is to provide the COR with shipment tracking information. The following is the delivery location: Iowa City VA Health Care System Medical Center, 601 Hwy 6 West, Iowa City, Iowa 52246. Installation Requirements Full installation of the system shall be included as a part of this contract. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation. Patient Health Information The Contractor shall safeguard patient health information. The Contractor shall report to the Biomedical Engineering Department any issues with disclosed or unsecure patient health information. WARRANTY The equipment shall have a warranty of one (1) year from the full installation/acceptance of the equipment. Warranty support shall include repair of the system. Warranty support shall include all parts, materials, labor, and travel to complete the repair, or replacement of a defective/broken device. Requests for warranty support shall be made to the telephone support number provided by the Contractor. Warranty support requests shall be responded to within 2 days. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services. 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. On-Site Procedures Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department. Contractor personnel shall sign in using the department’s vendor sign-in sheet or vendor check-in QR code, filling out all required information. Contractor personnel’s tool bags are subject to inspection by the Biomedical Engineering Department upon arrival and upon departure. Contractor personnel shall sign out upon completion of visit. 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. The VA campus is non-smoking. Contractor personnel are required to comply with this policy. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas. INSTALLATION Installation is required by the Contractor. Contractor shall contract the Point-of-Contact within ten (10) business days from issuance of award to schedule installation. Full installation of the system shall be included as a part of this contract. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation. Patient Health Information The Contractor shall safeguard patient health information. The Contractor shall report to the Biomedical Engineering Department any issues with disclosed or unsecure patient health information. TRAINING On-Site Training is required. Contractor shall contact the Point-of-Contact within ten (10) business days from issuance of award to schedule the On-Site Training. Contract shall include training for the end-users in the operation of the system. Training shall be on the function and use of the device. Contract shall include training for the technical professionals (Biomedical Equipment Support Specialists). Training shall cover the maintenance, troubleshooting, and repair of the system. Contractor Requirements All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government. …