NOTICE OF INTENT TO SOLE SOURCE: The Department of Veterans Affairs, Network Contracting Office 1 intends to award a sole source, firm-fixed price contract to Medtronics USA Inc to provide Carelink Express service with Medtronic Pacemakers. This service is in support of VA Connecticut medical center. The period of performance will be one year, with four option years. This contract action is for services for which the Government intends to solicit from only one Source under the authority of FAR 13.106-1, Single Source Awards. The NAICS code for this procurement is 811210- Electronic and Precision Equipment Repair and Maintenance size standard $34.0 Mil. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, interested parties may identify their interest and capability in response to this requirement by April 3, 2023 at 12:00 PM Eastern Standard Time (EST). The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses from responsible sources will be considered. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award. Interested parties are encouraged to furnish information by email only with RESPONSE TO INTENT TO SOLE SOURCE Medtronics USA Inc in the subject line. All documents submitted, will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Contract Specialist, James Moore at
[email protected]. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements. Statement of Work A.3 Statement of Work The contractor will provide CareLink Express monitoring services to VA Connecticut to remotely scan Medtronic Implantable Cardiac Devices (ICDs). During this process, the patient s implanted device is checked using the CareLink Express Monitor, and the patient device diagnostic data is synced to a provider-held App/Tablet for review by a Provider/Clinician. The App/Tablet receives Protected Health Information (PHI) and Personal Identifiable Information (PII) encrypted in accordance with HIPAA Policy where it is stored in the App/Tablets memory for 24 hours and transmitted to the Medtronic CareLink Network where it can then be accessed remotely by a Clinician and/or Medtronic representative who may provide a remote technical assessment of the data received. This data can then be transferred to the clinic or Hospital s Electronic Health Record (EHR) system and the Medtronic CareLink Network. Once the data is successfully uploaded to the Medtronic CareLink Network, the data is then deleted from the App/Tablet. The contractor will provide services for an unlimited amount of device scans per year. VA Connecticut is the only entity permitted to determine the number of devices that will be scanned. During the term of the contract, the contractor shall provide VA Connecticut with access to the CareLink Express Website. The contractor needs to take commercially reasonable steps to ensure Device Data provided on the website is accurate and free from viruses and other defects. The contractor will provide VA Connecticut with advanced notice of any changes to the website for a minimum of (7) seven days from when it is received by the contractor. For patients that have enrolled in the CareLink Express Network , device data will be uploaded to their profile and available at any time. Call Center The contractor shall provide 24/7 call center support to users of the CareLink Express Network . Users include all VA Staff who have signed up for accounts on the CareLink Express Network website. Monitor Kits The contractor will promptly replace or repair the Monitoring Kits, at the contractor s expense, upon notification by VA Connecticut. If this agreement is terminated for any reason, the contractor will provide VA Connecticut with all individually identified VA patient treatment records and/or other information in its possession, as well as any copies, within (7) seven business days of the termination of the agreement. Monitoring of Contract VA Connecticut s Program Specialist will be designated as the Point of Contact to monitor the contract and verify its compliance with technical requirements. However, any changes to the contract must be coordinated through a warranted Contracting Officer of VA Connecticut. Records Management - The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31, and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. The contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.