6525--Carto System Upgrade

1. This is a combined synopsis/solicitation for commercial services/items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. 1.A. Project Title: CARTO mapping system upgrade 1.B. Project Location: VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161 1.C. Solicitation Type - Number: Request for Quotes (RFQ) - 36C26222Q1129. 1.D. Set Aside: This solicitation is 100% set aside for Service-Disabled Veteran Owned Small Businesses IAW Public Law 109-461, 38 USC Section 8127 1.E. Applicable NAICS code: 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing 1.F. Small Business Size Standard: 1250 Employees 1.G. Type of Contract: Firm Fixed Price 1.H. Period of Performance: Delivery required within 30 days 2. Submit written offers in accordance with the following instructions, as well as Addendum to FAR 52.212-1, Instruction to Offerors. Oral offers will not be accepted. Complete and submit enclosure 2 via email no later than 10am Tuesday June 28, 2022 to contact@example.gov. Ensure the following are completed and/or included in the offer packet: 2.A. Vendor Information 2.B. Acknowledgement of amendments 2.C. Concurrence/non-concurrence with solicitation terms, conditions, and provisions 2.D. Schedule of services with projected ship date 2.E. FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items 2.F. 852.219-78 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products 2.G. VA Directive 6550 Appendix A and Manufacturer Disclosure Statement for Medical Device Security 3. Scope: The Veteran s Integrated Service Network 22 is seeking a contractor to provide upgraded hardware and software for the Biosense Webster CARTO mapping system. The CARTOSEG CT Segmentation Module provides anatomic detail to enable providers to efficiently plan their ablation strategy when treating complex arrhythmias. The CARTOSEG CT Segmentation Module automates the CT segmentation process, providing detailed anatomic 3D image integration in the CARTO® 3 System while highlighting discrete anatomic structures. This module semi-automatically segments all four chambers, aorta, coronary sinus, coronary arteries and esophagus. This requirement is for brand name only to ensure compatibility with the current system. 3.A. Required Items 3.A.1. Signal Processing Unit (SPU), Item # KT507000 3.A.2. CARTOSEG CT Module for CARTO 3 System, Item # KT5400160 3.A.3. Complex Fractional Atrial Electrograms (CFAE) Software to be used with the CARTO 3 System, Item # C3CFAE 3.A.4. V7.2 (Windows 10) Base SW Upgrade Kit, Item # KT5400250US 3.D. Additional Requirements. Place Of Delivery: VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161 Hours: Normal duty hours are 7:30 a.m. through 5:00 p.m., Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the Contractor shall coordinate these times with the designated COR, POC or designee. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Last Monday in January Memorial Day Last Monday in January Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th Noncontract Charges: The contractor shall not perform any service that will result in additional charges without prior approval from the Contracting Officer. Payment: Payment will be made upon receipt of a properly prepared invoice which references the period for which payment is due, the contract number and/or assigned purchase order number. The invoice must include the correct payment address. Waste Removal: The contractor is responsible to remove and properly dispose of all waste related to the services provide on-site at all VA facilities. 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. All shipping costs will be included in the cost of the contract. 4. SECURITY 4.A. Information Security 4.A.1. The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. 4.A.2. The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES sited in section C. Contract Clauses 4.A.2(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov 4.A.2(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov 4.B. Contract Personnel Security 4.B.1. All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident. 5. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 Effective May 26, 2022. The following provisions and clauses apply to this solicitation and can be found in enclosure 1. 5.a. FAR 52.212-1, Instructions to Offerors Commercial Items 5.b. FAR 52.212-2, Evaluation Commercial Items 5.c. FAR 52.212-4, Contract Terms and Conditions Commercial Items 5.d. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items 5.e. VAAR 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside 5.f. VAAR 852.219-74, Limitations on Subcontracting Monitoring and Compliance 5.g. FAR 52.252-2, Clauses Incorporated by Reference 5.h. VAAR 852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items 5.i. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment