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SOURCES SOUGHT NOTICE FOR: BREAST LESION LOCALIZATION SYSTEM The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 15 has a requirement for BREAST LESION LOCALIZATION SYSTEM at Joh... SOURCES SOUGHT NOTICE FOR: BREAST LESION LOCALIZATION SYSTEM The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 15 has a requirement for BREAST LESION LOCALIZATION SYSTEM at John Cochran St Louis VAMC 915 North Grand Blvd, St Louis, Missouri 63106. This is not a Presolicitation or Solicitation announcement. This is a sources sought notice only. The purpose of this sources sought notice is to gain market knowledge of potential small business sources and their size classifications; HUBZone, 8(a), Small Disadvantage Business, Woman Owned Business, Veteran Owned Business, Service Disabled Veteran Owned Business relative to NAICS Code 325120, with a small business size standard not to exceed 1,000 Employees. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources only. No solicitation is currently available at this time. After review of the responses to this sources sought announcement a synopsis and/or solicitation announcement may be published at a later time. Responses to this notice shall include company name, address, point of contact, size of business pursuant to North American Industrial Classification Code (NAICS) and must respond to the following questions: 1) Is your business a small business under NAICS code 339112? 2) Does your firm qualify as a small disadvantaged business? 3) If disadvantaged specify if your firm is certified under Section 8(a) of the Small Business Act? 4) Are you a certified HUBZone firm? 5) Are you a woman-owned or operated business? 6) Are you a certified Service-Disabled Veteran Owned or Veteran Owned business? 7) Is your business a large business? Please provide a capability statement addressing your organization s ability to perform as a prime contractor the work described in the draft PWS (below). Index your firm s capabilities to the tasks in the draft PWS so that your firm s capabilities can be readily assessed. This is not request for proposal and in no way obligates the Government to award any contract.  Please provide responses in writing no later than 16 March 2023 to: lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses to this sources sought announcement will not be considered as a response to any solicitation, a request to be added to a prospective offerors list, or to receive a copy of any solicitation. No solicitation is currently available at this time Scope of Work VA Saint Louis Health Care System Objective The VA Saint Louis Health Care System intends to procure a breast lesion localization system. This document highlights the technical specifications and services being requested by the facility for consideration towards purchase of the units. Vendors under this proposal shall provide all equipment and accessories, installation services, and project management support. Equipment Specifications Requirements 18-guage needle probe Wire-free marker Transport box FDA approval System functionality Localization system able to detect marker up to 60mm. Marker visible under X-ray and ultrasound Software Vendor shall ensure all software operating on the device provided is supported by the original manufacturer at time of delivery. For example, vendor shall not provide VA Saint Louis a device utilizing the Windows XP or Windows 7 operating system as they are no longer Microsoft supported. Proprietary software systems are acceptable so long as vendor supports the version provided to VA Saint Louis and it is the newest version at time of delivery. Access to all software shall be provided to VA Saint Louis in situations where re-installation is necessary. Software shall be provided to VA Saint Louis with unlimited perpetual licensing for the supported life of the device. In cases where vendor insists on utilizing a licensing fee model this should be noted in the bid provided for VA Saint Louis consideration. Network Security The vendor is required to fill out the five attached VA Security Forms if their equipment can be connected to the VA network. If these forms are not completed and submitted with the bid package the vendor can be disqualified from the bidding process. Cerner Compatibility All vendors providing a bid to this requirement shall provide a Cerner compatibility statement from the OEM of the equipment that they are proposing to the VA Saint Louis Health Care System. This statement will include an OEM attestation that the product proposed is Cerner verified and provide a list of healthcare organizations that have deployed the project with the Cerner EHR. The statement will also include any relevant information as to what data can be transmitted to Cerner. This statement will be dated within 60 days of the quote being provided to ensure it is recent and accurate. The statement will provide an OEM point of contact who can be reached to further discuss any questions or concerns over Cerner compatibility. If the device/system being proposed does not connect to the network or medical record the vendor shall note this in their proposal. Vendor bids that do not include a Cerner compatibility statement directly from the OEM will be discarded from consideration. Installation and Assembly Vendor shall be responsible for assembly and installation of systems after notification from VA Saint Louis Biomedical Engineering that it has been delivered to station. Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, O&IT staff, and others identified as needed. Install shall include unboxing and transportation of equipment to final use location. Assembly and install shall occur within 30 days of delivery to station. Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device. Training Vendor shall provide on-site clinical/applications training for relevant VA Saint Louis staff members. Vendor shall provide introductory system/maintenance training to VA Saint Louis Biomedical Engineering staff during installation. Vendor shall include all costs for travel to provide this training in their proposal. Vendor shall coordinate all installation and training dates with VA Saint Louis specified Biomedical Engineering POC who will communicate internally with clinical staff. Warranty and Service Service and Operator Manuals The vendor shall provide the following documentation for the proposed system: Two (2) copies of operator's instruction manuals per unit purchased Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, parts lists, and any other resources available to the manufacturer s service technicians. Two (2) copies of a system manager s manual outlining back-up procedures, managing privilege group limits, routine tasks, etc. Warranty The system, all accessories, and all software shall be covered under the manufacturer s warranty and shall include all parts and labor for at least one year following acceptance by the VAMC. A manufacturer s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period. The warranty period shall not begin until after the VA Saint Louis Biomedical Engineering POC has accepted the products delivery, installation, and functionality. The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration. All available software updates and security patches will be made available to the VA Saint Louis during the warranty period. Vendor shall provide response to applications and technical calls within 8 hours. Vendor shall ship replacement parts within 48 hours of identifying necessity by VA Saint Louis Biomedical Engineering staff. Other Features Value added features in the vendor s proposal that will be considered include but are not limited to: Options for Trade-in of existing equipment shall be proposed in bid package Extended Warranty options shall be outlined in bid package Service and Biomedical training options shall be outlined in bid package Options for this training should include all registration, travel, and lodging costs when possible Hours of Operation Normal hours of coverage are Monday through Friday, 7:00 AM to 3:30 PM Central Standard Time excluding national holidays. Vendor on-site visits will be coordinated with the VA Saint Louis Biomedical Engineering POC before being scheduled or conducted. Vendor representatives will check in with the VA Saint Louis Biomedical Engineering POC when they arrive on-site and check out upon completion of work each day. All services shall be performed during normal hours unless otherwise scheduled with the VA Saint Louis Biomedical Engineering POC. Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center. Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging and a clean sweep/mop of the area as required by work type. Vendor staff shall minimize noise as much as possible while working in all buildings. Vendor is responsible for providing all PPE necessary for their work. Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the VA Saint Louis Biomedical Engineering POC). Federal Holidays observed by VA Saint Louis are: New Year s Day Labor Day Martin Luther King Day Columbus Day President s Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day Delivery Vendor shall deliver purchased equipment within a reasonable amount of business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the VA Saint Louis Biomedical Engineering POC. Delivery will be to one of the two VA Saint Louis Health Care System main campuses. Vendor shall coordinate exact delivery location with the Contracting Officer and VA Saint Louis Biomedical Engineering POC at the time of the purchase. Vendor will ensure that equipment is sent to the Attention of Biomedical Engineering and will include the VA Saint Louis PO Number on the shipping label. Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with VA Saint Louis Biomedical Engineering POC who will communicate internally with Warehouse Staff. VA Saint Louis Health Care System Delivery Locations John Cochran 915 North Grand Blvd Saint Louis, MO 63106 ATTN: Biomedical Engineering PO Number for Order Jefferson Barracks 1 Jefferson Barracks Drive St. Louis, MO 63125 ATTN: Biomedical Engineering PO Number for Order RECORDS MANAGEMENT OBLIGATIONS A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. B. Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record: 1.includes VASTLHCS records. 2.does not include personal materials. 3.applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. 4.may include deliverables and documentation associated with deliverables. C. Requirements 1.Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2.In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3.In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4.[Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5.The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6.The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7.The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy. 8.The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract. 9.The 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 from public disclosure by an exemption to the Freedom of Information Act. 10.The [Agency] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11.Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown of requirements to subcontractors 1.The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. 2.Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.