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STATEMENT OF REQUIREMENT: Service Agreement for Primary Systems General Information Service Agreement: The St. Louis VA Medical Center is requesting to establish a service contract for maintenance and... STATEMENT OF REQUIREMENT: Service Agreement for Primary Systems General Information Service Agreement: The St. Louis VA Medical Center is requesting to establish a service contract for maintenance and repair on the GE Uroview at John Cochran (JC). The facilities are located at: VA St. Louis Healthcare System John Cochran Division 915 N. Grand Blvd. St. Louis, MO 63106 Scope of Work: The Contractor shall supply all labor, travel, materials, equipment, tools, supervision, and all incidentals required to complete on-site full-service preventative maintenance and corrective maintenance (repair) of the equipment identified in Section II, in accordance with Manufacturer’s recommendations, Joint Commission standards, design specifications, and the specifications, terms, and conditions of this contract. Background: Our Uroview 8K offers precision imaging, dynamic workflow, and optimal access for urological procedures. The equipment is critical for urological imaging at the VA Medical Center. This procurement is to establish a service contract required to cover preventative and corrective maintenance services. This contract is issued to ensure the continuous reliability of the equipment identified in the statement of work. The reliable and accurate operation of the equipment at all times, is considered critical to the health of patients. Performance Period: The Contractor shall begin the work required under this SOW commencing with the effective date of award, unless otherwise directed by the CO, and shall provide continuous service until the date of contract expiration. The contract would be for 1 year starting March 15, 2025 through March 14, 2026 with up to 4 additional option periods Type of Contract: Firm-fixed-price Equipment to be Serviced Each of the following items is to be serviced in accordance with the specifications, terms and conditions of this contract. Line Item Manufacturer Model Location 1 GE Healthcare UROVIEW 8K John Cochran Services to be Provided The contractor shall provide preventative and corrective maintenance, including emergencies, on the equipment outlined above in Section II. Summary of Services Annual PM on each system Priority scheduling for service calls and access to spare parts inventory Priority Remote Service response Second response, including labor and travel during standard hours of coverage One-hour initial response with four hour on-site response All spare parts that fail during normal use. (Excluding consumables) Parts Delivery 10:30AM Next Day Lifecycle Catalogue discount of 15% excluding UPS Proprietary operating system software enhancements without hardware changes (excludes software upgrades) Unlimited Technical Services (24x7) & Clinical Applications Telephone Support (Mon-Fri 8am - 5pm) Remote Service Support (includes Remote Desktop) Remote Proactive Monitoring Reports: PSI Eligible, service history, PMs on request, utilization reports, Customer Loyalty Meeting (Quarterly) Preventative Maintenance The Contractor shall perform preventive maintenance (PM) service to ensure that equipment listed in Section II performs in accordance with Section B.4 (g) Conformance Standards. The Contractor shall provide checklists and utilize procedures with worksheet originals indicating work performed and actual performance values obtained (as applicable). The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. This documentation shall be provided to the COR at the completion of the PM. PM services shall be provided on an annual basis (one PM each year). Any exceptions to the PM schedule shall be arranged and approved in advance with the COR and provided in writing to the Contracting Officer. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM shall be included within this contract’s agreed upon price, unless otherwise specifically excluded. Any fuel surcharges will not be authorized. The Contractor shall notify the COR and Biomed Supervisor at least 48 hours in advance of the date of contemplated preventative maintenance inspection. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of the COR or alternate COR if down time is not considered significant. The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. If the contractor identifies issues outside of the scope of the contract, the contractor shall provide a quote to resolve the issue as part of a separate agreement and allow the work to continue under the current contract scope. Corrective Maintenance The Contractor, COR, and Biomedical Engineering staff shall maintain the equipment in accordance with Section B.4 (g) Conformance Standards. Contractor shall provide unlimited telephone technical support and all required parts. Only the CO, COR, or designated alternate has the authority to approve/request a corrective maintenance service call to the Contractor. CO or COR authorization for any work must be received prior to performance of work or payment will not be authorized. Corrective maintenance service calls are unlimited and incur no charge for other than normal working hours. Technicians responding for emergency corrective maintenance service must report to the COR, Biomed Supervisor, or designee (after hours). Upon completion of service/repair, the technician shall again report to that person. Parts The Contractor shall have ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment and adhere to the Buy American Act. The contract shall include all parts except -if applicable - those parts specifically listed as being EXCLUDED. The Contractor shall use only new Original Equipment Manufacturer (OEM) or OEM-approved parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Parts removed from another system, rebuilt and/or used, shall not be installed without specific approval by the COR. All defective parts replaced become the property of the Contractor, unless otherwise specified by the COR or Alt COR. Consumables are excluded. Service Manuals/Tools/Equipment The VA shall not provide tools, test equipment, service manuals, or service diagnostic software to the contractor. Contractor shall obtain, have on file, and make available to its Field Service Engineer (FSE) all operational and technical documentation (such as operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service manuals, by name and/or the manuals themselves shall be provided to the COR upon request. The Contractor shall provide the COR and the Biomedical Engineering Shop Supervisor copies of all documentation that pertains to any hardware, software, or firmware upgrade or repair. Copies of the latest version(s) of all documentation and licensing agreements, which shall include operation, service, and diagnostic software. The COR shall have access to the same operation, service, diagnostic software, and documentation as the OEM's FSE. Contractor shall provide to the COR OEM Service Bulletins for the equipment covered under this contract. All documentation and service bulletins, etc. shall be provided within 30 days of award in either hard copy or electronic format. Any future service bulletins generated during the contract period shall be provided to the COR within 30 days of receipt in either hard copy or electronic format. Services Not Covered by Contract CO is the only individual with the authorization to approve any work outside the scope of this contract. The Contractor shall provide a quote for any work that is outside the scope of the contract and the CO will evaluate the price and if applicable, the CO will negotiate with the Contractor. If the CO and the Contractor agree on pricing and it is approved to add the new scope to the contract there will be a subsequent modification awarded to add the new scope. Removal of Equipment Approval from the COR must be obtained before removing any equipment from the VA Medical Facility. No transportation charges will be allowed for either the repair person or equipment to or from the Contractors facility. The Contractor will be responsible for all damage or loss of equipment. A loaner of the same type and functionality of the equipment removed, if required, shall be furnished, installed, and made fully operational by the contractor without additional cost. Competency of Contractor Personnel All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall have an established business, with an office and established/hired full-time staff. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs. “Fully Qualified" is based upon training and experience in the field. For training, the FSE(s) must have successfully completed a formal OEM Certified (or equivalent) training program for all equipment to be maintained and all equipment to be utilized in the performance of the contract. The preferred experience of the FSE(s) is a minimum of two years in the installation, calibration, maintenance, and repair of the specific equipment identified in Section II. If subcontractor(s) are used, they must meet the same competency standards as Contractor personnel and be preapproved by the CO. The Contractor shall submit any proposed change in subcontractor(s) to the CO for approval or disapproval. The CO and/or the COR or Alt COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on equipment. Condition of Equipment All equipment is currently fully operational per required standards as set forth by the manufacturer. A list of standards may be provided upon request during solicitation. Conformance Standards Contractor shall ensure that the equipment functions in conformance with the standards established by the manufacturer and Accrediting Organizations such as FDA, TJC, and VHA. These standards may be provided on request during solicitation. Hours of Coverage The Contractor will provide all non-emergent services within normal VA STL business hours (7:00 AM to 4:00 PM (CST) M-F). All services shall be performed during these normal hours of coverage unless one of the following conditions exists: The Contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the Contractor submits a request to the COR prior to the proposed start of the work, and the request is approved in writing by the COR before work has begun. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage. Work performed outside the normal hours of coverage must be pre-approved by the CO, COR, or Alt COR. The Contractor will provide a written estimate of the charges prior to approval of the work. The Contractor shall provide coverage 24 hours/day, 7 days/week and all holidays. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts. Hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government. Federal Holidays Observed by the VA Medical Center New Year’s Day, Martin Luther King, Jr. Day, President’s Day (Washington’s birthday), Memorial Day , Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States. Documentation/Reports No later than seven (7) business days after the conclusion of any maintenance or repair the Contractor will provide to the COR or Alt COR a signed detailed service/inspection report listing all devices, all repairs for each device, parts used to maintain or repair the devices, and operating efficiency of the devices. The service/inspection report shall contain, at a minimum, the following information: Date and time of the technician’s arrival on station. Type, model, and serial number(s) of all equipment on which maintenance was performed. Total time spent performing maintenance (exclusive of any travel time). Detailed narrative description of work performed. Complete list of parts replaced. Comments as to the cause of the malfunction when applicable Date and time the repair/preventive maintenance was completed. Security Requirements Upon arrival at the VA Medical Center, all Contractor personnel shall be required to report to the VA Medical Center Police for a temporary ID and then to the COR for check-in. This check-in process is mandatory. When the service is completed, the personnel shall be required to check out with the COR or Biomedical Engineering Shop Supervisor. Exposure to Blood Borne or Infectious Material There is a potential for exposure to blood borne or other infectious material with equipment throughout the medical centers. All maintenance persons must use the “Universal Precautions” (e.g., decontamination of medical equipment, wearing protective gloves, aprons, and goggles) during cleaning and maintenance/repair procedures. Test Equipment The Contractor shall provide the COR or Alt COR with a copy of the current calibration certification of all test equipment which is to be used by the Contractor in the performance of this contract. Test equipment calibration shall be traceable to a national standard. Identification, Parking, Smoking, and VA Regulations Contractor’s personnel shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from VA Police Service. VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not local district, state, or municipal court. Smoking is prohibited inside all VA buildings. Definitions/Acronyms CO – Contracting Officer COR – Contracting Officer’s Representative ESR - Engineering Service Report - Documentation provided by the vendor of the services rendered for each incidence of work performance under the terms and conditions of the contract. FSE - Field Service Engineer - A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the AVAHCS premises. NFPA - National Fire Protection Association. OEM – Original Equipment Manufacturer. OSHA – Occupational Safety and Health Administration. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions. Unscheduled repairs – emergency services required to restore equipment to working condition outside normal hours of coverage. UL – Underwriter’s Laboratories 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.