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SCOPE OF WORK: MPS Perfusion Full Service George E. Wahlen VA Medical Center 500 Foothill Dr Salt Lake City, UT 84148 Contractor shall provide a full-service service agreement, detailed below, for the... SCOPE OF WORK: MPS Perfusion Full Service George E. Wahlen VA Medical Center 500 Foothill Dr Salt Lake City, UT 84148 Contractor shall provide a full-service service agreement, detailed below, for the listed MPS perfusion equipment located at the VAMC in Salt Lake City. All services shall be provided in accordance with the specifications, terms and conditions contained herein. Covered Equipment and Systems Period of Performance: The Period of Performance is for one base year with (4) one-year options: Base Year Period: December 1, 2024 to November 30, 2025 Option Year 1: December 1, 2025 to November 30, 2026 Option Year 2: December 1, 2026 to November 30, 2027 Option Year 3: December 1, 2027 to November 30, 2028 Option Year 4: December 1, 2028 to November 30, 2029 The following equipment and systems are to be covered under this service contract. Table A: Equipment models, EEs, serials, and locations that must be included in this agreement. EE# SERIAL # MODEL 78584 3324 Quest Medical MPS2 78585 3325 Quest Medical MPS2 78586 3326 Quest Medical MPS2 DESCRIPTION/SPECIFICATIONS/WORK STATEMENT SERVICES: The C&A requirements do not apply, and that a Security Accreditation Package is not required. Contractor shall furnish the following: Preventative Maintenance including PM required parts and system verification are provided by the Contractor at no additional customer cost. Corrective Maintenance including required parts and system verification are provided by the Contractor at no additional customer cost. All parts shall be included in the contract cost and not charged separately. All parts shall be OEM certified and contain no gray material at no additional customer cost. All labor and travel shall be included in the contract cost and not charged separately. 2. DEFINITIONS/ACRONYMS: Biomedical Engineering - Supervisor or COR designee CO - Contracting Officer. COR - Contracting Officer's Representative. 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 operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer s latest established service procedures to ensure operation of equipment within manufacturer s or VA s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM. CM Corrective Maintenance. Maintenance tasks that are undertaken to identify, isolate and repair a fault in order to restore equipment, a machine or a system to an operational condition so it can perform its intended function. Services may include troubleshooting, disassembly, adjustment, repair, part replacement, realignment, and operational verification to manufacturer s or VA s performance specifications, whichever is most rigorous. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Outpatient Clinic premises. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. Acceptance Signature - VAMC employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR. NFPA - National Fire Protection Association. CDRH - Center for Devices and Radiological Health. VAMC - Department of Veterans Affairs Medical Center OEM - Original Equipment Manufacturer Gray material Products or components sold legally, but without the OEM s permission and outside the OEM s authorized distribution channels. 3. CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA. 4. PREVENTIVE MAINTENANCE (PM): Contractor shall perform Preventive Maintenance inspections and/or recertification and calibrations as listed in the above equipment table. PM and calibration required parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost. The contractor shall furnish documentation, including all measurements, calibrations, and recertifications data to certify that the system is performing in accordance with the performance specifications. 5. HOURS OF COVERAGE: Normal hours of coverage are (Monday through Friday) from 8:00am to 5:00pm, excluding holidays as identified in Section H. Work performed outside the normal hours of coverage at the request of COR will be billed at the government rate. A separate purchase order will be issued to cover the cost(s) associated with any call back service as described herein. 6. SERVICE MANUALS: The VAMC shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's 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 data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request. 7. DOCUMENTATION/REPORTS: The documentation will include equipment down time and detailed descriptions of the preventative maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail: Name of Contractor Name of FSE who performed services. Contractor Service ESR Number/Log Number. Date, Time (starting and ending), Hours-On-Site for service call. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced to include the following: Equipment ID # or EE#/MX#/Nuvolo# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action. Total Cost to be billed. Signatures from the following: FSE performing services described. VA Employee who witnessed service described. Equipment downtime calculated in accordance with Conformance Standards. NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED! 8. REPORTING REQUIREMENTS: The contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within 5 business days of work completion. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT. 9. ADDITIONAL CHARGES: There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. 10. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The Contractor shall immediately, but no later than 24 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. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs. 11. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in Section B, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract. 12. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to preventive maintenance on equipment identified in Section B. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VAMC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment. 13. TEST EQUIPMENT: Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard. 14. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS: The contractor's FSE shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court. 15. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD: The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall: Have methods by which all employees are educated as to risks associated with bloodborne pathogens. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract. Records Management Language for Contracts Required The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) 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. 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. INFORMATION SECURITY: Per VA Handbook 6500.6 Appendix B: Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. Per VA Handbook 6500.6 Appendix C: Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). END OF SOW