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Page 1 of 3 INTENT TO SOLE SOURCE: PROCUREMENT OF DIRECTCARE BASIC AND TECHCARE FOR MEDRAD EQUIPMENT INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. Th... Page 1 of 3 INTENT TO SOLE SOURCE: PROCUREMENT OF DIRECTCARE BASIC AND TECHCARE FOR MEDRAD EQUIPMENT INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored. The Department of Veterans Affairs White River Junction Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for DirectCARE and TechCARE for MedRad Equipment Service to be performed at VAMC White River Junction by Original Equipment Manufacturer Bayer HealthCare LLC Technology, knowledge, technical expertise, and servicing capabilities for the DirectCARE and TechCARE for MedRad Equipment Service are proprietary to Bayer HealthCare LLC. A Sole Source Letter was provided by the Original Equipment Manufacturer (OEM) describing the proprietary nature of the DirectCARE and TechCARE for MedRad Equipment Service establishing this requirement as being peculiar in distribution to Bayer HealthCare LLC. The letter states that only the Bayer HealthCare LLC is authorized to perform the DirectCARE and TechCARE for MedRad Equipment Service The authority for applying the Simplified Acquisition Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B). The intent is to procure these products on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 811210. The most current Business Size Rating for this NAICS is $30 Million. Capable parties may identify their interests and authorization to respond to this requirement by November 14th, 2022, at 10:00 AM (EDT). A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer. STATEMENT OF WORK PREVENTIVE & CORRECTIVE MAINTENANCE OF THE Bayer Injectors White River Junction VA Medical Center General Information: This is a service agreement with Bayer to provide maintenance and repair to 5 radiology injectors units located at the White River Junction VA Medical Center, 163 Veterans Dr, White River Junction, VT 05009. Type of Contract: Firm Fixed Price Service Contract Contract Performance Period: 12/1/2022-11/30/2023 Contract Transaction Number: Scope of Work Requirements for Equipment: EQUIPMENT IDENTIFICATION: Medrad Mark 7 Arterion SN 301540 Medrad Portegra2 system SN 115/20075, 1219/24935, 0510/12747 Medrad MRXperion MR Injection System SN 310445 Medrad Mark V Provis System SN 94316 OPERATIONAL UPTIME - REQUIREMENTS: The injector units shall be operable and available for use 98% of the normal operating hours of the equipment as detailed in paragraph 13, HOURS OF COVERAGE. Downtime will be computed from notification of problem during normal work hours. GUARANTEED RESPONSE TIME: Bayer will respond to VA s request within twenty-four (24) hours and will use reasonable efforts to provide the on-site service call within forty-eight (48) hours. Response times exclude weekends and VA holidays. VA will cooperate with Bayer during any service calls and will provide BAYER with uninterrupted access to the Equipment being repaired in a location with adequate access to power and utilities. PREVENTIVE MAINTENANCE: Bayer will perform on-site service calls and will provide one (1) annual preventive maintenance as determined by Bayer to be appropriate for the Equipment per its documentation. Such preventive maintenance may include inspections. Adjustments, and/or repairs of the Equipment. In addition, at VA s reasonable request, Bayer will provide on-site service calls in order to make necessary repairs and adjustments to the equipment. Service calls will be scheduled at a mutually agreed upon time by Bayer and VA, during normal business hours. Normal Business hours are Monday-Friday, 07:30 AM to 04:30 PM (WRJ VA s local time) excluding VA Holidays. LABOR & TRAVEL EXPENSES: All labor and travel conducted during normal business hours: Monday through Friday, 07:30 AM to 04:30 PM relative to VA s local time, (excludes VA holidays). CERTIFIED TRAINED TECHNICIANS AND KEY PERSONNEL: The scheduled maintenance and service calls shall be performed by Bayer trained personnel in accordance with the agreement. Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE s and technicians shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment. It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device-system, at the time of the maintenance event. HOURS OF COVERAGE: Normal hours of coverage are Monday through Friday from 07:30 AM to 04:30 PM, excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by the Contracting Officer s Representative (COR). Preventive maintenance will be performed in accordance with manufacturer's recommendations. Preventive maintenance will be performed during normal hours of coverage or as agreed to by user and the COR. NOTE: - Hardware/software update/upgrade installations will 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 COR or designated representatives. Government provides software/hardware upgrade/update. There shall 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. Federal Holidays observed by the VAMC are: New Years' Day, Martin Luther King Day, Presidents' Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans' Day, Thanksgiving Day, and Christmas Day Scheduled maintenance will be excluded from downtime. (Normal work hours are 07:30 AM to 04:30 PM, Monday thru Friday, excluding federal holidays). Operational Uptime will be computed during a month-long time period. Repeated failure to meet this requirement can subject the contractor to DEFAULT action. UNSCHEDULED MAINTENANCE (Emergency Repair Service): Contractor shall maintain the equipment in accordance with the manufacturer's specifications. The Contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished. The COR or government designated representatives are authorized to request and approve service calls from the Contractor. Response Time: Contractor's FSE must respond with a phone call to the COR or designated representative within 1 hour after receipt of telephoned notification during normal hours of coverage. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within 2 hours after receipt of this second notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are 07:30 AM to 04:30 PM, Mon. thru Fri., a 2-hour response means, if a call is placed at 8:45 AM., Monday August 10th; the FSE must start on-site service before 10:45 AM, Monday, August 10th. SCHEDULED MAINTENANCE: The Contractor shall perform Preventive Maintenance (PM) Service to ensure that equipment performs in accordance with Item 3, Conformance Standards. An outline of the PM procedures and schedule shall be provided to the COR or designated representative. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR or designated representative at the completion of the PM (preferably in electronic format). 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. At minimum, the contractor will perform electrical safety testing in accordance with NFPA-00 standards. PM services shall include, but need not be limited to, the following: Cleaning of equipment. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 2, Conformance Standards or the manufacturer's specifications. Calibrating and lubricating the equipment. Performing remedial maintenance of non-emergent nature. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying. Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: hardware, sensors, filters, and cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance. Returning the equipment to the operating condition. Providing documentation of services performed. Inspecting and calibrating the hard copy image device. PM Services shall be performed in accordance with the Original Equipment Manufacture guidelines, and during the hours defined in the Hours of Coverage. All exceptions to the PM schedule shall be arranged and approved in advance with the COR or designated representative. Service is to be requested and coordinated only through the designated COR, to be assured that it is covered within the scope of the contract (workday 07:30 AM to 04:30 PM typical), and so that records are available for inspection by accrediting organizations.  Any services not coordinated by the COR will not be considered authorized and completed and will be considered to fail to meet the terms of the contract. Preventative Maintenance should occur in intervals in accordance to the OEMs recommendations and electronic service reports should be sent to VHAWRJCE@VA.Gov PARTS: The Contractor shall furnish and replace parts to meet uptime requirements. The Contractor has ready access to all Original Equipment Manufacturer (OEM) parts, including unique and/or high mortality replacement parts. All parts supplied shall be from the OEM. The contract is full coverage and shall include all 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. SERVICE MANUALS/TOOLS/EQUIPMENT: The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its Facility Service Engineer s (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 data manuals, by name and/or the manuals themselves shall be provided to the COR and CO upon request. DOCUMENTATION/REPORTS: The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 3, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The Engineering Service Report (ESR) will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. Service reports must be sent to the COR or the requesting entity upon completion of each service issue. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail: Name of contractor and contract number. Name of FSE who performed services. Contractor service ESR number/log number. Date, time (starting and ending), equipment downtime and hours on-site for service call. VA purchase order number(s) covering the call if outside normal working hours. Description of problem reported by the COR or designated representative. Identification of equipment to be serviced: Equipment Entry number, Manufacturer's name, Device name, Model number, Serial number, Any other manufacturer's identification numbers. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including: Labor and Travel, Parts (with part numbers), Materials and Circuit Location of problem/corrective action. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage). Signatures: FSE performing services described. Authorized VA Employee who witnessed service described. NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed! REPORTING REQUIREMENTS: The Contractor shall be required to report to the Clinical Engineering Department to check in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to check out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user. VA COR: Rebecca Halmich 802-296-1249 PAYMENT: - Invoices will be paid in arrears on a quarterly basis. Invoices shall include at a minimum, the following information: Contract Number, Purchase Order/Task Order Number, Contractor Name, Item(s) covered (to include serial #'s) by the PMI and covered period of service. All invoices shall be mailed to the Department of Veterans Affairs Financial Services Center s address as follows: FMS-VA-1-650 P.O. Box 149971 Austin, TX 78714 ADDITIONAL CHARGES: There shall 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. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: - The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR and/or designated representative (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 to the COR or designated representative a written estimate of the cost to make necessary repairs. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's FSE's shall wear visible identification at all times while on the premises of the VAMC. The Contractor shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. 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. 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 a local district, state, or municipal court. All FSEs shall check in with Clinical Engineering prior to servicing equipment. Clinical Engineering is located in Granite Basement Room B16. All scheduled service should be scheduled at least 48 hrs. in advance by emailing VHAWRJCE@VA.Gov. MISCELLANEOUS Additional equipment may be added and/or removed throughout the life of this contract and shall be considered within scope. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS Security Requirements: All contractor personnel shall obtain a short term identification badge issued by the COR or government designated representative. Such badge shall be worn by the individual and prominently displayed at all times while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. In order to obtain a short-term identification badge, contractor personnel shall present to the COR a valid (non-expired) photo identification issued by a US federal, state or local government agency. Escort will be provided as required in sensitive work areas. 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. 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.