J065--Intent to Sole Source -Medtronic NIM 4.0 Service Contract

VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-12 Pre-solicitation Notice of Intent to Sole Source Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with: Medtronic Sofamor Danek USA, Inc ueiSAM: NCWZAMNGJKH8 1800 Pyramid Place Memphis, TN 38132-1703 The purpose of this acquisition is to obtain a service contract for the Medtronic ESC2-NIM4-RPPOSY1 For the West Haven VAMC. Medtronic is the only vendor/contractor that can provide this service, this acquisition will not be competed. Since the intent is to procure this on a sole source basis, no solicitation will be posted to Contracting Opportunities SAM.gov. The NAICS is 811210. The size standard is 30 million. The PSC/FSC is J065. This procurement is subject to prohibitions in VAAR 852.212-71 Gray Market Items and in 852.212-72 Gray Market and Counterfeit Items. This acquisition is subject to VAAR 852.212-73 Gray

Market and Counterfeit Items Information Technology (IT) Maintenance Allowing-Other-than-New Parts. The authority for this action is FAR 6.302.1-1 Only one responsible source and no other supplies or services will satisfy agency requirements. Interested persons may contact the Contracting Officer/Contract Specialist by email at Deborah.Reardon@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. PERFORMANCE OF WORK PREVENTIVE & CORRECTIVE MAINTENANCE OF THE Medtronic NIM 4.0 Response System VA MEDICAL CENTER, WEST HAVEN, CT General Information: Contractor shall provide all labor, equipment, materials, apparatus, tools, transportation, supervision, and disposal necessary to provide Preventive and Corrective Maintenance Services on the Medtronic NIM 4.0 Response system. The services shall include emergency service, unlimited parts, preventative maintenance, factory authorized updates/modifications, technical support, and application support as outlined in the Scope of Work. The equipment is located at the VA CT Health Care System, West Haven Campus, 950 Campbell Ave West Haven, CT 06516. Type of Contract: Firm-Fixed Price Service Contract. Contract Performance Period: Base Year. Base year effective dates 12/13/2022 12/12/2023 Contract Transaction Number: Scope: Requirements for Equipment: 1. EQUIPMENT IDENTIFICATION: Manufacturer: Medtronic Models // List: NIM 4.0 Response SRVC2-8253001ESP SN: C2110154 EE129544 SRVC2-8253001ESP SN: C2110155 EE129545 Location: Building 1 Room 3227-1-W, Surgical Service, VA CT Health Care System, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516 2. CONFORMANCE STANDARDS: Contractor shall provide service and ensure that the equipment functions in accordance with the equipment manufacturer s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state, and local governing any chemicals, equipment or work which may be used or performed in the work under this contract. 3. OPERATIONAL UPTIME - REQUIREMENTS: The Medtronic NIM 3.0 Response system 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. 4. GUARANTEED RESPONSE TIME: The Medtronic Field Service Engineers (FSE) will use commercially reasonable efforts to respond to Customer s requests within 24 hours of notification to Medtronic Service Team. 5. LIVE PHONE SUPPORT: Service shall include phone support with Medtronic Technical Support Engineers twenty-four hours per day, seven days a week. 6. AFTER HOURS PHONE SUPPORT: Service for after hour phone support shall include 24 Hours, 7 Days a week and 365 days a year for technical assistance when required. 7. SOFTWARE ENHANCEMENTS: Periodic software enhancements shall be provided as part of the firm fixed price contract and shall be considered within scope. 8. PREVENTIVE MAINTENANCE: Perform System maintenance inspections as outlined in the user s manual developed by the manufacturer. 9. PARTS EXCHANGE: All parts required for the repair of the System (excludes instruments and accessories) are covered. 10. PART PROTECTION: Preferred pricing on repairs or replacement due to accidental damage. 11. LABOR & TRAVEL EXPENSES: All labor and travel conducted during normal business hours: Monday through Friday, 8:00am 5:00pm relative to customer s local time, (excludes Medtronic company holidays). 12. CERTIFIED TRAINED TECHNICIANS AND KEY PERSONNEL: The scheduled maintenance and service calls shall be performed by Medtronic 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. 13. HOURS OF COVERAGE: A. Normal hours of coverage are Monday through Friday from 08:00 AM to 05:00 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). B. 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. D. 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 08:00 AM to 05:00 PM, Monday thru Friday, excluding federal holidays). Operational Uptime will be computed during a month-long time. Repeated failure to meet this requirement can subject the contractor to DEFAULT action. 14. UNSCHEDULED MAINTENANCE (Emergency Repair Service): A. 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. B. The COR or government designated representatives are authorized to request and approve service calls from the Contractor. C. 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 08:00 AM to 05:00 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 PM, Monday, August 10th. 15. SCHEDULED MAINTENANCE: A. 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 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: 1) Cleaning of equipment. 2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards, or the manufacturer's specifications. 3) Calibrating and lubricating the equipment. 4) Performing remedial maintenance of non-emergent nature. 5) Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn. 6) Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying. 7) Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance. 8) Returning the equipment to the operating condition [defined in Section 3, Conformance Standards]. 9) Providing documentation of services performed. 10) Inspecting and calibrating the hard copy image device. B. 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. C. 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 8-5 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. D. Preventative Maintenance should occur in intervals in accordance with the OEMs recommendations of at least 1 time each year. 16. 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 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. 18. PARTS AND SERVICES NOT COVERED OR EXCLUDED BY CONTRACT: Authorization received by the COR for any work or parts outside the scope of this contract must be received prior to performance of work or payment will not be authorized. Parts that are not covered by this contract will be purchased by the VA Medical Center. The contractor under the terms of this contract shall accomplish the full installation and complete testing of these parts. Separate Purchase Order Numbers for components/parts not covered under this contract for preventive maintenance will be issued when detailed information with pricing to the COR is submitted. 19. 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. 20. 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: A. Name of contractor and contract number. B. Name of FSE who performed services. C. Contractor service ESR number/log number. D. Date, time (starting and ending), equipment downtime and hours on-site for service call. E. VA purchase order number(s) covering the call if outside normal working hours. F. Description of problem reported by the COR or designated representative. G. Identification of equipment to be serviced: 1) Inventory ID number, 2) Manufacturer's name, 3) Device name, 4) Model number, 5) Serial number, 6) Any other manufacturer's identification numbers. H. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including: 1) Labor and Travel, 2) Parts (with part numbers), 3) Materials and Circuit Location of problem/corrective action. I. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage). J. Signatures: 1) FSE performing services described. 2) 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! 21. REPORTING REQUIREMENTS: The Contractor shall be required to report to the Clinical Engineering Department to log 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 log 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: Shaynise Rose VA Clinical Engineering Points of Contacts: Joseph Cianciolo 22. PAYMENT: - Invoices will be paid annually. 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 23. 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. 24. 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. 25. CONDITION OF EQUIPMENT: The Contractor shall accept responsibility for the equipment. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract. 26. TEST EQUIPMENT: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to the Original Equipment Manufacture s standard. 27. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's FSE's shall always wear visible identification 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. 28. TRAINING: The Contractor shall provide first call Clinical Engineering training for current qualified technicians at the VAMC, CT during regular service hours of Monday through Friday from 8:00am 5:00 PM EST. This is not an ongoing training and will only be provided on an annual basis as required. All training for upgrades to equipment shall be considered within scope throughout the life of the contract. 29. TRANSPORTATION CHARGES: All costs associated with transportation, from shipping point to the destination specified above, and all costs of removal after contract completion, shall be paid by the Contractor, and incorporated in the price proposal. The Contractor shall be responsible for all damage in transit including any transportation costs for replacement. 30. 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 which 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. 31. MISCELLANEOUS Additional equipment may be added and/or removed throughout the life of this contract and shall be considered within scope. 32. 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 always displayed while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. 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. The C&A requirements do not apply, and the security accreditation package is not required. The identified Sole Source Vendor shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in standard acquisition guidelines. Per the VA handbook 6500.6, no VA sensitive information will be transferred, shared, or stored with said vendor. As such, no additional mechanisms will be needed to ensure the protection of information. __Shaynise Rose 07/22/2022 COR Signature: Date Name: Shaynise Rose Title: Administrative Officer, COR ____________________________________ ______________________ Requesting Service Representative (if different than above) Date Name: Title: