J065--Notice of Intent to Sole Source Medtronic StealthStation with O-Arm; Annual Maintenance to Medtronic USA, INC.

NOTICE OF INTENT TO AWARD SOLE SOURCE I. The Department of Veterans Affairs, Network Contracting Office 16, Michael E. Debakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, TX 77030 hereby provides notice of its intent to award a sole-source, firm-fixed-price contract, for a base year and four 1-year options, to Medtronic USA, Inc., 7611 Northland Drive | Brooklyn Park, MN 55428. The contractor shall provide all labor, tools, material, parts, equipment, supervision, software maintenance, license, certification, transportation, management, and personnel required to perform yearly preventive maintenance service to Medtronic StealthStation S8 with O-Arm (S/N s: StealthStation S8- N07455363 and O-Arm- 00757) equipment located at Michael E. Debakey Medical Center, 2002 Holcombe Blvd, Houston, TX 77030. II. The North American Industry Classification (NAICS) code for this acquisition is 811219 Other Electronic and Precision Equipment Repair and Maintenance (SBA Size Standard $22 Million). III. This purchase will be made under Simplified Acquisition Procedures and Other than Full and Open Competition, as authorized by FAR 6.302-1 and in accordance with FAR 13.106-1(b). The Government intends to award a Firm-Fixed-Price contract, in accordance with FAR 16.202-1. IV. The anticipated award date is May 01, 2021. The Government intends to award a Firm-Fixed-Price contract V. Please note that this is not a request for competitive quotes and is being posted for informational purposes only. Interested contractors, in addition shall provide the following information as an attachment to your response: 1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. 2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. 3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies you are considering a Joint Venture and the ownership of each company. 4. Do you have an existing GSA or VA, Federal Supply Schedule contract, please include the contract details in your response. 5. Is the contractor a Medtronic authorize vendor with certified technicians to meet all government requirements and objectives? Contractor shall attach authorization letter to be viewed by the government to be considered as part of the Market Research and responsive to this Notice of Intent. 6. Does the Contractor possess the capability to obtain Software Updates/Licenses (Contractor needs to attach evidence) if required for Government Medtronic StealthStation S8? Contractor shall attach authorization letter to be viewed by the government to be considered as part of the Market Research and responsive to this Notice of Intent. 7. Does the Contractor possess all license/certification for Medtronic StealthStation S8 proprietary service materials? Contractor shall attach license/certification to be viewed by the government to be considered as part of the Market Research and responsive to this Notice of Intent. VI. Interested parties shall identify their interests and capability to respond to this requirement within Ten (10) calendar days of the publication of this notice. Any response to this notice shall show clear and convincing evidence that competition would be advantageous to the Government. Interested parties shall submit clear evidence with the capability to meet government requirement. To include but not limited to: 1. The contractor shall provide all labor, tools, material, parts, equipment, supervision, software maintenance, license, certification, transportation, management, and personnel required to perform yearly preventive maintenance services to Medtronic StealthStation S8 with O-Arm (S/N s: StealthStation S8- N07455363 and O-Arm- 00757) equipment located at Michael E. Debakey Medical Center, 2002 Holcombe Blvd, Houston, TX 77030. See Attached Draft Statement of Work Statement (SOW) VII. Questions regarding this notice should be sent to Contracting Specialist Albert Kelly no later than January 21, 2021 by 9:00am (CST) at [email protected] (DRAFT) MEDTRONIC Stealth Station ANNUAL MAINTENANCE SOW EQUIPMENT IDENTIFICATION  Equipment & Components MEDVAMC Asset Number Serial Number Medtronic O-Arm 1000 1098179 00757 Medtronic Stealth Station w/EM 1198077 N07455363 The Contractor accepts responsibility for the equipment 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. 1. GENERAL REQUIREMENT Michael E. Debakey Medical Center is requesting for a contractor to provide preventative maintenance and service on Medtronic ENT and Navigation products at the Michael E. Debakey Medical Center located at 2002 Holcombe Blvd, Houston, TX 77030. The Contractor shall furnish all labor, materials, parts, equipment, tools to service and perform repairs and yearly preventative maintenance and on the equipment. The Contractor shall provide calibration and preventive maintenance services by authorized service providers. Worn or defective parts shall be replaced when necessary, as per manufacturer s specifications. The full clinic listing of the equipment can be found at the beginning of the document in the Equipment Identification and Coverage Section. 2. DEFINITIONS/ACRONYMS A. Biomedical Engineer(ing) - Supervisor or designee. B. CO - Contracting Officer C. COR - Contracting Officer's Representative D. 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. E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises. F. 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. G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM or service has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status. H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR. I. NFPA - National Fire Protection Association. J. CDRH - Center for Devices and Radiological Health. K. VAMC - Department of Veterans Affairs Medical Center L. VAH - Department of Veterans Affairs Hospital M. OEM - Original Equipment Manufacture 3. CONFORMANCE STANDARDS Contract service shall ensure that the equipment functions in conformance with the specifications of the OEM, and any upgrades/updates, as well as following most current published standards/ specifications/regulations:  Manufacturer s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL) ,Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract. 4. HOURS OF COVERAGE A. Normal hours of coverage are Monday through Friday from 7:00 a.m. CT to 4:00 p.m CT., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR.          B. Work performed outside the normal hours of coverage at the request of COR or designee will be billed at the price listed in Vendor Contract. Billing will include service time and exclude parts, as they are included in this contract. The COR or designee will provide a credit card purchase order to cover charges outside of the scope of this contract. Purchase order number must be included on invoice for payment. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.  C. Telephone support shall be provided 24 hours per day, 7 days per week, 365 days per year. 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 Christmas Day  In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President s Proclamation  SUPPORT 5. SURGICAL SUPPORT The Contractor shall provide, at the staff requests, up to six (6) surgical support visits to provide guidance to staff using the Stealth Station (S/N N07455363). Each visit shall not exceed eight (8) hours or occur outside of the normal hours of coverage. Staff requesting a surgical support visit must be OEM-trained on the covered equipment eligible for surgical support visits. MAITENANCE 6. UNSCHEDULED MAINTENANCE (Emergency Repair Service) A. The Contractor shall provide repair service which may consist of inspections, 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 CO, COR or designee has the authority to approve/request a service call from the Contractor.  C. Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within two (2) days after receipt of this second notification and will proceed progressively to completion without undue delay unless service is prevented or delayed by any act or omission by the Government. This requirement for response time shall be the same for both services calls during the VA normal business hours and after-hour service calls. Corrective work shall be completed without undue delay.  D. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete unscheduled maintenance are included within this contract unless specifically stated in writing otherwise and approved by the COR. Coverage exclusions are as follows: repair of non-Medtronic products, needed repairs due to external power sources, needed repairs as a result of natural disaster and needed repairs due to accident/negligence.  E. Contractor shall provide mandatory safety and performance-related updates to covered equipment and software. Any necessary hardware/software update/firmware update installations as deemed necessary or available at no charge by the OEM will be scheduled at least three (3) days in advance and shall be performed at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR).  F. The Contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment. 7. SCHEDULED MAINTENANCE A. Preventive maintenance shall be performed yearly. The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with the Conformance Standards Section of this contract. Preventive maintenance inspections shall be scheduled at least three (3) days in advance with the Contracting Officer Representative (COR). The PM must be done in accordance with the latest OEM maintenance procedures and protocols. (An outline of the PM procedures and schedule shall be provided to the COR). 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 at the completion of the PM. 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. PM services shall include, but need not be limited to, the following: 1) Cleaning of equipment. 2) Reviewing of 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. 8) Returning the equipment to the operating condition in compliance with the "Conformance Standards" Section. 9) Providing documentation of services performed. 10) Inspecting and calibrating the hard copy image device.  B. PM services shall be performed in accordance with, and during the hours defined in the "Hours of Coverage" section and the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.  C. Any charges for parts, services, labor, travel, manuals, tools, installation, firmware or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR. PARTS, TRAVEL & EQUIPMENT 8. PARTS & TRAVEL Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or service for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No re-manufactures or gray market items will be acceptable. Any retrofitted parts shall be approved by the COR prior to installation and shall also be approved by the OEM prior to installation.  The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Contractor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA facility upon discovery of such items. The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) 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. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).  Travel for any and all service and preventative maintenance covered within this contract shall be covered by the Contractor and shall not be reimbursed by the CO, VAMC, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances.  9. SERVICE MANUALS/TOOLS/EQUIPMENT The VAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all travel, 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.  10. TEST EQUIPMENT Should the COR request it, 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 a national standard. EQUIPMENT REMOVAL 11. REMOVAL OF EQUIPMENT Should a piece of equipment require repair at the Contractor s plant, the Contractor shall coordinate with the COR the removal of equipment. Government property cannot be removed from the station without a signed Property Pass. This Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor s charge  ONSITE REPORTING & DOCUMENTATION 12. REPORTING REQUIREMENTS The Contractor shall be required to report to Biomedical Engineering to log in. 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. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR OR designee for an "authorization signature" unless otherwise stated by the COR. If the COR is unavailable, a hard copy or an electronic version of the FSR must also be submitted to the COR within 5 days after the service day. A signed, authorized copy of the ESR will be returned to the Contractor after the work can be reviewed (if requested or noted on the ESR). VA Biomedical Contact Persons:    Devang Patel, Rikesha George, Thomas Dawson and Charles Morris                                                                      Location (Building/Room Number):         BA-200                                                Telephone Number & Extension(s):         713-794-7271/7270                                  13. 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 the "Conformance Standards" section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The electronic 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. 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 numbers covering the call if outside normal working hours. F. Description of problem reported by COR. 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 before service is completed!  14. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE 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. PERSONNEL COMPETENCY & SAFETY 15. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT A. 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.  B. "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 and is OEM Certified. 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, on the covered equipment listed in the Equipment Identification Section.  C. All work shall be performed by "Fully Qualified", OEM Certified 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 prior to award. The COR may authenticate the training requirements, request locations, training certificates or credentials, and technician location from the Contractor at any time for any personnel who are servicing or installing any equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment if evidence is not provided when requested.  D. If subcontractor(s) are used, they must be approved by the COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. 16. SAFETY REQUIREMENTS In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.  The VAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence. NETWORK SECURITY 17. PRIVACY/SECURITY The contractor will have electronic connectivity to the VA network. The Vendor will have access to patient databases and PHI when troubleshooting the devices. Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property. 18. MOBILE MEDIA SCANNING The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally owned USB thumb drive utilization is prohibited. Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the Biomedical Engineering shop, Building 100, Room BA200.    INSURANCE 19. INSURANCE A. Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.  B. General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.  C. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.  PAYMENT & ADDITIONAL CHARGES 20. PAYMENT All invoices shall be submitted in arrears, properly prepared in accordance with FAR 52.212-4, contain sufficient details, and match with the service tickets for the work rendered.  A. Invoices  Invoices shall be properly prepared and sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. Invoices shall be sent in arrears at the beginning of the first month of each quarter following the quarter in which the services were rendered and billed for. At a minimum, all invoices shall include the following details: o Contract No. o Purchase Order No. Correct purchase order number which will be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor. o Item(s) covered (to include serial #'s) o Description of the services rendered o Billing period in which the services were rendered o Invoice number and date  Payments will be made in accordance with the prompt payment act out of the Government annual appropriated funds obligated in a purchase order which will be issued after the contract is awarded.  21. 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.  In any case, the VA shall be explicitly notified in advance that additional charges will be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform service, a separate purchase order will be issued to the Contractor for the work. Any service required which the Contractor believes to be in excess of the contract provisions and require additional payment (e.g., work beyond normal work hours) shall not be performed without prior authorization from the BIOMED COR, who will arrange a separate purchase order to pay for the additional service if desired by the VA.  The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc., on straight time or overtime work.  22. GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 52.212-4, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government. 23. END OF SERVICE PERIOD No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer.  Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date to the COR. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor s repairman shall report their arrival and departure to the COR.