Service Contract for Siemens MRI
Added: Aug 30, 2017 3:02 pm STATEMENT OF WORK (SOW) REQUIREMENT: Furnish all necessary labor, equipment, tools, materials, repair service, software updates, parts, and any other requirement for complete first call On-Site Maintenance Service and technical support for the Siemens 3T Magnetom Skyra located at the James J Peters Bronx VAMC. The equipment to be serviced / maintained includes the Siemens 3T Magnetom Skyra and its components including, but not limited to the MRI Chiller, UPS system, cold head, cryogen gas system (including vent), Siemens MRI coils, all servers, workstations, and peripherals. The equipment description is as follows: # ID# Serial# Manufacturer Model Equipment Category 1 53878 1E986B235148X7 Siemens Magnetom Skyra SCANNING SYSTEMS: MRI CONFORMANCE STANDARDS: Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, TJC, OSHA, CDRH, and performance standards and specifications used when the SIEMENS 3T MAGNETOM SKYRA was procured by VA National Acquisition Center and any upgrades/updates. SCHEDULED MAINTENANCE: Scheduled downtime is defined as the time the SIEMENS 3T MAGNETOM SKYRA is placed out of service for the purpose of accomplishing scheduled upgrades and/or preventive maintenance to be performed which would necessitate the shutdown of the SIEMENS 3T MAGNETOM SKYRA for a predetermined length of time, approved by the COR. All equipment shall be maintained in a satisfactory and safe operating condition in accordance with the requirements of these specifications, capable of providing their initial maximum capacity and performance at all times. The contractor shall perform all Preventive Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with Conformance Standards Section. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMs and a PM checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. All equipment listed above will have PM service performed Semi-Annual. Preventive Maintenances will be performed in the months of August and February. In no event shall more than SIX (6) months elapse between inspections. 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 to 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 which are likely to become faulty, fail or become worn. Measuring and adjusting and calibrating as necessary for optimal image quality. Inspecting electrical wiring and cables for wear and fraying. Inspecting all mechanical components including, but not limited to: 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. Performing Electrical Safety Inspections (Electrical Leakage), which should include line cord ground wire resistance and leakage as specified in the Conformance Standards. Returning the equipment to the operating condition defined Conformance Standards. Any other PM requirements as specified by the manufacturer of the equipment, SIEMENS. Providing documentation of services performed. PM services shall be performed in accordance with, and during the hours defined in, the Preventive Maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR. All parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise. Upon completion of the preventive maintenance and electrical safety inspection, the FSE must tag the equipment with the appropriate labels used by this facility. The FSE must fill-in label sections for: date inspected, date next due, and initials of FSE. Labels will be provided to the FSE when reporting (signing-in) to Clinical (Biomed) Engineering. UNSCHEDULED MAINTENANCE: CES will perform first call (first-look) for unscheduled maintenance. The contractor shall maintain the equipment in accordance with the Conformance Standards Section, by furnishing all necessary labor, management, equipment, tools, materials, repair service, instruments, software and hardware updates and parts for service (excluding consumables) in accordance with the terms, conditions and schedule of this agreement, regardless of circumstance. The contractor will 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. This INCLUDES Workstation Hardware, sound system, room oxygen monitor, chillers, cryogen gas refills, cryogen gas vent, Siemens MRI coils and UPS system service. Remote Access: The contractor can diagnose/repair any software issues with items listed in part I, equipment, remotely via VA approved VPN access. Only, the CO, COR or designated alternate has the authority to approve/request a service call from the contractor. Response Time: Contractor's FSE must respond with a phone call to the COR and his/her designee within [two (2) hours] after receipt of telephoned notification [24 hours per day]. If the problem cannot be corrected by phone, the FSE will commence work (via VPN on-site physical response)(if applicable) within [one (1) coverage hour] after receipt of notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are [8:00 am to 6:00 pm], a [1] coverage hour response means, if a call is placed at [3:45] pm [Monday], [September 9th], the FSE must start on-site service before [4:45 pm Monday], [September 9th], except when outside hours of coverage is authorized by the COR. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within [24 coverage hours] after receipt of notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are [8:00 am to 6:00 pm], a [24] coverage hour response means, if a call is placed at [3:45] pm [Monday], [September 9th], the FSE must start on-site service before [3:45 pm Tuesday], [September 10th], except when outside hours of coverage is authorized by the COR. Repair Up-Time: From the time when the FSE commences the on-site unscheduled maintenance, the repair/service and/or express delivery of replacement parts must be completed within 24 hours (24 hours/day). The contractor shall provide to the contracting officer and his/her designee with written proof that all gauging and measuring equipment used to check and calibrate the equipment has been calibrated according to the specifications of all applicable. SUPERVISION: General The contractor shall arrange for all satisfactory supervision of the contract work. The contractor or his supervisors shall be available at all times to receive notices, reports, or requests from the Contracting Officer or the COR only. It is the policy of the VA that Government direction or supervision of the contractor s employees, directly, shall not be exercised. Contract Manager The contractor shall provide the name telephone number and address of the contract manager, in writing to the Contracting Officer prior to the contract starting date. The contract manager shall have the authority to accept notices of deductions, inspections reports and all other correspondence on behalf of the contractor. The contract manager must be physically located so that he/she is readily available to deal with the day-to day-operation of the contract. PARTS: The contractor shall maintain a stock and furnish and replace parts to meet the repair up-time requirements as stated in Section V Unscheduled Maintenance, E, Repair Up-time. If parts cannot be furnished by this time, the COR must be notified. The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. This contract shall include all parts (including cryogen helium gas refill Dewar tanks) and all components for the SIEMENS 3T MAGNETOM SKYRA EXCEPT Glassware, Consumables, Transducers. The contractor shall use OEM and Siemens new parts only. New parts shall be furnished by the contractor and guaranteed against defects and/or failure for a period of 1 year from the date of completed installation of the component. Used parts, those removed from another SIEMENS 3T MAGNETOM SKYRA, shall not be installed without approval by the COR. The VA reserves the right to inspect the contractor s facilities to confirm that the parts are locally available. The contractor may recommend and initiate replacement of parts at no additional expense to the Government and schedule to do so with the COR as stated in, Section VI, Scheduled Maintenance. Government property shall remain the property of the Government in all respects, including but not limited to hard drives; ePHI (electronic patient healthcare information), etc. All parts replaced become the property of the Government. The contractor shall take all reasonable precautions, as directed by the Government, or in the absence of such direction, in accordance with sound industrial practices, to safeguard and protect Government property. Government property shall be used only in direct operations of providing contract services, and shall not be used in any manner for any personal advantage, business gain, or other personal endeavor by the contractor or the contractor s employees. Repair parts must be sent to the attention of the COR to the following address, at no additional expense to the Government: James J. Peters VA Medical Center Clinical (Biomedical) Engineering Room 6A05 130 West Kingsbridge Road Bronx, NY 10468 SERVICE MANUALS: The VAMC shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation and test equipment, (such as; operational and service manuals, schematics, diagnostic software 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. MISCELLANEOUS SERVICES: Telephone Technical Support: Telephone Technical Support shall be available on a 24 hour by 7 days basis via toll free number. DOCUMENTATION/REPORTS: The contractor shall maintain a log for each piece of equipment. The documentation will include legible detailed descriptions of the scheduled and unscheduled 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 Section. 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), Equipment Downtime and Hours-On-Site for service call. VA PO#(s) covering the call, if outside normal working hours. Description of Problem Reported by COR/User. Identification of Equipment to be serviced: INV. ID#, Manufacturer's Name, Device, Model#, Serial#, and any other Manufacturer's ID# s. Itemized Description of Service Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part#s) and Materials and Circuit Location of problem/corrective action. Total Cost to be billed. Signatures: FSE performing services described and VA Employee who witnessed service described. Equipment downtime NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COR BEFORE SERVICE IS COMPLETED! All records and logs shall be turned over to the COR at the completion of the work performed. REPORTING REQUIREMENTS: Once the contractor arrives on site, they must be issued a temporary identification badge by the VA Police and Security. It must be worn at all times above the waist, in front, with the face of the card visible. Once issued a temporary identification badge, they are to report to the Clinical Engineering Department to log in and sign the VA vendor sign-in sheet located on the outside door of the Clinical Engineering Department. This check in is mandatory. The contractor will then be escorted by Clinical Engineering personnel to the respective work site. 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 Clinical (Biomed) 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 for an "authorization signature". If the COR is unavailable, a signed authorized copy of the ESR will be sent to COR by the contractor after the work can be reviewed (if requested or noted on the ESR). If ESRs are available electronically, a signed authorized copy of the ESR will be sent to COR and Biomedical Engineering designee via email to the addresses identified above. The contractor is totally responsible for providing Service and Preventive Maintenance reports. Failure to provide the COR with service reports will result in an automatic 10% deduction from the payment due for that Preventive Maintenance time period. Leaving service reports with a person in the vicinity of the equipment may be performed in addition to the previous stated requirement, but is not to be used as a substitute. Failure to provide the COR with all records, service reports and logs within the quarter they were performed will result in an automatic 10% deduction from the payment due for that quarter. RESPONSE TIME: Unscheduled Maintenance On-Site Physical Response Time: The FSE must commence work as stated in Section V, Unscheduled Maintenance, D. If the on-site physical response time is not adhered to, there will be an automatic 1% deduction for every business hour after the on-site physical response. The reduction will be from the payment due for that quarter. Repair Up-time Requirements: The Contractor shall furnish and replace parts to meet up-time requirements. In-House CES will perform first call (first-look). The repair up-time requirements are 24 hours (24 hours/day) from the first on-site visit or notification via phone by the FSE in which parts were determined as needed. If these up-time requirements are not adhered to, then an automatic 1% reduction for every business hour after the up-time requirements will be deducted from the payment due for that quarter. If the Contractor is not on-site from the first service call within 24 hours (24 hours/day) and/or the up-time requirements are exceeded by 24 hours (24 hours/day), the COR may exercise the option to hire an alternative source to resolve the problem. The decision to exercise these alternatives will reside exclusively with the COR. All fees generated by the alternate Contractor(s) will be handled in accordance with the Default cause. Scheduled Maintenance Response Time: If all Preventive Maintenance inspection(s) are not performed as indicated in Section VI, Scheduled Maintenance, during the scheduled months stated in the Scheduled Maintenance Section, Part A or otherwise determined by the COR, will result in an automatic 10% reduction from the payment due for that quarterly period. PAYMENT: Purchase Order Payment Procedures: Payments will be made as stated in Section B, Base Year, I, quarterly in arrears upon receipt of properly prepared invoices which must show reference to the correct purchase order number and contract number issued upon the award of this contract. Each invoice must be provided in [triplicate] and must include the Service Reports (ESR's) for work performed during that time frame. ADDITIONAL CHARGES: There will be no additional charge to the Government 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 not 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. QUALIFICATIONS: Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in Section, I, 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. 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) has successfully completed a formalized training program, for the equipment identified in the Section I schedule. For field experience, the FSE(s) has a minimum of tee years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance, on the SIEMENS 3T MAGNETOM SKYRA, identified in Section I schedule. Contractor shall provide certifications of each Field Service Engineer (FSE) that will be working on the equipment listed in the scope before they will be able to work on the equipment. Additionally, if a certificate will expire before the contract ends, the contractor will provide the updated certificate within fifteen (15) days of certificate expiration. The FSEs shall be authorized by the contractor to perform the maintenance services. 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 will authenticate the training requirements, request 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 reserves the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment. If subcontractor(s) are used, they must be approved by the CO as well as the COR; the contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. Both new and replacement contract managers must meet these qualification standards. 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 be performed and provided on an annual basis. Test equipment calibration shall be traceable to a national standard. The contractor shall provide to the contracting officer and his/her designee with written proof that all gauging and measuring equipment used to check and calibrate the equipment has been calibrated according to the specifications of all applicable standards. The vendor/contractor will identify if removable media is required to perform their duties. Clinical Engineering will ensure the contractor s removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device or facilities system. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. Any viral infection/outbreak or downtime in equipment listed in Section I, resulting from the use of an improper or unapproved removable media cybersecurity incident by the contractor, the contractor will bare all remediation (direct or indirect) costs. 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. It is the responsibility of the contractor to 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. INSURANCE: Worker compensation and employer's liability. Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes. 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. Property Damage Liability. Contractors are required to have Property Damage Liability insurance coverage of at least $500,000. GENERAL INFORMATION SECURITY: Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS: A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed tough the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE: 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). The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. TRAINING: All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
VA24217Q1109 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2
8/30/17, 3:02 PM