1 STATEMENT OF WORK/SPECIFICATIONS FOR BRAND NAME ONLY SEIMENS MOBILE MR UNIT 1.0 OVERVIEW SERVICES: VA Boston Healthcare System requires the lease of mobile Seimens Aera Magnetic Resonance Imaging (MRI) unit. Contractor is to provide all expertise, trained personnel, equipment and supplies as necessary to deliver and install this unit at the West Roxbury campus of the VA Boston Healthcare System (VABHS). Contractor shall provide a Seimens Aera MRI system and associated equipment (hereinafter referred to as a mobile unit). Above shall include a 1.5T MR mobile scanner, which shall be delivered F.O.B. Destination to the West Roxbury campus, VABHS 1400 VFW Parkway West Roxbury, MA 02132. Contractor will be provided a minimum seventy-two (72) hours notice when the mobile unit is no longer required. This agreement shall include all labor, material, tools, maintenance/repairs, equipment, hookup, delivery, and the complete removal of the mobile unit upon conclusion of the contract period. Mobile unit will be delivered and removed on a date and time mutually agreed upon between the COR and the Contractor. It is also agreed upon and understood that only qualified/trained VA technologists will be allowed to perform scans on the Contractor furnished equipment. VA may need to perform MRI scans at anytime therefore, the Mobile unit will be available and the VA will have access on site 24 hours a day, 7 days a week (24/7) for the agreed upon period. Contractor shall be responsible to maintain all of the equipment in good working order at all times. 1.1 TERM OF CONTRACT: The contract is effective after award from the date specified for a 6 month period with an option to renew for additional 3 month periods. The contract is subject to the availability of VA funds. No service shall be performed by the Contractor after dates indicated, unless authorized by the Contracting Officer in writing. 1.2 TRAINING: Government or government contract personnel shall provide all patient services. Contractor is required to provide all necessary training for full operation of the Mobile MR unit if necessary. Contractor shall make the necessary arrangements with the Contracting Officer Representative (COR) to schedule training sessions. Training sessions are excluded from being performed on weekends and federal holidays. 1.3 USE OF EQUIPMENT: It is agreed upon and understood that a qualified VABHS MR technologist(s) (who has completed and received the proper training on the use of the equipment) will be authorized to use the Contractor s furnished equipment 24/7 to perform a variety of MR exams. This includes VABHS employees and contract staff. 1.4 AUTHORITY: This procurement is being conducted under Federal Acquisition Regulation (FAR) combination of Part 12, Acquisition of Commercial Items. The resultant contract is non-exclusive and shall not prohibit VA or Contractor from entering into agreement(s) with other health care providers or purchasers of health care services. 1.5 PURPOSE: The intent of the services is to provide interim services to improve patient access for MRI. It will also be used while the current MR scanner is being upgraded at the Jamaica Plain campus of VABHS. Contractor s equipment shall be state-of-the art in order to achieve high quality scans for VA patient diagnosis. 1.6 CONTRACTOR S FURNISHED EQUIPMENT: Equipment shall include but not be limited to a fully equipped 1.5T Magnetic Resonance scanner where studies will be performed on the contractor s furnished equipment. Contractor shall submit an equipment specification list of all equipment, including the MR Mobile Unit with his/her signed quotes as further detailed in Paragraph 1.7. Include name of manufacturer, model number, manufacturer s brochures, cut sheets, equipment specifications, and all pertinent data. All equipment to be used will be FDA approved imaging equipment placed at a location designated by the COR on site at the West Roxbury campus. The entire offering of a MR Mobile service shall meet all local, state, federal, industry, JC, NEC, NFPA, VA, OSHA, and other regulatory standards internal or external that the VABHS is currently accountable for. In addition, the MR Mobile unit must meet the following specifications: Max width of mobile: 16 feet Max length of mobile: 50 feet Mobile must be compatible with the following main electrical power specifications: 480V 200A 3 phase 4 pole 5 wire service in place with a Russelstoll outlet consisting of 4 #3/0 & 1 #6g MRI computer must run on an Original Equipment Manufacturer-supported operating system 1.7 SYSTEM CAPABILITY REQUIREMENTS: The Contractor shall provide a Magnetic Resonance scanner which will allow the VA personnel/staff to perform a wide range of exams as listed below as follows: 1. Diagnostic MR imaging, including MRI and MRA 2. MR scans including, but not limited to, all Body, MSK and Neuro MR Procedures. 3. Include, but not limited to: MR Spectroscopy capable, MR Perfusion capable, Enhanced and non- contrast MRA capable including non-contrast (MRA Native including extremities). 4. System will have Cardiac capability/licenses. Advanced Cardiac. Cardiac dot engine. Argus Flow. 5. System will have Body imaging capability/licenses. In line composing. HISTO. Liver segmentation. QISS. Native Renals. 5. System will have Neuro imaging capabilities/licenses. BLADE. WARP. TWIST (for MRA spines). Must also include Resolve and SWI sequences. 6. System must be capable of 3D T1 and T2 imaging 7. Syngo via post processing system included for cardiac imaging 8. MRI operating system will be at version D or E in order to export protocols. 9. Protocols will be exportable 10. System must include cardiac monitoring capabilities including respiratory gating which included chest EKG leads. 11. System must have liver lab software 1.8 SYTEM NETWORKING INTERFACES: to be provided at no additional cost to VABHS. Scanner and all associated equipment - Both hardware and software, which shall have ability to send DICOM images to VABHS PACS: System must be able to send to multiple DICOM destinations Must act as an SCP for third party workstations to pull DICOM The mobile unit shall be equipped with an Optical disk archival system however VA will be responsible for MOD. Notwithstanding, the patient data and optical disk is the property of the VABHS. The mobile unit shall be equipped with CD-R burning capabilities as a backup, these backups must be in DICOM format. Must be compatible with DICOM Modality Worklist C-Find (MWL) to query exams 1.9 ACCESSORY EQUIPMENT: Accessory equipment that shall be provided by the Contractor: Handicap accessibility - via ramp or lift Intercom system between the control room and scanning room Medical gas outlets (1 outlet each of air oxygen and suction) in the MRI room close to the head of the table Supply tanks/compressor for the source of the gases/suction shall be supplied with the mobile Changing area for patients within mobile unit (if available) MR safe Medrad Spectris Solaris EP Wireless Injector or similar injector which is compatible to the MR system provided 1.10 EQUIPMENT SPECIFICATIONS: The following minimum performance characteristics of the equipment are required: A 1.5T model Siemens MRI would be the preferred for this mobile space in order to ensure ease of use, the use and to prevent additional training for the clinical users. A GE 1.5T would be our next preferred option. If the unit varies from our current model, additional onsite training will be required by the contracted vendor for all clinical users. Despite whether the unit varies from our current model a Medrad Spetris Solaris EP Wireless Injector, or a similar and compatible model is necessary. Additionally, all coils must be included. In this instance, the coils to be included are: 20 CH Head coil 2X 18 CH body matrix coil 4 CH large flex coil Transmit/receive coil TxRx Head QED coil Neck Coil (Including anterior neck) Spine coil Cardiac & Abdomen coil (Torso Coil) 16 CH Lower Leg Array Coil 16 CH Leg Array coil Extremity coil 16 CH Foot coil 36 CH Peripheral Vascular coil 16 CH Wrist Coil Vascular Array Coil 16 CH large/small Shoulder coil 15 CH Knee coil Elbow coil Neurovascular coil 16 CH Hand coil 16 CH Ankle coil Additionally, the unit must include, but not be limited to, the following specifications: Magnet Strength: 1.5 T Magnet Bore Type: Closed Bore FOV: 48x48x48 Bore Diameter: >59cm Table Weight: >349 lbs RF Channels: At minimum 4 or 8 standard Detachable Table (option) Slew Rate: >49 T/m/s Spectroscopy software and processing capable MR perfusion software and processing capable Connectivity to PACS is required as well as all capabilities in Section 1.8 in the above document. Equipment provided shall also include the following: DICOM [connectivity / functionality between VABHS CareStream PACS] Optical disk archival system Contractor will be required to make whatever adaptations are necessary so that the Contractor s equipment is compatible with the VA furnished services defined herein. The Mobile MR shall provide images with consistently high technical diagnostic quality which meet the standard of care. The Mobile MR unit shall be ready for use regardless of outside environmental conditions. The Mobile MR unit shall maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for patient comfort. Meet all federal, state and local fire and safety requirements. Telecommunications: The mobile unit shall be equipped with an outlet connection capable of transmitting data and voice through a Government provided network cable. The Government will provide the connection required for the transmission of images, data and voice. (PACS interface contact person shall be provided to the successful Contractor during the post-award orientation). 1.11 ADDITIONAL REQUIREMENTS/MOBILE MR UNIT: Contractor shall provide a Mobile MR Unit that meets the following physical requirements: Has been approved by the FDA and meets or exceeds minimal standards for the type of equipment being provided as defined herein. The Contractor s Mobile MR shall provide the space sufficient for the monitoring of sedated patients and conducting CPR and code if needed. 1.12 ACCESS FROM BUILDING TO MOBILE UNIT: Contractor shall deliver unit to Building 3 of the West Roxbury address. VA Engineering will provide details and specification for the delivery post award 1.13 VA PROVIDED UTILITIES/SERVICES: VABHS SHALL PROVIDE THE FOLLOWING UTILITIES/SERVICES (IF NECESSARY) FOR OPERATION OF THE MRI MOBILE UNIT: Maintenance of the site which meets the requirements for the system. Housekeeping during use of the mobile unit. Provision of electricity utilities, telephone service and network (HVAC, water and steam will NOT be provided). Provision of a Radiologist to oversee procedures, to protocol studies. VA Staff to respond medical emergencies. VA will be responsible for scheduling of patients to maximize patient throughput and will provide clerical support for scheduling, patient registration and other administrative responsibilities related to the MR Schedule. Provision of medical staff when required for procedures. Transportation of patients to/from their medical ward or escort of patients from the waiting area to the mobile MR. Provision of medical supplies necessary to perform the procedure. Provision of standard protocols for MR technical staff and availability of radiologist to confer with regarding non-standard protocols. VA physicians will obtain any written consent that may be required in accordance with VA regulations. Canopy, walkway and covering for the safe transportation of patients to and from the hospital to the mobile unit Stable pad for MR to be placed on 1.14 EQUIPMENT MAINTENANCE/REPAIRS: Equipment provided shall be in good working order at all times in order to provide high quality scans required under this solicitation and any resulting contract. Contractor shall be completely responsible for the preventive maintenance, emergency and general repairs, replacement of any defective parts/components, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance/repairs on the MR mobile unit and all associated equipment shall be performed in accordance with the Conformance Standards and manufacturer s recommendations. If the equipment should fail during normal working hours, emergency repairs will be performed on-site by qualified service engineers within a four hour response time in order to reduce equipment downtime. Contract price shall be reduced by a reasonable amount in the event that the contractor is unable to meet the response times stated herein or as mutually agreed upon with the COR based upon patient scheduling. Notwithstanding, if it is determined that the equipment cannot be repaired on site within an agreed upon period of time, the contractor agrees to replace the Mobile Unit within forty-eight (48) hours of equipment failure. Contract price will be adjusted for any days in which the equipment cannot be used. VA shall be responsible for the overall housekeeping of the unit including but not limited to removal and proper disposal of all debris on a daily basis or as often as necessary to maintain a sanitized and neat environment in accordance with the Conformance Standards. 1.15 PARTS: The Contractor shall furnish and replace parts to meet times specified in this agreement. 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 required. The Contractor shall use new or rebuilt 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 another piece of equipment shall not be installed without specific approval by the CO or the COR. Contractor s equipment must be compatible with the VA existing equipment and/or systems in order to provide an interface between the Mobile MR Unit and the Contractor s equipment and the VA firewall. VA personnel will be assigned to the successful Contractor during the post award orientation to establish network connectivity from the trailer through the VABHS firewall. MR Mobile Unit Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed. Contractor is responsible for delivery and set up of unit on site. 1.16 RECORDS AND CONFIDENTIALITY Records created by the Contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal laws and regulations. Whenever possible, records and reports will be made available in digital form. The Clinical Engineering department staff at the VA Boston Healthcare System shall be provided with the system hard drive containing the patient data prior to the MRI leaving the VA Boston Healthcare System premises. The treatment and administrative records created by, or provided to, the Contractor under this agreement are covered by the VA system of records entitled Patient Medical records- VA (24VA136). In responding to VA Patient requests that copies of their patient records be released to a third party, the Contractor shall refer the VA patient/family to the Release of Information Act (ROI), located within the VA Business office for response. 1.17 TORT CLAIMS The Federal Tort Claims Act does not cover the Contractor and/or its employees. When the group or its employees has been identified as a provider in a tort claim, the Group or Group Employee is responsible for notifying their own legal counsel and/or insurance carrier. Any subsequent settlement or judgment arising from a group or Group employee s act or omission under this agreement is the responsibility of the Group, Group employee and/or insurance carrier unless such act or omission was at the direction of the VA clinical staff member or other VA employee. 1.18 QUALITY CONTROL All studies shall conform to VA protocol established by VA Radiologists prior to any examination being performed. Studies will be performed according to VA BHS protocols. VA estimates 15 MR exams to be completed daily. 1.19 INVOICES As full and complete compensation for all services provided by the Contractor to VA patients under this agreement, the VA agrees to make payment on a timely basis for services rendered, upon receipt of properly prepared invoices submitted by the Contractor as outlined. VA agrees to pay the rates specified by this agreement and any rate otherwise agreed upon through modification of this agreement. Rates are inclusive of all mediations, medical supplies, technical fees, facility fees, and interpretative charges for the term of this agreement. Payment shall be made by electronic transfer of funds. All payments will be made monthly in arrears, after receipt of a properly executed invoice. Contractor shall submit an itemized monthly statement. All invoices shall contain the following information: Contract Number Obligation Number Type of service provided (by line item as shown in the schedule of supplies/services) Quantity of each line item Cost per type of service provided Date service provided Invoices shall be mailed to: Financial Service Center P.O. Box 149971 Austin, Texas 78714 Payment from the VA for services provided under this agreement shall be considered payment in full. The Contractor, unless specifically authorized by the VA, shall not pursue any further collection activities from any other source. The Contractor shall not bill other third party insurance sources (including Medicare) for services rendered to VA patient under this contract.
