W023--WLR Mobile Siemens 1.5T Equipment Lease

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-03. This solicitation is set-aside for Service Disabled Veteran Owned Businesses. The associated North American Industrial Classification System (NAICS) code for this procurement is 532120, Truck, Utility

Trailer, and RV (recreational Vehicle) Rental and Leasing with a small business size standard of $38.5M. The FSC/PSC is W023, ground effect vehicles, motor vehicles, trailers, and cycles. The Great Lakes Acquisition Center, on behalf of the Jesse Brown VA Medical Center, in Chicago, IL is seeking to lease a Siemens Brand Name Only 1.5T Mobile MRI Trailer for the period of one year. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 One (1) Mobile Siemens 1.5 T System, to be housed in a mobile coach. 12 Month DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Scope. Contractor shall provide all materials, tools, equipment, maintenance, and repair of all Contractor furnished equipment (including a mobile trailer/unit) necessary to perform mobile MRI services utilizing a Siemens 1.5T Sola/Aera 70cm open bore design MRI system or better with a MEDRAD power injector at Jesse Brown VA Medical Center located at 820 S. Damen, Chicago, IL 60612. All equipment to be used during the performance of the contract must be FDA approved imaging equipment and placed at a location designated by the onsite COR at Jesse Brown VA Medical Center. Contractor shall be required to make whatever adaptations are necessary so that the Contractor s equipment is compatible with the VA system and structure of the bay. Contractor shall be responsible to maintain all equipment in good working order throughout the duration of the contract and shall make alternate accommodations for the VA for lost time resulting from defective workmanship or equipment failure. Jesse Brown VA Medical Center requires a Siemens 1.5T Sola/Aera 70cm open bore MRI system to be placed on-site and in a mobile trailer, with the most updated/current version hardware and software available from the manufacturer. The system must include 3D reconstruction package and be capable of performing the highest quality MRI scans possible. The system must include Vascular scanning for MR Angiography. Software and hardware shall be upgraded in concurrence with newest OEM factory releases no later than 3 months post release from OEM. Specific Tasks. Imaging services shall be performed by VA staff in the unit an estimated 24/7 hours per week. Equipment shall include but not be limited to a fully equipped Siemens 1.5T Sola/Aera open bore MRI system with MEDRAD power injector. Contractor furnished Mobile Trailer where studies will be performed on state-of-the-art equipment furnished by the Contractor. As further defined in 52.212-2, Evaluation Commercial Items, Contractor shall submit their equipment specifications on which MRI scan procedures will be performed; include name of manufacturer, model number, make and all pertinent information. All equipment to be used will be FDA approved imaging equipment placed at a location designated by the COR onsite at Jesse Brown VA Medical Center. The entire offering of a Siemens 1.5T Sola/Aera open bore MRI system trailer service shall meet all local, state, federal, industry, TJC, NEC, NFPA, VA, OSHA, and other regulatory standards internal or external which Jesse Brown VA Medical Center are currently held accountable. The Contractor shall provide a mobile Siemens 1.5T Sola open bore MRI system that is a full body MRI scanner system and MEDRAD power injector onsite in accordance with the terms and conditions of this contract. The unit shall have the ability to perform a wide range of exams as listed below: Complete MRI body imaging such as: MRI chest, abdomen, pelvis, whole body, etc. MRI of the Head, Neck, and Spine MR Angiography (MRA) of the entire body (head, neck, chest, abdomen, pelvis, runoff, etc.) Cardiac MRI Breast MRI 3D Imaging 3D non-contrast enhanced Peripheral Arterial Imaging Diffusion/Perfusion weighted imaging All other MRI procedures EQUIPMENT LIST: to be provided at no additional cost to Jesse Brown VA Medical Center. Siemens 1.5T Sola/Aera open bore MRI system 1.5 Tesla 70cm open bore design TIM 4G coil portfolio and BioMatrix Technology Turbo Suite and GO Technologies Inline Compressed Sensing GRASP-VIBE Tiltable BioMatrix Head/Neck 20- Tilt 18 degrees RESOLVE Diffusion Simultaneous multi-slice TSE MRCP with 3D T2w SPACE BioMatrix Beat Sensor Whole-body Dot Engine Syngo MR XA30 platform BioMatrix Select&GO BioMatrix dockable table with eDrive BLADE sequences CISS sequences Dose Reduction software. Metal Reduction software. Spatial resolution. DICOM VA Vista Rad and Vista Imaging compatible Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for both MRI Scanner and Injector. Injector: MedRad contrast injector to remotely inject during contrast enhanced MRI exams. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for both MRI Scanner and Injector. DICOM VA Vista Rad and Vista Imaging compatible; if applicable Additional Requirements: The semi-trailer that houses the MRI scanner must have sufficient space to provide for patient wheelchair access as well as service access. This is typically provided with 2 slide-out extensions within the MRI scan room. In addition, an operator control room with a door and an additional room for an office or storage. The control room shall have lockable storage cabinets. A MedRad dual syringe power injector shall be positioned on a wheel stand in the scan room with operator controls integrated into the MRI scanner console. The injector shall have adequate length power cables to reach to either side of the MRI table as needed. Contractor will need to install protocols from existing current Siemens MRI Scanner to the lease scanner prior to start of operating contract to ensure equipment is ready for patient care. Two height adjustable office chairs with wheels, to fit the space constraints, will be provided by the vendor. The MRI trailer must meet Federal codes for MRI safety, etc. The MRI trailer must have an ADA patient lift with guardrails for wheelchair & stretcher patient access with an outside remote switch hand control. Heavy duty non-slip stairs with dual handrails must also be provided for safe staff and patient access. Stairs must meet approval from the JB Safety manager. Vendor will provide accessories and positioning devices including MRI slicker, positioning pads and sponges, chin & body straps, head coil, spine coil, 2 body coils, knee coil, foot/ankle coil, runoff coil, small medium and large flex coils, blanket warmer for patient comfort. The MRI unit shall have the ability to perform MRI exams of the head, neck, body, and extremities, with the capability to perform 3D MR angiography, with a minimum table capacity of 550 lbs. and gantry bore of 70 cm. Vendor must provide full-service maintenance service and OEM parts & labor, including preventative maintenance (PM) as recommended by the original equipment manufacturer (OEM) specifications for all systems and devices provided (MRI and Injector). Vendor must schedule PMs with the Contracting Officer s Representative (COR) with at least 1-month advance notice. Technical Phone Support must be available within 1 hour from initial call for service Sunday through Saturday, 24 hours per day 7 days a week, 365 days per year. OEM service (including emergency repair) Sunday through Saturday, 24 hours per day 7 days a week, 365 days per year must be available within 4 hours from initial call for service and all repairs must be completed within 48 hours from initial call. Contractor shall provide a phone number to call for technical/repair services. Vendor must provide full-service maintenance and parts (all parts) on the MRI trailer, including heating, electrical and air conditioning. In addition, monthly and annual safety inspections in accordance with local/national regulations such as National Fire Protection Association (NFPA) 10, 101, 110 and Joint Commission EC standards must be performed. This includes, but is not limited to fire alarm, fire extinguishers and emergency lighting. Monthly emergency generator testing will also be required. These reports will be provided to the COR. Contractor shall provide a phone number to call for technical/repair services. Service tickets indicating work being done on the trailer, injector, MRI system will be provided to the COR as the work is done. Staffing: JB MRI Technologists will staff and operate the unit. The contractor shall provide 1 week of clinical applications training for two (2) JB MRI/Radiologic Technologists. MRI unit must send images via DICOM to our JB Vista PACS archiving system and must be an already approved Veteran Admiration (VA) DICOM interface verified by the Contractor. Contractors responding to this solicitation will provide compliance with VA and DICOM standards. Contactor shall assist the JB Vista PACS administrator and JB IT Department to set up the MRI unit and demonstrate that the images are transmitting to the JB Vista PACS system. Adequate length electrical & data cables must be provided to reach our connections on the outside of the building and shall be compatible with JB current outside connectors. JB will provide an estimated 24-foot-wide by 48-foot-deep pad with power and data outlets. Vendor will validate that existing utilities and pad will be sufficient for their system. MRI scanner must be certified/calibrated to OEM specifications and must be maintained with original OEM parts, including the MRI system. MedRad Dual Power Injector must be certified/calibrated to OEM specifications and must be maintained with original OEM parts. Mobile unit must have air conditioning, heating, and emergency backup generator. Backup generator will be tested upon arrival and tested by the vendor monthly and will be expected to operate correctly. Vendor shall provide diesel fuel for the generator. At the end of the lease or any time a hard disk drive is required to be replaced or removed the drive must be removed by the vendor and turned over to the COR for destruction at no cost to the JB or, patient data must be removed to the satisfaction of the Information Security officer (ISO). Any removable media used for diagnostic purposes will be required to be scanned by JB prior to use. Coordinate with the COR. Contractor will deliver, set-up and test unit. The contractor will be required to pay for a JB approved Licensed Radiation Physicist to inspect the CT Scanner upon delivery (if required by ACR/Joint Commission) and to inspect the operation any time maintenance or repair on the system would impact radiation output to ensure proper operation (i.e. tube changes). Mandatory annual testing is included in this requirement. The Vendor will make sure a copy of the Physicist report is provided to the COR each time the system is inspected. The MRI Unit is required to be operational 98% of the time. The 98% monthly uptime is calculated by the number of hours the system can see patients monthly by the number of hours that the clinic is available to see patients. Downtime is not counted for lack of facility staff, patient no shows or other situations, such as weather closures, where it was not the fault of the MRI system. Failure of the contractor to perform in accordance with this requirement may constitute a sufficient basis for termination of the contract. The following criteria apply for determining appropriate action: Notifications: The COR shall notify the contract holder of failure to meet the uptime standard through electronic mail within 1 hour of occurrence of downtime. CONTRACTOR FURNISHED EQUIPMENT: Mobile MRI scanner shall include a ramp and/or a lifting device for non-walking patients. Services shall include equipment maintenance, (scheduled and unscheduled) and required supplies necessary to perform services detailed herein. Contractor shall also be responsible for the control of waste management and proper disposal of all waste materials. Equipment shall include, but not be limited to, a fully equipped MRI. Contractor shall submit an equipment specification list of all equipment by location, including the MRI unit(s) with contractor s signed quote. Contractor should already have the MRI unit certified by Physicist prior to delivering unit or on site at time of commissioning unit. Contractor shall provide all equipment service records upon request. Include name of manufacturer, model number, manufacturer s brochures cut sheets, equipment specifications and all pertinent data with offer. All equipment to be used will be FDA approved imaging equipment placed at a location designated by the COR. MRI positing pads and table straps. MRI sandbags MRI safe wheelchair and stretcher with IV pole (gurney) Nonferrous MRI safe oxygen cylinder Capability to provide patient exam on CD. Dressing, waiting, and storage areas. MRI license for PACS Interface between MRI scanner and PACS, DICOM print, store and work list Optical disk archival device compatible with PACS Code kit and code call button MRI compatible 02 saturation monitor MRI safe patient monitor Patient oxygen delivery capabilities Contrast media and warmer MRI MEDRAD compatible power injector HOUSEKEEPING: Contractor shall be responsible for any serious health/cleaning issues, infestations, water damage, etc. The government will be responsible for daily cleaning of debris and other sanitation matters. TYPE OF MRI SCANS (MINIMUM) MRI Head/Neck MRI Brain without Contrast -MRI Brain with & without Contrast -MRI IAC without Contrast -MRI IAC with & without Contrast -MRI Pituitary Gland without Contrast -MRI Pituitary Gland with & without Contrast -MRI Orbit without Contrast -MRI Orbit with & without Contrast -MRI Face without Contrast -MRI Face with & without Contrast -MRI Trigeminal Neuralgia without Contrast -MRI Trigeminal Neuralgia with & without Contrast -MRI Soft Tissue Neck without Contrast -MRI Soft Tissue Neck with & without Contrast -MRI TMJ without Contrast -MRI TMJ with & without Contrast MRI Head/Neck MRI Brain without Contrast -MRI Brain with & without Contrast -MRI Brain Seizure Protocol 3 Tesla without Contrast -MRI Brain Seizure Protocol 3 Tesla with & without Contrast -MRI IAC without Contrast -MRI IAC with & without Contrast -MRI Pituitary Gland without Contrast -MRI Pituitary Gland with & without Contrast -MRI Orbit without Contrast -MRI Orbit with & without Contrast -MRI Face without Contrast -MRI Face with & without Contrast -MRI Trigeminal Neuralgia without Contrast -MRI Trigeminal Neuralgia with & without Contrast -MRI Soft Tissue Neck without Contrast -MRI Soft Tissue Neck with & without Contrast -MRI TMJ without Contrast -MRI TMJ with & without Contrast -MRI Multiple Myeloma Brain without Contrast -MRI Multiple Myeloma Brain with & without Contrast -MRI Multiple Sclerosis Brain without Contrast -MRI Multiple Sclerosis Brain with & without Contrast -MRA Head without Contrast -MRV Head without Contrast -MRV Head with & without Contrast -MRA Neck without Contrast -MRA Neck with & without Contrast -MRA Neck without Contrast Dissection -MRA Neck with & without Contrast Dissection MRI Neuro/Spine -MRI Cervical Spine without Contrast -MRI Cervical Spine with & without Contrast -MRI Thoracic Spine without Contrast -MRI Thoracic Spine with & without Contrast -MRI Lumbar Spine without Contrast -MRI Lumbar Spine with & without Contrast -MRI Cord Compression Survey Complete Spine -MRI Multiple Myeloma Cervical Spine without Contrast -MRI Multiple Myeloma Cervical Spine with & without Contrast -MRI Multiple Myeloma Thoracic Spine without Contrast -MRI Multiple Myeloma Thoracic Spine with & without Contrast -MRI Multiple Myeloma Lumbar Spine without contrast -MRI Multiple Myeloma Lumbar Spine with & without Contrast -MRI Brachial Plexus Left without Contrast -MRI Brachial Plexus Left with & without Contrast -MRI Brachial Plexus Right without Contrast -MRI Brachial Plexus Right with & without Contrast -MRI Sacral Plexus without Contrast -MRI Sacral Plexus with & without Contrast MRI Body -MRI Chest Wall/Pec Muscle tear without Contrast -MRI Chest Wall/Pec Muscle tear with & without Contrast -MRI Abdomen without Contrast -MRI Abdomen with & without Contrast -MRI Renal/Abdomen without Contrast -MRI Renal/Abdomen with & without Contrast -MRI Adrenal/Abdomen without Contrast -MRI Adrenal/Abdomen with & without Contrast -MR Elastography -MRCP/Abdomen without Contrast -MRCP/Abdomen with & without Contrast -MRI Urogram with & without Contrast -Enterography with & without Contrast (Oral & IV) -MRI Female Pelvis without Contrast -MRI Female Pelvis with & without Contrast -MRI Prostate Pelvis without Contrast -MRI Prostate Pelvis without & with Contrast -MRI Soft Tissue Pelvis without Contrast -MRI Soft Tissue Pelvis with & without Contrast -MRI Rectal Cancer/Pelvis without Contrast -MRI Rectal Cancer/Pelvis with & without Contrast -MRI Perianal Fistula without Contrast -MRI Perianal Fistula with & without Contrast -MRI Periurethral Diverticulum without Contrast -MRI Periurethral Diverticulum with & without Contrast -MRI Scrotum/Penis without Contrast -MRI Scrotum/Penis with & without Contrast -MRI Penile Prosthesis without Contrast -MRI Penile Prosthesis with & without Contrast -MRA Chest without Contrast Non-Cardiac -MRA Chest with & without Contrast Non-Cardiac -MRA Abdomen without Contrast -MRA Abdomen with & without Contrast -MRA Pelvis without Contrast -MRA Pelvis with & without Contrast -MRA Abdomen/Pelvis/LE Runoff without Contrast -MRA Abdomen/Pelvis/LE Runoff with & without Contrast E.MRI MSK Extremity Upper -MRI Shoulder Right without Contrast -MRI Shoulder Right with & without Contrast -MRI Shoulder Left without Contrast -MRI Shoulder Left with & without Contrast -MRI Humerus (long bone) Right without Contrast -MRI Humerus (long bone) Right with & without Contrast -MRI Humerus (long bone) Left without Contrast -MRI Humerus (long bone) Left with & without Contrast -MRI Elbow Right without Contrast -MRI Elbow Right with & without Contrast -MRI Elbow Left without Contrast -MRI Elbow Left with & without Contrast -MRI Forearm (long bone) Right without Contrast -MRI Forearm (long bone) Right with & without Contrast -MRI Forearm (long bone) Left without Contrast -MRI Forearm (long bone) Left with & without Contrast -MRI Wrist Right without Contrast -MRI Wrist Right with & without Contrast -MRI Wrist Left without Contrast -MRI Wrist Left with & without Contrast -MRI Hand Right without Contrast -MRI Hand Right with & without Contrast -MRI Hand Left without Contrast -MRI Hand Left with & without Contrast -MRI Finger Right 1st digit (thumb) without Contrast -MRI Finger Right 1st digit (thumb) with & without Contrast -MRI Finger Right 2nd digit (index) without Contrast -MRI Finger Right 2nd digit (index) with & without Contrast -MRI Finger Right 3rd digit (middle) without Contrast -MRI Finger Right 3rd digit (middle) with & without Contrast -MRI Finger Right 4th digit (ring) without Contrast -MRI Finger Right 4th digit (ring) with & without Contrast -MRI Finger Right 5th digit (pinky) without Contrast -MRI Finger Right 5th digit (pinky) with & without Contrast -MRI Finger Left 1st digit (thumb) without Contrast -MRI Finger Left 1st digit (thumb) with & without Contrast -MRI Finger Left 2nd digit (index) without Contrast -MRI Finger Left 2nd digit (index) with & without Contrast -MRI Finger Left 3rd digit (middle) without Contrast -MRI Finger Left 3rd digit (middle) with & without Contrast -MRI Finger Left 4th digit (ring) without Contrast -MRI Finger Left 4th digit (ring) with & without Contrast -MRI Finger Left 5th digit (pinky) without Contrast -MRI Finger Left 5th digit (pinky) with & without Contrast -MR Arthrogram Shoulder Right -MR Arthrogram Shoulder Left -MR Arthrogram Wrist Right -MR Arthrogram Wrist Left -MRA Upper Extremity Right -MRA Upper Extremity Left MRI MSK Extremity Lower -MRI Bony Pelvis without Contrast -MRI Bony Pelvis with & without Contrast -MRI Sacrum/SI Joints without Contrast -MRI Sacrum/SI Joints with & without Contrast -MRI Hip Right without Contrast -MRI Hip Right with & without Contrast -MRI Hip Left without Contrast -MRI Hip Left with & without Contrast -MRI Athletic Pubalgia without Contrast -MRI Athletic Pubalgia with & without Contrast -MRI Femur (long bone) Right without Contrast -MRI Femur (long bone) Right with & without Contrast -MRI Femur (long bone) Left without Contrast -MRI Femur (long bone) Left with & without Contrast -MRI Knee Right without Contrast -MRI Knee Right with & without Contrast -MRI Knee Left without Contrast -MRI Knee Left with & without Contrast -MRI Tibia & Fibula (long bone) Right without Contrast -MRI Tibia & Fibula (long bone) Right with & without Contrast -MRI Tibia & Fibula (long bone) Left without Contrast -MRI Tibia & Fibula (long bone) Left with & without Contrast -MRI Ankle Right without Contrast -MRI Ankle Right with & without Contrast -MRI Ankle Left without Contrast -MRI Ankle Left with & without Contrast -MRI Forefoot Right without Contrast -MRI Forefoot Right with & without Contrast -MRI Forefoot Left without Contrast -MRI Forefoot Left with & without Contrast -MR Arthrogram Hip Right -MR Arthrogram Hip Left -MRA Lower Extremity Right -MRA Lower Extremity Left MRI Cardiac -MRA Chest Aorta without Contrast EKG Gated -MRA Chest Aorta with & without Contrast EKG Gated -MRI Cardiac without Contrast -MRI Cardiac with & without Contrast MRI Whole Body Breast MRI New hardware and software necessary for the ability to: Transmit MRI Images to Jesse Brown VA Medical Center PACS for interpretation. Perform required Post processing, reformats, and reconstructions such as Multi Planar Reconstruction (MPR) and Maximum Intensity Projections (MIP) Inject contrast via power injector (MedRad Injection System). DICOM network connection to existing version of AFGA IMPAX The mobile unit shall be equipped with an Optical disk archival system. The patient data and optical disk is the property of Jesse Brown VA Medical Center. The mobile unit shall be equipped with CD-R burning capabilities as a backup to network transfer of data. The mobile unit shall be equipped with an Analysis Station. ACCESSORY EQUIPMENT: Accessory equipment that shall be provided by the Contractor: Handicap accessibility. Intercom system between the control room and scanning room. Equipment Specifications: The following minimum performance characteristics of the equipment are required: 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 MRI trailer must fit on a 58 x 18 (6 thick) concrete slab at Jesse Brown VA Medical Center. The MRI shall provide images with consistently high technical quality. The MRI Unit shall have a multi-gradient detector and be capable of acquiring a volume of images within one breath hold for different body parts. The MRI unit shall be capable of acquiring data for anatomic localization. The MRI system shall have attenuation correction algorithm(s) that are designed to use non-contrast enhanced MRI data. The MRI multimodality review station shall have attenuation correction algorithm(s) that are designed to use MRI data with intravenous contrast enhancement. The MRI multimodality review station shall have attenuation correction algorithm(s) that are designed to use MRI data with oral contrast enhancement with group II Gadolinium agents. The MRI system shall have attenuation correction algorithm(s) that are designed to use MRI data with oral contrast enhancement with negative contrast (water). Two MRI review stations shall be provided as follows: One standard MRI review station and One multimodality review station: This review station shall have multimodality display capability, including magnetic resonance imaging, computerized tomography, radiography, ultrasonography etc. with the capability to reconstruct and/or post-process magnetic resonance and computerized tomographyÂas well as MRI and Cardiac imaging. Both review stations shall be of diagnostic quality and shall have the capacity to handle the computational load of 3-dimensional datasets. The MRI review station shall have software packages that are designed to reconstruct/post-process MPRs and MIPs. The review stations shall have computers with high processing performance and large memory capacity to achieve real-time interactive navigation without compromising the native resolution of MRI images (spatial resolution and dynamic range). The review stations shall have image fusion and inline composing capability. The review stations shall have software tools that allow interpreting physicians to navigate between multidimensional MRI datasets efficiently with ease. The review stations shall have software tools that can provide three orthogonal planes of the MRI images alone. The Mobile MRI unit shall be ready for use regardless of outside environmental conditions. The Mobile MRI 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, including, but not limited to, proper magnet shielding of the trailer. Telecommunications: The mobile unit shall be equipped with an outlet connection capable of transmitting data. The Government will provide the connection required for the transmission of images and data. The Contractor s mobile unit must be able to connect to VISTA Imaging Network and to transmit all images to VISTA Imaging to include being compatible to DICOM 3 imaging standards. Performance Monitoring Contractor shall maintain a quality assurance documentation of the system and proficiency of the staff prior to and during the time the services are utilized by Jesse Brown VA Medical Center and should be able to provide such documentation upon request. As necessary, the contractor shall maintain staff training documentation and equipment service records to document performance reports. The Contractor shall provide MRI scanners that can consistently produce images that are of high quality and for ready interpretation. The Government may evaluate the quality of images. Security Requirements Remote connection must be coordinated through Information Security at Jesse Brown VA Medical Center. PACS interface contact person shall be provided to the successful Contractor during the post-award orientation. Clinical or other medical records of VA beneficiaries that are released to the Contractor shall be returned to the VA. The Contractor shall be responsible for the safekeeping of both the electronic and paper medical records (whichever is applicable). Patient Privacy Provisions and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations are applicable to the release of patient Information. If the contractor must be onsite to perform service, all mobile media (i.e. flash drives, CD/DVD disks, etc.) that are required to complete repairs or updates on the system must be given to Biomedical Engineering to be scanned for viruses prior to being connected to VA equipment.ÂIf the vendor must connect a vendor-owned laptop to perform the repairs, they must show proof that the laptop has current anti-virus software and that a recent scan shows no infections on the laptop. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive. VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then: The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. For additional security requirements, please see Attachment A. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) VA shall provide the following utilities/services (if necessary) for operation of the Mobile Unit: Water (Â3⁄4 male water supply connector) Electricity* (The provided receptacle is a Russellstoll #DF2504FRABO) Telephone Line(s) ** (Hubbell phone connectors, model PH-6597 provided) Data Port (10Base2 (coax) Ethernet connection provided) Housekeeping*** In accordance with the Original Equipment Manufacturers (OEM) electrical specifications. The government will provide all direct patient care medical supplies. These include, but are not limited to, contrast materials, syringes, IV tubing, oxygen masks and tubing, needles, emesis basins, gowns, and other similar direct patient care items. ** Use of telephone extension while mobile unit is on site to permit personnel of the unit to make and receive telephone calls, and to facilitate the movement of patients to and from the unit. *** VA shall be held responsible for areas within the hospital facility prior to entranc...