Attachment 4 - Tomah_Mobile_MRI_Lease_SOW.docx

SCOPE OF WORK

Mobile 1.5 Tesla Magnetic Resonance Imaging (MRI) Trailer Lease Tomah VA Health Care System

1. Scope The Contractor shall provide all equipment, services, tools, transportation, delivery, setup, installation, initial labor, maintenance, training, accessories, and support necessary to provide and maintain one fully operational mobile Magnetic Resonance Imaging (MRI) system housed in a mobile coach for use by VA-referred beneficiaries of the Tomah VA Health Care System, 500 E. Veterans Street, Tomah, Wisconsin (Tomah VA). MRI studies shall be performed by Tomah VA employees as medically appropriate and requested by Tomah VA. The Contractor is responsible for all Contractor personnel, subcontractors, agents, and anyone acting for or on behalf of the Contractor.

2. Term of Contract and Period of Performance The anticipated contract term consists of one (1) twelve-month base period and four (4) twelve-month option periods, for a potential total period of performance of sixty (60) months if all options are exercised. Exercise of any option is at the sole discretion of the Government.

Specific period-of-performance dates will be established at award. The contract is subject to the availability of VA funds.

3. Operating Hours The MRI trailer shall normally be used to perform studies Monday through Friday, 8:00 a.m. to 4:30 p.m. Extended hours and weekends may be utilized at the discretion of the facility. The facility will be closed on Federal holidays and any other day specifically declared by the President of the United States to be a Federal holiday.

4. Contractor Responsibilities

4.1 Transportation, Delivery, Setup, Site Interface, and Utilities The Contractor shall be responsible for transportation, delivery, positioning, setup, installation, commissioning, and connection of the mobile MRI system to Government-provided utilities and interfaces. All costs associated with these requirements shall be included in the monthly lease price.

The mobile MRI trailer will be located at the northwest corner of Building 400 on an existing concrete pad approximately 11 feet by 60 feet. The Contractor shall verify that the proposed trailer configuration is compatible with the available site, patient-access interface, delivery route, and Government-provided utilities before delivery.

Government-provided electrical service is 480 VAC, 3-phase, 150-amp service with a Russell-Stoll DS2504 FP female receptacle. Three telephone/communication connections are available at the exterior location. Three new cables have been installed at the exterior location for a future fire-protection connection. Final connection to the Building 400 fire-protection system will be accomplished through a separate Government project after the trailer model and accessory configuration are known. The Contractor shall provide technical information and reasonable coordination necessary to support that connection.

The hydraulic lift shall not be used as a means of egress for patients or staff from the building. The Contractor shall account for the nearby electrical transformer and confirm during commissioning that the installed MRI system is not subject to unacceptable electrical or electromagnetic interference.

4.2 Training, Manuals, and Initial Accessories

The Contractor shall provide one (1) week of OEM MRI applications training; MRI and MRI trailer manuals; applicable biomedical training; radiologist training; engineering employee training; a compatible MRI-safe wheelchair; MRI-safe patient transfer table; full-size walk-through metal detector; and all other required internal and external accessories necessary for year-round operation of the trailer and patient comfort. These costs shall be included in the monthly lease price.

4.3 Staffing

The Contractor is not responsible for providing MRI technologists or other clinical staffing. Tomah VA will provide technologist staffing to operate the mobile MRI system and accessories.

4.4 Preventive and Corrective Maintenance

The Contractor shall provide all routine and annual OEM-recommended preventive and corrective maintenance for the MRI system, mobile coach, and contractor-furnished accessories at no additional cost to the Government. This requirement includes annual testing by a qualified Medical Physicist. The Contractor shall provide maintenance, calibration, and physicist documentation to the COR.

The Contractor shall maintain the mobile unit in accordance with OEM requirements and shall provide evidence of required preventive maintenance and calibration upon request by the COR. Routine maintenance shall be scheduled so that it does not conflict with required clinical schedules unless otherwise approved by the COR. Scheduled preventive maintenance should be performed outside scheduled clinical operating hours when practicable.

4.5 Equipment Failure, Service Response, Restoration, and Replacement The Contractor shall provide a 24-hour-per-day, 7-day-per-week, 365-day-per-year telephone service line. Calls shall be answered immediately or within thirty (30) minutes. For emergency equipment failures requiring on-site support, Contractor service personnel shall arrive on site within two (2) hours of notification.

The Contractor shall restore the mobile MRI system to full operational capability within twelve (12) hours of the equipment failure or unavailability. VA personnel shall be notified immediately of any malfunction that could hinder completion of studies.

If the MRI system cannot be restored to full operational capability within twelve (12) hours, the Contractor shall continue corrective maintenance efforts and shall provide a fully operational replacement mobile MRI unit within forty-eight (48) hours of the initial equipment failure or unavailability. The replacement unit shall meet all minimum requirements of this SOW and shall be provided, delivered, installed, connected, tested, and made operational at no additional cost to the Government.

Activities necessary to restore or replace the system may be required outside normal operating hours and/or on weekends at no additional cost to the Government in order to minimize disruption to patient care and reduce patient backlog.

4.6 Parts and Accessories

All replacement parts required for the MRI system and mobile coach shall be OEM parts and shall be furnished and installed by the Contractor at no additional cost to the Government. Contractor-furnished accessories that fail, become unusable, or require replacement as a result of normal wear and tear shall be repaired or replaced by the Contractor at no additional cost to the Government. This requirement does not include consumable supplies identified in this SOW as Government-furnished.

4.7 Cleaning

VA personnel are responsible for day-to-day cleaning of mobile-unit work areas and disposal of trash in a VA-provided location. Cleaning required as part of equipment or coach maintenance is the responsibility of the Contractor.

4.8 Insurance

The Contractor shall maintain applicable insurance policies commensurate with normal business practices and as required by Federal, State, and local law, and shall provide certificates of insurance upon request. Before commencing work, the Contractor shall furnish evidence of required coverage to the Contracting Officer. Any required loss-payable or notice provisions shall be included as required by the resulting contract.

4.9 Contractor Personnel and Exclusions

Contractor personnel shall not be considered VA employees for any purpose. The Contractor shall ensure that personnel performing under the contract are not excluded from participation in Federal health care programs and shall comply with applicable HHS/OIG exclusion requirements.

4.10 Privacy, Security, and Patient Information

The Contractor shall protect patient records and VA information in accordance with applicable Federal law, VA policy, and the information security/privacy requirements incorporated into the solicitation and resulting contract. Contractor personnel shall release medical information obtained during performance only as authorized by VA and applicable law.

VA personnel are responsible for patient preparation, including safety screening, gowning, and metal screening. If conscious sedation is required, VA is responsible for sedation orders, dosage, pre- and post-sedation instructions, recovery, and the sedation drug. VA remains responsible for clinical care and patient safety during the examination.

4.11 Regulatory and Personnel Requirements

The Contractor shall perform the required work in accordance with applicable Joint Commission, VHA, OEM, and other regulatory and industry standards. Contractor personnel requiring access to VA information systems shall comply with the personnel-security, background-investigation, identification-badge, training, and access requirements incorporated into the contract. The Contractor shall maintain a drug-free workplace in accordance with applicable Federal requirements.

5. Government Responsibilities

5.1 Consumables and Linen

Tomah VA will provide clinical consumables such as contrast, gloves, syringes, and needles. Tomah VA will provide clean linen and launder dirty linen.

5.2 Site and Utilities

Tomah VA will provide the site and Government utility infrastructure described in Section 4.1. No water connection is provided.

5.3 Clinical Staffing and Interpretation

Tomah VA will provide MRI technologists. MRI scan interpretation will be provided by Tomah VA.

5.4 Emergency Response

A crash cart will be appropriately located within the Tomah VA Imaging Department. Clinical emergencies will be handled by the Tomah VA code team. Tomah VA will provide written emergency plans addressing patient codes, personal injury, fire, and disruptive behavior. VA MRI technologists will review MRI safety guidelines with emergency responders and will ensure that code patients are removed from the MRI scan room and that ferrous equipment is not brought into the MRI scan room.

6. MRI Equipment and Functional Requirements

6.1 General Equipment

The Contractor shall provide a clean, well-maintained mobile MRI unit with a minimum 1.5 Tesla magnet and minimum 70 cm bore, capable of body, abdominal, neurological, vascular, extremity, and joint imaging and meeting the minimum technical requirements in this SOW. Appropriate coils shall be provided for all imaging studies performed at Tomah VA.

6.2 PACS/DICOM Connectivity

The Contractor shall provide all software and licenses necessary for full DICOM communication between the MRI system and Tomah VA PACS and applicable radiology workstations and printers. Each MRI study shall be transferred to Tomah VA PACS immediately following acquisition so that it may be reviewed before the patient leaves the mobile MRI when necessary.

7. Information Technology and Network Security Requirements The proposed MRI system shall meet applicable VA network-security requirements and shall be an ERA-validated MRI system approved for connection to the VA network, as identified in the applicable solicitation attachment or other VA-provided approval documentation.

If the networked workstation uses a Microsoft Windows operating system, the operating system shall be at minimum Microsoft Windows 10 IoT Enterprise LTSC 2019. If that configuration is provided, the Contractor shall have a plan to upgrade, at no additional cost to the Government, to Microsoft Windows 10 IoT Enterprise LTSC 2021 by January 9, 2029.

The system shall support authorized vendor remote access for diagnostics and troubleshooting in accordance with VA information-security requirements and approvals.

The system shall communicate with VA's current Change Healthcare PACS.

The Contractor shall provide and install all OEM software and firmware updates required to maintain required functionality, cybersecurity compliance, compatibility with VA systems, and OEM supportability throughout the period of performance at no additional cost to the Government.

Applicable VA information security, privacy, system-interconnection, biomedical-device, media-protection, remote-access, and personnel-security requirements will be incorporated into the solicitation and resulting contract.

7.1 Storage Media Protection and Sanitization

Prior to removal, replacement, return, or disposal of the mobile MRI system or any associated storage media containing VA information, the Contractor shall coordinate with the Contracting Officer's Representative (COR) and designated VA information-security personnel.

Storage media containing VA-sensitive information shall not be removed from VA custody or returned to the Contractor without prior VA authorization and completion of applicable VA-approved media sanitization, retention, or other protective measures.

The Contractor shall provide documentation of completed media sanitization or other VA-approved disposition procedures upon request.

8. Minimum Technical Specifications The MRI system shall include, at a minimum, the following capabilities:

8.1 MRI Protocols

Brain MRI and MRA Orbit/Face/Neck Spine - Cervical, Thoracic, and Lumbar Routine musculoskeletal imaging Abdomen/Pelvis Male and female pelvis Brachial Plexus Carotid and Renal MRA

8.2 MRI Software

2D/3D Imaging ADC Mapping Neuro Angio Body Ortho

EPI/DWI

T2 Dark Fluid 3D TSE Fast Imaging (e.g., Blade or Propeller, or equivalent) Care Bolus 2D/3D Phase Contrast Post-processing Non-contrast MRA and CE MRA Parallel Imaging Single Shot EPI DICOM Worklist

DICOM SCU

8.3 Coils

Appropriate coils shall be included to accommodate and accurately perform all MRI procedures and protocols identified in this SOW.

8.4 System Features

Contrast power injector Minimum 500-pound patient table load capacity Ability to connect and use multiple coils simultaneously, as clinically appropriate HVAC system for environmental control Onboard generator capable of maintaining HVAC in the event of shore-power failure Capability to send images to required destinations, including PACS, applicable hospital RIS/workstations, and printers

8.5 Accessories

Minimum 70 cm bore to accommodate larger patients and reduce claustrophobia concerns Patient communication and comfort equipment, including audio communication; in-bore entertainment/infotainment equipment when included in the proposed configuration Positioning sponges and straps, with replacement as needed due to normal wear and tear MRI-safe patient transfer table Full-size walk-through metal detector Handheld metal detector MRI-safe wheelchair MRI-safe fire extinguisher All other accessories and equipment necessary for safe, year-round operation and patient comfort

9. Software/Firmware and Equipment Upgrades Throughout the period of performance, including exercised option periods, the Contractor shall provide at no additional cost to the Government all OEM software and firmware updates and upgrades necessary to maintain the MRI system's required functionality, cybersecurity compliance, compatibility with VA systems, and OEM supportability. The Contractor shall also provide equipment upgrades or replacement components necessary to maintain the contracted system configuration and capabilities and to ensure continued compliance with this SOW. Updates or upgrades shall not reduce system capability or prevent compliance with any minimum requirement.

10. Contract Performance Monitoring The COR will monitor Contractor performance using mechanisms that may include equipment-failure cancellations, maintenance schedules and records, QA/QC documentation, Medical Physicist reports, service-response records, system-availability records, and the performance standards below.

New or revised performance criteria shall not be imposed except through appropriate contract administration. Unsatisfactory performance may require corrective action or reperformance at no additional cost to the Government, consistent with the terms of the contract.

10.1 System Uptime Calculation

System uptime shall be measured during scheduled clinical operating hours and calculated monthly as follows: [(Scheduled Clinical Operating Hours - Countable Downtime) / Scheduled Clinical Operating Hours] x 100. Countable Downtime includes equipment failure, corrective maintenance, repair, and replacement of contractor-furnished equipment that prevents clinical use. Scheduled preventive maintenance approved in advance by the COR is excluded from the uptime calculation.

11. Contract Administration and COR The Contracting Officer (CO) is the only person authorized to approve changes to the contract or modify requirements that affect price, quantity, scope, or other contractual terms. Contractor personnel shall communicate contract-administration matters to the CO. Changes to the contract must be made by written modification issued by the CO.

A Contracting Officer's Representative (COR) will be designated to provide technical monitoring, guidance, and coordination within the scope of the COR designation. The COR is not authorized to change contractual terms or make commitments affecting price, scope, or schedule.

The Tomah VA Radiology Service COR will serve as the primary technical point of contact regarding imaging protocols and operational coordination. The Contractor shall notify the COR as soon as possible of any actual or anticipated disruption of MRI service.

12. Acronyms ARRT: American Registry of Radiologic Technologists DICOM: Digital Imaging and Communications in Medicine HIPAA: Health Insurance Portability and Accountability Act MRI: Magnetic Resonance Imaging OEM: Original Equipment Manufacturer OSHA: Occupational Safety and Health Administration PACS: Picture Archiving and Communication System RIS: Radiology Information System VA: Department of Veterans Affairs VAMC: VA Medical Center Tomah VA Health Care System - Mobile MRI Trailer Lease SOW