AN41--Tower Radiology MRI Services

Source and Sought Notice The Department of Veterans Affairs, VISN 08, James A. Haley Veterans Hospital (JAHVAH) is looking for certified, Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Small business and/or Large Business sources for the following: The Services provided by the VA-DoD Long-Term Impact of Military-Relevant Brain Injury Consortium (LIMBIC) LIMBIC-CENC Please see the attached Performance Work Statement (PWS). This is not a request for competitive quotes; however, any firm that believes it can meet these requirements, please provide written notification to the Contracting Officer within three (3) days from the date of the publication of this notice. SDVOSB or VOSB must be certified and verified in the U.S. Department of Veteran Affairs, Office of Small & Disadvantaged Business Utilization, Vendor Information Pages web site located at https://www.vetbiz.gov/. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses are due by 9/09/2022 4:30 PM, Eastern Standard Time (EST). The North America Industry Classification System (NAICS) Code is 621512. Business Size Standard is $16.5 millions of dollars .r Contracting Office Address: Department of Veterans Affairs NCO 08 Acquisitions 8875 Hidden River Parkway, Tampa Florida 33612. Point of Contact(s): Cyrouse Houshyani 813-631-2816. Cyrouse.houshyani@va..gov and Rosetta Quinn, 813-893-1814, Rosetta.quinn@va.gov. Contract Title: VA-DoD Long-Term Impact of Military-Relevant Brain Injury Consortium (LIMBIC) LIMBIC-CENC . The Government has a requirement for an offsite 3T MRI system, to support Research and Development, for the James A. Haley VAMC located at 13000 Bruce B. Downs Blvd, Tampa, FL 33612. The Research Study VA-DoD Long-Term Impact of Military-Relevant Brain Injury Consortium (LIMBIC) LIMBIC-CENC, hereinafter (LIMBIC CENC) requires one (1) MRI to be completed per study visit. During the time that contractor s personnel is performing VA responsibilities, they will be under the direction of the Clinical Director and VA Main Principal Investigator (MPI) Shannon Miles, PhD who will determine whether such work is satisfactory Responsibilities and specific tasks to be completed: The research activities to be conducted include but are not limited to the following: Perform MRI scans, per parameters provided in the research study protocol. Provide VA secure de-identified copies of the MRI to the study staff. Provide VA MPI results of the MRI in a timely manner. The Contractor will only receive VA patient name, last 4 of their social security number, and year of birth on the MRI order under the supervision of the VA MPI. Complete all reports as required by the neuroimaging core. The Contractor will fully comply with all VA regulations and Research Service protocols. Monitoring procedures: a. Weekly review/discussion of MRI Reports Qualifications: The qualifications of the Contractor unique equipment suited to the following: The contractor shall provide all 3 Telsa (3T) magnetic resonance imaging (MRIs) as required per the study protocol. All MRIs performed will be during the contractor s normal work hours, at the contractor s facility. Requirements for MRI: The imaging shall be performed using 3T scanner. Sequence parameters shall be adjusted for the GE scanner in Tampa, but T1-weighted, FLAIR, and fcMRI parameters shall be adapted from existing ADNI parameters for this scanner. In addition, similar phantoms are used with each to assess data quality and equivalency. Briefly, sequences shall include an axial resting state echo planar imaging (EPI) sequence for fcMRI analysis, a high-resolution sagittal T1-weighted for volumetric analysis, a 66-direction axial diffusion sequence for DTI and DKI, an axial ASL sequence for perfusion, an axial T2-weighted (fast field echo) for clinical reading and CDE coding (e.g., lesion analysis, detection of blood), and an axial FLAIR for detection of white matter hyperintensities, clinical reading, and CDE coding (e.g., lesion analysis, detection of gliosis). The specific protocol sequence that each participant shall undergo is as follows: Localizer 1a. Calibration/Reference Scan 2. Sagittal 3D T1 MPRAGE/IR-SPGR 3. Axial 3D T2* GRE/SWAN/SWI 4. Axial DTI 5. Axial Resting State fMRI Subjects should have eyes OPEN. 6. Axial 3D T2-FLAIR (CUBE/SPACE/VISTA) 7. Sagittal 3D T2 (CUBE/SPACE/VISTA) 8. Axial ASL 9. HDFT protocol (SAMMC and MEDVAMC only) Note: All scans are performed in straight orthogonal planes No manual adjustments should be made to this protocol. Primary Imaging Variables, numerous variables are generated from acquisition and analysis and shall be readily available for specific exploratory analysis at little additional effort. However, to reduce the number of variables and analyses for the primary aims of the grant, the following measures shall be used: Volumetrics (volume in cubic millimeters): Total frontal gray matter and white matter (GM, WM), total temporal GM/WM, total parietal GM/WM, right and left cingulate GM/WM, right and left hippocampus and amygdala, right and left caudate, right and left thalamus, right and left cerebellum GM/WM, total GM, total WM, ventricle-to-brain-ratio. DTI tractography (fractional anisotropy [FA] and mean diffusivity [MD]: right and left cingulum bundles, fornix, total corpus callosum, uncinate fasciculus, ventral striatum, anterior thalamic radiation. FLAIR white matter hyperintensity analysis: total lesion volume and count, anterior cerebral middle cerebral, posterior cerebral, and vertebral basilar system (feeding brainstem and cerebellum) vascular territories ASL cerebral blood flow (CBF) in the same vascular territories as detailed above as well as whole brain GM and WM CBF, and CBF of the thalamus and posterior cingulate fcMRI connectivity changes in seedpoints involving anterior cingulate cortex, lateral prefrontal cortex, default mode network, posterior cingulate cortex, and hippocampus. Common Data Elements: presence or absence of potentially clinically relevant pathology. A radiologist must provide a report for each scan indicating the presence of any clinical findings. The study staff will collect data from the Contractor on a weekly basis. When required, during regular 8:00 a.m. to 5:00 p.m., weekday hours, the contractor shall provide certified and/or licensed FMRI technicians on the premises, readily available, on the day when the procedure(s) is/are being performed. No studies will take place on Saturday, Sunday, or after hours. The FMRI technician shall be responsible for conducting MRI scans. The FMRI technician shall ensure that research participants follow safety procedures. Safety incidents shall be reported using a Patient Safety Report. All incidents shall be reported immediately (within 24 hours.) The contractor will keep the records of this study private and confidential. Care will be taken to ensure that sufficient backup procedures are in place. One MRI per study subject per visit. MRIs will be scheduled using Subjects Study ID numbers and Birth Dates as 1/1/ and the year of the birth. Study staff will schedule the MRI directly with the MRI staff. Research participants are to be scheduled within thirty (30) calendar days of their desired appointment date. A secure email will be sent to the MRI staff to confirm the appointment with only the subject s study ID and birth year. The study data (MRI scans) are only linked to the participants with their Study IDs. The MRIs will not be stored on the Contractor machine. The MRIs will be copied on discs. The study staff will pick up the discs from the Contractor in locked bags and return them to the Research Office, Valerie Larson, Program Manager (PM) located in Bldg. 38, Room B258 at the James A Haley VA. The MRI discs will be stored in the subject s study charts in locked file cabinets in the locked office. Completing the MRIs at the Contractor offsite is discussed in the informed consent form and has already been approved by the IRB and R&DC. The imaging data will be sent to VA Salt Lake City Health Care System, Baylor College of Medicine, University of Virginia, Brigham Young University, University of New Mexico, and National Institute of Health for analysis, and summary data from these analyses will be transmitted securely to the LIMBIC-CENC Data and Biostatistics Core (DBC) from storage and linking to the other study data. All images and data received by the members of the Neuroimaging Core will be coded with a subject identification (ID) number for tracking and linkage, and will not contain identifying information. The DBC is operated under Holmes McGuire VA Medical Center, Virginia Commonwealth University (VCU) and VA Salt Lake City Healthcare System. VA Policy regarding retention of research records will be in accordance with VHA s Records Control Schedule (RCS10-1), applicable FDA and DHHS regulations, or as described in VHA Handbook 1200.5, section 7.j. At the end of the retention period, the hard copy and electronic source data records will be destroyed in accordance with VA Policy. VA and other Federal privacy, confidentiality and HIPAA regulations will be strictly adhered to. Electronic data will be secured on a networked computer system behind two firewalls, and access to data folders will be password protected and restricted to study personnel who have a need. Data will be managed meticulously using written procedures and tracking systems. Storage of research data will be compliant to VA standards. De-identified electronic data, linked to the subject only by study ID, will be uploaded into the neuroimaging core s secure database that is also firewall protected. Due to HIPAA and Institutional Review Board (IRB) guidelines, any personal identifying information transmitted from the Contractor to the research office needs to remain private and confidential. These guidelines allow data to be faxed, electronically transmitted in an encrypted manner such as using PKI in Outlook, secure messaging, or mailed via traceable and secure carrier such as FedEx, UPS, or USPS. The contractor will certify that the personnel shall meet all requirements of Federal, State, or local laws, codes, and/or regulations regarding the operation/ performance of this type of service. The VA will inspect the establishment, facilities, and other qualifications to assure acceptable standards of performance. Thirty (30) days prior to expiration date, the contractor shall certify in writing to the Contracting Officer that all licenses and registration of personnel performing under this contract are valid and current and shall be renewed as necessary during any option year.