R--Research Project MRI Scans

The Veteran's Administration Office of Research and Development, Program Contracting Office - East in Pittsburgh, Pennsylvania, intends to negotiate a Sole Source basis with the University of Pittsburgh, Pittsburgh, PA, to award a Firm Fixed Price Contract, for the services for Structural and functional magnetic resonance imaging (MRI) for the neural activity study to be done by our affiliate, University of Pittsburgh, for subjects participating in the study "Covert Sensorimotor Mapping for Guiding Brain-Computer Interfaces", as described in the attached Sole Source Justification and Statement of Work. The sole source is pursuant to FAR 6.301 Estimated Contract Price; $68,355.00 This Notice of Intent is not a request for competitive proposals, however; any responsible source, who believes it is capable of meeting the requirement, may submit a capability statement to the Contracting Office no later than 4:00PM on 08/25/2014. Interest/capability statements may be sent to [email protected]. No telephone responses will be accepted. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Government. The NAICS Code for this procurement is 541720 and the Small Business Size Standard is 500 employees.? DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs VISN 4 VA Pittsburgh Healthcare System Contracting Office (90C-A) 1010 Delafield Road Pittsburgh, PA 15215 Transaction #: 646-15-1-5472-0003 2. Nature and/or Description of the Action Being Processed: Human Engineering Research Laboratories (HERL) is requesting approval to establish a sole source, firm fixed-price contract with: University of Pittsburgh, Department of Radiology Magnetic Resonance Research Center 3. Description of Supplies/Services Required to Meet the Agency's Needs: HERL requires the following supplies/services: Structural and functional magnetic resonance imaging (MRI) for the neural activity study to be done by our affiliate, University of Pittsburgh, for subjects participating in the study "Covert Sensorimotor Mapping for Guiding Brain-Computer Interfaces". Imaging will be conducted at the University of Pittsburgh's Department of Radiology Magnetic Resonance Research Center (MRRC). The research team has worked with MRRC on previous studies and developed specific protocols that will be used in this research study. Description Est. Qty. Unit Unit Price Total Price Base Year: October 1, 2014 through September 30, 2015 Structural and Functional MRI 30 Hour $651 $19,530 Option Year 1: October 1, 2015 through September 30, 2016 45 Hour $651 $29,295 Structural and Functional MRI Option Year 2: October 1, 2016 through September 30, 2017 15 Hour $651 $9,765 Structural and Functional MRI Option Year 3: October 1, 2017 through September 30, 2018 15 Hour $651 $9,765 Structural and Functional MRI Estimated total value for all years: $68,355 This contract should be awarded by: October 1, 2014 4. Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The MRRC center is noted as the source for the MRIs on this study (see attached), as part of the approved grant package. Therefore, this is the only site approved to send subjects for MRIs. The University of Pittsburgh's Department of Radiology Magnetic Resonance Research Center (MRRC) provides services for multiple clinical and research applications. They have extensive, specialized equipment and software support to manage this service. The research team has worked with the MRRC in previous studies for similar imaging procedures and has worked with the MRRC to design protocols for the desired imaging parameters. 6. Description of Efforts Made to Ensure that Offers are Solicited from as Many Potential Sources as Deemed Practicable: MRRC is uniquely qualified to conduct MRIs for this research study, so no efforts were made to attempt to solicit offers from other sources. The MRRC center is noted as the source for the MRIs on this study. It is part of the approved grant package. Therefore, this is the only site approved to send subjects for MRIs. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Market Research was conducted and the rate per MRI is consistent with the average, prevailing rates for this service. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The VA RR&D project, "Covert Sensorimotor Mapping for Guiding Brain-Computer Interfaces, currently has the Magnetic Resonance Research Center (MRRC) noted as the source for MRI Imaging for this study. The MR Research Facility is a 14,000 sq. ft. facility located on the eighth floor of UPMC Presbyterian University Hospital and is part of the Functional Imaging Research Program (FIRP), a joint facility of the University of Pittsburgh and UPMC. Major equipment in the MR facility includes a GE Signa 1.5 Tesla MR imaging/spectrometer and a GE Signa 3.0 Tesla machine. The instrumentation has full conventional capabilities. Both systems are interfaced to a high speed local area network for data transfer to offline computers for analysis. All conventional imaging and angiographic functions are fully supported within the eighth floor MR research facility. The magnet rooms are magnetically, acoustically, and RF shielded. Both magnets are passively shielded. MR scan data are transferred by Ethernet to offline computers for data analysis. There is no other facility in the Pittsburgh area that can match this facility's resources and we are confident that this will keep potential risk to our subjects that will participate in this study minimal. The MRRC center is noted as the source for the MRIs on this study. It is part of the approved grant package. Therefore, this is the only site approved to send subjects for MRIs. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Because the VA RR&D award was approved as written to include the use of the MRRC for imaging, no other source is suitable and full and open competition is not appropriate for this requirement. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: An Intent to Sole Source was posted on FBO and no responses were received expressing capability for this service. 11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making Subsequent Acquisitions for the Supplies or Services Required: N/A 12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____ ________________________ 5/27/2014 Dana Sinciline Date Administrative Officer/HERL VAPHS ? 13. Approvals in accordance with FAR 6.304 a. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Elaine DiBucci Date Contract Officer NCO 4 b. NCM/PCM (Required $3K and above): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Herb Byrns Date Deputy Director of Contracting NCO 04 ? STATEMENT OF WORK: MRI CONTRACT A. GENERAL GUIDANCE 1. Title of Project: Covert Sensorimotor Mapping for Guiding Brain-Computer Interfaces 2. Scope of Work: The University of Pittsburgh Department of Radiology Magnetic Resonance Research Center (MRRC) will conduct structural and functional MRI scans to record neural activity using a Siemens 3 Tesla system. A high quality MPRAGE protocol will be used for structural imaging. The anatomical images will be used in determining regions of brain activation during subsequent neural imaging scans. Functional imaging will be completed with the use of paradigms designed in E-Prime, a software program commonly used in fMRI data collection to selectively activate different regions of the brain. Functional imaging trials range from 3 to 6 minutes and scanner repetition time is set at 2 TRs. During the course of the study, up to 105 structural/functional MRI sessions will be conducted. Up to 35 total subjects will be recruited over the course of the study. Each will receive up to 3 hours of MRI scans. 3. Background: The MRRC has extensive experience with clinical and research imaging. The research team has worked with the MRRC in previous studies for similar imaging procedures and has worked with the MRRC to design protocols for the desired imaging parameters. The MRRC provides advanced facilities and technical expertise for research studies. 4. Performance Period: October 1, 2014 through September 30, 2018 B. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES To obtain MRI scans, study participants will present to the MRRC and provide a research requisition form to MRRC staff which includes name, address, phone, and date of birth. Data collected at the MRRC will be sent to HERL via mail, transferred in person or accessed through their online system. Their online system can only be accessed behind the UPMC firewall and requires a username and password. The MRRC will label the images with a code. If data is transferred in person from MRRC to HERL, the research staff member who receives the data from MRRC will remain in direct possession until it is returned to HERL. Data sent from MRRC to HERL via mail will utilize a service with a "chain of custody" such as UPS or FedEx. C. SCHEDULE FOR DELIVERABLES Data from each subject imaging session will be sent from MRRC to HERL. The MRRC will label the images with a code. It is expected that during the first year 10 subjects will be enrolled. D. REPORTING REQUIREMENTS The contractor will regularly communicate with the research team to coordinate subject testing and accessing data. E. GOVERNMENT RESPONSIBILITIES The VA will not provide any equipment or software for these imaging procedures. VA sensitive information will be disclosed under HIPAA Authorization. Contractor-owned IT equipment will be used to obtain the MRI images. This contract will not require services that involve connection of one or more contractor-owned IT devices to a VA internal trusted network. Therefore, the C&A requirement do not apply and a Security Accreditation Package is not required.