Q515--Control Recovery Brain Bank Transport Intent to Sole Source VAMC Boston Healthcare System

Page 1 of 4 NOTICE OF THE INTENT TO SOLE SOURCE Notice of Intent to Sole Source to Natural Disease Research Interchange. Response Due Date September 13, 2023, by 10:00 am (EST) Notice of the Intent to A Sole Source Synopsis Network Contract Office 1, Procurement Office East on behalf of The Department of Veterans Affairs, Boston VA Medical Center. The proposed procurement is for products/services for which the Government Intends to Solicit and Negotiate with only one source under the Authority of FAR 6.302-1-Only One Responsible Source and no other Supplies or Services will satisfy Agency Requirements 41 U.S.C.3304(a)(1). The North American Industry Classification System code (NAICS) for this requirement is 541714-Research and Development in the social sciences and Humanities. All responsible sources that feel they should be considered qualified to provide the below mentioned products may submit a response to this notice by the response due date shown above to Deborah.Reardon@va.gov. The Information provided shall include detailed and relevant documentation to allow the Government to perform adequate market research and make a proper determination. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. REQUEST FOR A SOLICITATION WILL NOT RECEIVE A RESPONSE Statement of Work GENERAL GUIDANCE Title of Project: VA Biorepository Brain Bank National PTSD Brain Bank Recovery of Veterans/civilians with PTSD/MDD or controls from Organ Procurement Organizations with National Disease Research Interchange (NDRI). Scope of Work: VA Biorepository Brain Bank (VABBB) is a human tissue bank that collects, processes, stores and gives out research specimens for future scientific studies. The overall goal of this project is for NDRI to identify an Organ Procurement Organization to provide PTSD/MDD or controls tissue for VABBB approved scientific studies. The project will include development and utilization of a project-specific Brain Donor Screening Worksheets (BDSW) and obtaining next of kin (NOK) authorization a post-donation follow-up interview by the VABBB (up to 2 hours). Performance Period: twenty-four months for recovering 12 brains from date of award of delivery order. GENERAL REQUIREMENTS Program Year (PY) 1- Project Development and initial donor accrual phase (12 months) NDRI will: finalize 3 screening questions per condition (PTSD, MDD, Controls) with VABBB and OPO to develop a BDSW to identify eligible donors for the project. get the BDWS reviewed and approved by NDRI s Institutional Review Board (IRB) at University of Pennsylvanian (UPENN) develop training tools to implement the BDSW at the OPO as addendum to the DRAI. develop a project-specific post-mortem authorization for the project through NDRI s IRB at UPENN that includes obtaining NOK authorization for donation and a post-donation follow up interview by the VABBB (up to 2 hours) identify one OPO for the project. train and support the OPO on the BDSW to identify eligible donors. train and support the OPO on the project-specific authorization. train and support the OPO to recover, preserve, package, and ship brain tissue according to standard operating procedures as attached in the base contract. provide SOP and shipping supplies to the OPO to support the brain recoveries. monitor OPO screening activities and progress. confirm the donor criteria match VABBB s protocol. verify the authorization includes the NOK authorization for donation and future contact to obtain additional information via interview! coordinate the acquisition of brain from adult donors according to standard operating procedures (SOP) coordinate the shipment of the recovered brain and supporting documents to VABBB. provide completed donor authorization to VABBB that includes contact information for NOK for future contact maintain a database of each case that includes copies of the completed authorization, BDSW, and donor s medical data! provide a dataset with de-identified medical information after each shipment. The data will be transferred to VA by NDRI via secure means on standardized forms. recover up to four brains in PY1. VABBB will: work with NDRI to finalize the initial screening questions to identify donors. review and approve the project-specific post-mortem authorization that NDRI develops. receive up to four brains in PY1. PY 2- Donor Accrual Phase (12 months) NDRI will: monitor OPO screening activities and progress. confirm the donor criteria match VABBB s protocol. verify the authorization includes the NOK authorization for donation and future contact to obtain additional information via interview! coordinate the acquisition of brain from adult donors according to standard operating procedures (SOP) coordinate the shipment of the recovered brain and supporting documents to VABBB. provide completed donor authorization to VABBB that includes contact information for NOK for future contact maintain a database of each case that includes copies of the completed authorization, BDSW, and donor s medical data! provide a dataset with de-identified medical information after each shipment. The data will be transferred to VA by NDRI via secure means on standardized forms. recover up to eight brains in PY2. VABBB will: contact NOK for follow-up interview at appropriate time, allowing for bereavement time. provide a summary of the interviews to NDRI for internal and OPO education. receive up to eight brains in PY2.