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VA SHIELD Pathologists FAQs

GOAL: Pathologists leading select VA Pathology laboratories are invited to participate in the approved VA-CIRB protocol to collect – and in conjunction with appointed research staff – send remainder biospecimens and associated health data to VA SHIELD biospecimen bank and data repository.

  • What is the VA SHIELD Biobank and Data Repository?
    • VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD) was established in January 2021 to provide the Veterans Health Administration (VHA) with a comprehensive specimen and data repository related to COVID-19 and other emerging life-threatening diseases. VA SHIELD will be implemented as a system of central and local biorepositories managed under a single laboratory information management system (LIMS).
  • What is the name of the protocol under which specimens and health data will be collected?
    • The name of the protocol is: Establishment of the VHA Biorepository, VA Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (VA SHIELD), with One Time Sweep of Existing Remainder Clinical Specimens and Data to Develop Assays, Laboratory Tests and Conduct Future Research on COVID-19.
    • This protocol (#E21-003) is a VA Central Institutional Review Board (VA-CIRB)-approved mechanism to obtain, store, and distribute human biological specimens and data.
  • What activities and samples are approved for collection under the protocol?
    • The protocol proposes to initially populate VA SHIELD with a ‘Sweep’ of remainder/discard clinical blood, body fluids, and/or tissues in VHA clinical or research laboratories. This consent exempt protocol allows SHIELD facilities and personnel to accept samples and data from Pathology laboratories and others across the VA healthcare system.
    • More urgently, VA SHIELD is responding to the COVID-19 pandemic by assembling blood serum samples for assessment of immunological and other chemical assays necessary for confirming recovery from COVID-19 illness or response to treatment and primary nasopharyngeal or bronchial washing samples for initial diagnostic assessment.
    • Plans are being implemented to amend the protocol to allow prospective collection of specimens of interest, such as for COVID-19 or other emerging diseases, under informed consent. These amendments will be placed before the VA-CIRB in FY2021. In the meantime, activities will be limited to the collection of remainder samples and accompanying data under the current approved Protocol #E21-003.
  • What is the role of Pathology labs in supporting VA SHIELD?
    • Relevant specimens will generally be processed under the authority of local VA Pathologists. Most immediately, VA SHIELD requests the assistance of Pathologists to help preserve remainder clinical specimens from SARS-CoV-2 infected and COVID-19 convalescent patients; prepare and deliver these specimens to the VA SHIELD central biorepository locations in Tucson or Palo Alto. Preparation and delivery of specimens will be primarily performed by appointed research staff.
  • How should VA SHIELD samples be labeled and stored?
    • As part of the effort to collect remainder samples from participating VA sites of care, VA SHIELD has established a set of standard operating procedures (SOPs) that provide guidance for how samples should be labeled and prepared for VA SHIELD use. Additionally, VA SHIELD requests that any clinical remainders identified for VA SHIELD inclusion be kept separate from other samples for security reasons.
    • Samples and data will also be managed under a LIMS designed specifically to support VA SHIELD needs regarding data management and protection. Samples will be accessioned at the central biorepository locations in Tucson and Palo Alto.
  • What kind support will VA provide to Pathologists to adequately support the biorepository?
    • Personnel resources will be available to assist Pathologists with collecting and shipping human biological samples and data.
    • VA SHIELD personnel will share developed SOPs and other protocol documents with Pathologists to support the shipment of samples and accompanying data.
    • Other site needs will be identified, and support will be provided as needed. Please contact VASHIELD@va.gov and visit the VA SHIELD webpage for additional information: https://www.research.va.gov/programs/shield/default.cfm.
  • How will VA SHIELD determine which VA sites of care can participate in VA SHIELD?
    • Pathologists with relevant specimens under their authority or who are willing to be poised to participate in VA SHIELD are strongly encouraged contact the national office at VASHIELD@va.gov to initiate training and assess readiness.
    • VA SHIELD personnel are working closely with leadership at specific initially identified VA sites, first, to implement VA SHIELD in a series of pilot projects and, second, to develop criteria to assess readiness of additional sites for specimen and data collection.
    • Site readiness criteria may include support from site local research and development committees, support from site leadership and personnel, local site budgeting, equipment, and consumable needs, COVID-19+ cases, and capacity to support information management systems.
  • Upon site approval, who will be responsible for sending remainder specimens to the central biorepositories?
    • VA SHIELD work with site Pathology leadership to identify existing personnel capacity to be able to prepare and ship samples to the central biorepository locations at Tucson, AZ and Palo Alto, CA. VA SHIELD will also work with Pathology leadership to determine budgeting needs, budget approvals, and to disperse funding as identified.
  • What next steps can responsive and participating VA Pathology labs expect?
    • Upon written support and “approval” of the protocol by VA Pathology Department, VA SHIELD personnel will reach out to selected VA sites to determine site willingness, support needs, and capacity to participate in the protocol. From there, VA SHIELD and site personnel will colla borate to determine next steps including local research and development approval, personnel and monetary needs.
    • Please contact VASHIELD@va.gov with questions related to supporting this effort and please visit the VA SHIELD webpage for general VA SHIELD information: https://www.research.va.gov/program/shield/default.cfm
  • We thank the VA Pathologists for all you do to help keep us all safe.


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Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.