Correlation of Ultrasound Shear Wave Speed Estimates in Human Liver with Mechanical Tests of Liver Samples Obtained by Core Needle Biopsy and use of Ultrasound to Track Tissue Displacement During Elastography and Tomosynthesis

Notice of Intent to Issue a Sole Source Purchase Order for Correlation of ultrasound shear wave speed estimates in human liver with mechanical tests of liver samples obtained by core needle biopsy and use of ultrasound to track tissue displacement during elastography and tomosynthesis The U.S. Food and Drug Administration (FDA) intend to issue a sole-source contract to Karen Alton Consulting, LLC. The anticipated contract is a logical follow-on to contract HHSF223201510640P for professional services to support research activities in ultrasound elastography and tissue motion analysis as part of the FDA, Division of Imaging, Diagnostics and Software Reliability, Office of Science and Engineering Laboratories. Contract HHSF223201510640P was developed to do Laboratory studies; ultrasound scanning and acoustical testing of completed phantoms, phantom materials, and testing of elastic properties of potential phantom materials. Writing and Forms Submission was also included in the subject contract for Preparation of Internal Review Board (IRB) applications including narrative summaries, Data Safety Material Project (DSMP) summaries and completion of the myriad of forms and revision of documents according to IRB requirements. Preparation of progress reports required by IRB and progress summaries for Office of Women's Health and the Office of the Chief Scientist and other oversight groups. Other tasks such as ordering of supplies, maintenance of phantom materials and phantoms, some testing of phantoms for durability and longevity are also provided. The follow-on purchase order will require support for both laboratory tests and Institutional Review Board (IRB) approval in: 1. Clinical research directed at precisely correlating shear wave speed estimates of tissue stiffness with actual mechanical measurements of stiffness of biopsy samples obtained from patients and 2. For evaluation of breast motion during tomosynthesis breast compression to better understand the sources of image degradation during mammographic tomosynthesis. This work will be conducted at the Washington DC VA Medical Center. Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements using Simplified Acquisition Procedures per FAR Part 13.5. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within seven (7) days after the publication of this synopsis which shall be considered by the agency. Responses received after seven (7) days or without the required information may not be considered. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Linda Troutman, Contracting Officer at contact@example.gov