6515--Intent to Sole Source

Brief Description of Services: The Veterans Health Administration (VHA) Office of Healthcare Innovation and Learning (OHIL) is coordinating a national bioprinting program known as the BioFabrication Community of Science (CoS). The flagship project of this program has the ambitious goal to create the first-ever FDA cleared 3D printed living bone product. The project, dubbed VA Impact , is a collaboration between Advanced Solutions Life Sciences and VHA. The product, named VA BioBone is a vascularized, living 3D printed bone that can be printed in the shape of a patient s bone defect, relieving the need to remove another piece of bone from elsewhere in the patient (such as the fibula bone in the lower leg). This product is designed to be manufactured within VA hospitals, at the point of care. It is created with a unique biomanufacturing suite of equipment made by Advanced Solutions Life Sciences, including a Bio-Assembly Bot bioprinter, a Biostorage Bot, and a biosafety enclosure that maintains needed environmental conditions for optimal fabrication. This equipment was previously purchased and is on site at VA Puget Sound Health Care System. This contract aims to significantly expand bioprinting across the VHA enterprise, including BioBone, as well as other current and future projects. Our goal is to deliver patient-specific bioprinted medical solutions for tissue repair and regenerative medicine at the point of care. The contractor shall provide: Printable formulations to mimic targeted tissues and restore damaged functions Product development, technical, engineering, and scientific support Processes to ensure reproducibility of all required activities to deliver safe and effective bioprinted medical solutions Pre-clinical and clinical studies to obtain data for submission of bioprinting projects for regulatory approval from FDA In vivo, in vitro, and benchtop studies for data collection according to applicable regulations and standards In vivo studies to demonstrate safety and efficacy of the medical product according to applicable regulations, including Good Laboratory Practices (GLP) studies when necessary to obtain reliable and reproducible results Support for VHA clinical implementation of the product, including FDA roadmap, clinical trials, and manufacturing optimization within the hospital On site contractor support for the development of all necessary activities for implementation of bioprinted medical solutions at the point of care in VHA medical centers Equipment, software, and maintenance service required to manufacture high quality bioprinted medical products Angiomics microvessels and other consumables Commercial licensing of Angiomics microvessel technologies On-site technical training and guidance at VA campuses Reason for Sole Source: This activity proposes to make a non-competitive award (sole source) to Definitive Healthcare, LLC a Large Business for subscription services to the Definitive Health Care Database. FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement due to: Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services. In accordance with FAR 13.501(a)(2)(ii) for a proposed contract exceeding $750,000 or the thresholds in paragraph (1) of the definition of simplified acquisition threshold in 2.101, but not exceeding $15 million, the advocate for competition for the procuring activity, designated pursuant to 6.501; or an official described in 6.304(a)(3) or (a)(4) must approve the justification and approval. This authority is not delegable. Points of Contact: Primary: Dylan Nolz contact@example.gov Secondary: Kimberly Sandi contact@example.gov