Single Source Justification MPT to SAT 3D 400 Series Bio-Printer_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 6, located at 100 Emancipation Dr, Hampton, VA 23667, in support of Durham VA Health Care System at 508 Fulton St, Durham NC 27705.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Durham Department of Veterans Affairs, Research and Development department with Duke academic affiliation are requesting the BioAssemblyBot400 3D printer, consumables, and on-site installation. The BioAssemblyBot400 will be used by surgical and basic science researchers to build biological structures such as custom defect fit structural bone grafting for orthopedics and OMFS/dental, vascular tissue, and other living tissue for initial research and for downstream clinical translation. This advancement will position the Durham VAMC to the forefront of bioprinting research, empowering the team to pursue research grants and share the outcomes with medical professionals and patients across various VA facilities.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Durham VA Medical Center requires a bioprinter that can print with living cells, and which can additionally print with a 6-degree of freedom robotic arm that will allow them to print on nonlinear surfaces such as a growing bone. The 6-degree of freedom robotic arm is required because it allows the printer to shift direction on a multi-plane surface. In addition, the 6- degree arm can use a variety of tools at one time and print multiple bones at one time. Advanced Solutions Life Sciences makes the only bioprinter with a 6 degree of freedom robotic arm on the market.

As part of the bioprinter procurement, the facility requires software that can interface with a patient's medical imaging data (in DICOM format) and the 3D printer. The TSIM (Tissue Structure Information Modeling), Advanced Solutions' software can meet this need.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted to identify available sources and to evaluate the availability of the marketplace to meet the requirement. Advanced Solutions Inc., provided a letter confirming the proprietary nature of the supplies and that they have no authorized distributors. The VA Rule of Two could not be met as no SDVOSB vendors were located that could fulfill the governments needs.

Based on the results of market research, the government determined that only one vendor possesses the capability to provide the needs of this request.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.