Intent to Sole Source - Octet® R2 system, System Installation, onsite training and transfer tools

The Hammoud Lab requires an Octet® R2 system from Sartorius for real-time, label-free analysis of biomolecular interactions, specifically for characterizing novel PET tracers. This Statement of Work outlines the need for an upgraded system as the lab's current Octet® K2 system is outdated and no longer supported by the vendor. The Octet® R2 system will enhance the lab's capabilities in determining binding affinity and kinetics, crucial for developing pathogen-specific PET tracers. Sartorius is the sole vendor for this instrument, and the scope of work includes system provision, installation, onsite training, and biosensor transfer tools. The purchase ensures continuity in data acquisition and improves research efficiency.

Sartorius Corporation issued Quotation CPQ-18810142 to the National Institute of Health for a total of $110,025.83. The quotation, valid until June 1, 2026, includes an Octet® R2 system for biomolecular detection ($96,770.00), installation services ($4,930.00), onsite instrument training ($4,940.00), and an Octet® AT - Biosensor Transfer Tool ($943.00), with additional freight charges of $2,442.83. Payment terms are Credit Card (A068) with CPT (Carriage Paid To) Bethesda. The customer is responsible for transport, packaging, freight, insurance, and any tariffs or duties. A crucial condition prohibits the re-export of goods to Russia and Belarus, with severe penalties for violations, including contract termination or a 30% penalty of the total value. The transaction is subject to Sartorius’s Terms and Conditions of Sale (USA).

The IT Security and Privacy Request Form is a critical document for evaluating IT hardware, software, and services within a government context, likely NIH. It assesses various aspects including the type of IT request (hardware, software, maintenance, medical/scientific instruments, or a combination), vendor responsibilities for configuration and maintenance, and network connectivity requirements. Key security questions address the need for Network Attached Storage (NAS) or external hard drives, and critically, whether the system will house Personally Identifiable Information (PII) or Public Health Information (PHI). The form also meticulously details vendor access, including on-site presence, privileged/administrative access to NIH/CC systems, remote access requirements, and potential access to PII/PHI data. It further scrutinizes off-premise system development or data housing, particularly if the vendor is FedRAMP Certified. The form concludes with additional review criteria for the Clinical Center Information Security Office, flagging requests that may require legal or pre-award contract reviews due to security concerns, off-premise data hosting, cloud-based systems, interconnection security agreements, or overall complexity.

The National Institutes of Health (NIH) Clinical Center is seeking to acquire an Octet® R2 system for biomolecular detection from a sole-source vendor. This Justification and Approval (J&A) outlines the need for the system to develop PET ligands for identifying pathogen reservoirs, improving the understanding of pathophysiology. The total acquisition cost is $110,025.83, including installation, training, and transfer tools. The justification for bypassing full and open competition is based on FAR 6.302-1, citing that the proposed vendor is the sole manufacturer of this instrument and provides continuity with the lab's existing, but discontinued, Octet® system. Market research confirmed the vendor's unique position, and the cost is deemed fair and reasonable based on market research and previous purchases. No other sources expressed interest, and no actions are planned to remove barriers to competition for this specific acquisition.