Notice of Intent to Sole Source 2 sets of QX200 ddPCR Systems

This Statement of Work outlines the renewal of a service contract for two QX200 AutoDG ddPCR Systems at the NIH Clinical Center. The contract covers maintenance, support, and emergency servicing for the systems, which are critical for lot release assays of VCN ddPCR on clinical and research cellular products. This preventive maintenance is essential for compliance with manufacturer and FDA 21 CFR 211.67 regulations, as the assays are vital for licensing blood products for patient treatment. The contractor will provide a 5-year full on-site complete support plan, including annual preventive maintenance, unlimited on-site repair visits (parts, labor, and travel included), covering the Auto Droplet Generator and Droplet Reader. The contract duration is from January 23, 2026, to January 22, 2027, with four renewable option years. The vendor will be on-site for 6-8 hours for complex issues but will not have remote access or access to PII/PHI data.

The National Institutes of Health (NIH) Clinical Center seeks a five-year service contract renewal for two QX200 AutoDG ddPCR Systems from Bio-Rad, costing $151,494.00. This non-competitive acquisition, justified under FAR 13.106-1(b)(1) due to the Simplified Acquisition Threshold, is essential for patient care testing, specifically for droplet digital PCR VCN detection and gene modification efficiency testing on clinical cellular products. Bio-Rad is the sole vendor capable of providing the necessary preventive maintenance and support for these unique, clinically approved instruments, which are critical for guiding immunotherapy and ensuring patient safety. The urgency and specialized nature of the equipment, along with FDA compliance requirements, preclude full and open competition. Failure to secure this service could lead to patient harm, as these systems are vital for patients with unique conditions undergoing research and testing at the NIH Clinical Center. The anticipated cost is considered fair and reasonable, with Bio-Rad offering a 15% government discount.