Preventative Maintenance Agreement for 36 Heracell Vios 160i CO2 incubators

No AI summary available for this file.

The Department of Health and Human Services, National Institutes of Health, Clinical Center, intends to award a firm-fixed-priced contract to Thermo Fisher Scientific for a preventative maintenance agreement covering 36 HERA VIOS 160i CO2 incubators. This sole-source acquisition, justified under FAR 13.106-1(b)(1) for purchases not exceeding the simplified acquisition threshold, is essential for maintaining critical equipment used in manufacturing cell-based therapies. The FDA mandates controlled maintenance of such equipment (21 CFR 211.63, 21 CFR 211.67). Thermo Fisher Scientific is the original equipment manufacturer, uniquely qualified to perform required software and firmware updates and is the only vendor approved by the Center for Cellular Engineering Quality Assurance Team. Transitioning to a new vendor would cause significant delays to patient treatments due to lengthy qualification processes. The estimated cost for this project is $55,311.32, and it supports the continuous, compliant operation of equipment vital for patient care.