QUALITY & SAFETY
The OpenBiome Quality & Safety Program governs our operations from donor assessment through stool processing, monitoring controls, and continuous improvement.
Here, you can learn about our rigorous donor screening and monitoring protocols, as well as our robust quality assurance measures. Members of our clinical network also have data reporting responsibilities as part of this program; to learn about these requirements, please see the Monitoring & Traceability section.
OpenBiome screens for antibiotic-resistant bacteria, including ESBL, and was not impacted by the FDA safety alert from June 2019. Learn more here.