OpenBiome launches its expanded Quality & Safety Program

The Quality & Safety Program builds on OpenBiome’s existing protocols and represents the most rigorous process published for the production of material for fecal microbiota transplantation

August 12, 2014
Contact: info@openbiome.org  |  617 575 2201  |  @OpenBiome
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Medford, MA – OpenBiome launched its Quality & Safety Program (Q&SP) to the members of its clinical network, announcing the consolidated and enhanced protocols that safeguard patient safety from bench to bedside.

The Q&SP spans donor assessment, production control, data collection, and risk mitigation.  Every protocol has been rigorously vetted by leading clinicians and academics in the field of FMT, and represents best practices in the screening and processing of stool for use in fecal transplantation.

As part of the enhancements that OpenBiome has made to its existing quality and safety protocols, members of OpenBiome’s clinical network will have access to the OpenBiome Clinical Advisory Board, a distinguished panel of medical practitioners and researchers, with questions concerning adverse events resulting from FMTs conducted using OpenBiome’s fecal microbiota preparations.  

“OpenBiome is dedicated to a continuous improvement philosophy to safety,” said James Burgess, Executive Director of OpenBiome. “I invite the members of our clinical network and all who are interested to explore the components of the Quality and Safety program, and participate in making safety an everyday priority.”

More information about the OpenBiome Q&SP, including a full packet of all protocols, is available at www.openbiome.org/safety. 

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OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines.