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.
Our Quality & Safety program is overseen by an independent Clinical Advisory Board of thought leaders from gastroenterology, infectious disease, and medical microbiology, and represents the standard of care in the field.
Prospective donors undergo a rigorous screening process, involving a 200-question Clinical Evaluation with an internal medicine specialist and a battery of serological and stool-based assays to screen for infectious pathogens.
Less than 3% of prospective donors pass the clinical evaluation and stool and serological screens to become active donors. Once active, donors contribute material for a minimum of 60 days and must fully re-qualify at the end of the collection window (see Stool Production Controls below).
We also perform high-throughput 16S rRNA sequence characterization on stool samples from each of our donors. While traditional approaches to FMT donor screening have focused on measuring what is absent, we believe that a holistic donor assessment should also evaluate what is present in an FMT donor's microbiome.
Stool Collection & Production Controls
Our screening, processing, storage and shipping controls have set the standard of care for FMT and stool production. From the moment donors donate their material to the moment we ship treatments to our clinical partners, we follow standardized, controlled processes that have been carefully evaluated by an independent panel of clinical experts.
Continuous Re-qualification & Quarantine Procedure
Donors contribute stool for a minimum of 60 days, during which time they are carefully assessed for changes in health status and their donated material is kept in quarantine. At the end of this 60-day period, donors are fully re-screened (clinical assessment, stool and serological testing). If they pass, then the material they donated in the first 38 days is released for clinical use.
Material donated in days 39-60 is not released until the donor has passed a third round of screening to ensure against a possible seroconversion window for infectious pathogens.
Continuous Donor Health Monitoring
Active donors are subjected to health checks throughout the 60 donation window. Routine monitoring between screening periods includes health check-ins during face-to-face sample drop-offs, as well as scheduled and random health checks by physicians. Additionally, stool samples are randomly selected for laboratory screening. Donors have 24/7 on-call access to a registered nurse or physician in the event of a health concern.
An aliquot of each stool sample is preserved for at least 24 months for safety and research purposes. If a suspected adverse event occurs, the material used in the procedure can be traced back to its safety aliquot and tested for pathology.
Tracking the safety and efficacy of our material is a vital component of OpenBiome’s Quality & Safety Program. This program allows us to continuously monitor the efficacy and safety of our treatments on a per-donor basis, and effectively respond to suspected adverse events in a timely manner. Additionally, the U.S. Food and Drug Administration (FDA) considers stool for fecal microbiota transplantation (FMT) an investigational drug, a classification that carries certain reporting requirements. We aggregate and share your submissions to our material tracking program with the FDA.
Our material tracking program has three constituent parts, each of which is instrumental to patient safety and complying with FDA reporting requirements:
1. Material Tracking Logs
A Material Tracking Log (MTL) listing the units released to your facility will be included with every shipment you receive from OpenBiome. We use this log to facilitate inventory tracking across our network. As units are received, stored, and eventually used in procedures, their status should be documented on your MTL, which must be submitted by the time you place your next order.
2. FMT Follow-Up Forms
An FMT Follow-Up Form must be completed for each patient that receives an FMT from OpenBiome. It requests de-identified patient specifics, including delivery modality, disease severity, and the treatment outcome. This form should be given to the administering physician or their staff at the time of treatment and returned to OpenBiome after the patient’s 8-week follow-up has been completed.
3. Reporting Adverse Events
We take great care in rigorously screening our donors through a clinical assessment by our medical staff and stool and serological testing in a CLIA-certified laboratory. However, in the case that a serious adverse event does occur, OpenBiome has established a series of actions that are triggered in response to your report. This decision algorithm allows us to coordinate timely and comprehensive investigations with our clinical partners, including submission of the Form FDA 3500A, when necessary. To report an adverse event, please see the instructions in the next section, or contact us at firstname.lastname@example.org or call (617) 575-2201, option 9.
For more information about what data to collect and submit on each form, please see our guide for Monitoring and Traceability. If you have any additional questions about this reporting system, please contact us at email@example.com or call 617-575-2201, option 3.
If you suspect one of your patients has experienced an adverse event that could be related to an OpenBiome FMT treatment, please fill out and submit OpenBiome's online Adverse Event Reporting Form within 24 hours to alert our Clinical Safety Team. Please review this checklist to ensure you have the necessary information ready to complete your report. Once submitted, an OpenBiome medical professional will contact you to discuss the specifics of your case and advise whether additional reporting requirements to the FDA may be needed.
If you have any questions regarding an adverse event, please contact us at firstname.lastname@example.org or call (617) 575-2201, option 9.
Quality and Safety Reports