FORMS & GUIDES
This section serves as a one-stop-shop for the important forms and resources at your disposal when you work with our material. Whether you're a new clinician interested in joining our network or a long-term partner who would like to provide educational material for your patients, you will find all of the resources you should need below.
Joining Our Clinical Network
- Clinical Partner Registration Form: a registration form for FMT providers new to our network.
- FDA Regulation of FMT: A memo outlining the current status of U.S. regulations of fecal microbiota for transplantation
Ordering Material, Shipping & Billing
- OpenBiome Order Form: a form for placing new orders for fecal preparations
- Storage Controls and Material Specifications: information about shipment sizes as well as instructions for how to store and handle our microbiota preparations
- Billing Guide: a guide to hospital billing for OpenBiome's material
- OpenBiome Clinical Primer: a guide for clinicians, by clinicians, on administration of FMT
- OpenBiome FMT DE Capsule Clinical Primer: a guide to the use of our FMT capsules
- Pre-FMT Patient Guide: background for patients about C. difficile and various treatment options, including FMT
- Post-FMT Patient Guide: a guide for post-FMT patients about how to minimize the risk of re-infection after their procedure
The OpenBiome Quality & Safety Program
- The OpenBiome Quality & Safety Program (Q&SP): the comprehensive guide to our quality metrics and material tracking protocols
- Quality & Safety Metrics: this section of the Q&SP focuses specifically on the quality and safety controls that guide our processes from donor selection through material collection and release
Quality & Safety Monitoring and Reporting
- Monitoring & Traceability: information about OpenBiome's forms for tracking the safety and efficacy of FMT material and how to complete them
- FMT Follow-Up Form: deidentified patient outcome data, to be submitted 8 weeks after FMT procedure for every patient treated
- Adverse Event Reporting Checklist: consult this checklist prior to reporting an adverse event to ensure that all relevant information is submitted
- FDA MedWatch Form 3500: the form FMT providers should submit to the FDA and OpenBiome in the case of a serious adverse event
Need more? If you don't see a form or resource that you would find helpful, please don't hesitate to email firstname.lastname@example.org and we'd be happy to provide what you're looking for.