Earlier this month, the FDA announced that they will resume in-person domestic inspections with a new risk assessment system beginning July 20, 2020. This announcement from the FDA was not specific to tissue establishments; however, AATB Accredited Institutions should take note.
To ensure the continued safety and quality of donated human tissue, AATB has remained committed to the inspection process that supports the AATB Accreditation Program. Following a brief suspension of on-site inspections in March and April, the AATB Accreditation Team began deployment of a new risk-based remote assessment process. Tissue establishments applying for accreditation or renewal are now asked to complete a risk assessment questionnaire as part of the application process. This questionnaire informs the decision for remote or on-site inspection.
AATB will continue to explore opportunities to meet the needs of our members during this time and use them as the foundation for developing new approaches for the Accreditation Program moving forward. As always, the health and safety of our employees, contract inspectors, and the employees at our member tissue establishments remains a top consideration in every decision we make.