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  • GAIA Level 2 Major Functional Defect is defined by two criteria: first, at least one of the following requirements must be met: a) For live births, there must be alterations in the functioning of one or more organs or body parts that are not due to a structural defect, that are present at live birth (or propensity to develop alteration present at live birth), and that persist beyond the immediate peripartum period, unless treated through gene therapy or stem cell transplantation; OR b) For stillbirths or for spontaneous or therapeutic abortions, there must be alterations in the function of one or more organs or body parts that are not due to a structural defect; second, there must be documented confirmation of a diagnosis made by a clinician who is experienced in diagnosing congenital anomalies, and who has the highest level of training in the diagnosis of functional defects for the specific setting.
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