Facilities must report death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area, including retained foreign objects, external projectiles, and pacemakers.
Facilities must report patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results. Includes events where failure to report increased neonatal bilirubin levels result in kernicterus. Examples of serious injury are a new diagnosis, or an advancing stage of an existing diagnosis (e.g., cancer). Failure to follow up or communicate can be limited to healthcare staff or can involve communication to the patient.