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MedWatch: The FDA Safety Information and Adverse Event Reporting Program. MedWatch, the FDAs medical product safety reporting program for health professionals, patients and consumers.
Alternate reporting methods: .fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
Sentinel surveillance involves creating a reporting system that detects early signs of preidentified problems at certain sites. This method allows for a triggering mechanism to alert humanitarian responders during early warning phases.
Root cause analysis (RCA) is a process for identifying the causal factors of a medical error that may result in a sentinel event.
FDA Adverse Event Reporting System (FAERS): FAERS is the database that contains adverse event reports, medication error reports, and reports of therapy quality issues that resulted in adverse events that were submitted to the FDA. FAERS covers drugs and biologics.
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Such events are called sentinel because they signal the need for immediate investigation and response. Each accredited organization is strongly encouraged, but not required, to report sentinel events to The Joint Commission.
The list of Sentinel Events includes, but is not limited to: Stage 3, 4, and unstageable pressure ulcer. Patient fall with serious injury or death. Unanticipated death with 48 hours of treatment.

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