Official Website of the Office of the National Coordinator for Health Information Technology
Unintended effects associated with clinical interventions.
Data Element |
Applicable Vocabulary Standard(s) |
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Adverse Event
A change to patient condition that could be an unintended effect of clinical interventions. |
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Adverse Event Outcome
Result or impact of an adverse event. Examples include but are not limited to hospitalized, recovered, recovered with sequelae, and death. |
Data Element |
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Data Element |
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Submitted by Riki Merrick on
SHIELD requests ASTP/ONC to clarify what kind of Adverse Events are covered with this class. Does it cover all of these: CLIA-certified laboratories reporting on laboratory-developed tests (LDTs)), Adverse event reporting as part of FDA post-market surveillance and NIH Clinical Trials?
Submitted by csnewman on
The Adverse Event data class doesn't describe the scope of an adverse event (is it an event that actually happened or an event that was avoided), if both are in scope, adding a data element indicating the actuality of the event (actual or potential) should be considered.
Adding a date data element to indicate the timing of the adverse event should be considered.
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Submitted by mturchioe on
ANI's comment on USCDI draft v7: Adverse Events
The Alliance for Nursing Informatics (ANI) strongly supports the introduction of Adverse Events as a new USCDI data class. This addition represents a long-overdue formal acknowledgment of nursing's central role in patient safety surveillance. Registered nurses are the primary detectors, reporters, and documenters of adverse events across virtually all care settings, and the absence of a standardized, interoperable adverse event data class has long undermined cross-organizational patient safety data exchange. Standardizing both Adverse Event and Adverse Event Outcome will enable structured documentation to follow patients across care transitions, which is a critical gap in post-acute and transitional care settings where nursing leads handoff workflows. We advocate for vocabulary guidance that extends beyond the currently specified SNOMED CT to encompass nursing-sensitive adverse event categories, including patient falls, pressure injury staging events, and medication errors, and we encourage ONC to provide implementation guidance that supports embedded, point-of-care adverse event capture rather than reliance on siloed safety reporting systems.