ISO/HL7 10781 - Electronic Health Record System Functional Model, Release 2.1
2.1.0 - CI Build

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Requirements: CP.1.9 Manage Adverse Events (Function)

Active as of 2024-11-23
Statement N:

Capture and maintain adverse events.

 Description I:

This function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR).

 Criteria N:
CP.1.9#01 SHALL

The system SHALL provide the ability to manage adverse events associated with a patient.
CP.1.9#02 dependent SHALL

The system SHALL capture and maintain as discrete data an adverse event. For example:a) Patient identificationb) Event date/timec) Event descriptiond) Event severitye) Event category (e.g., medication error, fall)f) Care providers associated with the eventaccording to scope of practice, organizational policy, and/or jurisdictional law.
CP.1.9#03 dependent SHALL

The system SHALL provide the ability to capture and render a Serious Adverse Event (SAE) report according to organizational policy, and/or jurisditional law.
CP.1.9#04 MAY

The system MAY provide the ability to render a set of Serious Adverse Event (SAE) data as modeled by the current release of HL7 ICSR (Individual Case Safety Reporting).