Unintended effects associated with clinical interventions.

Exclusions: This data class does not include patient safety analyses, internal risk management documentation, or patient safety work product as defined under the Patient Safety and Quality Improvement Act of 2005 (42 U.S.C. 299b 21 et seq.) and implementing regulations (42 CFR part 3). It is not intended to define data elements for the exchange of Patient Safety Organization (PSO) investigations, safety reviews, or facility level reporting activities.

Data Element
Adverse Event Severity
Submitted By: Vulcan / Vulcan
Data Element Information
Data Element Description Degree to which an an unfavorable or unintended disease, sign, or symptom that is temporally associated with the use of a medical treatment or procedure, affects the health and wellbeing of the subject.

Usage Note: Adverse event may or may not be directly caused by the medical treatment or procedure. Severity may be represented by several scales or descriptions.
Use Case Description(s)
Use Case Description This data element is used in submission of adverse events to FDA, both in pre and post-market. "Mild", "Moderate", and "Severe", which are used to describe adverse event severity.
In addition, NCI Common Terminology Criteria for Adverse Events (CTCAE) uses severity and grades it on a scale of 1 to 5, with 1 being mild and 5 being death related to the AE:
Grade 1: Mild AE that doesn't interfere with routine activities
Grade 2: Moderate AE that interferes with routine daily activities
Grade 3: Severe AE that's not immediately life-threatening
Grade 4: Life-threatening AE that requires urgent intervention
Grade 5: Death related to the A
Estimate the breadth of applicability of the use case(s) for this data element The maturity level for this data element is level 2 in FHIR R5. This data element has also been provided by FDA in previous uses. The use of severity has been represented in the Vulcan Adverse Event Clinical Research 1.0.1 - STU1 and CodeX Radiation Therapy 1.0.0 - STU 1.
Link to use case project page https://hl7.org/fhir/uv/ae-research-ig/
ONC Priority
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) The use of NCI CTCAE and SNOMED CT. The severity value sets of the adverse event are part of an existing FHIR CodeSystem: AdverseEventSeverity
http://terminology.hl7.org/ValueSet/adverse-event-severity
Additional Specifications The CodeX Radiation Therapy 1.0.0 - STU 1 references severity (see https://hl7.org/fhir/us/codexradiation-therapy/StructureDefinition-codexrt-radiotheraphy-adverse-event-severity-or-grade.html)
Current Use (Level 0) Captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration
Extent of exchange (Level 0) Limited environments, such as connectathons or pilots
Supporting Artifacts The provided supporting link describes all relevant details on Connectathon testing for the proposed data element.
https://confluence.hl7.org/display/VA/Project+Documentation
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None to described.
Restrictions on Use (e.g. licensing, user fees) None to described.
Privacy and Security Concerns None to described.
Estimate of Overall Burden The requested data element simply adds detail to an existing one, so the estimated burden is minimal.
Other Implementation Challenges No additional information available.
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 1 - Use cases apply to several care settings or specialties.

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Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

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Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

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