3.8.2.1.2 Alert observation
CONF-262: An alert observation (templateId 2.16.840.1.113883.10.20.1.18) SHALL be represented with Observation.
CONF-263: The value for “Observation / @moodCode” in an alert observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-264: An alert observation SHALL include exactly one Observation / statusCode.
CONF-265: The value for “Observation / statusCode” in an alert observation SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC.
CONF-266: An alert observation MAY contain exactly one Observation / effectiveTime, to indicate the biological timing of condition (e.g. the time the condition started, the onset of the illness or symptom, the duration of a condition).
CONF-267: The value for “Observation / value” in an alert observation MAY be selected from ValueSet 2.16.840.1.113883.1.11.20.4 AlertTypeCode STATIC 20061017.
CONF-268: The absence of known allergies SHOULD be represented in an alert observation by valuing Observation / value with 160244002 “No known allergies” 2.16.840.1.113883.6.96 SNOMED CT STATIC.
CONF-269: An alert observation SHALL contain one or more sources of information, as defined in section 5.2 Source.
3.8.2.3 Representation of agent
The agent indicates the entity that is the cause of the allergy or adverse reaction. While the agent is often implicit in the alert observation (e.g. “allergy to penicillin”), it should also be asserted explicitly as an entity.
NOTE: The agent responsible for an allergy or adverse reaction is not always a manufactured material, nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent.
CONF-273: An alert observation SHOULD contain at least one Observation / participant, representing the agent that is the cause of the allergy or adverse reaction.
CONF-274: An agent participation in an alert observation SHALL contain exactly one participant / participantRole / playingEntity.
CONF-275: The value for Observation / participant / @typeCode in an agent participation SHALL be “CSM” “Consumable” 2.16.840.1.113883.5.90 ParticipationType STATIC.
CONF-276: The value for Observation / participant / participantRole / @classCode in an agent participation SHALL be “MANU” “Manufactured” 2.16.840.1.113883.5.110 RoleClass STATIC.
CONF-277: The value for Observation / participant / participantRole / playingEntity / @classCode in an agent participation SHALL be “MMAT” “Manufactured material” 2.16.840.1.113883.5.41 EntityClass STATIC.
CONF-278: An agent participation in an alert observation SHALL contain exactly one participant / participantRole / playingEntity / code.
CONF-279: The value for “participant / participantRole / playingEntity / code” in an agent participation SHOULD be selected from the RxNorm (2.16.840.1.113883.6.88) code system for medications, and from the CDC Vaccine Code (2.16.840.1.113883.6.59) code system for immunizations .
3.8.2.4 Reaction observations and interventions
The template identifier for a reaction observation is 2.16.840.1.113883.10.20.1.54.
The template identifier for a severity observation is 2.16.840.1.113883.10.20.1.55.
A reaction represents an adverse event due to an administered or exposed substance. A reaction can be defined with respect to its severity, and can have been treated by one or more interventions.
CONF-280: An alert observation MAY contain one or more reaction observations (templateId 2.16.840.1.113883.10.20.1.54), each of which MAY contain exactly one severity observation (templateId 2.16.840.1.113883.10.20.1.55) AND/OR one or more reaction interventions.
CONF-281: The value for “entryRelationship / @typeCode” in a relationship between an alert observation and reaction observation SHALL be “MFST” “Is manifestation of” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC.
3.8.2.4.1.1 Reaction observation
CONF-282: A reaction observation (templateId 2.16.840.1.113883.10.20.1.54) SHALL be represented with Observation.
CONF-283: The value for “Observation / @classCode” in a reaction observation SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC.
CONF-284: The value for “Observation / @moodCode” in a reaction observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-285: A reaction observation SHALL include exactly one Observation / statusCode.
CONF-286: The value for “Observation / statusCode” in a reaction observation SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC.
3.8.2.4.1.2 Severity observation
CONF-287: A severity observation (templateId 2.16.840.1.113883.10.20.1.55) SHALL be represented with Observation.
CONF-288: The value for “entryRelationship / @typeCode” in a relationship between a reaction observation and severity observation SHALL be “SUBJ” “Has subject” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC.
CONF-289: The value for “Observation / @classCode” in a severity observation SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC.
CONF-290: The value for “Observation / @moodCode” in a severity observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-291: A severity observation SHALL include exactly one Observation / statusCode.
CONF-292: The value for “Observation / statusCode” in a severity observation SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC.
CONF-293: A severity observation SHALL contain exactly one Observation / code.
CONF-294: The value for “Observation / code” in a severity observation SHALL be “SEV” “Severity observation” 2.16.840.1.113883.5.4 ActCode STATIC.
CONF-295: A severity observation SHALL contain exactly one Observation / value.
3.8.2.4.1.3 Reaction intervention
CONF-296: The value for “entryRelationship / @typeCode” in a relationship between a reaction observation and reaction intervention SHALL be “RSON” “Has reason” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC.
CONF-297: A reaction intervention SHALL be represented as a procedure activity (templateId 2.16.840.1.113883.10.20.1.29), a medication activity (templateId 2.16.840.1.113883.10.20.1.24), or some other clinical statement.