3.8 Alerts

The template identifier for the alerts section is 2.16.840.1.113883.10.20.1.2.

This section is used to list and describe any allergies, adverse reactions, and alerts that are pertinent to the patient’s current or past medical history. At a minimum, currently active and any relevant historical allergies and adverse reactions should be listed.

CONF-256: CCDSHOULD contain exactly one and SHALL NOT contain more than one Alerts section (templateId 2.16.840.1.113883.10.20.1.2). The Alerts section SHALL contain a narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD include one or more problem acts (templateId 2.16.840.1.113883.10.20.1.27). A problem act SHOULD include one or more alert observations (templateId 2.16.840.1.113883.10.20.1.18).
CONF-257: The absence of known allergies, adverse reactions, or alerts SHALL be explicitly asserted.

3.8.1 Section conformance

CONF-258: The alert section SHALL contain Section / code.
CONF-259: The value for “Section / code” SHALL be “48765-2” “Allergies, adverse reactions, alerts” 2.16.840.1.113883.6.1 LOINC STATIC.
CONF-260: The alert section SHALL contain Section / title.
CONF-261: Section / titleSHOULD be valued with a case-insensitive language-insensitive text string containing “alert” and/or “allergies and adverse reactions”.

3.8.2 Clinical statement conformance

The following figure shows a subset of the CDA Clinical Statement model containing those classes being constrained or referred to in the conformance statements that follow.

Figure 10. CDA R2 clinical statement model for alerts

3.8.2.1 Representation of alerts

The template identifier for a problem act is 2.16.840.1.113883.10.20.1.27.
The template identifier for an alert observation is 2.16.840.1.113883.10.20.1.18.

A problem is a clinical statement that a clinician is particularly concerned about and wants to track. It has important patient management use cases (e.g. health records often present the problem list as a way of summarizing a patient's medical history).

NOTE: The HL7 Patient Care Technical Committee is developing a formal model for condition tracking. In that model, observations of problems or other clinical statements captured at a point in time are wrapped in a "Concern" act which represents the ongoing process tracked over time. This allows for binding related observations of problems. The conformance statements in this section are compatable with the evolving Patient Care model and define an outer "problem act" (representing the “Concern”) which can contain a nested "problem observation" or other nested clinical statements.

3.8.2.1.1 Problem act

The problem act (templateId 2.16.840.1.113883.10.20.1.27) is defined above in the Problem section (see section 3.5.2.1.1 Problem act).

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.

3.8.2.2 Representation of “status” values

The template identifier for an alert status observation is 2.16.840.1.113883.10.20.1.39.

CONF-270: An alert observation MAY contain exactly one alert status observation. CONF-271: An alert status observation (templateId 2.16.840.1.113883.10.20.1.39) SHALL be a conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as defined in section 5.1 “Type” and “Status” values). CONF-272: The value for “Observation / value” in an alert status observation SHALL be selected from ValueSet 2.16.840.1.113883.1.11.20.3 AlertStatusCode STATIC 20061017.

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.