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Allergy Observation

[Observation: templateId 2.16.840.1.113883.10.20.22.4.7]

This clinical statement represents that an allergy or adverse reaction exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a manufactured material participant playing entity in the allergy - intolerance observation. While the agent is often implicit in the alert observation (e.g. "allergy to penicillin"), it should also be asserted explicitly as an entity. The manufactured material participant is used to represent natural and non-natural occurring substances.
NOTE: The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), 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.

  1. SHALL contain exactly one [1..1] templateId ( CONF:7381, CONF:10488 ) such that it
    1. SHALL contain exactly one [1..1] @root="2.16.840.1.113883.10.20.22.4.7"
  2. SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: 2.16.840.1.113883.5.6 HL7ActClass) (CONF:7379)
  3. SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: 2.16.840.1.113883.5.1001 HL7ActMood) (CONF:7380)
  4. SHALL contain at least one [1..*] id (CONF:7382)
  5. SHALL contain exactly one [1..1] code (CONF:15947)/@code="ASSERTION" (CodeSystem: 2.16.840.1.113883.5.4 HL7ActCode) (CONF:15948)
  6. SHALL contain exactly one [1..1] statusCode/@code="completed" (CodeSystem: 2.16.840.1.113883.5.14 ActStatus) (CONF:7386)
  7. SHALL contain exactly one [1..1] effectiveTime (CONF:7387)
  8. SHALL contain exactly one [1..1] value with data type CD, where the @code SHALL be selected from ValueSet Allergy/Adverse Event Type 2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC (CONF:7390, CONF:9139)
  9. SHOULD contain zero or more [0..*] entryRelationship (CONF:7447, CONF:7907, CONF:15955)
    1. Contains @typeCode="MFST" MFST
    2. Contains exactly one [1..1] Reaction Observation (templateId: 2.16.840.1.113883.10.20.22.4.9)
  10. SHOULD contain zero or one [0..1] entryRelationship (CONF:9961, CONF:9962, CONF:15956)
    1. Contains @typeCode="SUBJ" SUBJ
    2. Contains exactly one [1..1] Severity Observation (templateId: 2.16.840.1.113883.10.20.22.4.8)
  11. MAY contain zero or one [0..1] entryRelationship (CONF:7440, CONF:7906, CONF:15954)
    1. Contains @typeCode="SUBJ" SUBJ
    2. Contains exactly one [1..1] Allergy Status Observation (templateId: 2.16.840.1.113883.10.20.22.4.28)
  12. SHOULD contain exactly one [1..1] participant (CONF:7402)
    1. This participant SHALL contain exactly one [1..1] @typeCode/@code="CSM" Consumable (CodeSystem: 2.16.840.1.113883.5.90 HL7ParticipationType) (CONF:7403)
    2. This participant SHALL contain exactly one [1..1] participantRole (CONF:7404)
      1. This participantRole SHALL contain exactly one [1..1] @classCode/@code="MANU" Manufactured Product (CodeSystem: 2.16.840.1.113883.5.110 HL7RoleClass) (CONF:7405)
      2. This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:7406)
        1. This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" (CONF:7407)
        2. This playingEntity SHALL contain exactly one [1..1] code (CONF:7419)
        3. This playingEntity In an allergy to a specific medication the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet 2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC (CONF:7421)
        4. This playingEntity In an allergy to a class of medications the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC (CONF:10083)
        5. This playingEntity In an allergy to a food or other substance the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC (CONF:10084)
        6. This playingEntity code SHOULD contain zero or one [0..1] originalText (CONF:7424)
        7. This playingEntity originalText, if present, SHOULD contain zero or one [0..1] reference (CONF:7425)
        8. This playingEntity reference, if present, SHOULD contain zero or one [0..1] @value (CONF:15952)
        9. This playingEntity reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1 (CONF:15953)
        10. This playingEntity code MAY contain zero or more [0..*] translation (CONF:7431)
  13. If it is unknown when the allergy began, this effectiveTime SHALL contain low/@nullFLavor="UNK" (CONF:9103)
  14. If the allergy is no longer a concern, this effectiveTime MAY contain zero or one [0..1] high (CONF:10082)
  15. value SHOULD contain zero or one [0..1] originalText (CONF:7422)
  16. originalText, if present, MAY contain zero or one [0..1] reference (CONF:15949)
  17. reference, if present, SHOULD contain zero or one [0..1] reference/@value (CONF:15950)
  18. reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (CONF:15951)
  19. entryRelationship with target entry AllergyStatusObservation SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7446)
  20. entryRelationship with target entry Reaction Observation SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:7449)
  21. entryRelationship with target entry Severity Observation SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:9964)
  22. In an allergy to a specific medication the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.16 Medication Brand Name DYNAMIC or the ValueSet 2.16.840.1.113883.3.88.12.80.17 Medication Clinical Drug DYNAMIC. In an allergy to a class of medications the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.18 Medication Drug Class DYNAMIC. In an allergy to a food or other substance the code SHALL be selected from the ValueSet 2.16.840.1.113883.3.88.12.80.20 Ingredient Name DYNAMIC (CONF:7421, CONF:10083, CONF:10084)

Allergy Observation example

<observation xmlns="urn:hl7-org:v3">
  <id root="MDHT" extension="1440553728"/>
  <code code="648947846"/>
  <effectiveTime>
    <low value="2013"/>
    <high value="2013"/>
  </effectiveTime>
  <participant typeCode="CSM">
    <participantRole classCode="MANU">
      <playingEntity classCode="MMAT"/>
    </participantRole>
  </participant>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="246080946"/>
      <code code="120672386"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
      <entryRelationship>
        <observation>
          <id root="MDHT" extension="1058685405"/>
          <code code="225738189"/>
          <effectiveTime>
            <low value="2013"/>
            <high value="2013"/>
          </effectiveTime>
        </observation>
      </entryRelationship>
      <entryRelationship>
        <procedure>
          <id root="MDHT" extension="1994060805"/>
          <code code="1729544607"/>
          <effectiveTime>
            <low value="2013"/>
            <high value="2013"/>
          </effectiveTime>
          <specimen/>
          <performer/>
          <entryRelationship typeCode="COMP" inversionInd="true"/>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <substanceAdministration/>
          </entryRelationship>
          <entryRelationship>
            <act/>
          </entryRelationship>
        </procedure>
      </entryRelationship>
      <entryRelationship>
        <substanceAdministration>
          <id root="MDHT" extension="2079902944"/>
          <code code="748602723"/>
          <effectiveTime value="20130627"/>
          <consumable/>
          <performer/>
          <entryRelationship>
            <supply/>
          </entryRelationship>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <act/>
          </entryRelationship>
          <entryRelationship>
            <observation/>
          </entryRelationship>
          <entryRelationship>
            <supply/>
          </entryRelationship>
          <precondition/>
        </substanceAdministration>
      </entryRelationship>
    </observation>
  </entryRelationship>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="1667661204"/>
      <code code="1304571072"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
    </observation>
  </entryRelationship>
  <entryRelationship>
    <observation>
      <id root="MDHT" extension="111925052"/>
      <code code="323866413"/>
      <effectiveTime>
        <low value="2013"/>
        <high value="2013"/>
      </effectiveTime>
    </observation>
  </entryRelationship>
</observation>