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Revision as of 16:14, 24 July 2017

Id2.16.840.1.113883.10.22.4.1Effective Date valid from 2016‑11‑10
StatusKyellow.png DraftVersion Label
NameIPSEntryAllergyOrIntoleranceDisplay NameIPS Allergy or Intolerance
Description
This template reflects a discrete observation about a patient's allergy or intolerance. 
Because it is a discrete observation, it will have a statusCode of "completed". 
The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient. 
For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago. 
The effectiveTime of the Allergy - Intolerance Observation gives an indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present. 
If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". 

It is recommended that the agent responsible for an allergy or adverse reaction would be used for describing the allergy, however the possibility that pre-coordinate codes (e.g. "allergy to nuts") will be used has been here also considered.
The agent responsible for  an allergy or adverse reaction it is not always a manufactured material (for example, food allergies), nor is it necessarily consumed; however  the playingEntity classCode = "MMAT" for all agents, manufactured or not is expected to be used. This choice depends on the characteristics of the base CDA R2 specification.
ContextParent nodes of template element with id 2.16.840.1.113883.10.22.4.1
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 3 templates, Uses 4 templates
Used by as NameVersion
2.16.840.1.113883.10.22.4.5ContainmentKyellow.png IPS Allergy and Intolerance Concern2016‑11‑11
2.16.840.1.113883.10.22.3.2Link.pngKyellow.png IPS Allergies and Intolerances Section2016‑11‑11
2.16.840.1.113883.10.22.1.1Link.pngKyellow.png International Patient Summary2017‑04‑11
Uses as NameVersion
2.16.840.1.113883.10.22.4.6ContainmentKyellow.png IPS Reaction ManifestationDYNAMIC
2.16.840.1.113883.10.22.4.18ContainmentKyellow.png IPS Criticality ObservationDYNAMIC
2.16.840.1.113883.10.22.4.19ContainmentKyellow.png IPS Certainty ObservationDYNAMIC
2.16.840.1.113883.10.22.4.21ContainmentKyellow.png IPS Allergy Status ObservationDYNAMIC
RelationshipAdaptation: template 2.16.840.1.113883.10.20.1.18 (DYNAMIC)
Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 (DYNAMIC)
Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.6 (DYNAMIC)
Example
Example
<observation classCode="OBS" moodCode="EVN">
  <templateId root="2.16.840.1.113883.10.22.4.1"/>  <id root=" " extension=" "/>  <!-- This is the code that shows what kind of allergy or intolerance derived from the epSOSAdverseEventType Value Set-->
  <code code="418038007" displayName="Propensity to adverse reactions to substance" codeSystem="2.16.840.1.113883.6.96"/>  <text>
    <reference value="#ref1"/>  </text>
  <statusCode code="completed"/>  <effectiveTime>
    <low value="20170701"/>  </effectiveTime>
  <!-- This is the allergen - the substance that caused the allergy -->
  <participant typeCode="CSM">
    <participantRole classCode="MANU">
      <playingEntity classCode="MMAT">
        <code code=" " codeSystem=" ">
          <originalText>
            <reference value="#substance"/>          </originalText>
        </code>
        <name/>      </playingEntity>
    </participantRole>
  </participant>
  <!-- This is how the allergy manifests itself -->
  <entryRelationship typeCode="MFST" inversionInd="true">
    <!-- template 2.16.840.1.113883.10.22.4.6 'IPS Reaction Manifestation' (dynamic) -->
  </entryRelationship>
  <entryRelationship typeCode="SUBJ" inversionInd="true">
    <!-- template 2.16.840.1.113883.10.22.4.18 'IPS Criticality Observation' (dynamic) -->
  </entryRelationship>
  <entryRelationship typeCode="SUBJ" inversionInd="true">
    <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) -->
  </entryRelationship>
  <entryRelationship typeCode="REFR" inversionInd="false">
    <!-- template 2.16.840.1.113883.10.22.4.21 'IPS Allergy Status Observation' (dynamic) -->
  </entryRelationship>
</observation>
Example
No Known Allergies
<observation classCode="OBS" moodCode="EVN">
  <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="419199007" displayName="Allergy to substance" codeSystem="2.16.840.1.113883.6.96"/>  <statusCode code="completed"/>  <effectiveTime>
    <low nullFlavor="UNK"/>  </effectiveTime>
  <value code="716186003" displayName="No known allergy" codeSystem="2.16.840.1.113883.6.96"/></observation>
Example
No Information available about allergies or intolerances
<observation classCode="OBS" moodCode="EVN">
  <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="418038007" displayName="Propensity to adverse reactions to substance" codeSystem="2.16.840.1.113883.6.96"/>  <statusCode code="completed"/>  <effectiveTime>
    <low nullFlavor="NA"/>  </effectiveTime>
  <value code="--codeToBeAssigned--" displayName="Allergic disposition not known" codeSystem="2.16.840.1.113883.6.96"/></observation>
Example
Minimum Set (active propensity; agent known)
<observation classCode="OBS" moodCode="EVN">
  <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="418038007" displayName="Propensity to adverse reactions to substance" codeSystem="2.16.840.1.113883.6.96"/>  <statusCode code="completed"/>  <effectiveTime>
    <low nullFlavor="UNK"/>  </effectiveTime>
  <participant typeCode="CSM">
    <participantRole classCode="MANU">
      <playingEntity classCode="MMAT">
        <code code="13577000" codeSystem="2.16.840.1.113883.6.96" displayName="Nut"/>      </playingEntity>
    </participantRole>
  </participant>
</observation>
ItemDTCardConfDescriptionLabel
hl7:observation
R(IPS…nce)
Treetree.png@classCode
cs1 … 1FOBS
Treetree.png@moodCode
cs1 … 1FEVN
Treetree.pnghl7:templateId
II1 … 1M(IPS…nce)
Treeblank.pngTreetree.png@root
uid1 … 1F2.16.840.1.113883.10.22.4.1
Treetree.pnghl7:id
II0 … *R(IPS…nce)
Treetree.pnghl7:code
CD.IPS1 … 1MThus element describes whether this condition refers to an allergy, non-allergy intolerance, or unknown class of intolerance (not known to be allergy or intolerance).(IPS…nce)
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.2 Allergy or Intolerance Type (DYNAMIC)
Treetree.pnghl7:text
ED0 … 1RThe <text> element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.(IPS…nce)
Treeblank.pngTreetree.pnghl7:reference
TEL1 … 1M(IPS…nce)
Treeblank.pngTreeblank.pngTreetree.png@value
1 … 1RWhen used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1
Treetree.pnghl7:statusCode
CS1 … 1MA clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.
(IPS…nce)
Treeblank.pngTreetree.png@code
cs1 … 1Fcompleted
Treetree.pnghl7:effectiveTime
IVL_TS1 … 1M The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago. The effectiveTime of the Allergy - Intolerance  Observation may give an indication of whether or not the underlying allergy/intolerance is resolved. 
The <low> and <high> values should be no more precise than known, but as precise as possible.
(IPS…nce)
Treeblank.pngTreetree.pnghl7:low
IVXB_TS1 … 1RThe effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active.
(IPS…nce)
Treeblank.pngTreetree.pnghl7:high
IVXB_TS0 … 1CThe effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became biologically resolved.
If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".
(IPS…nce)
 ConstraintIf this condition is known to be resolved, then the effectiveTime/high would be present.
Treetree.pnghl7:value
CD.IPS CWE0 … 1C

While the value may be a coded or an uncoded string, the type is always a coded value (xsi:type='CD'). If uncoded, all attributes other than xsi:type='CD' must be absent and may contain a <reference> to the <originalText> in the narrative where the allergy is described.

The coded form shall be used to indicate known absent conditions (e.g. NKA) or the nonavailability of infos about them; or in some cases the allergy to specific substances (e.g. allergy to nuts).
When the value is present in a coded form, no allergy agent is expected to be provided.

(IPS…nce)
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.10 Allergies to substances (DYNAMIC)
or
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.9 Absent or Unknown Allergies (DYNAMIC)
Treetree.pnghl7:participant
0 … 1CThe substance that causes the allergy or intolerance should be specified in the <participant> structure. 
This is the preferred way an allergy is supposed to be expressed.

However it is recognized that in some contexts a controlled vocabulary is used for describing the allergy to a substance; or for asserting known absence or unavailability of information. 
In this case the <participant> structure shall be omitted.

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, i.e., use playingEntity classCode = "MMAT" for all agents, manufactured or not.
(IPS…nce)
Treeblank.pngTreetree.png@typeCode
cs1 … 1FCSM
 ConstraintIF the observation/value element is present and coded then the observation/participant element SHALL be omitted.
Conditional: Omit if Observation.value is SNOMED-CT 160244002 No known Allergies
Treeblank.pngTreetree.pnghl7:participantRole
0 … 1C(IPS…nce)
Treeblank.pngTreeblank.pngTreetree.png@classCode
cs1 … 1FMANU
Treeblank.pngTreeblank.pngTreetree.pnghl7:playingEntity
1 … 1R(IPS…nce)
Treeblank.pngTreeblank.pngTreeblank.pngTreetree.png@classCode
cs1 … 1FMMAT
Treeblank.pngTreeblank.pngTreeblank.pngTreetree.pnghl7:code
CD.IPS1 … 1RCode for the substance causing the allergy or intolerance.
(IPS…nce)
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.11 Adverse Reaction Agents (DYNAMIC)
 Schematron assertroleKred.png error 
 testhl7:value[@code] or hl7:participantRole 
 MessageIF the observation/value element is present and coded then the observation/participant element SHALL be omitted 
Treetree.pnghl7:entryRelationship
0 … *RThe contained entry describes the reactions that are manifestations (typeCode='MFST') of the reported allergy or intolerance.
Contains 2.16.840.1.113883.10.22.4.6 IPS Reaction Manifestation (DYNAMIC)
(IPS…nce)
Treeblank.pngTreetree.png@typeCode
cs1 … 1FMFST
Treeblank.pngTreetree.png@inversionInd
cs1 … 1Ftrue
Treetree.pnghl7:entryRelationship
0 … 1RCriticality
The contained entry describes the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual.
Contains 2.16.840.1.113883.10.22.4.18 IPS Criticality Observation (DYNAMIC)
(IPS…nce)
Treeblank.pngTreetree.png@typeCode
cs1 … 1FSUBJ
Treeblank.pngTreetree.png@inversionInd
cs1 … 1Ftrue
Treetree.pnghl7:entryRelationship
0 … 1RCertainty or Verification Status
The contained entry describes the certainty associated with a propensity, or potential risk, of a reaction to the identified substance.

Contains 2.16.840.1.113883.10.22.4.19 IPS Certainty Observation (DYNAMIC)
(IPS…nce)
Treeblank.pngTreetree.png@typeCode
cs1 … 1FSUBJ
Treeblank.pngTreetree.png@inversionInd
cs1 … 1Ftrue
Treetree.pnghl7:entryRelationship
0 … 1RStatus of the Allergy or Intolerance 
The contained entry describes the current status of the allergy or intolerance, for example, whether it is active, in remission, resolved, and so on ...

Contains 2.16.840.1.113883.10.22.4.21 IPS Allergy Status Observation (DYNAMIC)
(IPS…nce)
Treeblank.pngTreetree.png@typeCode
cs1 … 1FREFR
Treeblank.pngTreetree.png@inversionInd
cs1 … 1Ffalse