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Template _Allergy - Intolerance Observation (harmonization)) 2020‑10‑16 15:17:11

Id2.16.840.1.113883.3.1937.99.61.30.10.58Effective Date2020‑10‑16 15:17:11
Statusdraft DraftVersion Labelwip
NamePCAllergy-IntoleranceObservationDisplay Name_Allergy - Intolerance Observation (harmonization))
Description
C-CDA
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 is the definitive 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". 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 
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.


======== TO DO =====

- add missing IPS elements (e.g. text) / entryRelationships (e.g. certanty)
- compare referred templates
ContextParent nodes of template element with id 2.16.840.1.113883.3.1937.99.61.30.10.58
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 1 template, Uses 5 templates
Used by as NameVersion
2.16.840.1.113883.3.1937.99.61.30.10.57Containmentdraft _Allergy Concern Act (harmonized) (wip)2020‑10‑16 13:50:40
Uses as NameVersion
2.16.840.1.113883.10.20.22.4.9Containmentdraft Reaction Observation (V2) (2.1)2014‑06‑09
2.16.840.1.113883.10.20.22.4.119Containmentdraft Author Participation (2.1)2015‑08‑13
2.16.840.1.113883.10.20.22.4.145Containmentdraft Criticality Observation (2.1)2015‑08‑13
2.16.840.1.113883.10.22.4.21Containmentpending IPS Allergy Status Observation (STU1)DYNAMIC
2.16.840.1.113883.10.22.10Containmentpending IPS Allergy Certainty Observation (STU1)DYNAMIC
RelationshipGeneralization: template 2.16.840.1.113883.10.20.22.4.7 Allergy - Intolerance Observation (V2) (2014‑06‑09)
ref
ccda-
ItemDTCardConfDescriptionLabel
cda:observation
Different approaches in the usage of code and value

C-CDA
code = "Assertion" ; value = [type]

IPS

code = [type]; value = missing if agent is present | absence code | diagnosis (intolerance latex) with agent missing 
PCAldotstion
@classCode
cs1 … 1FOBSCONFdots7379
 C-CDA (=IPS)
SHALL contain exactly one [1..1] @classCode="OBS" Observation (CodeSystem: HL7ActClass urn:oid:2.16.840.1.113883.5.6 STATIC) (CONF:1098-7379).
@moodCode
cs1 … 1FEVNCONFdots7380
 C-CDA (=IPS)
SHALL contain exactly one [1..1] @moodCode="EVN" Event (CodeSystem: ActMood urn:oid:2.16.840.1.113883.5.1001 STATIC) (CONF:1098-7380).
@negationInd
bl0 … 1 C-CDA
MAY contain zero or one [0..1] @negationInd (CONF:1098-31526). Note: Use negationInd="true" to indicate that the allergy was not observed.

IPS
An explicit code is used for known absent or unknown Allergies
CONFdots1526
hl7:templateId
II1 … 1MPCAldotstion
@root
uid1 … 1F2.16.840.1.113883.3.1937.99.61.30.10.58
cda:id
II1 … *RC-CDA
SHALL contain at least one [1..*] id (CONF:1098-7382).

IPS
0...* R
CONFdots7382
cda:code
CD1 … 1MC-CDA
SHALL contain exactly one [1..1] code (CONF:1098-15947).
a. This code SHALL contain exactly one [1..1] @code="ASSERTION" Assertion (CONF:1098-15948).
b. This code SHALL contain exactly one [1..1] @codeSystem="2.16.840.1.113883.5.4" (CodeSystem: HL7ActCode urn:oid:2.16.840.1.113883.5.4) (CONF:1098-32153).

IPS
This element describes whether this condition refers to an allergy, non-allergy intolerance, or unknown class of intolerance (not known to be allergy or intolerance).

The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.2 Allergy or Intolerance Type (DYNAMIC)
CONFdots5947
hl7:text
ED0 … 1RC-CDA
Not explicitly specified

IPS
The text element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.
PCAldotstion
hl7:reference
TEL1 … 1MPCAldotstion
@value
1 … 1RWhen used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1
cda:statusCode
CS1 … 1MIPS = C-CDA

C-CDA

SHALL contain exactly one [1..1] statusCode (CONF:1098-19084).
a. This statusCode SHALL contain exactly one [1..1] @code="completed" Completed (CodeSystem: HL7ActStatus urn:oid:2.16.840.1.113883.5.14 STATIC) (CONF:1098-19085).

IPS
A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the shall always have code='completed'.
CONFdots9084
@code
CONF1 … 1Fcompleted
cda:effectiveTime
IVL_TS1 … 1MC-CDA

SHALL contain exactly one [1..1] effectiveTime (CONF:1098-7387). Note: If the allergy/intolerance is known to be resolved, but the date of resolution is not known, then the high element SHALL be present, and the nullFlavor attribute SHALL be set to 'UNK'.

IPS
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.
CONFdots7387
cda:low
1 … 1R
C-CDA
a. This effectiveTime SHALL contain exactly one [1..1] low (CONF:1098-31538). Note: The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active.

IPS
The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active.
CONFdots1538
cda:high
0 … 1CC-CDA
b. This effectiveTime MAY contain zero or one [0..1] high (CONF:1098-31539). Note: The effectiveTime/high (a.k.a. "resolution date")

IPS
The 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".
CONFdots1539
cda:value
CD1 … 1MC-CDA
SHALL contain exactly one [1..1] value with @xsi:type="CD", where the code SHALL be selected from ValueSet Allergy and Intolerance Type urn:oid:2.16.840.1.113883.3.88.12.3221.6.2 DYNAMIC (CONF:1098-7390). Note: The consumable participant points to the precise allergen or substance of intolerance.
Because the consumable and the reaction are more clinically relevant than a categorization of the allergy/adverse event type, many systems will simply assign a fixed value here (e.g., "allergy to substance").

Code from value set: 2.16.840.1.113883.3.88.12.3221.6.2 (Dynamic)

IPS

0...1 

the coded form of the observation value can be used :
  • either to indicate known absent conditions (e.g. NKA) or the non-availability of information; 
  • or to provide pre-coordinated codes describing the propensity to specific substances (e.g. allergy to nuts). 
When the value is used to describe the absence of information the participant used for indicating the allergy agent shall be omitted.
CONFdots7390
cda:author
0 … *RC-CDA
SHOULD contain zero or more [0..*] Author Participation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.119) (CONF:1098-31143).

IPS
Not explicitly specified
Contains 2.16.840.1.113883.10.20.22.4.119 Author Participation (2015‑08‑13)
CONFdots1143
cda:participant
1 … 1MC-CDA
SHALL contain exactly one [1..1] participant (CONF:1098-7402) such that it

IPS
The 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.

CONTRAINT: 
IF the observation/value element is present and valued with a code derived form the  2.16.840.1.113883.11.22.9 Absent or Unknown Allergies value set THEN the  observation/participant element used to describe the agent SHALL be omitted.
CONFdots7402
@typeCode
cs1 … 1FCSMCONFdots7403
 C-CDA (=IPS)
SHALL contain exactly one [1..1] @typeCode="CSM" Consumable (CodeSystem: HL7ParticipationType urn:oid:2.16.840.1.113883.5.90 STATIC) (CONF:1098-7403).



cda:participantRole
1 … 1MC-CDA (=IPS)
SHALL contain exactly one [1..1] participantRole (CONF:1098-7404).
CONFdots7404
@classCode
cs1 … 1FMANUCONFdots7405
 C-CDA (=IPS)
This participantRole SHALL contain exactly one [1..1] @classCode="MANU" Manufactured Product (CodeSystem: RoleClass urn:oid:2.16.840.1.113883.5.110 STATIC) (CONF:1098-7405).
cda:playingEntity
1 … 1MC-CDA (=IPS)
This participantRole SHALL contain exactly one [1..1] playingEntity (CONF:1098-7406).
CONFdots7406
@classCode
cs1 … 1FMMATCONFdots7407
 C-CDA (=IPS)
This playingEntity SHALL contain exactly one [1..1] @classCode="MMAT" Manufactured Material (CodeSystem: EntityClass urn:oid:2.16.840.1.113883.5.41 STATIC) (CONF:1098-7407).
cda:code
CD1 … 1RC-CDA 
This playingEntity SHALL contain exactly one [1..1] code, which SHALL be selected from ValueSet Substance-Reactant for Intolerance urn:oid:2.16.840.1.113762.1.4.1010.1 DYNAMIC (CONF:1098-7419).

Code from value set: 2.16.840.1.113762.1.4.1010.1 (Dynamic)

IPS

The value of @code comes preferably from value set 2.16.840.1.113883.11.22.11 Adverse Reaction Agents (DYNAMIC)
CONFdots7419
hl7:entryRelationship
0 … 1RStatus of the Allergy or Intolerance 

C-CDA 
MAY contain zero or one [0..1] entryRelationship (CONF:1098-32939) such that it
a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1098-32940).
b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-32941).
c. SHALL contain exactly one [1..1] Allergy Status Observation (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.28:2019-06-20) (CONF:1098-32942).

IPS (SHOULD)
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)
PCAldotstion
@typeCode
cs1 … 1FREFR
@inversionInd
cs1 … 1Ffalse
cda:entryRelationship
0 … *R Reaction 

C-CDA

SHOULD contain zero or more [0..*] entryRelationship (CONF:1098-16337) such that it
a. SHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-16339).
b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-16338).
c. SHALL contain exactly one [1..1] Reaction Observation (V2) (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.9:2014-06-09) (CONF:1098-16340).

IPS
The 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)



Contains 2.16.840.1.113883.10.20.22.4.9 Reaction Observation (V2) (2014‑06‑09)
CONFdots7447
@typeCode
cs1 … 1FMFSTCONFdots7907
 SHALL contain exactly one [1..1] @typeCode="MFST" Is Manifestation of (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-7907).
@inversionInd
bl1 … 1FtrueCONFdots7449
 SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-7449).
cda:entryRelationship
0 … 1Severity

C-CDA

SHOULD NOT contain zero or one [0..1] entryRelationship (CONF:1098-16341) such that it
a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-16342).
b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-16343).
c. SHALL contain exactly one [1..1] Severity Observation (V2) (identifier: urn:hl7ii:2.16.840.1.113883.10.20.22.4.8:2014-06-09) (CONF:1098-16344).

IPS
No Severity at this level
CONFdots9961
@typeCode
cs1 … 1FSUBJCONFdots9962
 SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002 STATIC) (CONF:1098-9962).
@inversionInd
bl1 … 1FtrueCONFdots9964
 SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-9964).
cda:entryRelationship
0 … 1R Criticality

C-CDA

SHOULD contain zero or one [0..1] entryRelationship (CONF:1098-32935) such that it
a. SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1098-32936).
b. SHALL contain exactly one [1..1] @inversionInd="true" True (CONF:1098-32937).
c. SHALL contain exactly one [1..1] Criticality Observation (identifier: urn:oid:2.16.840.1.113883.10.20.22.4.145) (CONF:1098-32938).

IPS
Criticality
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)

-----------------------



Contains 2.16.840.1.113883.10.20.22.4.145 Criticality Observation (2015‑08‑13)
CONFdots2910
@typeCode
cs1 … 1FSUBJCONFdots2911
 SHALL contain exactly one [1..1] @typeCode="SUBJ" Has Subject (CodeSystem: HL7ActRelationshipType urn:oid:2.16.840.1.113883.5.1002) (CONF:1098-32911).
@inversionInd
bl0 … 1FtrueCONFdots2912
 SHALL contain zero or one [0..1] @inversionInd="true" True (CONF:1098-32912).
hl7:entryRelationship
0 … 1RCertainty or Verification Status

C-CDA 
Not explicit

IPS
The contained entry describes the certainty associated with a propensity, or potential risk, of a reaction to the identified substance.
Contains 2.16.840.1.113883.10.22.10 IPS Allergy Certainty Observation (DYNAMIC)
PCAldotstion
@typeCode
cs1 … 1FSUBJ
@inversionInd
cs1 … 1Ftrue