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Template XeH Laboratory Observation 2022‑02‑16 15:03:27

Id2.16.840.1.113883.2.51.10.56Effective Date2022‑02‑16 15:03:27
Statusactive ActiveVersion Label1.0
NameXeHLaboratoryObservationDisplay NameXeH Laboratory Observation
Description
The document SHALL contain at least one Laboratory Observation (See REFERENCE) under the Specimen Act of each Laboratory Data Processing Entry (See REFERENCE). The Laboratory Observation SHALL record a single laboratory observation in the document, either standalone or as part of a battery. It should be distinguished from the PCC Simple Observation template.
ContextParent nodes of template element with id 2.16.840.1.113883.2.51.10.56
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 3 templates, Uses 10 templates
Used by as NameVersion
2.16.840.1.113883.2.51.10.36Containmentactive XeH Laboratory Report Data Processing Entry (1.0)2021‑10‑07 00:14:07
2.16.840.1.113883.2.51.10.70Containmentactive XeH Laboratory Battery Organizer (2017)2022‑05‑09 22:33:51
2.16.840.1.113883.2.51.10.92Containmentactive XeH Laboratory Isolate Organizer (1.0)2022‑07‑31 07:54:30
Uses as NameVersion
1.3.6.1.4.1.19376.1.3.3.1.2.1Containmentactive Non-Human Subject (2017)DYNAMIC
1.3.6.1.4.1.19376.1.3.3.1.3.1Containmentactive Human Patient with Non-Human Subject (2017)DYNAMIC
1.3.6.1.4.1.19376.1.3.3.1.7Containmentactive Laboratory Performer (2017)DYNAMIC
1.3.6.1.4.1.19376.1.3.10.9.17Containmentactive Author with Name, Addr, Telecom (2017)DYNAMIC
1.3.6.1.4.1.19376.1.5.3.1.4.2Containmentactive IHE Comment Entry (2014)DYNAMIC
2.16.840.1.113883.2.51.10.18Containmentactive XeH Internal Reference (1.0)DYNAMIC
2.16.840.1.113883.2.51.10.42Containmentactive XeH Specimen Collection (2021)DYNAMIC
2.16.840.1.113883.2.51.10.74Includeactive XeH Lab Results Validator Participant (1.0)DYNAMIC
2.16.840.1.113883.2.51.10.91Includeactive XeH Lab Device Participant (1.0)DYNAMIC
2.16.840.1.113883.2.51.10.93Containmentactive XeH Laboratory Observation (local value) (1.0)DYNAMIC
RelationshipAdaptation: template 1.3.6.1.4.1.19376.1.3.1.6 Laboratory Observation (2008‑08‑08)
ref
XDLAB-

Generalization: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07)
ref
ad1bbr-
Example
Example
<observation classCode="OBS" moodCode="EVN">
  <templateId root="1.3.6.1.4.1.19376.1.3.1.6"/>  <id root=" " extension=" "/>  <code code="10912-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Lead Measurement, Quantitative">
    <originalText>
      <reference value="pbTest"/>    </originalText>  </code>  <statusCode code="completed"/>  <effectiveTime value="20071108000000.0000-0500"/>  <value xsi:type="PQ" unit="mg/dL" value="6.4"/>  <interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>  <methodCode code=" " codeSystem=" " codeSystemName=" "/>  <specimen typeCode="SPC">
    <specimenRole classCode="SPEC">
      <id extension="555847399003" root="1.3.6.1.4.1.19376.1.3.4"/>      <specimenPlayingEntity>
        <code code="BLD" codeSystem="2.16.840.1.113883.5.129" codeSystemName="HL7" displayName="Blood"/>      </specimenPlayingEntity>    </specimenRole>  </specimen>  <performer typeCode="PRF">
    <templateId root="1.3.6.1.4.1.19376.1.3.3.1.7"/>    <!-- ... -->
  </performer>  <author typeCode="AUT">
    <!-- ... -->
  </author>  <participant typeCode="AUTHEN">
    <templateId root="1.3.6.1.4.1.19376.1.3.3.1.5"/>    <!-- ... -->
  </participant>  <participant typeCode="RESP">
    <!-- ... -->
  </participant>  <participant typeCode="DEV">
    <!-- ... -->
  </participant>  <entryRelationship typeCode="COMP">
    <act classCode="ACT" moodCode="EVN">
      <templateId root="2.16.840.1.113883.10.20.1.40"/>      <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.2"/>      <code code="48767-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Annotation Comment"/>      <text>
        <reference value="pbTestComment"/>      </text>      <statusCode code="completed"/>    </act>  </entryRelationship>  <entryRelationship typeCode="REFR">
    <sequenceNumber value="1"/>    <observation classCode="OBS" moodCode="EVN">
      <templateId root="1.3.6.1.4.1.19376.1.3.1.6"/>      <code code="10912-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Lead Measurement, Quantitative">
        <originalText>
          <reference value="pbTest"/>        </originalText>      </code>      <statusCode code="completed"/>      <effectiveTime value="20071101000000.0000-0500"/>      <value xsi:type="PQ" unit="mg/dL" value="8.7"/>      <interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>      <entryRelationship typeCode="COMP">
        <act classCode="ACT" moodCode="EVN">
          <templateId root="2.16.840.1.113883.10.20.1.40"/>          <templateId root="1.3.6.1.4.1.19376.1.5.3.1.4.2"/>          <code code="48767-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Annotation Comment"/>          <text>
            <reference value="pbTestComment"/>          </text>          <statusCode code="completed"/>        </act>      </entryRelationship>    </observation>  </entryRelationship>  <referenceRange typeCode="REFV">
    <observationRange classCode="OBS" moodCode="EVN.CRT">
      <value xsi:type="IVL_PQ">
        <low value="0.0" unit="mg/dL"/>        <high value="5.0" unit="mg/dL"/>      </value>      <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>    </observationRange>    <lab:precondition typeCode="PRCN">
      <lab:criterion classCode="COND">
        <lab:code code="AGE"/>        <lab:value xsi:type="IVL_PQ">
          <lab:low value="35" unit="Y"/>          <lab:high value="55" unit="Y"/>        </lab:value>      </lab:criterion>    </lab:precondition>  </referenceRange></observation>
Example
Example
<observation classCode="OBS" moodCode="EVN">
  <templateId root="1.3.6.1.4.1.19376.1.3.1.3"/>  <code code="11273-0" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="ERYTHROCYTES"/>  <statusCode code="completed"/>  <effectiveTime value="20060321063000.0000-0500"/>  <value xsi:type="PQ" value="4.95" unit="10*6/mm3"/>  <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>  <entryRelationship typeCode="REFR">
    <!-- Previous result 4.85 from Mar 12, 2006 08:15 -->
    <observation classCode="OBS" moodCode="EVN">
      <code code="11273-0" codeSystem="2.16.840.1.113883.6.1"/>      <statusCode code="completed"/>      <effectiveTime value="20060312081500.0000-0500"/>      <value xsi:type="PQ" value="4.85" unit="10*6/mm3"/>    </observation>  </entryRelationship>  <!-- reference range given patient sex -->
  <referenceRange typeCode="REFV">
    <observationRange classCode="OBS" moodCode="EVN.CRT">
      <value xsi:type="IVL_PQ">
        <low value="4.50" unit="10*6/mm3"/>        <high value="6.00" unit="10*6/mm3"/>      </value>    </observationRange>    <lab:precondition typeCode="PRCN">
      <lab:criterion classCode="COND">
        <lab:code code="SEX"/>        <lab:value xsi:type="CD" code="M" codeSystem="2.16.840.1.113883.5.1"/>      </lab:criterion>    </lab:precondition>  </referenceRange></observation>
ItemDTCardConfDescriptionLabel
hl7:observation
1 … 1MXeHLdotstion
@classCode
cs1 … 1FOBS
@moodCode
cs1 … 1FEVN
hl7:templateId
II1 … 1MXeHLdotstion
@root
uid1 … 1F2.16.840.1.113883.2.51.10.56
hl7:id
II0 … 1A Laboratory Observation identifier MAY be present.XeHLdotstion
hl7:code
CD (preferred)1 … 1RUnique test code in an international standard (LOINC or SNOMED CT) or a national standard (e.g. JC10 in Japan)
XeHLdotstion
 CONF
The value of @code comes preferably from value set 2.16.840.1.113883.2.51.13.8 XeH Lab Test Code LOINC (DYNAMIC)
or
The value of @code comes preferably from value set 2.16.840.1.113883.2.51.13.10 XeH Lab Test Code NPU (DYNAMIC)
hl7:qualifier
CR0 … 1

Accreditation status

Accreditation status holds information about status of the test, i.e., whether laboratory has been accredited for provisioning of the test or not.
If this element is not given, the laboratory was accredited (default).

XeHLdotstion
hl7:value
CD (preferred)1 … 1MXeHLdotstion
 CONF
The value of @code comes preferably from value set 2.16.840.1.113883.2.51.13.15 XeH Lab Accreditation Status (DYNAMIC)
hl7:translation
CD0 … 1Local test code (e.g. internally used by the performing laboratory)XeHLdotstion
hl7:statusCode
CS (required)1 … 1M
Formal status of that observation according to IHE XD-LAB profile:

set to ‘completed’ when the result is present
set to ‘aborted’ if the test could not be performed

Note: it is merely the information, whether or not the value is present or not. It is the status seen from the layer of the document instance. It doesn NOT consider this value (or this document) being part of a process chain or workflow.
XeHLdotstion
 CONF
@code shall be "completed"
or
@code shall be "aborted"
xeh:observationStatus
CE.IPS (required)1 … 1M
Status of Laboratory Test in the context of the workflow / business process, such as preliminary, final, corrected, ...

The value must not contradict the value set in hl7:statusCode

Note: this is the more comprehensive status of that observation on the layer of workflow and process.
XeHLdotstion
 CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.2.51.13.1.3 FHIR Observation Status (DYNAMIC)
hl7:effectiveTime
IVL_TS0 … 1RPhysiologically relevant timeXeHLdotstion
Choice1 … 1Elements to choose from:
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
  • hl7:value
hl7:value
CE.IPS0 … 1RCoded resultsXeHLdotstion
hl7:value
ED0 … 1RTextual results: Text in the narrative text element should be referenced here
Media Results: Media (pictures, ...) can be embedded here in B64 encoding		XeHLdotstion
hl7:value
INT0 … 1RInteger numeric results
XeHLdotstion
hl7:value
IVL_INT0 … 1RInteger numeric interval resultsXeHLdotstion
hl7:value
PQ0 … 1RPhysical quantity results (value and unit)XeHLdotstion
hl7:value
IVL_PQ0 … 1RPhysical quantity interval results (value and unit)XeHLdotstion
hl7:value
REAL0 … 1RReal numeric resultsXeHLdotstion
hl7:value
IVL_REAL0 … 1RReal numeric interval resultsXeHLdotstion
hl7:value
RTO_QTY_QTY0 … 1RRatio result (integer numeric, real numeric, physical quantity)XeHLdotstion
hl7:value
TS0 … 1RTimestamp resultsXeHLdotstion
hl7:value
BL0 … 1RBoolean results (true / false)XeHLdotstion
xeh:measurementUncertainty
PQ0 … 1Measurement uncertainty in percent

Example: <xeh:measurementUncertainty value="2" unit="%"/>		XeHLdotstion
xeh:testCalibrator
CE.IPS0 … 1Test calibrators, either as "coded entry" or "narrative text" (direct or reference)

Examples:

<xeh:testCalibrator code="" codeSystem=""/>

-- or --

<xeh:testCalibrator>
  <originalText>IS 93/76</originalText>
</xeh:testCalibrator>

-- or --

<xeh:testCalibrator>
  <originalText><reference value="#ID_of_text_in_narrative"/></originalText>
</xeh:testCalibrator>
XeHLdotstion
hl7:interpretationCode
CE.IPS0 … 1RResult interpretation is usually documented within the referenceRange element to which it belongs.

If no referenceRange is present, this element SHALL be used for result interpretation, IF KNOWN.

If a referenceRange is present, this element SHALL NOT be used.


XeHLdotstion
hl7:methodCode
CE.IPS0 … 1RExaminationTechnique (method) used for this observation expressed with ObservationMethod vocabulary (CWE)XeHLdotstion
Choice0 … 1Elements to choose from:
hl7:subject
NPsubject in case of a non-human subject
Contains 1.3.6.1.4.1.19376.1.3.3.1.2.1 Non-Human Subject (DYNAMIC)		XeHLdotstion
@typeCode
cs0 … 1FSBJ
hl7:subject
0 … 1subject in case of a non-human subject
Contains 1.3.6.1.4.1.19376.1.3.3.1.3.1 Human Patient with Non-Human Subject (DYNAMIC)		XeHLdotstion
@typeCode
cs0 … 1FSBJ
hl7:performer
0 … *performer participation. Performer to supersede those recorded at higher level.
Contains 1.3.6.1.4.1.19376.1.3.3.1.7 Laboratory Performer (DYNAMIC)		XeHLdotstion
hl7:author
0 … *Rauthor participation used to supersede the authors of higher level.
Contains 1.3.6.1.4.1.19376.1.3.10.9.17 Author with Name, Addr, Telecom (DYNAMIC)		XeHLdotstion
hl7:participant
0 … 1AUTHEN: The verifier of the battery organizer. In the case where a laboratory report has multiple verifiers. Each verifier is attached to the subset of batteries/observations he or she verified, by the means of a <participant> element.

Note: See "other participants" ("AUTHEN", "RESP", "DEV") according to IHE XD-LAB profile		XeHLdotstion
where [@typeCode='AUTHEN']
@typeCode
cs1 … 1FAUTHEN
Included1 … 1M from 2.16.840.1.113883.2.51.10.74 XeH Lab Results Validator Participant (DYNAMIC)
hl7:time
TS1 … 1MXeHLdotspant
hl7:participantRole
1 … 1MXeHLdotspant
@classCode
cs0 … 1FROL
hl7:id
II1 … *RXeHLdotspant
hl7:code
CE.IPS (preferred)0 … 1A code, which identifies the profession/competence/specialty of the author when it is a person.
XeHLdotspant
 CONF
The value of @code comes preferably from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC)
hl7:addr
AD0 … *XeHLdotspant
hl7:telecom
TEL0 … *XeHLdotspant
hl7:playingEntity
0 … 1RXeHLdotspant
hl7:name
PN1 … 1RXeHLdotspant
hl7:participant
0 … 1RESP: The person responsible for the provision of the battery. In the case where this battery is subcontracted to an external laboratory, this external laboratory (with its address and telcom) and the actual performer is represented by a <performer> element, whereas the Director of this subcontractor laboratory is carried by the <participant> element being attached to the same level as the <performer> element.

Note: See "other participants" ("AUTHEN", "RESP", "DEV") according to IHE XD-LAB profile
XeHLdotstion
where [@typeCode='RESP']
@typeCode
cs1 … 1FRESP
hl7:participant
0 … 1DEV: A device or equipment, which was used to produce this battery of results (e.g. an analyzer).

Note: See "other participants" ("AUTHEN", "RESP", "DEV") according to IHE XD-LAB profile
XeHLdotstion
where [@typeCode='DEV']
@typeCode
cs1 … 1FDEV
Included1 … 1M from 2.16.840.1.113883.2.51.10.91 XeH Lab Device Participant (DYNAMIC)
hl7:participantRole
1 … 1MXeHLdotspant
hl7:id
II0 … *The UDI Device Identifier MAY be specified as a second id element.
XeHLdotspant
hl7:playingDevice
1 … 1MXeHLdotspant
hl7:code
CE.IPS0 … 1Coded product type
XeHLdotspant
hl7:manufacturerModelName
SC0 … 1The element manufacturerModelName“ is intended to be used in the same manner as element “modelNumber” specified in the FHIR device resource. It shall carry model information of the device or software provided in element softwareName
XeHLdotspant
hl7:softwareName
SC1 … 1M
The element softwareName is the primary element and intended to be used in the same manner as element “deviceName” specified in the FHIR device resource. It should carry the name of the device or software.

Is SHOULD including the manufacturer name.

Note: In case of usage for laboratory related documentation (e.g. Laboratory Result Report), the device structure is also used to record "Laboratory Kits" used for the examination.
XeHLdotspant
hl7:entryRelationship
0 … *RComment on this Observation
Contains 1.3.6.1.4.1.19376.1.5.3.1.4.2 IHE Comment Entry (DYNAMIC)		XeHLdotstion
hl7:entryRelationship
0 … *RSpecimen Collection
Contains 2.16.840.1.113883.2.51.10.42 XeH Specimen Collection (DYNAMIC)		XeHLdotstion
hl7:entryRelationship
0 … *RPrevious observations obtained for the same patient, test, same method, same unit (1)XeHLdotstion
where [@typeCode='REFR']
@typeCode
cs1 … 1FREFR
hl7:observation
1 … 1RXeHLdotstion
@classCode
cs1 … 1FOBS
@moodCode
cs1 … 1FEVN
hl7:code
1 … 1RXeHLdotstion
hl7:statusCode
1 … 1RXeHLdotstion
@code
1 … 1Fcompleted
hl7:effectiveTime
1 … 1RXeHLdotstion
hl7:value
1 … 1RXeHLdotstion
hl7:entryRelationship
0 … 1Internal reference to an "Order Id" provided in the header of the document (inFullfilmentOf/order/id).

Superseeds present references in overarching containers of this observation (e.g. battery)

Note: Usually used in case of multiple orders present 

Contains 2.16.840.1.113883.2.51.10.18 XeH Internal Reference (DYNAMIC)		XeHLdotstion
hl7:entryRelationship
0 … 1Internal reference to an "Ordering provider" provided in the header of the document (participant[@typeCode='REF']/associatedEntity/id).

Superseeds present references in overarching containers of this observation (e.g. battery)

Note: Usually used in case of multiple orders present

Contains 2.16.840.1.113883.2.51.10.18 XeH Internal Reference (DYNAMIC)		XeHLdotstion
hl7:entryRelationship
0 … 1Local Test Result Value
Contains 2.16.840.1.113883.2.51.10.93 XeH Laboratory Observation (local value) (DYNAMIC)		XeHLdotstion
hl7:referenceRange
0 … *ROne to many Reference ranges for the current test result
XeHLdotstion
@typeCode
cs0 … 1FREFV
hl7:observationRange
1 … 1MXeHLdotstion
@classCode
cs0 … 1FOBS
@moodCode
cs0 … 1FEVN.CRT
hl7:code
CD (preferred)0 … 1Result Interpretation Type

Type of the result interpretation indicates what part of the targeted reference population it applies to. For example, interpretation using normal or therapeutic range. Default is "normal" interpretation type.

XeHLdotstion
 CONF
The value of @code comes preferably from value set 2.16.840.1.113883.2.51.13.16 XeH Lab Reference Range Type (DYNAMIC)
Choice1 … 1
Reference range as interval
Elements to choose from:
  • hl7:value
  • hl7:value
  • hl7:value
hl7:value
IVL_INT0 … 1RInteger numeric interval resultsXeHLdotstion
hl7:value
IVL_PQ0 … 1RPhysical quantity interval results (value and unit)XeHLdotstion
hl7:value
IVL_REAL0 … 1RReal numeric interval resultsXeHLdotstion
hl7:interpretationCode
CE (preferred)1 … 1RResult Interpretation Code

One or more codes interpreting the result, expressed with ObservationInterpretation vocabulary (e.g. H = high, L = low)

In case of a antimicrobial susceptibility test in microbiology, the vocabulary domain is ObservationInterpretationSusceptibility: S = susceptible, R = resistant, I = intermediate, VS = very susceptible, MS = moderately susceptible
XeHLdotstion
 CONF
The value of @code comes preferably from value set 2.16.840.1.113883.2.51.13.11 XeH Lab Result Interpretation (DYNAMIC)
lab:precondition
0 … *Extension to CDA Clinical statementXeHLdotstion
@typeCode
cs1 … 1FPRCN
lab:criterion
1 … 1RXeHLdotstion
@classCode
cs1 … 1FCOND
@moodCode
cs1 … 1FEVN
lab:code
CE1 … 1RCode of the criterion (e.g. age, sex)XeHLdotstion
lab:value
1 … 1RValue of the criterionXeHLdotstion