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draft Template  XeH Laboratory Observation

Id 2.16.840.1.113883.2.51.10.56 Effective Date 2022‑02‑16 15:03:27
Status draft Draft Version Label 0.1
Name XeHLaboratoryObservation Display Name XeH 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.
Context Parent nodes of template element with id 2.16.840.1.113883.2.51.10.56
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Used by / Uses
Used by 0 transactions and 6 templates, Uses 6 templates
Used by as Name Version
2.16.840.1.113883.2.51.10.36 Containment draft XeH Laboratory Report Data Processing Entry (2017) 2021‑10‑07 00:14:07
2.16.840.1.113883.2.51.10.34 link draft XeH Laboratory Specialty Section, Variant 1 (0.1) 2021‑10‑01 12:00:38
2.16.840.1.113883.2.51.10.33 link draft XeH Laboratory Result Report (0.1) 2021‑10‑01 11:41:22
2.16.840.1.113883.2.51.10.55 link draft XeH Laboratory Report Item Section (0.1) 2022‑02‑16 11:32:28
2.16.840.1.113883.2.51.10.54 link draft XeH Laboratory Specialty Section, Variant 2 (0.1) 2022‑02‑16 10:55:28
2.16.840.1.113883.2.51.10.70 Containment draft XeH Laboratory Battery Organizer (2017) 2022‑05‑09 22:33:51
Uses as Name Version
1.3.6.1.4.1.19376.1.3.3.1.2.1 Containment active Non-Human Subject (2017) DYNAMIC
1.3.6.1.4.1.19376.1.3.3.1.3.1 Containment active Human Patient with Non-Human Subject (2017) DYNAMIC
1.3.6.1.4.1.19376.1.3.3.1.7 Containment active Laboratory Performer (2017) DYNAMIC
1.3.6.1.4.1.19376.1.3.10.9.17 Containment active Author with Name, Addr, Telecom (2017) DYNAMIC
1.3.6.1.4.1.19376.1.5.3.1.4.2 Containment active IHE Comment Entry (2014) DYNAMIC
2.16.840.1.113883.2.51.10.42 Containment draft XeH Specimen Collection (2021) DYNAMIC
Relationship Adaptation: 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>
notice There are open issues with this item:
Item DT Card Conf Description Label
hl7:observation
 		1 … 1 M (XeHdotsion)
@classCode
 		cs 1 … 1 F OBS
@moodCode
 		cs 1 … 1 F EVN
hl7:templateId
 		II 1 … 1 M (XeHdotsion)
@root
 		uid 1 … 1 F 2.16.840.1.113883.2.51.10.56
hl7:templateId
 		II 1 … 1 M (XeHdotsion)
@root
 		uid 1 … 1 F 1.3.6.1.4.1.19376.1.3.1.6
hl7:id
 		II 0 … 1 A Laboratory Observation identifier MAY be present. (XeHdotsion)
hl7:code
 		CD 1 … 1 R Unique test code in an international standard (LOINC or SNOMED CT) or a national standard (e.g. JC10 in Japan) (XeHdotsion)
  CONF
The value of @code shall be drawn from value set 2.16.840.1.113883.2.51.13.8 XeH Lab Test Code LOINC (DYNAMIC)
or
The value of @code shall be drawn from value set 2.16.840.1.113883.2.51.13.10 XeH Lab Test Code NPU (DYNAMIC)
hl7:statusCode
 		CS 1 … 1 M Formal status according to IHE XD-LAB profile:
‘completed’ when the result is present
‘aborted’ if the test could not be performed
 (XeHdotsion)
  CONF
@code shall be "completed"
or
@code shall be "aborted"
xeh:observationStatus
 		CO 1 … 1 M 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 		(XeHdotsion)
  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_TS 0 … 1 R Physiologically relevant time (XeHdotsion)
Choice 1 … 1 Elements 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.IPS 0 … 1 R Coded results (XeHdotsion)
hl7:value
 		ED 0 … 1 R Textual results: Text in the narrative text element should be referenced here
Media Results: Media (pictures, ...) can be embedded here in B64 encoding 		(XeHdotsion)
hl7:value
 		INT 0 … 1 R Integer numeric results
 (XeHdotsion)
hl7:value
 		IVL_INT 0 … 1 R Integer numeric interval results (XeHdotsion)
hl7:value
 		PQ 0 … 1 R Physical quantity results (value and unit) (XeHdotsion)
hl7:value
 		IVL_PQ 0 … 1 R Physical quantity interval results (value and unit) (XeHdotsion)
hl7:value
 		REAL 0 … 1 R Real numeric results (XeHdotsion)
hl7:value
 		IVL_REAL 0 … 1 R Real numeric interval results (XeHdotsion)
hl7:value
 		RTO_QTY_QTY 0 … 1 R Ratio result (integer numeric, real numeric, physical quantity) (XeHdotsion)
hl7:value
 		TS 0 … 1 R Timestamp results (XeHdotsion)
hl7:value
 		BL 0 … 1 R Boolean results (true / false) (XeHdotsion)
xeh:measurementUncertainty
 		PQ 0 … 1 Measurement uncertainty in percent

Example: <xeh:measurementUncertainty value="2" unit="%"/> 		(XeHdotsion)
xeh:testCalibrator
 		CE.IPS 0 … 1 Test 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>
 (XeHdotsion)
hl7:interpretationCode
 		CE 0 … 1 R 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 		(XeHdotsion)
hl7:methodCode
 		CE 0 … 1 R method used for this observation expressed with ObservationMethod vocabulary (CWE) (XeHdotsion)
Choice 0 … 1 Elements to choose from:
hl7:subject
 		NP subject 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) 		(XeHdotsion)
@typeCode
 		cs 0 … 1 F SBJ
hl7:subject
 		0 … 1 subject 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) 		(XeHdotsion)
@typeCode
 		cs 0 … 1 F SBJ
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) 		(XeHdotsion)
@typeCode
 		cs 0 … 1 F PRF
hl7:author
 		0 … * R author 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) 		(XeHdotsion)
@typeCode
 		cs 0 … 1 F AUT
hl7:participant
 		0 … 1 Other participants "AUTHEN", "RESP", and "DEV".
  • AUTHEN: 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.
(XeHdotsion)
where [@typeCode='AUTHEN']
@typeCode
 		cs 1 … 1 F AUTHEN
hl7:participant
 		0 … 1 Other participants "AUTHEN", "RESP", and "DEV".
  • RESP: 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.
(XeHdotsion)
where [@typeCode='RESP']
@typeCode
 		cs 1 … 1 F RESP
hl7:participant
 		0 … 1 Other participants "AUTHEN", "RESP", and "DEV".
  • DEV: A device or equipment, which was used to produce this battery of results (e.g. an analyzer).
(XeHdotsion)
where [@typeCode='DEV']
@typeCode
 		cs 1 … 1 F DEV
hl7:entryRelationship
 		0 … * R Comment on this Observation
Contains 1.3.6.1.4.1.19376.1.5.3.1.4.2 IHE Comment Entry (DYNAMIC) 		(XeHdotsion)
hl7:entryRelationship
 		0 … * R Specimen Collection
Contains 2.16.840.1.113883.2.51.10.42 XeH Specimen Collection (DYNAMIC) 		(XeHdotsion)
hl7:entryRelationship
 		0 … * R Previous observations obtained for the same patient, test, same method, same unit (1) (XeHdotsion)
where [@typeCode='REFR']
@typeCode
 		cs 1 … 1 F REFR
hl7:observation
 		1 … 1 R (XeHdotsion)
@classCode
 		cs 1 … 1 F OBS
@moodCode
 		cs 1 … 1 F EVN
hl7:code
 		1 … 1 R (XeHdotsion)
hl7:statusCode
 		1 … 1 R (XeHdotsion)
@code
 		1 … 1 F completed
hl7:effectiveTime
 		1 … 1 R (XeHdotsion)
hl7:value
 		1 … 1 R (XeHdotsion)
hl7:referenceRange
 		0 … 1 R Reference range for the current test result (XeHdotsion)
@typeCode
 		cs 0 … 1 F REFV
hl7:observationRange
 		1 … 1 M (XeHdotsion)
@classCode
 		cs 0 … 1 F OBS
@moodCode
 		cs 0 … 1 F EVN.CRT
hl7:value
 		0 … 1 nl-NL interval (IVL) representation (XeHdotsion)
hl7:interpretationCode
 		CE 1 … 1 R (XeHdotsion)
@code
 		CONF 0 … 1 F N
@codeSystem
 		0 … 1 F 2.16.840.1.113883.5.83 (Observation Interpretation)
lab:precondition
 		0 … * Extension to CDA Clinical statement (XeHdotsion)
@typeCode
 		cs 1 … 1 F PRCN
lab:criterion
 		1 … 1 R (XeHdotsion)
@classCode
 		cs 1 … 1 F COND
@moodCode
 		cs 1 … 1 F EVN
lab:code
 		CE 1 … 1 R Code of the criterion (e.g. age, sex) (XeHdotsion)
lab:value
 		1 … 1 R nl-NL Value of the criterion (XeHdotsion)