1.3.6.1.4.1.19376.1.3.1.6

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The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Trial.gif Laboratory Observation 1.3.6.1.4.1.19376.1.3.1.6

The document SHALL contain at least one Laboratory Observation under the Specimen Act of each Laboratory Data Processing Entry. The Laboratory Observation SHALL record a single laboratory observation in the document, either standalone or as part of a battery. It is similar to the Simple Observation, so differences are highlighted below. The figure below shows how the information for this element is coded, and further constraints are provided in the following sections.



Uses

See Templates using Laboratory Observation

Specification
Laboratory Observation Example
<ClinicalDocument>
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          <templateId root="1.3.6.1.4.1.19376.1.3.3.2.1"/>
          ...
          <entry typeCode="DRIV">
            <templateId root="1.3.6.1.4.1.19376.1.3.1"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <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"/>
                      <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>
                    </observationRange>
                    <precondition typeCode="PRCN">
                      <criterion classCode="COND" moodCode="ENV">
                        <code code="AGE"/>
                        <value xsi:type="IVL_PQ">
                          <low value="0" unit="Y"/>
                          <high value="18" unit="Y"/>
                        </value>
                      </criterion>
                    </precondition>
                  </referenceRange>

                </observation>
              </entryRelationship>
              ...
            </act>
          </entry>
          ...
        </section>
      </component>
      ...
    </structuredBody>
  </component>
</ClinicalDocument>


<observation classCode="OBS" moodCode="EVN">

A Laboratory Observation shall be recorded as shown above, classCode "OBS" and moodCode "EVN".

NOTE: Simple Observation uses typeCode OBS, rather than classCode OBS.

<templateId root="1.3.6.1.4.1.19376.1.3.1.6"/>

The <templateId> element identifies this <observation> as a Laboratory Observation. The templateId SHALL be recorded as shown above, root='1.3.6.1.4.1.19376.1.3.1.6'.

<id root=" " extension=" "/>

A Laboratory Observation identifier MAY be present.

NOTE: Simple Observation requires the use of an identifier.

<code code=" " codeSystem=" " codeSystemName=" " displayName=" "/>

A Laboratory Observation SHALL contain a unique test code from an international standard, such as LOINC.

<statusCode code=" "/>

A Laboratory Observation statusCode SHALL be either "completed", "aborted", or "obsolete". A status of completed means the test was performed and results obtained. A status of aborted means the test could not be performed and has no value. A status of obsolete means the Laboratory Observation has been replaced by a newer Laboratory Observation (following it) in this revision of the report.

NOTE: Simple Observation requires the status of "completed".

<effectiveTime value=" "/>

A Laboratory Observation MAY contain a relevant clinical time (ideally specimen collection time).

NOTE: Simple Observation requires the presence of effectiveTime. If the value is unknown, nullFlavor shall be used.

<value xsi:type=" " …/>

A Laboratory Observation value using the appropriate data type MAY be present. Numeric results shall use data type "PQ" as shown above as it includes units. The result is absent in the case of "aborted" observations.

<interpretationCode code=" " codeSystem=" "/>=

A Laboratory Observation MAY contain an interpretation of the Laboratory Observation result (e.g., low, high). One or more ObservationInterpretation vocabulary MAY be recorded within the interpretationCode element.

<methodCode code=" " codeSystem=" " codeSystemName=" "/>

A Laboratory Observation MAY contain a methodCode using the Observation Method vocabulary (CWE). The method MAY be explicit when LOINC vocabulary is used for the Laboratory Observation code.

<specimen typeCode="SPC"><specimenRole classCode="SPEC">...</specimen>

A Laboratory Observation MAY contain specimen documentation when it is different from the one documented at a higher level.

<performer typeCode="PRF"/>

A Laboratory Observation MAY contain the person who performed the test when it is different from the one documented at a higher level, including the header.

<author typeCode="AUT"/>

A Laboratory Observation SHALL contain author(s) of the Laboratory Observation when multiple header author(s) exist and not all apply to this Laboratory Observation. The author/time element carries the date&time the laboratory report was produced by the system.

<participant typeCode=" "/>

A Laboratory Observation MAY contain up to 3 types of participants "AUTHEN", "RESP", and "DEV".

AUTHEN: The verifier of the observations of this part of the report. In the case where a laboratory report has multiple verifiers. Each verifier is attached to the subset of observations he or she verified, by the means of a <participant> element.

RESP: The person responsible for the provision of the observations of this part of the report. In the case where a subset of the observations 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.

DEV: A device or equipment, which was used to produce this set of results (e.g. an analyzer).

<entryRelationship typeCode="COMP">

A Laboratory Observation MAY contain test comments that shall be recorded using the Annotation Comment template within the Laboratory Observation as shown above.

<entryRelationship typeCode="REFR">

A Laboratory Observation MAY be complemented by any number of previous results as pertinent information related to it delivering the previous result from a separate specimen, and carrying the same test code. In case there is more than one previous result, the entryRelationship elements are sorted in reverse chronological order, numbered from 1 to n by sequenceNumber.

<referenceRange typeCode="REFV">

A Laboratory Observation MAY have a reference range representing a value, not text. The reference range MAY be qualified with pre-conditions, each of which has a criterion.