PCC TF-1/PHLAB/XDSLAB Harmonization

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Intro

The use of content modules in XDS-Lab helps lab remain consistent with what other domains have accomplished as well as insures that the lab domain provides guidance to the other domains as they incorporate relevant laboratory data into their own content profiles.

Benefits:

  • Consistency with work done in other domains (example annotation comment)
  • Provide guidance to other domains incorporating laboratory data (example PCC)
  • Provide context to section of CDA (example intended recipient)

CDA Document Content Modules

  • XDS-Lab (1.3.6.1.4.1.19376.1.3.3)

CDA Header Content Modules

  • Intended Recipient
  • Referral Ordering Physician


Intended Recipient

XDS-Lab Current Specification: <informationRecipient> block

Proposed Specification: no change

Reason for template: content, re-usability

The intended recipients of a laboratory document are intended for a reason which is not currently conveyed in the standard mark up.

  • Per request of ordering physician
    • unknown relationship to patient
    • patient's primary provider
    • patient's specialist
  • Per laboratory requirement
    • infection control
    • notifiable to public health program


<ClinicalDocument
  ...
  <informationRecipient>
    <templateId root='TBD'/>
    <intendedRecipient>
      <id extension="0000" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>1600 Clifton Road</streetAddressLine>
        <city>Atlanta</city>
        <state>GA</state>
        <postalCode>30333</postalCode>
      </addr>
      <telecom value="tel: 404-639-3535"/>
      <informationRecipient>
        <name><family>Angulo</family><given>Fred</given></name>
      </informationRecipient>
      <receivedOrganization>
        <id extension="0000" root="1.19.6.11.13"/>
        <name>FoodNet</name>
        <telecom value="tel: 404-639-3535"/>
        <addr>
          <streetAddressLine>1600 Clifton Road</streetAddressLine>
          <city>Atlanta</city>
          <state>GA</state>
          <postalCode>30333</postalCode>

Referral Ordering Physician

XDS-Lab Current Specification: <participant>

Proposed Specification: no change

Reason for template: context, re-usability 

<ClinicalDocument
  ...
  <participant typeCode="REF">
    <templateId root='TBD'/>
    <time>
      <low value="20071104055700.0000-0500"/>
      <high value="20071104131600.0000-0500"/>
    </time>
    <associatedEntity classCode="PROV">
      <id extension="90573" root="1.19.6.11.13"/>
      <addr nullFlavor="UNK"/>
      <telecom nullFlavor="UNK"/>
      <associatedPerson>
        <name><family>Patel</family><given>Kiran</given><prefix>Dr.</prefix></name>
      </associatedPerson>
      <scopingOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Hospital</name>
        <telecom nullFlavor="UNK"/>
        <addr nullFlavor="UNK"/>

CDA Section Content Modules

CDA and HL7 Version 3 Entry Content Modules

  • Annotation Comment (PCC)

Annotation Comment (PCC)

We would like XDS-Lab to adopt the Annotation Comment content module for comments.


Reason for template: consistency with existing content module

Change Proposals: PCC Change Proposal Wiki List 


<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <text>
            <table>
              <thead ID="rabiesTest">
                <tr>
                  <th>Rabies Virus</th>
                  <th>Subject</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tfoot ID="rabiesTestComment">
                <tr>
                  <td>Repeat confirmed negative</td>
                </tr>
              </tfoot>
              <tbody>
                <tr>
                  <td>Rabies virus not found.</td>
                  <td>ferret</td>
                  <td ID="rabiestTestR1Comment">Reagent lot 34</td>
                </tr>
              </tbody>
            </table>
            <paragraph ID="sComment">Report level comment goes here.</paragraph>
          </text>
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <observation classCode="OBS" moodCode="EVN">
                  <code code="C58990" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Rabies Test">
                    <originalText><reference value="rabiesTest"/></originalText>
                  </code>
                  <statusCode code="completed"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
                  <value xsi:type="CE" code="59881000" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" 
                                       displayName="Rabies Virus"/>
                  <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="rabiestTestR1Comment"/></text>
                      <statusCode code='completed'/>
                    </act>
                  </entryRelationship>
                  <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="rabiestTestTComment"/></text>
                      <statusCode code='completed'/>
                    </act>
                  </entryRelationship>
                </observation>
              </entryRelationship>
              ...
              <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="sComment"/></text>
                  <statusCode code='completed'/>
                </act>
              </entryRelationship>

Laboratory Observation

XDS-Lab Current Specification: <observation> block

Proposed Specification: no change

Reason for template: re-usability

Note that Simple Observation cannot be used as is, XDS-LAB does not require an id. 

<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <observation classCode="OBS" moodCode="EVN">
                  <code code="23749-5" 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="7.4"/>
                  <interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>

Laboratory Organizer

XDS-Lab Current Specification: <organizer> block

Proposed Specification: no change

Reason for template: re-usability 

<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <organizer classCode="CLUSTER" moodCode="EVN">
                  ...
                  <component>
                    <organizer classCode="BATTERY" moodCode="EVN">
                      <templateId root="TBD"/>
                      <code code="29576-6" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" 
                            displayName="Microbiology Susceptibility">
                        <originalText><reference value="susceptibilityTest"/></originalText>
                      </code>
                      <statusCode code="completed"/>
                      <effectiveTime value="20071108000000.0000-0500"/>


Laboratory Organizer - Isolate Organizer

XDS-Lab Current Specification: <organizer><specimen><specimenRole> block

Proposed Specification: no change

Reason for template: re-usability 

<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <organizer classCode="CLUSTER" moodCode="EVN">
                  <templateId root="TBD"/>
                  <statusCode code="completed"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
                  <specimen>
                    <specimenRole classCode="ISLT">
                      <specimenPlayingEntity>
                        <code code="79153007" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                              displayName="Salmonella tennessee 6,7,14;z29;1,2,7">
                          <translation xsi:type="CE" code="L-17601" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" 
                                                     displayName="Salmonella tennessee 6,7,14;z29;1,2,7"/>

Notifiable Condition

XDS-Lab Current Specification: outstanding issue, not addressed today 



Proposed Specification: see below

Reason for template: re-usability



<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <observation classCode="OBS" moodCode="EVN">
                  <templateId extension="Lab.Report.Data.Notifiable.Entry" root="TBD"/>
                  <code code="170516003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                        displayName="Notification of Disease">
                    <qualifier>
                      <name code="246087005" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                            displayName="Source of Specimen"/>
                      <value code="116154003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                             displayName="Patient"/>
                    </qualifier>
                  </code>
                  <value xsi:type="CE" code="27268008" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                                       displayName="Salmonella">
                    <translation code="L-17100" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED"/>
                  </value>



Referral Ordering Physician


XDS-Lab Current Specification: <participant>

Proposed Specification: no change

Reason for template: context, re-usability



<ClinicalDocument
  ...
  <participant typeCode="REF">
    <templateId root='TBD'/>
    <time>
      <low value="20071104055700.0000-0500"/>
      <high value="20071104131600.0000-0500"/>
    </time>
    <associatedEntity classCode="PROV">
      <id extension="90573" root="1.19.6.11.13"/>
      <addr nullFlavor="UNK"/>
      <telecom nullFlavor="UNK"/>
      <associatedPerson>
        <name><family>Patel</family><given>Kiran</given><prefix>Dr.</prefix></name>
      </associatedPerson>
      <scopingOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Hospital</name>
        <telecom nullFlavor="UNK"/>
        <addr nullFlavor="UNK"/>








Specimen


XDS-Lab Current Specification: <specimen> block

Proposed Specification: no change

Reason for template: re-usability



<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <specimen typeCode="SPC">
                <templateId root='TBD'/>
                <specimenRole classCode="SPEC">
                  <id extension="555847" root="1.19.6.11.13"/>








Specimen Collection DateTime


XDS-Lab Current Specification:  CDA schema extension, lab:productOf



<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <specimen typeCode="SPC">
                <specimenRole classCode="SPEC">
                  <id extension="555847" root="1.19.6.11.13"/>
                  <specimenPlayingEntity classCode="MIC">
                    <code code="STL" codeSystem="2.16.840.1.113883.5.129" codeSystemName="HL7" displayName="Stool"/>
                  </specimenPlayingEntity>
                  <lab:productOf typeCode="PRD">
                    <lab:procedure classCode="PROC" moodCode="EVN">
                      <effectiveTime value="20071104000000.0000-0400"/>
                      <participant typeCode="PRF">
                        <participantRole>
                          <addr>
                            <streetAddressLine>7000 Hosptial Drive</streetAddressLine>
                            <city>Chicago</city>
                            <state>IL</state>
                            <postalCode>60622</postalCode>
                          </addr>
                          <telecom value="tel: 312-555-5555"/>



Proposed Specification: no CDA schema extension, alternative proposed by Keith Boone

Reason for template: re-usability



<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <act classCode="ACT" moodCode="EVN">
                  <templateId root='TBD'/>
                  <code code="33882-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" 
                        displayName="Collection Time"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
                  <participant typeCode="PRF">
                    <participantRole>
                      <addr>
                        <streetAddressLine>7000 Hosptial Drive</streetAddressLine>
                        <city>Chicago</city>
                        <state>IL</state>
                        <postalCode>60622</postalCode>
                      </addr>
                      <telecom value="tel: 312-555-5555"/>



Specimen Receive DateTime


XDS-Lab Current Specification: outstanding issue, not addressed today





Proposed Specification: alternative proposed by Keith Boone

Reason for template: re-usability



<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <act classCode="ACT" moodCode="EVN">
                  <templateId root='TBD'/>
                  <code code="SPC_REC_TBD" codeSystem="2.1.1.1.1.1.1" codeSystemName="TBD" 
                        displayName="Specimen Received"/>
                  <effectiveTime value="20071108000000.0000-0500"/>









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