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 that as they incorporate relevant laboratory data into their content profiles.

Benefits:

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


Annotation Comment (PCC)

Laboratory reports come with at least 3 tiers of comments (result, test, report). We would like XDS-Lab to adopt an adaptation (CP potential!) of [PCC-TF Annotation Comment content module] for test and report comments and to provide samples demonstrating Level 3 references to Level 2 content.


Result and Test level comments

XDS-Lab

  • result - footNote
  • test - similiar to PCC-TF Annotation comment with proposal to extend schema on the observation

We recommend placing test level comments them within the observation/

block using <tfoot> blocks. For consistency, we recommend re-use of the existing PCC-TF Annotation Comment content module within Level 3 Entry linked to the Report_Entry <entry><act> and <><> as shown in this example. This example provides a reason for adaptation to the current content module. 
<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>
                <tr>
                  <td>Repeat confirmed negative</td>
                </tr>
              </tfoot>
              <tbody>
                <tr>
                  <td>Rabies virus not found.</td>
                  <td>ferret</td>
                  <td>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>
                  <text>Reagent lot 34</text>
                  <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>Repeat confirmed negative</text>
                    </act>
                  </entryRelationship>
                </observation>
              </entryRelationship>


Report level comment

XDS-Lab report level comments are placed within the <text> block using <paragraph> blocks. For consistency, we recommend re-use of the existing PCC Annotation Comment content module within Level 3 Entry linked to the Report_Entry <entry><act> as shown in this example. 


<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <text>
            ...
            <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">
               <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">
                   <originalText><reference value="sComment"/></originalText>
                 </code>
                 <text>Report level comment goes here.</text>
                 <statusCode code='completed' />
               </act>
             </entryRelationship>

Intended Recipient

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 care provider (PCP)
    • patient's specialist
  • Per requirement
    • infection control
    • notifiable to public health program


Laboratory Observation

  • sondra to fill in here


Laboratory Organizer

  • sondra to fill in here


Laboratory Organizer - Isolate Organizer

  • sondra to fill in here

Notifiable Condition

  • sondra to fill in here

Referral Ordering Physician

XDS-Lab Current Specification: see below

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: see below

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="SPC_COL_TBD" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" 
                        displayName="Specimen Collected"/>
                  <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="2.16.840.1.113883.6.1" codeSystemName="LOINC" 
                        displayName="Specimen Received"/>
                  <effectiveTime value="20071108000000.0000-0500"/>















































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