Back to: PCC_TF-1/PHLAB

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 - ?profile incorporating lab data)
Provide context to section of CDA (example intended recipient)

Annotation Comment (PCC)

We would like XDS-Lab to adopt the [PCC-TF Annotation Comment content module] for report and test level comments and to provide documentation samples demonstrating Level 3 references to Level 2 content. XDS-Lab can use this content module as is today. However, in my work to support laboratory reports with at least 3 tiers of comments (result, test, report) I found a potential use of this module that deviates from it's original stated use and helps us differentiate result level vs test level comments. I am seeking feedback.

An observation supports a <text> block for result free-text (or comment). This <text> block is 0:1.

Report, Test, Result Comments

XDS-Lab Current Specification:

result - Level 2 footNote, Level 3 (?)
test - Level 2 paragraph, Level 3 similar to PCC-TF Annotation comment with proposal to extend schema on the observation

Proposed Specification:

result - Level 2 , Level 3 <text>

test - Level 2 <tfoot>, Level 3 <entryRelationship><act><templateId> with optional reference as referenced within table, no schema extension needed

Reason for template: consistency with existing 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>
              ...
              <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

XDS-Lab Current Specification: 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

XDS-Lab Current Specification: see below

Proposed Specification: no change

Reason for template: content, re-usability

<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>

Laboratory Observation

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">
              ...
              <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: 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">
              ...
              <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: 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">
              ...
              <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="6463-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
                                                     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="P0-007BF" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                        displayName="Notification of Disease">
                    <qualifier>
                      <name code="G-C186" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Source of Specimen"/>
                      <value code="S-16000" 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="6463-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
                    <translation code="L-17100" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED"/>
                  </value>

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"/>

PCC TF-1/PHLAB/XDSLAB Harmonization

Contents

Intro

Annotation Comment (PCC)

Report, Test, Result Comments

Intended Recipient

Laboratory Observation

Laboratory Organizer

Laboratory Organizer - Isolate Organizer

Notifiable Condition

Referral Ordering Physician

Specimen

Specimen Collection DateTime

Specimen Receive DateTime

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PCC TF-1/PHLAB/XDSLAB Harmonization

Intro

Annotation Comment (PCC)

Report, Test, Result Comments

Intended Recipient

Laboratory Observation

Laboratory Organizer

Laboratory Organizer - Isolate Organizer

Notifiable Condition

Referral Ordering Physician

Specimen

Specimen Collection DateTime

Specimen Receive DateTime

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