1.3.6.1.4.1.19376.1.3.3

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Development Only

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 Report Summary Specification 1.3.6.1.4.1.19376.1.3.3

This Content Integration Profile describes a clinical laboratory report as an electronic document to be published towards a document sharing resource such as an Electronic Health Record (EHR) or in Personal Health Record (PHR) shared by a community of care providers, using one of the document sharing profiles defined in ITI-TF.

Such an electronic document contains the set of releasable results produced by a clinical laboratory in fulfillment of one or more test Orders for a patient. The report is shared in a human-readable format. In addition, this electronic laboratory report SHALL contain test results in a machine-readable format, to facilitate the integration of these observations in the database of a consumersystem.

The scope covers all laboratory specialties except anatomic pathology. The human rendering of the laboratory report defined in this Integration Profile is compatible with laboratory regulations in numerous countries, including CLIA in the USA, GBEA in France.

The laboratory report described in this profile, with its set of test results in a machine-readable format, may also be used to share historical results with appropriate content anonymization and patient identification pseudonimization to create shared distributed repositories of laboratory information (Section 9, LTF vol 1).

This document describes the clinical laboratory report summary. Most of the constraints on this CDA are derived from national regulations and conventions, and therefore are defined in the context of a Realm (e.g. a country). Being international, this IHE does not supersede constraints that have been (or will be) defined by realm implementation guides.


Format Code

The XDSDocumentEntry format code for this content is urn:ihe:lab:xds-lab:2008

Parent Template

This document is an instance of the Medical Summary template.

Standards
CDAR2 HL7 CDA Release 2.0
CRS HL7 Care Record Summary
Data Element Index
Data Elements CDA Release 2.0
Human Patient recordTarget
Non-Human Subject recordTarget, entry/act/subject
Human Patient with Non-Human Subject recordTarget, entry/act/subject
Intended Recipient informationRecipient/intendedRecipient
Laboratory Result Verifier authenticator, entry/act/.../participant
Referral Ordering Physician participant
Laboratory Performer documentationOf/serviceEvent/performer, entry/act/.../performer
Laboratory Specialty Section component/structuredBody/component/section
Specification
Data Element Name Opt Template ID
Human Patient R2 1.3.6.1.4.1.19376.1.3.3.1.1
Non-Human Subject R2 1.3.6.1.4.1.19376.1.3.3.1.2
Human Patient with Non-Human Subject R2 1.3.6.1.4.1.19376.1.3.3.1.3
Intended Recipient O 1.3.6.1.4.1.19376.1.3.3.1.4
Laboratory Result Verifier O 1.3.6.1.4.1.19376.1.3.3.1.7
Referral Ordering Physician O 1.3.6.1.4.1.19376.1.3.3.1.5
Laboratory Performer O 1.3.6.1.4.1.19376.1.3.3.1.6
Laboratory Specialty Section R 1.3.6.1.4.1.19376.1.3.3.2.1


Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Summary content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample Laboratory Report Summary Document 
<ClinicalDocument xmlns='urn:hl7-org:v3'>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/>
  <templateId root='1.3.6.1.4.1.19376.1.3.3'/>
  <id root=' ' extension=' '/>
  <code code=' ' displayName=' '
    codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
  <title>Laboratory Report Summary</title>
  <effectiveTime value='20240416012005'/>
  <confidentialityCode code='N' displayName='Normal' 
    codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' />
  <languageCode code='en-US'/>     
     :
  <component><structuredBody>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.3.3.2.1'/>
        <!-- Required Laboratory Specialty Section Section content -->
      </section>
    </component>

       
  </structuredBody></component>
</ClinicalDocument>
Schematron
<pattern name='Template_1.3.6.1.4.1.19376.1.3.3'>
 <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.3.3"]'>
   <!-- Verify that the template id is used on the appropriate type of object -->
   <assert test='../cda:ClinicalDocument'>
     Error: The Laboratory Report Summary can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
     Error: The parent template identifier for Laboratory Report Summary is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Laboratory Report Summary must be {{{LOINC}}}
   </assert>
   <assert test='cda:code[@codeSystem = "2.16.840.1.113883.6.1"]'>
     Error: The document type code must come from the LOINC code 
     system (2.16.840.1.113883.6.1).
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.1"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Laboratory Report Summary Document should contain a(n) Human Patient HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.2"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Laboratory Report Summary Document should contain a(n) Non-Human Subject HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.3"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Laboratory Report Summary Document should contain a(n) Human Patient with Non-Human Subject HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.4"]'> 
     <!-- Note any missing optional elements -->
     Note: This Laboratory Report Summary Document does not contain a(n) Intended Recipient HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.7"]'> 
     <!-- Note any missing optional elements -->
     Note: This Laboratory Report Summary Document does not contain a(n) Laboratory Result Verifier HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.5"]'> 
     <!-- Note any missing optional elements -->
     Note: This Laboratory Report Summary Document does not contain a(n) Referral Ordering Physician HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.1.6"]'> 
     <!-- Note any missing optional elements -->
     Note: This Laboratory Report Summary Document does not contain a(n) Laboratory Performer HL7V3.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.3.3.2.1"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Laboratory Report Summary Document must contain a(n) Laboratory Specialty Section Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.3.3
   </assert> 
 </rule>
</pattern>

Laboratory Summary ClinicalDocument Header rendering

The header identifies the patient, the clinical laboratory that produced the report, the physician that ordered the tests performed, the encounter in which this act was performed and other participants to this summary act. This information, when present, shall be rendered to the human reader of the electronic document, together with the content of the body. This laboratory summary is based on the HL7 CDA R2 Standard and is subject to all conformance statements and requirements in that specification. Additionally, in compliance with it's parent template Medical Summary as well as the HL7 CRS Standard, all persons (including the patient) and all organizations mentioned in the document shall be represented with elements <font="courier new">name, <font="courier new">addr and <font="courier new">telecom.

Laboratory Summary ClinicalDocument Header constraints

<realmCode/>

ClinicalDocument/realmCode shall be present. The profile, used as is without further extension, is international in context. Thus the realmCode shall be "UV" (universal). Whenever national extension has been defined and used, the realmCode shall identify this national extension. Example for United States: 

<realmCode code="US">

Example for France: 

<realmCode code="FR">
<typeId/>

ClinicalDocument/typeId shall be present and shall be as stated in the HL7 CDA R2 Standard. Example: 

<typeId root="2.16.840.1.113883.1.3" extension="POCD_H000040"/>
<templateId root="1.3.6.1.4.1.19376.1.3.3"/>

ClinicalDocument/templateId shall be present and shall have root value of "1.3.1.4.1.19376.1.3.3" to signify that this ClinicalDocument conforms to the XDS-Lab content profile specification. The extension attribute shall also be set to "Lab.Report.Clinical.Document". 

<templateId extension="Lab.Report.Clinical.Document" root="1.3.6.1.4.1.19376.1.3.3"/>
<id>

ClinicalDocument/id shall be present in accordance with the HL7 CDA R2 standard.

ClinicalDocument/code shall be present and shall be used to signify the discipline of the laboratory report, whether it be single discipline or multi-disciplinary. In the event of a multi-disciplinary lab report the LOINC code shall be:

  • code= 11502-2
  • displayName = "LABORATORY REPORT.TOTAL"
  • codeSystem="2.16.840.1.113883.6.96"
  • codeSystemName="LOINC"

Example: 

<code code="18725-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Microbiology Studies"/>

XXXXX NOTE (SEK): did not use snomed code here - as not available universally and not permitted by cda standard

<title/>

ClinicalDocument/title may be present. It's use is encouraged for display purposes.

<effectiveTime/>

ClinicalDocument/effectiveTime shall be present and shall contain the date and time at which this laboratory report was created as an electronic document.

<confidentialityCode/>

ClinicalDocument/confidentialityCode shall be present shall be present in accordance with the HL7 CDA R2 standard.

<languageCode/>

ClinicalDocument/languageCode shall be present in accordance with the HL7 CDA R2 standard.

<setId/>

ClinicalDocument/setId shall be present to enable further updates to this ClinicalDocument. This identifier is to remain the same across all revisions of a laboratory report.

<versionNumber/>

ClinicalDocument/versionNumber may be present in accordance with the HL7 CDA R2 standard.

<recordTarget/>

ClinicalDocument/recordTarget shall be present and shall conform to either the Human Patient, Non-Human Subject or Human Patient with Non-Human Subject templates defined above. Example: 

  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <templateId root="TBD"/>
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr use="HP"><streetAddressLine>1313 Mockingbird Lane</streetAddressLine><city>Janesville</city><state>WI</state><postalCode>53545</postalCode><country>USA</country>PO BOX 53545</addr>
      <telecom value="tel: 608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F" codeSystem="2.16.840.113883.5.1" codeSystemName="HL7" displayName="FEMALE"/>
        <birthTime value="19401213000000.0000-0500"/>
        <religiousAffiliationCode code="C19207" codeSystem="2.16.840.1.113883" codeSystemName="HL7" displayName="INDEPENDENT"/>
        <ethnicGroupCode code="C15879" codeSystem="2.16.840.1.113883" codeSystemName="HL7" displayName="Not Hispanic or Latino"/>
        <birthplace>
          <place>
            <addr><country>USA</country></addr>
          </place>
        </birthplace>
      </patient>
    </patientRole>
  </recordTarget>
<author/>

At least one ClinicalDocument/author shall be present in accordance with the HL7 CDA R2 standard and further constrained by the HL7 CRS standard to require the presenes of <font="courier new">name, <font="courier new">addr and <font="courier new">telecom for all entities in the document. Example: 

  <author>
    <time value="20080124171911.0425-0500"/>
    <assignedAuthor>
      <id extension="AD2007" root="1.19.6.11.13"/>
      <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      <telecom value="tel: 408-555-5555"/>
      <assignedPerson>
        <name><family>Person</family><given>Author</given></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="AD2007" root="1.19.6.11.13"/>
        <name>Author Organization</name>
        <telecom value="tel: 408-555-5555"/>
        <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedAuthor>
  </author>
<custodian/>

ClinicalDocument/custodian shall be present in accordance with the HL7 CDA R2 standard and further constrained by the HL7 CRS standard to require the presenes of <font="courier new">name, <font="courier new">addr and <font="courier new">telecom for all entities in the document. Example: 

  <custodian typeCode="CST">
    <assignedCustodian classCode="ASSIGNED">
      <representedCustodianOrganization>
        <id nullFlavor="UNK"/>
        <name>Universal Custodian Services</name>
        <telecom value="tel: 789-555-2121"/>
        <addr><streetAddressLine>1600 Pennsylvania Ave</streetAddressLine><city>Washington DC</city><postalCode>98765</postalCode><country>USA</country></addr>
      </representedCustodianOrganization>
    </assignedCustodian>
  </custodian>
<informationRecipient/>

ClinicalDocument/informationRecipient may be present and shall conform to the template defined above. Example: 

  <informationRecipient>
    <intendedRecipient>
      <templateId root="TBD"/>
      <id extension="0000" root="1.19.6.11.13"/>
      <addr><streetAddressLine>1600 Clifton Road</streetAddressLine><city>Atlanta</city><state>GA</state><postalCode>30333</postalCode><country>USA</country></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><country>USA</country></addr>
      </receivedOrganization>
    </intendedRecipient>
  </informationRecipient>
<authenticator/>

ClinicalDocument/authenticator(s) may be present. If an authenticator represents the Laboratory Result Verifier it shall conform to the template defined above. Example of a Laboratory Result Verifier (documented in the CDA header): 

  <authenticator>
    <templateId root="TBD"/>
    <time value="20080124171911.0425-0500"/>
    <signatureCode code="S"/>
    <assignedEntity>
      <id extension="274" root="1.19.6.11.13"/>
      <addr><streetAddressLine>7000 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      <telecom value="tel: 312-555-5555"/>
      <assignedPerson>
        <name><suffix>MT ASCP</suffix><family>Technologist</family><given>274</given></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Laboratory</name>
        <telecom value="tel: 312-555-5555"/>
        <addr><streetAddressLine>1234 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedEntity>
  </authenticator>
<participant/>

ClinicalDocument/participant(s) may be present. If a participant represents the Referral Ordering Physician it shall conform to the template defined above. Example of a Referral Ordering Physician: 

  <participant typeCode="REF">
    <templateId root="TBD"/>
    <time>
      <low value="20080104055700.0000-0500"/>
      <high value="20080104131600.0000-0500"/>
    </time>
    <associatedEntity classCode="PROV">
      <id extension="90573" root="1.19.6.11.13"/>
      <addr><streetAddressLine>3113 Hospital Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      <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><streetAddressLine>7000 Hosptial Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      </scopingOrganization>
    </associatedEntity>
  </participant>
<documentationOf/>

ClinicalDocument/documentationOf(s) may be present. Use of documentationOf/serviceEvent/effectiveTime to document the time boundaries of events in the document is encouraged. Example: 

  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="20080104000000.0000-0500"/>
        <high value="20080108000000.0000-0500"/>
      </effectiveTime>
    </serviceEvent>
  </documentationOf>

ClinicalDocument/documentationOf/serviceEvent/performer(s) may be present. If a performer represents the Laboratory Performer it shall conform to the template defined above.

<relatedDocument/parentDocument/>

ClinicalDocument/relatedDocument/parentDocument shall be present in the case that this laboratory report is an update of a previous report. In this case, the relatedDocument@typeCode attribute shall be restricted to only the "RPLC" (replace) value, indicating that the new report is replacing the parent one.

Laboratory Summary ClinicalDocument Header Content Modules

The table above lists the additional requirements (conformance statements) for this laboratory report which are in the form of header content modules.

Laboratory Summary ClinicalDocument Complete Header Example

<ClinicalDocument xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3" xsi:schemaLocation="urn:hl7-org:v3 CDA.xsd">
  <realmCode code="US" codeSystem="2.16.1" codeSystemName="ISO3166-1" displayName="US"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId extension="Lab.Report.Clinical.Document" root="1.3.6.1.4.1.19376.1.3.3"/>
  <id root="1.19.6.11.13.106000025002095139.1201213151385.1"/>
  <code code="18725-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Microbiology Studies"/>
  <title>Laboratory Report</title>
  <effectiveTime value="20080124171911.0425-0500"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US" codeSystem="2.16.840.1.113883.6.99" codeSystemName="ISO639-1" displayName="en-US"/>
  <setId extension="2.16.840.1.113883.3.17.108000213000240133.1211315849651.6" root="2.16.840.1.113883.1.3"/>
  <versionNumber value="1"/>
  <recordTarget typeCode="RCT">
    <templateId root="TBD"/>
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr use="HP"><streetAddressLine>1313 Mockingbird Lane</streetAddressLine><city>Janesville</city><state>WI</state><postalCode>53545</postalCode><country>USA</country>PO BOX 53545</addr>
      <telecom value="tel: 608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F" codeSystem="2.16.840.113883.5.1" codeSystemName="HL7" displayName="FEMALE"/>
        <birthTime value="19401213000000.0000-0500"/>
        <religiousAffiliationCode code="C19207" codeSystem="2.16.840.1.113883" codeSystemName="HL7" displayName="INDEPENDENT"/>
        <ethnicGroupCode code="C15879" codeSystem="2.16.840.1.113883" codeSystemName="HL7" displayName="Not Hispanic or Latino"/>
        <birthplace>
          <place>
            <addr><country>USA</country></addr>
          </place>
        </birthplace>
      </patient>
    </patientRole>
  </recordTarget>
  <author>
    <time value="20080124171911.0425-0500"/>
    <assignedAuthor>
      <id extension="AD2007" root="1.19.6.11.13"/>
      <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      <telecom value="tel: 408-555-5555"/>
      <assignedPerson>
        <name><family>Person</family><given>Author</given></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="AD2007" root="1.19.6.11.13"/>
        <name>Author Organization</name>
        <telecom value="tel: 408-555-5555"/>
        <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedAuthor>
  </author>
  <author>
    <time value="20080124171911.0425-0500"/>
    <assignedAuthor>
      <id extension="AD2007" root="1.19.6.11.13"/>
      <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      <telecom value="tel: 408-555-5555"/>
      <assignedAuthoringDevice>
        <softwareName>IBM</softwareName>
      </assignedAuthoringDevice>
      <representedOrganization>
        <id extension="AD2007" root="1.19.6.11.13"/>
        <name>IBM DEVICE</name>
        <telecom value="tel: 408-555-5555"/>
        <addr><streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city><state>CA</state><postalCode>95120</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedAuthor>
  </author>
  <custodian typeCode="CST">
    <assignedCustodian classCode="ASSIGNED">
      <representedCustodianOrganization>
        <id nullFlavor="UNK"/>
        <name>Universal Custodian Services</name>
        <telecom value="tel: 789-555-2121"/>
        <addr><streetAddressLine>1600 Pennsylvania Ave</streetAddressLine><city>Washington DC</city><postalCode>98765</postalCode><country>USA</country></addr>
      </representedCustodianOrganization>
    </assignedCustodian>
  </custodian>
  <informationRecipient>
    <intendedRecipient>
      <templateId root="TBD"/>
      <id extension="0000" root="1.19.6.11.13"/>
      <addr><streetAddressLine>1600 Clifton Road</streetAddressLine><city>Atlanta</city><state>GA</state><postalCode>30333</postalCode><country>USA</country></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><country>USA</country></addr>
      </receivedOrganization>
    </intendedRecipient>
  </informationRecipient>
  <legalAuthenticator>
    <time value="20080124171911.0425-0500"/>
    <signatureCode code="S"/>
    <assignedEntity>
      <id extension="B092987200201" root="1.19.6.11.13"/>
      <addr><streetAddressLine>7000 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      <telecom value="tel: 312-555-5555"/>
      <assignedPerson>
        <name><family>Johnson</family><given>Linda</given><prefix>Dr</prefix></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Laboratory</name>
        <telecom value="tel: 312-555-5555"/>
        <addr><streetAddressLine>1234 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedEntity>
  </legalAuthenticator>
  <authenticator>
    <templateId root="TBD"/>
    <time value="20080124171911.0425-0500"/>
    <signatureCode code="S"/>
    <assignedEntity>
      <id extension="274" root="1.19.6.11.13"/>
      <addr><streetAddressLine>7000 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      <telecom value="tel: 312-555-5555"/>
      <assignedPerson>
        <name><suffix>MT ASCP</suffix><family>Technologist</family><given>274</given></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Laboratory</name>
        <telecom value="tel: 312-555-5555"/>
        <addr><streetAddressLine>1234 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      </representedOrganization>
    </assignedEntity>
  </authenticator>
  <participant typeCode="REF">
    <templateId root="TBD"/>
    <time>
      <low value="20080104055700.0000-0500"/>
      <high value="20080104131600.0000-0500"/>
    </time>
    <associatedEntity classCode="PROV">
      <id extension="90573" root="1.19.6.11.13"/>
      <addr><streetAddressLine>3113 Hospital Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      <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><streetAddressLine>7000 Hosptial Drive</streetAddressLine><city>Chicago</city><state>IL</state><postalCode>60622</postalCode><country>USA</country></addr>
      </scopingOrganization>
    </associatedEntity>
  </participant>
  <inFulfillmentOf>
    <order>
      <id extension="28902809" root="1.19.6.11.13"/>
    </order>
  </inFulfillmentOf>
  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="20080104000000.0000-0500"/>
        <high value="20080108000000.0000-0500"/>
      </effectiveTime>
    </serviceEvent>
  </documentationOf>
  <authorization>
    <consent classCode="CONS" moodCode="EVN">
      <statusCode code="completed"/>
    </consent>
  </authorization>
  <componentOf>
    <encompassingEncounter>
      <id extension="ENC1234" root="1.19.6.11.13"/>
      <effectiveTime value="20080104000000.0000-0500"/>
      <location>
        <healthCareFacility>
          <code code="HU" codeSystem="2.16.840.1.113883.5.10588" codeSystemName="HL7 Service Delivery Location" displayName="Hospital Unit"/>
        </healthCareFacility>
      </location>
    </encompassingEncounter>
  </componentOf>
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">

             ... clinical data here ...
    </structuredBody>
  </component>
</ClinicalDocument>

Laboratory Summary ClinicalDocument Body

The laboratory summary shall have a structured body. See section content modules for more information.

Laboratory Summary ClinicalDocument Section and Entry Content Modules

The table above links to the section, and subsequently the entry level content module requirements necessary to represent the clinical findings of this laboratory report.

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