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__TOC__
#redirect [[PCC TF-1/PHLAB]]
 
=Introduction=
''This is a draft of the Cross Enterprise Sharing of Laboratory Documents for Public Health (XDS-PHLab) to the Patient Care Coordination Technical Framework.  This draft is a work in progress, not the official supplement or profile.''
 
=Volume 1=
==Public Health Laboratory Report Integration Profile==
The motivation for developing this profile is as follows:
* Show that the same standards that support the current IHE profiles for clinical care interoperability can be leveraged by public health.
 
* Encourage the public health community to come forward to IHE with use cases to further enhance data sharing.
 
Our goal with this profile is to adapt XDS-LAB integration content profile to accommodate data for a public health laboratory report. Modifications to XDS-LAB will be needed to accommodate non-human subjects, document participants in the laboratory testing process, and to group tests for a reportable condition in a consistent manner. Leveraging the CDA R2 standard and XDS-LAB make the resultant document consumable by public health and incorporable in an effected patient’s medical record thereby completing a communication loop between individual and public care.
 
===Dependencies===
<pre>Add the following row(s) to the list of dependencies</pre>
{|style='background-color:#7f7f7f;' align='center' border='1' cellspacing='0'
!Integration Profile
!Dependency
!Dependency Type
!Purpose
|- style='background-color:#ffffff;' align='center'
|PHLab
|XDS-Lab
|PHLab is a conformant XDS-Lab document
|XDS-Lab constrains CDA R2 for the purposes of communicating any Laboratory Report
|-
|}
 
{{Content Profile Actors and Transactions|PHLab}}
 
{{PCC Content Profile Options|PHLab|Creator=}}
 
{{XD* Binding|Publc Health Laboratory Report|PHLab|
Bindings={{Binding|Publc Health Laboratory Report}}
}}
 
===PHLab Document Content Module===
An Public Health Laboratory Report content document is a type of laboratory report, and incorporates the constraints defined for laboratory reports found in section the XDS-Lab specification.  In addition, the PHLab profile modifies XDS-LAB integration content profile to accommodate data for a public health laboratory report. By leveraging the CDA R2 standard and XDS-LAB, a PHLab document is consumable by public health and incorporable in an effected patient’s medical record thereby completing a communication loop between individual and public care.
 
===PHLab Process Flow===
''NOTE: we are working with HITSP/PHDSC to refine this use case''
 
====Use Case 1: Case Report for a Public Health Reportable Condition with Laboratory Component====
''' Reality Today:'''
 
John Doe, MD sees a patient and suspects that this patient has an enteric pathogen. The patient follows through on the doctor’s orders and submits a stool specimen to the clinic's laboratory. Upon completion of laboratory analysis, the laboratory confirms the presence of Salmonella and performs susceptibility testing. When a microbiologist has time in the week, they gather all the reportable results and complete the forms for submission to the public health agency. Additionally, the clinical laboratory needs to submit the Salmonella specimen to the public health laboratory for serotyping and outbreak surveillance. This specimen is mailed along with a hand written requisition to the public health laboratory for epidemiological serotyping.
 
The public health laboratory enters the partial information written on the requisition and identifies the Salmonella serotype. A nightly batch process reports the serotype to the submitting clinician. A monthly batch process generates a file for the Disease Control agency. Nearby surveillance regions have small clusters of cases with this same Salmonella serotype but without knowledge of the other cases, no outbreak investigation is initiated.
 
The Disease Control agency detects this anomaly as monthly reports are received when observed across surveillance regions and an outbreak protocol is started to investigate the potential outbreak. The Disease Control agency requests PFGE (pulse field gel electrophoresis) on the known samples and the outbreak is finally confirmed two months later. Calls, faxes, and emails are used to transmit information to relevant regional and local programs as well as the submitters of outbreak samples. Significant efforts on identification, investigation, and resolution focus on getting the desired data to the necessary participants. The outbreak is investigated and linked to a restaurant supplier in a popular but off-season resort area.
 
 
'''After this profile is adopted:'''
 
[[Image:PHLab_Use_Case_1_Graphic.JPG|800px|right|Use Case 1 Sample Workflow]]
 
'''Preconditions:''' The clinical laboratory creates a laboratory report identifying the organism as a Salmonella isolate and that further serotyping will be done at the Public Health Lab. The laboratory report is sent to the clinician, stored within the patient’s electronic medical record, and registered in a clinical interoperability registry. The isolate is mailed to the public health lab.
 
'''Events:''' Upon arrival, the public health laboratory receiving department queries the clinical interoperability registry with the submitter’s patient ID and views the initial laboratory report. The public health laboratory information system pulls forward the patient’s demographic and specimen data from the initial laboratory report. The public health laboratory creates a new laboratory report identifying the Salmonella serotype. This report is sent to the clinician, stored within the patient’s electronic medical record, registered in the clinical interoperability registry, registered in the regional public health interoperability registry, and registered in the national public health interoperability registry.
 
The Disease Control agency monitors the national public health registry for new cases of Salmonella. An anomaly is immediately detected in the number of new cases for this particular Salmonella serotype when observed across regional surveillance boundaries and an outbreak protocol is started immediately to investigate the potential cross-border outbreak. The CDC requests PFGE (pulse field gel electrophoresis) on the current samples and alerts all public health laboratories to perform PFGE on new samples of this serotype. The outbreak is confirmed quickly and new cases are identified and tracked seamlessly.
 
'''Post conditions: '''Local, regional, and national epidemiologists and case workers have access to all laboratory reports within their respective interoperability registries and may potentially gain further access to the clinical interoperability registry for additional information, such as the ordering provider and care location, for initiating further investigation.
 
'''Key improvements include:'''
* avoid handwritten forms and data re-entry
* ease transition of data to and from clinical care and public health agencies
* ease transition of data from one public health agency to another
* monitor registries for anomalies in a real-time basis
* response protocols focus on response, not the access to data
 
 
=====Public Health Case Report types covered by Use Case 1=====
* Laboratory reportables <br> Reportable conditions can be specified at local and national levels. Common laboratory criteria that is diagnostic of a reportable condition include (but are not limited to):
** Anthrax - Bacillus anthracis
** Botulism - Clostridium botulinum
** Brucellosis - Brucella species
** Campylobacter
** Chlamydia trachomatis
** Cholera - Vibrio cholerae
** Dengue Fever - Dengue virus
** Diphtheria - Corynebacterium diphtheriae
** Escherichia coli O157:H7
** Giardiasis - Giardia lamblia
** Gonorrhea - Neisseria gonorrhoeae
** Haemophilus ducreyi
** Hepatitis virus
** Herpes Simplex virus
** HIV virus
** Legionellosis - Legionella pneumophila
** Leprosy - Mycobacterium leprae
** Leptospirosis - Leptospira
** Listeriosis - Listeria monocytogenes
** Lyme Disease - Borrelia burgdorferi
** Malaria - Plasmodium species
** Measles virus
** Meningococcal Disease - Neisseria meningitidis
** Mumps virus
** Pertussis - Bordetella pertussis
** Plague - Yersinia pestis
** Psittacosis - Chlamydia psittaci
** Rabies virus
** Rickettsia - Rickettsia rickettsii
** Rubella virus
** Salmonella
** Shigella
** Schistosomiasis
** Syphilis - Treponema pallidum
** Tuberculosis - Mycobacterium tuberculosis
 
<br>
 
===Grouping with Other Actors===
====Cross Enterprise Document Sharing, Media Interchange and Reliable Messaging====
The Content Creator and Content Consumer Actors shall be grouped with appropriate actors from the XDS, XDM or XDR integration profiles to support sharing of PHLab documents.
 
====Document Digital Signature (DSG)====
Content Creator actors should digitally sign all documents using the Digital Signature (DSG) Content Profile.
 
Content Consumer actors should verify the Digital Signature of the submission set before use of the information it contains.
 
<noinclude>
{{:PCC TF-1/Trailer}}
 
=Volume II=
<!--{{:PCC TF-2/Header}}-->
 
== Bindings to XDS, XDR, XDM ==
This section describes how the payload used in a transaction of an IHE profile is related to and/or constrains the data elements sent or received in those transactions.  This section is where any specific dependencies between the content and transaction are defined.
 
A content integration profile can define multiple bindings.  Each binding should identify the transactions and content to which it applies.
 
The source for all required and optional attributes have been defined in in the bindings below.  Three tables describe the three main XDS object types: XDSDocumentEntry, XDSSubmissionSet, and XDSFolder. XDSSubmissionSet and XDSDocumentEntry are required. Use of XDSFolder is optional.
 
The columns of the following tables are:
 
* '''<nowiki><</nowiki>XXX<nowiki>></nowiki> attribute''' – name of an XDS attribute, followed by any discussion of the binding detail.
 
 
* '''Optional?''' - Indicates the required status of the XDS attribute, and is one of R, R2, or O (optional). This column is filled with the values specified in the XDS Profile as a convenience.
 
 
* '''Source Type''' – Will contain one of the following values:
 
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|align = "center"|'''Source Type'''
|align = "center"|'''Description'''
|-
|align = "center"|'''SA'''
|'''Source document Attribute''' – value is copied directly from source document. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible.
|-
|align = "center"|'''SAT'''
|'''Source document Attribute with Transformation''' – value is copied from source document and transformed. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible. Extended Discussion column must not be empty and the transform must be defined in the extended discussion
|-
|align = "center"|'''FM'''
|'''Fixed (constant) by Mapping''' - for all source documents. Source/Value column contains the value to be used in all documents.
|-
|align = "center"|'''FAD'''
|'''Fixed by Affinity Domain''' – value configured into Affinity Domain, all documents will use this value.
|-
|align = "center"|'''CAD'''
|'''Coded in Affinity Domain''' – a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
|-
|align = "center"|'''CADT'''
|'''Coded in Affinity Domain with Transform - '''a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
|-
|align = "center"|'''n/a'''
|'''Not Applicable''' – may be used with an optionality R2 or O attribute to indicate it is not to be used.
|-
|align = "center"|'''DS'''
|'''Document Source''' – value comes from the Document Source actor. Use Source/Value column or Extended Discussion to give details.
|-
|align = "center"|'''O'''
|'''Other''' – Extended Discussion must be <nowiki>'</nowiki>yes<nowiki>'</nowiki> and details given in an Extended Discussion.
|-
|}
 
 
* '''Source/Value''' – This column indicates the source or the value used.
 
The following tables are intended to be summaries of the mapping and transforms.  The accompanying sections labeled <nowiki>'</nowiki>Extended Discussion<nowiki>'</nowiki> are to contain the details as necessary.
 
=== XDSDocumentEntry Metadata ===
''' NOTE: This binding differs from that that is specified in [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings Bindings]. We are working to resolve any differences that are not particular to this profile.'''
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|+ XDSDocumentEntry
! Attribute !! Optional? !! Source Type !!Source/ Value
|-
| availabilityStatus || R || DS ||Value assigned at point of submission. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
| authorInstitution || R2 || SAT || This attribute is the corresponding institution to the authorPerson below. Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|authorPerson ||R2 ||SAT || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|authorRole ||R2 ||DS ||Add value, if known. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|authorSpeciality ||R2 ||DS ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|classCode ||R ||CADT ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|comments ||O ||DS ||Optional, add if pertanant. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|confidentialityCode ||R ||CADT || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding]..
|-
|creationTime ||R ||SAT. <font color="#ff0000">This value is slightly different from the PCC-TF-2 binding.</font> ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|entryUUID ||R ||DS ||Assigned at time of submission by Document Source, Repository or Registry. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding.</font>
|-
|eventCodeList ||R2 ||DS||ClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / specimen / specimenRole / specimenPlayingEntity / code / @code.
This binding is particular to a PHLab document. If the document pertains to a reportable condition, then this code shall be among those listed in the eventCodeList. This has been enhanced from the XDS profile from O to R2.
|-
|formatCode ||R ||FM ||Value to be selected by the PCC Technical Committee.
|-
|healthcareFacilityTypeCode ||R ||CAD. <font color="#ff0000">This value is slightly different from the PCC-TF-2 binding.</font> ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|intendedRecipient ||R2 ||SAT || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|languageCode ||R ||SA || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|legalAuthenticator ||O ||SAT || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|mimeType ||R ||FM ||Fixed value “text/xml”. Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|parentDocumentRelationship ||R(when applicable) ||DS ||Context of a parent document in XDS cannot necessarily be derived from the CDA itself. This profile does not constrain this relation any further that originally specified in XDS. <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|parentDocumentId ||R(when parentDocumentRelationship is present) ||DS ||Context of a parent document in XDS cannot necessarily be derived from the CDA itself.  This profile does not constrain this relation any further that originally specified in XDS. <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|patientId ||R ||DS ||ID of the patient in the shared infrastructure, which is not necessarily the same as the patient id in the CDA. This is to be supplied at point of submission. <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|practiceSettingCode ||R ||CAD ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|serviceStartTime ||R ||SAT. <font color="#ff0000">This value is slightly different from the PCC-TF-2 binding.</font>||
For PHLab documents, we recommend to increase reqirement of R2 to R and have this timestamp correlate with either the encounter, specimen collection, reception, time (in that preference order). Otherwise, value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|serviceStopTime ||R2 ||SAT. <font color="#ff0000">This value is slightly different from the PCC-TF-2 binding.</font> || Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|sourcePatientId    ||R ||SAT ||ClinicalDocument / recordTarget / patient / id
<font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|sourcePatientInfo ||R ||SAT ||Assembled from various values within the ClinicalDocument / recordTarget / patient element.
<font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|title ||O ||SA ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|typeCode ||R||CADT. <font color="#ff0000">This value is slightly different from the PCC-TF-2 binding.</font> ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|uniqueId ||R ||SAT ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|}
 
=== XDSSubmissionSet Metadata ===
This content profile does not restrict submission set metadata. This content profile does not restrict usage of the XDS Submission Set.
 
''' NOTE: This binding differs from that that is specified in [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings Bindings]. We are working to resolve any differences that are not particular to this profile.'''
 
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|+ XDS Submission Set
! Attribute !! Optional? !! Source Type !!Source/ Value
|-
| availabilityStatus || R || DS ||Value assigned at point of submission. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
| authorInstitution || R2 || DS || <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|authorPerson ||R2 ||DS || <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|authorRole ||R2 ||DS ||Add value, if known. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|authorSpeciality ||R2 ||DS ||Add value, if known. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|contentTypeCode ||R  || CAD|| Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|comments ||O ||DS ||Optional, add if pertanant. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|entryUUID ||R ||DS ||Assigned at time of submission by Document Source, Repository or Registry. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding.</font>
|-
|patientId ||R ||DS ||ID of the patient in the shared infrastructure, which is not necessarily the same as the patient id in the CDA. This is to be supplied at point of submission. <font color="#ff0000">This metadata attribute is not not consistent PCC_TF-2 binding. We are working to resolve the differences.</font>
|-
|sourceId ||R ||DS ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|submissionTime ||R ||DS ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|-
|title ||O ||DS ||Optional, add if pertanant. <font color="#ff0000">This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.</font>
|-
|uniqueId ||R ||DS ||Value is consistent with the [http://wiki.ihe.net/index.php?title=PCC_TF-2/Bindings PCC-TF-2 binding].
|}
=== XDSFolder Metadata ===
''' NOTE: This binding is unique to PHLab documents, as PCC-TF-2 does not not specify specific XDSFolder Requirements'''
 
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|+ XDS Doument Folder
! Attribute !! Usage in XDS !! Source Type !!Source/ Value
|-
|availabilityStatus ||R ||DS ||Value assigned at point of submission.
|-
|codeList||R||DS||If any document in a folder pertains to a reportable condition, then the code identifying the reportable condition shall be among those listed in the codeList. This has been further refined from the original specification in XDS.
|-
|comments ||O ||DS ||Optional, add if pertanant.
|-
|entryUUID ||R ||DS ||Assigned at time of submission by Document Source, Repository or Registry.
|-
|lastUpdateTime ||R ||O ||Computed by the Registry upon folder access.
|-
|patientId ||R ||DS ||ID of the patient in the shared infrastructure, which is not necessarily the same as the patient id in the CDA. This is to be supplied at point of submission.
|-
|title ||O || DS||Optional, add if pertanant.
|-
|uniqueId ||R ||SAT ||ClinicalDocument / component / structuredBody / component / section / entry / act / specimen / specimenRole / id.
Documents pertaining to the same specimen shall be placed in a single folder identified by a global specimen id. See new CP in ITI for 'assoction' folder ids.  As this is still in CP format, this aspect of the PHLab binding cannot be implemented until the CP is processed.
|}
 
== CDA Release 2.0 Content Modules ==
This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides of the XDS-PHLab document.
 
It is assumed that the reader is familiar with both the HL7 CDA R2 specification as well as the XDS-Lab specification. Conformance statements made by either of those two specifications are implicitly understood to be required here, unless explicitly stated otherwise. We note that requirements specified below are to ensure the presence of a minimum amount of data in order to enhance description and facilitate sharing of the public health laboratory report document. Implementers of this profile can and should make use of additional annotation within the CDA document to provide richer context. The examples in the following sections contain the minimal amount of data, as specified, and in many cases do make use of additional CDA elements for enriched context.
 
'''We also take particular care to point out places where we suggest edits to the XDS-Lab profile. These elements are indicated with <font color="#ff0000">red</font> wiki section titles. These sections outline the suggested edit to XDS-Lab as well as link to a formal CP a the conclusion of this wiki section.'''
 
At present, wiki sections with <font color="#00ff00">green</font> represent incompleted sections.
 
=== <font color="#00ff00">Preface</font> ===
* Introduction: laboratory reporting concept and workflow definition.
* A PHLab document, much like a medical summary, serves the purpose of summarizing. While a medical summary captures a series of patient events from an EMR system resulting in a summary of a patient's current (and past) status, a PHLab document captures the series of events surrounding a biological sample resulting in a summary which documents the status of the sample (ie. what was found in it).
* scope is a single order and any (all) specimens stemming from that order and any (all) reportable contditions found among those specimens.
* Three varieties - Human (patient), Non-Human Subject, Human(patient) with Non-Human Subject
 
=== Clinical Document Header ===
==== General Constraints on the Header ====
# As in XDS-Lab, all entities in a PHLab document are required to be accompanied by a <font face="courier new">name</font>, <font face="courier new">address</font> and <font face="courier new">telecom</font> unless otherwise specified below.
# Header elements not further elaborated on in the following sections remain consistent in definition and as stated in CDA R2 and are subject only to refinements made in XDS-Lab.
 
==== ClinicalDocument Child-Less Header elements ====
<pre>
<?xml version="1.0" encoding="ASCII"?>
<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"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root="PHLab template id to go here"/>
  <id root="1.19.6.11.13.101000012039055145.1178052548502.1"/>
  <code code="18725-2" codeSystem="2.16.840.1.113883.6.1"
        codeSystemName="LOINC" displayName="Microbiology Studies"/>
  <title>SAMPLE PH-LAB REPORT</title>
  <effectiveTime value="20070501134908.0502-0700"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US"/>
  <setId root="1.19.6.11.13.101000012039055145.117805254283740.10"/>
  <versionNumber value="1"/>
</pre>
 
===== ClinicalDocument.realmCode =====
PHLab documents, like XDS-Lab documents, shall have a <font face="courier new">realmCode</font>.
 
===== ClinicalDocument.typeId =====
PHLab does not constrain the use of this element beyond what is stated in the CDA R2 documentation.
 
===== ClinicalDocument.templateId =====
The PCC Technical committee will assign a templateId for PHLab documents.
 
===== ClinicalDocument.id =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
===== ClinicalDocument.code =====
PHLab documents shall use the codes specified by XDS-Lab for code.
 
===== ClinicalDocument.title =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
===== ClinicalDocument.effectiveTime =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
===== ClinicalDocument.confidentialityCode =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
===== ClinicalDocument.languageCode =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
===== ClinicalDocument.setId =====
PHLab does not constrain the use of this element beyond what is stated in the CDA R2 documentation.
 
===== ClinicalDocument.versionNumber =====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.RecordTarget ====
As previously mentioned, a PHLab document has three variations dependent on the lab test subject. Each of these cases require different representation in the <font face="courier new">ClinicalDocument.recordTarget</font>.
===== Human Patient =====
When the lab test subject is a biological sample taken from a human patient, the following shall be present.
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.id</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.addr</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.telecom</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.name</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.administrativeGenderCode</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.birthTime</font>
PHLab does not further refine the meaning of these elements beyond what is stated in the CDA R2 documentation.
 
<pre>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>1313 Mockingbird Ln.</streetAddressLine>
        <city>Somewhere-ville</city>
        <state>NE</state>
        <postalCode>54321</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213"/>
      </patient>
    </patientRole>
  </recordTarget>
</pre>
 
If in the event a unit of information about the patient is not known or has been de-identified, the use of <font face="courier new">nullFlavor</font> is appropriate.
<pre>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine nullFlavor="MSK"/> <!-- masked value -->
        <city nullFlavor="MSK"/> <!-- masked value -->
        <state nullFlavor="MSK"/> <!-- masked value -->
        <postalCode>54321</postalCode>
        <country>USA</country>
      </addr>
      <telecom nullFlavor="UNK"/> <!-- unknown value -->
      <patient classCode="PSN">
        <name nullFlavor="MSK"/> <!-- masked value -->
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213"/>
      </patient>
    </patientRole>
  </recordTarget>
</pre>
 
===== Non-Human Subject =====
When the lab test subject is a sample taken from a non-human subject, such as an animal, a lake, soil or other environmental element, the following shall be present.
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.id</font> shall be present and shall represent the id of the non-human subject.
* The record target shall have a <font face="courier new">patient</font> sub-element and it's <font face="courier new">nullFlavor</font> shall be set to <font face="courier new">"OTH"</font>. This indicates that other information pertaining to the non-human subject can be found in the body of the document in [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Act.Subject section.entry.act.subject].
 
<pre>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="66373839" root="1.19.6.11.13"/>
      <patient nullFlavor="OTH">
    </patientRole>
  </recordTarget>
</pre>
 
===== Human Patient with Non-Human Subject =====
When the lab test subject is a sample taken from a non-human subject, such as an animal, a lake, soil or other environmental element, but the lab result findings directly impact a single patient (such as in the case of rabiies) the following shall be present.
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.id</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.addr</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.telecom</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.name</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.administrativeGenderCode</font>
* <font face="courier new">ClinicalDocument.recordTarget.patientRole.patient.birthTime</font>
PHLab does not further refine the meaning of these elements beyond what is stated in the CDA R2 documentation. Information pertaining to the non-human subject of the laboratory testing is in the body of the document in [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Act.Subject section.entry.act.subject].
<pre>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>1313 Mockingbird Ln.</streetAddressLine>
        <city>Somewhere-ville</city>
        <state>NE</state>
        <postalCode>54321</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213"/>
      </patient>
    </patientRole>
  </recordTarget>
</pre>
If in the event a unit of information about the patient is not known or has been de-identified, the use of <font face="courier new">nullFlavor</font> is appropriate. Please see [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Human_Patient ClinicalDocument.RecordTarget - Human Patient] for an example usage of <font face="courier new">nullFlavor</font>.
 
==== <font color="#ff0000">ClinicalDocument.Author</font> ====
A PHLab document author remains consistent in definition with the HL7 CDA R2 specification. We explictly note that XDS-Lab has constrained the use of the <font face="courier new">author</font> in Please see the following  [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#ClinicalDocument_Author CP to XDS-Lab] for additional comments we have regarding this constraint on the <font face="courier new">author</font>.
 
==== ClinicalDocument.DataEnterer ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.Informant ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.Custodian ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.InformationRecipient ====
A PHLab document intendedRecipient remains consistent in definition with the HL7 CDA R2 specification. The <font face="courier new">informationRecipient</font> may be present in a PHLab document, and inclusion of such information is beneficial. In public health, it is common for a public health laboratory identified reportable condition to be intended for delivery to several additional organizations. Inclusion of a list of <font face="courier new">informationRecipient</font> elements could enable notifications in a shared public health repository environment as well as alert clinicians within the clinical repository of the organizations that have been notified.
 
==== ClinicalDocument.LegalAuthenticator ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.Authenticator ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== <font color="#ff0000">Order Information</font> ====
No different from the clinical laboratory setting, a public health laboratory executes test in response to an order. The entity that gives an order to a laboratory is called the 'Order Placer'. Documentation of the order information may be present in a PHLab document. If it is to be present, it shall follow the structure specified below. We note that documentation of the ordering process her differs from XDS-Lab. Please see the following [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#CPs_to_XDS-Lab CP to XDS-Lab] for more information regarding documentaiton of the order.
 
===== <font color="#ff0000">ClinicalDocument.Participant (typeCode = 'REF')</font> =====
This participant, consistent in definition with XDS-Lab, represents the 'Order Placer Provier' (often a physician that creates and gives an order) which is defined by the HL7 v2.5 messaging specification (ORC-12). This participant may be present in a PHLab document.
 
 
If this participant is present, the following ''shall'' then be present:
* <font face="courier new">Participant.typeCode</font>
shall be present and shall be set to <font face="courier new">"REF"</font> to indicate that this participant is the 'Order Placer Provider'.
*<font face="courier new">Participant.associatedEntity.id</font>
shall be present and represents the id of the 'Order Placer Provier' which is defined by the HL7 v2.5 messaging specification (ORC-12)
*<font face="courier new">Participant.associatedEntity.addr</font>
shall be present and represents the address of the organization of the 'Order Placer Provider',  which is defined by the HL7 v2.5 messaging specification (ORD-21, 22, 23, 24)
*<font face="courier new">Participant.associatedEntity.telecom</font>
shall be present and represents the telecom of the organization of the 'Order Placer Provider',  which is defined by the HL7 v2.5 messaging specification (ORD-21, 22, 23, 24)
*<font face="courier new">Participant.associatedEntity.associatedPerson.name</font>
shall be present and represents the name of the 'Order Placer Provider',  which is defined by the HL7 v2.5 messaging specification (ORC-12)
 
 
If this participant is present, the following ''may'' then be present:
* <font face="courier new">Participant.time</font>
may be present and shall represent the 'Order Placer Order Effective Time' which is defined by HL7 v2.5 messaging specification (ORC-15).
 
<pre>
<participant typeCode=”REF”>
    <time value="20050329224512+0500"/>
    <associatedEntity>
      <id extension="1" root="1.3.6.4.1.4.1.2835.1"/>
      <addr>
          <streetAddressLine>21 North Ave</streetAddressLine>
          <city>Burlington</city>
      </addr>
      <telecom value="tel:(999)555-1212" use="DIR"/>
      <associatedPerson>
          <name>
              <given>Good</given>
              <family>Orderer</family>
          </name>
      </associatedPerson>
    </associatedEntity>
</participant>
</pre>
 
If in the event a unit of information about the 'Order Placer Provider' is not known or has been de-identified, the use of <font face="courier new">nullFlavor</font> is appropriate. Please see [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Human_Patient ClinicalDocument.RecordTarget - Human Patient] for an example usage of <font face="courier new">nullFlavor</font>.
 
===== <font color="#ff0000">ClinicalDocument.Participant (typeCode = 'ENT')</font> =====
This participant represents the 'Order Placer Enterer' (often a physician that creates and gives an order) which is defined by the HL7 v2.5 messaging specification (ORC-10). This participant may be present in a PHLab document.
 
 
If this participant is present, the following ''shall'' then be present:
* <font face="courier new">Participant.typeCode</font>
shall be present and shall be set to <font face="courier new">"ENT"</font> to indicate that this participant is the 'Order Placer Enterer'.
*<font face="courier new">Participant.associatedEntity.id</font>
shall be present and represents the id of the 'Order Placer Enterer' which is defined by the HL7 v2.5 messaging specification (ORC-10)
*<font face="courier new">Participant.associatedEntity.addr</font>
shall be present and represents the address of the the organization of the 'Order Placer Enterer',  which is defined by the HL7 v2.5 messaging specification (ORC-13, 17, 18)
*<font face="courier new">Participant.associatedEntity.telecom</font>
shall be present and represents the telecom of the organization of the 'Order Placer Enterer',  which is defined by the HL7 v2.5 messaging specification (ORC-13, 17, 18)
*<font face="courier new">Participant.associatedEntity.associatedPerson.name</font>
shall be present and represents the name of the 'Order Placer Enterer',  which is defined by the HL7 v2.5 messaging specification (ORC-10)
 
 
If this participant is present, the following ''may'' then be present:
* <font face="courier new">Participant.time</font>
may be present and shall represent the 'Order Placer Enterer Order Date/Time' which is defined by HL7 v2.5 messaging specification (ORC-9).
 
<pre>
<participant typeCode=”ENT”>
    <time value="20050329231509+0500"/>
    <associatedEntity>
      <id extension="2" root="1.3.6.4.1.4.1.2835.1"/>
      <addr>
          <streetAddressLine>21 North Ave</streetAddressLine>
          <city>Burlington</city>
      </addr>
      <telecom value="tel:(999)555-1212" use="DIR"/>
      <associatedPerson>
          <name>
              <given>Good</given>
              <family>Enterer</family>
          </name>
      </associatedPerson>
    </associatedEntity>
</participant>
</pre>
 
We note that the concept of the 'Order Placer Enterer Authorization' definded by the HL7v2.5 messagins specification (ORC-30) cannot be represented in a CDA participant element. Therefore this information is missing. If in the event a unit of information about the 'Order Placer Enterer' is not known or has been de-identified, the use of <font face="courier new">nullFlavor</font> is appropriate. Please see [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Human_Patient ClinicalDocument.RecordTarget - Human Patient] for an example usage of <font face="courier new">nullFlavor</font>.
 
===== <font color="#ff0000">ClinicalDocument.InFulfillmentOf</font> =====
This element documents the order number(s) from the 'Order Placer Provider' or 'Order Placer Enterer'. This element may be present in a PHLab document when either the 'Order Placer Provider' participant or the 'Order Placer Enterer' participant is present.
 
If one of the above participants is present, and if the <font face="courier new">inFulfillmentOf</font> is present, the following ''shall'' then be present:
*<font face="courier new">InfFulfillmentOf.Order.code</font>
Exactly one code shall be present for each type of laboratory test ordered and it's value shall be selected from among the LOINC universal test IDs.
 
 
If one of the above participants is present, and if the <font face="courier new">inFulfillmentOf</font> is present, the following ''may'' then be present:
*<font face="courier new">InFulfillmentOf.Order.id</font>
At least one id may be present and this id(s) shall represent the 'Order Placer Order Number(s)' which is defined by HL7 v2.5 messaging specification (ORC-2).
<pre>
<inFulfillmentOf>
    <order>
      <id extension="9383373939373" root="1.3.6.4.1.4.1.2835.1"/>
      <code=”890” codeSystem=” 2.16.840.1.113883.6.1” codeSystemName=”LOINC”
                  displayName=”Aerobic Culture”>
    </order>
</inFulfillmentOf>
</pre>
 
==== ClinicalDocument.DocumentationOf ====
A PHLab document, much like a medical summary, serves the purpose of summarizing. While a medical summary captures a series of patient events from an EMR system resulting in a summary of a patient's current (and past) status, a PHLab document captures the series of events surrounding a biological sample resulting in a summary which documents the status of the sample (ie. what was found in it). The <font face="courier new"> ClinicalDocument.DocumentationOf</font> element is used to this effect.
 
The <font face="courier new"> ClinicalDocument.DocumentationOf</font> shall be present and ''shall'' have the following:
* <font face="courier new">ServiceEvent.effectiveTime</font> shall be present and shall be specified using the <font face="courier new">low</font> and <font face="courier new">high</font> subelements. These times shall represent the time span of events described in the PHLab document.
** The <font face="courier new">low</font> shall correleate to the [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#ClinicalDocument.componentOf Encounter Time] or the [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Act.Specimen Specimen Collection Date/Time] or the [http://wiki.ihe.net/index.php?title=Lab_Public_Health_Reporting_Content#Act.Participant_.28typeCode_.3D_.22PRF.22.29 Specimen Recieved Date/Time], in that preference order.
** The <font face="courier new">high</font> shall correleate to chronologically latest time of authentication or legal authentication that is documented in the PHLab document.
 
 
The <font face="courier new"> ClinicalDocument.DocumentationOf</font> shall be present and ''may'' have the following:
* A PHLab document may make use of the CDA R2 extension <font face="courier new">ServiceEvent.statusCode</font> in accordance with the XDS-Lab specification. Therefore, <font face="courier new">ServiceEvent.statusCode</font> may be present.
* <font face="courier new">ServiceEvent.performer</font> may be present and shall represent the individual who produced the Result Event as further specified in XDs-Lab.
 
 
<pre>
  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="200612011130"/>
        <high value="200612071010"/>
      </effectiveTime>
      <performer typeCode="PRF">
        <assignedEntity>
          <id extension="rm83747" root="1.19.6.11.13"/>
          <addr>
              <streetAddressLine>789 Hamburger St.</streetAddressLine>
              <city>Greasytown</city>
              <state>TX</state>
              <postalCode>89012</postalCode>
              <country>USA</country>
          </addr>
          <telecom value="512-555-3456"/>
          <assignedPerson>
            <name><family>McDonald</family><given>Ronald</given></name>
          </assignedPerson>
          <representedOrganization>
            <id extension="rm83747" root="1.19.6.11.13"/>
            <name>Laboratory Name</name>
            <telecom value="512-555-3456"/>
            <addr>
              <streetAddressLine>789 Hamburger St.</streetAddressLine>
              <city>Greasytown</city>
              <state>TX</state>
              <postalCode>89012</postalCode>
              <country>USA</country>
            </addr>
          </representedOrganization>
        </assignedEntity>
      </performer>
    </serviceEvent>
  </documentationOf>
</pre>
 
==== ClinicalDocument.RelatedDocument ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.Authorization ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
==== ClinicalDocument.componentOf ====
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
 
<pre>
  <componentOf>
    <encompassingEncounter>
      <id extension=″9876543″ root=″1.21.331.45″/>
      <effectiveTime>
        <low value="200612011130"/>
        <high value="20061201200"/>
      </effectiveTime>
      <location>
        <healthCareFacility>
          <code code="HU" codeSystem="2.16.840.1.113883.5.10588" displayName="Hospital Unit"/>
        </healthCareFacility>
      </location>
    </encompassingEncounter>
  </componentOf>
</pre>
 
=== <font color="#00ff00">Clinical Document Body</font> ===
==== General Notes ====
* Consistent with XDS-Lab (Micro sectio 7.3.3.5.3 and example 9.3.4)
* Comment on use of organizers to group related content
* Each document section corresponds to a single laboratory section (see XDS-Lab). At least one
section shall be present.
* Each entry in a section shall contain a single act sub-element. This act
is hereafter referred to as the 'specimen act'
* Each specimen act shall contiain one or more entryRelationship elements. This entryRelationship
contains a single organizer element. This organizer is hereafter referred to as the 'reportable condition organizer'.
Permissible to document conditions or
findings that are not required to be reported in the same manner as described below.
 
==== Section ====
===== Section.code =====
* optional
===== Section.title =====
* optional
===== Section.text =====
* tabular form is recommended
* xml linkage with result in the structured content is required (particular note for linking in 'attachments' in
'observation media'
 
==== Specimen Act ====
* Reference XDS-Lab constraints on derived entries
===== Act.Specimen =====
===== Act.Subject =====
===== <font color="#ff0000">Act.Participant (typeCode = "AUTHEN")</font> =====
* among those listed in override of ClinicalDocument.authenticator
 
===== <font color="#ff0000">Act.Participant (typeCode = "PRF")</font> =====
* override of serviceEvent.performer
 
==== Reportable Condition Organizer ====
* Act.EntryRelationship will have a single organizer sub element
* organizer values:
** cluster
** statusCode = complete
 
===== Organizer.Specimen =====
* ISLT (extension), and what if it is not an isolate (non-micro)?
* code(s) for the reportable condition ,with link to text documentation
 
===== Organizer.Organizer (Battery Test) =====
* Examples of test batteries in PH
* Need yet another organizer to group elements of a battery test; this will be referred to as
the 'battery test organizer'.
* statusCode = completed
* code = coded value representing battery test type, optional use.
 
===== Test Results =====
* Either subelements under the reportable condition organizer or under
the battery test organizer.
* Recommended to use the Observation element
 
====== Observation.id ======
* NA anymore (will use observation code for this)
 
====== Observation.code ======
* code value, display and codeSystem = lab test id consistent with HL7 v2.5 OBR-4, required (LOINC recommended)
* code.originalText.reference to link to Section.text , required
 
====== Observation.value ======
* required
 
====== Observation.effectiveTime ======
* required
 
====== Observation.referenceRange ======
* optional
 
====== Observation.interpretationCode ======
* optional
 
====== Observation.methodCode ======
* optional
 
====== Observation.text ======
* used for result comments, optional
 
====== Observation.EntryRelationship.ObservationMedia ======
* B64 encoded attachment, if any
 
====== <font color="#ff0000">Observation.Performer </font> ======
* consitent with XDS-Lab when performer is different than documented in CDA header. MUST be a different laboratory ('''not just a different person''') if documented. override of serviceEvent.performer or act.performer
 
====== <font color="#ff0000">Observation.Participant (typeCode = "AUTHEN")</font> ======
* among those listed in override of ClinicalDocument.authenticator and/or 
and overrideOrganizer.participant (typeCode = "AUTHEN")
 
==== Comments on use of other Structured Body Elements ====
* go ahead, so long as minimum requirements are met?
 
=== CPs to XDS-Lab ===
* ClinicalDocument.typeId examples in samples
* ClinicalDocument.templateId for XDS-Lab documents
* ClinicalDocument.id missing in samples (invalid CDA)
* ClinicalDocument.recordTarget (meaning of identity is not clear)
* Bindings to XDS,XDM,XDR
* ClinicalDocument.author - XD-LAB specifies either a person or a system creates the report - not both. CDA allows both
and this constraint does not seem reasonable in all environments. Also, is not able to correlate with
XDS Metadata w/o an author person, given the generic CDA mapping to metadata.) This constraint does not appear
to have sufficient justification. Is it to determine if document came from LIMS or EMR?
* ClinicalDocument.documentationOf.serviceEvent.performer and Observation.performer 'overriding' semantics - '''must be a
different lab, not just a different person''' ... not particularly consistend with CDA semantics.
* Participant usage (specific type codes)
** usage of 'VRF' vs. 'AUTHEN' on participants
* THIS IS NOT ALWAYS TRUE:
XDS-LAB line 400 - In all use cases above, the laboratory report document is built and published
towards an EHR, generally after the order (or order group) is fulfilled.
 
 
==== ClinicalDocument RecordTarget ====
{|border="1" cellpadding="3" cellspacing="3"
|+
|-
|Submitter’s Name(s) and e-mail address(es):||Sarah Knoop and Sondra Renly
|-
|Submission Date:||Friday May 8, 2007
|-
|Integration Profile affected:||IHE Laboratory Technical Framework Supplement – Sharing Laboratory Reports
|-
|Version of IHE Technical Framework:||Supplement 2006-2007
|-
|Volume(s) and Section(s) affected:||Volume 2
|-
|colspan="2" align="left"|Rationale for Change:<br>
It is unclear the meaning of the word “identity”. This word is not a concept we could associate within the CDA schema.
|-
|colspan="2" align="left"|Suggested Edits:<br>
'''6.12 ClinicalDocument/recordTarget'''<br>
This element encapsulates the patient, target of this laboratory report, with its ID, <strike>identity,</strike> address and telecom.
|}
 
 
==== ClinicalDocument Author ====
{|border="1" cellpadding="3" cellspacing="3"
|+
|-
|Submitter’s Name(s) and e-mail address(es):||Sarah Knoop and Sondra Renly
|-
|Submission Date:||Friday May 8, 2007
|-
|Integration Profile affected:||IHE Laboratory Technical Framework Supplement – Sharing Laboratory Reports
|-
|Version of IHE Technical Framework:||Supplement 2006-2007
|-
|Volume(s) and Section(s) affected:||Volume 2
|-
|colspan="2" align="left"|Rationale for Change:<br>
Our interpretation of the XD*-LAB documentation as written is that it constrains the use of author on a distinction regarding whether the report comes from a laboratory system versus a physician system. In the case where the laboratory report is from a laboratory system the author is specified to be the laboratory software. In the case where the laboratory report is from a physician system the author is specified to be the physician. In both cases it is reasonable that a person and software system could be documented when applicable, but the verbage implies it should not be documented.<br><br>
We recognize that being able to distinquish a report as being from a laboratory or a physician source is important, but this does not seem appropriate to restrict the CDA author element in this way to indicate the source. We recommend that in either case both a person and software system could be documented when applicable.
|-
|colspan="2" align="left"|Suggested Edits:<br>
'''6.12 ClinicalDocument/author'''<br>
The author(s) of the laboratory report. <strike>In use cases 2.2 and 2.4, the laboratory report is produced by a software system represented by the element:<br>
author/assignedAuthor/assignedAuthoringDevice/softwareName. </strike><br>
The author/time element carries the date&time the laboratory report was produced by the system. <strike>In use cases 2.1, 2.3 and 2.5 the report is prepared by a physician who is the assignedPerson.</strike>
|}
 
 
<!--{{:PCC TF-2/Trailer}} -->
</noinclude>
 
=Open Issues=
* Still need to discuss the best way to accomodate a non-human subject in a CDA? How best to deliniate between non-human (animal or living) and non-human (environmental or non-living such as food or lake water or soil)?
* What of the proposed here should be fed back to XDS-Lab in the form of CPs?
* How to include attachments (such as images or pdf's) in addition to this structured content?
* Do we support the concept of "global specimen id" in the XDS metadata (folders? See Keith's CP in ITI Tech)? Can it be queried? For Example: "Find me all documents related to this specimen". Or should this concept be changed to(or add the concept of) a case number?
* Should we require XDSDocumentEntry.serviceStartTime, since in this context it correlates to either the original clinical encounter or the date of specimen collection (reception) which is particulary important in public health? If we really desire this to be in metadata, what do we do to the CDA to enforce that this information be there as well?
* How many specimens (sections/entries) or reportable conditions per document?
 
= Sample Documents =
 
'''Sample Laboratory Report Header'''
<pre>
<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"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root="2.16.840.1.113883.3.27.1776"/>
  <id extension="07SR012345" root="2.16.840.1.113883.1.3"/>
  <code code="18725-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
        displayName="Microbiology Studies"/>
  <title>Public Health Laboratory Report</title>
  <effectiveTime value="20070606233510.0969-0700"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US"/>
  <versionNumber value="1"/>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>1313 Mockingbird Lane</streetAddressLine>
        <city>Janesville</city>
        <state>WI</state>
        <postalCode>53545</postalCode>
        <country>USA</country></addr>
      <telecom value="608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213"/>
      </patient>
    </patientRole>
  </recordTarget>
  <author>
    <time value="20070606233510.0969-0700"/>
    <assignedAuthor>
      <id extension="phad2007" 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="408-555-5555"/>
      <assignedAuthoringDevice>
        <softwareName>IBM Public Health Application System</softwareName>
      </assignedAuthoringDevice>
    </assignedAuthor>
  </author>
  <custodian typeCode="CST">
    <assignedCustodian classCode="ASSIGNED">
      <representedCustodianOrganization>
        <id root="1.19.6.11.13"/>
        <name>Universal Custodian Services</name>
        <telecom value="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>
      <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="404-639-3535"/>
      <informationRecipient>
        <name><family>Angulo</family><given>Fred</given></name>
      </informationRecipient>
    </intendedRecipient>
  </informationRecipient>
  <legalAuthenticator>
    <time value="20070606233510.0969-0700"/>
    <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="312-555-5555"/>
      <assignedPerson>
        <name><family>Johnson</family><given>Linda</given><prefix>Dr</prefix></name>
      </assignedPerson>
    </assignedEntity>
  </legalAuthenticator>
  <participant typeCode="REF">
    <time>
      <low value="200706080600"/>
      <high value="200706081200"/>
    </time>
    <associatedEntity>
      <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 value="312-555-5555"/>
      <associatedPerson>
        <name><family>Patel</family><given>Kiran</given><prefix>Dr</prefix></name>
      </associatedPerson>
    </associatedEntity>
  </participant>
  <inFulfillmentOf>
    <order>
      <id extension="28902809" root="2.16.840.1.113883.1.3"/>
      <code code="20951-0" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"
            displayName="Salmonella Serotype"/>
    </order>
  </inFulfillmentOf>
  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="200612011130"/>
      </effectiveTime>
      <statusCode code=“completed”>
      <performer/>
      <performer typeCode="PRF">
        <assignedEntity>
          <id extension="rm83747" 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="312-555-5555"/>
          <assignedPerson>
            <name><family>Performer</family><given>Event</given></name>
          </assignedPerson>
          <representedOrganization>
            <id extension="rm83747" root="1.19.6.11.13"/>
            <name>Public Health Laboratory</name>
            <telecom value="312-555-5555"/>
            <addr>
              <streetAddressLine>7000 Laboratory Drive</streetAddressLine>
              <city>Chicago</city>
              <state>IL</state>
              <postalCode>60622</postalCode>
              <country>USA</country>
          </addr>
          </representedOrganization>
        </assignedEntity>
      </performer>
    </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>
        <low value="200612011130"/>
      </effectiveTime>
      <location>
        <healthCareFacility>
          <code code="HU" codeSystem="2.16.840.1.113883.5.10588" displayName="Hospital Unit"/>
        </healthCareFacility>
      </location>
    </encompassingEncounter>
  </componentOf>
 
</pre>
 
 
'''Sample Human Readable Body of the Laboratory Report'''
<pre>
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          <code code="18725-2" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Microbiology Studies"/>
          <title>LAB REPORT FROM PUBLIC HEALTH LABORATORY</title>
          <text><table>
              <thead ID="isoTest">
                <tr>
                  <th>Organism Isolated</th>
                  <th>Specimen Type</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>Salmonella Group C</td>
                  <td>stool</td>
                  <td></td>
                </tr>
              </tbody>
            </table><table>
              <thead ID="serotypeTest">
                <tr>
                  <th>Salmonella Serotype</th>
                  <th>LOINC</th>
                  <th>SNOMED</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>Salmonella virchow 6,7: r: 1,2</td>
                  <td>6463-4</td>
                  <td>5929008</td>
                </tr>
              </tbody>
            </table><table>
              <thead>
                <tr>
                  <th>Salmonella Susceptibility</th>
                  <th>Interpretation</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr ID="a1">
                  <td>Tetracycline</td>
                  <td>S</td>
                  <td></td>
                </tr>
                <tr ID="a2">
                  <td>Ciprofloxacin</td>
                  <td>S</td>
                  <td></td>
                </tr>
                <tr ID="a3">
                  <td>Trimethprim + Sulfamethoxazole</td>
                  <td>S</td>
                  <td></td>
                </tr>
                <tr ID="a4">
                  <td>Ampicillin</td>
                  <td>S</td>
                  <td></td>
                </tr>
                <tr ID="a5">
                  <td>Chloramphenicol</td>
                  <td>S</td>
                  <td></td>
                </tr>
                <tr ID="a6">
                  <td>Ceftriaxone</td>
                  <td>S</td>
                  <td></td>
                </tr>
              </tbody>
            </table>
          </text>
 
 
 
 
</pre>
 
 
'''Sample Document 1'''
<pre>
<?xml version="1.0" encoding="ASCII"?>
<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"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId root="2.16.840.1.113883.3.27.1776"/>
  <id root="1.19.6.11.13.101000012039055145.1178052548502.1"/>
  <code code="18725-2" codeSystem="2.16.840.1.113883.6.1"
        codeSystemName="LOINC" displayName="Microbiology Studies"/>
  <title>SAMPLE LAB REPORT: LIVING HUMAN SUBJECT</title>
  <effectiveTime value="20070501134908.0502-0700"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US"/>
    <versionNumber value="1"/>
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
      <id extension="sw54321" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>1313 Mockingbird Ln.</streetAddressLine>
        <city>Somewhere-ville</city>
        <state>NE</state>
        <postalCode>54321</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213"/>
        <birthplace>
          <place>
            <addr><city/><state/><country/></addr>
          </place>
        </birthplace>
      </patient>
    </patientRole>
  </recordTarget>
  <author typeCode="AUT">
    <time value="20070501134908.0502-0700"/>
    <assignedAuthor classCode="ASSIGNED">
      <id extension="ms87654" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>456 Gardinia Lane</streetAddressLine>
        <city>Great Kitchen</city>
        <state>CT</state>
        <postalCode>67845</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <assignedPerson classCode="PSN">
        <name><family>Stewart</family><given>Martha</given><suffix>MD</suffix></name>
      </assignedPerson>
      <representedOrganization>
        <id extension="lab87654" root="1.19.6.11.13"/>
        <name>Laboratory Name</name>
        <telecom value="589-555-1212"/>
        <addr>
          <streetAddressLine>456 Gardinia Lane</streetAddressLine>
          <city>Great Kitchen</city>
          <state>CT</state>
          <postalCode>67845</postalCode>
          <country>USA</country>
        </addr>
      </representedOrganization>
    </assignedAuthor>
  </author>
  <author>
    <time value="20070501134908.0502-0700"/>
    <assignedAuthor>
      <id extension="hal2001" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>456 Gardinia Lane</streetAddressLine>
        <city>Great Kitchen</city>
        <state>CT</state>
        <postalCode>67845</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <assignedAuthoringDevice>
        <softwareName>IBM PHAD Application System</softwareName>
      </assignedAuthoringDevice>
    </assignedAuthor>
  </author>
  <custodian typeCode="CST">
    <assignedCustodian classCode="ASSIGNED">
      <representedCustodianOrganization>
        <id root="1.19.6.11.13"/>
        <name>The President's Clinic</name>
        <telecom value="789-555-2121"/>
        <addr>
          <streetAddressLine>1600 Pennsylvania Ave</streetAddressLine>
          <city>Washington DC</city>
          <postalCode>98765</postalCode>
          <country>USA</country>
        </addr>
      </representedCustodianOrganization>
    </assignedCustodian>
  </custodian>
  <participant typeCode="AUTHEN">
    <time value="200612071010"/>
    <associatedEntity>
      <id extension="ms87654" root="1.19.6.11.13"/>
      <addr>
        <streetAddressLine>456 Gardinia Lane</streetAddressLine>
        <city>Great Kitchen</city>
        <state>CT</state>
        <postalCode>67845</postalCode>
        <country>USA</country>
      </addr>
      <telecom value="589-555-1212"/>
      <associatedPerson>
        <name><family>Stewart</family><given>Martha</given><suffix>MD</suffix></name>
      </associatedPerson>
    </associatedEntity>
  </participant>
  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="200612011130"/>
        <high value="200612071010"/>
      </effectiveTime>
      <performer typeCode="PRF">
        <assignedEntity>
          <id extension="rm83747" root="1.19.6.11.13"/>
          <addr>
              <streetAddressLine>789 Hamburger St.</streetAddressLine>
              <city>Greasytown</city>
              <state>TX</state>
              <postalCode>89012</postalCode>
              <country>USA</country>
          </addr>
          <telecom value="512-555-3456"/>
          <assignedPerson>
            <name><family>McDonald</family><given>Ronald</given></name>
          </assignedPerson>
          <representedOrganization>
            <id extension="rm83747" root="1.19.6.11.13"/>
            <name>Laboratory Name</name>
            <telecom value="512-555-3456"/>
            <addr>
              <streetAddressLine>789 Hamburger St.</streetAddressLine>
              <city>Greasytown</city>
              <state>TX</state>
              <postalCode>89012</postalCode>
              <country>USA</country>
            </addr>
          </representedOrganization>
        </assignedEntity>
      </performer>
    </serviceEvent>
  </documentationOf>
  <authorization>
    <consent classCode="CONS" moodCode="EVN">
      <statusCode code="completed"/>
    </consent>
  </authorization>
  <componentOf>
    <encompassingEncounter>
      <effectiveTime>
        <low value="200612011130"/>
        <high value="20061201200"/>
      </effectiveTime>
      <location>
        <healthCareFacility>
          <code code="HU" codeSystem="2.16.840.1.113883.5.10588" displayName="Hospital Unit"/>
        </healthCareFacility>
      </location>
    </encompassingEncounter>
  </componentOf>
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          <code code="18725-2" codeSystem="2.16.840.1.113883.6.1"
                codeSystemName="LOINC" displayName="Microbiology Studies"/>
          <title>LAB REPORT FROM XYZ LABORATORY</title>
          <text><table>
              <thead ID="isoTest">
                <tr>
                  <th>Organism Isolated</th>
                  <th>Specimen Type</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>Salmonella Group E</td>
                  <td>stool</td>
                  <td></td>
                </tr>
              </tbody>
            </table><table>
              <thead ID="serotypeTest">
                <tr>
                  <th>Salmonella Serotype</th>
                  <th>LOINC</th>
                  <th>SNOMED</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>Salmonella virchow</td>
                  <td>6463-4</td>
                  <td>L-17569</td>
                </tr>
              </tbody>
            </table><table>
              <thead>
                <tr>
                  <th>Salmonella Susceptibility</th>
                  <th>Interpretation</th>
                  <th>Result</th>
                  <th>Units</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr ID="a1">
                  <td>Ampicillin</td>
                  <td>S</td>
                  <td>5.0</td>
                  <td>mm</td>
                  <td></td>
                </tr>
                <tr ID="a2">
                  <td>Ciprofloxacin</td>
                  <td>R</td>
                  <td>9.0</td>
                  <td>mm</td>
                  <td></td>
                </tr>
                <tr ID="a3">
                  <td>Tetracycline</td>
                  <td>S</td>
                  <td>2.0</td>
                  <td>mm</td>
                  <td></td>
                </tr>
                <tr ID="a4">
                  <td>Trimethprim/Sulfametoxale</td>
                  <td>S</td>
                  <td>0.0</td>
                  <td>mm</td>
                  <td></td>
                </tr>
              </tbody>
            </table><table>
              <thead ID="phagetypeTest">
                <tr>
                  <th>Salmonella Phagetype</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>Salmonella virchow phagetype 4a</td>
                  <td>Linked to outbreak #R3092.</td>
                </tr>
                <tr>
                  <td></td>
                  <td>Performing PulseNet for confirmation.</td>
                </tr>
              </tbody>
            </table><table>
              <thead ID="PulseNetTest">
                <tr>
                  <th>Salmonella PulseNet</th>
                </tr>
              </thead>
              <tbody>
                <tr>
                  <td>PFGE confirmed link to outbreak #R3092.</td>
                </tr>
                <tr>
                  <td>http://www.pfge.net/reports.php/#189792879372162201900_1.html</td>
                </tr>
              </tbody>
            </table></text>
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry"
                        root="1.3.6.1.4.1.19376.1.3"/>
            <organizer classCode="CLUSTER" moodCode="EVN">
              <statusCode code="completed"/>
              <specimen typeCode="SPC">
                <specimenRole classCode="SPEC">
                  <id extension="55584739900388" root="1.19.6.11.13"/>
                  <specimenPlayingEntity>
                    <code code="STL" codeSystemName="2.16.840.1.113883.5.129"
                          displayName="Stool"/>
                  </specimenPlayingEntity>
                </specimenRole>
                <productOf classCode="PROC" moodCode="EVN">
                  <effectiveTime value="200612020908"/>
                  <performer>
                    <assignedEntity>
                      <id extension="performer.id" root="1.19.6.11.13"/>
                    </assignedEntity>
                  </performer>
                  <participant typeCode="AUT">
                    <participantRole>
                      <telecom value="crazyLabs@get.your.specimens.here.org"/>
                    </participantRole>
                  </participant>
                </productOf>
              </specimen>
              <participant typeCode="REFB">
                <participantRole>
                  <id extension="provider.id" 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="512-555-3456"/>
                  <playingEntity>
                  <name><family>Trenton</family><given>Douglas</given><suffix>MD</suffix></name>
                  </playingEntity>
                </participantRole>
              </participant>
              <participant typeCode="AUT">
                <participantRole>
                  <id extension="placer.system.id" root="1.19.6.11.13"/>
                  <addr>
                    <streetAddressLine>650 Harry Rd</streetAddressLine>
                    <additionalLocator>some order placer facility</additionalLocator>
                    <city>San Jose</city>
                    <state>CA</state>
                    <postalCode>95120</postalCode>
                    <country>USA</country>
                  </addr>
                  <telecom value="512-555-3456"/>
                  <playingDevice>
                    <softwareName>Software System</softwareName>
                  </playingDevice>
                  <scopingEntity>
                    <id extension="order.placer.order.number" root="1.19.6.11.13"/>
                  </scopingEntity>
                </participantRole>
              </participant>
              <participant typeCode="ENT">
                <participantRole>
                  <id extension="enterer.id" 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="512-555-3456"/>
                  <playingEntity>
                    <name><family>Trenton</family><given>Douglas</given></name>
                  </playingEntity>
                </participantRole>
              </participant>
              <participant typeCode="PRF">
                <time value="20061212"/>
                <participantRole>
                  <id extension="filler.id" 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="512-555-3456"/>
                  <playingDevice>
                    <softwareName>Order Filler System software name</softwareName>
                  </playingDevice>
                  <scopingEntity>
                    <id extension="order.filler.order.number" root="1.19.6.11.13"/>
                  </scopingEntity>
                </participantRole>
              </participant>
              <participant typeCode="AUTHEN">
                <time value="200612071010"/>
                <participantRole>
                  <id extension="ms87654" root="1.19.6.11.13"/>
                  <addr>
                      <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                      <city>Great Kitchen</city>
                      <state>CT</state>
                      <postalCode>67845</postalCode>
                      <country>USA</country>
                  </addr>
                  <telecom value="589-555-1212"/>
                  <playingEntity>
                    <name><family>Stewart</family><given>Martha</given><suffix>MD</suffix></name>
                  </playingEntity>
                </participantRole>
              </participant>
              <component>
                <organizer classCode="CLUSTER" moodCode="EVN">
                  <code code="6463-4" codeSystemName="LOINC" displayName="Salmonella virchow">
                    <translation code="L-17569" codeSystemName="SNOMED"
                                displayName="Salmonella virchow"/>
                    <translation code="6463-4" codeSystemName="ISOLATE_TYPE_LOINC"
                                displayName="Reportable Salmonella"/>
                    <translation code="L-17100" codeSystemName="ISOLATE_TYPE_SNOMED" 
                                displayName="Reportable Salmonella"/>
                  </code>
                  <statusCode code="completed"/>
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <id extension="isolation.order.filler.service.id" root="1.19.6.11.13.1"/>
                      <id extension="isolation.order.filler.diagnostic.service.section.id"
                          root="1.19.6.11.13.2"/>
                      <id extension="isolation.order.filler.test.id" root="1.19.6.11.13.3"/>
                      <code>
                        <originalText><reference value="isoTest"/></originalText>
                      </code>
                      <text>Isolation Test Result Comment</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20061218"/>
                      <value xsi:type="CE" code="L-17100" codeSystem="2.16.840.1.113883.6.1"
                            codeSystemName="LOINC" displayName="Salmonella Group E"/>
                      <methodCode code="CULTURE"
                                  codeSystem="1.2.820.99999.106000022002159086.1170200374775.3"
                                  displayName="Culture"/>
                      <performer>
                        <assignedEntity>
                          <id extension="rm83747" root="1.19.6.11.13"/>
                          <addr>
                              <streetAddressLine>789 Hamburger St.</streetAddressLine>
                              <city>Greasytown</city>
                              <state>TX</state>
                              <postalCode>89012</postalCode>
                              <country>USA</country>
                          </addr>
                          <telecom value="512-555-3456"/>
                          <assignedPerson>
                            <name><family>McDonald</family><given>Ronald</given></name>
                          </assignedPerson>
                        </assignedEntity>
                      </performer>
                      <participant typeCode="ENT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="filler.test.result.enterer.id" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="VRF">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.validator"
                              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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.reporter" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUTHEN">
                        <time value="200612071010"/>
                        <participantRole>
                          <id extension="ms87654" root="1.19.6.11.13"/>
                          <addr>
                            <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                            <city>Great Kitchen</city>
                            <state>CT</state>
                            <postalCode>67845</postalCode>
                            <country>USA</country>
                          </addr>
                          <telecom value="589-555-1212"/>
                          <playingEntity>
                            <name>
                                <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                    </observation>
                  </component>
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <id extension="serotype.order.filler.service.id" root="1.19.6.11.13.1"/>
                      <id extension="serotype.order.filler.diagnostic.service.section.id"
                          root="1.19.6.11.13.2"/>
                      <id extension="serotype.order.filler.test.id" root="1.19.6.11.13.3"/>
                      <code>
                        <originalText><reference value="serotypeTest"/></originalText>
                      </code>
                      <text>Serotype Test Result Comment</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20061218"/>
                      <value xsi:type="CE" code="L-17569" codeSystem="2.16.840.1.113883.6.1"
                            codeSystemName="LOINC" displayName="Salmonella virchow"/>
                      <methodCode code="AGARDIFFUSION"
                                  codeSystem="1.2.820.99999.106000022002159086.1170200374775.3"             
                                  displayName="Disk diffusion"/>
                      <performer>
                        <assignedEntity>
                          <id extension="rm83747" root="1.19.6.11.13"/>
                          <addr>
                              <streetAddressLine>789 Hamburger St.</streetAddressLine>
                              <city>Greasytown</city>
                              <state>TX</state>
                              <postalCode>89012</postalCode>
                              <country>USA</country>
                          </addr>
                          <telecom value="512-555-3456"/>
                          <assignedPerson>
                            <name><family>McDonald</family><given>Ronald</given></name>
                          </assignedPerson>
                        </assignedEntity>
                      </performer>
                      <participant typeCode="ENT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="filler.test.result.enterer.id" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="VRF">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.validator"
                              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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.reporter" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUTHEN">
                        <time value="200612071010"/>
                        <participantRole>
                          <id extension="ms87654" root="1.19.6.11.13"/>
                          <addr>
                            <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                            <city>Great Kitchen</city>
                            <state>CT</state>
                            <postalCode>67845</postalCode>
                            <country>USA</country>
                          </addr>
                          <telecom value="589-555-1212"/>
                          <playingEntity>
                            <name>
                                <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                    </observation>
                  </component>
                  <component>
                    <organizer classCode="BATTERY" moodCode="EVN">
                      <code code="29576-6" codeSystem="2.16.840.1.113883.6.1"
                            codeSystemName="LOINC" displayName="Salmonella Susceptibility Test"/>
                      <statusCode code="completed"/>
                      <effectiveTime value="20061218"/>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <id extension="ampicillin.order.filler.service.id"
                              root="1.19.6.11.13.1"/>
                          <id extension="ampicillin.order.filler.diagnostic.service.section.id"
                              root="1.19.6.11.13.2"/>
                          <id extension="ampicillin.order.filler.test.id" root="1.19.6.11.13.3"/>
                          <code code="Ampicillin" displayName="Ampicillin">
                            <originalText><reference value="a1"/></originalText>
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                              <playingEntity>
                            <name>
                                <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                              </playingEntity>
                            </participantRole>
                          </participant>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <id extension="trisulf.order.filler.service.id" root="1.19.6.11.13.1"/>
                          <id extension="trisulf.order.filler.diagnostic.service.section.id"
                              root="1.19.6.11.13.2"/>
                          <id extension="trisulf.order.filler.test.id" root="1.19.6.11.13.3"/>
                          <code code="trisulf" displayName="trisulf">
                            <originalText><reference value="a4"/></originalText>
                          </code>
                          <statusCode code="completed"/>
                          <effectiveTime value="20061218"/>
                          <value xsi:type="PQ" unit="mm" value="0.0"/>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219"
                                  displayName="Susceptable"/>
                          <methodCode code="EIA"
                                codeSystem="1.2.820.99999.106000022002159086.1170200374775.3"
                                displayName="Enzyme immunoassay"/>
                          <performer>
                            <assignedEntity>
                              <id extension="rm83747" root="1.19.6.11.13"/>
                              <addr>
                                  <streetAddressLine>789 Hamburger St.</streetAddressLine>
                                  <city>Greasytown</city>
                                  <state>TX</state>
                                  <postalCode>89012</postalCode>
                                  <country>USA</country>
                              </addr>
                              <telecom value="512-555-3456"/>
                              <assignedPerson>
                                <name><family>McDonald</family><given>Ronald</given></name>
                              </assignedPerson>
                            </assignedEntity>
                          </performer>
                          <participant typeCode="ENT">
                            <time value="20061218"/>
                            <participantRole>
                              <id extension="filler.test.result.enterer.id" 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="512-555-3456"/>
                              <playingEntity>
                                <name><family>Trenton</family><given>Douglas</given></name>
                              </playingEntity>
                            </participantRole>
                          </participant>
                          <participant typeCode="VRF">
                            <time value="20061218"/>
                            <participantRole>
                              <id extension="order.filler.test.result.validator"
                                  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="512-555-3456"/>
                              <playingEntity>
                                <name><family>Trenton</family><given>Douglas</given></name>
                              </playingEntity>
                            </participantRole>
                          </participant>
                          <participant typeCode="AUT">
                            <time value="20061218"/>
                            <participantRole>
                              <id extension="order.filler.test.result.reporter"
                                  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="512-555-3456"/>
                              <playingEntity>
                                <name><family>Trenton</family><given>Douglas</given></name>
                              </playingEntity>
                            </participantRole>
                          </participant>
                          <participant typeCode="AUTHEN">
                            <time value="200612071010"/>
                            <participantRole>
                              <id extension="ms87654" root="1.19.6.11.13"/>
                              <addr>
                                <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                                <city>Great Kitchen</city>
                                <state>CT</state>
                                <postalCode>67845</postalCode>
                                <country>USA</country>
                              </addr>
                              <telecom value="589-555-1212"/>
                              <playingEntity>
                            <name>
                                <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                              </playingEntity>
                            </participantRole>
                          </participant>
                        </observation>
                      </component>
                    </organizer>
                  </component>
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <id extension="phagetype.order.filler.service.id" root="1.19.6.11.13.1"/>
                      <id extension="phagetype.order.filler.diagnostic.service.section.id"
                          root="1.19.6.11.13.2"/>
                      <id extension="phagetype.order.filler.test.id" root="1.19.6.11.13.3"/>
                      <code code="PHAGETYPE_TEST" codeSystemName="PHAGETYPE TEST INDICATOR">
                        <originalText><reference value="phagetypeTest"/></originalText>
                      </code>
                      <text>Linked to outbreak #R3092. Performing PulseNet for
                            confirmation.</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20061218"/>
                      <value xsi:type="CE" code="XXXX-X" codeSystem="2.16.840.1.113883.6.1"
                            codeSystemName="LOINC" displayName="Salmonella virchow
                            phagetype 4a"/>
                      <methodCode code="CULTURE"
                            codeSystem="1.2.820.99999.106000022002159086.1170200374775.3"
                            displayName="Culture"/>
                      <performer>
                        <assignedEntity>
                          <id extension="rm83747" root="1.19.6.11.13"/>
                              <addr>
                                  <streetAddressLine>789 Hamburger St.</streetAddressLine>
                                  <city>Greasytown</city>
                                  <state>TX</state>
                                  <postalCode>89012</postalCode>
                                  <country>USA</country>
                              </addr>
                          <telecom value="512-555-3456"/>
                          <assignedPerson>
                            <name><family>McDonald</family><given>Ronald</given></name>
                          </assignedPerson>
                        </assignedEntity>
                      </performer>
                      <participant typeCode="ENT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="filler.test.result.enterer.id" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="VRF">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.validator"
                              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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.reporter" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUTHEN">
                        <time value="200612071010"/>
                        <participantRole>
                          <id extension="ms87654" root="1.19.6.11.13"/>
                              <addr>
                                <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                                <city>Great Kitchen</city>
                                <state>CT</state>
                                <postalCode>67845</postalCode>
                                <country>USA</country>
                              </addr>
                          <telecom value="589-555-1212"/>
                          <playingEntity>
                            <name>
                                <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                    </observation>
                  </component>
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <id extension="PulseNet.order.filler.service.id" root="1.19.6.11.13.1"/>
                      <id extension="PulseNet.order.filler.diagnostic.service.section.id"
                          root="1.19.6.11.13.2"/>
                      <id extension="PulseNet.order.filler.test.id" root="1.19.6.11.13.3"/>
                      <code code="PULSE_NET_RESULT" codeSystemName="PULSE NET TEST INDICATOR">
                        <originalText><reference value="PulseNetTest"/></originalText>
                      </code>
                      <text>PFGE confirmed link to outbreak #R3092.</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20061218"/>
                      <value xsi:type="TEL"
                          value="http://www.pfge.net/reports.php/#189792879372162201900_1.html">
                        <useablePeriod value="20081218"/>
                      </value>
                      <methodCode code="CULTURE"
                          codeSystem="1.2.820.99999.106000022002159086.1170200374775.3"
                          displayName="Culture"/>
                      <performer>
                        <assignedEntity>
                          <id extension="rm83747" root="1.19.6.11.13"/>
                              <addr>
                                  <streetAddressLine>789 Hamburger St.</streetAddressLine>
                                  <city>Greasytown</city>
                                  <state>TX</state>
                                  <postalCode>89012</postalCode>
                                  <country>USA</country>
                              </addr>
                          <telecom value="512-555-3456"/>
                          <assignedPerson>
                            <name><family>McDonald</family><given>Ronald</given></name>
                          </assignedPerson>
                        </assignedEntity>
                      </performer>
                      <participant typeCode="ENT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="filler.test.result.enterer.id" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="VRF">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.validator"
                              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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUT">
                        <time value="20061218"/>
                        <participantRole>
                          <id extension="order.filler.test.result.reporter" 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="512-555-3456"/>
                          <playingEntity>
                            <name><family>Trenton</family><given>Douglas</given></name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                      <participant typeCode="AUTHEN">
                        <time value="200612071010"/>
                        <participantRole>
                          <id extension="ms87654" root="1.19.6.11.13"/>
                              <addr>
                                <streetAddressLine>456 Gardinia Lane</streetAddressLine>
                                <city>Great Kitchen</city>
                                <state>CT</state>
                                <postalCode>67845</postalCode>
                                <country>USA</country>
                              </addr>
                          <telecom value="589-555-1212"/>
                          <playingEntity>
                            <name>
                              <family>Stewart</family><given>Martha</given><suffix>MD</suffix>
                            </name>
                          </playingEntity>
                        </participantRole>
                      </participant>
                    </observation>
                  </component>
                </organizer>
              </component>
            </organizer>
          </entry>
        </section>
      </component>
    </structuredBody>
  </component>
</ClinicalDocument>
</pre>

Latest revision as of 11:23, 14 June 2007

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