PCC TF-1/PHLAB

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NOTE: As of August 2008, PHLAB has been harmonized with XD-Lab v2.1 volume 3 'Content'. Please see this profile as the below is no longer current.

Contents


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 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

Add the following row(s) to the list of dependencies
Integration Profile Dependency Dependency Type Purpose
PHLab XDS-Lab PHLab is a conformant XDS-Lab document XDS-Lab constrains CDA R2 for the purposes of communicating any Laboratory Report

Actors/Transaction

There are two actors in the PHLab profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile. A Document Source or a Portable Media Creator may embody the Content Creator Actor. A Document Consumer, a Document Recipient or a Portable Media Importer may embody the Content Consumer Actor. The sharing or transmission of content or updates from one actor to the other is addressed by the use of appropriate IHE profiles described in the section on Content Bindings with XDS, XDM and XDR.

PHLab Actor Diagram


Options

Actor Option
PHLab Options
Content Consumer View Option (1)
Document Import Option (1)
Section Import Option (1)
Discrete Data Import Option (1)
Note 1: The Actor shall support at least one of these options.

Content Consumer Options

View Option

This option defines the processing requirements placed on Content Consumers for providing access, rendering and management of the medical document. See the View Option in PCC TF-2 for more details on this option.

A Content Creator Actor should provide access to a style sheet that ensures consistent rendering of the medical document content as was displayed by the Content Consumer Actor.

The Content Consumer Actor shall be able to present a view of the document using this style sheet if present.

Document Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing the entire medical document and managing it as part of the patient record. See the Document Import Option in PCC TF-2 for more details on this option.

Section Import Option

This option defines the processing requirements placed on Content Consumers for providing access to, and importing the selected section of the medical document and managing them as part of the patient record. See the Section Import Option in PCC TF-2 for more details on this option.

Discrete Data Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing discrete data from selected sections of the medical document and managing them as part of the patient record. See the Discrete Data Import Option in PCC TF-2 for more details on this option.


Coded Terminologies

This profile supports the capability to record entries beyond the IHE required coding associated with structured data. Actors from this profile may choose to utilize coded data, but interoperability at this level requires an agreement between the communicating parties that is beyond the scope of this Profile.

To facilitate this level of interoperability, the applications that implement actors within this profile shall provide a link to their HL7 conformance profile within their IHE Integration statement. The conformance profile describes the structure of the information which they are capable of creating or consuming. The conformance profile shall state which templates are supported by the application implementing the profile Actors, and which vocabularies and/or data types are used within those templates. It should also indicate the optional components of the entry that are supported.

An Example HL7 Conformance Profile is available to show how to construct such a statement. See the HL7 Refinement Constraint and Localization for more details on HL7 conformance profiles.

Cross Enterprise Document Sharing, Media Interchange and Reliable Messaging

Actors from the ITI XDS, XDM and XDR profiles embody the Content Creator and Content Consumer sharing function of this profile. A Content Creator or Content Consumer may be grouped with appropriate actors from the XDS, XDM or XDR profiles to exchange the content described therein. The metadata sent in the document sharing or interchange messages has specific relationships or dependencies (which we call bindings) to the content of the clinical document described in the content profile.

The Patient Care Coordination Technical Framework defines the bindings to use when grouping the Content Creator of this Profile with actors from the IHE ITI XDS, XDM or XDR Integration Profiles.


Publc Health Laboratory Report Bindings
Content Binding Actor Optionality
Public Health Laboratory Report Medical Document Binding to XD* Content Creator R
Content Consumer R


PHLab Document Content Module

A Public Health Laboratory Report content document is a type of laboratory report, and incorporates the constraints defined for laboratory reports found in the XDS-Lab specification. In addition, the PHLab profile modifies the 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:

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 Disease Control agency 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
    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


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.


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:

  • <XXX> 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:


Source Type Description
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.
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
FM Fixed (constant) by Mapping - for all source documents. Source/Value column contains the value to be used in all documents.
FAD Fixed by Affinity Domain – value configured into Affinity Domain, all documents will use this value.
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.
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.
n/a Not Applicable – may be used with an optionality R2 or O attribute to indicate it is not to be used.
DS Document Source – value comes from the Document Source actor. Use Source/Value column or Extended Discussion to give details.
O Other – Extended Discussion must be 'yes' 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 'Extended Discussion' are to contain the details as necessary.

XDSDocumentEntry Metadata

NOTE: This binding differs from what is specified in Bindings. We are working to resolve any differences that are not particular to this profile. Please see the following CP on this topic.

XDSDocumentEntry
Attribute Optional? Source Type Source/ Value
availabilityStatus R DS Value assigned at point of submission. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
authorInstitution R2 SAT This attribute is the corresponding institution to the authorPerson below. Value is consistent with the PCC-TF-2 binding.
authorPerson R2 SAT Value is consistent with the PCC-TF-2 binding.
authorRole R2 DS Add value, if known. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
authorSpeciality R2 DS Value is consistent with the PCC-TF-2 binding.
classCode R CADT Value is consistent with the PCC-TF-2 binding.
comments O DS Optional, add if pertinent. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
confidentialityCode R CADT Value is consistent with the PCC-TF-2 binding..
creationTime R SAT. This value is slightly different from the PCC-TF-2 binding. Value is consistent with the PCC-TF-2 binding.
entryUUID R DS Assigned at time of submission by Document Source, Repository or Registry. This metadata attribute is not present in the PCC_TF-2 binding.
eventCodeList R2 DSClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / observation(templateId=TBD)/code

AND

ClinicalDocument / component / structuredBody / component / section / entry / act / subject / 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. Additionally, if the document contains information about a non-human subject, then the code that indicates what this subject is shall be among those listed in the eventCodeList. Thus, this attribute 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. This value is slightly different from the PCC-TF-2 binding. Value is consistent with the PCC-TF-2 binding.
intendedRecipient R2 SAT Value is consistent with the PCC-TF-2 binding.
languageCode R SA Value is consistent with the PCC-TF-2 binding.
legalAuthenticator O SAT Value is consistent with the PCC-TF-2 binding.
mimeType R FM Fixed value “text/xml”. Value is consistent with the 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 than originally specified in XDS. This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
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 than originally specified in XDS. This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
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. This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
practiceSettingCode R CAD Value is consistent with the PCC-TF-2 binding.
serviceStartTime R SAT. This value is slightly different from the PCC-TF-2 binding.

For PHLab documents, we recommend to increase requirement of R2 to R and have this timestamp correlate with either the encounter, specimen collection, or specimen receive time (in that preference order). Otherwise, value is consistent with the PCC-TF-2 binding.

serviceStopTime R2 SAT. This value is slightly different from the PCC-TF-2 binding. Value is consistent with the PCC-TF-2 binding.
sourcePatientId R SAT ClinicalDocument / recordTarget / patient / id

This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.

sourcePatientInfo R SAT Assembled from various values within the ClinicalDocument / recordTarget / patient element.

This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.

title O SA Value is consistent with the PCC-TF-2 binding.
typeCode RCADT. This value is slightly different from the PCC-TF-2 binding. Value is consistent with the PCC-TF-2 binding.
uniqueId R SAT Value is consistent with the 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 Bindings. We are working to resolve any differences that are not particular to this profile. Please see the following CP on this topic.


XDS Submission Set
Attribute Optional? Source Type Source/ Value
availabilityStatus R DS Value assigned at point of submission. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
authorInstitution R2 DS This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
authorPerson R2 DS This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
authorRole R2 DS Add value, if known. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
authorSpeciality R2 DS Add value, if known. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
contentTypeCode R CAD Value is consistent with the PCC-TF-2 binding.
comments O DS Optional, add if pertinent. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
entryUUID R DS Assigned at time of submission by Document Source, Repository or Registry. This metadata attribute is not present in the PCC_TF-2 binding.
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. This metadata attribute is not consistent PCC_TF-2 binding. We are working to resolve the differences.
sourceId R DS Value is consistent with the PCC-TF-2 binding.
submissionTime R DS Value is consistent with the PCC-TF-2 binding.
title O DS Optional, add if pertinent. This metadata attribute is not present in the PCC_TF-2 binding. It was added to XDS in 2006-2007 cycle.
uniqueId R DS Value is consistent with the PCC-TF-2 binding.

XDSFolder Metadata

NOTE: PCC-TF-2 does not specify specific XDSFolder Requirements

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 red 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.

Preface

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 scope of a PHLab document is confined, at this time, to a single reportable condition found in a single specimen associated with a single, fulfilled order.

There are three varieties of PHLab documents: Human (patient), Non-Human Subject, Human(patient) with Non-Human Subject. For each variety we provide a short scenaio below to aid in the distinction among the varieties.

  • Human (patient): Shelly Winters appears at the hospital emergency room with a jar of recalled peanut butter and symptoms consistent with Salmonellosis. Her physician, Dr Patel, orders a stool culture and prescribes an initial antibiotic treatment. The hospital laboratory performs the stool culture test and identifies Salmonella group C. The patient’s history and isolate are sent to the local public health laboratory for epidemiological testing and confirmation of the relationship to the known outbreak. The public health laboratory performs further testing and confirms the patient is part of the existing outbreak. The reportable condition is escalated to additional recipients indicated in the report that is shared with the care provider and additional public health agencies.
  • Non-Human Subject: Water, milk, and meat samples are routinely tested to meet various regulatory requirements. Water testing includes municipal drinking water, well water, open swimming beaches, and public pools to test for coliform levels. Milk samples are tested for total bacteria counts prior to pasteurization. Meat is tested for harmful bacteria such as Escherichia coli 0157:H7.
  • Human(patient) with Non-Human Subject: Animal control authorities bring to the public health laboratory the head of a ferret that ferociously pursued and bit a young child. The specimen is to be tested for Rabies to determine if the child must undergo Rabies immunization. The public health laboratory gets the incident information and performs the rabies test while the child’s physician awaits the results. The rabies test is negative. A public health laboratory report is created for the physician that references the child as the patient and the test subject as the ferret.

Clinical Document Header

General Constraints on the Header

  1. As in XDS-Lab, all entities in a PHLab document are required to be accompanied by a name, address and telecom unless otherwise specified below.
  2. 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

<ClinicalDocument xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" 
                  xmlns="urn:hl7-org:v3" xmnls:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2" 
                  xsi:schemaLocation="urn:hl7-org:v3 CDA.xsd">
  <realmCode code="US" codeSystem="2.16.1" codeSystemName="ISO3166-1" displayName="US"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId extension="Lab.Report.Clinical.Document" root="1.3.6.1.4.1.19376.1.3.3"/>
  <id root="1.19.6.11.13.103000012000025132.1181266627192.1"/>
  <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="20070607183707.0222-0700"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US" codeSystem="2.16.840.1.113883.6.99" codeSystemName="ISO639-1" displayName="en-US"/>
  <setId extension="07SR012345" root="2.16.840.1.113883.1.3"/>
  <versionNumber value="1"/>
ClinicalDocument.realmCode

PHLab documents, like XDS-Lab documents, shall have a realmCode.

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 ClinicalDocument.recordTarget.

Human Patient

When the lab test subject is a biological sample taken from a human patient, the following shall be present.

  • ClinicalDocument.recordTarget.patientRole.id
  • ClinicalDocument.recordTarget.patientRole.addr
  • ClinicalDocument.recordTarget.patientRole.telecom
  • ClinicalDocument.recordTarget.patientRole.patient.name
  • ClinicalDocument.recordTarget.patientRole.patient.administrativeGenderCode
  • ClinicalDocument.recordTarget.patientRole.patient.birthTime

PHLab does not further refine the meaning of these elements beyond what is stated in the CDA R2 documentation.

  <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="tel:608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213000000.0000-0500"/>
      </patient>
    </patientRole>
  </recordTarget>

If in the event a unit of information about the patient is not known or has been de-identified, the use of nullFlavor is appropriate.

  <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>53545</postalCode>
         <country>USA</country>
      </addr>
      <telecom nullFlavor="UNK"/> <!-- unknown value -->
      <patient classCode="PSN">
        <name nullFlavor="MSK"/> <!-- masked value -->
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213000000.0000-0500"/>
      </patient>
    </patientRole>
  </recordTarget>
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.

  • ClinicalDocument.recordTarget.patientRole.id shall be present and shall represent the id of the non-human subject.
  • The record target shall have a patient sub-element and it's nullFlavor shall be set to "OTH". This indicates that other information pertaining to the non-human subject can be found in the body of the document in section.entry.act.subject.
  <recordTarget typeCode="RCT">
    <patientRole classCode="PAT">
       <id extension="66373839" root="1.19.6.11.13"/>
      <patient nullFlavor="OTH">
    </patientRole>
  </recordTarget>
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 rabies) the following shall be present.

  • ClinicalDocument.recordTarget.patientRole.id
  • ClinicalDocument.recordTarget.patientRole.addr
  • ClinicalDocument.recordTarget.patientRole.telecom
  • ClinicalDocument.recordTarget.patientRole.patient.name
  • ClinicalDocument.recordTarget.patientRole.patient.administrativeGenderCode
  • ClinicalDocument.recordTarget.patientRole.patient.birthTime

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 section.entry.act.subject.

  <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="tel:608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213000000.0000-0500"/>
      </patient>
    </patientRole>
  </recordTarget>

If in the event a unit of information about the patient is not known or has been de-identified, the use of nullFlavor is appropriate. Please see ClinicalDocument.RecordTarget - Human Patient for an example usage of nullFlavor.

ClinicalDocument.Author

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 author. Please see the following CP to XDS-Lab for additional comments we have regarding this constraint on the author. (CP accepted)

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 informationRecipient 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 informationRecipient 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.

Order Information

No different from the clinical laboratory setting, a public health laboratory executes tests 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. Please see the following CP to XDS-Lab (Partially Accepted) for more information regarding documentation of the order.

ClinicalDocument.Participant (typeCode = 'REF')

This participant, consistent in definition with XDS-Lab, represents the 'Order Placer Provider' (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:

  • Participant.typeCode

shall be present and shall be set to "REF" to indicate that this participant is the 'Order Placer Provider'.

  • Participant.associatedEntity.id

shall be present and represents the id of the 'Order Placer Provider' which is defined by the HL7 v2.5 messaging specification (ORC-12)

  • Participant.associatedEntity.addr

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)

  • Participant.associatedEntity.telecom

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)

  • Participant.associatedEntity.associatedPerson.name

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:

  • Participant.time

may be present and shall represent the 'Order Placer Order Effective Time' which is defined by HL7 v2.5 messaging specification (ORC-15).

  <participant typeCode="REF">
    <time>
      <low value="20071104055700.0000-0500"/>
      <high value="20071104131600.0000-0500"/>
    </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="tel:312-555-5555"/>
      <associatedPerson>
        <name><family>Patel</family><given>Kiran</given><prefix>Dr</prefix></name>
      </associatedPerson>
      <scopingOrganization>
        <id extension="rm83747" root="1.19.6.11.13"/>
        <name>Hospital</name>
        <telecom value="tel:312-555-5555"/>
        <addr>
          <streetAddressLine>7000 Hosptial Drive</streetAddressLine>
          <city>Chicago</city>
          <state>IL</state>
          <postalCode>60622</postalCode>
          <country>USA</country>
       </addr>
      </scopingOrganization>
    </associatedEntity>
  </participant>

If in the event a unit of information about the 'Order Placer Provider' is not known or has been de-identified, the use of nullFlavor is appropriate. Please see ClinicalDocument.RecordTarget - Human Patient for an example usage of nullFlavor.

ClinicalDocument.Participant (typeCode = 'ENT')

REMOVED
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. A participant of type "ENT" is not appropriate as the entry is not performed in the system generating the laboratory report. Unknown resolution. Left out of scope.

ClinicalDocument.InFulfillmentOf

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation, however, we make the following usage notes. This element can be used to document both the 'Placer Order Number'(OBR-2 in HL7 v2.5 messaging) and the 'Filler Order Number' (OBR-3 in HL7 v2.5 messaging).

  <inFulfillmentOf>
    <order>
      <id extension="28902809" root="1.19.6.11.13"/>
    </order>
  </inFulfillmentOf>

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 ClinicalDocument.DocumentationOf element is used to this effect.

The ClinicalDocument.DocumentationOf shall be present and shall have the following:

  • ServiceEvent.effectiveTime shall be present and shall be specified using the low and high subelements. These times shall represent the time span of events described in the PHLab document.


The ClinicalDocument.DocumentationOf shall be present and may have the following:

  • A PHLab document may make use of the CDA R2 extension ServiceEvent.statusCode in accordance with the XDS-Lab specification. Therefore, ServiceEvent.statusCode may be present.
  • ServiceEvent.performer may be present and shall represent the primary individual and laboratory organization that produced the Result Event. Results produced by assisting laboratories shall override this information in the body of the document. It is permissable to document all performers in the body of the document in their respective places. the ServiceEvent.performer is subject to the following refinements:
    • performer.assignedEntity.id,
      performer.assignedEntity.addr,
      performer.assignedEntity.telecom,
      performer.assignedEntity.assignedPerson.name
      shall be present and shall represent the performer which is equivalent in concept to the HL7v2.5 messaging concept Responsible Observer (OBX-15,OBX-16).
    • performer.time may be present and shall represent the HL7 v2.5 messaging concept Date/Time of Analysis (OBX-19).

Please additionally see the following CP to XDS-Lab (Accepted) for more information regarding the performer.

  <documentationOf>
    <serviceEvent>
      <effectiveTime>
        <low value="20071104000000.0000-0400"/>
        <high value="20071108000000.0000-0500"/>
      </effectiveTime>
      <performer/>
      <performer typeCode="PRF">
        <assignedEntity>
          <id extension="rm83747" root="1.19.6.11.13"/>
          <addr>
             <streetAddressLine>7000 Hospital Drive</streetAddressLine>
             <city>Chicago</city>
             <state>IL</state>
             <postalCode>60622</postalCode>
             <country>USA</country>
          </addr>
          <telecom value="tel:312-555-5555"/>
          <assignedPerson>
            <name><family>Trenton</family><given>Douglas</given><prefix>Dr.</prefix></name>
          </assignedPerson>
          <representedOrganization>
            <id extension="rm83747" root="1.19.6.11.13"/>
            <name>Hospital Laboratory</name>
            <telecom value="tel:312-555-5555"/>
            <addr>
             <streetAddressLine>7000 Hospital Drive</streetAddressLine>
             <city>Chicago</city>
             <state>IL</state>
             <postalCode>60622</postalCode>
             <country>USA</country>
            </addr>
          </representedOrganization>
        </assignedEntity>
      </performer>
    </serviceEvent>
  </documentationOf>

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, though we have a question regarding its use in XDS-Lab. See the following CP(Accepted).

ClinicalDocument.componentOf

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.

  <componentOf>
    <encompassingEncounter>
      <id extension="ENC1234" root="1.19.6.11.13"/>
      <effectiveTime value="20071104000000.0000-0400"/>
      <location>
        <healthCareFacility>
          <code code="HU" codeSystem="2.16.840.1.113883.5.10588" codeSystemName="HL7 Service Delivery Location" 
                displayName="Hospital Unit"/>
        </healthCareFacility>
      </location>
    </encompassingEncounter>
  </componentOf>

Clinical Document Body

General Constraints on the Body

  1. As in XDS-Lab, all entities in a PHLab document are required to be accompanied by a name, address and telecom unless otherwise specified below.
  2. Body 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.
  3. The body of a PHLab document is consistent in structure with XDS-Lab (Microbiology section 7.3.3.5.3 and example 9.3.4), though we extend it's use here beyond microbiology.
    • Each Section corresponds to a single laboratory section (as in XDS-Lab). One Section, described as follows, shall be present. Other Sections conforming to XDS-Lab document specifications which detail conditions or findings that are not required to be reported may be present.
    • There shall be one Entry in the Section and this Entry shall use the 'Lab.Report.Data.Processing.Entry' templateId.
    • The Entry shall contain a single Act sub-element. This Act is hereafter referred to as the 'Specimen Act'. There shall be exactly one Entry with one 'Specimen Act'.
    • Each 'Specimen Act' shall contain at least three EntryRelationship elements; one representing the Specimen Received Date/Time and one representing the Reportable Condition; and the third (or more) representing the laboratory test result(s).
    • In the case of a microbiology isolation, the EntryRelationship for test results shall contain a single Organizer element. This Organizer is groups the isolate identification with its respective laboratory tests.

Section

Each Section corresponds to a single laboratory section (as in XDS-Lab). One Section, described as follows, shall be present. Other Sections conforming to XDS-Lab document specifications which detail conditions or findings that are not required to be reported may be present.

The required section for the PHLab document Section shall have the following:

  • Section.text shall be present. Each result presented here in text shall be linked using xml "ID" with corresponding result markup in the structured Entry.


A Section may have the following:

  • Section.code

may be present and shall be chosen among the coded specialities specified in XDS-Lab (7.1.1) and shall be consistent with ClinicalDocument.code

  • Section.title

may be present and its use is encouraged.

  • Section.text.renderMultimedia

may be present. Inclusion of images or other external content associated with a particular result shall be structured according to CDA documentation. Additionally see Observation Media.

   <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>Public Health Laboratory Report</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 tennessee 6,7,14;z29;1,2,7</td>
                  <td>6463-4</td>
                  <td>79153007</td>
                </tr>
              </tbody>
            </table><table>
              <thead>
                <tr>
                  <th>Salmonella Susceptibility</th>
                  <th>Interpretation</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tbody>
                <tr ID="a0">
                  <td>Tetracycline</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
                <tr ID="a1">
                  <td>Ciprofloxacin</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
                <tr ID="a2">
                  <td>Trimethprim + Sulfamethoxazole</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
                <tr ID="a3">
                  <td>Ampicillin</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
                <tr ID="a4">
                  <td>Chloramphenicol</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
                <tr ID="a5">
                  <td>Ceftriaxone</td>
                  <td>Susceptible</td>
                  <td></td>
                </tr>
              </tbody>
            </table>
        </text>

Specimen Act

There shall be one Entry in the Section and this Entry shall use the 'Lab.Report.Data.Processing.Entry' templateId. The Entry shall contain a single Act sub-element. This Act is hereafter referred to as the 'Specimen Act'. There shall be exactly one Entry with one 'Specimen Act'. Each 'Specimen Act' shall contain at least three EntryRelationship elements; one representing the Specimen Received Date/Time and one representing the Reportable Condition; and the third (or more) representing the laboratory test result(s).

          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              <statusCode code="completed"/>
Act.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 Act.Subject shall be present and shall represent the non-human subject of laboratory testing. When RecordTarget.PatientRole.Patient.nullFlavor is set to "OTH", then RecordTarget.PatientRole.id shall represent the id of the non-human laboratory test subject. For more information, refer back to ClinicalDocument.RecordTarget.

When Act.Subject is present the following shall be present:

  • Subject.code shall be present and shall represent the type of animal or material tested (ex. chicken, fish, egg salad, water, soil, air, paint, etc.).


When Act.Subject is present the following may be present:

  • Subject.addr may be present and shall represent the location where this subject was found or originated (ex. farm address, restaurant address, factory address, reservoir address, etc.) If in the event a unit of information is not known or has been de-identified, the use of nullFlavor is appropriate.
         <subject>
            <relatedSubject>
                <code code="18998007" codeSystem="2.16.840.1.113883.6.96" 
                      codeSystemName="SNOMED-CT" displayName="Ferret species">
                    <qualifier>
                        <name code="105590001" codeSystem="2.16.840.1.113883.6.96" 
                              codeSystemName="SNOMED-CT" displayName="Substance"/>
                        <value code="39866004" codeSystem="2.16.840.1.113883.6.96" 
                               codeSystemName="SNOMED-CT" displayName="Animal"/>
                    </qualifier>
                 </code>
                 <addr>
                    <streetAddressLine>304 Portola Road</streetAddressLine>
                    <city>San Jose</city> 
                    <state>CA</state> 
                    <postalCode>95120</postalCode> 
                    <country>USA</country> 
                 </addr>
            </relatedSubject>
         </subject>

At present, if the document contains both a patient and a subject (as in the case of rabies), documentation of the id of the subject cannot be accomplished without an extension to CDA. See Open Issues #1.

Act.Specimen

This element represents the specimen recieved by the public health lab and is consistent with the XDS-Lab documentation, including the optional productOf CDA R2 extension.

         <specimen typeCode="SPC">
            <specimenRole classCode="SPEC">
               <id extension="55584739900388" root="1.19.6.11.13"/>
               <specimenPlayingEntity>
                   <code code="STL" codeSystem="2.16.840.1.113883.5.129" codeSystemName="HL7" displayName="Stool"/>
                </specimenPlayingEntity>
                <lab:productOf typeCode="PRD">
                  <lab:procedure classCode="PROC" moodCode="EVN">
                    <effectiveTime value="20071104000000.0000-0400"/>
                    <participant>
                      <participantRole>
                        <addr>
                          <streetAddressLine>7000 Hosptial Drive</streetAddressLine>
                          <city>Chicago</city>
                          <state>IL</state>
                          <postalCode>60622</postalCode>
                          <country>USA</country>
                        </addr>
                        <telecom value="tel:312-555-5555"/>
                      </participantRole>
                    </participant>
                  </lab:procedure>
                </lab:productOf>
            </specimenRole>
         </specimen>
Act.Performer

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation, though we have a question regarding its restricted use in XDS-Lab. See the following CP (Accepted).

Act.Participant (typeCode = "PRF")

PHLab uses this participant to document the performer of a laboratory test. Please additionally see the following CP to XDS-Lab (Accepted) for more information regarding the performer.

Act.Participant (typeCode = "DEV")

Zero or more Act.Participant (typeCode="DEV") may be present. This elementshall be used to represent the 'Equipment Instance', a concept further defined in HL7 v2.5 messaging (OBX-18), used to perform the lab test result.

If this participant is present and represents the 'Equipment Instance' the following shall be present:

  • Participant.ParticipantRole.PlayingDevice

shall be present and shall represent the 'Equipment Instance' device (OBX-18) which shall be represented using at least one of the following - PlayingDevice.code, PlayingDevice.softwareName, PlayingDevice.manufacturerModelName

To our knowledge, this concept is not in XDS-Lab, therefore we pose the following CP (Accepted).

Act.Participant (typeCode = "AUTHEN")

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation, though we have a question regarding its use in XDS-Lab. See the following CP (Accepted).

Specimen Received Date/Time EntryRelationship

The 'Specimen Act' shall have an EntryRelationship element that represents the act of specimen receiving. This shall be represented as an Act sub-element of this EntryRelationship .

The following shall be present:

  • Act.templateId shall be present and shall indicate this act is conforms to this specification for Specimen Received Date/Time. PCC will assign a templateId for this act.
  • Act.code shall be present and shall indicate the reception of the specimen.
    • code shall be set to 'SPC_REC'
    • codeSystem shall be set to the PHLab templateId (currently using XDS-Lab templateId until our reconciliation is complete).
    • codeSystemName shall be set to 'PHLab'.
  • Act.effectiveTime

shall be present and shall represent the 'Specimen Received Date/Time', a concept further from HL7 v2.5 messaging (OBR-14). PCC is committed to working with terminology developers to identify/assign a formal code for this concept.

              <entryRelationship typeCode="COMP">
                <act classCode="ACT" moodCode="EVN">
                  <templateId root="TBD"/>
                  <code code="SPC_REC_TBD" codeSystem="2.1.1.1.1.1.1" codeSystemName="TBD" 
                        displayName="Specimen Received"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
                </act>
              </entryRelationship>

For more information, see the following CP.

Reportable Condition EntryRelationship

The 'Specimen Act' shall have an EntryRelationship element that represents the reportable condition observation. This shall be represented as an Observation sub-element of this EntryRelationship .

The following shall be present:

  • Observation.templateId shall be present and shall indicate this observation conforms to this specification for Reportable Condition. PCC will assign a templateId for this observation.
  • Observation.code shall be present and shall indicate this observation represents the notifiable condition. The following values are recommended:
    • code="P0-007BF"
    • codeSystem="2.16.840.1.113883.6.96"
    • codeSystemName="SNOMED-CT"
    • displayName="Notification of Disease"
  • Observation.value shall be present and shall indicate the reportable condition.


The following may be present:

  • Observation.code.qualifier may be present
    • example qualifier use: (value code="F-611B1" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Animal")
    • example qualifier use: (value code="C-F0125" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Food")


<entryRelationship typeCode="COMP">
  <observation classCode="OBS" moodCode="EVN">
    <code code="P0-007BF" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Notification of Disease">
      <qualifier>
        <name code="G-C186" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Source of Specimen"/>
        <value code="S-16000" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Patient"/>
      </qualifier>
    </code>
    <value xsi:type="CE" code="27268008" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" displayName="Salmonella">
      <translation code="6463-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Salmonella"/>
      <translation code="L-17100" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" displayName="Salmonella"/>
    </value>
  </observation>
</entryRelationship>

Laboratory Test Result EntryRelationship(s)

The 'Specimen Act' shall have one or more EntryRelationship elements that representing the laboratory test result(s). In the case of a microbiology isolation, the EntryRelationship for test results shall contain a single Organizer element. This Organizer is groups the isolate identification with its respective laboratory tests.

Isolate Identification Organizer

The 'Isolate Identification Organizer' shall have the following:

  • Organizer.classCode

shall be present and shall have the value "CLUSTER".

  • Organizer.moodCode

shall be present and shall have the value "EVN".

  • Organizer.statusCode

shall be present and shall be set to a value appropriate.

              <entryRelationship typeCode="COMP">
                <organizer classCode="CLUSTER" moodCode="EVN">
                  <statusCode code="completed"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
Organizer.Specimen

In the case of an isolate identification, the Organizer.Specimen shall be present and shall represent the isolate identification.

The following shall be present:

  • Specimen.SpecimenRole

shall be present and its classCode shall be set to "ISLT".

  • Specimen.SpecimenRole.SpecimenPlayingEntity.code

shall be present and shall contain the code representing the isolate identification.


                  <specimen>
                    <specimenRole classCode="ISLT">
                      <specimenPlayingEntity>
                        <code code="79153007" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED-CT" 
                              displayName="Salmonella tennessee 6,7,14;z29;1,2,7"/>
                      </specimenPlayingEntity>
                    </specimenRole>
                  </specimen>
Battery Tests

Test Results, when part of a battery test, shall appear as sub-elements of an Organizer element. This Organizer shall be hereafter referred to as the 'Battery Test Organizer' and shall be a sub-element of the 'Isolate Identification Organizer', in the case of microbiology isolate identification, or of a Laboratory Test EntryRelationship. Each battery test result shall be represented as an Observation element. The 'Battery Test Organizer' shall have two or more component elements each containing an Observation element which shall be as documented specified in the following section.

The 'Battery Test Organizer' shall have the following:

  • Organizer.classCode

shall be present and shall have the value "BATTERY".

  • Organizer.moodCode

shall be present and shall have the value "EVN".

  • Organizer.statusCode

shall be present and shall be set to a value appropriate.

                  <component>
                    <organizer classCode="BATTERY" moodCode="EVN">
                      <code code="29576-6" codeSystem="2.16.840.1.113883.6.1" 
                            codeSystemName="LOINC" displayName="Microbiology Susceptibility"/>
                      <statusCode code="completed"/>
                      <effectiveTime value="20071108000000.0000-0500"/>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18993-6" codeSystem="2.16.840.1.113883.6.1" 
                                codeSystemName="LOINC" displayName="Tetracycline">
                            <originalText><reference value="a1"/></originalText>
                          </code>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219" 
                                             displayName="Susceptible"/>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18906-8" codeSystem="2.16.840.1.113883.6.1" 
                                codeSystemName="LOINC" displayName="Ciprofloxacin">
                            <originalText><reference value="a2"/></originalText>
                          </code>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219"
                                              displayName="Susceptible"/>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18995-5" codeSystem="2.16.840.1.113883.6.1" 
                                codeSystemName="LOINC" 
                                displayName="Trimethprim + Sulfamethoxazole">
                            <originalText><reference value="a3"/></originalText>
                          </code>
                          <interpretationCode code="S" 
                                              codeSystem="2.16.840.1.113883.11.10219" 
                                              displayName="Susceptible"/>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18864-9" codeSystem="2.16.840.1.113883.6.1"  
                                codeSystemName="LOINC" displayName="Ampicillin">
                            <originalText><reference value="a4"/></originalText>
                          </code>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219"
                                              displayName="Susceptible"/>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18903-5" codeSystem="2.16.840.1.113883.6.1" 
                                codeSystemName="LOINC" displayName="Chloramphenicol">
                            <originalText><reference value="a5"/></originalText>
                          </code>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219" 
                                              displayName="Susceptible"/>
                        </observation>
                      </component>
                      <component>
                        <observation classCode="OBS" moodCode="EVN">
                          <code code="18895-3" codeSystem="2.16.840.1.113883.6.1"
                                codeSystemName="LOINC" displayName="Ceftriaxone">
                            <originalText><reference value="a6"/></originalText>
                          </code>
                          <interpretationCode code="S" codeSystem="2.16.840.1.113883.11.10219" 
                                              displayName="Susceptible"/>
                        </observation>
                      </component>
                    </organizer>
                  </component>
Test Results

Test Results shall appear as components under the 'Battery Test Organizer', when results are a part of a battery test, as components under 'Isolate Identification Organizer', in the case of microbiology isolate identification, or as a sub-element of a Laboratory Test EntryRelationship(s). Each test result shall be represented as an Observation element. One or more laboratory test results shall be associated with this document.

For each Observation, the following shall be present:

  • Observation.code

shall be present and shall represent the lab test id consistent in meaning with HL7 v2.5 message component OBR-4. The use of LOINC test identifiers is recommended. Observation.code.originalText.reference shall be present and shall reference the element of Section.text where this result is also documented.

  • Observation.effectiveTime


For each Observation, the following may be present:

  • Observation.value
  • Observation.referenceRange
  • Observation.interpretationCode
  • Observation.methodCode
  • Observation.text
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <code code="89029-0" codeSystem="2.16.840.1.113883.6.1" 
                            codeSystemName="LOINC" displayName="Microbiology Culture">
                        <originalText><reference value="isoTest"/></originalText>
                      </code>
                      <text>Isolation Test Result Comment</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20071108000000.0000-0500"/>
                      <value xsi:type="CE" code="1116048001"
                             codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" 
                             displayName="Salmonella Group C"/>
                      <performer typeCode="PRF">
                        <assignedEntity>
                          <id extension="rm83747" root="1.19.6.11.13"/>
                          <addr>
                              <streetAddressLine>7000 Hospital Drive</streetAddressLine>
                              <city>Chicago</city>
                              <state>IL</state>
                              <postalCode>60622</postalCode>
                              <country>USA</country>
                          </addr>
                          <telecom value="tel:312-555-5555"/>
                          <assignedPerson>                     
                           <name>
                              <family>Trenton</family>
                              <given>Douglas</given>
                              <prefix>Dr.</prefix>
                           </name>
                          </assignedPerson>
                          <representedOrganization>
                            <id extension="rm83747" root="1.19.6.11.13"/>
                            <name>Hospital Laboratory</name>
                            <telecom value="tel:312-555-5555"/>
                            <addr>
                              <streetAddressLine>7000 Hospital Drive</streetAddressLine>
                              <city>Chicago</city>
                              <state>IL</state>
                              <postalCode>60622</postalCode>
                              <country>USA</country>
                            </addr>
                          </representedOrganization>
                        </assignedEntity>
                      </performer>
                    </observation>
                  </component>
                  <component>
                    <observation classCode="OBS" moodCode="EVN">
                      <code code="20951-0" codeSystem="2.16.840.1.113883.6.1"
                            codeSystemName="LOINC" displayName="Salmonella Serotype">
                        <originalText><reference value="serotypeTest"/></originalText>
                      </code>
                      <text>Serotype Test Result Comment</text>
                      <statusCode code="completed"/>
                      <effectiveTime value="20071108000000.0000-0500"/>
                      <value xsi:type="CE" code="79153007" codeSystem="2.16.840.1.113883.6.96"
                             codeSystemName="SNOMED" 
                             displayName="Salmonella tennessee 6,7,14;z29;1,2,7"/>
                    </observation>
                  </component>
Observation.EntryRelationship.ObservationMedia

Inclusion of images or other external content associated with a particular result shall be structured according to CDA documentation. When an image is included or other external content as part of a result and a Section.text.renderMultimedia is present, Observation.EntryRelationship.ObservationMedia shall be present on the corresponding Observation.

When Observation.EntryRelationship.ObservationMedia is present, the following shall be present:

  • ObservationMedia.value

shall be present. It shall contain as #CDATA the base-64 encoded content. Additionally, ObservationMedia.value.representation shall be "B64" and ObservationMedia.value.mediaType shall be present.

<observationMedia classCode="OBS" moodCode="EVN" ID="PULSE_NET_IMAGE">
    <id root="2.16.840.1.113883.19.2.1"/>
    <value mediaType="image/gif" representation="B64">Here is the inline B64 content</value>
</observationMedia>
Observation.Performer

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation, though we have a question regarding its restricted use in XDS-Lab. See the following CP (Accepted).

Observation.Participant (typeCode="PRF")

PHLab uses this participant to document the performer of a laboratory test. Please additionally see the following CP to XDS-Lab (Accepted) for more information regarding the performer.

Observation.Participant (typeCode="DEV")

Zero or more Observation.Participant (typeCode="DEV") may be present. This element shall be used to represent the 'Equipment Instance', a concept further defined in HL7 v2.5 messaging (OBX-18), used to perform the lab test result. Specifications for the 'Equipment Instance are identical to those in Act.Participant (typeCode="DEV") and may be specified on the test result when the 'Equipment Instance' for this test differs from that documented in the Act or when no 'Equipment Instance' is documented in the Act.

To our knowledge, this concept is not in XDS-Lab, therefore we pose the following CP(Accepted) .

Observation.Participant (typeCode = "AUTHEN")

PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation, though we have a question regarding its use in XDS-Lab. See the following CP (Accepted).

Change Proposals to Other IHE Profiles

ClinicalDocument.typeId CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

XML CDA Samples are missing <typeId> elements.

Suggested Edits:

Include the <typeId> element in CDA XML examples, for completeness.

Status:Accepted/Done - section 6.5

ClinicalDocument.templateId CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

XDS-Lab does not specify a document templateId for XDS-Lab documents. A templateId is present for other CDA-based content profiles.

Suggested Edits:

Generate a templateId for XDS-Lab documents and create a section between 6.4 and 6.5.

Status:Accepted/Done - section 6.6

ClinicalDocument.id CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

XML CDA Samples are missing <id> elements on the <ClinicalDocument> which renders the CDA invalid.

Suggested Edits:

Include the <id> element in CDA XML examples, for completeness and accuracy.

Status:Accepted/Done - section 6.7

ClinicalDocument.RecordTarget CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

It is unclear the meaning of the word “identity”. This word is not a concept we could associate within the CDA schema.

Suggested Edits:

6.12 ClinicalDocument/recordTarget
This element encapsulates the patient, target of this laboratory report, with its ID, identity, address and telecom.

Status:Accepted/Done - section 6.14 changed identity to demographics

ClinicalDocument.Author CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

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.

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, as consistent with CDA R2 documentation. See also here

Suggested Edits:

6.12 ClinicalDocument/author
The author(s) of the laboratory report. In use cases 2.2 and 2.4, the laboratory report is produced by a software system represented by the element:
author/assignedAuthor/assignedAuthoringDevice/softwareName.

The author/time element carries the date&time the laboratory report was produced by the system. In use cases 2.1, 2.3 and 2.5 the report is prepared by a physician who is the assignedPerson.

Status:Accepted/Done - section 6.15 "software system, a person, or both"

Paticipant and Performer Usage CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:
  • Lab Test Order: When reading through and learning about XDS-Lab we started to draw many comparisons between it and concepts existing in HL7 v2.5 messaging. We feel this conceptual correlation is valuable to include in XDS-Lab. We also have added the concept of the 'Order Placer Enterer' in addition to the 'Order Placer Provider', already present in XDS-Lab, for completeness. Order Placer Enterer is deemed out of scope for XD-LAB. Order Placer Provider is documented as a REF participant. This has been reflected in the PHLab document.
  • Lab Test Performance:
    • ClinicalDocument.DocumentationOf.ServiceEvent.Performer - When reading through and learning about XDS-Lab we started to draw many comparisons between it and concepts existing in HL7 v2.5 messaging. We feel this conceptual correlation is valuable to include in XDS-Lab.
    • Act.Performer - Text in the XDS-Lab imples that this performer is only to be used when the laboratory testing is execued by a different lab than the one documented in the header (if present, otherwise this is a mute point). However, this seems to narrow CDA semantics in which use of this element would be appropriate if the person performing the laboratory test is different than the one in the header, regardless of which lab they are from. Accepted/Done
    • Act.Participant (typeCode='PRF') - XDS-Lab does not seem to include mark-up on the following concepts: Equipment Instance (OBX-18),Filler Order Number (OBR-3), Specimen Received Date/Time (OBR-14, SPM-18). We recommend that these be able to included at this level of the document body. Device participant "DEV" added. Order Filler order ID added. Specimen receive date/time left out of scope, however we have an alternative proposal: see Specimen Recieved Date/Time
    • Obervation.Performer - subject to same restriction as Act.Performer. Accepted/Done
    • Observation.Participant (typeCode='PRF') - XDS-Lab does not seem to include mark-up on the following concepts: Equipment Instance (OBX-18),Filler Order Number (OBR-3), Specimen Received Date/Time (OBR-14, SPM-18). We recommend that these be able to included at this level of the document body as well as in the act. Device participant "DEV" added. Order Filler order ID added. Specimen receive date/time left out of scope.
  • Lab Test Verification: We completely agree with the usage of these kinds of participants, however question the use of the typeCode 'VRF' instead of the typeCode 'AUTHEN'. In the header, all verifiers are listed, en mass, as ClinicalDocument.authenticator, but in the body they are parsed out to their respective sections or observations as Participants with typeCode 'VRF', which means something slightly different. The key confusion here is what is the difference between 'authentication' and 'verification' from the laboratory perspective? The semantics seem to be mixed in the document XD-LAB leaves decision to Keith, Keith approves that the typeCode should be 'AUTHEN'.
Suggested Edits:
  • Lab Test Order: Please see the follwing section of this document: Ordering participants
  • Lab Test Performance:
  • Lab Test Verification: Suggest to make all Lab Test Verifiers Participants with typeCode="VRF" throughout the header and the body of the document. "VRF" is defined as 'A person who verifies the correctness and appropriateness of the service (plan, order, event, etc.) and hence takes on accountability.' This seems most consistent with laboratory verification. Alternatively, one could change 'VRF' to 'AUTHEN' on relavant participants in the body, if in fact this is truly the case. Authenticator and 'AUTHEN' are defined as 'A verifier who attests to the accuracy of an act, but who does not have privileges to legally authenticate the act. An example would be a resident physician who sees a patient and dictates a note, then later signs it. Their signature constitutes an authentication'.
Status:Accepted - see red comments above for completion notes

Usage of XDS-Lab CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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 1
Rationale for Change:

A statement is made in line 400 of the XDS-lab that is not necessarily true in all cases in which a laboratory report could be used.

Suggested Edits:

Volume 1, Line 400: In all use cases above, the laboratory report document is built and published towards an EHR towards a document sharing resource, generally after the order (or order group) is fulfilled.

Status:Accepted/Done - section 4.1

Correlation with Existing Standards CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

Volume 1, lines 239-255 describe how the XDS-Lab profile is consistent with HL7v3, ELINCS, CCD and the HL7v2.5 based LAB-3 transaction. It would be particularly useful to implementers of this content profile if Volume 2 of the XDS-lab identified the which portions of the XDS-Lab document aligned (or correlated conceptually) with which portions of these standards.

Suggested Edits:

Volume 2: Identify which concepts/components of the list of Volume 1 standards are applicable to a particular XDS-Lab structure. See Order Information for a suggested method for enhancement.

Status:Accepted/Done for Order Placer and order ID

Documentation of CDA Extensions CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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, Section 10
Rationale for Change:

XDS-Lab makes optional extensions to the CDA. These are currently documented with narrative description, example XML and RIM diagrams. For implementors, it would be good to call out the CDA data types in schema format that are being used to represent the extensions. This would make the extensions available in all the documentation formats which CDA itself is available and understandable.

Suggested Edits:

Volume 2, Section 10: Add CDA data type information to the CDA extension documentation. Example: "productOf" extension for Specimen Collection documentation can be inferred as a participant type with a procedure sub-element. But are there other elements? Is the participation type like POCD_MT000040.Participant2 or POCD_MT000040.Participant1? Or is it somthing different:

<xs:complexType name="LAB.Participant">
   <xs:sequence>
	<xs:element name="realmCode" type="CS" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="typeId" type="POCD_MT000040.InfrastructureRoot.typeId" minOccurs="0"/>
	<xs:element name="templateId" type="II" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="time" type="IVL_TS" minOccurs="0"/>
	<xs:element name="procedure" type="POCD_MT000040.Procedure"/>
   </xs:sequence>
   <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/>
   <xs:attribute name="typeCode" type="ParticipationType" use="required" fixed="PRD"/>
   <xs:attribute name="contextControlCode" type="ContextControl" use="optional" fixed="OP"/>
</xs:complexType>

OR

<xs:complexType name="LAB.Participant">
   <xs:sequence>
	<xs:element name="realmCode" type="CS" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="typeId" type="POCD_MT000040.InfrastructureRoot.typeId" minOccurs="0"/>
	<xs:element name="templateId" type="II" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="time" type="IVL_TS" minOccurs="0"/>
	<xs:element name="procedure" type="LAB.Procedure"/>
   </xs:sequence>
   <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/>
   <xs:attribute name="typeCode" type="ParticipationType" use="required" fixed="PRD"/>
   <xs:attribute name="contextControlCode" type="ContextControl" use="optional" fixed="OP"/>
</xs:complexType>

<xs:complexType name="LAB.Procedure">
   <xs:sequence>
	<xs:element name="realmCode" type="CS" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="typeId" type="POCD_MT000040.InfrastructureRoot.typeId" minOccurs="0"/>
	<xs:element name="templateId" type="II" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="effectiveTime" type="IVL_TS" minOccurs="0"/>
   </xs:sequence>
   <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/>
   <xs:attribute name="classCode" type="ActClass" use="required"/>
   <xs:attribute name="moodCode" type="x_DocumentProcedureMood" use="required"/>
   <xs:attribute name="negationInd" type="bl" use="optional"/>
</xs:complexType>

Schema snippets really help clarify this kind information for implementors who are not RIM-savvy.

Status:Accepted/Not Done to Liking - section 10.2.2
Recommend:
<xs:schema targetNamespace="urn:oid:1.3.6.1.4.1.19376.1.3.2" 
 xmlns="urn:oid:1.3.6.1.4.1.19376.1.3.2" 
 xmlns:cda="urn:hl7-org:v3" 
 xmlns:xs="http://www.w3.org/2001/XMLSchema" 
 elementFormDefault="qualified">
 
 	<!--  import the cda namespace -->
 	<xs:import namespace="urn:hl7-org:v3" schemaLocation="POCD_MT000040.xsd"/>
 
	<!--
*****************************************************************************************
* XML schema for the XDS Lab schema extensions
*****************************************************************************************
-->
<xs:complexType name="LAB.Participant">
<xs:sequence>
	<xs:element name="realmCode" type="cda:CS" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="typeId" type="cda:POCD_MT000040.InfrastructureRoot.typeId" minOccurs="0"/>
	<xs:element name="templateId" type="cda:II" minOccurs="0" maxOccurs="unbounded"/>
	<xs:element name="time" type="cda:IVL_TS" minOccurs="0"/>
	<xs:element name="procedure" type="cda:POCD_MT000040.Procedure"/>
   </xs:sequence>
   <xs:attribute name="nullFlavor" type="cda:NullFlavor" use="optional"/>
   <xs:attribute name="typeCode" type="cda:ParticipationType" use="required" fixed="PRD"/>
   <xs:attribute name="contextControlCode" type="cda:ContextControl" use="optional" fixed="OP"/>
</xs:complexType>
<xs:element name="productOf" type="LAB.Participant"/>
</xs:schema>

XDS-Lab Bindings CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 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
Rationale for Change:

XDS-Lab does not present content bindings to XDS, XDR, XDM Metadata.

Suggested Edits:

Volume 2, Section 5.4: Recommend replacing this section with the following Bindings table presented in this document, minus the small additions specific to PHLab documents. Or to directly reference the content Bindings section of the PCC Technical framework which will hopefully reconcile with the table presented here.

Status:Accepted/Done XD-Lab will reference the updated Bindings Section of the PCC Technical Framework

PCC TF Bindings CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Friday June 8, 2007
Integration Profile affected:IHE Patient Care Coordination Technical Framework
Version of IHE Technical Framework:Supplement 2006-2007
Volume(s) and Section(s) affected:Volume 2
Rationale for Change:

The XDS, XDR and XDM Bindings presented in the PCC TF Volume 2 are out of date with the XDS, XDR and XDM specifications. Additionally, some of the source values and source types do not appear to be valid in all use cases.

Suggested Edits:

See the Bindings table presented in this document. New CPs (June 2008) created to complete the edit(TF-PCC-CP-0030,TF-PCC-CP-0032). Discrepancies are in red.

Status:New CPs submitted to finish the edit. Once complete XD-Lab and PHLab with just reference this table and make note of minimal extensions.

XDS-Lab Harmonization CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Monday December 3, 2007
Integration Profile affected:IHE Lab Technical Framework
Version of IHE Technical Framework:Supplement 2006-2007
Volume(s) and Section(s) affected:Volume 2
Rationale for Change:

Introduction of content modules (templates) to XDS-Lab

Suggested Edits:

See PCC_TF-1/PHLAB/XDSLAB_Harmonization

Status:In Progress

XDS-Lab Subject CP

Submitter’s Name(s) and e-mail address(es):Sarah Knoop and Sondra Renly
Submission Date:Monday December 3, 2007
Integration Profile affected:IHE Lab Technical Framework
Version of IHE Technical Framework:Supplement 2006-2007
Volume(s) and Section(s) affected:Volume 2
Rationale for Change:

Inability to provide subject Id and qualified code for non-human subjects

Suggested Edits:

CDA schema extension with follow-up to HL7 on supporting Id and changing CD to CE on subject.

Status:In Progress



Open Issues

  1. Is what we have documented the best way to accomodate a non-human subject in a CDA? In the case in which we have both a human patient and a non-human subject (ex. rabies), there is no way to document the id of the non-human subject. This is a concern. See XML below for an example.
  2. The PHLab profile text is based on several CPs that are (will) open against XDS-Lab and PCC Technical Framework. For a trial text of this profile, we will need to decide which of these CPs we can retain as text in this profile and which we have to defer, thus necessitating that we revert the text in the PHLab profile to a "pre-CP" state of XDS-Lab or the PCC TF.
  3. How do we support the concept of a case number in this document?
  4. Should we require XDSDocumentEntry.serviceStartTime, since in this context it correlates to either the original clinical encounter or the date of specimen collection (or recieve date) which is particulary important in public health?
  5. Currently the scope of the document is a single order and any (all) specimens stemming from that order and any (all) reportable contditions found among those specimens. This is so the relationship of the order and the tests requestes and thier corresponding results is preserved. If multiple orders are allowed then this relationship less obvious. Is this a concern? Or is it better to allow for multiple orders? RESOLUTION: We have decided to narrow the scope of a PHLab document to a single reportable condition found in a single specimen associated with a single, fulfilled order. See Preface.
  6. In documentation of the reportable condition in ClinicalDocument.component.structuredBody.component.section.entry.act.entryRelationship.organizer.specimen we encounter restricted vocabulary when it comes to the classCode on this element. "SPEC" is rather too general, but possible, and "ISLT" only applies when the laboratory section is microbiology. Do we need to extend the specimen classCode vocabulary?


The following is an example of the desired extension for subject id. If this were enabled, we would duplicate the id under the RecordTarget and here in the subject in the case in which only a non-human subject is present:

         <subject>
            <id root="1.19.6.11.13" extension="8373636387"/>
            <relatedSubject>
                <id/>
                <id/> <!-- zero to many ids here --> 
                <code code="18998007" codeSystem="2.16.840.1.113883.6.96" 
                      codeSystemName="SNOMED-CT"
                      displayName="Ferret species"/>
                 <addr>
                    <streetAddressLine>304 Portola Road</streetAddressLine>
                    <city>San Jose</city> 
                    <state>CA</state> 
                    <postalCode>95120</postalCode> 
                    <country>USA</country> 
                 </addr>
            </relatedSubject>
         </subject>

Sample Documents

Sample Document 1

Sample Document 1
<ClinicalDocument xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="urn:hl7-org:v3"
                  xmlns:lab="urn:oid:1.3.6.1.4.1.19376.1.3.2" 
                  xsi:schemaLocation="urn:hl7-org:v3 CDA.xsd">
  <realmCode code="US" codeSystem="2.16.1" codeSystemName="ISO3166-1" displayName="US"/>
  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
  <templateId extension="Lab.Report.Clinical.Document" root="1.3.6.1.4.1.19376.1.3.3"/>
  <id root="1.19.6.11.13.103000012000025132.1181266627192.1"/>
  <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="20070607183707.0222-0700"/>
  <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="Normal"/>
  <languageCode code="en-US" codeSystem="2.16.840.1.113883.6.99" codeSystemName="ISO639-1" displayName="en-US"/>
  <setId extension="07SR012345" root="2.16.840.1.113883.1.3"/>
  <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="tel:608-555-5555"/>
      <patient classCode="PSN">
        <name><family>Winters</family><given>Shelly</given></name>
        <administrativeGenderCode code="F"/>
        <birthTime value="19401213000000.0000-0500"/>
      </patient>
    </patientRole>
  </recordTarget>
  <author>
    <time value="20070607183707.0222-0700"/>
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