PCC TF-1/PHLAB/XDSLAB Harmonization

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Intro

The use of content modules in XDS-Lab helps lab remain consistent with what other domains have accomplished as well as insures that the lab domain provides guidance to the other domains as they incorporate relevant laboratory data into their own content profiles.

Benefits:

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


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.

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

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.


CDA Document Content Modules

CDA Header Content Modules

CDA Section Content Modules

CDA and HL7 Version 3 Entry Content Modules

OPEN ISSUES

  • alignment with CCD? CRS?
  • templates for concepts that are duplicated in header and body (ex. lab performer, lab result verifier)
  • missing codes (LOINC)
  • end result documentation - in PCC, in XDS-Lab?

Differed for later discussion

use of serviceEvent/effective time

  • Laboratory Summary Date/Time Duration(template?)

Specimen

XDS-Lab Current Specification: <specimen> block

Proposed Specification: no change

Reason for template: re-usability 

<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <specimen typeCode="SPC">
                <templateId root='TBD'/>
                <specimenRole classCode="SPEC">
                  <id extension="555847" root="1.19.6.11.13"/>

Annotation Comment (PCC)

We would like XDS-Lab to adopt the Annotation Comment content module for comments.


Reason for template: consistency with existing content module

Change Proposals: PCC Change Proposal Wiki List 


<ClinicalDocument
  ...
  <component typeCode="COMP">
    <structuredBody classCode="DOCBODY" moodCode="EVN">
      <component typeCode="COMP">
        <section classCode="DOCSECT">
          ...
          <text>
            <table>
              <thead ID="rabiesTest">
                <tr>
                  <th>Rabies Virus</th>
                  <th>Subject</th>
                  <th>Comments</th>
                </tr>
              </thead>
              <tfoot ID="rabiesTestComment">
                <tr>
                  <td>Repeat confirmed negative</td>
                </tr>
              </tfoot>
              <tbody>
                <tr>
                  <td>Rabies virus not found.</td>
                  <td>ferret</td>
                  <td ID="rabiestTestR1Comment">Reagent lot 34</td>
                </tr>
              </tbody>
            </table>
            <paragraph ID="sComment">Report level comment goes here.</paragraph>
          </text>
          ...
          <entry typeCode="DRIV">
            <templateId extension="Lab.Report.Data.Processing.Entry" root="1.3.6.1.4.1.19376.1.3"/>
            <act classCode="ACT" moodCode="EVN">
              ...
              <entryRelationship typeCode="COMP">
                <observation classCode="OBS" moodCode="EVN">
                  <code code="C58990" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Rabies Test">
                    <originalText><reference value="rabiesTest"/></originalText>
                  </code>
                  <statusCode code="completed"/>
                  <effectiveTime value="20071108000000.0000-0500"/>
                  <value xsi:type="CE" code="59881000" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED" 
                                       displayName="Rabies Virus"/>
                  <entryRelationship typeCode="COMP">
                    <act classCode="ACT" moodCode="EVN">
                      <templateId root='2.16.840.1.113883.10.20.1.40'/>
                      <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
                      <code code="48767-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Annotation Comment"/>
                      <text><reference value="rabiestTestR1Comment"/></text>
                      <statusCode code='completed'/>
                    </act>
                  </entryRelationship>
                  <entryRelationship typeCode="COMP">
                    <act classCode="ACT" moodCode="EVN">
                      <templateId root='2.16.840.1.113883.10.20.1.40'/>
                      <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
                      <code code="48767-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Annotation Comment"/>
                      <text><reference value="rabiestTestTComment"/></text>
                      <statusCode code='completed'/>
                    </act>
                  </entryRelationship>
                </observation>
              </entryRelationship>
              ...
              <entryRelationship typeCode="COMP">
                <act classCode="ACT" moodCode="EVN">
                  <templateId root='2.16.840.1.113883.10.20.1.40'/>
                  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>
                  <code code="48767-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Annotation Comment"/>
                  <text><reference value="sComment"/></text>
                  <statusCode code='completed'/>
                </act>
              </entryRelationship>
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