Lab Public Health Reporting Content
Introduction
This is a draft of the Cross Enterprise Sharing of Laboratory Documents for Public Health (XDS-PHLab) to the Patient Care Coordination Technical Framework. This draft is a work in progress, not the official supplement or profile.
Volume 1
Public Health Laboratory Report Integration Profile
The motivation for developing this profile is as follows:
- Show that the same standards that support the current IHE profiles for clinical care interoperability can be leveraged by public health.
- Encourage the public health community to come forward to IHE with use cases to further enhance data sharing.
Our goal with this profile is to adapt XDS-LAB integration content profile to accommodate data for a public health laboratory report. Modifications to XDS-LAB will be needed to accommodate non-human subjects, document participants in the laboratory testing process, and to group tests for a reportable condition in a consistent manner. Leveraging the CDA R2 standard and XDS-LAB make the resultant document consumable by public health and incorporable in an effected patient’s medical record thereby completing a communication loop between individual and public care.
Dependencies
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.
Options
| Actor | Option |
|---|---|
| Content Consumer | View Option (1) |
| Document Import Option (1) | |
| Section Import Option (1) | |
| Discrete Data Import Option (1) |
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.
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.
| Content | Binding | Actor | Optionality |
| Publc Health Laboratory Report | Medical Document Binding to XD* | Content Creator | R |
| Content Consumer | R |
PHLab Document Content Module
An Public Health Laboratory Report content document is a type of laboratory report, and incorporates the constraints defined for laboratory reports found in section the XDS-Lab specification. In addition, the PHLab profile modifies XDS-LAB integration content profile to accommodate data for a public health laboratory report. By leveraging the CDA R2 standard and XDS-LAB, a PHLab document is consumable by public health and incorporable in an effected patient’s medical record thereby completing a communication loop between individual and public care.
PHLab Process Flow
NOTE: we are working with HITSP/PHDSC to refine this use case
Use Case 1: Case Report for a Public Health Reportable Condition with Laboratory Component
Reality Today:
John Doe, MD sees a patient and suspects that this patient has an enteric pathogen. The patient follows through on the doctor’s orders and submits a stool specimen to the clinic's laboratory. Upon completion of laboratory analysis, the laboratory confirms the presence of Salmonella and performs susceptibility testing. When a microbiologist has time in the week, they gather all the reportable results and complete the forms for submission to the public health agency. Additionally, the clinical laboratory needs to submit the Salmonella specimen to the public health laboratory for serotyping and outbreak surveillance. This specimen is mailed along with a hand written requisition to the public health laboratory for epidemiological serotyping.
The public health laboratory enters the partial information written on the requisition and identifies the Salmonella serotype. A nightly batch process reports the serotype to the submitting clinician. A monthly batch process generates a file for the Disease Control agency. Nearby surveillance regions have small clusters of cases with this same Salmonella serotype but without knowledge of the other cases, no outbreak investigation is initiated.
The Disease Control agency detects this anomaly as monthly reports are received when observed across surveillance regions and an outbreak protocol is started to investigate the potential outbreak. The Disease Control agency requests PFGE (pulse field gel electrophoresis) on the known samples and the outbreak is finally confirmed two months later. Calls, faxes, and emails are used to transmit information to relevant regional and local programs as well as the submitters of outbreak samples. Significant efforts on identification, investigation, and resolution focus on getting the desired data to the necessary participants. The outbreak is investigated and linked to a restaurant supplier in a popular but off-season resort area.
After this profile is adopted:
Preconditions: The clinical laboratory creates a laboratory report identifying the organism as a Salmonella isolate and that further serotyping will be done at the Public Health Lab. The laboratory report is sent to the clinician, stored within the patient’s electronic medical record, and registered in a clinical interoperability registry. The isolate is mailed to the public health lab.
Events: Upon arrival, the public health laboratory receiving department queries the clinical interoperability registry with the submitter’s patient ID and views the initial laboratory report. The public health laboratory information system pulls forward the patient’s demographic and specimen data from the initial laboratory report. The public health laboratory creates a new laboratory report identifying the Salmonella serotype. This report is sent to the clinician, stored within the patient’s electronic medical record, registered in the clinical interoperability registry, registered in the regional public health interoperability registry, and registered in the national public health interoperability registry.
The Disease Control agency monitors the national public health registry for new cases of Salmonella. An anomaly is immediately detected in the number of new cases for this particular Salmonella serotype when observed across regional surveillance boundaries and an outbreak protocol is started immediately to investigate the potential cross-border outbreak. The CDC requests PFGE (pulse field gel electrophoresis) on the current samples and alerts all public health laboratories to perform PFGE on new samples of this serotype. The outbreak is confirmed quickly and new cases are identified and tracked seamlessly.
Post conditions: Local, regional, and national epidemiologists and case workers have access to all laboratory reports within their respective interoperability registries and may potentially gain further access to the clinical interoperability registry for additional information, such as the ordering provider and care location, for initiating further investigation.
Key improvements include:
- avoid handwritten forms and data re-entry
- ease transition of data to and from clinical care and public health agencies
- ease transition of data from one public health agency to another
- monitor registries for anomalies in a real-time basis
- response protocols focus on response, not the access to data
Public Health Case Report types covered by Use Case 1
- Laboratory reportables
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.
Appendix A - Actor Descriptions
Actors are information systems or components of information systems that produce, manage, or act on information associated with operational activities in the enterprise.
- Content Creator
- The Content Creator Actor is responsible for the creation of content and transmission to a Content Consumer.
- Content Consumer
- A Content Consumer Actor is responsible for viewing, import, or other processing of content created by a Content Creator Actor.
- Clinical Data Consumer
- A clinical data consumer makes use of clinical patient data.
- Clinical Data Source
- A Clinical Data Sources maintains patient information about vital signs, problem and allergies, results from diagnostic tests (e.g., Lab, Imaging, or other test results), medications, immunizations or historical or planned visits and procedures.
Appendix B - Transaction Descriptions
Transactions are interactions between actors that transfer the required information through standards-based messages. The PCC Technical Framework does not define any specific transactions, as these are assumed to be carried out through the use of transactions defined in other IHE Profiles.
- Query Existing Data
- Request information about recent patient information, used to obtain vital signs measurements, problems and allergies, diagnostic results, medications, immunizations, or procedures or visits relevant for a patient. The query may request information about some or all of the above topics, or may request information on a specific topic, or one entered for a specific encounter or date range.
Appendix C - How to Prepare an IHE Integration Statement
IHE Integration Statements are documents prepared and published by vendors to describe the conformance of their products with the IHE Technical Framework. They identify the specific IHE capabilities a given product supports in terms of IHE actors and integration profiles described in the technical frameworks of each domain.
Users familiar with these concepts can use Integration Statements to determine what level of integration a vendor asserts a product supports with complementary systems and what clinical and operational benefits such integration might provide. Integration Statements are intended to be used in conjunction with statements of conformance to specific standards (e.g., HL7, IETF, DICOM, W3C, etc.).
IHE provides a process for vendors to test their implementations of IHE actors and integration profiles. The IHE testing process, culminating in a multi-party interactive testing event called the Connectathon, provides vendors with valuable feedback and provides a baseline indication of the conformance of their implementations. The process is not intended to independently evaluate, or ensure, product compliance. In publishing the results of the Connectathon and facilitating access to vendors' IHE Integration Statements, IHE and its sponsoring organizations are in no way attesting to the accuracy or validity of any vendor's IHE Integration Statements or any other claims by vendors regarding their products.
IMPORTANT -- PLEASE NOTE: Vendors have sole responsibility for the accuracy and validity of their IHE Integration Statements. Vendors' Integration Statements are made available through IHE simply for consideration by parties seeking information about the integration capabilities of particular products. IHE and its sponsoring organizations have not evaluated or approved any IHE Integration Statement or any related product, and IHE and its sponsoring organizations shall have no liability or responsibility to any party for any claims or damages, whether direct, indirect, incidental or consequential, including but not limited to business interruption and loss of revenue, arising from any use of, or reliance upon, any IHE Integration Statement.
Structure and Content of an IHE Integration Statement
An IHE Integration Statement for a product shall include:
- The Vendor Name
- The Product Name (as used in the commercial context) to which the IHE Integration Statement applies.
- The Product Version to which the IHE Integration Statement applies.
- A publication date and optionally a revision designation for the IHE Integration Statement.
- The following statement: "This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:"
- A list of IHE Integration Profiles supported by the product and, for each Integration Profile, a list of IHE Actors supported. For each integration profile/actor combination, one or more of the options defined in the IHE Technical Framework may also be stated. Profiles, Actors and Options shall use the names defined by the IHE Technical Framework Volume I. (Note: The vendor may also elect to indicate the version number of the Technical Framework referenced for each Integration Profile.)
Note that implementation of the integration profile implies implementation of all required transactions for an actor as well as selected options.
The statement shall also include references and/or internet links to the following information:
- Specific internet address (or universal resource locator [URL]) where the vendor's Integration Statements are posted
- URL where the vendor's standards conformance statements (e.g., HL7, DICOM, etc.) relevant to the IHE transactions implemented by the product are posted.
- URL of the IHE Initiative's web page for general IHE information www.himss.org/ihe.
An IHE Integration Statement is not intended to promote or advertise aspects of a product not directly related to its implementation of IHE capabilities.
Format of an IHE Integration Statement
Each Integration Statement shall follow the format shown below. Vendors may add a cover page and any necessary additional information in accordance with their product documentation policies.
| IHE Integration Statement | Date | 12 Oct 2005 |
| Vendor | Product Name | Version |
| Any Medical Systems Co. | IntegrateRecord | V2.3 |
| This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below: | ||
| Integration Profiles Implemented | Actors Implemented | Options Implemented |
| Cross-Enterprise Sharing of Medical Summaries | Document Consumer | View Option |
| Audit Trail and Node Authentication | Secure Node | none |
| Patient Identity Cross-referencing | Patient Identifier Cross-reference Consumer | PIX Update Notification |
| Internet address for vendor's IHE information:www.anymedicalsystemsco.com/ihe | ||
| Links to Standards Conformance Statements for the Implementation | ||
| HL7 | www.anymedicalsystemsco.com/hl7 | |
| Links to general information on IHE | ||
| In North America: www.ihe.het | In Europe: www.ihe-europe.org | In Japan: www.jira-net.or.jp/ihe-j |
IHE Integration Statement template
An IHE Integration Statement template (MS Word version) is available here.
The IHE Product Registry
The assumption of an integration statement is that all actors listed are functionally grouped and conform to any profile specifications for such groupings. In case of exceptions the vendor must explicitly describe the functional groupings.
IHE has developed a new Web-based database of Integration Statements. The IHE Product Registry enables developers to create, manage and publish Integration Statements for their commercial and open source healthcare IT systems. It allows users to browse for these systems based on their conformance with specific IHE Actors and Profiles. The system is open for use by developers and users now!
Appendix D - Braden Scale for Predicting Pressure Sore Risk
See File:Braden.pdf
Glossary
The following terms are used in various places within this technical framework, and are defined below. The complete IHE Glossary is available on the IHE Wiki at http://wiki.ihe.net/index.php/IHE_Glossary .
- Actor
- An entity within a use case diagram that can perform an action within a use case diagram. Possible actions are creation or consumption of a message
- Acuity Assessment
Also known as triage category, this is the acuity of the patient assigned during the process of ED triage. A number of evidenced based triage scales exist, including the Emergency Severity Index (ESI), Canadian Triage and Acuity Scale (CTAS), the Australasian Triage Scale (ATS), and the Manchester Triage System. In many emergency departments, patients may simply be classified as emergent, urgent or non-urgent.
- ADT
- Admit, Discharge & Transfer.
- Affinity Domain Policy
- Affinity Domain Policy that clearly defines the appropriate uses of the XDS Affinity Domain. Within this policy is a defined set of acceptable use Privacy Consent Policies that are published and understood.
- ASTM
- Formerly the American Society of Testing and Materials, now ASTM International. An SDO that develops a number of standards across a wide variety of industries, including healthcare.
- ATNA
- Audit Trail and Node Authentication. An IHE ITI profile.
- Care Context
- The participations surrounding the care provision act, and the attributes of that act. Everything in the document header. Data history, links to clinical reasoning.
- Continuity of Care Document(CCD)
- An HL7 Clinical Document Architecture (CDA) implementation alternative to ASTM ADJE2369 for institutions or organizations committed to HL7 standards. This specification was developed as a collaborative effort between ASTM and HL7. More information is available from http://www.hl7.org.
- Continuity of Care Record (CCR)
- A core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more encounters. The CCR is Designation E2369-05 of the ASTM (American Society for Testing and Materials, International). More information is available from http://www.astm.org.
- Clinical Document Architecture (CDA)
- An HL7 standard for the exchange for clinical documents. It specifies the structure and semantics of clinical documents. More information is available from http://www.hl7.org.
- Content Binding
- A content binding describes how the payload used in an IHE transaction is related to and/or constrained by the data elements contained within the content sent or received in those transactions.
- CRS
- Care Record Summary. An implementation guide that constrains CDA Release 2 for Care Record Summary documents.
- CT
- Consistent Time Integration Profile.
- DICOM
- Digital Imaging and Communication in Medicine
- DSG
- Digital Signatures. An IHE ITI Profile.
- EDIS
- An Emergency Department Information System (EDIS) is an extended EHR system used to manage data in support of Emergency Department patient care and operations. The functions of an EDIS may be provided by a single application or multiple applications.
- eMPI
- Enterprise Master Patient Index.
- EMR
- Electronic Medical Record, an Electronic Health Record system used within an enterprise to deliver care (also called EHR-CR by IHE-XDS).
- Estimated Time of Arrival
- the time the patient being referred can be expected to arrive in the emergency department.
- EUA
- Enterprise User Authentication Integration Profile.
- Expected Actions
- Actions which should occur as the result of a trigger event.
- HIMSS
- Healthcare Information and Management Systems Society.
- HL7
- Health Level Seven
- HIS
- Hospital Information System.
- IHE
- Integrating the Healthcare Enterprise.
- Interaction Diagram
- A diagram that depicts data flow and sequencing of events.
- IT
- Information Technology.
- Logical Observation Identifiers Names and Codes (LOINC®)
- A vocabulary developed by the Regenstrief Institute aimed at standardizing laboratory and clinical codes for use in clinical care, outcomes management, and research. Additional information found at http://www.regenstrief.org/medinformatics/loinc/.
- Mode of Arrival
- The method of transportation used to transport the patient to the Emergency Department.
- MPI
- Master Patient Index.
- MRN
- Medical Record Number.
- NAV
- Notification of Document Availability
- OID
- Object Identifier. (See also 'Globally Unique Identifier').
- Patient Identifier Cross-reference Domain
- Consists of a set of Patient Identifier Domains known and managed by a Patient Identifier Cross-reference Manager Actor. The Patient Identifier Cross-reference Manager Actor is responsible for providing lists of "alias" identifiers from different Patient Identifier Domains.
- Patient Identifier Domain
- A single system or a set of interconnected systems that all share a common identification scheme for patients. Such a scheme includes: (1) a single identifier-issuing authority, (2) an assignment process of an identifier to a patient, (3) a permanent record of issued patient identifiers with associated traits, and (4) a maintenance process over time. The goal of Patient Identification is to reduce errors.
- Portable Document Format.
- PIX
- Patient Identifier Cross Referencing. An IHE ITI Profile.
- PDQ
- Patient Demographics Query. An IHE ITI Profile.
- PHR
- Personal Health Record
- Procedure
- In the context of a "Pre-procedure History and Physical," the "procedure" is a surgery or an invasive examination of a patient that is required by quality review organizations to be preceded by a pre-procedure assessment of procedure risk and anesthesia risk. This assessment is typically referred to as a "Pre-operative" or "Pre-procedure History and Physical."
- Process Flow Diagram
- A graphical illustration of the flow of processes and interactions among the actors involved in a particular example.
- Proposed disposition
- the intended disposition (i.e. admission to ICU, discharge to home, transfer to psychiatric hospital), if known, that the referring provider expects the patient will end up after the emergency department intervention.
- Referral Source
- An individual, group, or agency that determined the patient should seek care at the ED. Referral source may be used to determine appropriate discharge referrals and services, or to provide surveillance data for program and service planning, or to examine referral patterns.
- Role
- The actions of an actor in a use case.
- RSNA
- Radiological Society of North America.
- sig.
- A Latin abbreviation for signetur used to represent the instruction following the medication name.
- Scope
- A brief description of the transaction.
SNOMED-CT® A comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a non-for-profit association in Denmark. The CAP continues to support SNOMED CT operations under contract to the IHTSDO and provides SNOMED-related products and services as a licensee of the terminology. More information available from http://www.ihtsdo.org/ or the United States National Library of Medicine at http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html
- Transport Mode
- the method the patient employs, or is provided to get to the emergency department.
- Trigger Event
- An event such as the reception of a message or completion of a process, which causes another action to occur.
- UID
- Unique Identifier (See also Globally Unique Identifier).
- Universal ID
- Unique identifier over time within the UID type. Each UID must belong to one of specifically enumerated species. Universal ID must follow syntactic rules of its scheme.
- Use Case
- A graphical depiction of the actors and operation of a system.
- XUA
- Cross Enterprise User Authentication
- XDS
- Cross Enterprise Document Sharing
Volume II
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 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.
| 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 pertanant. 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 | DS | ClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / specimen / specimenRole / specimenPlayingEntity / code / @code.
This binding is particular to a PHLab document. If the document pertains to a reportable condition, then this code shall be among those listed in the eventCodeList. This has been enhanced from the XDS profile from O to R2. |
| formatCode | R | FM | Value to be selected by the PCC Technical Committee. |
| healthcareFacilityTypeCode | R | CAD. 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 that originally specified in XDS. This metadata attribute is not 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 that originally specified in XDS. This metadata attribute is not 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 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 reqirement of R2 to R and have this timestamp correlate with either the encounter, specimen collection, reception, time (in that preference order). Otherwise, value is consistent with the 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 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 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 | R | CADT. 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.
| 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 not consistent PCC_TF-2 binding. We are working to resolve the differences. |
| authorPerson | R2 | DS | This metadata attribute is not 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 pertanant. 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 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 pertanant. 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: This binding is unique to PHLab documents, as PCC-TF-2 does not not specify specific XDSFolder Requirements
| Attribute | Usage in XDS | Source Type | Source/ Value |
|---|---|---|---|
| availabilityStatus | R | DS | Value assigned at point of submission. |
| codeList | R | DS | If any document in a folder pertains to a reportable condition, then the code identifying the reportable condition shall be among those listed in the codeList. This has been further refined from the original specification in XDS. |
| comments | O | DS | Optional, add if pertanant. |
| entryUUID | R | DS | Assigned at time of submission by Document Source, Repository or Registry. |
| lastUpdateTime | R | O | Computed by the Registry upon folder access. |
| patientId | R | DS | ID of the patient in the shared infrastructure, which is not necessarily the same as the patient id in the CDA. This is to be supplied at point of submission. |
| title | O | DS | Optional, add if pertanant. |
| uniqueId | R | SAT | ClinicalDocument / component / structuredBody / component / section / entry / act / specimen / specimenRole / id.
Documents pertaining to the same specimen shall be placed in a single folder identified by a global specimen id. See new CP in ITI for 'assoction' folder ids. As this is still in CP format, this aspect of the PHLab binding cannot be implemented until the CP is processed. |
CDA Release 2.0 Content Modules
This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides of the XDS-PHLab document.
It is assumed that the reader is familiar with both the HL7 CDA R2 specification as well as the XDS-Lab specification. Conformance statements made by either of those two specifications are implicitly understood to be required here, unless explicitly stated otherwise. We note that requirements specified below are to ensure the presence of a minimum amount of data in order to enhance description and facilitate sharing of the public health laboratory report document. Implementers of this profile can and should make use of additional annotation within the CDA document to provide richer context. The examples in the following sections contain the minimal amount of data, as specified, and in many cases do make use of additional CDA elements for enriched context.
We also take particular care to point out places where we suggest edits to the XDS-Lab profile. These elements are indicated with 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.
At present, wiki sections with green represent incompleted sections.
Preface
- Introduction: laboratory reporting concept and workflow definition.
- A PHLab document, much like a medical summary, serves the purpose of summarizing. While a medical summary captures a series of patient events from an EMR system resulting in a summary of a patient's current (and past) status, a PHLab document captures the series of events surrounding a biological sample resulting in a summary which documents the status of the sample (ie. what was found in it).
- scope is a single order and any (all) specimens stemming from that order and any (all) reportable contditions found among those specimens.
- Three varieties - Human (patient), Non-Human Subject, Human(patient) with Non-Human Subject:
- 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 subscribes 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:
- 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
- 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.
- 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"/>
<typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
<templateId root="PHLab template id to go here"/>
<id root="1.19.6.11.13.103000012000025132.1181266627192.1"/>
<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"/>
<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="608-555-5555"/>
<patient classCode="PSN">
<name><family>Winters</family><given>Shelly</given></name>
<administrativeGenderCode code="F"/>
<birthTime value="19401213"/>
</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="19401213"/>
</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 rabiies) 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="608-555-5555"/>
<patient classCode="PSN">
<name><family>Winters</family><given>Shelly</given></name>
<administrativeGenderCode code="F"/>
<birthTime value="19401213"/>
</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 in Please see the following CP to XDS-Lab for additional comments we have regarding this constraint on the author.
ClinicalDocument.DataEnterer
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
ClinicalDocument.Informant
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
ClinicalDocument.Custodian
PHLab does not constrain this element beyond what is stated in the CDA R2 and XDS-Lab documentation.
ClinicalDocument.InformationRecipient
A PHLab document intendedRecipient remains consistent in definition with the HL7 CDA R2 specification. The 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 test in response to an order. The entity that gives an order to a laboratory is called the 'Order Placer'. Documentation of the order information may be present in a PHLab document. If it is to be present, it shall follow the structure specified below. We note that documentation of the ordering process her differs from XDS-Lab. Please see the following CP to XDS-Lab for more information regarding documentaiton of the order.
ClinicalDocument.Participant (typeCode = 'REF')
This participant, consistent in definition with XDS-Lab, represents the 'Order Placer Provier' (often a physician that creates and gives an order) which is defined by the HL7 v2.5 messaging specification (ORC-12). This participant may be present in a PHLab document.
If this participant is present, the following shall then be present:
- 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 Provier' 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="200706080600"/>
<high value="200706081200"/>
</time>
<associatedEntity>
<id extension="90573" root="1.19.6.11.13"/>
<addr>
<streetAddressLine>3113 Hospital Drive</streetAddressLine>
<city>Chicago</city>
<state>IL</state>
<postalCode>60622</postalCode>
<country>USA</country>
</addr>
<telecom value="312-555-5555"/>
<associatedPerson>
<name><family>Patel</family><given>Kiran</given><prefix>Dr</prefix></name>
</associatedPerson>
</associatedEntity>
</participant>
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')
This participant represents the 'Order Placer Enterer' (often a physician that creates and gives an order) which is defined by the HL7 v2.5 messaging specification (ORC-10). This participant may be present in a PHLab document.
If this participant is present, the following shall then be present:
- Participant.typeCode
shall be present and shall be set to "ENT" to indicate that this participant is the 'Order Placer Enterer'.
- Participant.associatedEntity.id
shall be present and represents the id of the 'Order Placer Enterer' which is defined by the HL7 v2.5 messaging specification (ORC-10)
- Participant.associatedEntity.addr
shall be present and represents the address of the the organization of the 'Order Placer Enterer', which is defined by the HL7 v2.5 messaging specification (ORC-13, 17, 18)
- Participant.associatedEntity.telecom
shall be present and represents the telecom of the organization of the 'Order Placer Enterer', which is defined by the HL7 v2.5 messaging specification (ORC-13, 17, 18)
- Participant.associatedEntity.associatedPerson.name
shall be present and represents the name of the 'Order Placer Enterer', which is defined by the HL7 v2.5 messaging specification (ORC-10)
If this participant is present, the following may then be present:
- Participant.time
may be present and shall represent the 'Order Placer Enterer Order Date/Time' which is defined by HL7 v2.5 messaging specification (ORC-9).
<participant typeCode=”ENT”>
<time value="20070604"/>
<associatedEntity>
<id extension="90577" root="1.19.6.11.13"/>
<addr>
<streetAddressLine>3113 Hospital Drive</streetAddressLine>
<city>Chicago</city>
<state>IL</state>
<postalCode>60622</postalCode>
<country>USA</country>
</addr>
<telecom value="312-555-5555"/>
<associatedPerson>
<name>
<given>Samantha</given>
<family>Goodrich</family>
</name>
</associatedPerson>
</associatedEntity>
</participant>
We note that the concept of the 'Order Placer Enterer Authorization' definded by the HL7v2.5 messagins specification (ORC-30) cannot be represented in a CDA participant element. Therefore this information is missing. If in the event a unit of information about the 'Order Placer Enterer' is not known or has been de-identified, the use of nullFlavor is appropriate. Please see ClinicalDocument.RecordTarget - Human Patient for an example usage of nullFlavor.
ClinicalDocument.InFulfillmentOf
This element documents the order number(s) from the 'Order Placer Provider' or 'Order Placer Enterer'. This element may be present in a PHLab document when either the 'Order Placer Provider' participant or the 'Order Placer Enterer' participant is present.
If one of the above participants is present, and if the inFulfillmentOf is present, the following shall then be present:
- InfFulfillmentOf.Order.code
Exactly one code shall be present for each type of laboratory test ordered and it's value shall be selected from among the LOINC universal test IDs.
If one of the above participants is present, and if the inFulfillmentOf is present, the following may then be present:
- InFulfillmentOf.Order.id
At least one id may be present and this id(s) shall represent the 'Order Placer Order Number(s)' which is defined by HL7 v2.5 messaging specification (ORC-2).
<inFulfillmentOf>
<order>
<id extension="28902809" root="2.16.840.1.113883.1.3"/>
<code code="20951-0" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="Salmonella Serotype"/>
</order>
</inFulfillmentOf>
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 low time shall correleate to the Encounter Time or the Specimen Collection Date/Time or the Specimen Recieved Date/Time, in that preference order.
- The high time shall correleate to chronologically latest time of authentication or legal authentication that is documented 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 individual who produced the Result Event as further specified in XDs-Lab.
<documentationOf>
<serviceEvent>
<effectiveTime>
<low value="20070604"/>
<high value="20070608"/>
</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="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="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.
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="20070604"/>
<location>
<healthCareFacility>
<code code="HU" codeSystem="2.16.840.1.113883.5.10588" displayName="Hospital Unit"/>
</healthCareFacility>
</location>
</encompassingEncounter>
</componentOf>
Clinical Document Body
General Constraints on the Body
- 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.
- 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.
- 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). At least one Section shall be present.
- There shall be at least one Entry in each Section and this Entry shall us the 'Lab.Report.Data.Processing.Entry' templateId.
- Each Entry in a 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' for each documented specimen under a particular laboratory section.
- Each 'Specimen Act' shall contiain one or more EntryRelationship elements.
- This EntryRelationship shall contain a single Organizer element. This Organizer is hereafter referred to as the 'Reportable Condition Organizer'. Laboratory test results and identification of the reportable condition are grouped under the 'Reportable Condition Organizer'. If multiple reportable conditions are found they shall be documented under separate EntryRelationship elements in their respective 'Reportable Condition Organizer' element.
- Other Sections conformant to XDS-Lab document specifications which detail conditions or findings that are not required to be reported may be present, so long as the structure of the Sections containing the reportable condition findings remain conformant to this specification.
Section
Each Section corresponds to a single laboratory section (as in XDS-Lab). At least one Section shall be present.
A 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>
<tr>
<td>*Performed at Hospital Laboratory</td>
<td></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="a1">
<td>Tetracycline</td>
<td>Susceptible</td>
<td></td>
</tr>
<tr ID="a2">
<td>Ciprofloxacin</td>
<td>Susceptible</td>
<td></td>
</tr>
<tr ID="a3">
<td>Trimethprim + Sulfamethoxazole</td>
<td>Susceptible</td>
<td></td>
</tr>
<tr ID="a4">
<td>Ampicillin</td>
<td>Susceptible</td>
<td></td>
</tr>
<tr ID="a5">
<td>Chloramphenicol</td>
<td>Susceptible</td>
<td></td>
</tr>
<tr ID="a6">
<td>Ceftriaxone</td>
<td>Susceptible</td>
<td></td>
</tr>
</tbody>
</table>
</text>
Specimen Act
There shall be at least one Entry in each Section and this Entry shall us the 'Lab.Report.Data.Processing.Entry' templateId. Each Entry in a 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' for each documented specimen under a particular laboratory section.
<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.)
<subject>
<relatedSubject>
<code code="FRT" codeSystem="0.0.0.0.3.3"
codeSystemName="Animal Byte Identification System Name"
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>
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" codeSystemName="2.16.840.1.113883.5.129"
displayName="Stool"/>
</specimenPlayingEntity>
<lab:productOf classCode="PROC" moodCode="EVN">
<effectiveTime value="20070604"/>
</lab:productOf>
</specimenRole>
</specimen>
Act.Participant (typeCode = "AUTHEN")
- among those listed in override of ClinicalDocument.authenticator
- See CP
Act.Participant (typeCode = "PRF")
- override of serviceEvent.performer
- See CP
Reportable Condition Organizer
Each 'Specimen Act' shall contiain one or more EntryRelationship elements. This EntryRelationship shall contain a single Organizer element. This Organizer is hereafter referred to as the 'Reportable Condition Organizer'. Laboratory test results and identification of the reportable condition are grouped under the 'Reportable Condition Organizer'. If multiple reportable conditions are found they shall be documented under separate EntryRelationship elements in their respective 'Reportable Condition Organizer' element.
The 'Reportable Condition 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 apprpriate.
<entryRelationship typeCode="COMP">
<organizer classCode="CLUSTER" moodCode="EVN">
<statusCode code="completed"/>
<effectiveTime value="20070608"/>
Organizer.Specimen
- ISLT (extension), and what if it is not an isolate (non-micro)?
- use of translation
<specimen>
<specimenRole classCode="ISLT">
<specimenPlayingEntity>
<code code="79153007" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED"
displayName="Salmonella tennessee 6,7,14;z29;1,2,7"/>
</specimenPlayingEntity>
</specimenRole>
</specimen>
Organizer.Component.Organizer (Battery Test)
Test Results, when part of a battery test, shall appear as sub-elements of an Organizer element. This Organizer shall be hereafter reffered to as the a sub-elemenet of the 'Battery Test Organizer' and shall be a sub-element of th e'Reportable Condition Organizer'. 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 apprpriate.
<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="20070608"/>
<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 sub-elements under the 'Reportable Condition Organizer' or, when part of a battery test, under the 'Battery Test Organizer' which shall be a sub-element of the 'Reportable Condition Organizer'. Each test result shall be represented as an Observation element. The 'Reportable Condition Organizer' may have zero or more Observation sub-elements and zero or more 'Battery Test Organizer' sub-elements with two or more Observation elements each.
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 documentd
- Observation.value
- Observation.effectiveTime
For each Observation, the following may be present:
- 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="20070608"/>
<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="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="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="20070608"/>
<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 corresponging 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
- consitent with XDS-Lab when performer is different than documented in CDA header. MUST be a different laboratory (not just a different person) if documented. override of serviceEvent.performer or act.performer
- See CP
Observation.Participant (typeCode = "AUTHEN")
- among those listed in override of ClinicalDocument.authenticator and/or
and overrideOrganizer.participant (typeCode = "AUTHEN")
- See CP
Change Proposals to Other IHE Profiles
- CPs to XDS-Lab
- ClinicalDocument.typeId (missing in samples)
- ClinicalDocument.templateId (unspecified for XDS-Lab documents)
- ClinicalDocument.id (missing in samples)
- ClinicalDocument.recordTarget (meaning of identity is not clear)
- ClinicalDocument.author (restricted use is not clear)
- Participant and Performer Usage in XDS-Lab (questions and clarifications)
- Usage of XDS-Lab (questions and clarifications)
- Correlation with existing standard concepts and components (suggested enhancements)
- Documentation of XDS-Lab CDA R2 extensions (include schema types)
- XDS-Lab content bindings to XDS, XDR, XDM Metadata
- CPs to PCC Technical Framework
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. | |
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. | |
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. | |
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 | |
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. | |
| Suggested Edits: 6.12 ClinicalDocument/author | |
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: TODO | |
| Suggested Edits: TODO
| |
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 line 400 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 | |
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. | |
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. | |
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. | |
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. Discrepancies are in red. | |
Open Issues
- Is what we have documented the best way to accomodate a non-human subject in a CDA?
- The PHLab profile text is based on several CPs that are (will) open against XDS-Lab and PCC Technical Framework. For a trail 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.
- How do we support the concept of a case number in this document?
- Should we require XDSDocumentEntry.serviceStartTime, since in this context it correlates to either the original clinical encounter or the date of specimen collection (reception) which is particulary important in public health?
Sample Documents
Sample Document 1
<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"/>
<typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>
<templateId root="PHLab template id to go here"/>
<id root="1.19.6.11.13.103000012000025132.1181266627192.1"/>
<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"/>
<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="608-555-5555"/>
<patient classCode="PSN">
<name><family>Winters</family><given>Shelly</given></name>
<administrativeGenderCode code="F"/>
<birthTime value="19401213"/>
</patient>
</patientRole>
</recordTarget>
<author>
<time value="20070607183707.0222-0700"/>
<assignedAuthor>
<id extension="phad2007" root="1.19.6.11.13"/>
<addr>
<streetAddressLine>650 Harry Rd</streetAddressLine><city>San Jose</city>
<state>CA</state><postalCode>95120</postalCode><country>USA</country>
</addr>
<telecom value="408-555-5555"/>
<assignedAuthoringDevice>
<softwareName>IBM Public Health Application System</softwareName>
</assignedAuthoringDevice>
</assignedAuthor>
</author>
<custodian typeCode="CST">
<assignedCustodian classCode="ASSIGNED">
<representedCustodianOrganization>
<id root="1.19.6.11.13"/>
<name>Universal Custodian Services</name>
<telecom value="789-555-2121"/>
<addr>
<streetAddressLine>1600 Pennsylvania Ave</streetAddressLine><city>Washington DC</city>
<postalCode>98765</postalCode><country>USA</country>
</addr>
</representedCustodianOrganization>
</assignedCustodian>
</custodian>
<informationRecipient>
<intendedRecipient>
<id extension="0000" root="1.19.6.11.13"/>
<addr>
<streetAddressLine>1600 Clifton Road</streetAddressLine><city>Atlanta</city>
<state>GA</state><postalCode>30333</postalCode><country>USA</country>
</addr>
<telecom value="404-639-3535"/>
<informationRecipient>
<name><family>Angulo</family><given>Fred</given></name>
</informationRecipient>
</intendedRecipient>
</informationRecipient>
<legalAuthenticator>
<time value="20070607183707.0222-0700"/>
<signatureCode code="S"/>
<assignedEntity>
<id extension="B092987200201" root="1.19.6.11.13"/>
<addr>
<streetAddressLine>7000 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state>
<postalCode>60622</postalCode><country>USA</country>
</addr>
<telecom value="312-555-5555"/>
<assignedPerson>
<name><family>Johnson</family><given>Linda</given><prefix>Dr</prefix></name>
</assignedPerson>
<representedOrganization>
<id extension="rm83747" root="1.19.6.11.13"/>
<name>Public Health Laboratory</name>
<telecom value="312-555-5555"/>
<addr>
<streetAddressLine>1234 Laboratory Drive</streetAddressLine><city>Chicago</city><state>IL</state>
<postalCode>60622</postalCode><country>USA</country>
</addr>
</representedOrganization>
</assignedEntity>
</legalAuthenticator>
<authenticator>
<time value="20070607183707.0222-0700"/>
<signatureCode code="S"/>
<assignedEntity>
<id extension="274" root="1.19.6.11.13"/>
<addr>
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