Difference between revisions of "PCC TF-1/XPHR"

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===XPHR Integration Profile Process Flow===
 
===XPHR Integration Profile Process Flow===
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One key use scenarios has been identified as an example.  This use case originated in the Cross-Enterprise Document point-to-point Interchange (XDP) profile, and is reproduced here.
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One key use scenario has been identified as an example.  This use case originated with the Cross-Enterprise Document Sharing on Media (XDM) profile, and is reproduced here.
  
 
====Personal Health Record (PHR) to ED/Primary Care EHR====
 
====Personal Health Record (PHR) to ED/Primary Care EHR====

Revision as of 22:28, 23 July 2007

Volume 1

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Exchange of Personal Health Record Content (XPHR)
Technical Framework Supplement
Volume I

Revision 3.0
2008-2009

Public Comment



XPHR Integration Profile

The Exchange of Personal Health Record Content (XPHR) integration profile describes the content and format of summary information extracted from a PHR system used by a patient for import into healthcare provider information systems, and visa versa. The purpose of this profile is to support interoperability between PHR systems used by patients and the information systems used by healthcare providers. This profile does not address all the data exchange requirements of PHR systems. A PHR system may leverage other IHE Integration and Content Profiles for interoperability in addition to the XPHR Content Profile. For example, a PHR Systems may implement XDS-MS to import medical summaries produced by EHR systems, XDS-I to import imaging information, XDS-Lab to import laboratory reports, et cetera.

Exchange of Personal Health Record Content (XPHR)

Upon seeing a healthcare provider for the first time, patients are requested to provide a great deal of information, including, their address, telephone numbers, birth date, sex, marital status, emergency contacts, insurance information, a medical and family history, and current medications and allergies. This information is also reviewed and updated on subsequent visits. This information is usually obtained by having the patient fill out one or more forms, whose contents are then manually transferred in to the information systems used by the healthcare provider. Automating this process will reduce transcription errors during the transfer of information, speed up the registration and check-in processes for patients, and also makes it possible for patients to have more participation in the management of their health information.

Providers also need to participate in helping patients to manage their healthcare information, however, providers should not be solely responsible for updating the patient's health record, since they often are only participating in a portion of the patient's overall health activities.

PHR systems allow patients to manage their healthcare information. EHR and other information systems allow healthcare providers to manage the electronic records they maintain for their patients. These two systems, operating separately, are not sufficient to allow patients and providers to collaborate in the care of the patient. What is needed is a way to integrate the activities of patients using a PHR system and healthcare providers using an EHR or other information system to provide for collaborative care between the patient and their provider.

The XPHR profile is intended to provide a mechanism for patients to supply the information most often requested by their healthcare providers, and to allow those same providers to assist patients in keeping their personal healthcare information up to date. It achieves this by allowing patients to provide a summary of their PHR information to providers, and gives providers a mechanism to suggest updates to the patient's PHR upon completion of a healthcare encounter.

Actors/Transaction

There are two actors in the XPHR 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.

XPHR Actor Diagram


Options

Actor Option
XPHR Options
Content Consumer View Option (1)
Document Import Option (1)
Section Import Option (1)
Discrete Data Import Option (1)
Content Creator Update Option
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.


Content Creator Options

Update Option

This text needs to be fixed-->>Need to add text here<<--


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 Messages

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
PHR Extract Medical Document Binding to XDS, XDM and XDR Content Creator R
Content Consumer R
PHR Update Medical Document Binding to XDS, XDM and XDR Content Creator O
Content Consumer R

XPHR Content Modules

PHR Extract Module

The content exchanged shall be structured and coded as required by the PHR Extract Module Content. The Content Creator Actor creates a PHR Extract and shares it with the Content Consumer.

PHR Update Module

The content exchanged shall be structured and coded as required by the PHR Update Module Content. The Content Creator Actor creates a PHR Update document as an addendum to a previously exchanged PHR Extract document. This Update is an addendum to the prior document, and reflects changes to that document that are suggested by the Content Creator Actor. A Content Consumer actor shall support viewing of an Update document, and may support import of the Update to reflect those changes to the PHR.

The purpose of this content module is to provide a mechanism whereby healthcare providers, using applications that implement the Content Creator Actor, can suggest updates to a PHR for a patient.

This text needs to be fixed-->>SMoore changes to this profile<<--

XPHR Integration Profile Process Flow

One key use scenario has been identified as an example. This use case originated with the Cross-Enterprise Document Sharing on Media (XDM) profile, and is reproduced here.

Personal Health Record (PHR) to ED/Primary Care EHR

Precondition: A patient is using a Personal Health Record application system at home for the record keeping of patient-originated medical information (e.g. social history, family history), snapshots of clinical information that may have been provided from previous care encounters (e.g. medication list, immunization records, etc), and current observations from home care medical devices (e.g. blood pressure, blood sugar level, etc).

Events: The patient requests their provider give them initial information to initialize their new PHR system. Later the patient does an extract of his PHR onto a portable media (USB key, CD) to bring to the care facility as a current set of medical data for the clinician. The patient experiences a medical condition requiring that he needs to present at the ED or his PCP for care. The ED physician or primary care physician receives the portable media from the patient and loads it an office PC to display and/or import, as desired, the information provided on the portable media. Following the encounter, the provider does an extract of appropriate data elements from the office EMR to yield a snapshot of the patient's medical record. This snapshot is then transferred to an interchange media for the patient to bring home and update his private PHR. The patient imports this document and uses the information in it to update the content of their PHR: e.g., by applying the changes recorded in the PHR Update appropriately .

Postcondition: The patient's PHR is up to date.

Basic Process Flow in XPHR Profile

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 PHR Extracts and PHR Updates.

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:

  1. The Vendor Name
  2. The Product Name (as used in the commercial context) to which the IHE Integration Statement applies.
  3. The Product Version to which the IHE Integration Statement applies.
  4. A publication date and optionally a revision designation for the IHE Integration Statement.
  5. 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:"
  6. 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:

  1. Specific internet address (or universal resource locator [URL]) where the vendor's Integration Statements are posted
  2. URL where the vendor's standards conformance statements (e.g., HL7, DICOM, etc.) relevant to the IHE transactions implemented by the product are posted.
  3. 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.
PDF
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 2

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Exchange of Personal Health Record Content (XPHR)
Technical Framework Supplement
Volume II

Revision 3.0
2008-2009

Public Comment


IHE Transactions

This section defines each IHE transaction in detail, specifying the standards used, and the information transferred.

Cross Enterprise Document Content Transactions

At present, all transactions used by the PCC Content Profiles appear in ITI TF-2. General Options defined in content profiles for a Content Consumer are described below.

View Option

A Content Consumer that supports the View Option shall be able to:

  1. Use the appropriate XD* transactions to obtain the document along with associated necessary metadata.
  2. Render the document for viewing. This rendering shall meet the requirements defined for CDA Release 2 content presentation semantics (See Section 1.2.4 of the CDA Specification: Human readability and rendering CDA Documents). CDA Header information providing context critical information shall also be rendered in a human readable manner. This includes at a minimum the ability to render the document with the stylesheet specifications provided by the document source, if the document source provides a stylesheet. Content Consumers may optionally view the document with their own stylesheet, but must provide a mechanism to view using the source stylesheet.
  3. Support traversal of links for documents that contain links to other documents managed within the sharing framework.
  4. Print the document to paper.
Document Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Document Import Option shall be able to support the storage of the entire document (as provided by the sharing framework, along with sufficient metadata to ensure its later viewing) both for discharge summary or referral documents. This Option requires the proper tracking of the document origin. Once a document has been imported, the Content Consumer shall offer a means to view the document without the need to retrieve it again from the sharing framework. When viewed after it was imported, a Content Consumer may chose to access the sharing framework to find out if the related Document viewed has been deprecated, replaced or addended.


Note: For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.


Section Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Section Import Option shall be able to support the import of one or more sections of the document (along with sufficient metadata to link the data to its source) both for discharge summary or referral. This Option requires the proper tracking of the document section origin. Once sections have been selected, a Content Consumer shall offer a means to copy the imported section(s) into local data structures as free text. This is to support the display of section level information for comparison or editing in workflows such as medication reconciliation while discrete data import is not possible. When viewed again after it is imported, a Content Consumer may chose to access the sharing framework to find out if the related information has been updated.


Note: For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document whose sections were previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.


This Option does not require, but does not exclude the Content Consumer from offering a means to select and import specific subsets of the narrative text of a section.

Discrete Data Import Option

This Option does not require that the View, Import Document or Section Import Options be supported. The Content Consumer that supports the Discrete Data Import Option shall be able to support the storage of the structured content of one or more sections of the document. This Option requires that the user be offered the possibility to select among the specific sections that include structured content a set of clinically relevant record entries (e.g. a problem or an allergy in a list) for import as part of the local patient record with the proper tracking of its origin.


Note: The Discrete Data Import Option does not require the support of the View, Import Document or Import Sections Options so that it could be used alone to support implementations of Content Consumers such as Public Health Data or Clinical Research systems that might aggregate and anonymize specific population healthcare information data as Document Consumer Actors, but one where no care provider actually views the medical summaries.


When discrete data is accessed after it was imported, a Content Consumer may choose to check if the document related to the discrete data viewed has been deprecated, replaced or addended.

A Content Consumer Actor grouped with the XDS Document Source Actor may query the Document Registry about a document from which discrete data was previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.

IHE Patient Care Coordination Bindings

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 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. These concepts are universal to XDS, XDR and XDM.

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.

Medical Document Binding to XDS, XDM and XDR

This binding defines a transformation that generates metadata for the XDSDocumentEntry element of appropriate transactions from the XDS, XDM and XDR profiles given a medical document and information from other sources. The medical document refers to the document being stored in a repository that will be referenced in the registry. The other sources of information include the configuration of the Document Source actor, the Affinity Domain, the site or facility, local agreements, other documents in the registry/repository, and this Content Profile.

In many cases, the CDA document is created for the purposes of sharing within an affinity domain. In these cases the context of the CDA and the context of the affinity domain are the same, in which case the following mappings shall apply.

In other cases, the CDA document may have been created for internal use, and are subsequentyly being shared. In these cases the context of the CDA document would not neccessarily coincide with that of the affinity domain, and the mappings below would not necessarily apply.

Please note the specifics given in the table below.

XDSDocumentEntry Metadata

XDSDocumentEntry Attribute Optional? Source Type Source/ Value
availabilityStatus R DS  
authorInstitution R2 SAT

$inst <= /ClinicalDocument/author
/assignedAuthor
/representedOrganization

The authorInstitution can be formated
using the following XPath expression, where $inst in the expression below represents the representedOrganization.
concat($inst/name)

authorPerson R2 SAT

$person <= /ClinicalDocument/author

The author can be formatted using the following XPath expression, where $person in the expression below represents the author.
concat(
$person/id/@extension,"^",
$person/assignedPerson/name/family,"^",
$person/assignedPerson/name/given[1],"^",
$person/assignedPerson/name/given[2],"^",
$person/assignedPerson/name/suffix,"^",
$person/assignedPerson/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO")

authorRole R2 SAT This metadata element should be based on a mapping of the participation function defined in the CDA document to the set of author roles configured for the affinity domain. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClincicalDocument/author/
participationFunction
authorSpecialty R2 SAT This metadata element should be based on a mapping of the code associated with the assignedAuthor to detailed defined classification system for healthcare providers such configured in the affinitity domain. Possible classifications include those found in SNOMED-CT, or the HIPAA Healthcare Provider Taxonomy. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClinicalDocument/author/
assignedAuthor/code
classCode R CADT Derived from a mapping of /ClinicalDocument/code/@code to an Affinity Domain specified coded value to use and coding system. Affinity Domains are encouraged to use the appropriate value for Type of Service, based on the LOINC Type of Service (see Page 53 of the LOINC User's Manual). Must be consistent with /ClinicalDocument/code/@code
classCodeDisplayName R CADT DisplayName of the classCode derived. Derived from a mapping of /ClinicalDocument/code/@code to the appropriate Display Name based on the Type of Service. Must be Consitent with /ClinicalDocument/code/@code
confidentialityCode R CADT Derived from a mapping of /ClinicalDocument/confidentialityCode/@code to an Affinity Domain specified coded value and coding system. When using the BPPC profile, the confidentialyCode may also be obtained from the <authorization> element.


/ClinicalDocument/
confidentialityCode/@code
-AND/OR-
/ClinicalDocument/authorization/
consent[
templateId/@root=
'1.3.6.1.4.1.19376.1.5.3.1.2.5'
] /code/@code

comments O DS  
creationTime R SAT /ClinicalDocument/effectiveTime


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

entryUUID R DS  
eventCodeList O CADT These values express a collection of keywords that may be relevant to the consumer of the documents in the registry. They may come from anywhere in the CDA document, according to its purpose.
eventCodeDisplayNameList R
(if event
Code is valued) 		CADT These are the display names for the collection of keywords described above.
formatCode R FM The format code for each PCC Document content profile is provided within the document specifications.
healthcareFacilityTypeCode R CAD A fixed value assigned to the Document Source and configured form a set of Affinity Domain defined values. Must be concistent with /clinicalDocument/code
healthcareFacility
TypeCodeDisplay
Name 		R CAD Must be concistent with /clinicalDocument/code
intendedRecipient (for XDR, XDM) O SAT

$person <= /ClinicalDocument/intendedRecipient
and/or
$inst <= /ClinicalDocument/intendedRecipient/receivedOrganization

The intendedRecipient can be formated
using the following XPath expression, where $inst in the expression below represents the receivedOrganization and where $person in the expression below represents the intendedRecipient.
concat(
$person/id/@extension,"^",
$person/informationRecipient/name/family,"^",
$person/informationRecipient/name/given[1],"^",
$person/informationRecipient/name/given[2],"^",
$person/informationRecipient/name/suffix,"^",
$person/informationRecipient/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO",
"|"
$inst/name)

"^^^^^&",
$inst/id/@root, "&ISO", "^^^^", $inst/id/@extension)
-->

languageCode R SA /ClinicalDocument/languageCode
legalAuthenticator O SAT $person <= /ClinicalDocument/
legalAuthenticator


The legalAuthenticator can be formatted using the following XPath expression, where $person in the expression below represents the legalAuthenticator.
concat(
$person/id/@extension,"^",
$person/assignedPerson/name/family,"^",
$person/assignedPerson/name/given[1],"^",
$person/assignedPerson/name/given[2],"^",
$person/assignedPerson/name/suffix,"^",
$person/assignedPerson/name/prefix,"^",
"^^^&", $person/id/@root,"&ISO")

mimeType R FM text/xml
parentDocumentRelationship R
(when applicable) 		DS Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document.
The parentDocumentRelationship may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
/ClinicalDocument/relatedDocument/@typeCode
parentDocumentId R
(when parent
Document
Relationship is present) 		DS Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document.
The parentDocumentId may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:
$docID <= /ClinicalDocument/
relatedDocument/parentDocument/id


The parentDocumentId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier.
concat($docID/@root,"^", $docID/@extension)

patientId R DS The XDS Affinity Domain patient ID can be mapped from the patientRole/id element using transactions from the ITI PIX or PDQ profiles. See sourcePatientId below. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate:


$patID <= /ClinicalDocument/recordTarget/
patientRole/id

practiceSettingCode R CAD This elements should be based on a coarse classification system for the class of specialty practice. Recommend the use of the classification system for Practice Setting, such as that described by the Subject Matter Domain in LOINC.
practiceSettingCodeDisplayName R CAD This element shall contain the display names associated with the codes described above.
serviceStartTime R2 SAT /ClinicalDocument/documentationOf/
serviceEvent/effectiveTime/low/
@value


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

serviceStopTime R2 SAT /ClinicalDocument/documentationOf/
serviceEvent/effectiveTime/high/
@value


Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.

sourcePatientId R SAT $patID <= /ClinicalDocument/recordTarget/
patientRole/id


The patientId can be formatted using the following XPath expression, where $patID in the expression below represents the appropriate identifier.
concat($patID/@extension,"^^^&", $patID/@root, "&ISO")

sourcePatientInfo R SAT /ClinicalDocument/recordTarget/
patientRole


The sourcePatientInfo metadata element can be assembled from various components of the patientRole element in the clinical document.

title O SA /ClinicalDocument/title
typeCode R CADT /ClinicalDocument/code/@code


The typeCode should be mapped from the ClinicalDocument/code element to a set of document type codes configured in the affinity domain. One suggested coding system to use for typeCode is LOINC, in which case the mapping step can be omitted.

typeCodeDisplay
Name 		R CADT /ClinicalDocument/code/@displayName
uniqueId R SAT $docID <= /ClinicalDocument/id


The uniqueId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier.
concat($docID/@root,"^", $docID/@extension)

XDSSubmissionSet Metadata

The submission set metadata is as defined for XDS, and is not necessarily affected by the content of the clinical document. Metadata values in an XDSSubmissionSet with names identical to those in the XDSDocumentEntry may be inherited from XDSDocumentEntry metadata, but this is left to affinity domain policy and/or application configuration.

Use of XDS Submission Set

This content format uses the XDS Submission Set to create a package of information to send from one provider to another. All documents referenced by the Medical Summary in this Package must be in the submission set.

Use of XDS Folders

No specific requirements identified.

Configuration

IHE Content Profiles using this binding require that Content Creators and Content Consumers be configurable with institution and other specific attributes or parameters. Implementers should be aware of these requirements to make such attributes easily configurable. There shall be a mechanism for the publishing and distribution of style sheets used to view clinical documents.

Extensions from other Domains

Scanned Documents (XDS-SD)

XDS-SD is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XDS-SD leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:iti:xds-sd:pdf:2008 when the document is scanned pdf and urn:ihe:iti:xds-sd:text:2008 when the document is scanned text. The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSDocumentEntry.uniqueId

This value shall be the ClinicalDocument/id in the HL7 CDA R2 header. The root attribute is required, and the extension attribute is optional. In accordance with the XDS.a profile, total length is limited to 128 characters; for XDS.b the limit is 256 characters. Additionally see PCC-TF, volume 2, Section 5.1.1.1.1 or PCC_TF-2/Bindings for further content specification.

Relating instances of XDS-SD documents

In general, most instances of XDS-SD will not have parent documents. It is possible, however, in some specific use cases that instances of XDS-SD documents are related. For example, for a particular document it may be the case that both the PDF scanned content and somewhat equivalent plaintext need to be wrapped and submitted. Each document would correspond to separate XDSDocumentEntries linked via an XFRM Association that indicates one document is a transform of the other. These can be submitted in a single submission set, or in separate ones. Other specific examples may exist and this profile does not preclude the notion of a parent document for these cases.

XDSSubmissionSet

No additional constraints. Particular to this profile, a legitimate use of submission sets would be to maintain a logical grouping of multiple XDS-SD documents. We encourage such usage. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Basic Patient Privacy Consents (BPPC)

Laboratory Reports (XD-LAB)

XD-Lab is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XD-Lab leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.eventCodeList

XD-Lab documents further constrain the the XDSDocumentEntry.eventCodeList to the following.

XDSDocumentEntry
Attribute Optional? Source Type Source/ Value
eventCodeList R2 SAT ClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / organizer (templateId="1.3.6.1.4.1.19376.1.3.1.1")/ component / observation(templateId="1.3.6.1.4.1.19376.1.3.1.1.1")/code

AND

ClinicalDocument / component / structuredBody / component / section / entry / act / subject / code

If the document has Reportable Condition, then this code shall be among those listed in the eventCodeList. Additionally, if the document contains information about a Non-Human Subject, then the code that indicates what this subject is shall be among those listed in the eventCodeList. Thus, this attribute has been enhanced from the XDS profile from O to R2.

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:lab:xd-lab:2008 The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSSubmissionSet

No additional constraints. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Namespaces and Vocabularies

This section lists the namespaces and identifiers defined or referenced by the IHE PCC Technical Framework, and the vocabularies defined or referenced herein.

The following vocabularies are referenced in this document. An extensive list of registered vocabularies can be found at http://www.hl7.org/oid/.

Vocabularies Used
codeSystem codeSystemName Description
1.3.6.1.4.1.19376.1.5.3.1 IHE PCC Template Identifiers This is the root OID for all IHE PCC Templates. A list of PCC templates can be found below in CDA Release 2.0 Content Modules.
1.3.6.1.4.1.19376.1.5.3.2 IHEActCode See IHEActCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.3 IHE PCC RoleCode See IHERoleCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.4   Namespace OID used for IHE Extensions to CDA Release 2.0
2.16.840.1.113883.10.20.1 CCD Root OID Root OID used for by ASTM/HL7 Continuity of Care Document
2.16.840.1.113883.5.112 RouteOfAdministration See the HL7 RouteOfAdministration Vocabulary
2.16.840.1.113883.5.1063 SeverityObservation See the HL7 SeverityObservation Vocabulary
2.16.840.1.113883.5.7 ActPriority See the HL7 ActPriority Vocabulary
2.16.840.1.113883.6.1 LOINC Logical Observation Identifier Names and Codes
2.16.840.1.113883.6.96 SNOMED-CT SNOMED Controlled Terminology
2.16.840.1.113883.6.103 ICD-9CM (diagnosis codes) International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.104 ICD-9CM (procedure codes) International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.26 MEDCIN A classification system from MEDICOMP Systems.
2.16.840.1.113883.6.88 RxNorm RxNorm
2.16.840.1.113883.6.63 FDDC First DataBank Drug Codes
2.16.840.1.113883.6.12 C4 Current Procedure Terminology 4 (CPT-4) codes.
2.16.840.1.113883.6.257 Minimum Data Set for Long Term Care The root OID for Minimum Data Set Answer Lists
1.2.840.10008.2.16.4 DCM DICOM Controlled Terminology; PS 3.16 Content Mapping Resource, Annex D
2.16.840.1.113883.6.24 MDC ISO/IEEE 11073 Medical Device Nomenclature
2.16.840.1.113883.3.26.1.5 NDF-RT National Drug File Reference Terminology (NCI version)
2.16.840.1.113883.11.19465 nuccProviderCodes National Uniform Codes Council Healthcare Provider Terminology
2.16.840.1.113883.6.255.1336 X12DE1336 Insurance Type Code (ASC X12 Data Element 1336)
2.16.840.1.113883.6.256 RadLex RadLex (Radiological Society of North America)

The IHE FormatCode vocabulary is now managed in an Implementation Guide published using FHIR.

This FormatCode vocabulary represents:

  • Code System 1.3.6.1.4.1.19376.1.2.3
  • Value Set 1.3.6.1.4.1.19376.1.2.7.1

IHEActCode Vocabulary

CCD   ASTM/HL7 Continuity of Care Document
CCR   ASTM CCR Implementation Guide

The IHEActCode vocabulary is a small vocabulary of clinical acts that are not presently supported by the HL7 ActCode vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.2. These vocabulary terms are based on the vocabulary and concepts used in the CCR and CCD standards listed above.

Code Description
COMMENT This is the act of commenting on another act.
PINSTRUCT This is the act of providing instructions to a patient regarding the use of medication.
FINSTRUCT This is the act of providing instructions to the supplier regarding the fulfillment of the medication order.
IMMUNIZ The act of immunization of a patient using a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
DRUG The act of treating a patient with a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
INTOL An observation that a patient is somehow intollerant of (e.g., allergic to) a particular substance or class of substances using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
SUBSTANCE A qualifier that identifies the substance used to treat a patient in an immunization or drug treatment act. The substance is expected to be identified using a vocabulary such as RxNORM, SNOMED CT or other similar vocabulary and should be specific enough to identify the ingredients of the substance used.
SUBSTCLASS A qualifier that identifies the class of substance used to treat a patient in an immunization or drug treatment act. The class of substances is expected to be identified using a vocabulary such as NDF-RT, SNOMED CT or other similar vocabulary, and should be broad enough to classify substances by mechanism of action (e.g., Beta Blocker), intended effect (Dieuretic, antibiotic) or ...


For Public Comment What else needs to appear above for SUBSTCLASS?


IHERoleCode Vocabulary

The IHERoleCode vocabulary is a small vocabulary of role codes that are not presently supported by the HL7 Role Code vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.3.

IHERoleCode Vocabulary
Code Description
EMPLOYER The employer of a person.
SCHOOL The school in which a person is enrolled.
AFFILIATED An organization with which a person is affiliated (e.g., a volunteer organization).
PHARMACY The pharmacy a person uses.

HL7 Version 3.0 Content Modules

This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides.

CDA Document Content Modules

CDA Header Content Modules

CDA Section Content Modules

This list defines the sections that may appear in a medical document. It is intended to be a comprehensive list of all document sections that are used by any content profile defined in the Patient Care Coordination Technical Framework. All sections shall have a narrative component that may be freely formatted into normal text, lists, tables, or other appropriate human-readable presentations. Additional subsections or entry content modules may be required.


Other Condition Histories

The sections defined below provide historical information about the patient's conditions.

Medications

This section contains section content modules that describe activities surrounding the use of medication.


Plans of Care

This section provides content modules for sections that describe the plan of care intended for the patient.

Impressions

Administrative and Other Information

CDA and HL7 Version 3 Entry Content Modules

Appendix A - Examples Using PCC Content Profiles

Example documents conforming to each profile can be found on the IHE wiki at the following URLs.

Profile and Content URL
XDS-MS  
 Referral Summary XDSMS Example1
 Discharge Summary XDSMS Example1
XPHR  
 XPHR Content XPHR Example1
 XPHR Update XPHR Example2
(EDR) ED Referral EDR Example
(APS) Antepartum Summary APS Example
(EDES)  
 Triage Note EDES Example1
 ED Nursing Note EDES Example2
 Composite Triage and Nursing Note EDES Example3
 ED Physician Note EDES Example4
(FSA) Functional Status Section FSA Example

Appendix B - Validating CDA Documents using the Framework

Many of the constraints specified by the content modules defined in the PCC Technical Framework can be validated automatically by software. Automated validation is a very desirable capability, as it makes it easier for implementers to test the correctness of their implementations. With regard to validation of the content module, the PCC Technical Framework narrative is the authoritative specification, not any automated software tool. Having said that, it is still very easy to create a validation framework for the IHE PCC Technical Framework using a XML validation tool such as Schematron. Since each content module has a name (the template identifier), any XML instance that reports itself to be of that "class" can be validated by creating assertions that must be true for each constraint indicated for the content module. In the XML representation, the <templateId> element is a child of the element that is claiming conformance to the template named. Thus the general pattern of a Schematron that validates a specific template is shown below: 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- one or more assertions made by the content module -->
    </rule>
  </pattern>
</schema>

Validating Documents

For document content modules, the pattern can be extended to support common document content module constraints as shown below: 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='../ClinicalDocument'>
        Error: The referral content module can only be used on Clinical Documents.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
        Error: The parent template identifier for medical summary is not present.
      </assert>
      <!-- Verify the document type code -->
      <assert test='code[@code = "34133-9"]'>
        Error: The document type code of a referral summary must be
        34133-9 SUMMARIZATION OF EPISODE NOTE.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The document type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: A referral summary must contain a reason for referral.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'>
        Warning: A referral summary should contain a list of history of past illnesses.
      </assert>
      <!-- Note any missing optional elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.18"]'>
        Note: This referral summary does not contain the pertinent review of systems.
      </assert>
    </rule>
  </pattern>
</schema>

Validating Sections

The same pattern can be also applied to sections with just a few minor alterations. 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReasonForReferralUncoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Verify the section type code -->
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <!-- The parent template will have already verified the type of object -->
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Don't bother with the section type code, as the parent template caught it -->
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <!-- Note any missing optional elements -->
    </rule>
  </pattern>
</schema>

A similar pattern can also be followed for Entry and Header content modules, and these are left as an exercise for the reader.

Phases of Validation and Types of Errors

Note that each message in the Schematrons shown above start with a simple text string that indicates whether the message indicates one of the following conditions:

  • An error, e.g., the failure to transmit a required element,
  • A warning, e.g., the failure to transmit a required if known element,
  • A note, e.g., the failure to transmit an optional element.
  • A manual test, e.g., a reminder to manually verify some piece of content.

Schematron supports the capability to group sets of rules into phases by the pattern name, and to specify which phases of validation should be run during processing. To take advantage of this capability, one simply breaks each <pattern> element above up into separate patterns depending upon whether the assertion indicates an error, warning, note or manual test, and then associate each pattern with a different phase. This is shown in the figure below. 

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <phase id="errors">
    <active pattern="ReasonForReferralUncoded_Errors"/>
    <active pattern="ReasonForReferralCoded_Errors"/>
  </phase>
  <phase id="manual">
    <active pattern="ReasonForReferralUncoded_Manual"/>
  </phase>
  <pattern name='ReasonForReferralUncoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
    </rule>
  </pattern>
  <pattern name='ReasonForReferralUncoded_Manual'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral not present.
      </assert>
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
    </rule>
  </pattern>
</schema>

Using these simple "templates" for template validation one can simply create a collection of Schematron patterns that can be used to validate the content modules in the PCC Technical Framework. Such Schematrons are expected to be made available as part of the MESA test tools that are provided to IHE Connectathon participants, and which will also be made available to the general public after connectathon.

Appendix C - Extensions to CDA Release 2.0

This section describes extensions to CDA Release 2.0 that are used by the IHE Patient Care Coordination Technical Framework.

IHE PCC Extensions

All Extensions to CDA Release 2.0 created by the IHE PCC Technical Committee are in the namespace urn:ihe:pcc:hl7v3.

The approach used to create extension elements created for the PCC Technical Framework is the same as was used for the HL7 Care Record Summary (see Appendix E) and the ASTM/HL7 Continuity of Care Document (see secion 7.2).

replacementOf

The <replacementOf> extension element is applied to a section appearing in a PHR Update Document to indicate that that section's content should replace that of a previously existing section. The identifier of the previously existing section is given so that the PHR Manager receiving the Update content will know which section to replace. The model for this extension is shown below.

Model for replacementOf

Use of this extension is shown below. The <replacementOf> element appears after all other elements within the <section> element. The <id> element appearing in the <externalDocumentSection> element shall provide the identifier of the section being replaced in the parent document.

Example use of the replacementOf extension 
<section>
 <id root=' ' extension=' '/>
 
 <title>Name of the Section</title>
 <text>Text of the section</text>
 <entry></entry>
 <component></component>
 <pcc:replacementOf xmlns:pcc='urn:ihe:pcc:hl7v3'>
   <pcc:externalDocumentSection>
     <pcc:id root='58FCBE50-D4F2-4bda-BC1C-2105B284BBE3'/>
   <pcc:externalDocumentSection/>
 </pcc:replacementOf>
</section>

Extensions Defined Elsewhere used by IHE PCC

Entity Identifiers

There is often a need to record an identifer for an entity so that it can be subsequently referenced. This extension provides a mechnism to store that identifier. The element appears after any <realm>, <typeId> or <templateId> elements, but before all others in the entity where it is used: 

<playingEntity classCode='ENT' determinerCode='INSTANCE'>
 <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='EntityID'/>
   :
   .
</playingEntity>

Patient Identifier

There is a need to record the identifer by which a patient is known to another healthcare provider. This extension provides a role link between the assigned, related or associated entity, and the patient role.

Use of this extension to record the identifier under which the patient is known to a provider is shown below.

Example use of the Patient Identifier Extension 
<assignedEntity>
 <id extension='1' root='1.3.6.4.1.4.1.2835.1'/>
 
 <addr>
   <streetAddressLine>21 North Ave</streetAddressLine>
   <city>Burlington</city>
   <state>MA</state>
   <postalCode>01803</postalCode>
   <country>USA</country>
 </addr>
 <telecom value='tel:(999)555-1212' use='WP'/>
 <assignedPerson>
   <name>
     <prefix>Dr.</prefix><given>Bernard</given><family>Wiseman</family><suffix>Sr.</suffix>
   </name>
 </assignedPerson>
 <sdtc:patient xmlns:sdtc='urn:hl7-org:sdtc' >
   <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='PatientMRN'/>
 </sdtc:patient>
</assignedEntity>

The <patient> element records the link between the related, assigned or associated entity and the patient. The <id> element provides the identifier for the patient. The root attribute of the <id> should be the namespace used for patient identifiers by the entity. The extension attribute of the <id> element shall be the patient's medical record number or other identifier used by the entity to identify the patient.


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