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

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Upon hospital admission, Dr. Reed completes the record and, as the responsible attending physician, electronically signs the ED chart authenticating the EDER. The initial ED attending physician to see the patient is by default the legal authenticator, and may only delegate this responsibility to another provider through a formal transfer of care. The EDER is posted to the RHIO and also sent to the hospital information system. Using the HIS, the nurse on the intermediate care ward accesses the record and notes the time and administration of antibiotics. When Dr. Klein reaches the office in the morning, his office EHR-S notifies him that his patient was seen in the IHE ED the previous night, and displays the ED encounter record.
 
Upon hospital admission, Dr. Reed completes the record and, as the responsible attending physician, electronically signs the ED chart authenticating the EDER. The initial ED attending physician to see the patient is by default the legal authenticator, and may only delegate this responsibility to another provider through a formal transfer of care. The EDER is posted to the RHIO and also sent to the hospital information system. Using the HIS, the nurse on the intermediate care ward accesses the record and notes the time and administration of antibiotics. When Dr. Klein reaches the office in the morning, his office EHR-S notifies him that his patient was seen in the IHE ED the previous night, and displays the ED encounter record.
  
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==Actors==
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{{Content Profile Actors and Transactions|APS}}
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* [[Content Creator]]
 
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* [[Content Consumer]]
 
  
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=Volume 2=
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{{PCC Content Profile Options|APS}}
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{{:PCC TF-1/Coded Terminologies}}
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{{:PCC TF-1/Content Bindings with XDS, XDM and XDR|PCC_TF-1/APS|=
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|1.3.6.1.4.1.19376.1.5.3.1.1.10.1|Triage Note|Medical Document Binding to XDS, XDM and XDR|R|R|=
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|1.3.6.1.4.1.19376.1.5.3.1.1.10.2|Nursing Note|Medical Document Binding to XDS, XDM and XDR|R|R|=
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|1.3.6.1.4.1.19376.1.5.3.1.1.10.3|Composite Triage and Nursing Note|Medical Document Binding to XDS, XDM and XDR|R|R|=
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|1.3.6.1.4.1.19376.1.5.3.1.1.10.4|ED Physician Note|Medical Document Binding to XDS, XDM and XDR|R|R|=
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}}
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===Grouping===
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==== Cross Enterprise Document Sharing, Media Interchange and Reliable Messages ====
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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]] must be grouped with appropriate actors from the XDS, XDM or XDR profiles, and the metadata sent in the document sharing or interchange messages has specific relationships to the content of the clinical document described in the content profile.
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==== [[Notification of Document Availability]] (NAV) ====
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A Document Source should provide the capability to issue a [[Send Notification]] Transaction per the ITI [[Notification of Document Availability]] (NAV) Integration Profile in order to notify one or
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more [[Document Consumer]](s) of the availability of one or more documents for retrieval. One of the Acknowledgement Request options may be used to request from a Document Consumer that
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an acknowledgement should be returned when it has received and processed the notification.
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A Document Consumer should provide the capability to receive a [[Receive Notification]] Transaction per the NAV Integration Profile in order to be notified by Document Sources of the availability of one or more documents for retrieval. The [[Send Acknowledgement]] option may be used to issue a Send Acknowledgement to a [[Document Source]] that the notification was received and processed.
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==== [[Document Digital Signature]] (DSG)====
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When a [[Content Creator]] Actor needs to digitally sign a document in a submission set, it may support the Digital Signature (DSG) Content Profile as a [[Document Source]].
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When a [[Content Consumer]] Actor needs to verify a Digital Signature, it may retrieve the digital signature document and may perform the verification against the signed document content.
  
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==IHE Content Modules==
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<noinclude>
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{{:PCC TF-1/Trailer}}
  
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== Folder Content Specification ==
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=Volume 2=
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{{:X-EDERFolderLOINC}}
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{{Title Page|
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Domain=Patient Care Coordination|
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Volume=Emergency Department Referral<br/>Volume 2|
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Revision=2.0|
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Year=2006-2007|
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Status=Draft}}
  
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===CDA Release 2.0 Content Modules===
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{{:PCC TF-2/Header}}
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{{:1.3.6.1.4.1.19376.1.5.3.1.1.13.1.1}}
 
  
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{{:1.3.6.1.4.1.19376.1.5.3.1.1.13.1.2}}
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{{:CDA Release 2.0 Content Modules}}
  
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{{:1.3.6.1.4.1.19376.1.5.3.1.1.13.1.3}}
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{{:PCC TF-2/Trailer}}
  
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{{:1.3.6.1.4.1.19376.1.5.3.1.1.13.1.4}}
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[[Category:Draft Profile Supplement]]
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</noinclude>
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[[Category:Patient Care Coordination]]

Revision as of 12:33, 14 June 2007

Introduction

This is a draft of the Emergency Department Encounter Record (EDER) supplement to the Patient Care Coordination Technical Framework. This draft is a work in progress, not the official supplement or profile. A copy of the original profile proposal is here.

Profile Abstract

An Emergency Department "chart" is the entire collection of (multi-authored) documents and reports recording the assessments and care delivered by the entire ED team (including physicians, nurses, technologists and other providers) in response to an ED visit.

For the purposes of this integration profile, we define the Emergency Department Encounter Record (EDER) as a summary of the patient’s current health status and care rendered in the ED between arrival and ED departure. The EDER is not intended to replace the ED Chart as a complete, legal document of care, but is a collection of medical summaries with focused scope that are produced to fulfill a number of collaborative transfers of care.

Issue Log

Open Issues

  1. New LOINC codes for data elements
    • ED REFERRAL NOTE
    • PRE-HOSPITAL CARE NOTE (EMS Note)
    • ED TRIAGE NOTE
    • XASSES-X NURSING ASSESSMENTS PANEL
    • NURIN-T NURSING INTERVENTIONS PANEL
    • XIVFLU-X INTRAVENOUS FLUID ADMINISTERED (COMPOSITE)


Closed Issues

  1. The EDER is a multi-authored (but singly attested?) document. How should this best be implemented/reflected: Document to be attested to by ED attending physician.
  2. Patients frequently leave the ED prior to documentation being finalized. Triggers in workflow vary. How should the Draft vs. Final Status be handled: Only final documents will be posted to XDS.
  3. Potential for multiple entries: using folders, multiple sections do not occur.
  4. Timetable for CCD harmonization: done
  5. Target systems discussion: use case defined as EDIS posts to XDS.
  6. Use of Co-occurrence Constraint [Conditional Restraint] for Disposition elements: Yes.
  7. Snomed vs. DEEDS for Disposition: DEEDS

Glossary

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.
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.
Mode of Arrival
The method of transportation used to transport the patient to the Emergency Department.
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.

Systems

  • The Emergency Department Information System (EDIS) will produce an emergency department encounter record.
  • Both ambulatory and inpatient EHR-S will read and display this data.

Data Standards

  • Data Elements for Emergency Department Systems (DEEDS) 1.0
  • HL7 Version 3
  • HL7 CDA Release 2
  • HL7 CDA CCD
  • XML 1.0
  • IHE - Primary Care to ED Referral Request (2006)
  • IHE - Acute Care Discharge to Ambulatory Care Environment (2005)
  • IHE - Pre-procedure History and Physical (2006)

Technical Approach

The ED Encounter Record is a folder in XDS that defines a collection of documents. Separate content profiles must be created for the various kinds of documents that might be generated during an ED encounter. These content profiles include (existing and new):

  • Triage Note
  • Nursing Note
  • ED Physician Note
  • Pre-hospital Care Report
  • Diagnostic Imaging Reports
  • Laboratory Reports
  • Consultation Reports
  • Patient Consents for Treatment and Procedures
  • Transfer Summary
  • Summary of Death

As of this IHE cycle, we propose and define content profiles for Physician and Nursing documents within EDER.

It is expected that the transfers of care referred to in the use cases will occur in an environment where the EDIS, HIS, and Primary Care Physician EHR are coordinated within a Regional Health Information Organization (RHIO) environment or local community of care setting. As such a repository-based, or a peer-to-peer transfer of information is needed. It is expected that the XDS profile specified in the ITI Infrastructure domain would be the vehicle for transferring the EDER. HL7 CDA for creating XML-based extractions of the EMR will be constrained appropriately to reflect the inclusion of the sections/elements denoted in this use case. To ensure persistence of “care context” following the information transfer, an appropriate transformation Style Sheet (XSLT) will be described and included with the document. The subsequent care provider will use this transformed document as the default presentation option for the referral.

Risks

Both small and large EDIS product vendors must easily implement the solution defined. Simplified, iterative implementation approaches may need to be considered when identifying the technical solution. The solution must be able to accommodate multiple levels of “consumers” of these transfers of care documents. EHR-S or HIS vendors may choose not to engineer the ability to consume all elements in the EDER, but constrain machine readability to elements considered pertinent to their customers practice, such as new diagnoses, new prescriptions, medications administered during the visit, procedures performed, and disposition. Finally, time to implementation may constrain scope and or quality. The healthcare industry and Congress actively promote both EMR utilization and interoperability by its care practitioners and healthcare facilities. ONC through HITSP are currently This translates to numerous community-wide and medical societal-wide initiatives for the introduction of healthcare technology solutions by their constituents. As a side effect, expediency of action is important in order to be out ahead of these initiatives as much as possible to lead them in their decision/selection process. Care must be taken to ensure that the technical solution is able to be implemented expediently and engineered for change as feedback from these early initiatives is absorbed and reacted to by the healthcare industry. This work partially positions IHE to address the most recent AHIC challenge to ONC/HITSP for the development of an emergency response use case for EHR adoption, as the ED (and hence the ED encounter) figure prominently in the chain of information transfer outlined in the first drafts of this use case: http://www.hhs.gov/healthit/erehr.html.

Summary

Data released by the Centers for Disease Control and Prevention (CDC) estimates that there were over 110 million emergency department visits in 2004, making the emergency department (ED) chart (hereafter called encounter record) one of the most common medical summaries in use today. Currently, the ED encounter record remains largely a paper based artifact, and when produced by an Emergency Department information system (EDIS) is almost exclusively delivered as unstructured or loosely structured text. The ED chart is used to communicate the details of an emergency department visit in a variety of ways. The chart is most frequently faxed or mailed to primary care providers, and is increasingly archived electronically to hospital clinical data repositories. The original (or a copy) must accompany the patient to the ward upon hospital admission where is can be reviewed by hospital providers, or a copy may be sent with the patient on transfer from ED to ED or from ED to other medical treatment facilities. Unfortunately, these frequently become lost or misplaced. ED encounter records have no standardized format, and may be frequently be difficult to read by users unfamiliar with their formatting. None yet carry any semantic meaning that could be consumed by a receiving EHR system (EHR-S).

The production and delivery of the ED encounter record solves a number of problems, including:

  • Communication with and transfer of care back to the patient’s primary care physician.
  • Communication with care providers in the inpatient setting for patients admitted to the hospital from the emergency department.

The ED encounter record could also be employed in:

  • Transfer of information to hospital and provider billing systems.
  • Transfer of information to regulatory and public health agencies requesting data from emergency department encounters.

References

  1. Emergency Care Special Interest Group, Health Level 7:Emergency Department Information Systems (EDIS) Functional Profile. Draft Version 1.04 (3/2/2007)


Volume 1

Add the following bullet to the list of profiles
  • Emergency Department Encounter Record (EDER) as a summary of the patient’s current health status and a summary of care rendered in the ED between arrival and ED departure. The EDER is not (yet) intended to replace the ED Chart as a complete, legal document of care, but is intended as a collection of medical summaries with focused scope that can be used to fulfill a number of collaborative transfers of care. The ED encounter record may include links to diagnostic tests performed during the ED encounter, as well as links to an initial ED referral (a 2006 IHE work product), prehospital (EMS) records (IHE roadmap 2008), and the consultations of other providers for patients seen in the ED.

Use Case

Emergency Department Visit

This use case presumes the patient is cared for at a hospital facility with an EDIS as well as a hospital information system. Additionally, the patient’s primary care provider is also assumed to posses an interoperable EHR system. This use case begins upon the arrival of the patient to the emergency department. Data including mode of arrival, chief complaint, and other arrival data are manually entered into the EDIS. Additional data including past medical problems, medications and allergies, are obtained in one of the following ways:

  1. Entered manually into the EDIS by the triage nurse
  2. Imported from a legacy ED encounter within the EDIS
  3. Imported from the hospital information system or CDR, perhaps using Query for Existing Data.
  4. Imported from an Emergency Department Referral (IHE 2006-2007)
  5. Imported from a prehospital EMS report (Emergency Medical Services (EMS) to Emergency Dept Data Transfer, PCC Roadmap 2008-2009)

The patient undergoes assessments by a triage nurse, is assigned a triage category (i.e. emergent, urgent, non-urgent). The patient is then registered and demographic data is obtained. One taken to the treatment area, the patient undergoes additional assessments by a primary RN, and seen by an ED physician who performs a history and physical, orders various diagnostic tests, determines a course of therapy, orders medications to be administered in the ED and performs procedures on the patient. Upon completion of ED care, the patient is either admitted to the hospital, discharged from the ED, or transferred to another facility. Hence, the use case can take one of three branches:

  1. If admitted, the EDER is sent to the hospital information system where it can be viewed by providers, or read by the EHR system so that medical summary data and details of care rendered in the ED available to inpatient providers.
  2. If the patient is discharged the EDER is sent to the patients primary care physician as a summary of care rendered during the ED encounter.
  3. If the patient is transferred to another facility, the EDER is posted to the RHIO and made available for providers at the receiving facility.

Example

Mr. John Smith, a longstanding patient of Dr. Mark Klein, is 62 year old man with hypertension and diabetes who awoke with acute onset of fever, right-sided chest pain and cough. He presents to the IHE ED via EMS where he is triaged by nurse Karen Ross who collects his past medical history, medications, allergies, mode of arrival, and inputs this data into the EDIS. Mr. Smith is taken directly to the treatment area where he is assigned to nurse Barbara Reiter who obtains vital signs, baseline pulse oximetry, places the patient on oxygen, and obtains IV access. She documents her assessments and interventions in the EDIS. The patient is seen by Dr. William Reed who performs and records a history and physical examination, orders an ECG, chest radiograph, CBC, electrolytes, and blood cultures. The chest radiograph reveals bi-lobar pneumonia and the ECG is slightly abnormal. Ceftriaxone 1gm IV plus Azythromycin 500mg PO are administered. After multiple attempts by Dr. Reed to contact Dr. Klein, Mr. Smith is admitted to a intermediate care bed under the care of Dr. Herman Edwards the IHE hospitalist. Upon hospital admission, Dr. Reed completes the record and, as the responsible attending physician, electronically signs the ED chart authenticating the EDER. The initial ED attending physician to see the patient is by default the legal authenticator, and may only delegate this responsibility to another provider through a formal transfer of care. The EDER is posted to the RHIO and also sent to the hospital information system. Using the HIS, the nurse on the intermediate care ward accesses the record and notes the time and administration of antibiotics. When Dr. Klein reaches the office in the morning, his office EHR-S notifies him that his patient was seen in the IHE ED the previous night, and displays the ED encounter record.

Actors/Transaction

There are two actors in the APS 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.

APS Actor Diagram


Options

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

Content Consumer Options

View Option

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

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

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

Document Import Option

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

Section Import Option

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

Discrete Data Import Option

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


Coded Terminologies

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

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

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

Cross Enterprise Document Sharing, Media Interchange and Reliable 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
Triage Note Medical Document Binding to XDS, XDM and XDR Content Creator R
Content Consumer R
Nursing Note Medical Document Binding to XDS, XDM and XDR Content Creator R
Content Consumer R
Composite Triage and Nursing Note Medical Document Binding to XDS, XDM and XDR Content Creator R
Content Consumer R
ED Physician Note Medical Document Binding to XDS, XDM and XDR Content Creator R
Content Consumer R

Grouping

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 must be grouped with appropriate actors from the XDS, XDM or XDR profiles, and the metadata sent in the document sharing or interchange messages has specific relationships to the content of the clinical document described in the content profile.

Notification of Document Availability (NAV)

A Document Source should provide the capability to issue a Send Notification Transaction per the ITI Notification of Document Availability (NAV) Integration Profile in order to notify one or more Document Consumer(s) of the availability of one or more documents for retrieval. One of the Acknowledgement Request options may be used to request from a Document Consumer that an acknowledgement should be returned when it has received and processed the notification. A Document Consumer should provide the capability to receive a Receive Notification Transaction per the NAV Integration Profile in order to be notified by Document Sources of the availability of one or more documents for retrieval. The Send Acknowledgement option may be used to issue a Send Acknowledgement to a Document Source that the notification was received and processed.

Document Digital Signature (DSG)

When a Content Creator Actor needs to digitally sign a document in a submission set, it may support the Digital Signature (DSG) Content Profile as a Document Source. When a Content Consumer Actor needs to verify a Digital Signature, it may retrieve the digital signature document and may perform the verification against the signed document content.


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

Technical Framework
Emergency Department Referral
Volume 2

Revision 2.0
2006-2007

Draft


HIMSS and RSNA
Integrating the Healthcare Enterprise

IHEBandW.png

IHE Patient Care Coordination

Technical Framework
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.

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.

Reasons for Care

The sections described below describe various reasons why healthcare is being provided to the patient.

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.

Physical Exams

Relevant Studies

Plans of Care

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

Procedures Performed

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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