PCC TF-1/XDS-MS

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Technical Framework
Cross-Enterprise Sharing of Medical Summaries (XDS-MS) Integration Profile

Revision 2.0
2006-2007

Draft

Volume 1

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Technical Framework
Volume I

Revision 3.0
2008-2009

Public Comment

• (PCC TF-1/Preface)Preface to Volume I of the PCC Technical Framework

• (PCC TF-1/Introduction)Introduction to the PCC Technical Framework

• (PCC TF-1/About)About the Patient Care Coordination Integration Profiles

• (PCC TF-1/Dependencies)Dependencies of the PCC Integration Profiles

• (PCC TF-1/Overview)PCC Integration Profiles Overview

• (PCC TF-1/History)History of Annual Changes

• (PCC TF-1/Product Implementations)Product Implementations

Cross-Enterprise Sharing of Medical Summaries (XDS-MS) Integration Profile

Scope and Purpose

Patient, clinician, industry and governmental demands for improved healthcare quality have created increased focus to make patient healthcare information interoperability across disparate systems a reality.

A solution for interoperability is, however, not a simple undertaking. Unstructured textual data forms remains the predominate mechanism for information exchange among health care providers, and a good majority of data needed by physicians and other health care providers to make good clinical decisions is embedded in this free text. Efficient and effective interoperability therefore begins by identifying the most relevant documents and the most relevant sections within those documents.

By their nature, Medical Summaries form a class of clinical documents that contain the most relevant portions of this information. As the name would indicate they have the purpose of summarizing, both abstracting the most important pieces of information from the EMR and recording free-text summaries at the time of medical summary creation. Operationally, they are commonly created at points in time of transfers of care from one provider to another or from one setting to another.

Patient transfers and, therefore, the summary documents that accompany these transfers can be categorized into 3 primary types: Episodic, Collaborative, or Permanent. These categories are important because they represent a breadth of use case scenarios for Medical Summaries. For example, summaries for collaborative transfers of care such as referral notes have a focused objective for providing the most relevant information about the patient intended for a specific provider. Collaborative summaries have a general audience that is generated as an artifact since they also provide the most relevant spot to obtain information about specific classes of patient problems that the patient has.

By contrast, episodic summaries have the primary purpose of highlighting the most relevant details of focused periods of time in a patient history. Examples include discharge summaries or history and physicals. Episodic summaries are written for a broad audience by intent.

Permanent transfers have yet a third purpose of summarizing the entirety of a patient's medical history and therefore covers a broader range of patient problems. The audience may be focused (as in a transfer to a new provider) or general (as in a discharge from the military).

The challenge is to identify the clinically relevant documents (and data elements those documents contain) that are used in typical "transfer of care" scenarios and then to provide interoperability standards to promote ease in transmission of those documents (and data elements). The Cross-Enterprise Sharing of Medical Summary (XDS-MS) Integration Profile facilitates this by defining the appropriate standards for document transmission and a minimum set of "record entries" that should be forwarded or made available to subsequent care provider(s) during specific transfer of care scenarios. In addition, this integration profile needs to define the utilization requirements/options for the receiving entity in order to ensure that the "care context" of the sending entity is appropriately maintained following the information transfer.

Process Flow

The basic process flow supported by XDS-MS mirrors current manual practices: someone gathers the appropriate documents from the patient medical record, copies them, packages them up with a cover letter explaining the reason the information is being sent, and then ships the package to the receiving provider. This is often accompanied by a telephone call from the sending provider to the receiving provider that indicates that such information is forthcoming.

Because the Collaborative care transfers and Episodic Care transfers differ significantly, these two use cases are defined. Users or implementers of this Integration Profile are offered options in the support of either of these two use cases. Permanent Care Summaries also differ significantly. However their use is less frequent; so this use case was deferred for future work.

Use Case 1: Ambulatory Specialist Referral

This use case involves a "collaborative" transfer of care for the referral of a patient from a primary care provider (PCP) to a specialist. This use case is a central component of an "e-referral" process, which typically requires an appropriate level of agreement/collaboration between the two parties prior to the actual transfer of clinical information being initiated.

The preconditions assume a PCP sees a patient in his office. The PCP has talked to the patient and performed an examination, and has decided to refer the patient to a specialist. An assumption is made that the PCP has an EMR system with capability to write notes and manage data elements. The specific data elements managed by the PCP's EMR are expected to be the source for the information used in creating the medical summary document related to this transfer of care. A variety of EMR implementations and usage by clinicians may result in some variability in the content of the medical summary.

The detailed content of the medical summary to support this use case will be detailed as part of the document content profile specification (See the Referral Summary Content Module below).

Steps to identify the specialist and obtain insurance preauthorization have been placed out of scope for this Integration Profile.

Post conditions include the specialist physician receiving the notification of referral, locating the documents (via the Document Registry), retrieving the Documents and viewing them and optionally importing data. Import assumes the specialist with an EMR system with the capability for managing those discrete data elements.

Use Case 2: Acute Care Discharge to Ambulatory Care Environment

This use case involves an episodic transfer of care in the form of a patient discharge from a hospital to home. The attending physician in the hospital generates a discharge summary document that is used by the hospital record keeping and billing abstraction. The attending physician in the hospital may or may not also be serving as the ambulatory PCP. If not, a copy of this record is sent to the PCP as well as other specialist providers that will have ambulatory follow-up care.

The events of the use case involve creation of the discharge summary, sharing it, and notifying other providers such as the PCP's office and the surgeon's office.

The post conditions include the receipt and viewing of the discharge summary with optional import into the ambulatory EMR system.

The detailed content of the medical summary to support this use case will be detailed as part of the document content profile specification (See the Discharge Summary Content Module below).

Note that the two use cases above use the same set of transactions and differs only in the content of the Medical Summary. A process flow for these use cases using XDS and NAV is shown in the figure below. Other process flows are possible using XDM and/or XDR.

Use Case Process Flow Diagram

These steps are:

1. Extract/capture a collection of records into a set of documents packaged as an XDS Submission Set. This submission contains a Medical Summary, and may contain a number of other related clinical documents. Medical Summaries are clinical documents (already known in the paper world), which often serve a dual purpose of documenting an encounter, while providing the rationale for sending the information to another provider. This step utilizes the transactions provided by the ITI XDS profile to place the records in an XDS Repository (local or shared).
2. The Repository ensures that the documents of the submission set are registered with the XDS Registry of the Affinity Domain (set of cooperating care delivery institutions).
3. Notify the other provider that documents are now available for review. This step utilizes the transactions provided by the ITI NAV profile to perform the e-mail notification.
4. The e-mail notification that contains no patient identified information is received by the specialist EMR system.
5. The receiving provider can then utilize existing query transactions from the XDS profile to find the URL of the Documents.
6. Finally, the receiving provider may choose to display the document, or import relevant information from these records into their own EMR system.

Use Case for Unplanned Access to past Medical Summaries

In many cases, a provider may need to assess information from the patient care history, and patients may have Medical Summaries in the XDS repository from prior visits to other providers. For example, Medical Summaries, as well as other documents such as laboratory and radiology reports are critical for emergency physicians and nurses to provide the best care to patient in acute conditions. The figure below shows the transactions required for this use case, again, using XDS. Other process flows are possible using XDM and/or XDR.

Unplanned Access Process Flow Diagram

Content Interoperability Levels

The use cases described above imply different levels of interoperability. At the lowest level, a clinician simply needs to be able to access and view some content such as a medical summary. At this level, minimal structured data elements must be present – just enough metadata to verify that access to that document can be accessed appropriately associated with a visual representation of the document.

Beyond this simple metadata, nearly all medical summary documents have organizational elements that group the relevant parts of the medical summary. For humans this allows for more rapid review because it is easier to skip to portions of interest for care. Computers too can take advantage of this structuring. For example, it is relevant to see the list of discharge medications from a discharge summary in relation to current medications for comparison and reconciliation.

At a very high level of interoperability, the ability to pass fully structured and codified data is necessary for computer processing and mapping. For example, the ability to import medications identified in medical summaries from another institution could have tremendous potential for ensuring that medication orders are transferred correctly. Unfortunately, the cost for providing high levels of semantic interoperability is increased complexity of implementation, and therefore long implementation times.

The HL7 Clinical Document Architecture (CDA) standard and Care Record Summary (CRS) CDA implementation guides support progressive interoperability at multiple levels of complexity, from those needed to provide simple low level interoperability for supporting the most important use case of simple viewing to those providing a path to progressively higher levels of interoperability for vendors and providers wishing to implement it. CDA as constrained in the CRS implementation guides is therefore the base standard for the XDS-MS content profile.

The XDS-MS content profile builds on and further constrains the CDA-CRS implementation guide by defining the required and optional sections required for the Acute Care Discharge and Specialist Referral use cases. Additionally, it places constraints for the most important sections (Medication, Allergy and Problems) of Medical Summaries to ensure that structured field level data are provided.

The figure below shows how the XDS-MS Content profile defines these progressive levels of interoperability for sections of different importance. Header metadata must be present and coded. Most sections must define, at minimum, a section label to identify that section. For the Medication, Allergy, and Problems Sections, data must contain a more granular field level data as discrete text (for example dose or frequency). This is referred to as structured textual representation. Note that the textual strings in this structured text are not duplicates of the textual strings in the human readable text, but simply referenced extracts from the human readable text content, reducing the risk for inconsistencies

Granular field level data may then be optionally coded. If any coded terminology is used it shall be uniquely identified.

Tiered Interoperability Levels

Note: The lack of mature and broadly accepted standards for coded terminology requires that this integration profile not specify specific coded vocabularies. However, when agreements can be reached, the capability to exchange coded level information is possible. IHE has on its roadmap to continue working with appropriate standards bodies so that coded terminology standards can be added to this profile in the future.

Use Case Conclusion

The process flow of this profile exhibits a great deal more power and flexibility than the existing manual process. The physician workflow is improved by reusing an existing work product in the very first step (the summary report) to accomplish two purposes: recording care that has been provided, and communicating with another provider.

Secondly, each step utilizes the power of inter-connected EMR systems to make the entire process faster, easier, and less reliant on human labor to accomplish the same feats. This results in reduced time to transfer records between providers, safer transport of the information, and more reliable receipt.

Lastly, the process facilitates the import of relevant data from one set of patient records to the receiving physicians EMR system, resulting in more reliable transfer of information, reduced labor costs transferring information from one provider to another and less time required by the patient to provide information that is already in the physician's possession.

Actors/Transaction

There are two actors in the XDS-MS 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.

XDS-MS Actor Diagram

Options

XDS-MS Options

Actor	Option
Content Consumer	View Option (1)
	Document Import Option (1)
	Section Import Option (1)
	Discrete Data Import Option (1)
Content Creator	Referral Option (1)
	Discharge Summary 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.

Content Creator Options

Referral Option

Content Creators implementing this option shall create Referrals that comply with the Referral Content Module.

Discharge Summary Option

Content Creators implementing this option shall create Discharge Summaries that comply with the Discharge Summary Content Module.

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
Referral Summary	Medical Document Binding to XDS, XDM and XDR	Content Creator	O (Note 1)
		Content Consumer	R
Discharge Summary	Medical Document Binding to XDS, XDM and XDR	Content Creator	O (Note 1)
		Content Consumer	R

Note 1: Content Creators must support generation of at least one type of content from this table with a transaction in order for the transaction to meet the requirements of the XDS-MS profile. Content Consumers must support both types of content to meet these requirements.

Content Modules

Content modules describe the content of a payload found in an IHE transaction. Content profiles are transaction neutral. They do not have dependencies upon the transaction that they appear in. These dependencies are reflected in the Bindings listed above.

Referral Summary

All referral summaries shall be structured and coded as required by the Referral Summary Content Module described in PCC TF-2. The inclusion of the specific coded attributes explicitly defined as optional, may be supported by specific implementations of Document Sources using an IHE identified coded terminology of their choice. The requirements and manner in which implementations support such capabilities is beyond the scope of this Integration Profile.

Discharge Summary

All discharge summaries shall be structured and coded as required by the Discharge Summary Content Module described in PCC TF-2. The inclusion of the specific coded attributes explicitly defined as optional, may be supported by specific implementations of Document Sources using an IHE identified coded terminology of their choice. The requirements and manner in which implementations support such capabilities is beyond the scope of this Integration Profile.

Grouping with other Profile Actors

Content profiles may impose additional requirements on the transactions used when grouped with actors from other IHE 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 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. These are described in 3.7 Content Bindings with XDS, XDM and XDR above.

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 of the XDS-MS Integration Profile needs to digitally sign a medical summary or any other documents in a submission set, it may support the Digital Signature (DSG) Content Profile as a Document Source.

When a Content Consumer Actor of the XDS-MS Integration Profile needs to verify a Digital Signature, it may retrieve the digital signature document and may perform the verification against the signed document content.

Security Considerations

The XDS-MS Integration Profile assumes that a minimum security and privacy environment has been established across all participants. There must exist security policies regarding the use of training, agreements, risk management, business continuity and network security that need to be already in place prior to the implementation of XDS-MS.

The IHE ITI ATNA Integration Profile is required of the actors involved in the IHE transactions specified in this profile to protect node-to-node communication and to produce an audit trail of the PHI related actions when they exchange messages.

In addition, the IHE ITI DSG Integration Profiles can be applied to the actors involved in the transactions specified in this profile to securely identify individuals involved in transactions and verify document integrity and authorizations (DSG).

Interested parties should also read the detailed Security Considerations sections provided for each of the aforementioned profiles in the IHE ITI Technical Framework and its supplements.

The XDS-MS profile does have a few security considerations of its own.

EMR systems should be thoughtfully designed so that providers are able to review and verify information before it is imported into their EMR system, and that positive user acknowledgements are made before import, and audit trails are recorded when imports occur.

Imported information should be traceable both to the source [the sharing EMR], and the receiver that accepted it into the EMR system. XDS Affinity domain policies should support policies and procedures for tracing information flows between EMR systems.

Because the information being transferred is in XML, it will be common that different EMR systems utilize different transformations to render the contents into human readable form. A Content Creator should make available the transforms used by the sending provider to review the documents, and a Content Consumer must support rendering the information as seen by the sending provider, allowing both providers to see what was sent in its original rendered form.

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

IHE Patient Care Coordination

Technical Framework
Volume II

Revision 3.0
2008-2009

Public Comment

• (PCC TF-2/Preface)Preface

• (PCC TF-2/Introduction)Introduction

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.

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.

• formal canonical URI https://profiles.ihe.net/fhir/ihe.formatcode.fhir/ValueSet-formatcode.html
• formal publication URL https://profiles.ihe.net/fhir/ihe.formatcode.fhir/
• FormatCode gitHub repository for source of the Implementation Guide can be used to register issues, or create pull requests for modifications. Formal governance is managed by ITI Technical Committee.

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.

Folder Content Modules

This section contains modules that describe the content requirements of XDS Folders. At present, the IHE PCC Technical Framework has not defined any Folder Modules.

CDA Release 2.0 Content Modules

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

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Medical Documents Specification 1.3.6.1.4.1.19376.1.5.3.1.1.1

This section defines the base set of constraints used by almost all medical document profiles described the PCC Technical Framework.

Standards

CDAR2	HL7 CDA Release 2.0
CDTHP	CDA for Common Document Types History and Physical Notes (DSTU)
XMLXSL	Associating Style Sheets with XML documents

Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below.

Sample Medical Documents Document

<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.1'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Medical Documents</title> <effectiveTime value='20240515012005'/> <confidentialityCode code='N' displayName='Normal' codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/> : <component><structuredBody>     </structuredBody></component> </ClinicalDocument>

 

   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Medical Documents must be {{{LOINC}}}
   </assert>
   <assert test='cda: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>

Specification

The constraints for encoding of the CDA Header (Level 1) can be found in the CDA for Common Document Types History and Physical Implementation Guide, in the section 2. CDA Header -- General Constraints.

• IHE Medical Documents shall follow all constraints found in that section with the exception of the constraint on realmcode found in CONF-HP-15:.
• IHE Medical Documents which are implemented for the US Realm shall follow ALL constraints found in that section, and shall use both the IHE Medical Document templateId (1.3.6.1.4.1.19376.1.5.3.1.1.1) and the HL7 General Header Constraints templateId (2.16.840.1.113883.10.20.3).}}

Realm	Constraints	Template IDs Required
Universal	CONF-HP-1 through CONF-HP-14 CONF-HP-16 through CONF-HP-52	1.3.6.1.4.1.19376.1.5.3.1.1.1
US	CONF-HP-1 through CONF-HP-52	1.3.6.1.4.1.19376.1.5.3.1.1.1 2.16.840.1.113883.10.20.3

Style Sheets

Document sources should provide an XML style sheet to render the content of the Medical Summary document. The output of this style sheet shall be an XHTML Basic (see http://www.w3.org/TR/xhtml-basic/) document that renders the clinical content of a Medical Summary Document as closely as possible as the sending provider viewed the completed document. When a style sheet is provided, at least one processing instruction shall be included in the document that including a link to the URL for the XML style sheet. To ensure that the style sheet is available to all receivers, more than one stylesheet link may be included.

When a stylesheet is used within an XDS Affinity domain, the link to it shall be provided using an HTTPS or HTTP URL.

<?xml-stylesheet href='https://foobar:8080/mystylesheet.xsl' type='text/xsl'?>

When using XDM or XDR to exchange documents, the stylesheet shall also be exchanged on the media. The link to the stylesheet shall be recorded as a relative URL.

<?xml-stylesheet href='../../stylesheets/mystylesheet.xsl' type='text/xsl'?>

Style sheets should not rely on graphic or other media resources. If graphics other media resources are used, these shall be accessible in the same way as the stylesheet. The Content Creator need not be the provider of the resources (stylesheet or graphcs).

When a Content Creator provides a style sheet, Content Consumers must provide a mechanism to render the document with that style sheet. Content Consumers may view the document with their own style sheet.

To record the stylesheet within a CDA Document that might be used in both an XDS and XDM environment, more than one stylesheet processing instruction is required. In this case, all style sheet processing instructions included must include the alternate='yes' attribute.

<?xml-stylesheet href='https://foobar:8080/mystylesheet.xsl' type='text/xsl' alternate='yes'?>
<?xml-stylesheet href='../../stylesheets/mystylesheet.xsl' type='text/xsl' alternate='yes'?>

A Content Consumer that is attempting to render a document using the document supplied stylesheet may use the first style sheet processing instruction for which it is able to obtain the style sheet content, and shall not report any errors if it is able to find at least one stylesheet to render with.

Distinctions of None

Information that is sent must clearly identify distinctions between

None

It is known with complete confidence that there are none. Used in the context of problem and medication lists, this indicates that the sender knows that there is no relevant information that can be sent.

None Known

None are known at this time, but it is not known with complete confidence than none exist. Used in the context of allergy lists, where essentially, it is impossible to prove the negative that no allergies exist, it is only possible to assert that none have been found to date.

None Known Did Ask

None are known at this time, and it is not known with complete confidence than none exist, but the information was requested. Also used in the context of allergy lists, where essentially, it is impossible to prove the negative that no allergies exist, it is only possible to assert that none have been found to date.

Unknown

The information is not known, or is otherwise unavailable.

In the context of CDA, sections that are required to be present but have no information should use one of the above phrases where appropriate.

An appropriate machine readable entry shall be present for problems, medications and allergies to indicate the reason that no information. Codes for recording unknown or no information are provided in the section on the Problem, Allergy and Medications Entry.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Medical Summary Specification 1.3.6.1.4.1.19376.1.5.3.1.1.2

A medical summary contains a snapshot of the patient's medical information, including at the very least, a list of the patients problems, medications and allergies. A Medical Summary is an abstract template that is expected to be further refined by additional document templates.

Parent Template

This document is an instance of the Medical Document template.

Standards

CDAR2

HL7 CDA Release 2.0

Specification

Data Element Name	Opt	Template ID
Problem Concern Entry	R	1.3.6.1.4.1.19376.1.5.3.1.4.5.2
Allergy Concern Entry	R	1.3.6.1.4.1.19376.1.5.3.1.4.5.3
Medications	R	1.3.6.1.4.1.19376.1.5.3.1.4.7

Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Document content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample Medical Summary Document

<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.1'/>  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Medical Summary</title> <effectiveTime value='20240515012005'/> <confidentialityCode code='N' displayName='Normal' codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/> : <component><structuredBody>     </structuredBody></component> </ClinicalDocument>

Schematron

<pattern name='Template_1.3.6.1.4.1.19376.1.5.3.1.1.2'>
 <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
   <!-- Verify that the template id is used on the appropriate type of object -->
   <assert test='../cda:ClinicalDocument'>
     Error: The Medical Summary can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.1"]'>
     Error: The parent template identifier for Medical Summary is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Medical Summary must be {{{LOINC}}}
   </assert>
   <assert test='cda: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> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.5.2"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Problem Concern Entry Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.5.3"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Allergy Concern Entry Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.7"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Medical Summary Document must contain a(n) Medications Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.2
   </assert> 
 </rule>
</pattern>

Document Specification

A medical summary is a type of medical document, and incorporates the constraints defined for Medical Documents, and requires the recording of Problems, Allergies and Medications.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Referral Summary Specification 1.3.6.1.4.1.19376.1.5.3.1.1.3

The use case is described fully in PCC_TF-1 for the Ambulatory Specialist Referral. Briefly, it involves a "collaborative" transfer of care for the referral of a patient from a primary care provider (PCP) to a specialist. The important document data elements identified by physicians and nurses for this use case are listed in the table below under the column "Data Elements". These were then mapped to the categories given HL7 Care Record Summary Implementation Guide, and HL7 CDA Release 2.0. These mappings are provided in the next two columns.

A referral summary is a type of Medical Summary, and incorporates the constraints defined for a Medical Summary(1.3.6.1.4.1.19376.1.5.3.1.1.2) above. This section defines additional constraints for Medical Summary Content used in a Referral summary. These tables present the Categories, as defined in Section 3 of CRS. In no case are these IHE requirements less strict than those defined by CRS.

Format Code

The XDSDocumentEntry format code for this content is urn:ihe:pcc:xds-ms:2007

Parent Template

This document is an instance of the Medical Summary template.

Standards

CDAR2	HL7 CDA Release 2.0
CRS	HL7 Care Record Summary
CCD	ASTM/HL7 Continuity of Care Document

Data Element Index

Data Elements	HL7 Care Record Summary	CDA Release 2.0
Reason for Referral	Reason for Referral	REASON FOR REFERRAL
History Present Illness	History of Present Illness	HISTORY OF PRESENT ILLNESS
Active Problems	Conditions	PROBLEM LIST
Current Meds	Medications	HISTORY OF MEDICATION USE
Allergies	Allergies and Adverse Reactions	HISTORY OF ALLERGIES
History of Past Illness	Conditions	HISTORY OF PAST ILLNESS
List of Surgeries	Past Surgical History	HISTORY OF PRIOR SURGERIES
Immunizations	Immunizations	HISTORY OF IMMUNIZATIONS
Family History	Family History	HISTORY OF FAMILY ILLNESS
Social History	Social History	SOCIAL HISTORY
Pertinent Review of Systems	Review of Systems	REVIEW OF SYSTEMS
Vital Signs	Physical Exam	VITAL SIGNS
Physical Exam	Physical Exam	GENERAL STATUS, PHYSICAL FINDINGS
Relevant Diagnostic Surgical Procedures / Clinical Reports (including links)	Studies and Reports	RELEVANT DIAGNOSTIC TESTS AND/OR LABORATORY DATA
Relevant Diagnostic Test and Reports (Lab, Imaging, EKG's, etc.) including links.	Studies and Reports	RELEVANT DIAGNOSTIC TESTS AND/OR LABORATORY DATA
Plan of Care (new meds labs, or x-rays ordered)	Care Plan	TREATMENT PLAN
Advance Directives	Advance Directives	ADVANCE DIRECTIVES
Patient Administrative Identifiers	Header	patientRole/id
Pertinent Insurance Information	Participant	participant[@classCode='HLD']
Data needed for state and local referral forms, if different than above	Optional Sections	section

Specification

Data Element Name	Opt	Template ID
Reason for Referral	R	1.3.6.1.4.1.19376.1.5.3.1.3.1
History Present Illness	R	1.3.6.1.4.1.19376.1.5.3.1.3.4
Active Problems	R	1.3.6.1.4.1.19376.1.5.3.1.3.6
Current Meds	R	1.3.6.1.4.1.19376.1.5.3.1.3.19
Allergies	R	1.3.6.1.4.1.19376.1.5.3.1.3.13
History of Past Illness	R2	1.3.6.1.4.1.19376.1.5.3.1.3.8
List of Surgeries	R2	1.3.6.1.4.1.19376.1.5.3.1.3.11
Immunizations	R2	1.3.6.1.4.1.19376.1.5.3.1.3.23
Family History	R2	1.3.6.1.4.1.19376.1.5.3.1.3.14
Social History	R2	1.3.6.1.4.1.19376.1.5.3.1.3.16
Pertinent Review of Systems	O	1.3.6.1.4.1.19376.1.5.3.1.3.18
Vital Signs	R2	1.3.6.1.4.1.19376.1.5.3.1.3.25
Physical Exam	R2	1.3.6.1.4.1.19376.1.5.3.1.3.24
Relevant Diagnostic Surgical Procedures / Clinical Reports and Relevant Diagnostic Test and Reports (Lab, Imaging, EKG's, etc.) including links.	R2	1.3.6.1.4.1.19376.1.5.3.1.3.27
Plan of Care (new meds, labs, or x-rays ordered)	R2	1.3.6.1.4.1.19376.1.5.3.1.3.31
Advance Directives	R2	1.3.6.1.4.1.19376.1.5.3.1.3.34
Patient Administrative Identifiers Handled by the Medical Documents Content Profile by reference to constraints in HL7 CRS.	R
Pertinent Insurance Information Refer to Appropriate Payers Section -- TBD	R2
Data needed for state and local referral forms, if different than above These are handed by including additional sections within the summary.	R2

Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Summary content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample Referral Summary Document

<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/>  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.3'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Referral Summary</title> <effectiveTime value='20240515012005'/> <confidentialityCode code='N' displayName='Normal' codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/> : <component><structuredBody>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.1'/> <!-- Required Reason for Referral Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.4'/> <!-- Required History Present Illness Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.6'/> <!-- Required Active Problems Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.19'/> <!-- Required Current Meds Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.13'/> <!-- Required Allergies Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.8'/> <!-- Required if known History of Past Illness Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.11'/> <!-- Required if known List of Surgeries Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.23'/> <!-- Required if known Immunizations Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.14'/> <!-- Required if known Family History Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.16'/> <!-- Required if known Social History Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.18'/> <!-- Optional Pertinent Review of Systems Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/> <!-- Required if known Vital Signs Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.24'/> <!-- Required if known Physical Exam Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.27'/> <!-- Required if known Relevant Diagnostic Surgical Procedures / Clinical Reports and Relevant Diagnostic Test and Reports Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.31'/> <!-- Required if known Plan of Care (new meds, labs, or x-rays ordered) Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.34'/> <!-- Required if known Advance Directives Section content --> </section> </component>     </structuredBody></component> </ClinicalDocument>

Schematron

<pattern name='Template_1.3.6.1.4.1.19376.1.5.3.1.1.3'>
 <rule context='*[cda: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='../cda:ClinicalDocument'>
     Error: The Referral Summary can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
     Error: The parent template identifier for Referral Summary is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Referral Summary must be {{{LOINC}}}
   </assert>
   <assert test='cda: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> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.1"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) Reason for Referral Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.4"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) History Present Illness Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.6"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) Active Problems Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.19"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) Current Meds Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.13"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) Allergies Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) History of Past Illness Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.11"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) List of Surgeries Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.23"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Immunizations Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.14"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Family History Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.16"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Social History Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.18"]'> 
     <!-- Note any missing optional elements -->
     Note: This Referral Summary Document does not contain a(n) Pertinent Review of Systems Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.25"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Vital Signs Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.24"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Physical Exam Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.27"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Relevant Diagnostic Surgical Procedures / Clinical Reports and Relevant Diagnostic Test and Reports Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3 
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.31"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Plan of Care (new meds, labs, or x-rays ordered) Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.34"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Advance Directives Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3
   </assert> 
   <assert test='.//cda:templateId[@root = ""]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Referral Summary Document must contain a(n) Patient Administrative Identifiers Entry.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3 
   </assert> 
   <assert test='.//cda:templateId[@root = ""]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Pertinent Insurance Information Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3 
   </assert> 
   <assert test='.//cda:templateId[@root = ""]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Referral Summary Document should contain a(n) Data needed for state and local referral forms, if different than above Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.3 
   </assert> 
 </rule>
</pattern>

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Discharge Summary Specification 1.3.6.1.4.1.19376.1.5.3.1.1.4

This use case is described fully in the XDS-MS profile found in PCC TF-1. Briefly, it involves an episodic transfer of care in the form of a patient discharge from a hospital to home. The important data elements identified by physicians and nurses for this use case are listed in the table below under the column "Data Elements". These are mapped to the categories given HL7 Care Record Summary Implementation Guide, and HL7 CDA Release 2.0 in the next two columns.

A discharge summary is a type of medical summary, and incorporates the constraints defined for Medical Summaries.

This section defines additional constraints for Medical Summary Content used in a Discharge Summary. These tables present the data elements described above, along with their optionality, and references to the section and template where these sections or header data elements are further defined.

In no case are these IHE requirements less strict than those defined by the HL7 Care Record Summary.

Format Code

The XDSDocumentEntry format code for this content is urn:ihe:pcc:xds-ms:2007

Parent Template

This document is an instance of the Medical Summary template.

Standards

CDAR2	HL7 CDA Release 2.0
CRS	HL7 Care Record Summary
CCD	ASTM/HL7 Continuity of Care Document

Data Element Index

Data Elements	HL7 Care Record Summary	CDA Release 2.0
Date of Admission	Header	encompassingEncounter/effectiveTime
Date of Discharge	Header	encompassingEncounter/effectiveTime
Participating Providers and Roles	Header	documentationOf/serviceEvent/performer
Discharge Disposition (who, how, where)	Care Plan	DISCHARGE DISPOSITION
Admitting Diagnosis	Conditions	HOSPITAL ADMISSION DX
History of Present Illness	History of Present Illness	HISTORY OF PRESENT ILLNESS
Hospital Course	Hospital Course	HOSPITAL COURSE
Discharge Diagnosis (including active and resolved problems)	Conditions	HOSPITAL DISCHARGE DX
Selected Medicine Administered during Hospitalization	Medications	HISTORY OF MEDICATION USE
Discharge Medications	Medications	HOSPITAL DISCHARGE MEDICATIONS
Allergies and adverse reactions	Allergies and Adverse Reactions	HISTORY OF ALLERGIES
Discharge Diet	Optionally found in Care Plan	DISCHARGE DIET
Review of Systems	Review of Systems	REVIEW OF SYSTEMS
Vital Signs (most recent, high/low/average)	Physical Exam	VITAL SIGNS
Functional Status	Functional Status	HISTORY OF FUNCTIONAL STATUS
Relevant Procedures and Reports (including links)	Studies and Reports	HOSPITAL DISCHARGE STUDIES
Relevant Diagnostic Tests and Reports (including links)	Studies and Reports	HOSPITAL DISCHARGE STUDIES
Plan of Care	Care Plan	TREATMENT PLAN
Administrative Identifiers	Header	patient/id
Pertinent Insurance Information	Header	participant[@classCode='HLD']

Specification

Data Element Name	Opt	Template ID
Active Problems	R	1.3.6.1.4.1.19376.1.5.3.1.3.6
Resolved Problems	R	1.3.6.1.4.1.19376.1.5.3.1.3.8
Discharge Diagnosis	R	1.3.6.1.4.1.19376.1.5.3.1.3.7
Admitting Diagnosis	R	1.3.6.1.4.1.19376.1.5.3.1.3.3
Selected Meds Administered	R2	1.3.6.1.4.1.19376.1.5.3.1.3.21
Discharge Meds	R	1.3.6.1.4.1.19376.1.5.3.1.3.22
Admission Medications	R2	1.3.6.1.4.1.19376.1.5.3.1.3.20
Allergies	R	1.3.6.1.4.1.19376.1.5.3.1.3.13
Hospital Course	R	1.3.6.1.4.1.19376.1.5.3.1.3.5
Advance Directives	O	1.3.6.1.4.1.19376.1.5.3.1.3.34
History of Present Illness	R2	1.3.6.1.4.1.19376.1.5.3.1.3.4
Functional Status	O	1.3.6.1.4.1.19376.1.5.3.1.3.17
Review of Systems	O	1.3.6.1.4.1.19376.1.5.3.1.3.18
Physical Examination	O	1.3.6.1.4.1.19376.1.5.3.1.3.24
Vital Signs	O	1.3.6.1.4.1.19376.1.5.3.1.3.25
Discharge Procedures Tests, Reports	O	1.3.6.1.4.1.19376.1.5.3.1.3.29
Plan of Care	R	1.3.6.1.4.1.19376.1.5.3.1.3.31
Discharge Diet	O	1.3.6.1.4.1.19376.1.5.3.1.3.33

Conformance

CDA Release 2.0 documents that conform to the requirements of this content module shall indicate their conformance by the inclusion of the appropriate <templateId> elements in the header of the document. This is shown in the sample document below. A CDA Document may conform to more than one template. This content module inherits from the Medical Summary content module, and so must conform to the requirements of that template as well, thus all <templateId> elements shown in the example below shall be included.

Sample Discharge Summary Document

<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.2'/>  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.4'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Discharge Summary</title> <effectiveTime value='20240515012005'/> <confidentialityCode code='N' displayName='Normal' codeSystem='2.16.840.1.113883.5.25' codeSystemName='Confidentiality' /> <languageCode code='en-US'/> : <component><structuredBody>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.6'/> <!-- Required Active Problems Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.8'/> <!-- Required Resolved Problems Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.7'/> <!-- Required Discharge Diagnosis Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.3'/> <!-- Required Admitting Diagnosis Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.21'/> <!-- Required if known Selected Meds Administered Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.22'/> <!-- Required Discharge Meds Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.20'/> <!-- Required if known Admission Medications Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.13'/> <!-- Required Allergies Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.5'/> <!-- Required Hospital Course Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.34'/> <!-- Optional Advance Directives Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.4'/> <!-- Required if known History of Present Illness Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.17'/> <!-- Optional Functional Status Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.18'/> <!-- Optional Review of Systems Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.24'/> <!-- Optional Physical Examination Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/> <!-- Optional Vital Signs Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.29'/> <!-- Optional Discharge Procedures Tests, Reports Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.31'/> <!-- Required Plan of Care Section content --> </section> </component>  <component> <section> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.33'/> <!-- Optional Discharge Diet Section content --> </section> </component>     </structuredBody></component> </ClinicalDocument>

Schematron

<pattern name='Template_1.3.6.1.4.1.19376.1.5.3.1.1.4'>
 <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.4"]'>
   <!-- Verify that the template id is used on the appropriate type of object -->
   <assert test='../cda:ClinicalDocument'>
     Error: The Discharge Summary can only be used on Clinical Documents.
   </assert> 
   <!-- Verify that the parent templateId is also present. -->
   <assert test='cda:templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
     Error: The parent template identifier for Discharge Summary is not present.
   </assert> 
   <!-- Verify the document type code -->
   <assert test='cda:code[@code = "{{{LOINC}}}"]'>
     Error: The document type code of a Discharge Summary must be {{{LOINC}}}
   </assert>
   <assert test='cda: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> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.6"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Active Problems Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Resolved Problems Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.7"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Discharge Diagnosis Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.3"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Admitting Diagnosis Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.21"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Discharge Summary Document should contain a(n) Selected Meds Administered Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.22"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Discharge Meds Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.20"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Discharge Summary Document should contain a(n) Admission Medications Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.13"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Allergies Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.5"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Hospital Course Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.34"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Advance Directives Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.4"]'> 
     <!-- Alert on any missing required if known elements -->
     Warning: The  Discharge Summary Document should contain a(n) History of Present Illness Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.17"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Functional Status Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.18"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Review of Systems Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.24"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Physical Examination Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.25"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Vital Signs Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.29"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Discharge Procedures Tests, Reports Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.31"]'> 
     <!-- Verify that all required data elements are present -->
     Error: The Discharge Summary Document must contain a(n) Plan of Care Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
   <assert test='.//cda:templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.33"]'> 
     <!-- Note any missing optional elements -->
     Note: This Discharge Summary Document does not contain a(n) Discharge Diet Section.
     See http://wiki.ihe.net/index.php?title=1.3.6.1.4.1.19376.1.5.3.1.1.4
   </assert> 
 </rule>
</pattern>

CDA Header Content Modules

The following content modules define the structure of elements in the header of CDA Release 2.0 document.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Language Communication 1.3.6.1.4.1.19376.1.5.3.1.2.1

Languages spoken shall be recorded using the languageCommunication infrastructure class associated with the patient. The <languageCommunication> element describes the primary and secondary languages of communication for a person. When used, these shall be described using the languageCommunication element as follows.

Uses

See Templates using Language Communication

Specification

Language Communication Example

<languageCommunication> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.1'/> <languageCode code='en-US'/> <modeCode code='' codeSystem='2.16.840.1.113883.5.60' codeSystemName='LanguageAbilityMode'/> <preferenceInd value='true|false'/> </languageCommunication>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.1'/>

The <templateId> element identifies this <languageCommunication> element for validation of the content. The templateId must have root='1.3.6.1.4.1.19376.1.5.3.1.2.1'.

<languageCode code=' '/>

This element describes the language code. It uses the same vocabulary described for the ClinicalDocument/languageCode element described in more detail in HL7 CRS: 2.1.1. This element is required.

<modeCode code=' ' codeSystem='2.16.840.1.113883.5.60' codeSystemName='LanguageAbilityMode'/>

This element describes the mode of use, and is only necessary when there are differences between expressive and receptive abilities. This element is optional. When not present, the assumption is that any further detail provided within the languageCommunication element refers to all common modes of communication. The coding system used shall be the HL7 LanguageAbilityMode vocabulary when this element is communicated.

<proficiencyLevelCode code=' ' codeSystem='2.16.840.1.113883.5.61' codeSystemName='LanguageProficiencyCode' />

This element describes the proficiency of the patient (with respect to the mode if specified). This element is optional. The coding system used shall be the HL7 LanguageProficiencyCode vocabulary when this element is communicated.

<preferenceInd value=' '/>

This element shall be present on all languageCommunication elements when more than one is provided. It shall be valued "true" if this language is the patient’s preferred language for communication, or "false" if this is not the patient’s preferred language. More than one language may be preferred, and at least one must be preferred.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Employer and School Contacts 1.3.6.1.4.1.19376.1.5.3.1.2.2

Employer and school informational contacts shall be recorded as participants in the CDA Header as demonstrated in the figure below. These contacts shall conform to the General Constraints found in HL7 CRS: 2.1.1 with respect to the requirements for name, address, telephone numbers and other contact information.

The figure below shows how the information for this element is coded, and further constraints are provided in the following sections.

Uses

See Templates using Employer and School Contacts

Specification

Employer and School Contacts Example

<participant typeCode='IND'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.2'/> <time> <low value=''/> <high value=''/> </time> <associatedEntity classCode='CON'> <id root='' extension=''/> <code code='EMPLOYER|SCHOOL|AFFILIATED' codeSystem='1.3.5.1.4.1.19376.1.5.3.3' codeSystemName='IHERoleCode'/> <associatedPerson><name>…</name></associatedPerson> <scopingOrganization> <name>…</name> <telecom value='' use=''/> <addr>…</addr> </scopingOrganization> </associatedEntity> </participant>

<participant typeCode='IND'>

The typeCode of the participant shall be IND.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.2'/>

The <templateId> element identifies this <participant> as a school or employer contact for validation of the content. The templateId must have root='1.3.6.1.4.1.19376.1.5.3.1.2.2'.

<time><low value=' '/><high value=' '/>

The time element indicates the start and stop time range for this contact. These dates shall correspond to the start and stop dates for employment, enrollment, or other affiliation with the organization described.

<associatedEntity classCode='CON'>

The <associatedEntity> element provides the contact information (classCode='CON') for the school, employer or affiliated organization.

<code code='EMPLOYER|SCHOOL|AFFILIATED' codeSystem='1.3.5.1.4.1.19376.1.5.3.3' codeSystemName='IHERoleCode'/>

The code value shall indicate whether the participant is the employer, school or other affiliated (e.g., volunteer) organization. See also the IHE Role Code Vocabulary(1.3.5.1.4.1.19376.1.5.3.3)

<associatedPerson><name>…</name></associatedPerson>

This element should be present. When present is shall provide the name of a contact person within the organization.

<scopingOrganization><name>…</name><telecom value= use=/><addr>…</addr></scopingOrganization>

This element shall be present, and shall provide the name, address and telephone number of the organization.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Healthcare Providers and Pharmacies 1.3.6.1.4.1.19376.1.5.3.1.2.3

Healthcare providers (including pharmacies) shall be recorded as described in CCD: 3.17. The identifier that the patient is known by to these providers may be included using the Patient Identifier extension described in Extensions to HL7 CDA Release 2.0. See the example shown in for use of this extension element.

Uses

See Templates using Healthcare Providers and Pharmacies

Specification

Healthcare Providers and Pharmacies Example

<documentationOf> <serviceEvent classCode="PCPR"> <effectiveTime><low value=""/><high value=""/></effectiveTime> <performer typeCode="PRF"> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.3'/> <functionCode code='' displayName='' codeSystem='' codeSystemName=''/> <time> <low value=''/> <high value=''/> </time> <assignedEntity> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> <addr></addr> <telecom value='' use=''/> <assignedPerson><name></name></assignedPerson> <representedOrganization><name></name></representedOrganization> <sdtc:patient> <sdtc:id root='' extension=''/> </sdtc:patient> </assignedEntity> </performer> </serviceEvent> <documentationOf>

<documentationOf>

The <documentationOf> element records the service events that were performed. This element shall be present.

<serviceEvent classCode="PCPR">

The <serviceEvent> element describes the activity being documented. This element shall be present, and shall have a classCode attribute of 'PCPR'.

<effectiveTime><low value=""/><high value=""/></effectiveTime>

The <effectiveTime> element records the time over which care provision activities are recorded in the document. There shall be a <low> element which records the starting date of care provision, and a <high> element which records the ending date of care provision. The ending date may extend into the future in the document describes care that is intended to be provided, but that has not actually occurred.

<performer typeCode="PRF">

The <performer> elements in the <serviceEvent> identify the providers of care. At least one <performer> element should be present. When a provider gives care over two distinct time intervals (e.g., as in the case of a specialist who treats the patient for short periods of time in different years), the provider may be recorded multiple times as a performer.

<functionCode code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The function of the provider in the care of the patient should be present, and will be described in the <functionCode> element. This may be used for example, to identify the primary care provider.

<time><low value=' '/><high value=' '/>

The element is used to show the time period over which the provider gave care to the patient. The <low> and <high> elements must be present, and indicate the time over which care was (or is to be) provided.

<assignedEntity classCode='ASSIGNED'>

The <assignedEntity> element contains elements that identify the individual provider, and shall be present.

<id root=' ' extension=' '/>

The <id> element may be present and identifies the provider.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <code> element describes the type of provider and can be used to distinguish pharmacies from other providers.

<addr></addr>

The <addr> element gives the address of the provider.

<telecom value=' ' use=' '/>

The <telecom> element gives the telephone number of the provider.

<assignedPerson><name></name></assignedPerson>

The providers name should be present. If not present, then the <scopingOrganization> shall be present (see below).

<representedOrganization><name></name></representedOrganization>

This element should be present, and shall provide the name of the organization.

<sdtc:patient><sdtc:id root=' ' extension=' '/></sdtc:patient>

The <sdtc:patient> element may be present to represent the patient's medical record number with the given provider. The root attribute of <sdtc:id> element shall be present and identifies the namespace used for the identifier. The extension attribute shall be present and is the patient's medical record or account number with the provider. This element is an HL7 extension to CDA Release 2.0.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Patient Contacts 1.3.6.1.4.1.19376.1.5.3.1.2.4

Patient contacts are recorded as described in HL7 CCD: 3.3

Uses

See Templates using Patient Contacts

Specification

Patient Contacts Example

<guardian classCode='GUARD'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.4'/> <code code='' displayName='' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/> <addr></addr> <telecom /> <guardianPerson> <name></name> </guardianPerson> </guardian> Guardians <participant typeCode='IND'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.4'/> <time value='20070213'/> <associatedEntity classCode='AGNT|CAREGIVER|ECON|NOK|PRS'> <code code='' displayName='' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/> <addr></addr> <telecom value='' use=''/> <assignedPerson><name></name></assignedPerson> </associatedEntity> </participant>

<guardian classCode='GUARD'>

The guardians of a patient shall be recorded in the <guardian> element beneath the <patient> element.

<participant typeCode='IND'>

Other contacts are recorded as <participant> elements appearing in the document header. The classCode attribute shall be set to 'IND'.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.4'/>

The <templateId> element identifies this person as a patient contact and must be recorded exactly as shown above.

<time value=' '>

The element may be present and indicates the time of the participation.

<associatedEntity classCode='AGNT|CAREGIVER|ECON|NOK|PRS'>

The <associatedEntity> element identifies the type of contact. The classCode attribute shall be present, and contains a value from the set AGNT, CAREGIVER, ECON, NOK, or PRS to identify contacts that are agents of the patient, care givers, emergency contacts, next of kin, or other relations respectively.

<code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/>

The relationship between the patient and the guardian or other contact should be recorded in the <code> element. The code attribute is required and comes from the HL7 PersonalRelationshipRoleType vocabulary. The codeSystem attribute is required and shall be represented exactly as shown above.

<addr>

The address of the guardian or other contact should be present, and shall be represented as any other address would be in CDA.

<telecom>

The phone number of the guardian or other contact should be present, and shall be represented as any other phone number would be in CDA.

<guardianPerson><name/> or <assignedPerson><name/>

The name of the guardian or other contact shall be present, and shall be represented as any other name would be in CDA.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Authorization 1.3.6.1.4.1.19376.1.5.3.1.2.5

Each <authorization> element in the CDA Header represents an informed consent. When the document being shared represents the informed consent to a policy expressed by the XDS Affinity Domain within the document, it shall do so in an <authorization> element. More than one <authorization> element may be present. The consent to share informaiton shall have a unique identifier contained in the <id> element, representing the patient consent to that policy. The policy being consented to shall be represented in the <code> element. Note that other <authorization> elements may be present representing other sorts of consents associated with the document.

Uses

See Templates using Authorization

Specification

Authorization Example

<authorization typeCode='AUTH'> <consent classCode='CONS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.5'/> <id root=''/> <code code='' codeSystem='' codeSystemName='' displayName=''/> <statusCode code='completed'/> </consent> </authorization>

Policies are identified using an Affinity Domain specified coding system. Each coded value in that vocabulary represents one affinity domain specific policy.

<authorization typeCode='AUTH'>

At least one <authorization> element must be present in a consent medical document in documents shared by Document Source actors that implement the privacy option. The typeCode attribute shall be present and be valued with AUTH, indicating that this is an authorization act related to the document.

<consent classCode='CONS' moodCode='EVN'>

Each authorization element shall have one <consent> element. The classCode shall be present and be valued with CONS, indicating that the related act is an informed consent. The moodCode shall be EVN, indicating that this element represents and act that has occurred.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.5'/>

The <templateId> element shall be recorded as shown above and identifies this consent as an authorization entry.

<id root=' '/>

The <consent> element shall have one identifier that is used to uniquely identify the consent act. This identifier shall contain a root attribute, and shall not contain an extension attribute.

<code code=' ' codeSystem=' ' codeSystemName=' ' displayName=' '/>

The <consent> element shall have one <code> element that is used to identify the consent policy that was agreed to by the patient.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Consent Service Events 1.3.6.1.4.1.19376.1.5.3.1.2.6

Within a consent document, the effective time of the consent shall be specified within the documentationOf/serviceEvent element.

Uses

See Templates using Consent Service Events

Specification

Consent Service Events Example

<documentationOf typeCode='DOC'> <serviceEvent classCode='ACT' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.6'/> <id root=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> <effectiveTime> <low value=''/> <high value=''/> </effectiveTime> </serviceEvent> </documentationOf>

<documentationOf typeCode='DOC'>

At least one <documentationOf> element shall exist within a consent to share information, describing the service event of provision of consent. This element shall have a typeCode attribute with the value DOC.

<serviceEvent classCode='ACT' moodCode='EVN'>

One <serviceEvent> shall exist for each consent to share information given, describing the duration of the provision of consent. This element shall have a classCode attribute set to ACT, and a moodCode attribute of EVN.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.6'/>

The <templateId> element shall be recorded exactly as shown above, and identifies this <serviceEvent> as recording consent to share information.

<id root=' ' />

The service event shall have one <id> element, providing an identifier for the service event. The root attribute of this element shall be present, and shall be a GUID or OID. The extension attribute shall not be present.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <code> element shall be present, and shall indicate the consent given. The code attribute indicates the consent given, and the codeSystem attribute indicates the code system from which this consent is given. The displayName attribute may be present, and describes the consent given. The codeSystemName attribute may be present, and describes the code system.

<effectiveTime><low value=' '/><high value=' '/></effectiveTime>

The <effectiveTime> element shall be present, and shall indicated the effective time range over which consent is given. The low value must be provided . The high value may be present. If present, is shall indicate the maximum effective time of the consent.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Related Document 1.3.6.1.4.1.19376.1.5.3.1.2.7

The relatedDocument element using this templateId shall refer to a document conforming to the PHR Extract Content module. All XML content with the exception of the <id> element must appear exactly as shown below.

Uses

See Templates using Related Document

Specification

Related Document Example

<relatedDocument typeCode='APND'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.7'/> <parentDocument classCode='DOCCLIN' moodCode='EVN'> <id root=' ' extension=' '/> </parentDocument> </relatedDocument>

<relatedDocument typeCode='APND'>

Indicates that this CDA document is an addendum to a preceeding CDA document. The typeCode attribute shall have the value APND.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.2.7'/>

This template identifier indicates that the <relatedDocument> entry conforms to the rules of this specification.

<parentDocument classCode='DOCCLIN' moodCode='EVN'>
<id root=' ' extension=' '/>

The related document shall be recorded in the <parentDocument> document element by identifying the the PHR Extract that is being updated in the <id> element.

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.

• (1.3.6.1.4.1.19376.1.5.3.1.3.1)Reason for Referral

• (1.3.6.1.4.1.19376.1.5.3.1.3.2)Coded Reason for Referral

• (1.3.6.1.4.1.19376.1.5.3.1.3.3)Hospital Admission Diagnosis

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.1)Proposed Procedure

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.2)Expected Blood Loss

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.3)Proposed Anesthesia

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.4)Reason for Procedure

Other Condition Histories

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

• (1.3.6.1.4.1.19376.1.5.3.1.3.4)History of Present Illness

• (1.3.6.1.4.1.19376.1.5.3.1.3.5)Hospital Course

• (1.3.6.1.4.1.19376.1.5.3.1.3.6)Active Problems

• (1.3.6.1.4.1.19376.1.5.3.1.3.7)Discharge Diagnosis

• (1.3.6.1.4.1.19376.1.5.3.1.3.8)Resolved Problems

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.3)Encounter Histories

• (1.3.6.1.4.1.19376.1.5.3.1.3.9)History of Outpatient Visits

• (1.3.6.1.4.1.19376.1.5.3.1.3.10)History of Inpatient Visits

• (1.3.6.1.4.1.19376.1.5.3.1.3.11)List of Surgeries

• (1.3.6.1.4.1.19376.1.5.3.1.3.12)Coded List of Surgeries

• (1.3.6.1.4.1.19376.1.5.3.1.3.13)Allergies and Other Adverse Reactions

• (1.3.6.1.4.1.19376.1.5.3.1.3.14)Family Medical History

• (1.3.6.1.4.1.19376.1.5.3.1.3.15)Coded Family Medical History

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.5)Pre-procedure Family Medical History

• (1.3.6.1.4.1.19376.1.5.3.1.3.16)Social History

• (1.3.6.1.4.1.19376.1.5.3.1.3.17)Functional Status

• (1.3.6.1.4.1.19376.1.5.3.1.3.18)Review of Systems

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.13)Preprocedure Review of Systems

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.1)Hazardous Working Conditions

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4)Pregnancy History

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.5)Medical Devices

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.6)Foreign Travel

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.8)History of Tobacco Use

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.10)Current Alcohol/Substance Abuse

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.12)Transfusion History

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.14)Anesthesia Risk Review of Systems

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.46)Implanted Medical Device Review

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.47)Pregnancy Status Review

Medications

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

• (1.3.6.1.4.1.19376.1.5.3.1.3.19)Medications

• (1.3.6.1.4.1.19376.1.5.3.1.3.20)Admission Medication History

• (1.3.6.1.4.1.19376.1.5.3.1.3.21)Medications Administered

• (1.3.6.1.4.1.19376.1.5.3.1.3.22)Hospital Discharge Medications

• (1.3.6.1.4.1.19376.1.5.3.1.3.23)Immunizations

Physical Exams

• (1.3.6.1.4.1.19376.1.5.3.1.3.24)Physical Exam

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.15)Physical Exam (with subsections)

• (1.3.6.1.4.1.19376.1.5.3.1.3.26)Hospital Discharge Physical Exam

• (1.3.6.1.4.1.19376.1.5.3.1.3.25)Vital Signs

• (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2)Coded Vital Signs

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.16)General Appearance

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.48)Visible Implanted Medical Devices

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.17)Integumentary System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.18)Head

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.19)Eyes

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.20)Ears, Nose, Mouth and Throat

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.21)Ears

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.22)Nose

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.23)Mouth, Throat, and Teeth

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.24)Neck

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.25)Endocrine System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.26)Thorax and Lungs

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.27)Chest Wall

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.28)Breasts

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.29)Heart

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.30)Respiratory System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.31)Abdomen

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.32)Lymphatic System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.33)Vessels

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.34)Musculoskeletal System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.35)Neurologic System

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.36)Genitalia

• (1.3.6.1.4.1.19376.1.5.3.1.1.9.37)Rectum

Relevant Studies

• (1.3.6.1.4.1.19376.1.5.3.1.3.27)Results

•  1.3.6.1.4.1.19376.1.5.3.1.3.28

•  1.3.6.1.4.1.19376.1.5.3.1.3.29

•  1.3.6.1.4.1.19376.1.5.3.1.3.30

•  1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2

Plans of Care

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

•  1.3.6.1.4.1.19376.1.5.3.1.3.31

• (1.3.6.1.4.1.19376.1.5.3.1.1.10.3.1)ED Care Plan

•  1.3.6.1.4.1.19376.1.5.3.1.3.32

•  1.3.6.1.4.1.19376.1.5.3.1.3.33

•  1.3.6.1.4.1.19376.1.5.3.1.3.34

•  1.3.6.1.4.1.19376.1.5.3.1.3.35

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.40

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.45

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.50

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.41

• (1.3.6.1.4.1.19376.1.5.3.1.1.10.3.2)Transport Mode

Procedures Performed

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.38

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.38

Impressions

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.42

•  1.3.6.1.4.1.19376.1.5.3.1.1.9.44

Administrative and Other Information

•  1.3.6.1.4.1.19376.1.5.3.1.1.5.3.7

Entry Content Modules

This section describes the HL7 Version 3 structures used as entries in CDA documents and found in other HL7 Version 3 messaging standards. These entries describe information such as conditions, problems, medications, and references to external documents, as well as several common components that may be used by these entries, including:

• Severity observations allow practitioners to indicate the severity of a condition.
• Unstructured comments allow practitioners to specify additional information that they feel is relevant.
• Medication instructions allow practitioners to specify additional instructions for the use of a medication.

These common structures are included in the target act using the <entryRelationship> element defined in the CDA Schema, or the appropriate act relationship structure when used in an HL7 Version 3 message. This allows for arbitrary act relationships to be described.

The normal containment structure includes the target of the related act inside an act relationship element that is contained in the source act. To invert the direction of the relationship the inversionInd attribute of act relationship element is set to true (inversionInd='true') in the samples below.

Linking Narrative and Coded Entries

This section defines a linking mechanism that allows entries or portions thereof to be connected to the text of the clinical document.

Standards

RIM	HL7 Version 3 Reference Information Model
CDAR2	HL7 Clinical Document Architecture Release 2.0

Constraints for CDA

Elements within the narrative <text> will use the ID attribute to provide a destination for links. Elements within an <entry> will be linked to the text via a URI reference using this attribute as the fragment identifier. This links the coded entry to the specific narrative text it is related to within the CDA instance, and can be traversed in either direction. This serves three purposes:

1. It supports diagnostics during software development and testing.
2. It provides a mechanism to enrich the markup that can be supported in the viewing application.
3. It eliminates the need to duplicate content in two places, which prevents a common source of error, and eliminates steps needed to validate that content that should be identical in fact is.

Each narrative content element within CDA may have an ID attribute. This attribute is of type xs:ID. This means that each ID in the document must be unique within that document. Within an XML document, an attribute of type xs:ID must start with a letter, and may be followed one or more letters, digits, hyphens or underscores . Three different examples showing the use of the ID attribute, and references to it appear below:

<td>Table Cell 2

</tr>

Example Uses of ID

Use of ID	References to ID
<tr ID='foo'> <td ID='bar'>Table Cell 1	<code> <originalText>​<reference value='#foo'>​</originalText> </code> <code> <originalText>​<reference value='#bar'>​</originalText> </code>
<list> <item ID='baz'>List item 1</item> </list>	<code> <originalText>​<reference value='#baz'>​</originalText> </code>
<paragraph ID='p-1'>A paragraph <content ID='c-1'>with content</content> </paragraph>	<code> <originalText>​<reference value='#p-1'>​</originalText> </code> <code> <originalText>​<reference value='#c-1'>​</originalText> </code>

This allows the text to be located with a special type of URI reference, which simply contains a fragment identifier. This URI is local to the document and so just begins with a hash mark (#), and is followed by the value of the ID being referenced. Given one of these URIs stored in a variable named theURI, the necessary text value can be found via the following XPath expression:

string(//*[@ID=substring-after('#',$theURI)])

The table below shows the result of this expression using the examples above:

URI Dereference Result

$theURI	Returned Value
"#bar"	"Table Cell 1"
"#foo"	"Table Cell 1Table Cell 2" (note the spacing issue between 1 and T)
"#p-1"	"A paragraph with content"
"#c-1"	"with content"

If your XSLT processor is schema aware, even more efficient mechanisms exist to locate the element than the above expression.

Having identified the critical text in the narrative, any elements using the HL7 CD datatype (e.g., <code>) can then contain a <reference> to the <originalText> found in the narrative. That is why, although CDA allows <value> to be of any type in <entry> elements, this profile restricts them to always be of xsi:type='CD'.

Now, given an item with an ID stored in a variable named theID all <reference> elements referring to it can be found via the following XPath expression:

//cda:reference[@URI=concat('#',$theID)]

Constraints for HL7 Version 3 Messages

Unlike CDA entries, structured statements in HL7 Version 3 Messages do not have a related narrative text section. Therefore full text representations should be included in the <text> element care statement acts.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Severity 1.3.6.1.4.1.19376.1.5.3.1.4.1

Any condition or allergy may be the subject of a severity observation. This structure is included in the target act using the <entryRelationship> element defined in the CDA Schema.

The example below shows the recording the condition or allergy severity, and is used as the context for the following sections.

Standards

PatCareStruct	HL7 Care Provision Domain (DSTU)
CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Severity

Specification

Severity Example

<observation classCode='COND' moodCode='EVN'> <entryRelationship typeCode='SUBJ' inversionInd='true'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.55'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1'/> <code code='SEV' displayName='Severity' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ActCode' /> <text><reference value='#severity-2'/></text> <statusCode code='completed'/> <value xsi:type='CD' code='H|M|L' codeSystem='2.16.840.1.113883.5.1063' codeSystemName='ObservationValue' /> </observation> </entryRelationship> </observation>

This specification models a severity observation as a separate observation from the condition. While this model is different from work presently underway by various organizations (i.e., SNOMED, HL7, TermInfo), it is not wholly incompatible with that work. In that work, qualifiers may be used to identify severity in the coded condition observation, and a separate severity observation is no longer necessary. The use of qualifiers is not precluded by this specification. However, to support semantic interoperability between EMR systems using different vocabularies, this specification does require that severity information also be provided in a separate observation. This ensures that all EMR systems have equal access to the information, regardless of the vocabularies they support.

<entryRelationship typeCode='SUBJ' inversionInd='true'>

The related statement is made about the severity of the condition (or allergy). For CDA, this observation is recorded inside an <entryRelationship> element occurring in the condition, allergy or medication entry. The containing <entry> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'. For HL7 Version 3 Messages this relationship is represented with a <sourceOf> element, however the semantics, typeCode, and inversionInd is unchanged.

<observation moodCode='EVN' classCode='OBS'>

The related statement is another event (moodCode='EVN') observing (<observation classCode='OBS'>) the severity of the (surrounding) related entry (e.g., a condition or allergy).

<templateId root='2.16.840.1.113883.10.20.1.55'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1'/>

The <templateId> elements identifies this <observation> as a severity observation, allowing for validation of the content. As a side effect, readers of the CDA can quickly locate and identify severity observations. The templateId elements shown above must be present.

<code code='SEV' codeSystem='2.16.840.1.113883.5.4' displayName='Severity' codeSystemName='ActCode' />

This observation is of severity, as indicated by the <code> element listed above. This element is required. The code and codeSystem attributes shall be recorded exactly as shown above.

<text><reference value='#severity-2'/></text>

The <observation> element shall contain a <text> element. For CDA, the <text> elements shall contain a <reference> element pointing to the narrative where the severity is recorded, rather than duplicate text to avoid ambiguity. For HL7 Version 3 Messages, the <text> element should contain the full narrative text.

<statusCode code='completed'/>

The code attribute of <statusCode> for all severity observations shall be completed. While the <statusCode> element is required in all acts to record the status of the act, the only sensible value of this element in this context is completed.

<value xsi:type='CD' code='H|M|L' codeSystem='2.16.840.1.113883.5.1063' codeSystemName='SeverityObservation'>

The <value> element contains the level of severity. It is always represented using the CD datatype (xsi:type='CD'), even though the value may be a coded or uncoded string. If coded, it should use the HL7 SeverityObservation vocabulary (codeSystem='2.16.840.1.113883.5.1063') containing three values (H, M, and L), representing high, moderate and low severity depending upon whether the severity is life threatening, presents noticeable adverse consequences, or is unlikely substantially effect the situation of the subject.

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Problem Status Observation 1.3.6.1.4.1.19376.1.5.3.1.4.1.1

Any problem or allergy observation may reference a problem status observation. This structure is included in the target observation using the <entryRelationship> element defined in the CDA Schema. The clinical status observation records information about the current status of the problem or allergy, for example, whether it is active, in remission, resolved, et cetera. The example below shows the recording of clinical status of a condition or allergy, and is used as the context for the following sections.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Problem Status Observation

Specification

Problem Status Observation Example

<entry> <observation classCode='OBS' moodCode='EVN'> <entryRelationship typeCode='REFR' inversionInd='false'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.57'/> <templateId root='2.16.840.1.113883.10.20.1.50'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1.1'/> <code code='33999-4' displayName='Status' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC' /> <text><reference value='#cstatus-2'/></text> <statusCode code='completed'/> <value xsi:type='CE' code=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> </observation> </entryRelationship> </observation> </entry>

This CCD models a problem status observation as a separate observation from the problem, allergy or medication observation. While this model is different from work presently underway by various organizations (i.e., SNOMED, HL7, TermInfo), it is not wholly incompatible with that work. In that work, qualifiers may be used to identify problem status in the coded condition observation, and a separate clinical status observation is no longer necessary. The use of qualifiers in the problem observation is not precluded by this specification or by CCD. However, to support semantic interoperability between EMR systems using different vocabularies, this specification does require that problem status information also be provided in a separate observation. This ensures that all EMR systems have equal access to the information, regardless of the vocabularies they support.

<entryRelationship typeCode='REFR' inversionInd='false'>

The related statement is made about the clinical status of the problem or allergy. For CDA, this observation is recorded inside an <entryRelationship> element occurring in the problem or allergy. For HL7 Version 3 Messages, the <entryRelationship> tag name is <sourceOf>, though the typeCode and inversionInd attributes and other semantics remain the same. The containing observation refers to (typeCode='REFR') this new observation.

<observation moodCode='EVN' classCode='OBS'>

The related statement is another event (moodCode='EVN') observing (<observation classCode='OBS'>) the clinical status of the (surrounding) related observation (e.g., a problem or allergy).

<templateId root='2.16.840.1.113883.10.20.1.57'/>
<templateId root='2.16.840.1.113883.10.20.1.50'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1.1'/>

These <templateId> elements identify this <observation> as a problem status observation, allowing for validation of the content.

<code code='33999-4' codeSystem='2.16.840.1.113883.6.1' displayName='Status' codeSystemName='LOINC' />

This observation is of clinical status, as indicated by the <code> element. This element must be present. The code and codeSystem shall be recorded exactly as shown above.

<text><reference value='#cstatus-2'/></text>

The <observation> element shall contain a <text> element that points to the narrative text describing the clinical status. For CDA, the <text> elements shall contain a <reference> element pointing to the narrative section (see Linking Narrative and Coded Entries), rather than duplicate text to avoid ambiguity. For HL7 Version 3 Messages, the <text> element SHALL contain the full narrative text.

<statusCode code='completed'/>

The code attribute of <statusCode> for all clinical status observations shall be completed. While the <statusCode> element is required in all acts to record the status of the act, the only sensible value of this element in this context is completed.

<value xsi:type='CE' code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'>

The <value> element contains the clinical status. It is always represented using the CE datatype (xsi:type='CE'). It shall contain a code from the following set of values from SNOMED CT.

Clinical Status Values

Code	Description
55561003	Active
73425007	Inactive
90734009	Chronic
7087005	Intermittent
255227004	Recurrent
415684004	Rule out
410516002	Ruled out
413322009	Resolved

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Health Status 1.3.6.1.4.1.19376.1.5.3.1.4.1.2

A problem observation may reference a health status observation. This structure is included in the target observation using the <entryRelationship> element defined in the CDA Schema. The health status observation records information about the current health status of the patient. The example below shows the recording the health status, and is used as the context for the following sections.

Uses

See Templates using Health Status

Specification

Health Status Example

<entry> <observation classCode='OBS' moodCode='EVN'> <entryRelationship typeCode='REFR' inversionInd='false'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.51'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1.2'/> <code code='11323-3' displayName='Health Status' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC' /> <text><reference value='#hstatus-2'/></text> <statusCode code='completed'/> </value> <value xsi:type='CE' code=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> </observation> </entryRelationship> </observation> </entry>

This specification models a health status observation as a separate observation about the patient.

<entryRelationship typeCode='REFR'>

The related statement is made about the health status of the patient. For CDA, this observation is recorded inside an <entryRelationship> element occurring in the observation. The contained observersation is referenced (typeCode='REFR') by the observation entry. For HL7 Version 3 Messages, the entryRelationship tagName is sourceOf, though the typeCode and inversionInd attributes and other semantics remain the same.

<observation moodCode='EVN' classCode='OBS'>

The related statement is another event (moodCode='EVN') observing (<observation classCode='OBS'>) the health status of the patient.

<templateId root='2.16.840.1.113883.10.20.1.51'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.1.2'/>

The <templateId> element identifies this <observation> as a health status observation, allowing for validation of the content.

<code code='11323-3'
displayName='Health Status'
codeSystem='2.16.840.1.113883.6.1'
codeSystemName='LOINC' />

This observation is of health status, as indicated by the <code> element. This element must be present. The code and codeSystem attributes shall be recorded exactly as shown above.

<text><reference value='#hstatus-2'/></text>

The <observation> element shall contain a <text> element that contains the narrative text describing the clinical status. For CDA, the <text> elements shall contain a <reference> element pointing to the narrative section (see Linking Narrative and Coded Entries, rather than duplicate text to avoid ambiguity. For HL7 Version 3 Messages, the <text> element shall contain the full narrative text.

<statusCode code='completed'/>

The code attribute of <statusCode> for all health status observations shall be completed. While the <statusCode> element is required in all acts to record the status of the act, the only sensible value of this element in this context is completed.

<value xsi:type='CE' code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'>

The <value> element contains the clinical status. It is always represented using the CE datatype (xsi:type='CE').

Health Status Codes

Code	Description
81323004	Alive and well
313386006	In remission
162467007	Symptom free
161901003	Chronically ill
271593001	Severely ill
21134002	Disabled
161045001	Severely disabled
419099009	Deceased

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Comments 1.3.6.1.4.1.19376.1.5.3.1.4.2

This entry allows for a comment to be supplied with each entry. For CDA this structure is usually included in the target act using the <entryRelationship> element defined in the CDA Schema, but can also be used in the <component> element when the comment appears within an <organizer>. The example below shows recording a comment for an <entry>, and is used as context for the following sections. For HL7 Version 3 Messages, this relationship is represented with the element <sourceOf>, although the remainder of the typecodes and semantics are unchanged.

Any condition or allergy may be the subject of a comment.

Standards

CareStruct	HL7 Care Provision Care Structures (DSTU)
CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Comments

Specification

Comments Example

<entry> <observation classCode='OBS' moodCode='EVN'> ∶ <entryRelationship typeCode='SUBJ' inversionInd='true'> <act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.40'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/> <code code='48767-8' displayName='Annotation Comment' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC' /> <text><reference value='#comment-2'/></text> <statusCode code='completed' /> <author> <time value=''/> <assignedAuthor> <id root='' extension=''> <addr></addr> <telecom value='' use=''> <assignedPerson><name></name></assignedPerson> <representedOrganization><name></name></representedOrganization> </assignedAuthor> </author> </act> </entryRelationship> ∶ </observation> </entry> <entry> <organizer> <component typeCode='COMP'> <act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.40'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/> <code code='48767-8' displayName='Annotation Comment' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC' /> : </act> </component> </organizer> </entry>

<entryRelationship typeCode='SUBJ' inversionInd='true'> or <component typeCode='COMP'/>

A related statement is made about an act, or a cluster or battery of results. In CDA the former shall be recorded inside an <entryRelationship> element occurring at the end of the entry. The containing act is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'.

For HL7 Version 3 Messages, the relationship element is <sourceOf>, however the typeCode and inversionInd remain the same.

In the latter case, the comment shall be recorded inside a <commponent> element contained within the <organizer> element.

<act classCode='ACT' moodCode='EVN'>

The related statement is an event (moodCode='EVN') describing the act (classCode='ACT') of making an arbitrary comment or providing instruction on the related entry.

<templateId root='2.16.840.1.113883.10.20.1.40'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.2'/>

These <templateId> elements identify this <act> as a comment, allowing for validation of the content.

<code code='48767-8' displayName='Annotation Comment' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC' />

The <code> element indicates that this is a comment and shall be recorded as shown above. The codeSystem and code attributes shall use the values specified above.

<text><reference value='#comment-2'/></text>

The <text> element provides a way to represent the <reference> to the text of the comment in the narrative portion of the document. For CDA, this SHALL be represented as a <reference> element that points to the narrative text section of the CDA. The comment itself is not the act being coded, so it appears in the <text> of the <observation>, not as part of the <code>. For HL7 Version 3 Messages, the <text> element SHALL contain the full narrative text.

<statusCode code='completed' />

The code attribute of <statusCode> for all comments must be completed.

<author>

The comment may have an author.

The time of the comment creation shall be recorded in the element when the <author> element is present.

<assignedAuthor>
 <id root=' ' extension=' '>
 <addr></addr>
 <telecom value=' ' use=' '>

The identifier of the author, and their address and telephone number must be present inside the <id>, <addr> and <telecom> elements when the <author> element is present.

<assignedPerson><name></name></assignedPerson>
<representedOrganization><name></name></representedOrganization>

The author's and/or the organization's name must be present when the <author> element is present.

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Patient Medication Instructions 1.3.6.1.4.1.19376.1.5.3.1.4.3

Any medication may be the subject of further instructions to the patient, for example to indicate that it should be taken with food, et cetera.

This structure is included in the target substance administration or supply act using the <entryRelationship> element defined in the CDA Schema. The example below shows the recording of patient medication instruction for an <entry>, and is used as context for the following section.

Standards

Pharmacy

HL7 Pharmacy Domain (Normative)

Uses

See Templates using Patient Medication Instructions

Specification

Patient Medication Instructions Example

<entry> <substanceAdministration classCode='SBADM' moodCode='EVN'> ∶ <entryRelationship typeCode='SUBJ' inversionInd='true'> <act classCode='ACT' moodCode='INT'> <templateId root='2.16.840.1.113883.10.20.1.49'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.3'/> <code code='PINSTRUCT' codeSystem='1.3.6.1.4.1.19376.1.5.3.2' codeSystemName='IHEActCode' /> <text><reference value='#comment-2'/></text> <statusCode code='completed' /> </act> </entryRelationship> ∶ </substanceAdministration> </entry>

<entryRelationship typeCode='SUBJ' inversionInd='true'>

Again, a related statement is made about the medication or immunization. This observation is recorded inside an <entryRelationship> element occurring at the end of the substance administration or supply entry. The containing <entry> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'.

<act classCode='ACT' moodCode='INT'>

The related statement is the intent (moodCode='INT') on how the related entry is to be performed. .

<templateId root='2.16.840.1.113883.10.20.1.49'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.3'/>

These <templateId> elements identify this <act> as a medication instruction, allowing for validation of the content. As a side effect, readers of the CDA can quickly locate and identify medication instructions.

<code code='PINSTRUCT' codeSystem='1.3.6.1.4.1.19376.1.5.3.2' codeSystemName='IHEActCode' />

The <code> element indicates that this is a patient medication instruction. This element shall be recorded exactly as specified above.

Note:

These values will be sent to HL7 for harmonization with the HL7 Act Vocabulary.

<text><reference value='#comment-2'/></text>

The <text> element indicates the text of the comment. For CDA, this SHALL be represented as a <reference> element that points at the narrative portion of the document. The comment itself is not the act being coded, so it appears in the <text> of the <observation>, not as part of the <code>. For HL7 Version 3 Messages, the full text SHALL be represented here.

<statusCode code='completed' />

The code attribute of <statusCode> for all comments must be completed.

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Medication Fulfillment Instructions 1.3.6.1.4.1.19376.1.5.3.1.4.3.1

Any medication may be the subject of further instructions to the pharmacist, for example to indicate that it should be labeled in Spanish, et cetera.

This structure is included in the target substance administration or supply act using the <entryRelationship> element defined in the CDA Schema. The figure below is an example of recording an instruction for an <entry>, and is used as context for the following sections.

Standards

Pharmacy

HL7 Pharmacy Domain (Normative)

Uses

See Templates using Medication Fulfillment Instructions

Specification

Medication Fulfillment Instructions Example

<entry> <supply classCode='SPLY' moodCode='EVN'> ∶ <entryRelationship typeCode='SUBJ' inversionInd='true'> <act classCode='ACT' moodCode='INT'> <templateId root='2.16.840.1.113883.10.20.1.43'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.3.1'/> <code code='FINSTRUCT' codeSystem='1.3.6.1.4.1.19376.1.5.3.2' codeSystemName='IHEActCode' /> <text><reference value='#comment-2'/></text> <statusCode code='completed' /> </act> </entryRelationship> ∶ </supply> </entry>

<entryRelationship typeCode='SUBJ' inversionInd='true'>

Again, a related statement is made about the medication or immunization. In CDA, this observation is recorded inside an <entryRelationship> element occurring at the end of the substance administration or supply entry. The containing <act> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'. For HL7 Version 3 Messages, this relationship is represented with the <sourceOf> element however the semantics, typeCode, and inversionInd remain the same.

<act classCode='ACT' moodCode='INT'>

The related statement is the intent (moodCode='INT') on how the related entry is to be performed.

<templateId root='2.16.840.1.113883.10.20.1.43'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.3.1'/>

These <templateId> elements identify this <act> as a medication fulfillment instruction, allowing for validation of the content.

<code code='FINSTRUCT' codeSystem='1.3.6.1.4.1.19376.1.5.3.2' codeSystemName='IHEActCode' />

The <code> element indicates that this is a medication fulfillment instruction. This element shall be recorded exactly as specified above.

Note:

These values will be sent to HL7 for harmonization with the HL7 Act Vocabulary.

<text><reference value='#comment-2'/></text>

The <text> element contains a free text representation of the instruction. For CDA this SHALL contain a provides a <reference>element to thelink text of the comment in the narrative portion of the document. The comment itself is not the act being coded, so it appears in the <text> of the <observation>, not as part of the <code>. For HL7 Version 3 Messages, the full text SHALL be represented here.

<statusCode code='completed' />

The code attribute of <statusCode> for all comments must be completed.

References

Development Only

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External References 1.3.6.1.4.1.19376.1.5.3.1.4.4

CDA Documents may reference information contained in other documents. While CDA Release 2.0 supports references in content via the <linkHtml> element, this is insufficient for many EMR systems as the link is assumed to be accessible via a URL, which is often not the case. In order to link an external reference, one needs the document identifier, and access to the clinical system wherein the document resides. For a variety of reasons, it is desirable to refer to the document by its identity, rather than by linking through a URL.

1. The identity of a document does not change, but the URLs used to access it may vary depending upon location, implementation, or other factors.
2. Referencing clinical documents by identity does not impose any implementation specific constraints on the mechanism used to resolve these references, allowing the content to be implementation neutral. For example, in the context of an XDS Affinity domain the clinical system used to access documents would be an XDS Registry and one or more XDS Repositories where documents are stored. In other contexts, access might be through a Clincial Data Repository (CDR), or Document Content Management System (DCMS). Each of these may have different mechanisms to resolve a document identifier to the document resource.
3. The identity of a document is known before the document is published (e.g., in an XDS Repository, Clincial Data Repository, or Document Content Management System), but its URL is often not known. Using the document identity allows references to existing documents to be created before those documents have been published to a URL. This is important to document creators, as it does not impose workflow restrictions on how links are created during the authoring process.

Fortunately, CDA Release 2.0 also provides a mechanism to refer to external documents in an entry, as shown below.

Uses

See Templates using External References

Specification

External References Example

<entry> <act classCode='ACT' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4'/> <id root='' extension=''/> <code nullFlavor='NA' /> <text><reference value='#study-1'/></text> <!-- For CDA --> <reference typeCode='REFR|SPRT'> <externalDocument classCode='DOC' moodCode='EVN'> <id extension='' root=''/> <text><reference value='http://foo..'/></text> </externalDocument> </reference> <!-- For HL7 Version 3 Messages <sourceOf typeCode='REFR|SPRT'> <act classCode='DOC' moodCode='EVN'> <id extension='' root=''/> <text><reference value='http://foo…'</text> </act> </sourceOf> --> </act> </entry>

<act classCode='ACT' moodCode='EVN'>

The external reference is an act that refers to documentation of an <act> (classCode='ACT'), that previously occurred (moodCode='EVN').

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4'/>

The <templateId> element identifies this <act> as a reference act, allowing for validation of the content. As a side effect, readers of the CDA can quickly locate and identify reference acts. The templateId must have root='1.3.6.1.4.1.19376.1.5.3.1.4.1.4.4'.

<id root=' ' extension=' '/>

The reference is an act of itself, and must be uniquely identified. If there is no explicit identifier for this act in the source EMR system, a GUID may be used for the root attribute, and the extension may be omitted. Although HL7 allows for multiple identifiers, this profile requires that one and only one be used.

<code nullFlavor='NA'/>

The reference act has no code associated with it.

<text><reference value='#study-1'/></text>

In order to connect this external reference to the narrative text which it refers, the value of the <reference> element in the <text> element is a URI to an element in the CDA narrative of this document.

<reference typeCode='SPRT|REFR'>
<externalDocument classCode='DOC' moodCode='EVN'>

External references are listed as either supporting documentation (typeCode='SPRT') or simply reference material (typeCode='REFR') for the reader. If this distinction is not supported by the source EMR system, the value of typeCode should be REFR. For CDA, the reference is indicated by a <reference> element containing an <externalDocument> element which documents (classCode='DOC') the event (moodCode='EVN'). For HL7 Version 3 Messages, the reference is represented with the element <sourceOf> and the external document is representated with a <act> element, however semantics, and attributes remain otherwise without change.

<id extension=' ' root=' '/>

The identifier of the document is supplied in the <id> element.

<text><reference value=' '/></text>

A link to the original document may be provided here. This shall be a URL where the referenced document can be located. For CDA, the link should also be present in the narrative inside the CDA Narrative in a <linkHTML> element.

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Internal References 1.3.6.1.4.1.19376.1.5.3.1.4.4.1

CDA and HL7 Version 3 Entries may reference (point to) information contained in other entries within the same document or message as shown below.

Uses

See Templates using Internal References

Specification

Internal References Example

∶ <entryRelationship typeCode='' inversionInd='true|false'> <act classCode='' moodCode=''> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> </act> </entryRelationship>

<entryRelationship typeCode=' ' inversionInd='true|false'>

For CDA the act being referenced appears inside a related entryRelationship. The type (typeCode) and direction (inversionInd) attributes will be specified in the entry content module that contains the reference. For HL7 Version 3 Messages, the relationship is indicated with a <sourceOf> element, however typeCodes and semantics remain unchanged.

<act classCode=' ' moodCode=' '>

The act being referred to can be any CDA Clinical Statement element type (act, procedure, observation, substanceAdministration, supply, et cetera). For compatibility with the Clinical Statement model the internal reference shall always use the <act> class, regardless of the XML element type of the act it refers to.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/>

The <templateId> element identifies this as an internal reference that conforms to all rules specified in this section.

<id root=' ' extension=' '/>

This element shall be present. The root and extension attributes shall identify an element defined elsewhere in the same document.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

This element shall be present. It shall be valued when the internal reference is to element that has a <code> element, and shall have the same attributes as the <code> element in the act it references. If the element it references does not have a <code> element, then the nullFlavor attribute should be set to "NA".

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Concern Entry 1.3.6.1.4.1.19376.1.5.3.1.4.5.1

This event (moodCode='EVN') represents an act (<act classCode='ACT') of being concerned about a problem, allergy or other issue. The <effectiveTime> element describes the period of concern. The subject of concern is one or more observations about related problems (see 1.3.6.1.4.1.19376.1.5.3.1.4.5.2) or allergies and intolerances (see 1.3.6.1.4.1.19376.1.5.3.1.4.5.3). Additional references can be provided having additional information related to the concern. The concern entry allows related acts to be grouped. This allows representing the history of a problem as a series of observation over time, for example.

Standards

CCD	ASTM/HL7 Continuity of Care Document
CareStruct	HL7 Care Provision Care Structures (DSTU)
ClinStat	ClinStat HL7 Clinical Statement (DRAFT)

Uses

See Templates using Concern Entry

Specification

Concern Entry Example

<act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.27'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/> <id root='' extension=''/> <code nullFlavor='NA'/> <statusCode code='active|suspended|aborted|completed'/> <effectiveTime> <low value=''/> <high value=''/> </effectiveTime> <!-- one or more entry relationships identifying problems of concern --> <entryRelationship typeCode='SUBJ' inversionInd='false'> : </entryRelationship> <!-- For HL7 Version 3 Messages <sourceOf typeCode='SUBJ' inversionInd='false'> : </sourceOf> --> <!-- optional entry relationship providing more information about the concern --> <entryRelationship typeCode='REFR'> : </entryRelationship> <!-- For HL7 Version 3 Messages <sourceOf typeCode='REFR' inversionInd='false'> : </sourceOf> --> </act>

<act classCode='ACT' moodCode='EVN'>

All concerns reflect the act of recording (<act classCode='ACT'>) the event (moodCode='EVN') of being concerned about a problem, allergy or other issue about the patient condition.

<templateId root='2.16.840.1.113883.10.20.1.27'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/>

These template identifiers indicates this entry conforms to the concern content module. This content module inherits constraints from the HL7 CCD Template for problem acts, and so also includes that template identifier.

<id root=' ' extension=' '/>

This required element identifies the concern.

<code nullFlavor='NA'/>

The code is not applicable to a concern act, and so shall be recorded as shown above.

<statusCode code='active|suspended|aborted|completed'/>

The statusCode associated with any concern must be one of the following values:

Status Code Values

Value	Description
active	A concern that is still being tracked.
suspended	A concern that is active, but which may be set aside. For example, this value might be used to suspend concern about a patient problem after some period of remission, but before assumption that the concern has been resolved.
aborted	A concern that is no longer actively being tracked, but for reasons other than because the problem was resolved. This value might be used to mark a concern as being aborted after a patient leaves care against medical advice.
completed	The problem, allergy or medical state has been resolved and the concern no longer needs to be tracked except for historical purposes.

Note:

A concern in the "active" state represents one for which some ongoing clinical activity is expected, and that no activity is expected in other states. Specific uses of the suspended and aborted states are left to the implementation.

<effectiveTime><low value=' '/><high value=' '/></effectiveTime>

The <effectiveTime> element records the starting and ending times during which the concern was active. The <low> element shall be present. The <high> element shall be present for concerns in the completed or aborted state, and shall not be present otherwise.

<!-- 1..* entry relationships identifying problems of concern -->
<entryRelationship type='SUBJ' inversionInd='false'>

Each concern is about one or more related problems or allergies. This entry shall contain one or more problem or allergy entries that conform to the specification in section Problem Entry or Allergies and Intolerances. This is how a series of related observations can be grouped as a single concern.

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element. The typeCode SHALL be ‘SUBJ’ for both HL7 Version 3 and CDA. HL7 Version 3 additionally requires that inversionInd SHALL be ‘false’.

Note:

The Allergy and Intolerances entry is a refinement of the Problem entry.

<!-- 0..n optional entry relationship providing more information about the concern -->
<entryRelationship type='REFR' inversionInd='false'>

Each concern may have 0 or more related references. These may be used to represent related statements such related visits. This may be any valid CDA clinical statement, and SHOULD be an IHE entry template. For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <subjectOf> element. The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘false’

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Problem Concern Entry 1.3.6.1.4.1.19376.1.5.3.1.4.5.2

This entry is a specialization of the Concern Entry, wherein the subject of the concern is focused on a problem. Elements shown in the example below in gray are explained in the Concern Entry.

Standards

CCD	ASTM/HL7 Continuity of Care Document
CareStruct	HL7 Care Provision Care Structures (DSTU)
ClinStat	HL7 Clinical Statement Pattern (Draft)

Parent Template

The parent of this template is Concern Entry. This template is compatible with the ASTM/HL7 Continuity of Care Document template: 2.16.840.1.113883.10.20.1.27

Uses

See Templates using Problem Concern Entry

Specification

Problem Concern Entry Example

<act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.27'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/> <id root=' ' extension=' '/> <code nullFlavor='NA'/> <statusCode code='active|suspended|aborted|completed'/> <effectiveTime> <low value=' '/> <high value=' '/> </effectiveTime> <!-- 1..* entry relationships identifying problems of concern --> <entryRelationship type='SUBJ'> <observation classCode='OBS' moodCode='EVN'/> <templateID root='1.3.6.1.4.1.19376.1.5.3.1.4.5'> : </observation> </entryRelationship> <!-- optional entry relationship providing more information about the concern --> <entryRelationship type='REFR'> </entryRelationship> </act>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/>

This entry has a template identifier of 1.3.6.1.4.1.19376.1.5.3.1.4.5.2, and is a subtype of the Concern Entry, and so must also conform to that specification, with the template identifier of 1.3.6.1.4.1.19376.1.5.3.1.4.5.1. These elements are required and shall be recorded exactly as shown above.

<!-- 1..* entry relationships identifying problems of concern -->
 <observation classCode='OBS' moodCode='EVN'>
  <templateID root=' 1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
   …
 </observation>
<entryRelationship type='SUBJ'>

This entry shall contain one or more problem entries that conform to the Problem Entry template 1.3.6.1.4.1.19376.1.5.3.1.4.5. For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <subjectOf> element. The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘false’

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Allergy and Intolerance Concern 1.3.6.1.4.1.19376.1.5.3.1.4.5.3

This entry is a specialization of the Concern Entry, wherein the subject of the concern is focused on an allergy or intolerance. Elements shown in the example below in gray are explained in that entry.

Standards

CCD	ASTM/HL7 Continuity of Care Document
CareStruct	HL7 Care Provision Care Structures (DSTU)
ClinStat	HL7 Clinical Statement Pattern (Draft)

Parent Template

The parent of this template is Concern Entry. This template is compatible with the ASTM/HL7 Continuity of Care Document template: 2.16.840.1.113883.10.20.1.27

Uses

See Templates using Allergy and Intolerance Concern

Specification

Allergy and Intolerance Concern Example

<act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.27'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.3'/> <id root=' ' extension=' '/> <code nullFlavor='NA'/> <statusCode code='active|suspended|aborted|completed'/> <effectiveTime> <low value=' '/> <high value=' '/> </effectiveTime> <!-- 1..* entry relationships identifying allergies of concern --> <entryRelationship typeCode='SUBJ'> <observation classCode='OBS' moodCode='EVN'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6'/> : </observation> </entryRelationship> <!-- optional entry relationship providing more information about the concern --> <entryRelationship type='REFR'> </entryRelationship> </act>

<templateId root='2.16.840.1.113883.10.20.1.27'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.1'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.3'/>

This entry has a template identifier of 1.3.6.1.4.1.19376.1.5.3.1.4.5.3, and is a subtype of the Concern entry, and so must also conform to the rules of the Concern Entry. These elements are required and shall be recorded exactly as shown above.

<!-- 1..* entry relationships identifying allergies of concern -->
 <observation classCode='OBS' moodCode='EVN'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6'/>
   :
</observation>
<entryRelationship typeCode='SUBJ'>

This entry shall contain one or more allergy or intolerance entries that conform to the Allergy and Intolerance Entry. For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element. The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘false’

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Problem Entry 1.3.6.1.4.1.19376.1.5.3.1.4.5

This section makes use of the linking, severity, clinical status and comment content specifications defined elsewhere in the technical framework. In HL7 RIM parlance, observations about a problem, complaint, symptom, finding, diagnosis, or functional limitation of a patient is the event (moodCode='EVN') of observing (<observation classCode='OBS'>) that problem. The <value> of the observation comes from a controlled vocabulary representing such things. The <code> contained within the <observation> describes the method of determination from yet another controlled vocabulary. An example appears below in the figure below.

Standards

CCD	ASTM/HL7 Continuity of Care Document
CareStruct	HL7 Care Provision Care Structures (DSTU)
ClinStat	HL7 Clinical Statement Pattern (Draft)

Parent Template

This template is compatible with the ASTM/HL7 Continuity of Care Document template: 2.16.840.1.113883.10.20.1.28

Uses

See Templates using Problem Entry

Specification

Problem Entry Example

<observation classCode='OBS' moodCode='EVN' negationInd=' false|true '> <templateId root='2.16.840.1.113883.10.20.1.28'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> <text><reference value=' '/></text> <statusCode code='completed'/> <effectiveTime><low value=' '/><high value=' '/></effectiveTime> <value xsi:type='CD' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '> <originalText><reference value=' '/></originalText> </value> < <!-- zero or one <entryRelationship typeCode='REFR' inversionInd='false'> elements identifying the health status of concern --> <!-- zero or one <entryRelationship typeCode='REFR' inversionInd='false'> elements containing clinical status --> <!-- zero to many <entryRelationship typeCode='REFR' inversionInd='true'> elements containing comments --> </observation>

<observation classCode='OBS' moodCode='EVN' negationInd='false|true'>

The basic pattern for reporting a problem uses the CDA <observation> element, setting the classCode='OBS' to represent that this is an observation of a problem, and the moodCode='EVN', to represent that this is an observation that has in fact taken place. The negationInd attribute, if true, specifies that the problem indicated was observed to not have occurred (which is subtly but importantly different from having not been observed). The value of negationInd should not normally be set to true. Instead, to record that there is "no prior history of chicken pox", one would use a coded value indicated exactly that. However, it is not always possible to record problems in this manner, especially if using a controlled vocabulary that does not supply pre-coordinated negations , or which do not allow the negation to be recorded with post-coordinated coded terminology.

<templateId root='2.16.840.1.113883.10.20.1.28'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>

These <templateId> elements identify this <observation> as a problem, under both IHE and CCD specifications. This SHALL be included as shown above.

<id root=' ' extension=' '/>

The specific observation being recorded must have an identifier (<id>) that shall be provided for tracking purposes. If the source EMR does not or cannot supply an intrinsic identifier, then a GUID shall be provided as the root, with no extension (e.g., <id root='CE1215CD-69EC-4C7B-805F-569233C5E159'/>). While CDA allows for more than one identifier element to be provided, this profile requires that only one be used.

<code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'>

The <code> describes the process of establishing a problem. The code element should be used, as the process of determining the value is important to clinicians (e.g., a diagnosis is a more advanced statement than a symptom). The recommended vocabulary for describing problems is shown in the table below. Subclasses of this content module may specify other vocabularies. When the list below is used, the codeSystem is '2.16.840.1.113883.6.96' and codeSystemName is SNOMED CT.

Problem Codes

Code	Description
64572001	Condition
418799008	Symptom
404684003	Finding
409586006	Complaint
248536006	Functional limitation
55607006	Problem
282291009	Diagnosis

<text><reference value=' '/></text>

The <text> element is required and points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.

<statusCode code='completed'/>

A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.

<effectiveTime><low value=' '/><high value=' '/></effectiveTime>

The <effectiveTime> of this <observation> is the time interval over which the <observation> is known to be true. The <low> and <high> values should be no more precise than known, but as precise as possible. While CDA allows for multiple mechanisms to record this time interval (e.g. by low and high values, low and width, high and width, or center point and width), we are constraining Medical summaries to use only the low/high form. The <low> value is the earliest point for which the condition is known to have existed. The <high> value, when present, indicates the time at which the observation was no longer known to be true. Thus, the implication is made that if the <high> value is specified, that the observation was no longer seen after this time, and it thus represents the date of resolution of the problem. Similarly, the <low> value may seem to represent onset of the problem. Neither of these statements is necessarily precise, as the <low> and <high> values may represent only an approximation of the true onset and resolution (respectively) times. For example, it may be the case that onset occurred prior to the <low> value, but no observation may have been possible before that time to discern whether the condition existed prior to that time. The <low> value should normally be present. There are exceptions, such as for the case where the patient may be able to report that they had chicken pox, but are unsure when. In this case, the <effectiveTime> element shall have a <low> element with a nullFlavor attribute set to 'UNK'. The <high> value need not be present when the observation is about a state of the patient that is unlikely to change (e.g., the diagnosis of an incurable disease).

<value xsi:type='CD' code=' ' codeSystem=' ' codeSystemName=' ' displayName=' '>

The <value> is the condition that was found. This element is required. While the value may be a coded or an un-coded string, the type is always a coded value (xsi:type='CD'). If coded, the code and codeSystem attributes shall be present. The codeSystem should reference a controlled vocabulary describing problems, complaints, symptoms, findings, diagnoses, or functional limitations, e.g., ICD-9, SNOMED-CT or MEDCIN, or others. The table below is an incomplete listing of acceptable values for the codeSystem attribute, along with the codeSystemName.

Example Problem Vocabularies

CodeSystem	codeSystemName	Description
2.16.840.1.113883.6.96	SNOMED-CT	SNOMED Controlled Terminology
2.16.840.1.113883.6.103	ICD-9CM (diagnoses)	International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.26	MEDCIN	A classification system from MEDICOMP Systems.

It is recommended that the codeSystemName associated with the codeSystem, and the displayName for the code also be provided for diagnostic and human readability purposes, but this is not required by this profile.

If uncoded, all attributes other than xsi:type='CD' must be absent.

In cases where information about a problem or allergy is unknown or where there are no problems or allergies, an entry shall use codes from the table below to record this fact:

Entry Type	Code	Display Name	Description
Problem	396782006	Past Medical History Unknown	To indicate unknown medical history
Problem	407559004	Family History Unknown	To indicate that the patient's family history is not known.
Problem	160243008	No Significant Medical History	To indicate no relevant medical history
Problem	160245001	No current problems or disability	To indicate that the patient has no current problems (as distinct from no history).
Allergy	409137002	No Known Drug Allergies	To indicate that there are no known Drug allergies for this patient.
Allergy	160244002	No Known Allergies	To indicate that there are no known allergies for this patient.
Allergy	64970000	Substance Type Unknown	To indicate the state where there is a known allergy or intollerance to an unknown substance

<originalText><reference value=' '/></originalText>

The <value> contains a <reference> to the <originalText> in order to link the coded value to the problem narrative text (minus any dates, comments, et cetera). The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.

<!-- zero or one <entryRelationship typeCode='SUBJ' inversionInd='true'> elements containing severity -->

An optional <entryRelationship> element may be present indicating the severity of the problem. When present, this <entryRelationship> element shall contain a severity observation conforming to the Severity entry template (1.3.6.1.4.1.19376.1.5.3.1.4.1).

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <subjectOf> element. The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘true’.

<!-- zero or one <entryRelationship typeCode='REFR' inversionInd='false'> elements containing clinical status -->

An optional <entryRelationship> may be present indicating the clinical status of the problem, e.g., resolved, in remission, active. When present, this <entryRelationship> element shall contain a clinical status observation conforming to the Problem Status Observation template (1.3.6.1.4.1.19376.1.5.3.1.4.1.1).

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element. The typeCode SHALL be ‘REFR’ and inversionInd SHALL be ‘false’.

<!-- zero or one <entryRelationship typeCode='REFR' inversionInd='false'> elements identifying the health status of concern -->

An optional <entryRelationship> may be present referencing the health status of the patient, e.g., resolved, in remission, active. When present, this <entryRelationship> element shall contain a clinical status observation conforming to the Health Status Observation template (1.3.6.1.4.1.19376.1.5.3.1.4.1.2). The typeCode SHALL be ‘REFR’ and inversionInd SHALL be ‘false’.

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element.

<!-- zero to many <entryRelationship typeCode='SUBJ' inversionInd='true'> element containing comments -->

One or more optional <entryRelationship> elements may be present providing an additional comments (annotations) for the condition. When present, this <entryRelationship> element shall contain a comment observation conforming to the Comment entry template (1.3.6.1.4.1.19376.1.5.3.1.4.2). The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘true’.

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Allergies and Intolerances 1.3.6.1.4.1.19376.1.5.3.1.4.6

Allergies and intolerances are special kinds of problems, and so are also recorded in the CDA <observation> element, with classCode='OBS'. They follow the same pattern as the problem entry, with exceptions noted below.

Standards

CCD	ASTM/HL7 Continuity of Care Document
CareStruct	HL7 Care Provision Care Structures (DSTU)
ClinStat	HL7 Clinical Statement Pattern (Draft)

Uses

See Templates using Allergies and Intolerances

Specification

Allergies and Intolerances Example

<observation classCode='OBS' moodCode='EVN' negationInd='false'> <templateId root='2.16.840.1.113883.10.20.1.18'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/> <id root=' ' extension=' '/> <code code='ALG|OINT|DALG|EALG|FALG|DINT|EINT|FINT|DNAINT|ENAINT|FNAINT' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ObservationIntoleranceType'/> <text><reference value=' '/></text> <statusCode code='completed'/> <effectiveTime> <low value=' '/> <high value=' '/> </effectiveTime> <value xsi:type='CD' code=' ' codeSystem=' ' displayName=' ' codeSystemName=' '/> <participant typeCode='CSM'> <participantRole classCode='MANU'> <playingEntity classCode='MMAT'> <code code=' ' codeSystem=' '> <originalText><reference value='#substance'/></originalText> <name></name> </playingEntity> </participantRole> </participant> <!-- zero to many <entryRelationship> elements containing reactions --> <!-- zero or one <entryRelationship> elements containing severity --> <!-- zero or one <entryRelationship> elements containing clinical status --> <!-- zero to many <entryRelationship> elements containing comments --> </observation>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6'/>

This entry has a template identifier of 1.3.6.1.4.1.19376.1.5.3.1.4.6, and is a subtype of the Problem Entry, and so must also conform to the rules of the problem entry, which has the template identifier of 1.3.6.1.4.1.19376.1.5.3.1.4.5. These elements are required and shall be recorded exactly as shown above.

<code code='ALG|OINT|DINT|EINT|FINT|DALG|EALG|FALG|DNAINT|ENAINT|FNAINT' displayName=' ' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ObservationIntoleranceType'/>

The <code> element represents the kind of allergy observation made, to a drug, food or environmental agent, and whether it is an allergy, non-allergy intolerance, or unknown class of intolerance (not known to be allergy or intolerance). The <code> element of an allergy entry shall be provided, and a code and codeSystem attribute shall be present. The example above uses the HL7 ObservationIntoleranceType vocabulary domain, which does provide suitable observation codes. Other vocabularies may be used, such as SNOMED-CT or MEDCIN. The displayName and codeSystemName attributes should be present.

<value xsi:type='CD' code=' ' codeSystem=' ' codeSystemName=' ' displayName=' '>

The <value> is a description of the allergy or adverse reaction. While the value may be a coded or an uncoded string, the type is always a coded value (xsi:type='CD'). If coded, the code and codeSystem attributes must be present. The codingSystem should reference a controlled vocabulary describing allergies and adverse reactions, see Table 5.4 12Table 5.4 12 above . If uncoded, all attributes other than xsi:type='CD' must be absent. The allergy or intolerance may not be known, in which case that fact shall be recorded appropriately. This might occur in the case where a patient experiences an allergic reaction to an unknown substance.

<participant typeCode='CSM'>
 <participantRole classCode='MANU'>
  <playingEntity classCode='MMAT'>

The substance that causes the allergy or intolerance may be specified in the <participant> element.

<code code=' ' codeSystem=' '>
 <originalText><reference value=' '/></originalText>
  

The <code> element shall be present. It may contain a code and codeSystem attribute to indicate the code for the substance causing the allergy or intolerance. It shall contain a <reference> to the <originalText> in the narrative where the substance is named.

<!-- zero to many <entryRelationship> elements containing reactions -->

An allergy entry can record the reactions that are manifestations of the allergy or intolerance as shown below.

Adverse Reaction Example

<entryRelationship typeCode='MFST'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.6.1'/> <!-- a problem entry --> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.54'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/> ∶ </observation> </entryRelationship>

<entryRelationship typeCode='MFST'>

This is a related entry (<entryRelationship>) that indicates the manifestations (typeCode='MFST') the reported allergy or intolerance. These are events that may occur, or have occurred in the past as a reaction to the allergy or intolerance.

<observation classCode='OBS' moodCode='EVN'>
 <templateId root='2.16.840.1.113883.10.20.1.54'/>
 <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
  ∶
 </observation>

The entry contained with this entry relationship is some sort of problem that is a manifestation of the allergy. It is recorded using the Problem Entry structure, with the additional template identifier (2.16.840.1.113883.10.20.1.54) indicating that this problem is a reaction.

<!-- zero or one <entryRelationship typeCode='SUBJ' inversionInd='true'> elements containing severity -->

An optional <entryRelationship> element may be present indicating the severity of the problem. When present, this <entryRelationship> element shall contain a severity observation conforming to the Severity entry template (1.3.6.1.4.1.19376.1.5.3.1.4.1). For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element. The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘true’.

<!-- zero or one <entryRelationship typeCode='REFR' inversionInd='false'> elements containing clinical status -->

An optional <entryRelationship> may be present indicating the clinical status of the allergy, e.g., resolved, in remission, active. When present, this <entryRelationship> element shall contain a clinical status observation conforming to the Problem Status Observation template (1.3.6.1.4.1.19376.1.5.3.1.4.1.1). The typeCode SHALL be ‘REFR’ and inversionInd SHALL be ‘false’. For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element.

<!-- zero to many <entryRelationship typeCode='SUBJ' inversionInd='true'> element containing comments -->

One or more optional <entryRelationship> elements may be present providing an additional comments (annotations) for the allergy. When present, this <entryRelationship> element shall contain an entry conforming to the Comment entry template (1.3.6.1.4.1.19376.1.5.3.1.4.2). The typeCode SHALL be ‘SUBJ’ and inversionInd SHALL be ‘true’.

For CDA this SHALL be represented with the <entryRelationship> element. For HL7 Version 3 Messages, this SHALL be represented as a <sourceOf> element.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Medications 1.3.6.1.4.1.19376.1.5.3.1.4.7

This content module describes the general structure for a medication. All medication administration acts will be derived from this content module.

Standards

Pharmacy	HL7 Pharmacy Domain (Normative)
CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Medications

Specification

Medications Example

<substanceAdministration classCode='SBADM' moodCode='INT|EVN'> <templateId root='2.16.840.1.113883.10.20.1.24'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7'/> <templateId root=''/> <id root='' extension=''/> <code code='' codeSystem='' displayName='' codeSystemName=''/> <text><reference value='#med-1'/></text> <statusCode code='completed'/> <effectiveTime xsi:type='IVL_TS'> <low value=''/> <high value=''/> </effectiveTime> <effectiveTime operator='A' xsi:type='TS|PIVL_TS|EIVL_TS|PIVL_PPD_TS|SXPR_TS'> : </effectiveTime> <routeCode code='' codeSystem='' displayName='' codeSystemName=''/> <doseQuantity value='' unit=''/> <approachSiteCode code='' codeSystem='' displayName='' codeSystemName=''/> <rateQuantity value='' unit=''/> <consumable> : . </consumable> <!-- 0..* entries describing the components --> <entryRelationship typeCode='COMP' > <sequenceNumber value=''/> </entryRelationship> <!-- An optional entry relationship that indicates the the reason for use --> <entryRelationship typeCode='RSON'> <act classCode='ACT' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/> <id root='' extension=''/> </act> </entryRelationship> <!-- An optional entry relationship that provides prescription activity --> <entryRelationship typeCode='REFR'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/> : . </entryRelationship> <precondition> <criterion> <text><reference value=''></text> </criterion> </precondition> </substanceAdministation>

This section makes use of the linking, severity and instruction entries.

Medications are perhaps the most difficult data elements to model due to variations in the ways that medications are prescribed.

This profile identifies the following relevant fields of a medication as being important to be able to generate in a medical summary. The table below identifies and describes these fields, and indicates the constraints on whether or not they are required to be sent. The fields are listed in the order that they appear in the CDA XML content.

Medication Fields

Medication Fields

Field	Opt.	CDA Tag	Description
Start and Stop Date	R2	<effectiveTime>	The date (and time if available) when the medication regimen began and is expected to finish. The first component of the <effectiveTime> encodes the lower and upper bounds over which the <substanceAdministration> occurs, and the start time is determined from the lower bound. If the medication has been known to be stopped, the high value must be present, but expressed as a flavor of null (e.g., Unknown).
Frequency	R2	<effectiveTime>	The frequency indicates how often the medication is to be administered. It is often expressed as the number of times per day, but which may also include information such as 1 hour before/after meals, or in the morning, or evening.The second <effectiveTime> element encodes the frequency. In cases where split or tapered doses are used, these may be found in subordinate <substanceAdministration> elements.
Route	R2	<routeCode>	The route is a coded value, and indicates how the medication is received by the patient (by mouth, intravenously, topically, et cetera).
Dose	R2	<doseQuantity>	The amount of the medication given. This should be in some known and measurable unit, such as grams, milligrams, et cetera. It may be measured in "administration" units (such as tablets or each), for medications where the strength is relevant. In this case, only the unit count is specified , no units are specified. It may be a range.
Site	O	<approachSiteCode>	The site where the medication is administered, usually used with IV or topical drugs.
Rate	R2	<rateQuantity>	The rate is a measurement of how fast the dose is given to the patient over time (e.g., .5 liter / 1 hr), and is often used with IV drugs.
Product	R1	<consumable>  <name> </consumable>	The name of the substance or product. This should be sufficient for a provider to identify the kind of medication. It may be a trade name or a generic name. This information is required in all medication entries. If the name of the medication is unknown, the type, purpose or other description may be supplied. The name should not include packaging, strength or dosing information. Note: Due to restrictions of the CDA schema, there is no way to explicitly link the name to the narrative text.
Strength	R2	<consumable>  <code>   <originalText/>   </consumable>	The name and strength of the medication. This information is only relevant for some medications, as the dose of the medication is often sufficient to indicate how much medication the patient receives. For example, the medication Percocet comes in a variety of strengths, which indicate specific amounts of two different medications being received in single tablet. Another example is eye-drops, where the medication is in a solution of a particular strength, and the dose quantity is some number of drops. The originalText referenced by the <code> element in the consumable should refer to the name and strength of the medication in the narrative text.Note: Due to restrictions of the CDA schema, there is no way to separately record the strength.
Code	R2	<consumable>  <code/> </consumable>	A code describing the product from a controlled vocabulary, such as RxNorm, First DataBank, et cetera.
Instructions	R2	<entryRelationship>	A place to put free text comments to support additional relevant information, or to deal with specialized dosing instructions. For example, "take with food", or tapered dosing.
Indication	O	<entryRelationship>	A link to supporting clinical information about the reason for providing the medication (e.g., a link to the relevant diagnosis).

1	A consumable is not neccessary when the substanceAdministration code indicates none or unknown medications.

<substanceAdministration classCode='SBADM' moodCode='INT|EVN'>

The general model is to record each prescribed medication in a <substanceAdministration> intent (moodCode='INT'). Medications that have been reported by the patient or administered (instead of prescribed ), are recorded in the same element, except that this is now an event (moodCode='EVN'). The <substanceAdministration> element may contain subordinate <substanceAdministration> elements in a related component entry to deal with special cases (see the section below on Special Cases). These cases include split, tapered, or conditional dosing, or combination medications. The use of subordinate <substanceAdministration> elements to deal with these cases is optional. The comment field should always be used in these cases to provide the same information as free text in the top level <substanceAdministration> element. There are a variety of special cases for dosing that need to be accounted for. These are described below. Most of these special cases involve changing the dosage or frequency over time, or based on some measurement. When the dosage changes, then additional entries are required for each differing dosage. The last case deals with combination medications.

Normal Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.7.1

This template identifier is used to identify medication administration events that do not require any special processing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. Medications that use this template identifier shall not use subordinate <substanceAdministation> acts.

Tapered Doses 1.3.6.1.4.1.19376.1.5.3.1.4.8

This template identifier is used to identify medication administration events that require special processing to handle tapered dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A tapered dose is often used for certain medications where abrupt termination of the medication can have negative consequences. Tapered dosages may be done by adjusting the dose frequency, the dose amount, or both.

When merely the dose frequency is adjusted, (e.g., Prednisone 5mg b.i.d. for three days, then 5mg. daily for three days, and then 5mg every other day), then only one medication entry is needed, multiple frequency specifications recorded in <effectiveTime> elements. When the dose varies (eg. Prednisone 15mg daily for three days, then 10 mg daily for three days, the 5 mg daily for three days), subordinate medication entries should be created for each distinct dosage.

Split Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.9

This template identifier is used to identify medication administration events that require special processing to handle split dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A split dose is often used when different dosages are given at different times (e.g., at different times of day, or on different days). This may be to account for different metabolism rates at different times of day, or to simply address drug packaging deficiencies (e.g., and order for Coumadin 2mg on even days, 2.5mg on odd days is used because Coumadin does not come in a 2.25mg dose form).

In this case a subordinate <substanceAdministration> entry is required for each separate dosage.

Conditional Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.10

This template identifier is used to identify medication administration events that require special processing to handle conditional dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A conditional dose is often used when the dose amount differs based on some measurement (e.g., an insulin sliding scale dose based on blood sugar level). In this case a subordinate <substanceAdministration> entry is required for each different dose, and the condition should be recorded.

Combination Medications 1.3.6.1.4.1.19376.1.5.3.1.4.11

This template identifier is used to identify medication administration events that require special processing to handle combination medications. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A combination medication is made up of two or more other medications. These may be prepackaged, such as Percocet, which is a combination of Acetaminophen and oxycodone in predefined ratios, or prepared by a pharmacist, such as a GI cocktail.

In the case of the prepackaged combination, it is sufficient to supply the name of the combination drug product, and its strength designation in a single <substanceAdministation> entry. The dosing information should then be recorded as simply a count of administration units.

In the latter case of a prepared mixture, the description of the mixture should be provided as the product name (e.g., "GI Cocktail") , in the <substanceAdministration> entry. That entry may, but is not required, to have subordinate <substanceAdministration> entries included beneath it to record the components of the mixture.

<templateId root='2.16.840.1.113883.10.20.1.24'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7' />

All medications entries use the <templateId> elements specified above to indicate that they are medication acts. This element is required. In addition, a medication entry shall further identify itself using one of the template identifiers detailed in the next section.

<templateId root=' ' />

The <templateId> element identifies this <entry> as a particular type of medication event, allowing for validation of the content. As a side effect, readers of the CDA can quickly locate and identify medication events. The templateId must use one of the values in the table below for the root attribute.

Extension values for <templateId> in <substanceAdministration>

root	Description
1.3.6.1.4.1.19376.1.5.3.1.4.7.1	A "normal" <substanceAdministration> act that may not contain any subordinate <substanceAdministration> acts.
1.3.6.1.4.1.19376.1.5.3.1.4.8	A <substanceAdministration> act that records tapered dose information in subordinate <substanceAdministration> act.
1.3.6.1.4.1.19376.1.5.3.1.4.9	A <substanceAdministration> act that records split dose information in subordinate <substanceAdministration> acts.
1.3.6.1.4.1.19376.1.5.3.1.4.10	A <substanceAdministration> act that records conditional dose information in subordinate <substanceAdministration> acts.
1.3.6.1.4.1.19376.1.5.3.1.4.11	A <substanceAdministration> act that records combination medication component information in subordinate <substanceAdministration> acts.

<id root=' ' extension=' '/>

A top level <substanceAdministration> element must be uniquely identified. If there is no explicit identifier for this observation in the source EMR system, a GUID may be used for the root attribute, and the extension may be omitted. Although HL7 allows for multiple identifiers, this profile requires that one and only one be used. Subordinate <substanceAdministration> elements may, but need not be uniquely identified.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '>

The <code> element is used to supply a code that describes the <substanceAdminstration> act, not the medication being administered or prescribed. This may be a procedure code, such as those found in CPT-4 (and often used for billing), or may describe the method of medication administration, such as by intravenous injection. The type of medication is coded in the consumable, do not supply the code for the medication in this element. This element is optional.

One of the following values from SNOMED CT shall be used in the <code> element to record that a patient is either not on medications, or that medications are not known.

Entry Type	Code	Display Name	Description
Medication	182904002	Drug Treatment Unknown	To indicate lack of knowledge about drug therapy
Medication	182849000	No Drug Therapy Prescribed	To indicate the absense of any prescribed medications
Medication	408350003	Patient Not On Self-Medications	To indicate no treatment

<text><reference value=' '/></text>

The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In an HL7 message, the content of the text element shall contain the complete text describing the medication.

<statusCode code='completed'/>

The status of all <substanceAdministration> elements must be "completed". The act has either occurred, or the request or order has been placed.

<effectiveTime xsi:type='IVL_TS'>

The first <effectiveTime> element encodes the start and stop time of the medication regimen. This an interval of time (xsi:type='IVL_TS'), and must be specified as shown. This is an additional constraint placed upon CDA Release 2.0 by this profile, and simplifies the exchange of start/stop and frequency information between EMR systems.

<low value=' '/><high value=' '/>

The <low> and <high> values of the first <effectiveTime> element represent the start and stop times for the medication. The <low> value represents the start time, and the <high> value represents the stop time. If either the <low> or the <high> value is unknown, this shall be recorded by setting the nullFlavor attribute to UNK. The <high> value records the end of the medication regime according to the information provided in the prescription or order. For example, if the prescription is for enough medication to last 30 days, then the high value should contain a date that is 30 days later then the <low> value. The rationale is that a provider, seeing an un-refilled prescription would normally assume that the medication is no longer being taken, even if the intent of the treatment plan is to continue the medication indefinitely.

<effectiveTime operator='A' xsi:type='TS|PIVL_TS|EIVL_TS|PIVL_PPD_TS|SXPR_TS' />

The second <effectiveTime> element records the frequency of administration. This <effectiveTime> element must be intersected with the previous time specification (operator='A'), producing the bounded set containing only those time specifications that fall within the start and stop time of the medication regimen. Several common frequency expressions appear in the table below, along with their XML representations.

Specifying Medication Frequency

Sample Frequency Specifications

Freq	Description	XML Representation
b.i.d.	Twice a day	<effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='12' unit='h' /></effectiveTime>
q12h	Every 12 hours	<effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='12' unit='h' /></effectiveTime>
Once	Once, on 2005-09-01 at 1:18am.	<effectiveTime xsi:type='TS' value='200509010118'/>
t.i.d.	Three times a day, at times determined by the person administering the medication .	<effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='8' unit='h' /></effectiveTime>
q8h	Every 8 hours	<effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='8' unit='h' /></effectiveTime>
qam	In the morning	<effectiveTime xsi:type='EIVL' operator='A'> <event code='ACM'/></effectiveTime>
	Every day at 8 in the morning for 10 minutes	<effectiveTime xsi:type='PIVL_TS' operator='A'> <phase> <low value="198701010800" inclusive="true"/> <width value="10" unit="min"/> </phase> <period value='1' unit='d'/></effectiveTime>
q4-6h	Every 4 to 6 hours.	<effectiveTime xsi:type='PIVL_PPD_TS' institutionSpecified='false' operator='A'> <period value='5' unit='h' /> <standardDeviation value='1' unit='h'></effectiveTime>

The last frequency specification is about as bad as it gets, but can still be represented accurately within the HL7 V3 datatypes. The mean (average) of the low and high values is specified for the period. The mean of 4 and 6 is 5. The standard deviation is recorded as one half the difference between the high and low values, with an unspecified distribution. The type attribute of the <effectiveTime> element describes the kind of frequency specification it contains. More detail is given for each type in the table below.

Data types used in Frequency Specifications

<effectiveTime> types used in Frequency Specifications

xsi:type	Description
TS	An xsi:type of TS represents a single point in time, and is the simplest of all to represent. The value attribute of the <effectiveTime> element specifies the point in time in HL7 date-time format (CCYYMMDDHHMMSS)
PIVL_TS	An xsi:type of PIVL_TS is the most commonly used, representing a periodic interval of time. The <low> element of <phase> may be present. If so it specifies the starting point, and only the lower order components of this value are relevant with respect to the <period>. The <width> element represents the duration of the dose administration (e.g., for IV administration). The <period> indicates how often the dose is given. Legal values for the unit attribute of <period> are s, min, h, d, wk and mo representing seconds, minutes, hours, days, weeks, and months respectively.
EIVL_TS	An xsi:type of EIVL_TS represents an event based time interval, where the event is not a precise time, but is often used for timing purposes (e.g. with meals, between meals, before breakfast, before sleep). Refer to the HL7 TimingEvent vocabulary for the codes to use for the <event> element. This interval may specify an <offset> which provides information about the time offset from the specified event (e.g., <offset><low value='-1' unit='h'/><width value='10' unit='min'/></offset> means 1 hour before the event. In that same example, the <width> element indicates the duration for the dose to be given.
PIVL_PPD_TS	An xsi:type of PIVL_PPD_TS represents an probabilistic time interval and is used to represent dosing frequencies like q4-6h. This profile requires that the distributionType of this interval be left unspecified. The <period> element specifies the average of the time interval, and the value of the <standardDeviation> shall be computed as half the width of the interval. The unit attributes of the <period> and <standardDeviation> elements shall be the same.
SXPR_TS	An xsi:type of SXPR_TS represents a parenthetical set of time expressions. This type is used when the frequency varies over time (e.g., for some cases of tapered dosing, or to handle split dosing). The <comp> elements of this <effectiveTime> element are themselves time expressions (using any of the types listed above). Each <comp> element may specify an operator (e.g. to intersect or form the union of two sets).

<routeCode code=' ' displayName=' ' codeSystem='2.16.840.1.113883.5.112' codeSystemName='RouteOfAdministration'>

The <routeCode> element specifies the route of administration using the HL7 RouteOfAdministration vocabulary. A code must be specified if the route is known, and the displayName attribute should be specified. If the route is unknown, this element shall not be sent.

<approachSiteCode code=' ' codeSystem=' '>
 originalText><reference value=' '/></originalText>
</approachSiteCode>

The <approachSiteCode> element describes the site of medication administrion. It may be coded to a controlled vocabulary that lists such sites (e.g., SNOMED-CT). In CDA documents, this element contains a URI in the value attribute of the <reference> that points to the text in the narrative identifying the site. In a message, the <originalText> element shall contain the text identifying the site.

<doseQuantity> <low value=' ' unit=' '/><high value=' ' unit=' '/> </doseQuantity>

The dose is specified if the <doseQuantity> element. If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high> bounds are specified in their respective elements, otherwise both <low> and <high> have the same value. If the dose is in countable units (tablets, caplets, "eaches"), then the unit attribute is not sent. Otherwise the units are sent. The unit attribute should be derived from the HL7 UnitsOfMeasureCaseSensitive vocabulary .

<low|high value=' '> <translation> <originalText><reference value=' '/></originalText> </translation></low|high >

Any <low> and <high> elements used for <doseQuantity> or <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document. In a CDA document, any <low> and <high> elements used for <doseQuantity> or <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document. In a message, the <originalText> may contain the original text used to describe dose quantity.

<rateQuantity><low value=' ' unit=' '/><high value=' ' unit=' '/></rateQuantity>

The rate is specified in the <rateQuantity> element. The rate is given in units that have measure over time. In this case, the units should be specified as a string made up of a unit of measure (see doseQuantity above), followed by a slash (/), followed by a time unit (s, min, h or d).

Again, if a range is given, then the <low> and <high> elements contain the lower and upper bound of the range, otherwise, they contain the same value.

<consumable>

The <consumable> element shall be present, and shall contain a <manufacturedProduct> entry conforming to the Product Entry template

<entryRelationship typeCode='REFR'>
&nsbp;<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/>

The top level <substanceAdministration> element may contain a reference (typeCode='REFR') to related prescription activity as described in the Supply Entry.

<entryRelationship typeCode='COMP'>
 <sequenceNumber value=' '>

A top level <substanceAdministration> element may contain one or more related components, either to handle split, tapered or conditional dosing, or to support combination medications.

In the first three cases, the subordinate components shall specify only the changed <frequency> and/or <doseAmount> elements. For conditional dosing, each subordinate component shall have a <precondition> element that specifies the <observation> that must be obtained before administration of the dose. The value of the <sequenceNumber> shall be an ordinal number, starting at 1 for the first component, and increasing by 1 for each subsequent component. Components shall be sent in <sequenceNumber> order.

<entryRelationship typeCode='SUBJ' inversionInd='true'/>

At most one instruction may be provided for each <substanceAdministration> entry. If provided, it shall conform to the requirements listed for Patient Medication Instructions. The instructions shall contain any special case dosing instructions (e.g., split, tapered, or conditional dosing), and may contain other information (take with food, et cetera).

<entryRelationship typeCode='RSON'>
 <act classCode='ACT' moodCode='EVN'>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/>
  <id root=' ' extension=' '/>
 </act>
</entryRelationship>

A <substanceAdministration> event may indicate one or more reasons for the use of the medication. These reasons identify the concern that was the reason for use via the Internal Reference entry content module.

The extension and root of each observation present must match the identifier of a concern entry contained elsewhere within the CDA document.

A consumer of the Medical Summary is encouraged, but not required to maintain these links on import.

<precondition><criterion>
 <text><reference value=' '></text>
</criterion></precondition>

In a CDA document, the preconditions for use of the medication are recorded in the <precondition> element. The value attribute of the <reference> element is a URL that points to the CDA narrative describing those preconditions.

<condition typeCode='PRCN'>
 <criterion>
  <text></text>
  <value nullFlavor='UNK'/>
  <interpretationCode nullFlavor='UNK'/>
 </criterion>
</condition>

In a message, the preconditions for use of the medication are recorded in the <condition> element. The typeCode shall be PRCN. The <text> element of the criterion shall contain a text description of the precondition. The <value> element is required, and may be recorded in a structured data type if known, and if not, may be recorded using a nullFlavor as shown above. The same is true for <interpretationCode>.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Immunizations 1.3.6.1.4.1.19376.1.5.3.1.4.12

An immunizations entry is used to record the patient's immunization history.

Uses

See Templates using Immunizations

Specification

Immunizations Example

<substanceAdministration typeCode='SBADM' moodCode='EVN{{!}}INT' negationInd='true{{!}}false'> <templateId root='2.16.840.1.113883.10.20.1.24'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.12'/> <id root='' extension=''/> <code code='IMMUNIZ' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ActCode'/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=''/> <!-- The reasonCode would normally provide a reason why the immunization was not performed. It isn't supported by CDA R2, and so comments will have to suffice. <reasonCode code='' codeSystem='' codeSystemName='ActNoImmunizationReasonIndicator'/> --> <routeCode code='' codeSystem='' codeSystemName='RouteOfAdministration'/> <approachSiteCode code='' codeSystem='' codeSystemName='HumanSubstanceAdministrationSite'/> <doseQuantity value='' units=''/> <consumable typeCode='CSM'> <manufacturedProduct classCode='MANU'> <manufacturedLabeledDrug classCode='MMAT' determinerCode='KIND'> <code code='' codeSystem='' codeSystemName=''> <originalText><reference value='#yyy'/></originalText> </code> </manufacturedLabeledDrug> </manufacturedProduct> </consumable> <!-- An optional entry relationship that provides prescription activity --> <entryRelationship typeCode='REFR'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/> : . </entryRelationship> <!-- An optional entry relationship that identifies the immunization series number --> <entryRelationship typeCode='SUBJ'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.46'/> <code code='30973-2' displayName='Dose Number' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <statusCode code='completed'/> <value xsi:type='INT' value=''/> </observation> </entryRelationship> <entryRelationship inversionInd='false' typeCode='CAUS'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.28'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/> <templateId root='2.16.840.1.113883.10.20.1.54'/> <id root='' extension=''/> </observation> </entryRelationship> <!-- Optional <entryRelationship> element containing comments --> </substanceAdministration>

<substanceAdministration typeCode='SBADM' moodCode='EVN|INT' negationInd='true|false'>

To record an immunization that has been given, use a substance administration event, with moodCode='EVN'. An immunization entry may also be a record of why a specific immunization was not performed. In this case, negationInd shall be set to "true", otherwise, it shall be false.

To record (e.g., in a care plan), the intent to give an immunization at a future time, use the intent mood (moodCode='INT').

<templateId root='2.16.840.1.113883.10.20.1.24'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.12'/>

The <templateId> elements identifies this <substanceAdministration> as an immunization. Both elements shall be present as shown above.

<id root=' ' extension=' '/>

This shall be the identifier for the immunization event.

<code code='IMMUNIZ' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ActCode'/>

This required element records that the act was an immunization. The substance administration act must have a <code> element with code and codeSystem attributes present. If no coding system is used by the source, then simply record the code exactly as shown above. Another coding system that may be used for codes for immunizations are the CPT-4 codes for immunization procedures. This <code> element shall not be used to record the type of vaccine used from a vocabulary of drug names.

Vaccination Codes

codeSystem	codeSystemName	Description
2.16.840.1.113883.5.4	IMMUNIZ	The IMMUNIZ term from the HL7 ActCode vocabulary.
2.16.840.1.113883.6.12	C4	Current Procedure Terminology 4 (CPT-4) codes.

<text><reference value='#xxx'/></text>

In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the immunization activity. In an HL7 message, the content of the text element shall contain the complete text describing the immunization activity.

<statusCode code='completed'/>

The statusCode shall be set to "completed" for all immunizations.

<effectiveTime value=' '/>

The effectiveTime element shall be present and should contain a time value that indicates the date of the substance administration. If the date is unkown, this shall be recorded using the nullFlavor attribute, with the reason that the information is unknown being specified. Otherwise, the date shall be recorded, and should have precision of at least the day.

<routeCode code=' ' codeSystem=' ' codeSystemName='RouteOfAdministration'/>

See routeCode under Medications.

<approachSiteCode code=' ' codeSystem=' ' codeSystemName='HumanSubstanceAdministrationSite'/>

See approachSiteCode under Medications.

<doseQuantity value=' ' units=' '/>

See doseQuantity under Medications.

<consumable typeCode='CSM'>

See consumable under Medications.

<entryRelationship typeCode='REFR'>
 <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/>

The top level <substanceAdministration> element may contain a reference (typeCode='REFR') to related Supply entry

<entryRelationship typeCode='SUBJ'>
 <observation classCode='OBS' moodCode='EVN'>
  <templateId root='2.16.840.1.113883.10.20.1.46'/>

This optional entry relationship may be present to indicate that position of this immunization in a series of immunizations.

<code code='30973-2' displayName='Dose Number' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>

The <code> element shall be present and must be recorded with the code and codeSystem attributes shown above. This element indicates that the observation describes the dose number for the immunization.

<statusCode code='completed'/>

The <statusCode> element shall be present, and must be recorded exactly as shown above. This element indicates that the observation has been completed.

<value xsi:type='INT' value=' '/>

The <value> element shall be present, and shall indicate the immunization series number in the value attribute.

<entryRelationship inversionInd='false' typeCode='CAUS'>

This repeatable element should be used to identify adverse reactions caused by the immunization.

<observation classCode='OBS' moodCode='EVN'>

This element is required, and provides a pointer to the the adverse reaction caused by the immunization.

<templateId root='2.16.840.1.113883.10.20.1.28'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5'/>
<templateId root='2.16.840.1.113883.10.20.1.54'/>

It shall contain a conforming Problem Entry that also conform to the CCD Reaction template.

<id root=' ' extension=' '/>

This element is required, and gives the identifier of the adverse reaction. The adverse reaction pointed to by this element shall be described in more detail using the Allergies entry, elsewhere in the document where this element was found.

<!-- Optional <entryRelationship> element containing comments -->

An immunization entry can have negationInd set to true to indicate that an immunization did not occur. In this case, it shall have at least one comment that provides an explaination for why the immunization did not take place . Other comments may also be present.

Development Only

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Supply Entry 1.3.6.1.4.1.19376.1.5.3.1.4.7.3

The supply entry describes a prescription activity.

Uses

See Templates using Supply Entry

Specification

Supply Entry Example

<substanceAdministration classCode='SBADM' moodCode='INT|EVN'> : . <entryRelationship typeCode='REFR' inversionInd='false'> <sequenceNumber value=''/> <supply classCode='SPLY' moodCode='INT|EVN'> <templateId root='2.16.840.1.113883.10.20.1.34'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/> <id root='' extension=''/> <repeatNumber value=''/> <quantity value='' unit=''/> <author> <time value=''/> <assignedAuthor> <id root='' extension=''/> <addr></addr> <telecom use='' value=''/> <assignedPerson><name></name></assignedPerson> <representedOrganization><name></name></representedOrganization> </assignedAuthor> </author> <performer typeCode='PRF'> <time value=''/> <assignedEntity> <id root='' extension=''/> <addr></addr> <telecom use='' value=''/> <assignedPerson><name></name></assignedPerson> <representedOrganization><name></name></representedOrganization> </assignedEntity> </performer> <!-- Optional Fulfillment instrctions --> <entryRelationship typeCode='SUBJ'> </entryRelationship> </supply> </entryRelationship> </substanceAdministration>

<entryRelationship typeCode='REFR' inversionInd='false'>

A <substanceAdministration> act may reference (typeCode='REFR') a prescription activity in an <entryRelationship> element in a CDA document. In a message, the relationship is recorded using a <sourceOf> element instead of the <entryRelationship> element. The typeCode and inversionInd attributes, and the semantics remain identical.

<sequenceNumber value=' '/>

The prescription activity may have a <sequenceNumber> element to indicate the fill number. A value of 1, 2 or N indicates that it is the first, second, or Nth fill respectively of a specific prescription. This element should be present when the embedded <supply> element has a moodCode attribute of EVN.

<supply classCode='SPLY' moodCode='INT|EVN'>

The <supply> element shall be present. The moodCode attribute shall be INT to reflect that a medication has been prescribed, or EVN to indicate that the prescription has been filled.

<templateId root='2.16.840.1.113883.10.20.1.34'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.3'/>

The <templateId> elements shown above shall be present, and identify this supply act as a Supply Entry.

<id root=' ' extension=' '/>

Each supply act shall have an identifier to uniquely identify the supply entry.

<repeatNumber value=' '/>

Each supply entry should have a <repeatNumber> element that indicates the number of times the prescription can be filled.

<quantity value=' ' unit=' '/>

The supply entry should indicate the quantity supplied. The value attribute shall be present and indicates the quantity of medication supplied. If the medication is supplied in dosing units (tablets or capsules), then the unit attribute need not be present (and should be set to 1 if present). Otherwise, the unit element shall be present to indicate the quantity (e.g., volume or mass) of medication supplied.

<author>

A supply entry that describes an intent (<supply classCode='SPLY' moodCode='INT'>) may include an <author> element to identify the prescribing provider.

The element must be present to indicate when the author created the prescription. If this information is unknown, it shall be recorded by setting the nullFlavor attribute to UNK.

<assignedAuthor>

The <assignedAuthor> element shall be present, and identifies the author.

<id root=' ' extension=' '/>

One or more <id> elements should be present. These identifiers identify the author of the act. When the author is the prescribing physician they may include local identifiers or regional identifiers necessary for prescribing.

<assignedPerson><name/></assignedPerson>
<representedOrganization><name/></ representedOrganization>

An <assignedPerson> and/or <representedOriganization> element shall be present. This element shall contain a <name> element to identify the prescriber or their organization.

<performer typeCode='PRF'>

The <performer> element may be present to indicate who is intended (moodCode='INT'), or actually filled (moodCode='EVN') the prescription.

The element shall be present to indicate when the prescription was filled (moodCode='EVN'). If this information is unknown, it shall be recorded by setting the nullFlavor attribute to UNK.

The element should be present to indicate when the prescription is intended to be filled (moodCode='INT').

<assignedEntity>

The < assignedEntity> element shall be present, and identifies the filler of the prescription.

<id root=' ' extension=' '/>

One or more <id> elements should be present. These identify the performer.

<assignedPerson><name/></assignedPerson>
<representedOrganization><name/></ representedOrganization>

An <assignedPerson> and/or <representedOriganization> element shall be present. This element shall contain a <name> element to identify the filler or their organization.

<!-- Optional Fulfillment instrctions -->
 <entryRelationship typeCode='SUBJ'>
</entryRelationship>

An entry relationship may be present to provide the fulfillment instructions. When present, this entry relationship shall contain a Medication Fulfillment Instructions entry.

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Product Entry 1.3.6.1.4.1.19376.1.5.3.1.4.7.2

The product entry describes a medication or immunization used in a <substanceAdministration> or <supply> act. It adopts the constraints of the ASTM/HL7 Continuity of Care Document.

Uses

See Templates using Product Entry

Specification

Product Entry Example

<!-- Within a CDA Document --> <manufacturedProduct> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.2'/> <templateId root='2.16.840.1.113883.10.20.1.53'/> <manufacturedMaterial> <code code='' displayName='' codeSystem='' codeSystemName=''> <originalText><reference value=''/></originalText> </code> <name></name> </manufacturedMaterial> </manufacturedProduct> <!-- Within a message --> <administerableMaterial> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.2'/> <templateId root='2.16.840.1.113883.10.20.1.53'/> <administerableMaterial> <code></code> <desc></desc> </administerableMaterial> </administerableMaterial>

<manufacturedProduct> -OR- <administerableMaterial>
 <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7.2'/>
 <templateId root='2.16.840.1.113883.10.20.1.53'/>
 <manufacturedMaterial> -OR- <administerableMaterial>

In a CDA document, the name and strength of the medication are specified in the elements under the <manufacturedMaterial> element. In a message, the are contained within the <administeredMaterial> element, inside another <administerableMaterial> element¹. The templateId elements are required and identify this as a product entry.

1	This duplication of element names is an artifact of the standard.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '>
 <originalText><reference value=' '/></originalText>

The <code> element of the <manufacturedMaterial> describes the medication. This may be coded using a controlled vocabulary, such as RxNorm, First Databank, or other vocabulary system for medications, and should be the code that represents the generic medication name and strength (e.g., acetaminophen and oxycodone -5/325), or just the generic medication name alone if strength is not relevant (Acetaminophen).

In a CDA document, the <originalText> shall contain a <reference> whose URI value points to the generic name and strength of the medication, or just the generic name alone if strength is not relevant. Inside a message, the <originalText> may contain the actual text that describes the medication in similar fashion.

Note:

When the text is supplied from the narrative, the implication is that if you supply the components of a combination medication in an entry, you must also display these in the narrative text, otherwise you would not be able to break the combination medication down into its component parts. This is entirely consistent with the CDA Release 2.0 requirements that the narrative supply the necessary and relevant human readable information content.

The <code> element is also used to support coding of the medication. If coded, it must provide a code and codeSystem attribute using a controlled vocabulary for medications. The displayName for the code and codeSystemName should be provided as well for diagnostic and human readability purposes, but are not required. The table below provides the codeSystem and codeSystemName for several controlled terminologies that may be used to encode medications and/or immunizations.

Example Medication and Immunization Vocabularies

codeSystem	codeSystemName	Description
2.16.840.1.113883.6.88	RxNorm	RxNorm
2.16.840.1.113883.6.69	NDC	National Drug Codes
2.16.840.1.113883.6.63	FDDC	First DataBank Drug Codes
2.16.840.1.113883.6.96	SNOMED-CT	SNOMED Controlled Terminology
2.16.840.1.113883.6.59	CVX	CDC Vaccine Codes

The code used for an immunization may use code systems other than what might be used for other medications, such as the CDC maintained CVX codes. Code systems that describe vaccination procedures (such as CPT-4) shall not be used to describe the vaccine entry.

<name> -OR- <desc>

In a CDA document, the <name> element should contain the brand name of the medication (or active ingredient in the case of subordinate <substanceAdministration> elements used to record components of a medication). Within a message, this information shall be provided in the <desc> element.

Development Only

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Simple Observations 1.3.6.1.4.1.19376.1.5.3.1.4.13

The simple observation entry is meant to be an abstract representation of many of the observations used in this specification. It can be made concrete by the specification of a few additional constraints, namely the vocabulary used for codes, and the value representation. A simple observation may also inherit constraints from other specifications (e.g., ASTM/HL7 Continuity of Care Document).

Uses

See Templates using Simple Observations

Specification

Simple Observations Example

<observation classCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> <!-- for CDA --> <text><reference value='#xxx'/></text> <!-- For HL7 Version 3 Messages <text>text</text> --> <statusCode code='completed'/> <effectiveTime value=''/> <repeatNumber value=''/> <value xsi:type='' …/> <interpretationCode code='' codeSystem='' codeSystemName=''/> <methodCode code='' codeSystem='' codeSystemName=''/> <targetSiteCode code='' codeSystem='' codeSystemName=''/> <author typeCode='AUT'> <assignedAuthor typeCode='ASSIGNED'><id ... /></assignedAuthor> <!-- for CDA --> <!-- For HL7 Version 3 Messages <assignedEntity typeCode='ASSIGNED'> <Person classCode='PSN'> <determinerCode root=''> <name>…</name> </Person> <assignedEntity> --> </author> </observation>

<observation classCode='OBS' moodCode='EVN'>

These acts are simply observations that have occurred, and so are recored using the <observation> element as shown above.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>

The <templateId> element identifies this <observation> as a simple observation, allowing for validation of the content. The templateId must appear as shown above.

<id root=' ' extension=' '/>

Each observation shall have an identifier.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

Observations shall have a code describing what was measured. The code system used is determined by the vocabulary constraints on the types of measurements that might be recorded in a section. Content modules that are derived from the Simple Observation content module may restrict the code system and code values used for the observation.

<text><reference value='#xxx'/></text> -OR- <text>text</text>

Each observation measurement entry may contain a <text> element providing the free text that provides the same information as the observation within the narrative portion of the document with a <text> element. For CDA based uses of Simple Observations, this element SHALL be present, and SHALL contain a <reference> element that points to the related string in the narrative portion of the document. For HL7 Version 3 based uses, the <text> element MAY be included.

<statusCode code='completed'/>

The status code of all observations shall be completed.

<effectiveTime value=' '/>

The <effectiveTime> element shall be present in standalone observations , and shall record the date and time when the measurement was taken. This element should be precise to the day. If the date and time is unknown, this element should record that using the nullFlavor attribute.

<value xsi:type=' ' …/>

The value of the observation shall be recording using a data type appropriate to the observation. Content modules derived from the Simple Observation content module may restrict the allowable data types used for the observation.

<interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>

If there is an interpretation that can be performed using an observation result (e.g., high, borderline, normal, low), these may be recorded within the interpretationCode element.

<methodCode code=' ' codeSystem=' ' codeSystemName=' '/>

The methodCode element may be used to record the specific method used to make an observation when this information is not already pre-coordinated with the observation code .

<targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>

The targetSiteCode may be used to record the target site where an observation is made when this information is not already pre-coordinated with the observation code.

<author><assignedAuthor classCode='ASSIGNED'>...<assignedAuthor></author>

In CDA uses, SimpleObservations are assumed to be authored by the same author as the document through context conduction. However specific authorship of observation may be represented by listing the author in the header and referencing the author in a <author> relationship. If authors are explicitly listed in documents, an <id> element SHOULD reference the ID of the author in the header through an assignedAuthor Role. If the author of the observation is not an author of the document the <person> object including a name and ID SHALL be included.

For HL7 Version 3 purposes, the <author> element SHOULD be present unless it can be determined by conduction from organizers or higher level structures. When used for HL7 Version 3 the role element name is <assignedEntity> and the author is represented a <assignedPerson> element.

Development Only

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Vital Signs Organizer 1.3.6.1.4.1.19376.1.5.3.1.4.13.1

A vital signs organizer collects vital signs observations.

Uses

See Templates using Vital Signs Organizer

Specification

Vital Signs Organizer Example

<organizer classCode='CLUSTER' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.32'/> <templateId root='2.16.840.1.113883.10.20.1.35'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.1'/> <id root='' extension=''/> <code code='46680005' displayName='Vital signs' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> <statusCode code='completed'/> <effectiveTime value=''/> <!-- For HL7 Version 3 Messages <author classCode='AUT'> <assignedEntity1 typeCode='ASSIGNED'> : <assignedEntity1> </author> --> <!-- one or more vital signs observations --> <component typeCode='COMP'> <observation classCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.2'/> : </observation> </component> </organizer>

<organizer classCode='CLUSTER' moodCode='EVN'>

The vital signs organizer is a cluster of vital signs observations.

<templateId root='2.16.840.1.113883.10.20.1.32'/>
 <templateId root='2.16.840.1.113883.10.20.1.35'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.1'/>

The vital signs organizer shall have the <templateId> elements shown above to indicate that it inherits constraints from the ASTM/HL7 CCD Specification for Vital signs, and the constraints of this specification.

<id root=' ' extension=' '/>

The organizer shall have an <id> element.

<code code='46680005' displayName='Vital signs'
   codeSystem='2.16.840.1.113883.6.96'
   codeSystemName='SNOMED CT'/>

The <code> element shall be recorded as shown above to indicate that this organizer captures information about patient vital signs.

<statusCode code='completed'/>

The observations have all been completed.

<effectiveTime value=' '/>

The effective time element shall be present to indicate when the measurement was taken.

<author typeCode='AUT'><assignedEntity1 typeCode='ASSIGNED'>...</assignedEntity1></author>

For use with HL7 Version 3, Vital Sign organizers SHALL contain an <author> element to represent the person or device.

<!-- one or more vital signs observations -->
  <component typeCode='COMP'>

The organizer shall have one or more <component> elements that are <observation> elements using the Vital Signs Observation template.

Development Only

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Vital Signs Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.2

A vital signs observation is a simple observation that uses a specific vocabulary, and inherits constraints from CCD.

Uses

See Templates using Vital Signs Observation

Specification

Vital Signs Observation Example

<observation classCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='2.16.840.1.113883.10.20.1.31'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.2'/> <id root=' ' extension=' '/> <code code=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type='PQ' value=' ' unit=' '/> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> </observation>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
  <templateId root='2.16.840.1.113883.10.20.1.31'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.2'/>

A vital signs observation shall have the <templateId> elements shown above to indicate that it inherits constraints from the ASTM/HL7 CCD Specification for Vital signs, and the constraints of this specification.

<code code=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>

A vital signs observation entry shall use one of the following LOINC codes, with the specified data types and units.

Vital Signs Codes

LOINC	Description	Units	Type
9279-1	RESPIRATION RATE	/min	PQ
8867-4	HEART BEAT
2710-2	OXYGEN SATURATION	%
8480-6	INTRAVASCULAR SYSTOLIC	mm[Hg]
8462-4	INTRAVASCULAR DIASTOLIC
8310-5	BODY TEMPERATURE	Cel or [degF]
8302-2	BODY HEIGHT (MEASURED)	m, cm,[in_us] or [in_uk]
8306-3	BODY HEIGHT^LYING
8287-5	CIRCUMFRENCE.OCCIPITAL-FRONTAL (TAPE MEASURE)
3141-9	BODY WEIGHT (MEASURED)	kg, g, [lb_av] or [oz_av]

<value xsi:type='PQ' value=' ' unit=' '/>

The <value> element shall be present, and shall be of the appropriate data type specified for measure in the table above.

<interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>

The interpretation code may be present to provide an interpretation of the vital signs measure (e.g., High, Normal, Low, et cetera).

<methodCode code=' ' codeSystem=' ' codeSystemName=' '/>

The <methodCode> element may be present to indicate the method used to obtain the measure. Note that method used is distinct from, but possibly related to the target site.

<targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>

The target site of the measure may be identified in the <targetSiteCode> element (e.g., Left arm [blood pressure], oral [temperature], et cetera).

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Family History Organizer 1.3.6.1.4.1.19376.1.5.3.1.4.15

The family history organizer collects the problems of a patient's family member.

Uses

See Templates using Family History Organizer

Specification

Family History Organizer Example

<entry> <organizer classCode='CLUSTER' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.23'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.15'/> <subject typeCode='SBJ'> <relatedSubject classCode='PRS'> <code code='' displayName='' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/> <subject> <sdtc:id root='' extension=''/> <administrativeGenderCode code='' displayName='' codeSystem='' codeSystemName=''/> </subject> </relatedSubject> </subject> <!-- zero or more participants linking to other relations --> <participant typeCode='IND'> <participantRole classCode='PRS'> <code code='' displayName='' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/> <playingEntity classCode='PSN'> <sdtc:id root='' extension=''/> </playingEntity> </participantRole> </participant> <!-- one or more entry relationships for family history observations --> <component typeCode='COMP'> <observation classCode='OBS' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.22'/> </observation> </component> </organizer> </entry>

<organizer classCode='CLUSTER' moodCode='EVN'>

Each family history entry is organized (classCode='CLUSTER') into a group of observations about a family member.

<templateId root='2.16.840.1.113883.10.20.1.23'/>
 <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.15'/>

The organizer is identified by the <templateId> elements, which shall be present as shown above.

<subject typeCode='SUBJ'>
    <relatedSubject classCode='PRS'>

The <subject> element shall be present and relates the subject of the observations to the patient. It shall contain a <relatedSubject> element that is a personal relation of the patient (classCode='PRS').

<code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/>

The <code> element shall be present, and give the relationship of the subject to the patient. The code attribute shall be present, and shall contain a value from the HL7 FamilyMember vocabulary. The codeSystem attribute shall be present and shall use the value shown above.

<subject>

The <subject> element contains information about the relation.

<sdtc:id root=' ' extension=' '/>

The <sdtc:id> element should be present. It is used to identify the patient relation to create a pedigree graph.

<administrativeGenderCode code=' ' />

The <administrativeGenderCode> element should be present. It gives the gender of the relation.

<participant typeCode='IND'>
 <participantRole classCode='PRS'>

The <participant> element may be present to record the relationship of the subject to other family members to create a pedigree graph. It shall contain a <participantRole> element showing the relationship of the subject to other family members (classCode='PRS').

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <code> element shall be present, and gives the relationship of the participant to the subject. The code attribute shall be present, and shall contain a value from the HL7 FamilyMember vocabulary. The codeSystem attribute shall be present and shall use the value shown above.

<playingEntity classCode='PSN'>

The <playingEntity> element identifies the related person. It shall be recorded as shown above.

<sdtc:id root=' ' extension=' '/>

The <sdtc:id> element shall be present. It must have the same root and extension attributes of the <subject> of a separate family history organizer. See Appendix C of PCC-TF for definition of this extension to CDA.

<component typeCode='COMP'>
    <observation classCode='OBS' moodCode='EVN'>
     <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.3'/>

The family history organizer shall contain one or more components using the <component> element shown above. These components must conform the Family History Observation template.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Family History Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.3

A family history observation is a Simple Observation that uses a specific vocabulary, and inherits constraints from CCD. Family history observations are found inside Family History Organizers.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Parent Template

The parent of this template is Simple Observation. This template is compatible with the ASTM/HL7 Continuity of Care Document template: 2.16.840.1.113883.10.20.1.22

Uses

See Templates using Family History Observation

Specification

Family History Observation Example

<observation typeCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='2.16.840.1.113883.10.20.1.22'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.3'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type='CD' .../> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> </observation>

<templateId root='2.16.840.1.113883.10.20.1.22'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.3'/>

The <templateId> elements identify this observation as a family history observation, and shall be present as shown above.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <code> indicates the type of observation made (e.g., Diagnosis, et cetera). See the code element in the Problem Entry entry for suggested values.

<value xsi:type='CD' code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <value> element indicates the information (e.g., diagnosis) of the family member. See the value element in the Problem Entry for suggested values.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Social History Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.4

A social history observation is a simple observation that uses a specific vocabulary, and inherits constraints from CCD.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Parent Template

The parent of this template is Simple Observation. This template is compatible with the ASTM/HL7 Continuity of Care Document template: 2.16.840.1.113883.10.20.1.33

Uses

See Templates using Social History Observation

Specification

Social History Observation Example

<observation typeCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='2.16.840.1.113883.10.20.1.33'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.4'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type=' ' /> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> </observation>

<templateId root='2.16.840.1.113883.10.20.1.33'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.4'/>

These <templateId> elements identify this as a Social History observation.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

The <code> element identifies the type social history observation.

Social History Codes

Code	Description	Data Type	Units
229819007	Smoking	PQ	{pack}/d or {pack}/wk or {pack}/a
256235009	Exercise		{times}/wk
160573003	ETOH (Alcohol) Use		{drink}/d or {drink}/wk
364393001	Diet	CD	N/A
364703007	Employment
425400000	Toxic Exposure
363908000	Drug Use
228272008	Other Social History	ANY

<repeatNumber value=' '/>

The <repeatNumber> element should not be used in a social history observation.

<value xsi:type=' ' ... />

The <value> element reports the value associated with the social history observation. The data type to use for each observation should be drawn from the table above.

Observations in the table above using the PQ data type have a unit in the form {xxx}/d, {xxx}/wk or {xxx}/a represent the number of items per day, week or year respectively. The value attribute indicates the number of times of the act performed, and the units represent the frequency. The example below shows how to represent 1 drink per day.

    :
  <code code='160573003' displayName='ETOH Use' 
        codeSystem='2.16.840.1.113883.6.96' 
        codeSystemName='SNOMED CT'/>
    :
  <value xsi:type='PQ' value='1' unit='{drink}/d'/>
    :

Observations in the table using the CD data type should include coded values from an appropriate vocabulary to represent the social history item. The example below shows the encoding to indicate drug use of cannabis.

    :
  <code code='363908000' displayName='Drug Use' 
        codeSystem='2.16.840.1.113883.6.96' 
        codeSystemName='SNOMED CT'/>
    :
  <value xsi:type='CD' code='398705004' displayName='cannabis' 
         codeSystem='2.16.840.1.113883.6.96' 
         codeSystemName='SNOMED CT'/>
    :

Other social history observations may use any appropriate data type.

<interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>
<methodCode code=' ' codeSystem=' ' codeSystemName=' '/>
<targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>

The <interpretationCode>, <methodCode>, and <targetSiteCode> elements should not be used in a social history observation.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Pregnancy Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.5

A pregnancy observation is a Simple Observation that uses a specific vocabulary to record observations about a patient's pregnancy history.

Parent Template

The parent of this template is Simple Observation.

Uses

See Templates using Pregnancy Observation

Specification

Pregnancy Observation Example

<observation classCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.5'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type=' ' .../> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> </observation>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
 <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.5'/>

These <templateId> elements identify this <observation> as a pregnancy observation, allowing for validation of the content. The <templateId> elements shall be recorded as shown above.

<code code=' ' displayName=' '
  codeSystem='2.16.840.1.113883.6.1'
  codeSystemName='LOINC'/>

A pregnancy observation shall have a code describing what facet of patient's pregnancy history is being recorded. These codes should come from the list of codes shown below. Additional codes may be used to reflect additional information about the pregnancy history.

Pregnancy Observation Codes

LOINC CODE	Description	Type	Units or Vocabulary
Summary over All Pregnancies
11636-8	BIRTHS LIVE (REPORTED)	INT	N/A
11637-6	BIRTHS PRETERM (REPORTED)
11638-4	BIRTHS STILL LIVING (REPORTED)
11639-2	BIRTHS TERM (REPORTED)
11640-0	BIRTHS TOTAL (REPORTED)
11612-9	ABORTIONS (REPORTED)
11613-7	ABORTIONS INDUCED (REPORTED)
11614-5	ABORTIONS SPONTANEOUS (REPORTED)
33065-4	ECTOPIC PREGNANCY (REPORTED)
Detailed Pregnancy Data
11449-6	PREGNANCY STATUS	CE	SNOMED CT, ICD-9-CM (V22)
8678-5	MENSTRUAL STATUS		SNOMED CT
8665-2	DATE LAST MENSTRUAL PERIOD	TS	N/A
11778-8	DELIVERY DATE (CLINICAL ESTIMATE)	TS
11779-6	DELIVERY DATE (ESTIMATED FROM LAST MENSTRUAL PERIOD)
11780-4	DELIVERY DATE (ESTIMATED FROM OVULATION DATE)
11884-4	FETUS, GESTATIONAL AGE (CLINICAL ESTIMATE)	PQ	d, wk or mo
11885-1	FETUS, GESTATIONAL AGE (ESTIMATED FROM LAST MENSTRUAL PERIOD)
11886-9	FETUS, GESTATIONAL AGE (ESTIMATED FROM OVULATION DATE)
11887-7	FETUS, GESTATIONAL AGE (ESTIMATED FROM SELECTED DELIVERY DATE)
45371‑2	MULTIPLE PREGNANCY

<repeatNumber value=' '/>

The <repeatNumber> element should not be present in a pregancy observation.

<value xsi:type=' ' .../>

The value of the observation shall be recording using a data type appropriate to the coded observation according to the table above.

<interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>
<methodCode code=' ' codeSystem=' ' codeSystemName=' '/>
<targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>

The <interpretationCode>, <methodCode>, and <targetSiteCode> should not be present in a pregnancy observation.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Advance Directive Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.7

An advance directive observation is a simple observation that uses a specific vocabulary, and inherits constraints from CCD.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Advance Directive Observation

Specification

Advance Directive Observation Example

<observation typeCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='2.16.840.1.113883.10.20.1.17'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.7'/> <id root=' ' extension=' '/> <code code=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type='BL' value='true|false'/> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> <reference typeCode='REFR'> <templateId root='2.16.840.1.113883.10.20.1.36'/> <externalDocument classCode='DOC' moodCode='EVN'> <id root=' ' extension=' '/> <text><reference value=' '/></text> </externalDocument> </reference> </observation>

An advanced directive <observation> shall be represented as shown above. They shall not contain any <repeatNumber>, <interpretationCode>, <methodCode> or <targetSiteCode> elements.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
  <templateId root='2.16.840.1.113883.10.20.1.17'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.7'/>

The <templateId> elements shown above shall be present, and indicated that this is an Advance Directive entry.

<code code=' ' codeSystem='2.16.840.1.113883.6.96' codeSystemName='SNOMED CT'/>

The <code> element records the type of advance directive. It should use one of the following SNOMED codes in the table below.

Advance Directive Type Codes

Code	Description	Data Type
304251008	Resuscitation	BL
52765003	Intubation
225204009	IV Fluid and Support
89666000	CPR
281789004	Antibiotics
78823007	Life Support
61420007	Tube Feedings
116859006	Transfusion of blood product
71388002	Other Directive	<value> not permitted

<value xsi:type='BL' value='true|false'/>

The advance directive observation may include a <value> element using the Boolean (xsi:type='BL') data type to indicate simply whether the procedure described is permitted. Absence of the the <value> element indicates that an advance directive of the specified type has been recorded, and must be examined to determine what type of treatment should be performed. The value element is not permitted when the <code> element describes an Other directive.

<reference typeCode='REFR'>
  <templateId root='2.16.840.1.113883.10.20.1.36'/>
  <externalDocument classCode='DOC' moodCode='EVN'>
   <id root=' ' extension=' '/>
   <text><reference value=' '/></text>

The advanced directive observation may contain a single reference to an external document. That reference shall be recorded as shown above. The <id> element shall contain the appropriate root and extension attributes to identify the document. The <text> element may be present to provide a URL link to the document in the value attribute of the <reference> element. If the <reference> element is present, the Advance Directive in the narrative shall contain a <linkHTML> element to the same URL found in the value attribute.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Blood Type Observation 1.3.6.1.4.1.19376.1.5.3.1.4.13.6

The blood type observation is a Simple Observation of the patient's blood type. It conforms to the CCD Result observation template.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Parent Template

The parent of this template is Simple Observation.

Uses

See Templates using Blood Type Observation

Specification

Blood Type Observation Example

<observation typeCode='OBS' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.6'/> <templateId root='2.16.840.1.113883.10.20.1.31'/> <id root=' ' extension=' '/> <code code='882-1' displayName='ABO+RH GROUP' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <text><reference value='#xxx'/></text> <statusCode code='completed'/> <effectiveTime value=' '/> <repeatNumber value=' '/> <value xsi:type='CE' code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/> <interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/> <methodCode code=' ' codeSystem=' ' codeSystemName=' '/> <targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/> <observation>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13'/>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.6'/>
  <templateId root='2.16.840.1.113883.10.20.1.31'/>

These <templateId> elements identify this as a blood type observation. They shall be present in the <observation> element as shown above.

<code code='882-1' displayName='ABO+RH GROUP'
   codeSystem='2.16.840.1.113883.6.1'
   codeSystemName='LOINC'/>

The <code> element shall be present to represent this as a finding of the patient's composite blood type. It shall use the code and codeSystem attributes shown above.

<repeatNumber value=' '/>

The <repeatNumber> element should not be present in a blood type observation.

<value xsi:type='CE' code=' ' displayName=' '
   codeSystem=' ' codeSystemName=' '/>

The <value> element shall be present and shall use the CE data type. The code attribute should be valued using a vocabulary that supports encoding of blood types. The table below shows some coding systems that may be used to encode blood type.

Blood Type Coding Systems

Coding System	OID
ISBT 128	2.16.840.1.113883.6.18
SNOMED CT	2.16.840.1.113883.6.96

<interpretationCode code=' ' codeSystem=' ' codeSystemName=' '/>
<methodCode code=' ' codeSystem=' ' codeSystemName=' '/>
<targetSiteCode code=' ' codeSystem=' ' codeSystemName=' '/>

The <interpretationCode>, <methodCode>, and <targetSiteCode> should not be present in a blood type observation.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Encounters 1.3.6.1.4.1.19376.1.5.3.1.4.14

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Encounters

Specification

Encounters Example

<encounter classCode='ENC' moodCode='PRMS|ARQ|EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.14'/> <templateId root='2.16.840.1.113883.10.20.1.21'/> <templateId root='2.16.840.1.113883.10.20.1.25'/> <id root=' ' extension=' '/> <code code=' ' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ActEncounterCode' /> <text><reference value='#xxx'/></text> <effectiveTime> <low value=' '/> <high value=' '/> </effectiveTime> <priorityCode code=' '/> <performer typeCode='PRF'> <low value=' '/><high value=' '/> <assignedEntity>...</assignedEntity> </performer> <author /> <informant /> <participant typeCode='LOC'> <participantRole classCode='SDLOC'> <id/> <code/> <addr>...</addr> <telecom value=' ' use=' '/> <playingEntity classCode='PLC' determinerCode='INST'> <name></name> </playingEntity> </participantRole> </participant> </encounter>

<encounter classCode='ENC' moodCode='PRMS|ARQ|EVN'>

This element is an encounter. The classCode shall be 'ENC'. The moodCode may be PRMS to indicated a scheduled appointment, ARQ to describe a request for an appointment that has been made but not yet scheduled by a provider, or EVN, to describe an encounter that has already occurred.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.14'/>

The templateId indicates that this <encounter> entry conforms to the constraints of this content module. NOTE: When the encounter is in event mood (moodCode='EVN'), this entry conforms to the CCD template 2.16.840.1.113883.10.20.1.21, and when in other moods, this entry conforms to the CCD template 2.16.840.1.113883.10.20.1.25.

<id root=' ' extension=' '/>

This required element shall contain an identifier for the encounter. More than one encounter identifier may be present.

<code code=' ' codeSystem='2.16.840.1.113883.5.4'
  codeSystemName='ActEncounterCode' />

This required element should contain a code from the HL7 ActEncounterCode vocabulary describing the type of encounter (e.g., inpatient, ambulatory, emergency, et cetera). Developers should take care to check that rational combinations of encounter.code and encounter.moodCode are used , but this profile does not restrict any combination.

<text><reference value='#xxx'/></text>

The <text> element shall contain a reference to the narrative text describing the encounter.

<effectiveTime><low value=' '/><high value=' '/></effectiveTime>

This element records the time over which the encounter occurred (in EVN mood), or the desired time of the encounter in ARQ or APT mood. In EVN or APT mood, the effectiveTime element should be present. In ARQ mood, the effectiveTime element may be present, and if not, the priorityCode may be present to indicate that a callback is required to schedule the appointment.

<priorityCode code='CS'/>

This element may be present in ARQ mood to indicate a callback is requested to schedule the appointment.

<performer>

For encounters in EVN mood, at least one performer should be present that identifies the provider of the service given during the encounter. More than one performer may be present. The element should be used to indicate the duration of the participation of the performer when it is substantially different from that of the effectiveTime of the encounter. In ARQ mood, the performer may be present to indicate a preference for a specific provider. In APT mood, the performer may be present to indicate which provider is scheduled to perform the service.

<participant typeCode='LOC'>
 <participantRole classCode='SDLOC'>

A <participant> element with typeCode='LOC' may be present to provide information about the location where the encounter is to be or was performed. This element shall have a <participantRole> element with classCode='SDLOC' that describes the service delivery location.

<id/>

The <id> element may be present to identify the service delivery location.

<code/>

The <code> element may be present to classify the service delivery location.

<addr>...</addr>

The <addr> element should be present, and gives the address of the location.

<telecom value=' ' use=' '/>

The <telecom> element should be present, and gives the telephone number of the location.

<playingEntity classCode='PLC'>
 <name>...</name>
</playingEntity>

The <playingEntity> shall be present, and gives the name of the location in the required <name> element.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Update Entry 1.3.6.1.4.1.19376.1.5.3.1.4.16

The update entry shall contain references to the entries or sections which are being replaced or updated. This reference shall not be present when the update entry is adding a new entries or sections.

Entries and sections can be added, updated, or removed from a PHR. An update entry indicates the entry in the original PHR Extract that should be replaced or updated with new information contained within the entry. Only one organizer of this type is allowed in a section, and if present, it must be the first entry in the section.

Uses

See Templates using Update Entry

Specification

Update Entry Example

<entry> <organizer classCode='BATTERY' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.16'/> <reference typeCode='RPLC'> <externalAct classCode='ACT' moodCode='EVN'> <id root='' extension=''/> </externalAct> </reference> </organizer> </entry>

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.16'/>

This templateId indicates that the organizer is used to update a PHR Extract.

<reference typeCode='RPLC'>

A reference element shall be present with typeCode RPLC. The reference element lists the acts that are affected by the update. It indicates that any referenced act is being replaced with new information. This element must be present, and may be repeated to replace more than one act at a time.

<externalAct classCode='ACT' moodCode='EVN'>

This element must appear as shown above. It indicates that the reference is to an external act (a section or entry contained in the parent document).

<id root=' ' extension=' '/>

This element identifies the information being replaced or updated. The identifer is of the entry or section being replaced. If the identifier is to a section being replaced, only one reference element is permitted.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Procedure Entry 1.3.6.1.4.1.19376.1.5.3.1.4.19

The procedure entry is used to record procedures that have occured, or which are planned for in the future.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Procedure Entry

Specification

Procedure Entry Example

<procedure classCode='PROC' moodCode='EVN|INT'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.19'/> <templateId root='2.16.840.1.113883.10.20.1.29'/><!-- see text of section 0 --> <templateId root='2.16.840.1.113883.10.20.1.25'/><!-- see text of section 0 --> <id root='' extension=''/> <code code='' codeSystem='2.16.840.1.113883.5.4' codeSystemName='ActCode' /> <text><reference value='#xxx'/></text> <statusCode code='completed|active|aborted|cancelled'/> <effectiveTime> <low value=''/> <high value=''/> </effectiveTime> <priorityCode code=''/> <approachSiteCode code='' displayName='' codeSystem='' codeSystemName=''/> <targetSiteCode code='' displayName='' codeSystem='' codeSystemName=''/> <author /> <informant /> <entryRelationship typeCode='COMP' inversionInd='true'> <act classCode='ACT' moodCode=''> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/> <id root='' extension=''/> </act> </entryRelationship> <entryRelationship typeCode='RSON'> <act classCode='ACT' moodCode='EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1'/> <id root='' extension=''/> </act> </entryRelationship> </procedure>

<procedure classCode='PROC' moodCode='EVN|INT'>

This element is a procedure. The classCode shall be 'PROC'. The moodCode may be INT to indicated a planned procedure or EVN, to describe a procedure that has already occurred.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.19'/>

The templateId indicates that this <procedure> entry conforms to the constraints of this content module. NOTE: When the procedure is in event mood (moodCode='EVN'), this entry conforms to the CCD template 2.16.840.1.113883.10.20.1.29, and when in intent mood, this entry conforms to the CCD template 2.16.840.1.113883.10.20.1.25.

<id root=' ' extension=' '/>

This required element shall contain an identifier for the procedure. More than one procedure identifier may be present.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' ' />

This element shall be present, and should contain a code describing the type of procedure.

<text><reference value='#xxx'/></text>

The <text> element shall contain a reference to the narrative text describing the procedure.

<statusCode code='completed|active|aborted|cancelled'/>

The <statusCode> element shall be present when used to describe a procedure event. It shall have the value 'completed' for procedures that have been completed, and 'active' for procedures that are still in progress. Procedures that were stopped prior to completion shall use the value 'aborted', and procedures that were cancelled before being started shall use the value 'cancelled'.

<effectiveTime><low value=' '/><high value=' '/></effectiveTime>

This element should be present, and records the time at which the procedure occurred (in EVN mood), or the desired time of the procedure in INT mood.

<priorityCode code=' '/>

This element shall be present in INT mood when effectiveTime is not provided, it may be present in other moods. It indicates the priority of the procedure.

<approachSiteCode code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

This element may be present to indicate the procedure approach.

<targetSiteCode code=' ' displayName=' ' codeSystem=' ' codeSystemName=' '/>

This element may be present to indicate the target site of the procedure.

<entryRelationship typeCode='COMP' inversionInd='true'>

This element may be present to point the encounter in which the procedure was performed, and shall contain an internal reference to the encounter. See Internal References for more details.

<entryRelationship typeCode='RSON'>

A <procedure> act may indicate one or more reasons for the procedure. These reasons identify the concern that was the reason for the procedure via an Internal Reference to the concern. The extension and root of each observation present must match the identifier of a concern entry contained elsewhere within the CDA document.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Transport 1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1

A transport entry indicates the intended or actual mode of transport and time of departure and/or arrival of the patient.

Uses

See Templates using Transport

Specification

Transport Example

<entry> <act classCode='ACT' moodCode='INT|EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1'/> <id root=' ' extension=' '/> <code code=' ' displayName=' ' codeSystem='2.16.840.1.113883.6.102.4.2' codeSystemName='DEEDS4.02'> <originalText><reference value='#(ID of text coded)/></orginalText> <text><reference value='#text/></text> <high value=/> </effectiveTime> </act> </entry>

<act classCode='ACT' moodCode='INT|EVN'>

This element indicates that the entry is an act (of transporting the patient, as indicated by the code below). This entry records the mode, and intended or actual ending time of transportation. In intent mood (moodCode='INT') this is how the estimated time of departure or arrival is indicated. In event mood (moodCode='EVN') this is how the actual departure or arrival of the patient is recorded.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1'/>

The <templateId> element identifies this <act> as about the tranportation of the patient. The templateId must have root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1'.

<id root=' ' extension=' '/>

The entry must have an identifier.

<code code=' ' displayName=' '
 codeSystem='2.16.840.1.113883.6.102.4.2'  codeSystemName='DEEDS4.02'>

The code describes the intented mode of transport. For transport between facilities, IHE recommends the use of a code system based on the DEEDS Mode of Transportation data element value set. However, the vocabulary used within an affinity domain should be determined by a policy agreement within the domain.

<originalText><reference value='#xxx'/><orginalText>

This is a reference to the narrative text within the section that describes the mode of transportation.

<text><reference value='#text/></text>

This is a reference to the narrative text cooresponding to the transport act.

<effectiveTime>

The effectiveTime element shall be sent. It records the interval of time over which transport occurs.

<low value=' '/>

This element records the time of departure. This element shall be sent using the TS data type, as shown above.

<high value=' '/>

This element records the time of arrival. If unknown, it must be recorded using a flavor of null. This element shall be sent using the TS data type as shown above.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Encounter Disposition 1.3.6.1.4.1.19376.1.5.3.1.1.10.4.2

This element records the intended or actual disposition for the patient (e.g., admit, discharge home after treatment, et cetera).

Uses

See Templates using Encounter Disposition

Specification

Encounter Disposition Example

<act classCode='ACT' moodCode='INT|EVN'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.2'/> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName='' /> <text><reference value='#xxx'/></text> <statusCode code='normal|completed'/> <effectiveTime value=''/> <performer typeCode='PRF'> <assignedEntity> <id root='' extension=''/> <addr></addr> <telecom value='' use=''/> <assignedPerson> <name></name> </assignedPerson> </assignedEntity> </performer> <participant typeCode='RCV'> <time value=''/> <participantRole classCode='ROL'> <id root='' extension=''/> <addr></addr> <telecom value='' use=''/> <playingEntity> <name></name> </playingEntity> </participantRole> </participant> <entryRelationship typeCode='COMP'> <act classCode='ACT'> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1'/> : </act> </entryRelationship> </act>

<act classCode='ACT' moodCode='INT|EVN'>

The disposition is recorded in an act element, to describe the disposition action taken during the encounter¹ . In intent mood (moodCode='INT'), this records the expected disposition of the patient. In event mood (moodCode='EVN'), this records the actual disposition.

1	The HL7 RIM allows this portion of the encounter to be recorded in the dischargeDispositionCode RIM Attribute of the Encounter class, but the Encounter class is constrained within CDA. To record the disposition act therefore requires the use of the Act class.

<templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.2'/>

The templateId indicates that this <encounter> entry conforms to the constraints of this content module.

<id root=' ' extension=' '/>

This required element shall contain an identifier.

<code code=' ' displayName=' ' codeSystem=' ' codeSystemName=' ' />

This required element indicates the disposition of the patient. The code shall come from a coding system that is able to record common patient dispositions (e.g., Discharged, Transferred, Admitted). The "Administrative Procedure" concept (14734007) of SNOMED CT contains several code values that cover a wide variety of dispositions routinely recorded. Other vocabularies that are commonly in use to describe discharge disposition codes are DEEDS (See section 8.02), and in the US, the Uniform National Billing Code.

<text><reference value='#xxx'/></text>

The <text> element shall contain a reference to the narrative text describing the disposition of the patient. <statusCode code='normal|completed'/> When the disposition act has occurred (moodCode='EVN'), the statusCode element shall be present, and shall contain the value 'completed'. When the disposition act is intended (moodCode='EVN') the statusCode element shall contain the value 'normal'.

<effectiveTime><low value=' '/><high value=' '/><effectiveTime/>

When the disposition has occurred, this element shall be sent, and indicates the effective time for the disposition process. This element may be sent to record when the disposition act is intended to occur. The <low> element records the time at which the disposition process was started. The <high> value records the time at which the disposition process was completed.

<performer typeCode='PRF'>

The <performer> element provides information about the person that performs the discharge, admission or transfer of the patient. When the disposition is in intent mood, this element describes any expectations with respect to the performer, and is optional. When the disposition is in event mood, this element is required.

<assignedEntity>

The <assignedEntity> element identifies the performer of the disposition.

<id root=' ' extension=' '/>

The <id> element shall be sent when the disponsition has occurred, and identifies the performer of the act.

<addr></addr>

The <addr> element may be sent to provide a contact postal address for the performer of the disposition.

<telecom value=' ' use=' '/>

The <telecom> element may be sent to provide a contact postal address for the performer of the disposition.

<assignedPerson><name/></assignedPerson>

The <assignedPerson> element shall be sent to identify the person who performed the disposition of the patient.

<participant typeCode='RCV'>
 
 <participantRole classCode='ROL'>
  <id root=' ' extension=' '/>
  <addr></addr>
  <telecom value=' ' use=' '/>
  <playingEntity><name/></playingEntity>

This element identifies the person or organization that is receiving the patient.

<entryRelationship typeCode='COMP'>
 <act classCode='ACT'>
  <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.10.4.1'/>

If the disposition of the patient requires transport to another location, this information shall be recorded in a subordinate act that conforms to the Transport template described above.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Coverage Entry 1.3.6.1.4.1.19376.1.5.3.1.4.17

Payers shall be recorded as described in CCD: 3.1.2.1.2.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Coverage Entry

Specification

Coverage Entry Example

<act classCode='ACT' moodCode='DEF'> <templateId root='2.16.840.1.113883.10.20.1.20'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.17'/> <id root='' extension='' /> <code code='35525-4' displayName='FINANCING AND INSURANCE' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <statusCode code='completed'/> <entryRelationship typeCode='COMP'> <sequenceNumber value=''/> : </entryRelationship> </act>

<act classCode='ACT' moodCode='DEF'>

Coverage shall be recorded in an <act> that groups all patient coverage together, and defines (moodCode='DEF') the payers.

<templateId root='2.16.840.1.113883.10.20.1.20'/>
<templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.17'/>

The <act> conforms to CCD: 3.1.2.1.1 as well as this specification. This shall be reflected by including the <templateId> elements shown above.

<id root=' ' extension=' '/>

The <id> element shall be present.

<code code='35525-4' displayName='FINANCING AND INSURANCE' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>

The <code> element shall be recorded exactly as shown above.

<statusCode code='completed'/>

The <statusCode> element shall be present exactly as shown above.

<entryRelationship typeCode='COMP'>

The coverage <act> shall have one or more <entryRelationship> elements. These elements define the coverage. The entry relationships must contain Payer Entries.

<sequenceNumber value=' '/>

The <sequenceNumber> element may be present. If present, it shall contain a value attribute that indicates the priority of the payment source.

Development Only

The PCC Wiki Content is used only for development of IHE PCC Content. The Normative content of the PCC Technical Framework and the current supplements can be found at http://www.ihe.net/Technical_Framework/index.cfm#PCC

Payer Entry 1.3.6.1.4.1.19376.1.5.3.1.4.18

The payer entry allows information about the patient's sources of payment to be recorded.

Standards

CCD	ASTM/HL7 Continuity of Care Document

Uses

See Templates using Payer Entry

Specification

Payer Entry Example

<act classCode='ACT' moodCode='EVN'> <templateId root='2.16.840.1.113883.10.20.1.26'/> <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.18'/> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> <statusCode code='completed'/> <performer typeCode='PRF'><!-- payer --> <assignedEntity classCode='ASSIGNED'> <id root='' extension=''/> <code code='PAYOR|GUAR|PAT' displayName='' codeSystem='2.16.840.1.113883.5.110' codeSystemName='RoleClass'/> <addr></addr> <telecom value='' use=''/> <representedOrganization typeCode='ORG'> <name></name> </representedOrganization> </assignedEntity> </performer> <participant typeCode='COV'><!-- member --> <participantRole classCode='PAT'> <id root='' extension=''/> <code code='' displayName='' codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/> <addr></addr> <telecom value='' use=''/> <playingEntity><name></name></playingEntity> </participantRole> </participant> <participant typeCode='HLD'><!-- subscriber --> <participantRole classCode='PAT'> <id root='' extension=''/> <playingEntity><name></name></playingEntity> </participantRole> </participant> <entryRelationship typeCode='REFR'> <act classCode='ACT' moodCode='DEF'> <id root='' extension=''/> <code code='' displayName='' codeSystem='' codeSystemName=''/> <text><reference value=''/></text> </act> </entryRelationship> </act>

<act classCode='ACT' moodCode='EVN'>

The policy entry <act> describes the policy or program that has agreed to pay (moodCode='EVN') for the patient's treatment.

<templateId root='2.16.840.1.113883.10.20.1.26'/>
   <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.18'/>

The <act> conforms to CCD: 3.1.2.1.2 and this guide. This shall be reflected by including the <templateId> elements shown above.

<id root=' ' extension=' '/>

The <act> shall contain at least one <id> element that represents the policy or group number of the coverage. That identifier shall appear in the extension attribute.

<code code=' ' displayName=' '
    codeSystem=' ' codeSystemName=' '/>

The <code> element should be present, and represents the type of coverage provided by the payer. Potential vocabularies to use include:

Payer Type Vocabularies

Vocabulary	Description	OID
HL7 ActCoverageType	The HL7 ActCoverageType vocabulary describes payers and programs. Note that HL7 does not have a specific code to identify an individual payer, e.g., in the role of a guarantor or patient.	2.16.840.1.113883.5.4
X12 Data Element 1336	The X12N 271 implementation guide includes various types of payers. This code set does include a code to identify individual payers.	2.16.840.1.113883.6.255.1336

<statusCode code='completed'/>

The <statusCode> element shall be present, and should be recorded exactly as shown above.

<performer typeCode='PRF'>
    <assignedEntity classCode='ASSIGNED'>

The <performer> element shall be present to represent the payer of the coverage.

<id root=' ' extension=' '/>

The identity of the performer should be recorded in the <id> element.

<code code='PAYOR|GUAR|PAT' displayName=' '
      codeSystem='2.16.840.1.113883.5.110'
      codeSystemName='RoleClass'/>

The <code> element describes the role of the payer. It shall contain one of the values listed in the table below.

Payer Role Codes

Code	Description
PAYOR	Used to indicate that the payer is a payor for a policy or program.
GUAR	Used to indicate that the payer is a guarantor for the patient.
PAT	Used to indicate that the payer is the patient.

<addr></addr>

The <addr> element shall be used to record the address of the payer. This information will usually come from the back of an insurance card.

<telecom value=' ' use=' '/>

The <telecom> element shall be used to record the phone number of the payer. This information will usually come from the back of an insurance card.

<representedOrganization typeCode='ORG'>
 <name></name>

The name of the payer organization shall be provided in the <name> element contained within the <representedOrganization> element.

<participant typeCode='COV'>
 <participantRole classCode='PAT'>

Information about the patient with respect to the policy or program shall be recorded in the <participantRole> element shown above. This element shall be present when the patient is a member of a policy or program.

<id root=' ' extension=' '/>

The <id> element should contain the identifier of the patient with respect to the payer (the subscriber or member id).

<code code= displayName= codeSystem='2.16.840.1.113883.5.111' codeSystemName='RoleCode'/>

The <code> element shall indicate the covered parties relationship to the subscriber, and should come from the HL7 CoverageRoleType value set.

<addr></addr>

The <addr> element should be used to record the address of the patient as known to the payer when different from that recorded in the <patientRole> element.

<telecom value=' ' use=' '/>

The <telecom> element should be used to record the phone number of the patient when different from that recorded in the <patientRole> element.

<playingEntity><name></name></playingEntity>

The <name> element should be used to record the member name when it is different from that recorded in the <patient> element.

<participant typeCode='HLD'>
 <participantRole classCode='IND'>

Information about subscriber to the policy or program shall be recorded in the <participantRole> element shown above. This element shall be present when the subscriber is different from the patient.

<id root=' ' extension=' '/>

The <id> element shall contain the identifier of the subscriber when the subscriber is not the patient.

<addr></addr>

The <addr> element shall be used to record the address of the subscriber when the subscriber is not the patient.

<telecom value=' ' use=' '/>

The <telecom> element shall be used to record the phone number of the subscriber when the subscriber is not the patient.

<playingEntity><name></name></playingEntity>

The name of the subscriber shall be recorded in the <name> element of the <playingEntity>.

<entryRelationship typeCode='REFR'>
 <act classCode='ACT' moodCode='DEF'>

The plan information may be provided in the elements described above.

<id root=' ' extension=' '/>

The health plan identifier is recorded in the <id> element.

<text><reference value=' '/></text>

This <reference> element shown above should be present and the value attribute should point to the name of the plan contained in the narrative of the document.

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.