DraftCDA2.1.b

1 CDA Overview

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2 Introduction to CDA Technical Artifacts

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3 CDA Document Exchange in HL7 Messages

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4 CDA Templating

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5 CDA Design

NOTE: The definitive description of HL7 V3 model refinement, R-MIM development and interpretation can be found here.

The CDA R-MIM POCD_RM000040 can be found here: Link to wide graphic (opens in a new window)

A CDA document is comprised of a header and a body. The header identifies and classifies the document; provides information on authentication, the encounter, the patient, and the provider; and sets the context for the document as a whole. The body contains the clinical report, and is conceptually divided up into nested sections, each containing a narrative block to be rendered along with structured entries and external references.

5.1 Clinical Document

The ClinicalDocument class is the entry point into the CDA R-MIM, and corresponds to the <ClinicalDocument> XML element that is the root element of a CDA document instance. This section will outline the CDA Document's physical design, first in the header and then the body.

A CDA document is logically broken up into a CDA Header and a CDA Body. The CDA Header is comprised of ClinicalDocument attributes, participants, and act relationships. The CDA Body is the target of the ClinicalDocument component act relationship.

5.2 Header

The purpose of the CDA header is to enable clinical document exchange across and within institutions; facilitate clinical document management; and facilitate compilation of an individual patient's clinical documents into a lifetime electronic patient record. The CDA header sets the context for the document as a whole and the context for understanding the content contained in the document.

5.2.1 ClinicalDocument

The CDA schema was produced by serialization of the CDA model. The starting point for his serialization was the ClinicalDocument class. The ClinicalDocument is the root element in a CDA document instance.

5.2.1.1 ClinicalDocument Attributes

This section describes attributes defined in the ClinicalDocument class.

The table below identifies the attributes of ClinicalDocument. For each item, the name is provided, along with the data type, wire cardinality*, code bindings, and binding type or strength. The links allow will access to the item's definition, data type definition, and when appropriate, the concept domain or value set used with the item.

Table X: ClinicalDocument Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
typeId	II	[1..1]
templateId	II	[0..*]
id	II	[1..1]
code	CE	[1..1]	D:DocumentType	Open
title	ST	[0..1]
effectiveTime	TS	[0..1]
confidentialityCode	SET<CE>	[0..*]	V:x_BasicConfidentialityKind	Open
languageCode	CE	[0..1]	D:HumanLanguage	Closed
setId	II	[0..1]
versionNumber	ST.SIMPLE	[0..1]
copyTime (Deprecated)	TS	[0..1]

Note*: The wire cardinality represents is the effective cardinality of an element, taking into account 1.3.1 Recipient Responsibilities, relaxation of the requirement to exchange fixed and defaulted values. The logical cardinality expressed in the CDA Hierarchical Description is still present, but assumed by the recipient, not imposed on the wire format of an instance of a CDA document.

ClinicalDocument.classCode

The ClinicalDocument.classCode in the CDA model is fixed to "DOCCLIN". As a result, in the CDA R2.1 Schema, the ClinicalDocument/@classCode has been fixed to "DOCCLIN".

As noted in section 1.3.1 Recipient Responsibilities, fixed and default values asserted in this standard are not required to be present in CDA document instances. However, CDA Implementation Guides can still require them via conformance statements.

Table X: Fixed ClinicalDocument.classCode

Code	Display Name
DOCCLIN	clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ClinicalDocument.moodCode

The ClinicalDocument.moodCode in the CDA model is fixed to "EVN" or event mood to indicate that this is documentation of a past service. In the CDA R2.1 Schema, the ClinicalDocument/@moodCode has been fixed to "EVN".

Table X: Fixed ClinicalDocument.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

The ClinicalDocument class inherits various attributes from the InfrastructureRoot class of the RIM, including ClinicalDocument.templateId and ClinicalDocument.typeId which are discussed here. All CDA classes inherit from infrastructureRoot, which is discussed in Section (link here).

ClinicalDocument.typeId

ClinicalDocument.typeId is a technology-neutral explicit reference to this CDA, Release Two specification, and must be valued as follows: ClinicalDocument.typeId.root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models); ClinicalDocument.typeId.extension = "POCD_HD000040" (which is the unique identifier for the CDA, Release Two Hierarchical Description).

ClinicalDocument.templateId

When a templateId is present in a CDA element, it signals the imposition of a set of template-defined constraints for that element. The templateId is one of the infrastructure attributes added to all CDA classes. It has only been displayed for ClinicalDocument, but is present in all CDA classes, where it can be used to identify constraints defined in an external Implementation Guide template. See 4.3.2 Template Versioning.

ClinicalDocument.id

Represents the unique instance identifier of a clinical document.

ClinicalDocument.code

The code specifying the particular kind of document (e.g. History and Physical, Discharge Summary, Progress Note). The value set is drawn from LOINC, and has a CWE coding strength.

Within the LOINC database, beginning with version 2.09, May 2003, document type codes are those that have a value of "DOC" in the Scale component. This subset of LOINC is included in the appendix (see LOINC Document Codes).

ClinicalDocument.title

Represents the title of the document. It's commonly the case that clinical documents do not have a title, and are collectively referred to by the display name of ClinicalDocument.code (e.g. a "consultation" or "progress note"). Where these display names are rendered to the clinician, or where the document has a unique title, the ClinicalDocument.title component should be used. In the example document in the appendix (see Sample Document), the value of ClinicalDocument.title = "Good Health Clinic Consultation Note".

ClinicalDocument.effectiveTime

Signifies the document creation time, when the document first came into being. Where the CDA document is a transform from an original document in some other format, the ClinicalDocument.effectiveTime is the time the original document was created. The time when the transform occurred is not currently represented in CDA.

ClinicalDocument.ConfidentialityCode

Confidentiality is a required contextual component of CDA, where the value expressed in the header holds true for the entire document, unless overridden by a nested value (as further described in CDA Context). A best practice for clinical documents is to assert the highest level of confidentiality present within a document at the header level.

Table X: Value set for ClinicalDocument.confidentialityCode

x_BasicConfidentialityKind [2.16.840.1.113883.1.11.16926] (OPEN)
Code	Display Name		Code	Display Name
N	normal		R	restricted
V	very restricted
Code System: Confidentiality (HL7) Code System OID: 2.16.840.1.113883.5.25

* The codeSystem value is included here because confidentialityCode is of type CE, and therefore must carry both a code and a codeSystem.

ClinicalDocument.languageCode

Specifies the human language of character data (whether they be in contents or attribute values). The values of the attribute are language identifiers as defined by the IETF (Internet Engineering Task Force) RFC 3066 for the Identification of Languages, ed. H. Alvestrand. 1995, which obsoletes RFC 1766. The HL7 code system for these values is "2.16.840.1.113883.6.121". Language is a contextual component of CDA, where the value expressed in the header holds true for the entire document, unless overridden by a nested value (as further described in CDA Context).

ClinicalDocument.setId

Represents an identifier that is common across all document revisions.

ClinicalDocument.versionNumber

An integer value used to version successive replacement documents.

ClinicalDocument.copyTime (Deprecated)

Represents the time a document is released (i.e. copied or sent to a display device) from a document management system that maintains revision control over the document. Once valued, it cannot be changed. The intent is to give the viewer of the document some notion as to how long the document has been out of the safe context of its document management system.

Included for backwards compatibility with CDA, Release One. ClinicalDocument.copyTime has been deprecated because it is not part of the document at the time it is authenticated, but instead represents metadata about the document, applied at some variable time after authentication. Further use is discouraged.

5.2.2 Header Participants

This section describes classes related to the root ClinicalDocument class via a Participation.

5.2.2.1 authenticator

Represents a participant who has attested to the accuracy of the document, but who does not have privileges to legally authenticate the document. An example would be a resident physician who sees a patient and dictates a note, then later signs it. (See also legalAuthenticator)

A clinical document can have zero to many authenticators. Both authentication and legal authentication require that a document has been signed manually or electronically by the responsible individual.

Table X: Authenicator

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUTHEN	Fixed
time	TS	[1..1]
signatureCode	CV	[0..1]	S	Fixed
signatureText	ED	[0..1]

authenticator.typeCode

The authenticator.typeCode is fixed to "AUTHEN" to indicate that a participant has attested his participation through a signature.

Table X: Fixed authenticator.typeCode

Code	Display Name
AUTHEN	authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

authenticator.time

Authenticator has a required authenticator.time indicating the time of authentication.

authenticator.signatureCode

Authenicator has a required authenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: Fixed authenticator.signatureCode

Code	Display Name
S (Fixed)	signed
Code System: ParticipationSignature (HL7) Code System OID: 2.16.840.1.113883.5.89

Note: CDA Release One represented either an intended ("X") or actual ("S") authenticator. CDA Release 2 and 2.1 only represents an actual authenticator, so usage of "X" and "I" are deprecated.

authenticator.signatureText

A new attribute, SignatureText has been added to authenticator. The signature can be represented either inline or by reference according to the ED data type. Typical cases are:

1. Paper-based signatures: the ED data type may refer to a document or other resource that can be retrieved through an electronic interface to a hardcopy archive.
2. Electronic signature: this attribute can represent virtually any electronic signature scheme.
3. Digital signature: this attribute can represent digital signatures by reference to a signature data block that is constructed in accordance to a digital signature standard, such as XML-DSIG, PKCS#7, PGP, etc.

5.2.2.1.1 AssignedEntity

An authenticator is a person in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class). (See here for a description of "player" and "scoper" role associations.)

Table X: AssignedEntity

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssignedEntity.classCode

The classCode is fixed to "ASSIGNED", which is used in this context to indicate that a person in the employ of an organization was acting as their agent.

Table X: Fixed AssignedEntity.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssignedEntity.id

In this context, it is a unique identifier for the person in this Role.

AssignedEntity.code

Identifies the specific kind of Role to which an Role-instance belongs. The AssignedEntity.code is bound to D:RoleCode, which enables any code from the HL7 RoleCode vocabulary.

AssignedEntity.addr

A postal address for the Entity while in the Role.

AssignedEntity.telecom

A telecommunication address for the Entity while in the Role.

5.2.2.1.2 Person

Refer to Person as defined for Author participation.

5.2.2.1.3 Organization

Table X: Organization

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ORG	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[0..*]
name	SET<ON>	[0..1]
telecom	SET<TEL>	[0..*]
addr	SET<AD>	[0..*]
standardIndustryClassCode	CE	[0..1]	D:OrganizationIndustryClass

Organization.classCode With the code fixed to "ORG", it indicates we are referencing an Organization.

Table X: Fixed Organization.classCode

Code	Display Name
ORG	organization
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Organization.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that the scoping organization referenced, is a specific instance of an organization.

Table X: Fixed Organization.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Organization.id

A unique identifier for the Organization.

Organization.name

A non-unique textual identifier or moniker for the organization.

Organization.telecom

A telecommunication address for the Organization.

Organization.addr

The postal or residential address of an organization.

Organization.standardIndustryClassCode

A code which identifies the industrial category of an organization. In the US Realm, it has been bound to the Code System: North American Industry Classification System [2.16.840.1.113883.6.85] (NAICS). The binding type is Open, so other code system and values sets may be used in the US and other realms. D:OrganizationIndustryClass

5.2.2.1.4 OrganizationPartOf

A scoping organization can be part of a larger organization. Where there is a need to include whole-part relationships, the OrganizationPartOf role can be used. OrganizationPartOf.statusCode indicates the state of the whole-part relationship (e.g. "active", "terminated").

Table X: OrganizationPartOf

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PART	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
statusCode	CS	[0..1]	V:RoleStatus	Closed
effectiveTime	IVL<TS >	[0..1]

OrganizationPartOf.classCode

Table X: Fixed OrganizationPartOf.classCode

Code	Display Name
PART	part
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

OrganizationPartOf.id

A unique identifier for the player organization in this Role.

OrganizationPartOf.code

The specific kind of Role to which an Role-instance belongs.

OrganizationPartOf.statusCode

The state of this Role as defined in the state-transition model.

Table X: Value set for OrganizationPartOf.statusCode

V:RoleStatus [2.16.840.1.113883.5.1068] (CLOSED)
Code	Display Name		Code	Display Name
normal	normal		active	active
cancelled	cancelled		pending	pending
suspended	suspended		terminated	terminated
nullified	nullified
Code System: RoleStatus (HL7) Code System OID: 2.16.840.1.113883.5.1068

OrganizationPartOf.effectiveTime

The OrganizationPartOf.effectiveTime is an interval of time specifying the period during which the whole-part relationhship is in effect, if such time limit is applicable and known.

5.2.2.2 author

author

Represents the humans and/or machines that authored the document.

Table X: author

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUT	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]

author.typeCode

The author.typeCode is fixed to "AUT", used to indicate the party that originates the document and is responsible for the information in the document.

Table X: Fixed author.typeCode

Code	Display Name
AUT	author
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

author.functionCode

The author.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

In some cases, the role or function of the author is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "Medical Student Progress Note". The role of the author can also be recorded in the Author.functionCode or AssignedAuthor.code attribute. If either of these attributes is included, they should be equivalent to or further specialize the role inherent in the ClinicalDocument.code (such as where the ClinicalDocument.code is simply "Physician Progress Note" and the value of Author.functionCode is "rounding physician"), and shall not conflict with the role inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

author.contextControlCode

The author.contextControlCode is fixed to "OP". It means that the author will replace the set of author participations that have propagated from ancestor Acts, and will itself be the only author to propagate to any child Acts that allow context to be propagated.

Table X: Fixed author.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

author.time

The author.time is used to capture the time this specific author contributed content to the document.

5.2.2.2.1 AssignedAuthor

An author is a person in the role of an assigned author (AssignedAuthor class). The entity playing the role is a person (Person class) or a device (AuthoringDevice class). The entity scoping the role is an organization (Organization class), and is the organization from which the document originates.

Table X: AssignedAuthor

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed
id	SET<II>	[1..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssignedAuthor.classCode

The classCode is fixed to "ASSIGNED", which is used in this context to indicate that a person in the employ of an organization was acting as their agent.

Table X: Fixed AssignedAuthor.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssignedAuthor.id

In this context, it is a unique identifier for the person in this Role.

AssignedAuthor.code

Identifies the specific kind of Role to which an Role-instance belongs. The AssignedEntity.code is bound to D:RoleCode, which enables any code from the HL7 RoleCode vocabulary.

AssignedAuthor.addr

A postal address for the Entity while in the Role.

AssignedAuthor.telecom

A telecommunication address for the Entity while in the Role.

5.2.2.2.2 Person

A human being.

Table X: Person

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PSN	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
name	SET<PN>	[0..*]
desc	ED	[0..1]
birthTime	TS	[0..1]

Person.classCode

With the code fixed to "PSN", it indicates we are referencing a Person.

Table X: Fixed Person.classCode

Code	Display Name
PSN	person
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Person.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that we are dealing with a specific person.

Table X: Fixed Person.determinerCode

Code	Display Name
INSTANCE (Fixed)	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Person.name

The person's name.

Note: The person name data type "PN" supports current, and historical names using validTime, and the specification of different use codes can indicate legal name, tribal name, stage name and others.

Person.desc

A textual or multimedia depiction of the person.

Person.birthTime

The date and time of a person's birth.

5.2.2.2.3 AuthoringDevice

Table X: AuthoringDevice

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DEV	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
code	CE	[0..1]	D:EntityCode
manufacturerModelName	SC	[0..1]	D:ManufacturerModelName
softwareName	SC	[0..1]	D:SoftwareName

AuthoringDevice.classCode

The AuthoringDevice.classCode if fixed to "DEV" indicating that a device was used to generate content in the document.

Table X: Fixed AuthoringDevice.classCode

Code	Display Name
DEV	role
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

AuthoringDevice.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates we are referencing a specific device.

Table X: Fixed AuthoringDevice.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

AuthoringDevice.code

The AuthoringDevice.code is bound to the EntityCode domain.

AuthoringDevice.manufacturerModelName

Is used to convey a coded name for the device.

AuthoringDevice.softwareName

Is used to convey a coded name for the software used to author content.

5.2.2.2.4 MaintainedEntity

NOTE: In CDA, Release One, it was possible to specify those individuals responsible for the device. This functionality has been deprecated in CDA, Release Two. The MaintainedEntity class is present for backwards compatibility, and its use is discouraged, except where needed to support the transformation of CDA, Release One documents.

Table X: MaintainedEntity

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	MNT	Fixed
effectiveTime	IVL<TS>	[0..1]

MaintainedEntity.classCode

With the classCode fixed to "MNT", it indicates that AuthoringDevice is maintained by person assuming responsibility for proper operation, quality, and safety.

Table X: Fixed MaintainedEntity.classCode

Code	Display Name
MNT	maintained entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

MaintainedEntity.effectiveTime

An interval of time specifying the period during which the Role is in effect.

5.2.2.3 custodian

custodian

Represents the organization that is in charge of maintaining the document. The custodian is the steward that is entrusted with the care of the document. Every CDA document has exactly one custodian.

The custodian participation satisfies the CDA definition of Stewardship (see What is the CDA). Because CDA is an exchange standard and may not represent the original form of the authenticated document, the custodian represents the steward of the original source document.

Table X: custodian

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	CST	Fixed

custodian.typeCode

The custodian.typeCode is fixed to "CST", which indicates in this instance an organization that is in charge of maintaining this document. Examples: Medical Records Dept in hospital, Health Information Management Dept., etc.

Table X:Fixed custodian.typeCode

Code	Display Name
CST	custodian
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

A custodian is a scoping organization in the role of an assigned custodian (AssignedCustodian class). The steward organization (CustodianOrganization class) is an entity scoping the role of AssignedCustodian, and has a required CustodianOrganization.id.

5.2.2.3.1 AssignedCustodian

Table X: AssignedCustodian

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ASSIGNED	Fixed

AssignedCustodian.classCode

Table X: Fixed AssignedCustodian.classCode

Code	Display Name
ASSIGNED	assigned entity
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

5.2.2.3.2 CustodianOrganization

Table X: CustodianOrganization

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ORG	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id	SET<II>	[1..*]
name	SET<ON>	[0..1]
telecom	SET<TEL>	[0..*]
addr	SET<AD>	[0..*]

CustodianOrganization.classCode With the code fixed to "ORG", it indicates we are referencing an Organization.

Table X: Fixed CustodianOrganization.classCode

Code	Display Name
ORG	organization
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

CustodianOrganization.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates that the scoping organization referenced, is a specific instance of an organization.

Table X: Fixed CustodianOrganization.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

CustodianOrganization.id

A unique identifier for the Organization.

CustodianOrganization.name

A non-unique textual identifier or moniker for the organization.

CustodianOrganization.telecom

A telecommunication address for the Organization.

CustodianOrganization.addr

The postal or residential address of an organization.

5.2.2.4 dataEnterer (Transcriptionist)

dataEnterer

Represents the participant who has transformed a dictated note into text.

Table X: dataEnterer

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	ENT	Fixed
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]

dataEnterer.typeCode

The dataEnterer.typeCode is fixed to "ENT".

Table X: Fixed dataEnterer.typeCode

Code	Display Name
ENT	data entry person
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

dataEnterer.contextControlCode

The dataEnterer.contextControlCode is fixed to "OP".

Table X: Fixed dataEnterer.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

dataEnterer.time

The date and time the data was entered into the originating system.

5.2.2.4.1 AssignedEntity

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.5 encounterParticipant

See EncompassingEncounter for a description of the encounterParticipant participant.

5.2.2.6 informant

informant

An informant (or source of information) is a person that provides relevant information, such as the parent of a comatose patient who describes the patient's behavior prior to the onset of coma.

Table X: informant

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	INF	Fixed
contextControlCode	CS	[0..1]	OP	Fixed

informant.typeCode The informant.typeCode is fixed to "INF", which indicates the source of reported information (e.g., a next of kin who answers questions about the patient's history).

Table X: Fixed informant.typeCode

Code	Display Name
INF	informant
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

informant.contextControlCode

The informant.contextControlCode is fixed to "OP". It means that the informant will replace the set of informant participations that have propagated from ancestor Acts, and will itself be the only informant to propagate to any child Acts that allow context to be propagated.

Table X: Fixed informant.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

An informant can be a person in one of two roles RelatedEntity or AssignedEntity.

5.2.2.6.1 RelatedEntity

The RelatedEntity role is used to represent an informant without a role.id (e.g. a parent or guy on the street). The informant in this case bears some formal or personal relationship to the patient. The role is unscoped, with the assumption that the patient is always the implied scoper. RelatedEntity.code can be used to specify the nature of the relationship.

Table X: RelatedEntity

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	v:RoleClassMutualRelationship	Closed
code	CE	[0..1]	D:PersonalRelationshipRoleType	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]
effectiveTime	IVL<TS>	[0..1]

RelatedEntity.classCode

Table X: Value set for RelatedEntity.classCode

v:RoleClassMutualRelationship [2.16.840.1.113883.1.11.19316] (CLOSED)
Code	Display Name		Code	Display Name
AFFL	affiliate		AGNT	agent
ASSIGNED	assigned entity		COMPAR	commissioning party
SGNOFF	signing authority or officer		CON	contact
ECON	emergency contact		NOK	next of kin
GUARD	guardian		CIT	citizen
COVPTY	covered party		CLAIM	claimant
NAMED	named insured		DEPEN	dependent
INDIV	individual		SUBSCR	subscriber
PROG	program eligible		CRINV	clinical research investigator
CRSPNSR	clinical research sponsor		EMP	employee
MIL	military person		GUAR	guarantor, GuarantorRole
INVSBJ	Investigation Subject		CASEBJ	Case Subject
RESBJ	research subject		LIC	licensed entity
NOT	notary public		PROV	healthcare provider
PAT	patient		PAYEE	payee
PAYOR	invoice payor		POLHOLD	policy holder
QUAL	qualified entity		SPNSR	coverage sponsor
STD	student		UNDWRT	underwriter
CAREGIVER	caregiver		PRS	personal relationship
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

RelatedEntity.code

The RelatedEntity.code is bound to the PersonalRelationshipRoleType concept domain.

RelatedEntity.addr

The RelatedEntity.addr is used to convey the postal address for the informant.

RelatedEntity.telecom

The RelatedEntity.telecom is used to convey the phone number for the informant.

RelatedEntity.effectiveTime

The RelatedEntity.effectiveTime is used to convey the time period that the role is/was in effect.

5.2.2.6.2 AssignedEntity

The AssignedEntity role is used for an identified informant, and is scoped by an Organization.

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.7 informationRecipient

informationRecipient

Represents a recipient who should receive a copy of the document.

NOTE: The information recipient is an entity to whom a copy of a document is directed, at the time of document authorship. It is not the same as the cumulative set of persons to whom the document has subsequently been disclosed, over the life-time of the patient. Such a disclosure list would not be contained within the document, and it outside the scope of CDA.

Table X: informationRecipient

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	V:x_InformationRecipient	Closed

informationRecipient.typeCode

Two values are available for the informationRecipient.typeCode, the default value is primary information recipient an alternative value is tracker.

Table X: Value set for informationRecipient.typeCode

v:x_InformationRecipient [2.16.840.1.113883.1.11.19366] (CLOSED)
Code	Display Name		Code	Display Name
PRCP (Default)	primary information recipient		TRC	tracker
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.2.2.7.1 IntendedRecipient

Identifies the person(s), organization or health chart to receive the document.

Table X: IntendedRecipient

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:x_InformationRecipientRole	Closed
id	SET<II>	[1..*]
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

IntendedRecipient.classCode

Where a person is the intended recipient (IntendedRecipient class), the IntendedRecipient.classCode is valued with "ASSIGNED", and the playing entity is a person (Person class), optionally scoped by an organization (Organization class). Where the intended recipient is an organization, the IntendedRecipient.classCode is valued with "ASSIGNED", and the recipient is reflected by the presence of a scoping Organization, without a playing entity. Where a health chart is the intended recipient, the IntendedRecipient.classCode is valued with "HLTHCHRT" (health chart). In this case there is no playing entity, and an optional scoping organization (Organization class).

Table X: Value set for IntendedRecipient.classCode

V:x_InformationRecipientRole [2.16.840.1.113883.1.11.16772] (CLOSED)
Code	Display Name		Code	Display Name
ASSIGNED (Default)	assigned entity		HLTHCHRT	health chart
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

IntendedRecipient.id

Optional identifier of the intended recipient.

IntendedRecipient.addr

Optional postal address of the intended recipient.

IntendedRecipient.telecom

Optional phone number for the intended recipient.

5.2.2.7.2 Person

Refer to Person as defined for Author participation.

5.2.2.7.3 Organization

Refer to organization as defined for authenticator participation.

5.2.2.8 legalAuthenticator

Represents the participant(s) who has legally authenticated the document.

CDA R2.1, now supports [0..*] legal authentications. This enhancement was put into CDA to support the sharing of medical documents needing to take more than one legal authentication signature.

The CDA is a standard that specifies the structure of exchanged clinical documents. In the case where a local document is transformed into a CDA document for exchange, authentication occurs on the local document, and that fact is reflected in the exchanged CDA document. A CDA document can reflect the unauthenticated, authenticated, or legally authenticated state. The unauthenticated state exists when no authentication information has been recorded (i.e., it is the absence of being either authenticated or legally authenticated).

Both authentication and legal authentication require that a document has been signed manually or electronically by the responsible individual. A legalAuthenticator has a required legalAuthenticator.time indicating the time of authentication, and a required legalAuthenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: legalAuthenticator[0..*]

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	LA	Fixed
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]
signatureCode	CV	[0..1]	S	Fixed
signatureText	ED	[0..1]

legalAuthenticator.typeCode

The ClinicalDocument.typeCode is fixed to "LA" to indicate that a participant has legally attested his participation through a signature.

Table X: Fixed legalAuthenticator.typeCode

Code	Display Name
AUTHEN	authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

legalAuthenticator.contextControlCode

The legalAuthenticator.contextControlCode is fixed to "OP". It means that the legalAuthenticator will propagate to any child Acts that allow context to be propagated.

legalAuthenticator.time

legalAuthenticatorhas a required legalAuthenticator.time indicating the time of authentication.

legalAuthenticator.signatureCode

legalAuthenticatorhas a required legalAuthenticator.signatureCode, indicating that a signature has been obtained and is on file.

Table X: Fixed legalAuthenticator.signatureCode

Code	Display Name
S (Fixed)	signed
Code System: ParticipationSignature (HL7) Code System OID: 2.16.840.1.113883.5.89

Note: CDA Release One represented either an intended ("X") or actual ("S") legalAuthenticator. CDA Release 2 and 2.1 only represents an actual legalAuthenticator, so only S / Signed can be indicated for the signatureCode.

legalAuthenticator.signatureText

A new attribute, SignatureText has been added to legalAuthenticator. The signature can be represented either inline or by reference according to the ED data type. Typical cases are:

1. Paper-based signatures: the ED data type may refer to a document or other resource that can be retrieved through an electronic interface to a hardcopy archive.
2. Electronic signature: this attribute can represent virtually any electronic signature scheme.
3. Digital signature: this attribute can represent digital signatures by reference to a signature data block that is constructed in accordance to a digital signature standard, such as XML-DSIG, PKCS#7, PGP, etc.

Table X: Fixed legalAuthenticator.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

A legalAuthenticator is a person in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

5.2.2.8.1 AssignedEntity

Refer to AssignedEntity as defined for authenticator participation.

5.2.2.8.2 Person

Refer to Person as defined for Author participation.

5.2.2.8.3 Organization

Refer to Organization as defined for authenticator participation.

5.2.2.8.4 OrganizationPartOf

Refer to OrganizationPartOf as defined for authenticator participation.

5.2.2.9 participant

participant

Table X: participant

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	ParticipationType	Fixed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
contextControlCode	CS	[0..1]	OP	Fixed
time	TS	[1..1]

participant.typeCode

The participant.typeCode is can be any code defined in the ParticipationType domain. Which can be used to represent other participants not explicitly mentioned by other classes, that were somehow involved in the documented acts.

Table X: Value set for participant.typeCode

v:ParticipationType [2.16.840.1.113883.1.11.10901] (CLOSED)
Code	Display Name		Code	Display Name
PART	Participation		ADM	admitter
ATND	attender		ADM	admitter
CALLBCK	callback contact		CON	consultant
DIS	discharger		ESC	escort
REF	referrer		TRANS	Transcriber
ENT	data entry person		WIT	witness
CST	custodian		DIR	direct target
BBY	baby		DEV	device
NRD	non-reuseable device		RDV	reusable device
EXPAGNT	ExposureAgent		EXPART	ExposureParticipation
EXPTRGT	ExposureTarget		EXSRC	ExposureSource
IND	indirect target		BEN	beneficiary
CAGNT	causative agent		COV	coverage target
GUAR	guarantor party		HLD	holder
DON	donor		RCV	receiver
IRCP	information recipient		NOT	ugent notification contact
PRCP	primary information recipient		REFB	Referred By
REFT	Referred to		TRC	tracker
LOC	location		DST	destination
ELOC	entry location		ORG	origin
RML	remote		VIA	via
RESP	responsible party		VRF	verifier
AUTHEN	authenticator
Use the following participations, only if the other participations provided in CDA will not work
RCT	record target		AUT	author (originator)
INF	informant		CSM	consumable
PRD	product		SBJ	subject
SPC	specimen		PRF	performer
DIST	distributor		PPRF	primary performer
SPRF	secondary performer		LA	legal authenticator
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

participant.functionCode

The participant.functionCode is bound to the concept domain ParticipationFunction, which is used to specify the exact function an actor had in a service in all necessary detail. This domain may include local extensions (Open).

participant.contextControlCode

The participant.contextControlCode is fixed to "OP". It means that the participantType code specified in participant.typeCode will replace the set of author participations that have propagated from ancestor Acts, and will itself be the only author to propagate to any child Acts that allow context to be propagated.

Table X: Fixed participant.contextControlCode

Code	Display Name
OP (Fixed)	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

participant.typeCode.time

The participant.typeCode.time is the date and time the specific participation occurred.

5.2.2.9.1 AssociatedEntity

A participant is a person or organization in the role of a participating entity (AssociatedEntity class). The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

Table X: AssociatedEntity

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	V:RoleClassAssociative	Closed
id	SET<II>	[0..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

AssociatedEntity.classCode

When the participating entity is an organization, this is reflected by the presence of a scoping Organization, without a playing entity. Otherwise, the participating entity is considered a person with or without a scoping Organization.

Table X: Value set for ParticipatingEntity.classCode

V:RoleClassAssociative [2.16.840.1.113883.1.11.19313] (CLOSED)
Code	Display Name		Code	Display Name
ROL (Default)	role		AFFL	affiliate
AGNT	agent		ASSIGNED	assigned entity
COMPAR	commissioning party		SGNOFF	signing authority or officer
CON	contact		ECON	emergency contact
NOK	next of kin		GUARD	guardian
CIT	citizen		COVPTY	covered party
CLAIM	claimant		NAMED	named insured
DEPEN	dependent		INDIV	individual
SUBSCR	subscriber		PROG	program eligible
CRINV	clinical research investigator		CRSPNSR	clinical research sponsor
EMP	employee		MIL	military person
GUAR	guarantor		INVSBJ	Investigation Subject
CASEBJ	Case Subject		RESBJ	research subject
LIC	licensed entity		NOT	notary public
PROV	healthcare provider		PAT	patient
PAYEE	payee		PAYOR	invoice payor
POLHOLD	policy holder		QUAL	qualified entity
SPNSR	underwriter		STD	student
UNDWRT	coverage sponsor		CAREGIVER	caregiver
PRS	personal relationship		ACCESS	access
ADMM	Administerable Material		BIRTHPL	birthplace
DEATHPLC	place of death		DST	distributed material
RET	retailed material		EXPR	exposed entity
HLD	held entity		HLTHCHRT	health chart
IDENT	identified entity		MANU	manufactured product
THER	therapeutic agent		MNT	maintained entity
OWN	owned entity		RGPR	regulated product
SDLOC	service delivery location		DSDLOC	dedicated service delivery location, health care facility
ISDLOC	incidental service delivery location		TERR	territory of authority
USED	used entity		WRTE	warranted product
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

AssociatedEntity.id

An identifier for the associate person (when present) or the organization.

AssociatedEntity.code

An optional role code taken from the RoleCode concept domain. This binding is open so other code systems can be used.

AssociatedEntity.addr

The postal address for the associate person (when present) or the organization.

AssociatedEntity.telecom

The phone number for the associated person (when present) or the organization.

5.2.2.9.2 Person

Refer to Person as defined for Author participation.

5.2.2.9.3 Organization

Refer to Organization as defined for authenticator participation.

5.2.2.10 performer

See ServiceEvent for a description of the performer participant.

5.2.2.11 recordTarget

recordTarget

The recordTarget identifies the specified patient's medical record that the document belongs to.

A clinical document typically has exactly one recordTarget participant. In the uncommon case where a clinical document (such as a group encounter note) is placed into more than one patient chart, more than one recordTarget participant can be stated.

Note: The recordTarget(s) of a document are stated in the header and propagate to nested content, where they cannot be overridden. However, the patient(s) specified by the recordTarget are assumed to be the default subjects of the clinical document. Unlike the recordTarget, which can not be overridden, the patients or subjects propagate to nested components, and can be overridden at the section or entry level. (see See CDA Context).

Table X: recordTarget

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	RCT	Fixed
contextControlCode	CS	[0..1]	OP	Fixed

recordTarget.typeCode

The recordTarget.typeCode is fixed to "RCT" and indicates that this is a record target participation.

Table X: Fixed recordTarget.typeCode

Code	Display Name
RCT	record target
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

recordTarget.contextControlCode

The recordTarget.contextControlCode is fixed to "OP". It means that the recordTarget identified in the header will propagate to any child Acts that allow context to be propagated.

Table X: Fixed recordTarget.contextControlCode

Code	Display Name
OP	overriding, propagating
Code System: ContextControl (HL7) Code System OID: 2.16.840.1.113883.5.1057

A recordTarget is represented as a relationship between a person and an organization, where the person is in a patient role (PatientRole class). The entity playing the role is a patient (Patient class). The entity scoping the role is an organization (Organization class). A patient is uniquely identified via the PatientRole.id attribute.

5.2.2.11.1 PatientRole

Table X: PatientRole

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PAT	Fixed
id	SET<II>	[1..*]
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

PatientRole.classCode

The PatientRole.classCode is fixed to "PAT" to indicate a person (Patient) as a recipient of health care services from a healthcare provider.

Table X: Fixed PatientRole.classCode

Code	Display Name
PAT	patient
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

PatientRole.id

A unique identifier for the person in this patient role.

PatientRole.addr

The postal address for the Patient.

PatientRole.telecom

The phone number for the Patient.

5.2.2.11.2 Patient

Table X: Patient

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PSN	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
id (Deprecated)	SET<II>	[0..*]
name	SET<PN>	[0..*]
desc	ED	[0..1]
administrativeGenderCode	CE	[0..1]	D:administrativeGender	Open
birthTime	TS	[0..1]
deceasedInd	BL	[0..1]
deceasedTime	TS	[0..1]
multipleBirthInd	BL	[0..1]
multipleBirthOrderNumber	INT	[0..1]
maritalStatusCode	CE	[0..1]	D:MaritalStatus	Open
religiousAffiliationCode	CE	[0..1]	D:ReligousAffiliation	Open
raceCode	SET<CE>	[0..*]	D:Race	Open
ethnicGroupCode	SET<CE>	[0..*]	D:Ethnicity	Open

Patient.classCode

The Patient.classCode is fixed to "PSN", indicating that the entity is a person.

Table X: Fixed Patient.classCode

Code	Display Name
PSN	person
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Patient.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates a specific person is a patient.

Table X: Fixed Patient.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Patient.id (Deprecated)

CDA Release 1.0 allowed for additional person identifiers, corresponding to the Patient.id attribute in CDA Release 2.1. This attribute is included for backwards compatibility and has been deprecated because having two different ways to identify a patient can result in inconsistent usage. Further use of Patient.id is discouraged.

Patient.name

The patient's name.

Note: The person name data type "PN" supports current, and historical names using validTime, and the specification of different use codes can indicate legal name, tribal name, stage name and others.

Patient.desc

A textual or multimedia depiction of the patient.

Patient.administrativeGenderCode

The gender (i.e., the behavioral, cultural, or psychological traits typically associated with one sex) of a living subject as defined for administrative purposes.

Patient.birthTime

The date and time of the patient's birth.

Patient.deceasedInd

An indication that the subject is dead.

Patient.deceasedTime

The date and time that the patient's death occurred.

Patient.multipleBirthInd

An indication as to whether the patient was part of a multiple birth.

Patient.multipleBirthOrderNumber

The order within a multiple birth in which this patient was born.

Patient.maritalStatusCode

The domestic partnership status of the patient.

Patient.religiousAffiliationCode

The primary religious preference of the patient.

Patient.raceCode

The race of the patient.

Note: More than one race code is now supported in CDA R2.1.

Patient.ethnicGroupCode

The ethnic group of the patient.

Note: More than one ethnic group is now supported in CDA R2.1.

Note: See 2.7 Backwards and Forwards Compatibility, for discussion on sdtc: extensions defined for CDA R2.0 and CDA R2.1.

5.2.2.11.3 Organization

The optional Organization in recordTarget identifies the Patient's healthcare organization. Refer to Organization as defined for authenticator participation for details.

5.2.2.11.4 LanguageCommunication

A patient's language communication skills can be expressed in the associated LanguageCommunication class.

Table X: LanguageCommunication

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
languageCode	CE	[0..1]	D:HumanLanguage	Open
modeCode	CE	[0..1]	D:LanguageAbilityMode	Open
proficiencyLevelCode	CE	[0..1]	D:LanguageAbilityProficiency	Open
preferenceInd	BL	[0..1]

LanguageCommunication.languageCode

A language for which the patient has some level of proficiency for communication.

LanguageCommunication.modeCode

The method of expression of the language, e.g. expressed spoken, expressed written, expressed signed, received spoken, received written, received signed

LanguageCommunication.proficiencyLevelCode

The level of proficiency the patient has in a particular language, e.g. excellent, good, fair, poor

LanguageCommunication.preferenceInd

An indicator specifying whether the language is preferred by the patient for the associated mode.

5.2.2.11.5 Birthplace

A Patient's birthplace is represented as a relationship between a patient and a place. The Birthplace class is played by a place (Place class), and scoped by the patient (Patient class).

Table X: Birthplace

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	BIRTHPL	Fixed

Birthplace.classCode

The Birthplace.classCode it fixed to "BIRTHPL" indicating in this context, that the Place referenced is the birth place of the patient.

Table X: Fixed Birthplace.classCode

Code	Display Name
BIRTHPL	birthplace
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

5.2.2.11.6 Place

Table X: Place

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	PLC	Fixed
determinerCode	CS	[0..1]	INSTANCE	Fixed
name	SET<ON>	[0..1]
addr	SET<AD>	[0..*]

Place.classCode

A physical place or site with its containing structure. May be natural or man-made. The geographic position of a place may or may not be constant.

Table X: Fixed Place.classCode

Code	Display Name
PLC	place
Code System: EntityClass (HL7) Code System OID: 2.16.840.1.113883.5.41

Place.determinerCode

The determinerCode is fixed to "INSTANCE", which indicates a specific place is being identified.

Table X: Fixed Place.determinerCode

Code	Display Name
INSTANCE	specific
Code System: EntityDeterminer (HL7) Code System OID: 2.16.840.1.113883.5.30

Place.name

The name of place of birth (E.g. Queen Mary)

Place.addr

The postal address for the patient's birthplace.

5.2.2.11.7 Guardian

A patient's guardian is a person or organization in the role of guardian (Guardian class). The entity playing the role of guardian is a person (Person class) or organization (Organization class). The entity scoping the role is the patient (Patient class).

Where a guardian is not explicitly stated, the value should default to local business practice (e.g. the patient makes their own health care decisions unless incapacitated in which case healthcare decisions are made by the patient's spouse).

Table X: Guardian

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[1..1]	GUARD	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	D:RoleCode	Open
addr	SET<AD>	[0..*]
telecom	SET<TEL>	[0..*]

Guardian.classCode

The Guardian.classCode is fixed to "GUARD", indicating that the associated person or institution are legally empowered with responsibility for the care of a ward.

Table X: Fixed Guardian.classCode

Code	Display Name
GUARD	guardian
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

Guardian.code

An optional role code taken from the RoleCode concept domain. This binding is open so other code systems can be used.

Guardian.addr

The guardian's postal address.

Guardian.telecom

The guardian's phone number.

5.2.2.11.8 Person

Refer to Person as defined for Author participation.

5.2.2.11.9 Organization

Refer to organization as defined for authenticator participation.

5.2.2.12 responsibleParty

See EncompassingEncounter for a description of the responsibleParty participant.

5.2.2.13 Participant Scenarios

Several CDA Header participations can be played by the same person. In such cases, the person should be identified as the player for each appropriate participation. For instance, if a person is both the author and the authenticator of a document, the CDA Header should identify that person as both the author participant and the authenticator participant.

On other occasions, CDA Header participants are played by different people. The following table shows a number of scenarios and the values for various participants.

Table X: CDA participation scenarios

1. StaffPhysicianOne sees a patient as a consultant, dictates a note, and later signs it.

Author — StaffPhysicianOne Encounter Participant — StaffPhysicianOne (typeCode="CONS") Legal Authenticator — StaffPhysicianOne

2. StaffPhysicianOne sees a patient and dictates a note. StaffPhysicianTwo later signs the note. *

Author — StaffPhysicianOne Legal Authenticator — StaffPhysicianTwo

3. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note and later signs it. The note is co-signed by StaffPhysicianOne. *

Author — ResidentOne Authenticator — ResidentOne Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianOne

4. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note and later signs it. The note is co-signed by StaffPhysicianTwo. *

Author — ResidentOne Authenticator — ResidentOne Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianTwo

5. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note, and goes off on vacation. The note is signed by ResidentTwo and by StaffPhysicianOne. *

Author — ResidentOne Authenticator — ResidentTwo Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianOne

6. ResidentOne sees a patient with StaffPhysicianOne. ResidentOne dictates a note, which is later signed by ResidentTwo and StaffPhysicianTwo. *

Author — ResidentOne Authenticator — ResidentTwo Encounter Participant — StaffPhysicianOne (typeCode="ATND") Legal Authenticator — StaffPhysicianTwo

7. StaffPhysicianOne receives an abnormal lab result, attempts to contact patient but can't, and writes and signs a progress note.

Author — StaffPhysicianOne Legal Authenticator — StaffPhysicianOne

8. ResidentSurgeonOne is operating on a patient with StaffSurgeonOne. StaffSurgeonOne dictates an operative report and later signs it.

Author — StaffSurgeonOne Authenticator — null (need not be included) Legal Authenticator — StaffSurgeonOne Performer — StaffSurgeonOne (typeCode="PPRF") Performer — ResidentSurgeonOne (typeCode="SPRF")

* Note that the ability of one clinician to co-sign or to sign on behalf of another clinician is subject to regulatory and local practice constraints.

5.2.3 Header Relationships

This section describes classes related to the root ClinicalDocument class via an ActRelationship.

5.2.3.1 ParentDocument

ParentDocument

The ParentDocument represents the source of a document revision, addenda, or transformation.

5.2.3.1.1 relatedDocument

The optional relatedDocument class is used to associate a ClinicalDocument to a ParentDocument.

Table X: relatedDocument Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	x_ActRelationshipDocument	Closed
inversionInd	BL	[0..1]

relatedDocument.typeCode

Allowable values for the intervening relatedDocument.typeCode are shown in the following table.

Table X: Value set for relatedDocument.typeCode

v:x_ActRelationshipDocument [2.16.840.1.113883.1.11.11610] (CLOSED)
Code	Display Name		Code	Display Name
APND	is appendage		RPLC	replaces
XFRM]	transformation
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

A conformant CDA document can have a single relatedDocument with typeCode "APND"; a single relatedDocument with typeCode "RPLC"; a single relatedDocument with typeCode "XFRM"; a combination of two relatedDocuments with typeCodes "XFRM" and "RPLC"; or a combination of two relatedDocuments with typeCodes "XFRM" and "APND". No other combinations are allowed.

relatedDocument.inversionInd

Technical note: CDA R2.0 design assumes that ClinicalDocument was the source for all typecodes found in relatedDocument, ("APND", "RPLC" and "XFRM"). For "APND" and "RPLC" this is correct, however for "XFRM", the RIM definition indicates that "it is used when the target Act is a transformation of the source Act...". This technically is an error in CDA R2.0's design, which normally should have required the use of inversionInd to establish the ClinicalDocument as the target and the ParentDocument as the source for the "XFRM" relation.

As a result, in CDA R2.1 when "XFRM" is assigned to the relatedDocument.typeCode, the associated inversionInd will be assumed to be fixed to true, but will not be required to be present in the instance document. In all other cases, "APND", "RPLC" the associated inversionInd will not be present and will be assumed to be false. This enables wire format compatibility between CDA R2.0 and CDA R2.1, and ensures proper interpretation of the "XFRM" ActRelationshipType code.

5.2.3.1.2 ParentDocument

The ParentDocument identifies and optionally provides a reference to the original document serving as the source for the current document revision, addendum or transformation.

Table X: ParentDocument Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	DOCCLIN	Fixed
moodCode	CS	[0..1]	EVN	Fixed
typeId	II	[1..1]
id	II	[1..*]
code	CE	[1..1]	D:DocumentType	Open
text	ED	[0..1]
setId	II	[0..1]
versionNumber	ST.SIMPLE	[0..1]

ParentDocument.classCode

The ParentDocument.classCode is fixed to "DOCCLIN".

Table X: Fixed ParentDocument.classCode

Code	Display Name
DOCCLIN	clinical document
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ParentDocument.moodCode

The ParentDocument.moodCode is fixed to "EVN".

Table X: Fixed ParentDocument.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ParentDocument.id

The ParentDocument.id is a required identifier, which uniquely identifies the parent document.

ParentDocument.code

The code specifying the particular kind of document (e.g. History and Physical, Discharge Summary, Progress Note). The value set is drawn from LOINC, and has a CWE coding strength.

ParentDocument.text

ParentDocument.text is modeled as an ED data type - allowing for the expression of the MIME type of the parent document. It is not to be used to embed the related document, and thus ParentDocument.text.BIN is precluded from use.

ParentDocument.setId

Optional setID for the parent document.

ParentDocument.versionNumber

Optional versionNumber of the parent document.

Additional Information on Document Identification, Revisions, and Addenda

A clinical document can be replaced by a new document and/or appended with an addendum.

A replacement document is a new version of the parent document. The parent document is considered superseded, but a system may retain it for historical or auditing purposes. The parent document being replaced is referenced via act relationship relatedDocument, where relatedDocument.typeCode is set to equal "RPLC" (for "replaces"). An example is a report found to contain an error that is subsequently replaced by the corrected report.

An addendum is a separate document that references the parent document, and may extend or alter the observations in the prior document. The parent document remains a current component of the patient record, and the addendum and its parent are both read by report recipients. The parent report (represented by the ParentDocument class) being appended is referenced via act relationship relatedDocument, where relatedDocument.typeCode is set to equal "APND" (for "appends").

Every CDA document must have a unique ClinicalDocument.id, and thus the replacement or addendum documents each have ClinicalDocument.id that is different from that of the parent document.

CDA documents may also contain a ClinicalDocument.setId and a ClinicalDocument.versionNumber, which together support a document identification and versioning scheme used in some document management systems. In this scheme, all documents in a chain of replacements have the same ClinicalDocument.setId and are distinguished by an incrementing ClinicalDocument.versionNumber. The initial version of a document gets, in addition to a new unique value for ClinicalDocument.id, a new value for ClinicalDocument.setId, and has the value of ClinicalDocument.versionNumber set to equal "1". A replacement document gets a new globally unique ClinicalDocument.id value, and uses the same value for ClinicalDocument.setId as the parent report being replaced, and increments the value of ClinicalDocument.versionNumber by 1. (Note that version number must be incremented by one when a report is replaced, but can also be incremented more often to meet local requirements.)

These relationships are illustrated in the following exhibit "Document Identification, Revisions, and Addenda Scenarios". Typical scenarios are a simple relacement (e.g. ClinicalDocument.id "1.2.345.6789.266" replacing ClinicalDocument.id "1.2.345.6789.123") and a simple append (e.g. ClinicalDocument.id "1.2.345.6789.456" appends ClinicalDocument.id "1.2.345.6789.123"). More complex scenarios that might be anticipated include: [1] replacement of an addendum (e.g. ClinicalDocument.id "1.2.345.6789.224" replaces ClinicalDocument.id "1.2.345.6789.456", which itself is an addendum to ClinicalDocument.id "1.2.345.6789.123") - expected behavior would be to render the replacement as the addendum (e.g. render ClinicalDocument.id "1.2.345.6789.224" as the addendum to ClinicalDocument.id "1.2.345.6789.123"); [2] addendum to a replaced document (e.g. ClinicalDocument.id "1.2.345.6789.456" appends ClinicalDocument.id "1.2.345.6789.123", which has been replaced by ClinicalDocument.id "1.2.345.6789.266") - expected behavior would be to render the addendum along with the replacement (e.g. render ClinicalDocument.id "1.2.345.6789.456" as an addendum to ClinicalDocument.id "1.2.345.6789.266").

Document transformations

A CDA document can be a transformation from some other format, meaning that it has undergone a machine translation from some other format (such as DICOM SR). In this case, relatedDocument.typeCode should be set to "XFRM".

A proper transformation must ensure that the human readable clinical content of the report is not impacted. Local business rules determine whether or not a transformed report replaces the source, but typically this would not be the case. If it is, an additional relationship of type "RPLC" is to be used. The "XFRM" relationship can also be used when translating a document in a local format into CDA for the purpose of exchange. In this case, the target of the "XFRM" relationship is the local document identifier.

Link to wide graphic (opens in a new window)

5.2.3.2 ServiceEvent

ServiceEvent

The ServiceEvent is used to represent the main activity being documented. It may used to represent a specific procedure, such as a colonoscopy, an appendectomy, or other clinical activity. When the ClinicalDocument represents a summary of care, the ServiceEvent.code can be set to "PCPR" to indicate the service is care provisioning.

5.2.3.2.1 documentationOf

The optional documentationOf class is used to associate a ClinicalDocument to a ServiceEvent.

Table X: documentationOf Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	DOC	Fixed

documentationOf.typeCode

The documentationOf.typeCode is fixed to "DOC" which indicates that the ClinicalDocument provides documentation is about ServiceEvent.

Table X: Fixed documentationOf.typeCode

Code	Display Name
DOC	documents
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.2.2 ServiceEvent

In some cases, the ServiceEvent is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "History and Physical Report" and the procedure being documented is a "History and Physical". A ServiceEvent can further specialize the act inherent in the ClinicalDocument.code, such as where the ClinicalDocument.code is simply "Procedure Report" and the procedure was a "colonoscopy". If ServiceEvent is included, it must be equivalent to or further specialize the value inherent in the ClinicalDocument.code, and shall not conflict with the value inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

Table X: ServiceEvent Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	V:ActClassRoot	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	D:ActCode	Open
statusCode	CS	[0..1]	V:ActStatus	Closed
effectiveTime	IVL<TS>	[0..1]

ServiceEvent.classCode

The ServiceEvent.classCode identifies the RIM Act class code of the service event instance.

Table X: Value set for ServiceEvent.classCode

V:ActClassRoot [2.16.840.1.113883.1.11.13856] (CLOSED)
Code	Display Name		Code	Display Name
ACT (Default)	act		COMPOSITION	composition, Attestable unit
DOC	document		DOCCLIN	clinical document
CDALVLONE	CDA Level One clinical document		CONTAINER	record container
CATEGORY	category		DOCBODY	document body
CATEGORY	document section, Section		TOPIC	topic
EXTRACT	extract		EHR	electronic health record
FOLDER	folder		GROUPER	grouper
CLUSTER	Cluster		ACCM	accommodation
ACCT	account		ACSN	accession
ADJUD	financial adjudication, financial adjudication results		CACT	control act
ACTN	action		INFO	information
STC	state transition control		CNTRCT	contract
FCNTRCT	financial contract		COV	coverage
CONS	consent		CONTREG	container registration
CTTEVENT	clinical trial timepoint event		DISPACT	disciplinary action
EXPOS	exposure		AEXPOS	acquisition exposure
TEXPOS	transmission exposure		INC	incident
INFRM	inform		INVE	invoice element
LIST	working list		MPROT	monitoring program
OBS	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		PCPR	care provision
ENC	encounter		POLICY	policy
JURISPOL	jurisdictional policy		ORGPOL	organizational policy
SCOPOL	scope of practice policy		STDPOL	standard of practice policy
PROC	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection		SBADM	substance administration
REG	registration		REV	review
SPCTRT	specimen treatment		SPLY	supply
DIET	diet		STORE	storage
SUBST	Substitution		TRFR	transfer
TRNS	transportation		XACT	financial transaction
CNOD (Deprecated)	Condition Node		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

ServiceEvent.moodCode

The ServiceEvent.moodCode is fixed to "EVN", which indicates documentation of a past service.

Table X: Fixed ServiceEvent.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

ServiceEvent.id

The optional unique identifier for the ServiceEvent.

ServiceEvent.code

The particular kind of service event that the this instance represents within its class code. The ServiceEvent.code is bound to the D:ActCode concept domain.

ServiceEvent.statusCode

The ServiceEvent.statusCode can take on any of the values defined in the D:ActStatus domain.

ServiceEvent.effectiveTime

ServiceEvent.effectiveTime can be used to indicate the time the actual event (as opposed to the encounter surrounding the event) took place.

5.2.3.2.3 performer

The performer participant represents clinicians who actually and principally carry out the ServiceEvent.

Table X: performer

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	x_ServiceEventPerformer	Closed
functionCode	CE	[0..1]	D:ParticipationFunction	Open
time	TS	[1..1]

performer.typeCode

Allows for the optional identification of performers, primary performers and secondary performers.

Table X: Value set for performer.typeCode

v:x_ServiceEventPerformer [2.16.840.1.113883.1.11.19601] (CLOSED)
Code	Display Name		Code	Display Name
PRF	performer		PPRF	primary performer
SPRF	secondary performer
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

performer.functionCode

Performer.functionCode can be used to specify addition detail about the function of the performer (e.g. scrub nurse, third assistant). The functionCode is bound to the D:ParticipationFunction concept domain.

performer.time

Performer.time can be used to specify the time during which the performer is involved in the activity.

5.2.3.2.4 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.2.5 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person] class).

5.2.3.2.6 Organization

The entity scoping the role is an organization (Organization class).

5.2.3.3 Order

Order

This class represents those orders that are fulfilled by this document. For instance, a provider orders an X-Ray. The X-Ray is performed. A radiologist reads the X-Ray and generates a report. The X-Ray order identifier is transmitted in the Order class, the performed X-Ray procedure is transmitted in the ServiceEvent class, and the ClinicalDocument.code would be valued with "Diagnostic Imaging Report".

5.2.3.3.1 inFullfillmentOf

The optional inFullfillmentOf class is used to associate a ClinicalDocument to an Order.

Table X: Fixed InFulfillmentOf.typeCode

Code	Display Name
FLFS	fulfills
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.3.2 Order

A reference to the fulfilled order.

Table X: Order Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	V:ActClassRoot	Closed
moodCode	CS	[0..1]	RQO	Fixed
id	II	[1..*]
code	CD	[0..1]	D:ActCode	Open
priorityCode	CS	[0..1]	V:ActPriority	Open

Order.classCode

The Order.classCode identifies the RIM Act class code of the order instance.

Table X: Value set for Order.classCode

V:ActClassRoot [2.16.840.1.113883.1.11.13856] (CLOSED)
Code	Display Name		Code	Display Name
ACT (Default)	act		COMPOSITION	composition, Attestable unit
DOC	document		DOCCLIN	clinical document
CDALVLONE	CDA Level One clinical document		CONTAINER	record container
CATEGORY	category		DOCBODY	document body
CATEGORY	document section, Section		TOPIC	topic
EXTRACT	extract		EHR	electronic health record
FOLDER	folder		GROUPER	grouper
CLUSTER	Cluster		ACCM	accommodation
ACCT	account		ACSN	accession
ADJUD	financial adjudication, financial adjudication results		CACT	control act
ACTN	action		INFO	information
STC	state transition control		CNTRCT	contract
FCNTRCT	financial contract		COV	coverage
CONS	consent		CONTREG	container registration
CTTEVENT	clinical trial timepoint event		DISPACT	disciplinary action
EXPOS	exposure		AEXPOS	acquisition exposure
TEXPOS	transmission exposure		INC	incident
INFRM	inform		INVE	invoice element
LIST	working list		MPROT	monitoring program
OBS	Observation		ALRT	detected issue
BATTERY	battery		CLNTRL	clinical trial
CONC	concern		COND	Condition
CASE	public health case		OUTB	outbreak
DGIMG	diagnostic image		GEN	genomic observation
DETPOL	determinant peptide		EXP	expression level
LOC	locus		PHN	phenotype
POL	polypeptide		SEQ	bio sequence
SEQVAR	bio sequence variation		INVSTG	investigation
OBSSER	observation series		OBSCOR	correlated observation sequences
POS	position		POSACC	position accuracy
POSCOORD	position coordinate		SPCOBS	specimen observation
VERIF	Verification		ROIBND	bounded ROI
ROIOVL	overlay ROI		PCPR	care provision
ENC	encounter		POLICY	policy
JURISPOL	jurisdictional policy		ORGPOL	organizational policy
SCOPOL	scope of practice policy		STDPOL	standard of practice policy
PROC	procedure		SBEXT	Substance Extraction
SPECCOLLECT	Specimen Collection		SBADM	substance administration
REG	registration		REV	review
SPCTRT	specimen treatment		SPLY	supply
DIET	diet		STORE	storage
SUBST	Substitution		TRFR	transfer
TRNS	transportation		XACT	financial transaction
CNOD (Deprecated)	Condition Node		LLD (Deprecated)	left lateral decubitus
PRN (Deprecated)	prone		RLD (Deprecated)	right lateral decubitus
SFWL (Deprecated)	Semi-Fowler's		SIT (Deprecated)	sitting
STN (Deprecated)	standing		SUP (Deprecated)	supine
RTRD (Deprecated)	reverse trendelenburg		TRD (Deprecated)	trendelenburg
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Order.moodCode

The Order.moodCode is fixed to "RQO", which indicates we are referencing the actual order instance.

Table X: Fixed Order.moodCode

Code	Display Name
RQO	request
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Order.id

The Order.id is a unique identifier for the order that was fulfilled.

Order.code

The particular kind of order that the this instance represents within its class code. The optional Order.code is bound to the D:ActCode concept domain.

Order.priorityCode

The optional Order.priorityCode, identifies the priority requested when the order was placed. It is bound to the D:ActPriority concept domain.

5.2.3.4 Consent

Consent

Provides references to consents on file.

5.2.3.4.1 authorization

The optional authorization class is used to associate a ClinicalDocument to a Consent.

Table X: authorization Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	AUTH	Fixed

authorization.typeCode

Table X: Fixed authorization.typeCode

Code	Display Name
AUTH	authorized by
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.4.2 Consent

This class references the consents associated with this document.

Table X: Consent Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	CONS	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	D:ActCode	Open
statusCode	CS	[1..1]	completed	Fixed

Consent.classCode

The Consent.classCode is fixed to "CONS" to represent a consent. The Consent class represents informed consents and all similar medico-legal transactions between the patient (or his legal guardian) and the provider.

Table X: Fixed Consent.classCode

Code	Display Name
CONS	consent
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

Consent.moodCode

The Consent.moodCode is fixed to "EVN" (event) which indicates the consent has already been captured and is assumed to be on file.

Table X:Fixed Consent.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

Consent.id

Optional identifier for the consent.

Consent.code

The Consent.code is bound to the D:ActCode concept domain. It is used to optionally identify the type of consent (e.g. a consent to perform the related ServiceEvent, a consent for the information contained in the document to be released to a third party).

Consent.statusCode

Consents referenced in the CDA Header have been finalized (Consent.statusCode must equal "completed") and should be on file.

Table X: Fixed Consent.statusCode

Code	Display Name
completed	completed
Code System: ActStatus (HL7) Code System OID: 2.16.840.1.113883.5.14

5.2.3.5 EncompassingEncounter

EncompassingEncounter

This optional class represents the setting of the clinical encounter during which the documented act(s) or ServiceEvent occurred. Documents are not necessarily generated during an encounter, such as when a clinician, in response to an abnormal lab result, attempts to contact the patient but can't, and writes a Progress Note.

5.2.3.5.1 componentOf

The optional componentOf class is used to associate the ClinicalDocument to an EncompassingEncounter.

Table X: componentOf Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[0..1]	COMP	Fixed

componentOf.typeCode

The componentOf.typeCode is fixed to "COMP", which indicates that the ClinicalDocument was created within the context of an encounter (encompassingEncounter).

Table X: Fixed componentOf.typeCode

Code	Display Name
COMP	component
Code System: ActRelationshipType (HL7) Code System OID: 2.16.840.1.113883.5.1002

5.2.3.5.2 EncompassingEncounter

The EncompassingEncounter represents an interaction between a patient and care provider(s) for the purpose of providing healthcare-related service(s).

Table X: EncompassingEncounter Attributes

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	ENC	Fixed
moodCode	CS	[0..1]	EVN	Fixed
id	II	[0..*]
code	CD	[0..1]	V:ActEncounterCode	Open
effectiveTime	IVL<TS>	[0..1]
admissionReferralSourceCode	CE	[0..1]	D:EncounterReferralSourceCode	Open
dischargeDispositionCode	CE	[0..1]	D:EncounterDischargeDisposition	Open

EncompassingEncounter.classCode

The EncompassingEncounter.classCode is fixed to "ENC" to represent a encounter. The encounter class is used to represent an interaction between a patient and healthcare participant(s) for the purpose of providing patient service(s) or assessing the health status of a patient.

Table X: Fixed EncompassingEncounter.classCode

Code	Display Name
ENC	encounter
Code System: ActClass (HL7) Code System OID: 2.16.840.1.113883.5.6

EncompassingEncounter.moodCode

The EncompassingEncounter.moodCode is fixed to "EVN" (event) which indicates that the encounter is on-going or completed.

Table X: Fixed EncompassingEncounter.moodCode

Code	Display Name
EVN	event
Code System: ActMood (HL7) Code System OID: 2.16.840.1.113883.5.1001

EncompassingEncounter.id

The optional EncompassingEncounter.id can be used to uniquely identify the encounter.

EncompassingEncounter.code

The optional EncompassingEncounter.code is bound to the ActEncounterCode value set.

Table X: Value set for EncompassingEncounter.code

V:ActEncounterCode [2.16.840.1.113883.1.11.13955] (OPEN)
Code	Display Name		Code	Display Name
AMB	ambulatory		EMER	emergency
FLD	field		HH	home health
IMP	inpatient encounter		ACUTE	inpatient acute
NONAC	virtual		SS	short stay
VR	inpatient non-acute
Code System: ActCode (HL7) Code System OID: 2.16.840.1.113883.5.4

EncompassingEncounter.effectiveTime

For Encounters, the effectiveTime is the "administrative" time, i.e., the encounter start and end date as established by business rules. For inpatient encounters, the effectiveTime/low value is the admission date and time and the effectiveTime/high value is the discharge date and time. Note: If the encounter is still active at the time of document creation, the effectiveTime/high element can be omitted to indicate the encounter is on-going.

EncompassingEncounter.admissionReferralSourceCode

The optional EncompassingEncounter.admissionReferralSourceCode can be use to depict the type of place or organization responsible for the patient's care immediately prior to a patient encounter.

EncompassingEncounter.dischargeDispositionCode

The optional EncompassingEncounter.dischargeDispositionCode can be used to depict the disposition of the patient at the time of hospital discharge (e.g., discharged to home, expired, against medical advice, etc.).

5.2.3.5.3 location

The location participant (location class) relates a healthcare facility (HealthCareFacility class) to the encounter to indicate where the encounter took place.

Table X: location

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	LOC	Fixed

location.typeCode

Table X: Fixed participant.typeCode

Code	Display Name
LOC	location
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

5.2.3.5.4 HealthCareFacility

The HealthCareFacility class supports the identification of the service delivery location. The location may be the setting (place) with an optional organizational reference, or a reference to the healthcare organization.

Table X: HealthCareFacility

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
classCode	CS	[0..1]	SDLOC	Fixed
id	SET<II>	[0..*]
code	CE	[0..1]	V:ServiceDeliveryLocation	Open

HealthCareFacility.classCode

The HealthCareFacility.classCode is bound to the ServiceDeliveryLocation value set and defaulted to the "SDLOC" to indicate the service delivery location.

Table X: Value set for HealthCareFacility.classCode

v:RoleClassServiceDeliveryLocation [2.16.840.1.113883.1.11.16927] (CLOSED)
Code	Display Name		Code	Display Name
SDLOC (Default)	service delivery location		DSDLOC	dedicated service delivery location, health care facility
ISDLOC	incidental service delivery location
Code System: RoleClass (HL7) Code System OID: 2.16.840.1.113883.5.110

HealthCareFacility.id

An optional HealthCareFacility.id can be sent to uniquely identify the health care facility.

HealthCareFacility.code

The setting of an encounter (e.g. cardiology clinic, primary care clinic, rehabilitation hospital, skilled nursing facility) can be expressed in HealthCareFacility.code. A value set ServiceDeliveryLocationRoleType is provided for the this field.

Note: In some cases, the setting of the encounter is inherent in the ClinicalDocument.code, such as where ClinicalDocument.code is "Diabetes Clinic Progress Note". The setting of an encounter can also be transmitted in the HealthCareFacility.code attribute. If HealthCareFacility.code is sent, it should be equivalent to or further specialize the value inherent in the ClinicalDocument.code (such as where the ClinicalDocument.code is simply "Clinic Progress Note" and the value of HealthCareFacility.code is "cardiology clinic"), and shall not conflict with the value inherent in the ClinicalDocument.code, as such a conflict would constitute an ambiguous situation.

5.2.3.5.5 Place

The entity playing the role of HealthCareFacility is a place (Place class).

The setting (place) and physical location are not the same. There is a many-to-many relationship between setting and the physical location where care is delivered. Thus, a particular room can provide the setting for cardiology clinic one day, and for primary care clinic another day; and cardiology clinic today might be held in one physical location, but in another physical location tomorrow.

5.2.3.5.6 Organization

The entity scoping the HealthCareFacility role is an organization (Organization class). When the location is an organization, this is indicated by the presence of a scoping Organization, without a playing Place.

5.2.3.5.7 responsibleParty

The responsibleParty participant represents the participant having primary legal responsibility for the encounter. This differs from the legalAuthenticator participant in that the legalAuthenticator may or may not be the responsible party, and is serving a medical records function by signing off on the document, moving it into a completed state.

responsibleParty.typeCode

The responsibleParty.typeCode is fixed to "RESP" to indicate the responsible party i.e. The person or organization that has primary responsibility for the encounter. The responsible party is not necessarily present in an action, but is accountable for the action through the power to delegate, and the duty to review actions with the performing actor after the fact. This responsibility may be ethical, legal, contractual, fiscal, or fiduciary in nature.

Table X: Fixed responsibleParty.typeCode

Code	Display Name
RESP	responsible party
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

A responsibleParty is a person or organization in the role of an assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

When the responsible party is an organization, the value for AssignedEntity.classCode is "ASSIGNED", and the responsible party is reflected by the presence of a scoping Organization, without a playing entity.

5.2.3.5.8 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.5.9 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a Person class.

5.2.3.5.10 Organization

The entity scoping the role is an organization (Organization class).

5.2.3.5.11 encounterParticipant

The encounterParticipant participant represents clinicians directly associated with the encounter (e.g. by initiating, terminating, or overseeing it).

Table X: performer

Attribute Name	Data Type	Wire Cardinality	Code Binding	Binding Type
typeCode	CS	[1..1]	V:x_EncounterParticipant	Closed
time	TS	[0..1]

encounterParticipant.typeCode

The encounterParticipant typeCode is bound to the x_EncounterParticipant value set. It supports for the following participation: admitter, attender, consultant, discharger, and referrer.

Table X: Value set for encounterParticipant.typeCode

V:x_EncounterParticipant [2.16.840.1.113883.1.11.19600] (CLOSED)
Code	Display Name		Code	Display Name
ADM	admitter		ATND	attender
CON	consultant		DIS	discharger
REF
Code System: ParticipationType (HL7) Code System OID: 2.16.840.1.113883.5.90

encounterParticipant.time

An encounterParticipant is an entity in the role of assigned entity (AssignedEntity class). An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a person (Person class). The entity scoping the role is an organization (Organization class).

5.2.3.5.12 AssignedEntity

A performer is an entity in the role of assigned entity (AssignedEntity class).

5.2.3.5.13 Person

An assigned entity is a person assigned to the role by the scoping organization. The entity playing the role is a Person class.

5.2.3.5.14 Organization

The entity scoping the role is an organization (Organization class).

5.3 Body

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5.4 CDA Context

CDA context is set in the CDA header and applies to the entire document. Context can be overridden at the level of the body, section, and/or CDA entry.

5.4.1 Overview of CDA Context

A document, in a sense, is a contextual wrapper for its contents. Assertions in the document header are typically applicable to statements made in the body of the document, unless overridden. For instance, the patient identified in the header is assumed to be the subject of observations described in the body of the document, unless a different subject is explicitly stated, or the author identified in the header is assumed to be the author of the entire document, unless a different author is explicitly identified on a section. The objective of the CDA context rules are to make these practices explicit with relationship to the RIM, such that a computer will understand the context of a portion of a document the same way that a human interprets it.

At the same time, there is no guarantee that machine processing will identify a mistaken application of contextual rules. If a physician records an "outside diagnosis" in narrative but does not nullify the "informant" context, machine processing will not identify the switch in attribution. This is a special case illustrating the limits of automated validation of electronic records and would apply regardless of the context inheritance mechanism. In other words, from some errors of encoding, there is no recovery other than human review.

CDA's approach to context, and the propagation of that context to nested document components, follows these design principles:

• CDA uses the RIM context mechanism (contextControlCode for Participations; contextConductionInd for ActRelationships), and assigns fixed values to these attributes to accomplish the design objectives below, thus constraining the RIM context model. CDA extends the context propagation property to designated attributes of the CDA Header, which also propagate through any ActRelationship for which contextConductionInd="true".
• The CDA Header sets context for the entire document. A propagating value specified in the document header holds true throughout the document, unless explicitly overridden. This principal applies to both Participations and to designated attributes of the CDA Header. Contextual header components (i.e., those that have propagating values) include:
  • Author
  • Confidentiality
  • Data enterer
  • Human language
  • Informant
  • Legal authenticator
  • Participant
  • Record target
• Context components that can be overridden at the level of the document body include:
  • Confidentiality
  • Human language
• Context components that can be overridden at the level of a document section include:
  • Author
  • Confidentiality
  • Human language
  • Informant
  • Subject
• Context components that can be overridden at the level of a CDA entry include:
  • Author
  • Human language
  • Informant
  • Participant
  • Subject
• Context propagates from outer tags to nested tags. Context that is specified on an outer tag holds true for all nested tags, unless overridden on a nested tag. Context specified on a tag within the CDA body always overrides context propagated from an outer tag. For instance, the specification of authorship at a document section level overrides all authorship propagated from outer tags.
• Context is sometimes known precisely, and is sometimes unknown, such as in the case where a document is comprised of a large unparsed narrative block that potentially includes statements that contradict outer context. Because CDA context always propagates unless overridden, the representation of unknown context is achieved by overriding with a null value.

5.4.2 Technical Aspects of CDA Context

The RIM defines the "context" of an act as those participants of the act that can be propagated to nested acts. In the RIM, whether or not contextual participants do propagate to nested acts depends on whether or not the intervening act relationship between parent and child act allows for conduction of context. The explicit representation of context, and whether or not the context on an act can propagate to nested acts, is expressed via the RIM attributes Participation.contextControlCode and ActRelationship.contextConductionInd. CDA constrains the general RIM context mechanism such that context always overrides and propagates, as shown in the following table.

Table X: CDA constraints on RIM context attributes

RIM attribute	Cardinality	Conformance	Fixed Value
Participation.contextControlCode	1..1	Mandatory (NULL values not permitted)	"OP" (overriding, propagating)
ActRelationship.contextConductionInd	1..1	Mandatory (NULL values not permitted)	"true"*

*The one exception to this is entryRelationship.contextConductionInd, which is defaulted to "true", but can be changed to "false". See entryRelationship for details.

Where the context of a nested component is unknown, the propagated context must be overridden with a null-valued component, as shown in the following table.

Table X: Blocking context propagation with null values

Context	Null value representation
Author	AssignedAuthor.id = NULL; No playing entity; No scoping entity.
Confidentiality	confidentialityCode = NULL.
Human language	languageCode = NULL.
Informant	AssignedEntity.id = NULL; No playing entity; No scoping entity.
Participant	ParticipantRole.id = NULL; No playing entity; No scoping entity.

The following exhibit illustrates the CDA context model. ClinicalDocument has an author participant, a confidentialityCode, and a languageCode, all of which will propagate to nested acts. The component act relationship going from ClinicalDocument to bodyChoice has contextConductionInd fixed as "true", thus allowing for the propagation of context. The bodyChoice classes, NonXMLBody and StructuredBody, contain a confidentialityCode and languageCode which can be used to override the value specified in the header. The component act relationship going from StructuredBody to Section has contextConductionInd fixed at "true", thus the context on StructuredBody will propagate through to Section. Section can override confidentialityCode, languageCode, and author. A null value for the Section's author participant indicates that the author for that particular section is unknown.

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Because context is always overriding and propagating, one can compute the context of a given node by looking for the most proximate assertion. The following example is a sample XPath expression that can be used to identify the <author> context of a section or entry:

Example X

(ancestor-or-self::*/author)[position()=last()]

5.4.3 InfrastructureRoot & CDA Classes

All of CDA classes inherits 1 attribute and 3 element from InfrastructureRoot. Infrastructure Root provides a set of infrastructure attributes that may be used in instances of HL7-specified, RIM-based classes. When valued in an instance, these attributes indicate whether the information structure is being constrained by specifically defined templates, realms or common element types.

• An optional nullFlavor attribute has been added to each CDA class. When the class is null, this code can be used to indicate the flavor of null that is intended.

The following 3 optional elements have been added at the beginning of each CDA class:

• realmCode, is vocabulary domain qualifier that allows the vocabulary domain of coded attributes to be specialized according to the geographical, organizational, or political environment where the HL7 standard is being used. It is defined as a SET<CS>data type.
• typeId, is a unique identifier for an HL7 static structure that imposes constraints on an artifact. In CDA it must be defined at the root element, to indicate a CDA R2.1 document,with ClinicalDocument.typeId.root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models); ClinicalDocument.typeId.extension = "POCD_HD000040UV" (which is the unique identifier for the CDA, Release Two Hierarchical Description). As CMETs are not used in CDA, this element will not be used in other classes. It is defined as a II data type.
• templateId, is an optional unique identifier, which indicates to a receiver that a set of constraints have been defined for a given class and it's attributes. See section 4 on templates in CDA.

6 CDA Hierarchical Description

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7 CDA XML Implementation

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8 Appendix

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