2 CCR Header Representation
The CCR Header defines the document parameters, including its unique identifier, language, version, date/time, the patient whose data it contains, who or what has generated the CCR, to whom or what the CCR is directed, and the CCR’s purpose.
The following figure shows a subset of the CDA R2 Header model containing those classes being constrained or referred to in the conformance statements that follow.
2.1 CCR Unique Identifier
Represents a unique identifier for the current CCR instance. Corresponds to the ClinicalDocument / id in CDA R2. Required in both CCR and CDA. In addition, CDA R2 provides a ClinicalDocument / code, whose value is fixed by this specification
2.2 Language
No controlled vocabulary has been specified for Language in the CCR data set, whereas in CDA R2, the language is represented by a coded value using RFC-3066. Language is required in CCR, whereas it is optional in CDA R2.
CONF-5: CCD SHALL contain exactly one ClinicalDocument / languageCode.
CONF-6: ClinicalDocument / languageCode SHALL be in the form nn, or nn-CC. The nn portion SHALL be an ISO-639-1 language code in lower case. The CC portion, if present, SHALL be an ISO-3166 country code in upper case.
2.3 Version
Represents the version of the implementation guide used to create a given instance. In CDA, ClinicalDocument / templateId performs the same function, as described above in section 1.4 Asserting conformance to this Implementation Guide.
CONF-7: CCD SHALL contain one or more ClinicalDocument / templateId.
CONF-8: At least one ClinicalDocument / templateId SHALL value ClinicalDocument / templateId / @root with “2.16.840.1.113883.10.20.1”, and SHALL NOT contain ClinicalDocument / templateId / @extension.
2.4 CCR Creation Date/Time
Represents the exact clock time that the summarization was created, corresponding to the CDA R2 ClinicalDocument / effectiveTime. CCR further requires that the time be precise to the second, and must express a time zone offset.
CONF-9: ClinicalDocument / effectiveTimeSHALL be expressed with precision to include seconds.
CONF-10: ClinicalDocument / effectiveTimeSHALL include an explicit time zone offset.
2.5 Patient
Represents the patient to which the summarization refers. Corresponds to CDA R2 ClinicalDocument / recordTarget. CCR can only be about one patient with the extreme exception of conjoined twins.
CONF-11: CCD SHALL contain one to two ClinicalDocument / recordTarget.
2.6 From
Identifies who or what has generated the summarization, corresponding to CDA’s author paricipant. CDA R2 requires an author (which may be a person or a device), and stipulates that a completed document has been legally authenticated. CDA R2 also requires that a clinical document have a defined custodian. Where a CCD document is generated by a machine, legal authentication is represented as the organization responsible for generating the data.
CDA R2 author participant has a required participant time, which should be set to equal the ClinicalDocument / effectiveTime, and thus map back to CCR’s creation date/time.
CONF-12: CCD SHALL contain one or more ClinicalDocument / author / assignedAuthor / assignedPerson and/or ClinicalDocument / author / assignedAuthor / representedOrganization.
2.7 To
Represents to whom or what the summarization is targeted. Corresponds to the CDA R2 ClinicalDocument / informationRecipient participant. This is optional in both CCR and CDA.
CONF-14: CCD MAY contain one or more ClinicalDocument / informationRecipient.
2.8 Purpose
Represents the specific reason for which the summarization was generated, such as in response to a request.
The general use case does not require a purpose. Purpose should be utilized when the CCD has a specific purpose such as a transfer, referral, or patient request.
NOTE: Purpose is represented as a document body section in CCD. The template identifier for the Purpose section is 2.16.840.1.113883.10.20.1.13.
CONF-15: CCD MAY contain exactly one and SHALL NOT contain more than one Purpose section (templateId 2.16.840.1.113883.10.20.1.13). The Purpose section SHALL contain a narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD include one or more purpose activities (templateId 2.16.840.1.113883.10.20.1.30).
2.8.1 Section conformance
CONF-16: The purpose section SHALL contain Section / code.
CONF-17: The value for “Section / code” SHALL be “48764-5” “Summary purpose” 2.16.840.1.113883.6.1 LOINC STATIC.
CONF-18: The purpose section SHALL contain Section / title.
CONF-19: Section / titleSHOULD be valued with a case-insensitive language-insensitive text string containing “purpose”.
2.8.2 Clinical statement conformance
The following figure shows a subset of the CDA Clinical Statement model containing those classes being constrained or referred to in the conformance statements that follow.
2.8.2.1 Purpose activity
The template identifier for a purpose activity is 2.16.840.1.113883.10.20.1.30.
CCD represents the ASTM CCR <Purpose> object as a relationship between two classes – the source represents the act of creating a summary document, the target is the reason for creating the document, and the relationship type is “RSON” (has reason). The target act may be an Observation, Procedure, or some other kind of act, and it may represent an order, an event, etc.
CONF-20: A purpose activity (templateId 2.16.840.1.113883.10.20.1.30) SHALL be represented with Act.
CONF-21: The value for “Act / @classCode” in a purpose activity SHALL be “ACT” 2.16.840.1.113883.5.6 ActClass STATIC.
CONF-22: The value for “Act / @moodCode” in a purpose activity SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-23: A purpose activity SHALL contain exactly one Act / statusCode.
CONF-24: The value for “Act / statusCode” in a purpose activity SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC.
CONF-25: A purpose activity SHALL contain exactly one Act / code, with a value of “23745001” “Documentation procedure” 2.16.840.1.113883.6.96 SNOMED CT STATIC.
CONF-26: A purpose activity SHALL contain exactly one Act / entryRelationship / @typeCode, with a value of “RSON” “Has reason” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC, to indicate the reason or purpose for creating the CCD.
CONF-27: The target of Act / entryRelationship / @typeCode in a purpose activity SHALL be an Act, Encounter, Observation, Procedure, SubstanceAdministration, or Supply.
2.9 ASTM CCR Header Mapping
The following table is the CCR Header subset of ASTM CCR Table A1.1 “CCR Data Fields Spreadsheet”.
Table 1. CCR Header mapping to CDA R2CCR Data Object | CCR XML Element | CCR Required or Optional | CDA R2 Correspondence | Mapping Comments |
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CCR Header Objects |
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| /ccr:ContinuityOfCareRecord/ | | /ClniicalDocument/ | |
CCR Unique Identifier | ccr:CCRDocumentObjectID | Required | id | See section 5.4.5 Identifiers for more details. |
Language | ccr:Language | Required | languageCode | |
Version | ccr:Version | Required | templateId | |
CCR Creation Date/Time | ccr:DateTime | Required | effectiveTime | |
Patient | ccr:Patient | Required | recordTarget | |
From | ccr:From | Required | author | |
To | ccr:To | Optional | informationRecipient | |
Purpose | ccr:Purpose | Optional | Act / entryRelationship [@typeCode = “RSON”] / | Represented as a document body section in CCD |
| ccr:DateTime | Optional | Act / effectiveTime | |
| ccr:Description | Required | Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] | |
| ccr:OrderRequest | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] | |
| ccr:Indications | Optional | Act / entryRelationship [@typeCode = “RSON”] / [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
3 CCR Body Representation
The CCR Body contains the core patient-specific data, such as current and past medications, problems, and procedures. Data are aggregated into sections based on common clinical conventions.
In a typical scenario, the body is dynamically created by pulling in existing data from a variety of sources, and no new content is specifically created for the summary. In some cases the source data will be narrative; in other cases there may be coded data supporting some aspects of the narrative; and in some cases the source data will be fully coded. Where the body is dynamically created by pulling in existing data, the originating application creating the Continuity of Care Document can create (narrative, partially coded, or fully coded) entries corresponding to the source data, and then algorithmically construct each CDA Narrative Block (ClinicalDocument / component / structuredBody / component / section / text). In such a situation, the entry relationship "DRIV" (is derived from) (ClinicalDocument / component / structuredBody / component / section / entry / @typeCode=”DRIV”) can be used, to indicate that the CDA Narrative Block is fully derived from the (coded and/or non-coded) entries, and that the narrative contains no clinical content not derived from the entries.
CONF-28: The value for “ClinicalDocument / component / structuredBody / component / section / entry / @typeCode” MAY be “DRIV” “is derived from” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC, to indicate that the CDA Narrative Block is fully derived from the structured entries.
CDA provides a mechanism to explicitly reference from an entry to the corresponding narrative, as illustrated in the following example (see CDA Release 2, section 4.3.5.1 <content> for details):
<section> <code/> <title/> <text> <content ID="Blob1">...procedure/code original text...</content> <content ID="Blob2">...act/text uncoded text blob...</content> </text> <entry> <procedure> <code code="12345" codeSystem="2.16.840.1.113883.19.1"/> <originalText><reference value="#Blob1"/></originalText> </code> </procedure> </entry> <entry> <act> <text><reference value="#Blob2"/></text> </act> </entry> </section>
CCD recommends the use of these references to facilitate translation of CCD into ASTM’s XML CCR format.
CONF-29: A CCD entry SHOULD explicitly reference its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1 <content>).
....
3.1 Payers
....
3.2 Advance Directives
....
3.3 Support
....
3.4 Functional Status
....
3.5 Problems
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3.6 Family History
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3.7 Social History
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3.8 Alerts
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3.9 Medications
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3.10 Medical Equipment
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3.11 Immunizations
....
3.12 Vital Signs
....
3.13 Results
....
3.14 Procedures
....
3.15 Encounters
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3.16 Plan of Care
....
3.17 Healthcare Providers
Represents the healthcare providers involved in the current or pertinent historical care of the patient. At a minimum, the patient’s key healthcare providers should be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors.
As noted above in section 2.1 CCR Unique Identifier, and illustrated in Figure 3 Subset of CDA R2 Header, the CDA R2 Header contains a ServiceEvent class which is to be used to indicate the time range being summarized. The main activity being described by the CCD is the provision of healthcare over a period of time. Relevant care providers during the summarization period are represented as ClinicalDocument / documentationOf / serviceEvent / performer, where performer / time is used to show the specific time period that the particular provider was involved in the patient’s care.
The CDA R2 Header contains additional participants, such as ClinicalDocument / author and ClinicalDocument / informationRecipient. 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 an author and a performer, the CDA Header should identify that person as both the author participant and as the serviceEvent / performer participant.
NOTE: CCR Healthcare Providers are not represented as a CCD Body section, but rather, are represented as performer participants in the CCD Header.
CONF-492: The value for “ClinicalDocument / documentationOf / serviceEvent / performer / @typeCodeSHALL be “PRF” “Participation physical performer” 2.16.840.1.113883.5.90 ParticipationType STATIC.
CONF-493: A value for “ClinicalDocument / documentationOf / serviceEvent / performer / assignedEntity / id” MAY be the HIPAA National Provider Identifier.
CONF-494: A value for “ClinicalDocument / documentationOf / serviceEvent / performer / assignedEntity / code” MAY be the National Uniform Claims Committee Provider Taxonomy Code.
3.18 ASTM CCR Body Mapping
The following table is the CCR Body subset of ASTM CCR Table A1.1 “CCR Data Fields Spreadsheet”.
Table 3. CCR Body mapping to CDA R2CCR Data Object | CCR XML Element | CCR Required or Optional | CDA R2 Correspondence | Mapping Comments |
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CCR Body Objects |
Payers | ccr:Payer | Required | Act | |
| ccr:CCRDataObjectID | Required | Act / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Act / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:Type | Optional | Act / code | |
| ccr:PaymentProvider | ccr:ActorID is Required; ccr:ActorRole is Optional | Act / performer [@typeCode=”PRF”] | |
| ccr:Subscriber | ccr:ActorID is Required; ccr:ActorRole is Optional | Act / participant [@typeCode=”COV”]; Act / participant [@typeCode=”HLD”] | |
| ccr:Authorizations | Optional | Act | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Advance Directives | ccr:AdvanceDirective | Required if known | Observation | |
| ccr:CCRDataObjectID | Required if known | Observation / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Observation / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Observation / id; Role / id | |
| ccr:Type | Required | Observation / code | |
| ccr:Description | Required | Observation / value | |
| ccr:Status | Required | Observation / value | See section 3.2.2.2 Representation of “status” values for more details. |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Support | ccr:SupportProvider | Optional | ClinicalDocument / recordTarget / patientRole / patient / guardian ; ClinicalDocument / participant | |
Functional Status | ccr:Function | Optional | Observation; Act | |
| ccr:CCRDataObjectID | Required | Observation / id; Act / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Observation / effectiveTime; Act / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:Type | Required | Observation / code | |
| ccr:Description | Optional | Act | |
| ccr:Status | Required | Observation / value | See section 3.4.2.1 Representation of “status” values for more details. |
| ccr:Problem | Optional | See section 3.5 Problems. | |
| ccr:Test | Optional | See section 3.13 Results. | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Problems | ccr:Problem | Optional | Act | See section 3.5.2.1 Representation of problems for more details. |
| ccr:CCRDataObjectID | Required | Act / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Act / effectiveTime; Observation / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | ParticipantRole / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | Observation / value | |
| ccr:Status | Optional | Observation / value | See section 3.5.2.2 Representation of “status” values for more details. |
| ccr:Episodes | Optional | Observation / reference / @typeCode=”ELNK” / ExternalObservation; Act / reference / @typeCode=”ELNK” / ExternalAct | |
| ccr:HealthStatus | Optional | Observation / value | See section 3.5.2.2 Representation of “status” values for more details. |
| ccr:PatientKnowledge | Optional | Observation / participation / awarenessCode; Act / participation / awarenessCode | See section 3.5.2.4 Patient awareness of a problem for more details. |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Family History | ccr:FamilyProblemHistory | Optional | Observation | See section 3.6.2.1 Family history representation for more details. |
| ccr:CCRDataObjectID | Required | Observation / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Observation / effectiveTime; RelatedSubject / subject / birthTime; RelatedSubject / subject / deceasedTime | See section 3.6.2.4 Representation of age for more details. See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | RelatedSubject / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | Observation / value | |
| ccr:Status | Optional | Observation / value | See section 3.5.2.2 Representation of “status” values for more details. |
| ccr:Problem | Optional | See section 3.5 Problems. | |
| ccr:FamilyMember | Optional | subject / RelatedSubject | See section 3.6.2.3 Family history participants for more details. |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Social History | ccr:SocialHistoryElement | Optional | Observation | |
| ccr:CCRDataObjectID | Required | Observation / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Observation / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Observation / id; Role / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | Observation / value | |
| ccr:Status | Optional | Observation / value | See section 3.5.2.2 Representation of “status” values for more details. |
| ccr:Episodes | Optional | Observation | See section 3.7.2.3 Episode observations for more details. |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Alerts | ccr:Alert | Optional | Act | |
| ccr:CCRDataObjectID | Required | Act / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Act / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Act / id; Role / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | Observation / code; Observation / value | |
| ccr:Status | Optional | Observation / value | See section 3.8.2.2 Representation of “status” values for more details. |
| ccr:Agent | Optional. <Unknown> is required content. | Observation / participant [@typeCode=”CSM”] / participantRole / playingEntity | |
| ccr:Reaction | Optional | Observation / entryRelationship [@typeCode=”MFST”] / Observation | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Medications | ccr:Medication | Optional | SubstanceAdministration | |
| ccr:CCRDataObjectID | Required | SubstanceAdministration / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | SubstanceAdministration / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Act / id; Role / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | Section / text | |
| ccr:Status | Optional | Observation / value | See section 3.9.2.3 Representation of “status” values for more details. |
| ccr:Product | Required | ManufacturedProduct / material | |
| ccr:ProductName | Required | ManufacturedProduct / material / code / originalText | |
| ccr:BrandName | Optional | ManufacturedProduct / material / name | |
| ccr:Strength | Optional | ManufacturedProduct / material / code | |
| ccr:Form | Optional | ManufacturedProduct / material / code | |
| ccr:Concentration | Optional | ManufacturedProduct / material / code | |
| ccr:Size | Optional | ManufacturedProduct / id | See section 3.9.2.4 Representation of a product for more details. |
| ccr:Manufacturer | Optional | ManufacturedProduct / manufacturerOrganization | |
| ccr:IDs | Optional | ManufacturedProduct / id | |
| ccr:Quantity | Optional | Supply / quantity | |
| ccr:Directions | Optional | Section / text | |
| ccr:DoseIndicator | Optional | Section / entry / @typeCode | The “DRIV” relationship indicates that narrative is derived from the component entries. |
| ccr:DeliveryMethod | Optional | SubstanceAdministration / routeCode | |
| ccr:Dose | Optional | SubstanceAdministration / doseQuantity | |
| ccr:DoseCalculation | Optional | SubstanceAdministration / doseQuantity; SubstanceAdministration / rateQuantity | |
| ccr:Vehicle | Optional | SubstanceAdministration / entryRelationship [@typeCode = “COMP”] / SubstanceAdministration | For example, a 313 mg vial of lyophilized hematin can be reconstituted with 132 mL of 25% human serum albumin (which is the vehicle), resulting in a hemin concentration of 2.4 mg/mL.: - SubstanceAdministration (hematin in albumin)
- / component / SubstanceAdministration (hematin)
- / component / SubstanceAdministration (albumin)
|
| ccr:Route | Optional | SubstanceAdministration / routeCode | |
| ccr:Site | Optional | SubstanceAdministration / approachSiteCode | |
| ccr:AdministrationTiming | Optional | SubstanceAdministration / effectiveTime | |
| ccr:Frequency | Optional | SubstanceAdministration / effectiveTime | |
| ccr:Interval | Optional | SubstanceAdministration / effectiveTime | |
| ccr:Duration | Optional | SubstanceAdministration / effectiveTime | |
| ccr:DoseRestriction | Optional | SubstanceAdministration / maxDoseQuantity | |
| ccr:Indication | Optional | SubstanceAdministration / precondition / criterion; Observation | See section 3.9.2.2 Medication related information for more details. |
| ccr:StopIndicator | Optional | SubstanceAdministration / effectiveTime | |
| ccr:DirectionSequencePosition | Optional | SubstanceAdministration | Each direction in CCD is a distinct SubstanceAdministration. |
| ccr:MultipleDirectionModifier | Optional | Section / text | Complex directions in CCD are expressed as free text. |
| ccr:PatientInstructions | Optional | Observation | See section 3.9.2.2 Medication related information for more details. |
| ccr:FulfillmentInstructions | Optional | Observation | See section 3.9.2.2 Medication related information for more details. |
| ccr:Refill | Optional | Supply / repeatNumber | |
| ccr:SeriesNumber | Optional | Observation | See section 3.9.2.2 Medication related information for more details. |
| ccr:Consent | Optional | ClinicalDocument / authorization / consent | |
| ccr:Reaction | Optional | Observation | See section 3.9.2.2 Medication related information for more details. |
| ccr:FulfillmentHistory | Optional | Supply | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Medical Equipment | ccr:Equipment | Optional | Supply | |
Immunizations | ccr:Immunization | Optional | SubstanceAdministration | |
Vital Signs | ccr:Result | Optional | Organizer | |
Results | ccr:Result | Optional | Organizer | |
| ccr:CCRDataObjectID | Required | Organizer / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Organizer / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Organizer / id; Role / id | |
| ccr:Type | Required | Organizer / code | |
| ccr:Description | Optional | Organizer / code | |
| ccr:Procedure | Optional | Organizer / component / procedure | |
| ccr:Substance | Optional | Organizer / specimen | |
| ccr:Test | Optional | Observation | |
| ccr:DateTime | Optional | Observation / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Observation / id; Role / id | |
| ccr:Type | Required | Observation / code | |
| ccr:Description | Optional | Observation / code | |
| ccr:Status | Optional | Observation / statusCode | |
| ccr:Method | Optional | Observation / methodCode | |
| ccr:Agent | Optional | Observation / participant | |
| ccr:TestResult | Required | Observation / value | |
| ccr:NormalResult | Optional | Observation / referenceRange | |
| ccr:Flag | Optional | Observation / interpretationCode | |
| ccr:ConfidenceValue | Optional | Observation / value | HL7 Version 3 datatypes UVP (uncertain value, probabilistic), NPPD (non-parametric probability distribution), and PPD (parametric probability distribution) can be used to express confidence in an observation value. |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Procedures | ccr:Procedure | Optional | Procedure | |
| ccr:CCRDataObjectID | Required | Procedure / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Procedure / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Procedure / id; role / id | |
| ccr:Type | Optional | Procedure / code | |
| ccr:Description | Optional | Procedure / code | |
| ccr:Status | Optional | Procedure / statusCode | |
| ccr:Location | Optional | Procedure / participant [@typeCode=”LOC”] | |
| ccr:Practitioner | Optional | Procedure / performer | |
| ccr:Frequency | Optional | Observation | CDA R2 Procedure / effectiveTime is IVL_TS data type, so can’t represent frequency. A nested frequency observation can be used. |
| ccr:Duration | Optional | Procedure / effectiveTime | |
| ccr:Indication | Optional | Procedure / entryRelationship [@typeCode=”RSON”] | |
| ccr:Product | Optional | Participant / participantRole [@typeCode=”DEV”] | |
| ccr:Substance | Optional | Procedure / entryRelationship / substanceAdministration | |
| ccr:Method | Optional | Procedure / methodCode | |
| ccr:Position | Optional | Procedure / methodCode | |
| ccr:Site | Optional | Procedure / targetSiteCode | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Encounters | ccr:Encounter | Optional | Encounter | |
| ccr:CCRDataObjectID | Required | Encounter / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | Encounter / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | Encounter / id | |
| ccr:Type | Optional | Encounter / code | |
| ccr:Description | Required | Encounter / code | |
| ccr:Location | Optional | Encounter / participant [@typeCode=”LOC”] | |
| ccr:Practitioner | Optional | Encounter / performer | |
| ccr:Frequency | Optional | Observation | CDA R2 Encounter / effectiveTime is IVL_TS data type, so can’t represent frequency. A nested frequency observation can be used. |
| ccr:Duration | Optional | Encounter / effectiveTime | |
| ccr:Indication | Optional | Observation | |
| ccr:Instructions | Optional | Encounter / entryRelationship [@typeCode=”SUBJ”] / Act [@classCode=”ACT”] | |
| ccr:Consent | Optional | ClinicalDocument / authorization / consent | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Plan of Care | ccr:Plan | Optional | Act; Encounter; Observation; Procedure; SubstanceAdministration; Supply | |
| ccr:CCRDataObjectID | Required | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / id | See section 5.4.5 Identifiers for more details. |
| ccr:DateTime | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / id; Role / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / code | |
| ccr:Status | Optional | Observation / statusCode | |
| ccr:OrderRequest | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / code | |
| ccr:DateTime | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:IDs | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / id; Role / id | |
| ccr:Type | Optional | Observation / code | |
| ccr:Description | Optional | [Act | Encounter | Observation | Procedure | SubstanceAdministration | Supply] / code | |
| ccr:Status | Optional | Observation / statusCode | |
| ccr:Procedure | Optional | Act; Observation; Procedure | |
| ccr:Product | Optional | Supply | |
| ccr:Medication | Optional | SubstanceAdministration | |
| ccr:Immunization | Optional | SubstanceAdministration | |
| ccr:Service | Optional | Act | |
| ccr:Encounter | Optional | Encounter | |
| ccr:Authorization | Optional | Act | |
| ccr:Goals | Optional | Observation / @moodCode = GOL | |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
Healthcare Providers | ccr:Providers | Optional | ClinicalDocument / documentOf / serviceEvent / performer | |
4 CCR Footer Representation
The CCR Footer contains data defining all of the actors, as well as information about external references, all text comments, and signatures associated with any data within the CCR.
4.1 Actors
Used as a container to define all of the individuals, organizations, locations, and systems associated with data in the summary document. Within the CCR data set, an Actor is a <Person>, <Organization> or <Device>. These correspond to the HL7 RIM Entity classes: LivingSubject, Person, Organization or Device, and are mapped accordingly to these classes as exposed in a CDA document. Whereas ASTM CCR enumerates all Actors in the CCR Footer and references those Actors from within the CCR Body with the <ActorLink> element, CCD defines many participants within the document header and body.
Actor roles are constructed in the CCR by relating an Actor to an element in the CCR via the <ActorLink> element. This element indicates the entity (person, organization or device) by reference in the <ActorID> element, and the role in the <ActorRole> element. Within CDA R2, the role typically includes the entity by value, not by reference. However, appropriate construction of a CDA document, and application of the Care Record Summary extensions, will allow use of entities by reference as follows:
CONF-495: Each actor SHALL appear in the appropriate section of the CDA at least once with all information fully specified, and SHOULD include an entity identifier.
CONF-496: Other references to the same entity (a person or organization) in the same or different role NEED NOT fully specify the actor information, provided they include the same entity identifier.
CONF-497: There SHALL be a one-to-one relationship between entity identifiers in a CDA and ActorID as represented in the CCR data set.
Table 4. CCR <ActorLink> correspondence to CDACCR data element | CDA R2 correspondence | Comments |
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ccr:ActorLink | | |
ccr:ActorID | Role / Entity / id | There is a one to one relationship between ActorID and Entity / id, although the values need not be equivalent. |
ccr:ActorRole | Role / code | |
ccr:Text | Role / code / originalText | |
ccr:Code | Role / code / @code ; Role / code / @codeSystem | |
4.2 References
Used to list the details concerning references to external data sources. Corresponds to the CDA R2 <reference> element. Whereas ASTM CCR enumerates all references in the CCR Footer, CCD defines the reference within the section where it occurs.
CONF-498: A clinical statement in a CCD section MAY contain one or more Observation / reference / externalDocument, to represent externally an externally referenced document.
CONF-499: An externally referenced document MAY contain exactly one Observation / reference / ExternalDocument / text / reference, to indicate the URL of the referenced document. A <linkHTML> element containing the same URL SHOULD be present in the associated CDA Narrative Block.
CONF-500: An externally referenced document MAY contain exactly one Observation / reference / ExternalDocument / text / @mediaType, to indicate the MIME type of the referenced document.
CONF-501: Where the value of Observation / reference / seperatableInd is “false”, the referenced document SHOULD be included in the CCD exchange package. The exchange mechanism SHOULD be based on Internet standard RFC 2557 “MIME Encapsulation of Aggregate Documents, such as HTML (MHTML)” (http://www.ietf.org/rfc/rfc2557.txt). (See CDA Release 2, section 3 “CDA Document Exchange in HL7 Messages” for examples and additional details).
4.3 Comments
The template identifier for a comment is 2.16.840.1.113883.10.20.1.40.
Used to contain comments associated with any of the data within the document. Whereas ASTM CCR enumerates all comments in the CCR Footer, CCD defines the comments within the section where they occur. CDA R2 represents comments as Acts.
CONF-502: A CCD section MAY contain one or more comments, either as a clinical statement or nested under another clinical statement.
CONF-503: A comment (templateId 2.16.840.1.113883.10.20.1.40) SHALL be represented with Act.
CONF-504: The value for “Act / @classCode” in a comment SHALL be “ACT” 2.16.840.1.113883.5.6 ActClass STATIC.
CONF-505: The value for “Act / @moodCode” in a comment SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-506: A comment SHALL contain exactly one Act / code.
CONF-507: The value for “Act / code” in a comment SHALL be 48767-8 “Annotation comment” 2.16.840.1.113883.6.1 LOINC STATIC.
4.4 Signatures
Used by ASTM CCR as a container for all signatures associated with any data in the summary document.
While electronic signatures are not captured in a CDA document, 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.
Application systems sending and receiving CDA documents are responsible for meeting all legal requirements for document authentication, confidentiality, and retention. For communications over public media, cryptographic techniques for source/recipient authentication and secure transport of encapsulated documents may be required, and should be addressed with commercially available tools outside the scope of the CDA specification.
4.5 ASTM CCR Footer Mapping
The following table is the CCR Footer subset of ASTM CCR Table A1.1 “CCR Data Fields Spreadsheet”.
Table 5. CCR Footer mapping to CDA R2CCR Data Object | CCR XML Element | CCR Required or Optional | CDA R2 Correspondence | Mapping Comments |
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CCR Footer Objects |
Actors | ccr:Actor | Required | A participating entity (e.g. Person, Organization, Device) | |
| ccr:ActorObjectID | Required | Entity / id | |
| ccr:Person | Optional | Person | |
| ccr:Name | Optional | See section 5.4.2 Names. | |
| ccr:BirthName | Optional | See section 5.4.2 Names. | |
| ccr:AdditionalName | Optional | See section 5.4.2 Names. | |
| ccr:CurrentName | Optional | See section 5.4.2 Names. | |
| ccr:DisplayName | Optional | See section 5.4.2 Names. | |
| ccr:DateOfBirth | Optional | Patient / birthTime; subject / relatedSubject / subject / birthTime | HL7: Date of Birth is only present for the patient or subject. It is not used elsewhere in the CDA. |
| ccr:Gender | Optional | Patient / administrativeGenderCode; subject / administrativeGenderCode | ASTM: Value set limited to Male, Female, Other and Unknown. HL7: Gender is only present for the patient or subject. It is not used elsewhere in the CDA. HL7 AdministrativeGender vocabulary covers Male, Female and Undifferentiated. |
| ccr:Organization | Optional | assignedAuthor / representedOrganization; assignedEntity / representedOrganization; intendedRecipient / recievedOrganization; associatedEntity / scopingOrganization | |
| ccr:InformationSystem | Optional | assignedAuthoringDevice; playingDevice | |
| ccr:IDs | Optional | Entity / id; Role / id | HL7: Entities and Roles can have identifiers. Role identifiers are related to a specific role, but entities may participate in more than one role (and thus have more than one identifier). However, CDA Release 2.0 does not usually allow for Persons to have identifiers. CCD provides an extension that would allow recording of an arbitrary identifier for a person. |
| ccr:Relation | Optional | sdtc:asPatientRelationship | See section 7.4 Extensions to CDA R2. |
| ccr:Specialty | Optional | Performer / functionCode | |
| ccr:Address | Optional | Role / address | HL7: Both roles and entities can have addresses. Storing these on the Entity is most closely aligned with the CCR notion of an Actor, however CDA Release 2.0 often limits storage of this information to Roles. |
| ccr:Telephone | Optional | Role / telecom | HL7: Both roles and entities can have telephjone numbers. Storing these on the Entity is most closely aligned with the CCR notion of an Actor, however CDA Release 2.0 often limits storage of this information to Roles |
| ccr:Email | Optional | Role / telecom | HL7: Both roles and entities can have e-mail addresses. Storing these on the Entity is most closely aligned with the CCR notion of an Actor, however CDA Release 2.0 often limits storage of this information to Roles |
| ccr:URL | Optional | Role / telecom | HL7: Both roles and entities can have web addresses. Storing these on the Entity is most closely aligned with the CCR notion of an Actor, however CDA Release 2.0 often limits storage of this information to Roles |
| ccr:Status | Optional | -none- | HL7: Not needed in CCD |
| ccr:Source | Required | See section 5.2 Source. | |
| ccr:InternalCCRLink | Optional | See section 5.3 InternalCCRLink. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
| ccr:CommentID | Optional | See section 4.3 Comments. | |
References | ccr:Reference | Optional | <reference> | |
| ccr:ReferenceObjectID | Required | Not applicable | HL7: Because CCD states the reference within the section where it occurs, a referenceable object identifier is not required. |
| ccr:DateTime | Optional | -none- | HL7: CDA R2 doesn’t currently contain an effectiveTime attribute in the ExternalDocument class. |
| ccr:Description | Optional | ExternalDocument / code | |
| ccr:Source | Optional | See section 5.2 Source. | |
| ccr:Locations | Optional | ExternalDocument / text / reference | |
Comments | ccr:Comment | Optional | Act | |
| ccr:CommentObjectID | Required | Not applicable | HL7: Because CCD states the comment within the section where it occurs, a referenceable object identifier is not required. |
| ccr:DateTime | Optional | Act / effectiveTime | See section 5.4.1 Dates and Times for more details. |
| ccr:Description | Required | Act / code; Act / text | |
| ccr:Source | Optional | See section 5.2 Source. | |
| ccr:ReferenceID | Optional | See section 4.2 References. | |
Signatures | ccr:CCRSignature | Optional | See section 4.4 Signatures. | |
| ccr:SignatureObjectID | Required | See section 4.4 Signatures. | |
| ccr:ExactDateTime | Optional | See section 4.4 Signatures. | |
| ccr:Type | Optional | See section 4.4 Signatures. | |
| ccr:IDs | Optional | See section 4.4 Signatures. | |
| ccr:Source | Optional | See section 4.4 Signatures. | |
| ccr:Signature | Optional | See section 4.4 Signatures. | |
5 General Constraints
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5.1 “Type” and “Status” values
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5.2 Source
ASTM CCR requires that all data objects have a stated source (or state explicitly that the source is unknown) so that any data within the summary can be validated. The source of data may be a person, organization, reference to some other data object, etc.
CONF-520: A person source of information SHALL be represented with informant.
CONF-521: An organization source of information SHALL be represented with informant.
CONF-522: A reference source of information SHALL be represented with reference [@typeCode = “XCRPT”].
CONF-523: Any other source of information SHALL be represented with a source of information observation.
CONF-524: A source of information observation SHALL be the target of an entryRelationship whose value for “entryRelationship / @typeCode” SHALL be “REFR” “Refers to” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC.
CONF-525: A source of information observation SHALL be represented with Observation.
CONF-526: The value for “Observation / @classCode” in a source of information observation SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC.
CONF-527: The value for “Observation / @moodCode” in a source of information observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-528: A source of information observation SHALL contain exactly one Observation / statusCode.
CONF-529: The value for “Observation / statusCode” in a source of information observation SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC.
CONF-530: A source of information observation SHALL contain exactly one Observation / code.
CONF-531: The value for “Observation / code” in a source of information observation SHALL be “48766-0” “Information source” 2.16.840.1.113883.6.1 LOINC STATIC.
CONF-532: A source of information observation SHALL contain exactly one Observation / value.
CONF-533: The absence of a known source of information SHALL be explicity asserted by valuing Observation / value in a source of information observation with the text string “Unknown”.
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5.3 InternalCCRLink
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5.4 Data Types
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5.5 Terminology conformance
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6 Acknowledgements
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7 Appendix
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7.1 Sample
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7.2 Summary of CCD template identifiers
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7.3 Summary of CCD value sets
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7.4 Extensions to CDA R2
Where the ASTM CCR defines important components for which there is no suitable mapping in CDA R2, extensions to CDA R2 have been developed. These extensions are described above in the context of the section where they are used. This section serves to summarize the extensions and provide implementation guidance.
Extensions created for CCD include:
- AssignedPerson / id
- AssociatedPerson / id
- GuardianPerson / id
- InformationRecipient / id
- MaintainingPerson / id
- RelatedPerson / id
- Subject / id
- Subject / deceasedInd
- Subject / deceasedTime
- asPatientRelationship
- asPatientRelationship / @classCode
- asPatientRelationship / code
These extensions are illustrated in Figure 8 CDA R2 clinical statement model for family history and Figure 15 CDA R2 extensions.
Figure 15. CDA R2 extensions
To resolve issues that need to be addressed by extension, the developers of this guide chose to approach extensions as follows:
- An extension is a collection of element or attribute declarations and rules for their application to the CDA Release 2.0.
- All extensions are optional. An extension may be used, but need not be under this guide.
- A single namespace for all extension elements or attributes that may be used by this guide will be defined.
- The namespace for extensions created by the HL7 Structured Documents Technical Committee shall be urn:hl7-org:sdtc.
- This namespace shall be used as the namespace for any extension elements or attributes that are defined by this implementation guide.
- Each extension element shall use the same HL7 vocabularies and data types used by CDA Release 2.0.
- Each extension element shall use the same conventions for order and naming as is used by the current HL7 tooling.
- An extension element shall appear in the XML where the expected RIM element of the same name would have appeared had that element not been otherwise constrained from appearing in the CDA XML schema.