The value for “ClinicalDocument / code” SHALL be “34133-9” “Summarization of episode note” 2.16.840.1.113883.6.1 LOINC STATIC
2.1
13
A CCD SHALL contain exactly one ClinicalDocument / documentationOf / serviceEvent
2.1
14
The value for “ClinicalDocument / documentationOf / serviceEvent / @classCode”
SHALL be “PCPR” “Care provision” 2.16.840.1.113883.5.6 ActClass STATIC
2.1
14
ClinicalDocument / documentationOf / serviceEvent SHALL contain exactly one
serviceEvent / effectiveTime / low and exactly one serviveEvent / effectiveTime /
high
2.1
14
CCD SHALL contain exactly one ClinicalDocument / languageCode
2.2
14
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
2.2
14
CCD SHALL contain one or more ClinicalDocument / templateId
2.3
14
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
2.3
14
ClinicalDocument / effectiveTime SHALL be expressed with precision to include
seconds
2.4
14
ClinicalDocument / effectiveTime SHALL include an explicit time zone
offset
2.4
14
CCD shall contain one to two ClinicalDocument / recordTarget
2.5
15
CCD SHALL contain one or more ClinicalDocument / author / assignedAuthor /
assignedPerson and/or ClinicalDocument / author / assignedAuthor /
representedOrganization
2.6
15
If author has an associated representedOrganization with no assignedPerson or
assignedAuthoringDevice, then the value for “ClinicalDocument / author / assignedAuthor
/ id / @NullFlavor” SHALL be “NA” “Not applicable” 2.16.840.1.113883.5.1008 NullFlavor
STATIC
2.6
15
CCD MAY contain one or more ClinicalDocument / informationRecipient
2.7
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
15
The purpose section SHALL contain Section / code
2.8.1
15
The value for “Section / code” SHALL be “48764-5” “Summary purpose”
2.16.840.1.113883.6.1 LOINC STATIC
2.8.1
16
The purpose section SHALL contain Section / title
2.8.1
16
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “purpose”
2.8.1
16
A purpose activity (templateId 2.16.840.1.113883.10.20.1.30) SHALL be represented
with Act
2.8.2.1
16
The value for “Act / @classCode” in a purpose activity SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
2.8.2.1
17
The value for “Act / @moodCode” in a purpose activity SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
2.8.2.1
17
A purpose activity SHALL contain exactly one Act / statusCode
2.8.2.1
17
The value for “Act / statusCode” in a purpose activity SHALL be “completed”
2.16.840.1.113883.5.14 ActStatus STATIC
2.8.2.1
17
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
2.8.2.1
17
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
2.8.2.1
17
The target of Act / entryRelationship / @typeCode in a purpose activity SHALL be
an Act, Encounter, Observation, Procedure, SubstanceAdministration, or
Supply
2.8.2.1
17
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
3
19
A CCD entry SHOULD explicitly reference its corresponding narrative (using the
approach defined in CDA Release 2, section 4.3.5.1 <content>)
3
19
CCD SHOULD contain exactly one and SHALL NOT contain more than one Payers section
(templateId 2.16.840.1.113883.10.20.1.9). The Payers section SHALL contain a narrative
block, and SHOULD contain clinical statements. Clinical statements SHOULD include one or
more coverage activities (templateId 2.16.840.1.113883.10.20.1.20)
3.1
20
The payer section SHALL contain Section / code
3.1.1
20
The value for “Section / code” SHALL be “48768-6” “Payment sources”
2.16.840.1.113883.6.1 LOINC STATIC
3.1.1
20
The payer section SHALL contain Section / title
3.1.1
20
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “insurance” or “payers”
3.1.1
20
A coverage activity (templateId 2.16.840.1.113883.10.20.1.20) SHALL be
represented with Act
3.1.2.1.1
21
The value for “Act / @classCode” in a coverage activity SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
3.1.2.1.1
21
The value for “Act / @moodCode” in a coverage activity SHALL be “DEF”
2.16.840.1.113883.5.1001 ActMood STATIC
3.1.2.1.1
21
A coverage activity SHALL contain at least one Act / id
3.1.2.1.1
21
A coverage activity SHALL contain exactly one Act / statusCode
3.1.2.1.1
21
The value for “Act / statusCode” in a coverage activity SHALL be “completed”
2.16.840.1.113883.5.14 ActStatus STATIC
3.1.2.1.1
21
A coverage activity SHALL contain exactly one Act / code
3.1.2.1.1
21
The value for “Act / code” in a coverage activity SHALL be “48768-6” “Payment
sources” 2.16.840.1.113883.6.1 LOINC STATIC
3.1.2.1.1
21
A coverage activity SHALL contain one or more Act / entryRelationship
3.1.2.1.1
21
An entryRelationship in a coverage activity MAY contain exactly one
entryRelationship / sequenceNumber, which serves to prioritize the payment
sources
3.1.2.1.1
22
The value for “Act / entryRelationship / @typeCode” in a coverage activity SHALL
be “COMP” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.1.2.1.1
22
The target of a coverage activity SHALL be a policy activity (templateId
2.16.840.1.113883.10.20.1.26)
3.1.2.1.1
22
A coverage activity SHALL contain one or more sources of information, as defined
in section 5.2 Source
3.1.2.1.1
22
A policy activity (templateId 2.16.840.1.113883.10.20.1.26) SHALL be represented
with Act
3.1.2.1.2
22
The value for “Act / @classCode” in a policy activity SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
3.1.2.1.2
22
The value for “Act / @moodCode” in a policy activity SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.1.2.1.2
22
A policy activity SHALL contain at least one Act / id, which represents the group
or contract number related to the insurance policy or program
3.1.2.1.2
22
A policy activity SHALL contain exactly one Act / statusCode
3.1.2.1.2
22
The value for “Act / statusCode” in a policy activity SHALL be “completed”
2.16.840.1.113883.5.14 ActStatus STATIC
3.1.2.1.2
22
A policy activity SHOULD contain zero to one Act / code., which represents the
type of coverage
3.1.2.1.2
22
The value for “Act / code” in a policy activity SHOULD be selected from ValueSet
2.16.840.1.113883.1.11.19832 ActCoverageType DYNAMIC
3.1.2.1.2
22
A policy activity SHALL contain exactly one Act / performer [@typeCode=”PRF”],
representing the payer
3.1.2.1.2
22
A payer in a policy activity SHALL contain one or more performer / assignedEntity
/ id, to represent the payer identification number. For pharamacy benefit programs this
can be valued using the RxBIN and RxPCN numbers assigned by ANSI and NCPDP respectively.
When a nationally recognized payer identification number is available, it would be
placed here
3.1.2.1.2
22
A policy activity SHALL contain exactly one Act / participant [@typeCode=”COV”],
representing the covered party
3.1.2.1.2
22
A covered party in a policy activity SHOULD contain one or more participant /
participantRole / id, to represent the patient’s member or subscriber identifier with
respect to the payer
3.1.2.1.2
22
A covered party in a policy activity SHOULD contain exactly one participant /
participantRole / code, to represent the reason for coverage (e.g. Self, Family
dependent, student)
3.1.2.1.2
22
The value for “participant / participantRole / code” in a policy activity’s
covered party MAY be selected from ValueSet 2.16.840.1.113883.1.11.19809
PolicyOrProgramCoverageRoleType DYNAMIC
3.1.2.1.2
23
A covered party in a policy activity MAY contain exactly one participant / time,
to represent the time period over which the patient is covered
3.1.2.1.2
23
A policy activity MAY contain exactly one Act / participant [@typeCode=”HLD”],
representing the subscriber
3.1.2.1.2
23
A subscriber in a policy activity SHOULD contain one or more participant /
participantRole / id, to represent the subscriber’s identifier with respect to the
payer
3.1.2.1.2
23
A subscriber in a policy activity MAY contain exactly one participant / time, to
represent the time period for which the subscriber is enrolled
3.1.2.1.2
23
The value for “Act / entryRelationship / @typeCode” in a policy activity SHALL be
“REFR” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.1.2.1.2
23
The target of a policy activity with Act / entryRelationship / @typeCode=”REFR”
SHALL be an authorization activity (templateId 2.16.840.1.113883.10.20.1.19) or an Act,
with Act [@classCode = “ACT”] and Act [@moodCode = “DEF”], representing a description of
the coverage plan
3.1.2.1.2
23
A description of the coverage plan SHALL contain one or more Act / Id, to
represent the plan identifier
3.1.2.1.2
23
An authorization activity (templateId 2.16.840.1.113883.10.20.1.19) SHALL be
represented with Act
3.1.2.1.3
23
The value for “Act / @classCode” in an authorization activity SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
3.1.2.1.3
23
An authorization activity SHALL contain at least one Act / id
3.1.2.1.3
23
The value for “Act / @moodCode” in an authorization activity SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.1.2.1.3
23
An authorization activity SHALL contain one or more Act /
entryRelationship
3.1.2.1.3
23
The value for “Act / entryRelationship / @typeCode” in an authorization activity
SHALL be “SUBJ” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.1.2.1.3
23
The target of an authorization activity with Act / entryRelationship /
@typeCode=”SUBJ” SHALL be a clinical statement with moodCode = “PRMS”
(Promise)
3.1.2.1.3
23
The target of an authorization activity MAY contain one or more performer, to
indicate the providers that have been authorized to provide treatment
3.1.2.1.3
23
CCD SHOULD contain exactly one and SHALL NOT contain more than one Advance
directives section (templateId 2.16.840.1.113883.10.20.1.1). The Advance directives
section SHALL contain a narrative block, and SHOULD contain clinical statements.
Clinical statements SHOULD include one or more advance directive observations
(templateId 2.16.840.1.113883.10.20.1.17). An advance directive observation MAY contain
exactly one advance directive reference (templateId 2.16.840.1.113883.10.20.1.36) to an
external advance directive document
3.2
24
The advance directive section SHALL contain Section / code
3.2.1
24
The value for “Section / code” SHALL be “42348-3” “Advance directives”
2.16.840.1.113883.6.1 LOINC STATIC
3.2.1
24
The advance directive section SHALL contain Section / title
3.2.1
24
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “advance directives”
3.2.1
24
An advance directive observation (templateId 2.16.840.1.113883.10.20.1.17) SHALL
be represented with Observation
3.2.2.1
25
The value for “Observation / @classCode” in an advance directive observation
SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC
3.2.2.1
25
The value for “Observation / @moodCode” in an advance directive observation SHALL
be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.2.2.1
25
An advance directive observation SHALL contain at least one Observation /
id
3.2.2.1
25
An advance directive observation SHALL contain exactly one Observation /
statusCode
3.2.2.1
25
The value for “Observation / statusCode” in an advance directive observation
SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.2.2.1
25
An advance directive observation SHOULD contain exactly one Observation /
effectiveTime, to indicate the effective time of the directive
3.2.2.1
25
An advance directive observation SHALL contain exactly one Observation /
code
3.2.2.1
25
The value for “Observation / code” in an advance directive observation MAY be
selected from ValueSet 2.16.840.1.113883.1.11.20.2 AdvanceDirectiveTypeCode STATIC
20061017
3.2.2.1
25
There SHOULD be an advance directive observation whose value for “Observation /
code” is “304251008” “Resuscitation status” 2.16.840.1.113883.6.96 SNOMED CT
STATIC
3.2.2.1
25
A verification of an advance directive observation (templateId
2.16.840.1.113883.10.20.1.58) SHALL be represented with Observation /
participant
3.2.2.1
25
An advance directive observation MAY include one or more
verifications
3.2.2.1
25
The value for “Observation / participant / @typeCode” in a verification SHALL be
“VRF” “Verifier” 2.16.840.1.113883.5.90 ParticipationType STATIC
3.2.2.1
25
A verification of an advance directive observation SHOULD contain Observation /
participant / time
3.2.2.1
25
The data type of Observation / participant / time in a verification SHALL be TS
(time stamp)
3.2.2.1
25
An advance directive observation SHALL contain one or more sources of
information, as defined in section 5.2 Source
3.2.2.1
25
An advance directive observation SHALL contain exactly one advance directive
status observation
3.2.2.2
26
An advance directive status observation (templateId 2.16.840.1.113883.10.20.1.37)
SHALL be a conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as
defined in section 5.1 “Type” and “Status” values)
3.2.2.2
26
The value for “Observation / value” in an advance directive status observation
SHALL be selected from ValueSet 2.16.840.1.113883.1.11.20.1 AdvanceDirectiveStatusCode
STATIC 20061017
3.2.2.2
26
An advance directive reference (templateId 2.16.840.1.113883.10.20.1.36) SHALL be
represented with Observation / reference / ExternalDocument
3.2.2.3
26
An advance directive observation MAY contain exactly one advance directive
reference
3.2.2.3
26
The value for “Observation / reference / @typeCode” in an advance directive
reference SHALL be “REFR” 2.16.840.1.113883.5.1002 ActRelationshipType
STATIC
3.2.2.3
26
ExternalDocument SHALL contain at least one ExternalDocument / id
3.2.2.3
26
The URL of a referenced advance directive document MAY be present, and SHALL be
represented in Observation / reference / ExternalDocument / text / reference. A
<linkHTML> element containing the same URL SHOULD be present in the associated CDA
Narrative Block
3.2.2.3
26
The MIME type of a referenced advance directive document MAY be present, and
SHALL be represented in Observation / reference / ExternalDocument / text /
@mediaType
3.2.2.3
26
Where the value of Observation / reference / seperatableInd is “false”, the
referenced advance directive 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)
3.2.2.3
26
CCD MAY contain one or more patient guardians
3.3
26
A patient guardian SHALL be represented with ClinicalDocument / recordTarget /
patientRole / patient / guardian
3.3
27
CCD MAY contain one or more next of kin
3.3
27
A next of kin SHALL be represented with ClinicalDocument / participant /
associatedEntity
3.3
27
The value for “ClinicalDocument / participant / @typeCode” in a next of kin
participant SHALL be “IND” “Indirect participant” 2.16.840.1.113883.5.90
ParticipationType STATIC
3.3
27
The value for “ClinicalDocument / participant / associatedEntity / @classCode” in
a next of kin participant SHALL be “NOK” “Next of kin” 2.16.840.1.113883.5.41
EntityClass STATIC
3.3
27
The value for “ClinicalDocument / participant / associatedEntity / code” in a
next of kin participant SHOULD be selected from ValueSet 2.16.840.1.113883.1.11.19579
FamilyHistoryRelatedSubjectCode DYNAMIC or 2.16.840.1.113883.1.11.20.21
FamilyHistoryPersonCode DYNAMIC
3.3
27
CCD MAY contain one or more emergency contact
3.3
27
An emergency contact SHALL be represented with ClinicalDocument / participant /
associatedEntity
3.3
27
The value for “ClinicalDocument / participant / @typeCode” in an emergency
contact participant SHALL be “IND” “Indirect participant” 2.16.840.1.113883.5.90
ParticipationType STATIC
3.3
27
The value for “ClinicalDocument / participant / associatedEntity / @classCode” in
an emergency contact participant SHALL be “ECON” “Emergency contact”
2.16.840.1.113883.5.41 EntityClass STATIC
3.3
27
CCD MAY contain one or more patient caregivers
3.3
27
A patient caregiver SHALL be represented with ClinicalDocument / participant /
associatedEntity
3.3
27
The value for “ClinicalDocument / participant / @typeCode” in a patient caregiver
participant SHALL be “IND” “Indirect participant” 2.16.840.1.113883.5.90
ParticipationType STATIC
3.3
27
The value for “ClinicalDocument / participant / associatedEntity / @classCode” in
a patient caregiver participant SHALL be “CAREGIVER” “Caregiver” 2.16.840.1.113883.5.41
EntityClass STATIC
3.3
27
CCD SHOULD contain exactly one and SHALL NOT contain more than one Functional
status section (templateId 2.16.840.1.113883.10.20.1.5). The Functional status section
SHALL contain a narrative block, and SHOULD contain clinical statements. Clinical
statements SHOULD include one or more problem acts (templateId
2.16.840.1.113883.10.20.1.27) and/or result organizers (templateId
2.16.840.1.113883.10.20.1.32)
3.4
28
The functional status section SHALL contain Section / code
3.4.1
28
The value for “Section / code” SHALL be “47420-5” “Functional status assessment”
2.16.840.1.113883.6.1 LOINC STATIC
3.4.1
28
The functional status section SHALL contain Section / title
3.4.1
28
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “functional status”
3.4.1
28
A problem observation or result observation in the functional status section
SHALL contain exactly one observation / code
3.4.2
28
The value for “Observation / code” in a problem observation or result observation
in the functional status section MAY be selected from ValueSet
2.16.840.1.113883.1.11.20.6 FunctionalStatusTypeCode STATIC 20061017
3.4.2
28
If the functional status was collected using a standardized assessment
instrument, then the instrument itself SHOULD be represented in the “Organizer / code”
of a result organizer, with a value selected from LOINC (codeSystem
2.16.840.1.113883.6.1) or SNOMED CT (codeSystem 2.16.840.1.113883.6.96)
3.4.2
29
If the functional status was collected using a standardized assessment
instrument, then the question within that instrument SHOULD be represented in the
“Observation / code” of a result observation, with a value selected from LOINC
(codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem
2.16.840.1.113883.6.96)
3.4.2
29
If the functional status was collected using a standardized assessment instrument
containing questions with enumerated values as answers, then the answer SHOULD be
represented in the “Observation / value” of a result observation
3.4.2
29
If Observation / value in a result observation in the functional status section
is of data type CE or CD, then it SHOULD use the same code system used to code the
question in Observation / code
3.4.2
29
Observation / value in a result observation in the functional status section MAY
be of datatype CE or CD and MAY contain one or more Observation / value / translation,
to represent equivalent values from other code systems
3.4.2
29
A problem observation or result observation in the functional status section MAY
use codes from the International Classification of Functioning, Disability, and Health
(ICF, http://www.who.int/classifications/icf/en/) (codeSystem
2.16.840.1.113883.6.254)
3.4.2
29
A problem observation in the functional status section SHALL contain exactly one
status of functional status observation
3.4.2.1
29
A result observation in the functional status section SHALL contain exactly one
status of functional status observation
3.4.2.1
29
A status of functional status observation (templateId
2.16.840.1.113883.10.20.1.44) SHALL be a conformant status observation (templateId
2.16.840.1.113883.10.20.1.57) (as defined in section 5.1 “Type” and “Status”
values)
3.4.2.1
29
The value for “Observation / value” in a status of functional status observation
SHALL be selected from ValueSet 2.16.840.1.113883.1.11.20.5 StatusOfFunctionalStatusCode
STATIC 20061017
3.4.2.1
29
CCD SHOULD contain exactly one and SHALL NOT contain more than one Problem
section (templateId 2.16.840.1.113883.10.20.1.11). The Problem section SHALL contain a
narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more problem acts (templateId 2.16.840.1.113883.10.20.1.27). A problem
act SHOULD include one or more problem observations (templateId
2.16.840.1.113883.10.20.1.28)
3.5
29
The problem section SHALL contain Section / code
3.5.1
30
The value for “Section / code” SHALL be “11450-4” “Problem list”
2.16.840.1.113883.6.1 LOINC STATIC
3.5.1
30
The problem section SHALL contain Section / title
3.5.1
30
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “problems”
3.5.1
30
A problem act (templateId 2.16.840.1.113883.10.20.1.27) SHALL be represented with
Act
3.5.2.1.1
31
The value for “Act / @classCode” in a problem act SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
3.5.2.1.1
31
The value for “Act / @moodCode” in a problem act SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.5.2.1.1
31
A problem act SHALL contain at least one Act / id
3.5.2.1.1
31
The value for “Act / code / @NullFlavor” in a problem act SHALL be “NA” “Not
applicable” 2.16.840.1.113883.5.1008 NullFlavor STATIC
3.5.2.1.1
31
A problem act MAY contain exactly one Act / effectiveTime, to indicate the timing
of the concern (e.g. the interval of time for which the problem is a
concern)
3.5.2.1.1
31
A problem act SHALL contain one or more Act / entryRelationship
3.5.2.1.1
31
A problem act MAY reference a problem observation, alert observation (see section
3.8 Alerts) or other clinical statement that is the subject of concern, by setting the
value for “Act / entryRelationship / @typeCode” to be “SUBJ” 2.16.840.1.113883.5.1002
ActRelationshipType STATIC
3.5.2.1.1
31
The target of a problem act with Act / entryRelationship / @typeCode=”SUBJ”
SHOULD be a problem observation (in the Problem section) or alert observation (in the
Alert section, see section 3.8 Alerts), but MAY be some other clinical
statement
3.5.2.1.1
31
A problem observation (templateId 2.16.840.1.113883.10.20.1.28) SHALL be
represented with Observation
3.5.2.1.2
31
The value for “Observation / @moodCode” in a problem observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.5.2.1.2
31
A problem observation SHALL include exactly one Observation /
statusCode
3.5.2.1.2
31
The value for “Observation / statusCode” in a problem observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.5.2.1.2
32
A problem observation SHOULD contain exactly one Observation / effectiveTime, to
indicate the biological timing of condition (e.g. the time the condition started, the
onset of the illness or symptom, the duration of a condition)
3.5.2.1.2
32
The value for “Observation / code” in a problem observation MAY be selected from
ValueSet 2.16.840.1.113883.1.11.20.14 ProblemTypeCode STATIC 20061017
3.5.2.1.2
32
The value for “Observation / entryRelationship / @typeCode” in a problem
observation MAY be “SUBJ” “Subject” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC
to reference an age observation (templateId 2.16.840.1.113883.10.20.1.38)
3.5.2.1.2
32
A problem observation SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.5.2.1.2
32
A problem observation MAY contain exactly one problem status
observation
3.5.2.2
32
A problem status observation (templateId 2.16.840.1.113883.10.20.1.50) SHALL be a
conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as defined in
section 5.1 “Type” and “Status” values)
3.5.2.2
32
The value for “Observation / value” in a problem status observation SHALL be
selected from ValueSet 2.16.840.1.113883.1.11.20.13 ProblemStatusCode STATIC
20061017
3.5.2.2
32
A problem observation MAY contain exactly one problem healthstatus
observation
3.5.2.2
32
A problem healthstatus observation (templateId 2.16.840.1.113883.10.20.1.51)
SHALL be a conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as
defined in section 5.1 “Type” and “Status” values), except that the value for
“Observation / code” in a problem healthstatus observation SHALL be “11323-3” “Health
status” 2.16.840.1.113883.6.1 LOINC STATIC
3.5.2.2
32
The value for “Observation / value” in a problem healthstatus observation SHALL
be selected from ValueSet 2.16.840.1.113883.1.11.20.12 ProblemHealthStatusCode STATIC
20061017
3.5.2.2
32
A problem act MAY contain exactly one episode observation
3.5.2.3
33
An episode observation (templateId 2.16.840.1.113883.10.20.1.41) SHALL be
represented with Observation
3.5.2.3
33
The value for “Observation / @classCode” in an episode observation SHALL be “OBS”
2.16.840.1.113883.5.6 ActClass STATIC
3.5.2.3
33
The value for “Observation / @moodCode” in an episode observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.5.2.3
33
An episode observation SHALL include exactly one Observation /
statusCode
3.5.2.3
33
The value for “Observation / statusCode” in an episode observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.5.2.3
33
The value for “Observation / Code” in an episode observation SHOULD be
“ASSERTION” 2.16.840.1.113883.5.4 ActCode STATIC
3.5.2.3
33
“Observation / value” in an episode observation SHOULD be the following SNOMED CT
expression
3.5.2.3
33
An episode observation SHALL be the source of exactly one entryRelationship whose
value for “entryRelationship / @typeCode” is “SUBJ” “Has subject”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC. This is used to link the episode
observation to the target problem act or social history observation
3.5.2.3
33
An episode observation MAY be the source of one or more entryRelationship whose
value for “entryRelationship / @typeCode” is “SAS” “Starts after start”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC. The target of the entryRelationship
SHALL be a problem act or social history observation. This is used to represent the
temporal sequence of episodes
3.5.2.3
33
Patient awareness (templateId 2.16.840.1.113883.10.20.1.48) of a problem,
observation, or other clinical statement SHALL be represented with
participant
3.5.2.4
33
A problem act MAY contain exactly one patient awareness
3.5.2.4
33
A problem observation MAY contain exactly one patient awareness
3.5.2.4
33
The value for “participant / @typeCode” in a patient awareness SHALL be “SBJ”
“Subject” 2.16.840.1.113883.5.90 ParticipationType STATIC
3.5.2.4
33
Patient awareness SHALL contain exactly one participant /
awarenessCode
3.5.2.4
33
Patient awareness SHALL contain exactly one participant / participantRole / id
3.5.2.4
34
which SHALL have exactly one value, which SHALL also be present in ClinicalDocument /
recordTarget / patientRole / id
3.5.2.4
34
CCD SHOULD contain exactly one and SHALL NOT contain more than one Family history
section (templateId 2.16.840.1.113883.10.20.1.4). The Family history section SHALL
contain a narrative block, and SHOULD contain clinical statements. Clinical statements
SHOULD include one or more family history observations (templateId
2.16.840.1.113883.10.20.1.22), which MAY be contained within family history organizers
(templateId 2.16.840.1.113883.10.20.1.23)
3.6
34
The family history section SHALL contain Section / code
3.6.1
34
The value for “Section / code” SHALL be “10157-6” “History of family member
diseases” 2.16.840.1.113883.6.1 LOINC STATIC
3.6.1
34
The family history section SHALL contain Section / title
3.6.1
34
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “family history”
3.6.1
34
The family history section SHALL NOT contain Section / subject
3.6.1
34
A family history observation (templateId 2.16.840.1.113883.10.20.1.22) SHALL be
represented with Observation
3.6.2.1.1
35
The value for “Observation / @moodCode” in a family history observation SHALL be
“EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.6.2.1.1
35
A family history observation SHALL contain at least one Observation /
id
3.6.2.1.1
35
A family history observation SHALL include exactly one Observation /
statusCode
3.6.2.1.1
35
The value for “Observation / statusCode” in a family history observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.6.2.1.1
35
A family history observation SHOULD include Observation / effectiveTime. (See
also section 3.6.2.4 Representation of age)
3.6.2.1.1
35
A family history cause of death observation (templateId
2.16.840.1.113883.10.20.1.42) SHALL conform to the constraints and is a kind of family
history observation (templateId 2.16.840.1.113883.10.20.1.22)
3.6.2.1.1
35
A family history cause of death observation SHALL contain one or more
entryRelationship / @typeCode
3.6.2.1.1
35
The value for at least one “entryRelationship / @typeCode” in a family history
cause of death observation SHALL be “CAUS” “is etiology for” 2.16.840.1.113883.5.1002
ActRelationshipType STATIC, with a target family history observation of
death
3.6.2.1.1
35
A family history observation SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.6.2.1.1
36
A family history organizer (templateId 2.16.840.1.113883.10.20.1.23) SHALL be
represented with Organizer
3.6.2.1.2
36
The value for “Organizer / @classCode” in a family history organizer SHALL be
“CLUSTER” 2.16.840.1.113883.5.6 ActClass STATIC
3.6.2.1.2
36
The value for “Organizer / @moodCode” in a family history organizer SHALL be
“EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.6.2.1.2
36
A family history organizer SHALL contain exactly one Organizer /
statusCode
3.6.2.1.2
36
The value for “Organizer / statusCode” in a family history organizer SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.6.2.1.2
36
A family history organizer SHALL contain one or more Organizer /
component
3.6.2.1.2
36
The target of a family history organizer Organizer / component relationship
SHOULD be a family history observation, but MAY be some other clinical
statement
3.6.2.1.2
36
The representation of “status” values in the family history
section is the same as the representation in the problems section
3.6.2.2
36
A family history observation act MAY contain exactly one problem status
observation (templateId 2.16.840.1.113883.10.20.1.50) (see section 3.5.2.2
Representation of “status” values)
3.6.2.2
36
A family history organizer SHALL contain exactly one subject participant,
representing the family member who is the subject of the family history
observations
3.6.2.3
36
A family history observation not contained within a family history organizer
SHALL contain exactly one subject participant, representing the family member who is the
subject of the observation
3.6.2.3
36
Where the subject of an observation is explicit in a family history observation
code (e.g. SNOMED CT concept 417001009 “Family history of tuberous sclerosis”), the
subject participant SHALL be equivalent to or further specialize the code
3.6.2.3
36
Where the subject of an observation is not explicit in a family history
observation code (e.g. SNOMED CT concept 44054006 “Diabetes Mellitus type 2”), the
subject participant SHALL be used to assert the affected relative
3.6.2.3
37
A subject participant SHALL contain exactly one RelatedSubject, representing the
relationship of the subject to the patient
3.6.2.3
37
The value for “RelatedSubject / @classCode” SHALL be “PRS” “Personal
relationship” 2.16.840.1.113883.5.110 RoleClass STATIC
3.6.2.3
37
RelatedSubject SHALL contain exactly one RelatedSubject / code
3.6.2.3
37
The value for “RelatedSubject / code” SHOULD be selected from ValueSet
2.16.840.1.113883.1.11.19579 FamilyHistoryRelatedSubjectCode DYNAMIC or
2.16.840.1.113883.1.11.20.21 FamilyHistoryPersonCode DYNAMIC
3.6.2.3
37
Representation of a pedigree graph SHALL be done using RelatedSubject / code
values (e.g. “great grandfather”) to designate a hierarchical family tree
3.6.2.3
37
RelatedSubject SHOULD contain exactly one RelatedSubject / subject
3.6.2.3
37
RelatedSubject / subject SHOULD contain exactly one RelatedSubject / subject /
administrativeGenderCode
3.6.2.3
37
RelatedSubject / subject SHOULD contain exactly one RelatedSubject / subject /
birthTime
3.6.2.4
37
RelatedSubject / subject MAY contain exactly one RelatedSubject / subject /
sdtc:deceasedInd. (See section 7.4 Extensions to CDA R2 for details on representation of
CDA extensions)
3.6.2.4
37
RelatedSubject / subject MAY contain exactly one RelatedSubject / subject /
sdtc:deceasedTime. (See section 7.4 Extensions to CDA R2 for details on representation
of CDA extensions)
3.6.2.4
37
The age of a relative at the time of a family history observation SHOULD be
inferred by comparing RelatedSubject / subject / birthTime with Observation /
effectiveTime
3.6.2.4
37
The age of a relative at the time of death MAY be inferred by comparing
RelatedSubject / subject / birthTime with RelatedSubject / subject /
sdtc:deceasedTime
3.6.2.4
37
The value for “Observation / entryRelationship / @typeCode” in a family history
observation MAY be “SUBJ” “Subject” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC
to reference an age observation
3.6.2.4
37
An age observation (templateId 2.16.840.1.113883.10.20.1.38) SHALL be represented
with Observation
3.6.2.4
37
The value for “Observation / @classCode” in an age observation SHALL be “OBS”
2.16.840.1.113883.5.6 ActClass STATIC
3.6.2.4
38
The value for “Observation / @moodCode” in an age observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.6.2.4
38
The value for “Observation / code” in an age observation SHALL be “397659008”
“Age” 2.16.840.1.113883.6.96 SNOMED CT STATIC
3.6.2.4
38
An age observation SHALL include exactly one Observation / statusCode
3.6.2.4
38
The value for “Observation / statusCode” in an age observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.6.2.4
38
An age observation SHALL include exactly one Observation / value, valued using
appropriate datatype
3.6.2.4
38
CCD SHOULD contain exactly one and SHALL NOT contain more than one Social history
section (templateId 2.16.840.1.113883.10.20.1.15). The Social history section SHALL
contain a narrative block, and SHOULD contain clinical statements. Clinical statements
SHOULD include one or more social history observations (templateId
2.16.840.1.113883.10.20.1.33)
3.7
38
The social history section SHALL contain Section / code
3.7.1
38
The value for “Section / code” SHALL be “29762-2” “Social history”
2.16.840.1.113883.6.1 LOINC STATIC
3.7.1
38
The social history section SHALL contain Section / title
3.7.1
38
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “social history”
3.7.1
38
A social history observation (templateId 2.16.840.1.113883.10.20.1.33) SHALL be
represented with Observation
3.7.2.1
39
The value for “Observation / @classCode” in a social history observation SHALL be
“OBS” 2.16.840.1.113883.5.6 ActClass STATIC
3.7.2.1
39
The value for “Observation / @moodCode” in a social history observation SHALL be
“EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.7.2.1
39
A social history observation SHALL contain at least one Observation /
id
3.7.2.1
39
A social history observation SHALL include exactly one Observation /
statusCode
3.7.2.1
39
The value for “Observation / statusCode” in a social history observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.7.2.1
39
The value for “Observation / code” in a social history observation SHOULD be
selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem
2.16.840.1.113883.6.96), or MAY be selected from ValueSet 2.16.840.1.113883.1.11.20.18
SocialHistoryTypeCode STATIC 20061017
3.7.2.1
39
Observation / value can be any datatype. Where Observation / value is a physical
quantity, the unit of measure SHALL be expressed using a valid Unified Code for Units of
Measure (UCUM) expression
3.7.2.1
39
A social history observation SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.7.2.1
39
A social history observation MAY contain exactly one social history status
observation
3.7.2.2
40
A social history status observation (templateId 2.16.840.1.113883.10.20.1.56)
SHALL be a conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as
defined in section 5.1 “Type” and “Status” values)
3.7.2.2
40
The value for “Observation / value” in a social history status observation SHALL
be selected from ValueSet 2.16.840.1.113883.1.11.20.17 SocialHistoryStatusCode STATIC
20061017
3.7.2.2
40
The representation of episode in the social history section is the same as the
representation in the problems section. See section 3.5.2.3 Episode observations for
details
3.7.2.3
40
A social history observation MAY contain exactly one episode observation
(templateId 2.16.840.1.113883.10.20.1.41) (see section 3.5.2.3 Episode
observations)
3.7.2.3
40
Marital status SHOULD be represented as ClinicalDocument / recordTarget /
patientRole / patient / maritalStatusCode. Additional information MAY be represented as
social history observations
3.7.2.4
40
Religious affiliation SHOULD be represented as ClinicalDocument / recordTarget /
patientRole / patient / religiousAffiliationCode. Additional information MAY be
represented as social history observations
3.7.2.4
40
A patient’s race SHOULD be represented as ClinicalDocument / recordTarget /
patientRole / patient / raceCode. Additional information MAY be represented as social
history observations
3.7.2.4
40
The value for “ClinicalDocument / recordTarget / patientRole / patient /
raceCode” MAY be selected from codeSystem 2.16.840.1.113883.5.104 (Race)
3.7.2.4
40
A patient’s ethnicity SHOULD be represented as ClinicalDocument / recordTarget /
patientRole / patient / ethnicGroupCode. Additional information MAY be represented as
social history observations
3.7.2.4
40
The value for “ClinicalDocument / recordTarget / patientRole / patient /
ethnicGroupCode” MAY be selected from codeSystem 2.16.840.1.113883.5.50
(Ethnicity)
3.7.2.4
40
CCD SHOULD contain exactly one and SHALL NOT contain more than one Alerts section
(templateId 2.16.840.1.113883.10.20.1.2). The Alerts section SHALL contain a narrative
block, and SHOULD contain clinical statements. Clinical statements SHOULD include one or
more problem acts (templateId 2.16.840.1.113883.10.20.1.27). A problem act SHOULD
include one or more alert observations (templateId
2.16.840.1.113883.10.20.1.18)
3.8
41
The absence of known allergies, adverse reactions, or alerts SHALL be explicitly
asserted
3.8
41
The alert section SHALL contain Section / code
3.8.1
41
The value for “Section / code” SHALL be “48765-2” “Allergies, adverse reactions,
alerts” 2.16.840.1.113883.6.1 LOINC STATIC
3.8.1
41
The alert section SHALL contain Section / title
3.8.1
41
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “alert” and/or “allergies and adverse reactions”
3.8.1
41
An alert observation (templateId 2.16.840.1.113883.10.20.1.18) SHALL be
represented with Observation
3.8.2.1.2
42
The value for “Observation / @moodCode” in an alert observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.8.2.1.2
43
An alert observation SHALL include exactly one Observation /
statusCode
3.8.2.1.2
43
The value for “Observation / statusCode” in an alert observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.8.2.1.2
43
An alert observation MAY contain exactly one Observation / effectiveTime, to
indicate the biological timing of condition (e.g. the time the condition started, the
onset of the illness or symptom, the duration of a condition)
3.8.2.1.2
43
The value for “Observation / value” in an alert observation MAY be selected from
ValueSet 2.16.840.1.113883.1.11.20.4 AlertTypeCode STATIC 20061017
3.8.2.1.2
43
The absence of known allergies SHOULD be represented in an alert observation by
valuing Observation / value with 160244002 “No known allergies” 2.16.840.1.113883.6.96
SNOMED CT STATIC
3.8.2.1.2
43
An alert observation SHALL contain one or more sources of information, as defined
in section 5.2 Source
3.8.2.1.2
43
An alert observation MAY contain exactly one alert status observation
3.8.2.2
43
An alert status observation (templateId 2.16.840.1.113883.10.20.1.39) SHALL be a
conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as defined in
section 5.1 “Type” and “Status” values)
3.8.2.2
43
The value for “Observation / value” in an alert status observation SHALL be
selected from ValueSet 2.16.840.1.113883.1.11.20.3 AlertStatusCode STATIC
20061017
3.8.2.2
43
An alert observation SHOULD contain at least one Observation / participant,
representing the agent that is the cause of the allergy or adverse reaction
3.8.2.3
43
An agent participation in an alert observation SHALL contain exactly one
participant / participantRole / playingEntity
3.8.2.3
43
The value for Observation / participant / @typeCode in an agent participation
SHALL be “CSM” “Consumable” 2.16.840.1.113883.5.90 ParticipationType STATIC
3.8.2.3
43
The value for Observation / participant / participantRole / @classCode in an
agent participation SHALL be “MANU” “Manufactured” 2.16.840.1.113883.5.110 RoleClass
STATIC
3.8.2.3
43
The value for Observation / participant / participantRole / playingEntity /
@classCode in an agent participation SHALL be “MMAT” “Manufactured material”
2.16.840.1.113883.5.41 EntityClass STATIC
3.8.2.3
44
An agent participation in an alert observation SHALL contain exactly one
participant / participantRole / playingEntity / code
3.8.2.3
44
The value for “participant / participantRole / playingEntity / code” in an agent
participation SHOULD be selected from the RxNorm (2.16.840.1.113883.6.88) code system
for medications, and from the CDC Vaccine Code (2.16.840.1.113883.6.59) code system for
immunizations
3.8.2.3
44
An alert observation MAY contain one or more reaction observations (templateId
2.16.840.1.113883.10.20.1.54), each of which MAY contain exactly one severity
observation (templateId 2.16.840.1.113883.10.20.1.55) AND/OR one or more reaction
interventions
3.8.2.4
44
The value for “entryRelationship / @typeCode” in a relationship between an alert
observation and reaction observation SHALL be “MFST” “Is manifestation of”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.8.2.4
44
A reaction observation (templateId 2.16.840.1.113883.10.20.1.54) SHALL be
represented with Observation
3.8.2.4.1.1
44
The value for “Observation / @classCode” in a reaction observation SHALL be “OBS”
2.16.840.1.113883.5.6 ActClass STATIC
3.8.2.4.1.1
44
The value for “Observation / @moodCode” in a reaction observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.8.2.4.1.1
44
A reaction observation SHALL include exactly one Observation /
statusCode
3.8.2.4.1.1
44
The value for “Observation / statusCode” in a reaction observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.8.2.4.1.1
44
A severity observation (templateId 2.16.840.1.113883.10.20.1.55) SHALL be
represented with Observation
3.8.2.4.1.2
44
The value for “entryRelationship / @typeCode” in a relationship between a
reaction observation and severity observation SHALL be “SUBJ” “Has subject”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.8.2.4.1.2
45
The value for “Observation / @classCode” in a severity observation SHALL be “OBS”
2.16.840.1.113883.5.6 ActClass STATIC
3.8.2.4.1.2
45
The value for “Observation / @moodCode” in a severity observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.8.2.4.1.2
45
A severity observation SHALL include exactly one Observation /
statusCode
3.8.2.4.1.2
45
The value for “Observation / statusCode” in a severity observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
3.8.2.4.1.2
45
A severity observation SHALL contain exactly one Observation / code
3.8.2.4.1.2
45
The value for “Observation / code” in a severity observation SHALL be “SEV”
“Severity observation” 2.16.840.1.113883.5.4 ActCode STATIC
3.8.2.4.1.2
45
A severity observation SHALL contain exactly one Observation / value
3.8.2.4.1.2
45
The value for “entryRelationship / @typeCode” in a relationship between a
reaction observation and reaction intervention SHALL be “RSON” “Has reason”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.8.2.4.1.3
45
A reaction intervention SHALL be represented as a procedure activity (templateId
2.16.840.1.113883.10.20.1.29), a medication activity (templateId
2.16.840.1.113883.10.20.1.24), or some other clinical statement
3.8.2.4.1.3
45
CCD SHOULD contain exactly one and SHALL NOT contain more than one Medications
section (templateId 2.16.840.1.113883.10.20.1.8). The Medications section SHALL contain
a narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more medication activities (templateId 2.16.840.1.113883.10.20.1.24)
and/or supply activities (templateId 2.16.840.1.113883.10.20.1.34)
3.9
45
The absence of known medications SHALL be explicitly asserted
3.9
45
The medications section SHALL contain Section / code
3.9.1
45
The value for “Section / code” SHALL be “10160-0” “History of medication use”
2.16.840.1.113883.6.1 LOINC STATIC
3.9.1
46
The medications section SHALL contain Section / title
3.9.1
46
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “medication”
3.9.1
46
A medication activity (templateId 2.16.840.1.113883.10.20.1.24) SHALL be
represented with SubstanceAdministration
3.9.2.1.1
47
The value for “SubstanceAdministration / @moodCode” in a medication activity
SHALL be “EVN” or “INT” 2.16.840.1.113883.5.1001 ActMood STATIC
3.9.2.1.1
47
A medication activity SHALL contain at least one SubstanceAdministration /
id
3.9.2.1.1
47
A medication activity SHOULD contain exactly one SubstanceAdministration /
statusCode
3.9.2.1.1
47
A medication activity SHOULD contain one or more SubstanceAdministration /
effectiveTime elements, used to indicate the actual or intended start and stop date of a
medication, and the frequency of administration. (See section 5.4.1 Dates and Times for
additional details about time representation)
3.9.2.1.1
47
A medication activity SHOULD contain exactly one SubstanceAdministration /
routeCode
3.9.2.1.1
47
The value for “SubstanceAdministration / routeCode” in a medication activity
SHOULD be selected from the HL7 RouteOfAdministration (2.16.840.1.113883.5.112) code
system
3.9.2.1.1
47
A medication activity SHOULD contain exactly one SubstanceAdministration /
doseQuantity or SubstanceAdministration / rateQuantity
3.9.2.1.1
47
A medication activity MAY contain exactly one SubstanceAdministration /
maxDoseQuantity, which represents a maximum dose limit
3.9.2.1.1
47
A medication activity MAY contain one or more SubstanceAdministration /
performer, to indicate the person administering a substance
3.9.2.1.1
47
A medication activity MAY have one or more associated consents, represented in
the CCD Header as ClinicalDocument / authorization / consent
3.9.2.1.1
47
A medication activity SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.9.2.1.1
47
A supply activity (templateId 2.16.840.1.113883.10.20.1.34) SHALL be represented
with Supply
3.9.2.1.2
48
The value for “Supply / @moodCode” in a supply activity SHALL be “EVN” or “INT”
2.16.840.1.113883.5.1001 ActMood STATIC
3.9.2.1.2
48
A supply activity SHALL contain at least one Supply / id
3.9.2.1.2
48
A supply activity SHOULD contain exactly one Supply / statusCode
3.9.2.1.2
48
A supply activity SHOULD contain exactly one Supply / effectiveTime, to indicate
the actual or intended time of dispensing
3.9.2.1.2
48
A supply activity MAY contain exactly one Supply / repeatNumber, to indicate the
number of fills. (Note that Supply / repeatNumber corresponds to the number of “fills”,
as opposed to the number of “refills”)
3.9.2.1.2
48
A supply activity MAY contain exactly one Supply / quantity, to indicate the
actual or intended supply quantity
3.9.2.1.2
48
A supply activity MAY contain one or more Supply / author, to indicate the
prescriber
3.9.2.1.2
48
A supply activity MAY contain one or more Supply / performer, to indicate the
person dispensing the product
3.9.2.1.2
48
A supply activity MAY contain exactly one Supply / participant / @typeCode =
“LOC”, to indicate the supply location
3.9.2.1.2
48
A supply activity SHALL contain one or more sources of information, as defined in
section 5.2 Source
3.9.2.1.2
48
A medication activity MAY contain one or more SubstanceAdministration /
precondition / Criterion, to indicate that the medication is administered only when the
associated (coded or free text) criteria are met
3.9.2.2.1
48
A medication activity MAY contain one or more SubstanceAdministration /
entryRelationship, whose value for “entryRelationship / @typeCode” SHALL be “RSON” “Has
reason” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC, where the target of the
relationship represents the indication for the activity
3.9.2.2.1
48
SubstanceAdministration / entryRelationship / @typeCode=”RSON” in a medication
activity SHALL have a target of problem act (templateId 2.16.840.1.113883.10.20.1.27),
problem observation (templateId 2.16.840.1.113883.10.20.1.28), or some other clinical
statement
3.9.2.2.1
49
A medication activity MAY contain one or more patient instructions
3.9.2.2.2
49
A patient instruction (templateId 2.16.840.1.113883.10.20.1.49) SHALL be
represented with Act
3.9.2.2.2
49
The value for “Act / @moodCode” in a patient instruction SHALL be “INT” “Intent”
2.16.840.1.113883.5.1001 ActMood STATIC
3.9.2.2.2
49
The value for “entryRelationship / @typeCode” in a relationship to a patient
instruction SHALL be “SUBJ” “Subject” 2.16.840.1.113883.5.1002 ActRelationshipType
STATIC
3.9.2.2.2
49
A supply activity MAY contain one or more fulfillment instructions
3.9.2.2.3
49
A fulfillment instruction (templateId 2.16.840.1.113883.10.20.1.43) SHALL be
represented with Act
3.9.2.2.3
49
The value for “Act / @moodCode” in a fulfillment instruction SHALL be “INT”
“Intent” 2.16.840.1.113883.5.1001 ActMood STATIC
3.9.2.2.3
49
The value for “entryRelationship / @typeCode” in a relationship between a supply
activity and fulfillment instruction SHALL be “SUBJ” “Subject” 2.16.840.1.113883.5.1002
ActRelationshipType STATIC
3.9.2.2.3
49
A medication activity MAY contain exactly one medication series number
observations
3.9.2.2.4
49
The value for “entryRelationship / @typeCode” in a relationship between a
medication activity and medication series number observation SHALL be “SUBJ” “Subject”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.9.2.2.4
49
A medication series number observation (templateId 2.16.840.1.113883.10.20.1.46)
SHALL be represented with Observation
3.9.2.2.4
49
The value for “Observation / @classCode” in a medication series number
observation SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC
3.9.2.2.4
49
The value for “Observation / @moodCode” in a medication series number observation
SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.9.2.2.4
50
A medication series number observation SHALL include exactly one Observation /
statusCode
3.9.2.2.4
50
A medication series number observation SHALL contain exactly one Observation /
code
3.9.2.2.4
50
The value for “Observation / code” in a medication series number observation
SHALL be “30973-2” “Dose number” 2.16.840.1.113883.6.1 LOINC STATIC
3.9.2.2.4
50
A medication series number observation SHALL contain exactly one Observation /
value
3.9.2.2.4
50
The data type for “Observation / value” in a medication series number observation
SHALL be INT (integer)
3.9.2.2.4
50
A medication activity MAY contain one or more reaction observations (templateId
2.16.840.1.113883.10.20.1.54), each of which MAY contain exactly one severity
observation (templateId 2.16.840.1.113883.10.20.1.55) AND/OR one or more reaction
interventions
3.9.2.2.5
50
The value for “entryRelationship / @typeCode” in a relationship between a
medication activity and reaction observation SHALL be “CAUS” “Is etiology for”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC
3.9.2.2.5
50
A medication activity MAY contain exactly one medication status
observation
3.9.2.3
50
A supply activity MAY contain exactly one medication status
observation
3.9.2.3
50
A medication status observation (templateId 2.16.840.1.113883.10.20.1.47) SHALL
be a conformant status observation (templateId 2.16.840.1.113883.10.20.1.57) (as defined
in section 5.1 “Type” and “Status” values)
3.9.2.3
50
The value for “Observation / value” in a medication status observation SHALL be
selected from ValueSet 2.16.840.1.113883.1.11.20.7 MedicationStatusCode STATIC
20061017
3.9.2.3
50
A medication activity SHALL contain exactly one SubstanceAdministration /
consumable, the target of which is a product template
3.9.2.4
51
A supply activity MAY contain exactly one Supply / product, the target of which
is a product template
3.9.2.4
51
A product (templateId 2.16.840.1.113883.10.20.1.53) SHALL be represented with the
ManufacturedProduct class
3.9.2.4
51
A ManufacturedProduct in a product template SHALL contain exactly one
manufacturedProduct / manufacturedMaterial
3.9.2.4
51
A manufacturedMaterial in a product template SHALL contain exactly one
manufacturedMaterial / code
3.9.2.4
51
The value for “manufacturedMaterial / code” in a product template SHOULD be
selected from the RxNorm (2.16.840.1.113883.6.88) code system for medications, and from
the CDC Vaccine Code (2.16.840.1.113883.6.59) code system for immunizations, or MAY be
selected from ValueSet 2.16.840.1.113883.1.11.20.8 MedicationTypeCode STATIC
20061017
3.9.2.4
51
The value for “manufacturedMaterial / code” in a product template MAY contain a
precoordinated product strength, product form, or product concentration (e.g.
“metoprolol 25mg tablet”, “amoxicillin 400mg/5mL suspension”)
3.9.2.4
51
If manufacturedMaterial / code contains a precoordinated unit dose (e.g.
“metoprolol 25mg tablet”), then SubstanceAdministration / doseQuantity SHALL be a
unitless number that indicates the number of products given per
administration
3.9.2.4
51
If manufacturedMaterial / code does not contain a precoordinated unit dose (e.g.
“metoprolol product”), then SubstanceAdministration / doseQuantity SHALL be a physical
quantity that indicates the amount of product given per administration
3.9.2.4
51
A manufacturedMaterial in a product template SHALL contain exactly one Material /
code / originalText, which represents the generic name of the product
3.9.2.4
51
A manufacturedMaterial in a product template MAY contain exactly one Material /
name, which represents the brand name of the product
3.9.2.4
51
A ManufacturedProduct in a product template MAY contain exactly one
manufacturedProduct / manufacturerOrganization, which represents the manufacturer of the
Material
3.9.2.4
51
A ManufacturedProduct in a product template MAY contain one or more
manufacturedProduct / id, which uniquely represent a particular kind of
product
3.9.2.4
51
If ManufacturedProduct in a product template contains manufacturedProduct / id,
then ManufacturedProduct SHOULD also contain manufacturedProduct /
manufacturerOrganization
3.9.2.4
51
A medication activity MAY contain one or more product instance templates
(templateId 2.16.840.1.113883.10.20.1.52) (see section 3.14.2.2 Procedure related
products), to identify a particular product instance
3.9.2.4
52
A supply activity MAY contain one or more product instance templates (templateId
2.16.840.1.113883.10.20.1.52) (see section 3.14.2.2 Procedure related products), to
identify a particular product instance
3.9.2.4
52
Supply / participant / participantRole / id SHOULD be set to equal a [Act |
Observation | Procedure] / participant / participantRole / id (see section 3.14.2.2
Procedure related products) to indicate that the Supply and the Procedure are referring
to the same product instance
3.9.2.4
52
CCD SHOULD contain exactly one and SHALL NOT contain more than one Medical
Equipment section (templateId 2.16.840.1.113883.10.20.1.7). The Medical Equipment
section SHALL contain a narrative block, and SHOULD contain clinical statements.
Clinical statements SHOULD include one or more supply activities (templateId
2.16.840.1.113883.10.20.1.34) and MAY include one or more medication activities
(templateId 2.16.840.1.113883.10.20.1.24)
3.1
52
The medical equipment section SHALL contain Section / code
3.1
52
The value for “Section / code” SHALL be “46264-8” “History of medical device use”
2.16.840.1.113883.6.1 LOINC STATIC
3.1
52
The medical equipment section SHALL contain Section / title
3.1
52
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “equipment”
3.1
52
CCD SHOULD contain exactly one and SHALL NOT contain more than one Immunizations
section (templateId 2.16.840.1.113883.10.20.1.6). The Immunizations section SHALL
contain a narrative block, and SHOULD contain clinical statements. Clinical statements
SHOULD include one or more medication activities (templateId
2.16.840.1.113883.10.20.1.24) and/or supply activities (templateId
2.16.840.1.113883.10.20.1.34)
3.11
53
The immunizations section SHALL contain Section / code
3.1
53
The value for “Section / code” SHALL be “11369-6” “History of immunizations”
2.16.840.1.113883.6.1 LOINC STATIC
3.1
53
The immunizations section SHALL contain Section / title
3.1
53
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “immunization”
3.1
53
CCD SHOULD contain exactly one and SHALL NOT contain more than one Vital signs
section (templateId 2.16.840.1.113883.10.20.1.16). The Vital signs section SHALL contain
a narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more vital signs organizers (templateId 2.16.840.1.113883.10.20.1.35),
each of which SHALL contain one or more result observations (templateId
2.16.840.1.113883.10.20.1.31)
3.1
53
The vital signs section SHALL contain Section / code
3.12.1
54
The value for “Section / code” SHALL be “8716-3” “Vital signs”
2.16.840.1.113883.6.1 LOINC STATIC
3.12.1
54
The vital signs section SHALL contain Section / title
3.12.1
54
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “vital signs”
3.12.1
54
A vital signs organizer (templateId 2.16.840.1.113883.10.20.1.35) SHALL be a
conformant results organizer (templateId 2.16.840.1.113883.10.20.1.32)
3.12.2
54
A vital signs organizer SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.12.2
54
CCD SHOULD contain exactly one and SHALL NOT contain more than one Results
section (templateId 2.16.840.1.113883.10.20.1.14). The Results section SHALL contain a
narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more result organizers (templateId 2.16.840.1.113883.10.20.1.32), each of
which SHALL contain one or more result observations (templateId
2.16.840.1.113883.10.20.1.31)
3.13
54
The result section SHALL contain Section / code
3.13.1
55
The value for “Section / code” SHALL be “30954-2” “Relevant diagnostic tests
and/or laboratory data” 2.16.840.1.113883.6.1 LOINC STATIC
3.13.1
55
The results section SHALL contain Section / title
3.13.1
55
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “results”
3.13.1
55
A result organizer (templateId 2.16.840.1.113883.10.20.1.32) SHALL be represented
with Organizer
3.13.2.1.1
56
The value for “Organizer / @moodCode” in a result organizer SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.13.2.1.1
56
A result organizer SHALL contain at least one Organizer / id
3.13.2.1.1
56
A result organizer SHALL contain exactly one Organizer / statusCode
3.13.2.1.1
56
A result organizer SHALL contain exactly one Organizer / code
3.13.2.1.1
56
The value for “Organizer / code” in a result organizer SHOULD be selected from
LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem
2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem
2.16.840.1.113883.6.12) or ValueSet 2.16.840.1.113883.1.11.20.16 ResultTypeCode
STATIC
3.13.2.1.1
56
A result organizer SHOULD include one or more Organizer / specimen if the
specimen isn't inherent in Organizer / code
3.13.2.1.1
56
Organizer / specimen SHALL NOT conflict with the specimen inherent in Organizer /
code
3.13.2.1.1
56
Organizer / specimen / specimenRole / id SHOULD be set to equal a Procedure /
specimen / specimenRole / id (see section 3.14 Procedures) to indicate that the Results
and the Procedure are referring to the same specimen
3.13.2.1.1
56
A result organizer SHALL contain one or more Organizer / component
3.13.2.1.1
56
The target of one or more result organizer Organizer / component relationships
MAY be a procedure, to indicate the means or technique by which a result is obtained,
particularly if the means or technique isn’t inherent in Organizer / code or if there is
a need to further specialize the Organizer / code value
3.13.2.1.1
56
A result organizer Organizer / component / procedure MAY be a reference to a
procedure described in the Procedure section. (See section 5.3 InternalCCRLink for more
on referencing within CCD)
3.13.2.1.1
56
The target of one or more result organizer Organizer / component relationships
SHALL be a result observation
3.13.2.1.1
56
A result organizer SHALL contain one or more sources of information, as defined
in section 5.2 Source
3.13.2.1.1
56
A result observation (templateId 2.16.840.1.113883.10.20.1.31) SHALL be
represented with Observation
3.13.2.1.2
57
The value for “Observation / @moodCode” in a result observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.13.2.1.2
57
A result observation SHALL contain at least one Observation / id
3.13.2.1.2
57
A result observation SHALL contain exactly one Observation /
statusCode
3.13.2.1.2
57
A result observation SHOULD contain exactly one Observation / effectiveTime,
which represents the biologically relevant time (e.g. time the specimen was obtained
from the patient)
3.13.2.1.2
57
A result observation SHALL contain exactly one Observation / code
3.13.2.1.2
57
The value for “Observation / code” in a result observation SHOULD be selected
from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT (codeSystem
2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem
2.16.840.1.113883.6.12)
3.13.2.1.2
57
A result observation MAY contain exactly one Observation / methodCode if the
method isn't inherent in Observation / code or if there is a need to further specialize
the method in Observation / code
3.13.2.1.2
57
Observation / methodCode SHALL NOT conflict with the method inherent in
Observation / code
3.13.2.1.2
57
A result observation SHALL contain exactly one Observation / value
3.13.2.1.2
57
Where Observation / value is a physical quantity, the unit of measure SHALL be
expressed using a valid Unified Code for Units of Measure (UCUM) expression
3.13.2.1.2
57
A result observation SHOULD contain exactly one Observation / interpretationCode,
which can be used to provide a rough qualitative interpretation of the observation, such
as “N” (normal), “L” (low), “S” (susceptible), etc. Interpretation is generally provided
for numeric results where an interpretation range has been defined, or for antimicrobial
susceptibility test interpretation
3.13.2.1.2
57
A result observation SHOULD contain one or more Observation / referenceRange to
show the normal range of values for the observation result
3.13.2.1.2
57
A result observation SHALL NOT contain Observation / referenceRange /
observationRange / code, as this attribute is not used by the HL7 Clinical Statement or
Lab Committee models
3.13.2.1.2
57
A result observation SHALL contain one or more sources of information, as defined
in section 5.2 Source
3.13.2.1.2
57
CCD SHOULD contain exactly one and SHALL NOT contain more than one Procedures
section (templateId 2.16.840.1.113883.10.20.1.12). The Procedures section SHALL contain
a narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more procedure activities (templateId
2.16.840.1.113883.10.20.1.29)
3.14
58
The procedure section SHALL contain Section / code
3.14.1
58
The value for “Section / code” SHALL be “47519-4” “History of procedures”
2.16.840.1.113883.6.1 LOINC STATIC
3.14.1
58
The procedure section SHALL contain Section / title
3.14.1
58
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “procedures”
3.14.1
58
A procedure activity (templateId 2.16.840.1.113883.10.20.1.29) SHALL be
represented with Act, Observation, or Procedure
3.14.2.1
59
The value for “[Act | Observation | Procedure] / @moodCode” in a procedure
activity SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
3.14.2.1
59
A procedure activity SHALL contain at least one [Act | Observation | Procedure] /
id
3.14.2.1
59
A procedure activity SHALL contain exactly one [Act | Observation | Procedure] /
statusCode
3.14.2.1
59
The value for “[Act | Observation | Procedure] / statusCode” in a procedure
activity SHALL be selected from ValueSet 2.16.840.1.113883.1.11.20.15
ProcedureStatusCode STATIC 20061017
3.14.2.1
59
A procedure activity SHOULD contain exactly one [Act | Observation | Procedure] /
effectiveTime
3.14.2.1
59
A procedure activity SHALL contain exactly one [Act | Observation | Procedure] /
code
3.14.2.1
59
The value for “[Act | Observation | Procedure] / code” in a procedure activity
SHOULD be selected from LOINC (codeSystem 2.16.840.1.113883.6.1) or SNOMED CT
(codeSystem 2.16.840.1.113883.6.96), and MAY be selected from CPT-4 (codeSystem
2.16.840.1.113883.6.12), ICD9 Procedures (codeSystem 2.16.840.1.113883.6.104), ICD10
Procedure Coding System (codeSystem 2.16.840.1.113883.6.4)
3.14.2.1
59
A procedure activity MAY contain one or more [Observation | Procedure] /
methodCode if the method isn't inherent in [Observation | Procedure] / code or if there
is a need to further specialize the method in [Observation | Procedure] / code.
[Observation | Procedure] / methodCode SHALL NOT conflict with the method inherent in
[Observation | Procedure] / code
3.14.2.1
60
A procedure activity MAY contain one or more [Observation | Procedure] /
targetSiteCode to indicate the anatomical site or system that is the focus of the
procedure, if the site isn't inherent in [Observation | Procedure] / code or if there is
a need to further specialize the site in [Observation | Procedure] / code. [Observation
| Procedure] / targetSiteCode SHALL NOT conflict with the site inherent in [Observation
| Procedure] / code
3.14.2.1
60
A procedure activity MAY contain one or more location participations (templateId
2.16.840.1.113883.10.20.1.45) (see section 3.15.2.2 Encounter location), to represent
where the procedure was performed
3.14.2.1
60
A procedure activity MAY contain one or more [Act | Observation | Procedure] /
performer, to represent those practioners who performed the procedure
3.14.2.1
60
A procedure activity MAY contain one or more entryRelationship /
@typeCode=”RSON”, the target of which represents the indication or reason for the
procedure
3.14.2.1
60
[Act | Observation | Procedure] / entryRelationship / @typeCode=”RSON” in a
procedure activity SHALL have a target of problem act (templateId
2.16.840.1.113883.10.20.1.27), problem observation (templateId
2.16.840.1.113883.10.20.1.28), or some other clinical statement
3.14.2.1
60
A procedure activity MAY contain one or more patient instructions (templateId
2.16.840.1.113883.10.20.1.49) (see section 3.9.2.2.2 Patient instructions), to represent
any additional information provided to a patient related to the procedure
3.14.2.1
60
A procedure activity MAY have one or more associated consents, represented in the
CCD Header as ClinicalDocument / authorization / consent
3.14.2.1
60
A Procedure in a procedure activity MAY have one or more Procedure / specimen,
reflecting specimens that were obtained as part of the procedure
3.14.2.1
60
Procedure / specimen / specimenRole / id SHOULD be set to equal an Organizer /
specimen / specimenRole / id (see section 3.13 Results) to indicate that the Procedure
and the Results are referring to the same specimen
3.14.2.1
60
The value for “[Act | Observation | Procedure] / entryRelationship / @typeCode”
in a procedure activity MAY be “SUBJ” “Subject” 2.16.840.1.113883.5.1002
ActRelationshipType STATIC to reference an age observation (templateId
2.16.840.1.113883.10.20.1.38)
3.14.2.1
60
A procedure activity MAY have one or more [Act | Observation | Procedure] /
entryRelationship [@typeCode=”COMP”], the target of which is a medication activity
(templateId 2.16.840.1.113883.10.20.1.24) (see section 3.9.2.1.1 Medication activity),
to describe substances administered during the procedure
3.14.2.1
60
A procedure activity SHALL contain one or more sources of information, as defined
in section 5.2 Source
3.14.2.1
60
A procedure activity MAY have one or more [Act | Observation | Procedure] /
participant [@typeCode=”DEV”], the target of which is a product instance
template
3.14.2.2
61
A product instance (templateId 2.16.840.1.113883.10.20.1.52) SHALL be represented
with the ParticipantRole class
3.14.2.2
61
The value for “participantRole / @classCode” in a product instance SHALL be
“MANU” “Manufactured product” 2.16.840.1.113883.5.110 RoleClass STATIC
3.14.2.2
61
If participantRole in a product instance contains participantRole / id, then
participantRole SHOULD also contain participantRole / scopingEntity
3.14.2.2
61
[Act | Observation | Procedure] / participant / participantRole / id SHOULD be
set to equal a Supply / participant / participantRole / id (see section 3.9.2.4
Representation of a product) to indicate that the Procedure and the Supply are referring
to the same product instance
3.14.2.2
61
CCD SHOULD contain exactly one and SHALL NOT contain more than one Encounters
section (templateId 2.16.840.1.113883.10.20.1.3). The Encounters section SHALL contain a
narrative block, and SHOULD contain clinical statements. Clinical statements SHOULD
include one or more encounter activities (templateId
2.16.840.1.113883.10.20.1.21)
3.15
61
The encounters section SHALL contain Section / code
3.15.1
61
The value for “Section / code” SHALL be “46240-8” “History of encounters”
2.16.840.1.113883.6.1 LOINC STATIC
3.15.1
61
The encounters section SHALL contain Section / title
3.15.1
61
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “encounters”
3.15.1
61
An encounter activity (templateId 2.16.840.1.113883.10.20.1.21) SHALL be
represented with Encounter
3.15.2.1
62
The value for “Encounter / @classCode” in an encounter activity SHALL be “ENC”
2.16.840.1.113883.5.6 ActClass STATIC
3.15.2.1
62
The value for “Encounter / @moodCode” in an encounter activity SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
3.15.2.1
62
An encounter activity SHALL contain at least one Encounter / id
3.15.2.1
62
An encounter activity SHOULD contain exactly one Encounter / code
3.15.2.1
62
The value for “Encounter / code” in an encounter activity SHOULD be selected from
ValueSet 2.16.840.1.113883.1.11.13955 EncounterCode 2.16.840.1.113883.5.4 ActCode
DYNAMIC
3.15.2.1
63
An encounter activity MAY contain exactly one Encounter / effectiveTime, to
indicate date, time, and/or duration of an encounter
3.15.2.1
63
An encounter activity MAY contain one or more Encounter / entryRelationship,
whose value for “entryRelationship / @typeCode” SHALL be “RSON” “Has reason”
2.16.840.1.113883.5.1002 ActRelationshipType STATIC, where the target of the
relationship represents the indication for the activity
3.15.2.1
63
An encounter activity MAY contain one or more Encounter / performer, used to
define the practioners involved in an encounter
3.15.2.1
63
Encounter / performer MAY contain exactly one Encounter / performer /
assignedEntity / code, to define the role of the practioner
3.15.2.1
63
An encounter activity MAY contain one or more patient instructions (templateId
2.16.840.1.113883.10.20.1.49)
3.15.2.1
63
The value for “Encounter / entryRelationship / @typeCode” in an encounter
activity MAY be “SUBJ” “Subject” 2.16.840.1.113883.5.1002 ActRelationshipType STATIC to
reference an age observation (templateId 2.16.840.1.113883.10.20.1.38)
3.15.2.1
63
An encounter activity SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.15.2.1
63
An encounter activity MAY contain one or more location participations
3.15.2.2
63
A location participation (templateId 2.16.840.1.113883.10.20.1.45) SHALL be
represented with the participant participation
3.15.2.2
63
The value for “participant / @typeCode” in a location participation SHALL be
“LOC” 2.16.840.1.113883.5.90 ParticipationType STATIC
3.15.2.2
63
A location participation SHALL contain exactly one participant /
participantRole
3.15.2.2
63
The value for “participant / participantRole / @classCode” in a location
participation SHALL be “SDLOC” “Service delivery location” 2.16.840.1.113883.5.110
RoleClass STATIC
3.15.2.2
63
Participant / participantRole in a location participation MAY contain exactly one
participant / participantRole / code
3.15.2.2
63
The value for “participant / participantRole / code” in a location participation
SHOULD be selected from ValueSet 2.16.840.1.113883.1.11.17660
ServiceDeliveryLocationRoleType 2.16.840.1.113883.5.111 RoleCode DYNAMIC
3.15.2.2
63
Participant / participantRole in a location participation MAY contain exactly one
participant / participantRole / playingEntity
3.15.2.2
63
The value for “participant / participantRole / playingEntity / @classCode” in a
location participation SHALL be “PLC” “Place” 2.16.840.1.113883.5.41 EntityClass
STATIC
3.15.2.2
63
CCD SHOULD contain exactly one and SHALL NOT contain more than one Plan of Care
section (templateId 2.16.840.1.113883.10.20.1.10). The Plan of Care section SHALL
contain a narrative block, and SHOULD contain clinical statements. Clinical statements
SHALL include one or more plan of care activities (templateId
2.16.840.1.113883.10.20.1.25)
3.16
64
The plan of care section SHALL contain Section / code
3.16.1
64
The value for “Section / code” SHALL be “18776-5” “Treatment plan”
2.16.840.1.113883.6.1 LOINC STATIC
3.16.1
64
The plan of care section SHALL contain Section / title
3.16.1
64
Section / title SHOULD be valued with a case-insensitive language-insensitive
text string containing “plan”
3.16.1
64
A plan of care activity (templateId 2.16.840.1.113883.10.20.1.25) SHALL be
represented with Act, Encounter, Observation, Procedure, SubstanceAdministration, or
Supply
3.16.2.1
64
A plan of care activity SHALL contain at least one [Act | Encounter | Observation
| Procedure | SubstanceAdministration | Supply] / id
3.16.2.1
64
A plan of care activity SHALL contain exactly one [Act | Encounter | Observation
| Procedure | SubstanceAdministration | Supply] / @moodCode
3.16.2.1
64
The value for “[Act | Encounter | Procedure] / @moodCode” in a plan of care
activity SHALL be [“INT” (intent) | “ARQ” (appointment request) | “PRMS” (promise) |
“PRP” (proposal) | “RQO” (request)] 2.16.840.1.113883.5.1001 ActMood STATIC
3.16.2.1
64
The value for “[SubstanceAdministration | Supply] / @moodCode” in a plan of care
activity SHALL be [“INT” (intent) | “PRMS” (promise) | “PRP” (proposal) | “RQO”
(request)] 2.16.840.1.113883.5.1001 ActMood STATIC
3.16.2.1
65
The value for “Observation / @moodCode” in a plan of care activity SHALL be
[“INT” (intent) | “PRMS” (promise) | “PRP” (proposal) | “RQO” (request) | “GOL” (goal)]
2.16.840.1.113883.5.1001 ActMood STATIC
3.16.2.1
65
A plan of care activity SHALL contain one or more sources of information, as
defined in section 5.2 Source
3.16.2.1
65
The value for “ClinicalDocument / documentationOf / serviceEvent / performer /
@typeCode SHALL be “PRF” “Participation physical performer” 2.16.840.1.113883.5.90
ParticipationType STATIC
3.17
65
A value for “ClinicalDocument / documentationOf / serviceEvent / performer /
assignedEntity / id” MAY be the HIPAA National Provider Identifier
3.17
65
A value for “ClinicalDocument / documentationOf / serviceEvent / performer /
assignedEntity / code” MAY be the National Uniform Claims Committee Provider Taxonomy
Code
3.17
66
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
4.1
80
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
4.1
80
There shall be a one-to-one relationship between entity identifiers in a CDA and
ActorID as represented in the CCR data set
4.1
80
A clinical statement in a CCD section MAY contain one or more Observation /
reference / externalDocument, to represent externally an externally referenced
document
4.2
81
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
4.2
81
An externally referenced document MAY contain exactly one Observation / reference
/ ExternalDocument / text / @mediaType, to indicate the MIME type of the referenced
document
4.2
81
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)
4.2
81
A CCD section MAY contain one or more comments, either as a clinical statement or
nested under another clinical statement
4.3
81
A comment (templateId 2.16.840.1.113883.10.20.1.40) SHALL be represented with
Act
4.3
81
The value for “Act / @classCode” in a comment SHALL be “ACT”
2.16.840.1.113883.5.6 ActClass STATIC
4.3
81
The value for “Act / @moodCode” in a comment SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
4.3
81
A comment SHALL contain exactly one Act / code
4.3
81
The value for “Act / code” in a comment SHALL be 48767-8 “Annotation comment”
2.16.840.1.113883.6.1 LOINC STATIC
4.3
81
A status observation (templateId 2.16.840.1.113883.10.20.1.57) SHALL be
represented with Observation
5.1
86
A status observation SHALL be the target of an entryRelationship whose value for
“entryRelationship / @typeCode” SHALL be “REFR” 2.16.840.1.113883.5.1002
ActRelationshipType STATIC
5.1
86
The value for “Observation / @classCode” in a status observation SHALL be “OBS”
2.16.840.1.113883.5.6 ActClass STATIC
5.1
86
The value for “Observation / @moodCode” in a status observation SHALL be “EVN”
2.16.840.1.113883.5.1001 ActMood STATIC
5.1
86
A status observation SHALL contain exactly one Observation / code
5.1
86
The value for “Observation / code” in a status observation SHALL be “33999-4”
“Status” 2.16.840.1.113883.6.1 LOINC STATIC
5.1
86
A status observation SHALL contain exactly one Observation /
statusCode
5.1
86
The value for “Observation / statusCode” in a status observation SHALL be
“completed” 2.16.840.1.113883.5.14 ActStatus STATIC
5.1
86
A status observation SHALL contain exactly one Observation / value, which SHALL
be of datatype “CE”
5.1
86
A status observation SHALL NOT contain any additional Observation
attributes
5.1
86
A status observation SHALL NOT contain any Observation participants
5.1
86
A status observation SHALL NOT be the source of any Observation
relationships
5.1
86
A person source of information SHALL be represented with informant
5.2
87
An organization source of information SHALL be represented with
informant
5.2
87
A reference source of information SHALL be represented with reference [@typeCode
= “XCRPT”]
5.2
87
Any other source of information SHALL be represented with a source of information
observation
5.2
87
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
5.2
87
A source of information observation SHALL be represented with
Observation
5.2
87
The value for “Observation / @classCode” in a source of information observation
SHALL be “OBS” 2.16.840.1.113883.5.6 ActClass STATIC
5.2
87
The value for “Observation / @moodCode” in a source of information observation
SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC
5.2
87
A source of information observation SHALL contain exactly one Observation /
statusCode
5.2
87
The value for “Observation / statusCode” in a source of information observation
SHALL be “completed” 2.16.840.1.113883.5.14 ActStatus STATIC
5.2
87
A source of information observation SHALL contain exactly one Observation /
code
5.2
87
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
5.2
87
A source of information observation SHALL contain exactly one Observation /
value
5.2
87
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”
5.2
87
When representing the any of the coding systems listed above, the codeSystem
attribute shall be present using the values listed in that table
5.5.2
98
When the codeSystemName attribute is present, it shall be valued with the
appropriate values from Table 18 above
5.5.2
98
Where SNOMED CT is used, it shall be used per the “Using SNOMED CT in HL7 Version
3” Implementation Guide
5.5.2
98
An assignedPerson, informationRecipient, maintainingPerson, guardianPerson,
relatedPerson, associatedPerson or subject MAY include an id element from the
urn:hl7-org:sdtc namespace to uniquely identify the person
7.4.1
110
The id element SHALL use the instance identifier (II) data type
7.4.1
110
The id element SHALL appear just before the name element of the
entity
7.4.1
110
A subject MAY include a deceasedInd element from the urn:hl7-org:sdtc namespace
to indicate whether the person is deceased
7.4.2
110
The deceasedInd element SHALL be of the Boolean (BL) data type
7.4.2
110
The deceasedInd element SHALL appear immediately following the birthTime
element
7.4.2
110
A subject MAY include a deceasedTime element from the urn:hl7-org:sdtc namespace
to indicate when the person died
7.4.2
110
The deceasedTime element SHALL be of the Time Stamp (TS) data type
7.4.2
110
The deceasedTime element SHALL appear immediately following the deceasedInd
element
7.4.2
110
sdtc:asPatientRelationship SHALL contain exactly one sdtc:asPatientRelationship /
@classCode, valued with “PRS”
7.4.3
111
sdtc:asPatientRelationship SHALL contain exactly one sdtc:asPatientRelationship /
code, of datatype CE
7.4.3
111
The value for “sdtc:asPatientRelationship / code” SHOULD be selected from
ValueSet 2.16.840.1.113883.1.11.19579 FamilyHistoryRelatedSubjectCode DYNAMIC or
2.16.840.1.113883.1.11.20.21 FamilyHistoryPersonCode DYNAMIC
7.4.3
111
An informant SHALL NOT contain any relatedPerson / sdtc:asPatientRelationship
elements
7.4.3
111