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HL7/ASTM Implementation Guide for CDA Release 2 –
Continuity of Care Document
Based on HL7 CDA Release 2.0 and ASTM CCR (E 2369-05)
Editor:
Robert H. Dolin, MD
Kaiser Permanente
robert.h.dolin@kp.org
Editor
Editor:
Editor:
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1st Informative Ballot
March 26, 2006
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Table of Contents
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1.1
1.2
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TERMINOLOGY CONFORMANCE ....................................................................................................... 5
CCD HEADER ..................................................................................................................................... 6
3.1
3.2
3.3
4
SCOPE.............................................................................................................................................. 4
APPROACH ...................................................................................................................................... 4
GENERAL CONSTRAINTS............................................................................................................... 5
2.1
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INTRODUCTION ................................................................................................................................ 4
<DATETIME> .................................................................................................................................. 6
<IDS>.............................................................................................................................................. 6
<SOURCE>....................................................................................................................................... 6
CCD BODY ........................................................................................................................................... 7
4.1
PROTOTYPE SECTION....................................................................................................................... 7
4.2
FUNCTIONAL STATUS ...................................................................................................................... 7
4.3
PROBLEMS ....................................................................................................................................... 7
4.4
FAMILY HISTORY ............................................................................................................................ 7
4.5
SOCIAL HISTORY ............................................................................................................................. 7
4.6
ALLERGIES AND ADVERSE REACTIONS ........................................................................................... 8
4.7
MEDICATIONS ................................................................................................................................. 8
4.8
IMMUNIZATIONS .............................................................................................................................. 8
4.9
VITAL SIGNS ................................................................................................................................... 8
4.10 RESULTS .......................................................................................................................................... 8
4.10.1
Section conformance............................................................................................................... 8
4.10.2
Clinical statement conformance ............................................................................................. 8
4.10.3
Extensions ..............................................................................................................................10
4.10.4
ASTM CCR Mapping .............................................................................................................10
4.10.5
Example .................................................................................................................................11
4.10.5.1
Rendered ........................................................................................................................11
4.10.5.2
CDA-encoded ................................................................................................................11
4.10.5.3
CCR-encoded.................................................................................................................13
4.11 PROCEDURES ..................................................................................................................................15
4.12 ENCOUNTERS .................................................................................................................................15
4.13 PLAN OF CARE................................................................................................................................16
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REFERENCES ....................................................................................................................................17
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APPENDIX ..........................................................................................................................................18
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Figures
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Figure 1. CDA R2 clinical statement model for results ..................................... 8
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Tables
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Table 1. ASTM CCR TABLE A2.13 <Result> Object Type Definition Table ....... 10
Table 2. ASTM CCR TABLE A2.14 TestType Definition Table .......................... 10
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1 Introduction
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1.1 Scope
The purpose of this document is to describe constraints on the HL7 Clinical Document Architecture,
Release 2 (CDA) specification in accordance with requirements set forward in the ASTM Continuity of
Care Record (CCR) specification.
The CCR is a core data set of the most relevant administrative, demographic, and clinical information facts
about a patient's healthcare, covering one or more healthcare encounters. It provides a means for one
healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward
it to another practitioner, system, or setting to support the continuity of care. The primary use case for the
CCR is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative
data for a specific patient.
The CDA is a document markup standard that specifies the structure and semantics of clinical documents
for the purpose of exchange. From its inception, CDA has supported the ability to represent professional
society recommendations, national clinical practice guidelines, and standardized data sets. From the
perspective of CDA, the CCR is a standardized data set that can be used to constrain CDA specifically for
summary documents.
The resulting specification, known as the Continuity of Care Document (CCD), is developed as a
collaborative effort between ASTM and HL7.
1.2 Approach
The approach taken in the development of this specification is intended to reflect the ASTM CCR
requirements in an HL7 CDA R2 framework, and to do so in such a way that CDA in constrained in
accordance with models being developed by other HL7 committees.
The general steps taken include:
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Review a section of CCR, focusing on identifying the data requirements. For instance, review the CCR
section describing the representation of lab results.
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Review overlapping HL7 domain models to see how similar data requirements have been represented.
For instance, review the domain model from the Lab committee to see how it accommodates lab
results.
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Review additional relevant references and standards for further cross-validation of requirements.

Represent the CCR data requirements as a set of constraints against the HL7 Clinical Statement model,
in a way that is isomorphic to existing HL7 domain models. This constrained Clinical Statement model
can then be used by any HL7 committee wanting to implement similar requirements in their own
specifications.

Reflect the Clinical Statement constraints as constraints against CDA R2, making minor adjustments as
necessary to accommodate the differences between the models.
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2 General constraints
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2.1 Terminology conformance
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CONF-1:
Where SNOMED CT is used, it SHALL be used per the "Using SNOMED CT in HL7
Version 3" Implementation Guide.
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3 CCD Header
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3.1 <DateTime>
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3.2 <IDs>
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3.3 <Source>
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From ASTM CCR:
Used to define the person, system, or institution that is the <Source> of the data. Source can be a
link to an <Actor> with an <ActorRole> or a <Reference>. <Source> also has children
<DateTime> and <Comment>. <Source> is required of all CCRDataObjects. This is so that any
data within the CCR can be validated as to its origin/source. Can be a link to a laboratory,
healthcare provider, the patient, their parent, child, relative, guardian, durable power, a healthcare
record, etc.
CDA R2 distinguishes between an informant participant and an excerpt relationship. The distinction can be
blurry at times - such as in the case of recording a patient's medication history where the clinician may
obtain the information from an informant or may excerpt the information from a pharmacy computer
system. An informant is a person who provides relevant information. An informant class is in the header,
and can be overridden in the body. An excerpt is a sub portion of some other act.
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4.1 Prototype Section
NOTE: This section will be removed from the document. It is here to ensure consistency between
the sections as they are developed by different editors.

Section
[General introduction to the section, described mainly in narrative. Needs to define the scope of
the section as precisely as possible.]
o Section conformance
[Conformance rules for the section, using formal conformance verbs. Includes section
cardinality and section.code value at a minimum. May also give guidance on
section.title.]
o Clinical statement conformance
[Conformance rules for the entries, using formal conformance verbs. Things not
specifically precluded are allowed. Include a figure that is a subset of the CDA Clinical
Statement model containing those classes being constrained or referred to ]
o Extensions
[Extensions to the model are summarized here.]
o ASTM CCR Mapping
[Use the definition tables from the CCR appendix for the scope of mapping. Add columns
for CDA R2 correspondence and for comments. Include comments relevant to mapping in
either direction.]
o Example
 Rendered
[Examples do not add new conformance requirements. They are intended to help
the reader understand the specification.]
 CDA-encoded
[Examples do not add new conformance requirements. They are intended to help
the reader understand the specification.]
 CCR-encoded
[CCR example corresponds to the CDA example]
4.2 Functional Status
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4.3 Problems
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4.4 Family History
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4.5 Social History
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4.6 Allergies and Adverse Reactions
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4.7 Medications
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4.8 Immunizations
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4.9 Vital Signs
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4.10 Results
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This section contains the results of observations typically generated by laboratories providing analytic
services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology,
microbiology, and/or virology. These observations are based on analysis of specimens obtained from the
patient, submitted to the lab.
CONF-2:
This section MAY contain all results for the period of time being summarized, but
SHOULD include notable results such as abnormal values or relevant trends.
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4.10.1
Section conformance
CONF-3:
This section MAY be present, and SHALL NOT be present more than once.
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CONF-4:
If present, the section SHALL include section.code, which SHALL be valued with
LOINC 30954-2 (RELEVANT DIAGNOSTIC TESTS AND/OR LABORATORY
DATA).
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CONF-5:
If present, the section SHALL include section.title, which SHOULD be valued with a
text string containing "results".
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4.10.2
Clinical statement conformance
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Figure 1 shows a subset of the CDA Clinical Statement model containing those classes being constrained or
referred to in the conformance statements that follow. Other portions of the model may be used (e.g. the
Procedure class, the Organizer class), but are not included in the figure since there are no constraints
currently defined for them.
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Figure 1. CDA R2 clinical statement model for results
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CONF-6:
Results SHALL include Observation.moodCode, which SHALL be valued with
"EVN".
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CONF-7:
Results SHOULD include Observation.id.
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CONF-8:
Results SHALL include Observation.code, which SHOULD be valued with a LOINC
or SNOMED CT code. Other codes, such as CPT codes, MAY be included as
translations.
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CONF-9:
Results SHALL include Observation.value. Where the value is a physical quantity, the
units of measure SHALL be expressed using a valid UCUM expression.
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CONF-10:
Results SHALL include Observation.statusCode.
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CONF-11:
Results SHALL include Observation.effectiveTime.
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CONF-12:
Results SHOULD include Observation.interpretationCode, which can be used to
provide a rough qualitative interpretation of the observation, such as "normal",
"abnormal", resistant", "susceptible", etc.
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CONF-13:
Results MAY include 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. If present, it SHALL NOT conflict with the method inherent in
Observation.code.
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CONF-14:
Results SHOULD include Observation.referenceRange to show the normal range of
values for the observation result. If present, it SHALL include ObservationRange.code,
which SHALL be valued the same as Observation.code.
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CONF-15:
Results SHOULD include Observation.specimen if the specimen isn't inherent in
Observation.code. If present, it SHALL NOT conflict with the specimen inherent in
Observation.code.
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Often times, an ordered test is reported with multiple component results (e.g. Complete Blood Count,
Chemistry Panel), in which case the following conformance rules apply:
CONF-16:
Where an ordered test is reported with multiple component results (e.g. Complete Blood
Count, Chemistry Panel), the result SHALL be represented as an Observation
representing the ordered test, with nested component Observations representing each
component result.
CONF-17:
The outer Observation representing the ordered test SHALL NOT include
Observation.value.
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CONF-18:
The outer Observation representing the ordered test SHALL have an entryRelationship
link to each component result. Each entryRelationship SHALL have an
entryRelationship.typeCode, which SHALL be valued with "COMP".
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CONF-19:
Each component result SHALL be an Observation.
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CONF-20:
The absence of Observation.statusCode on a component result SHALL imply that the
status of the result equals the status of the outer Observation.
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CONF-21:
The absence of Observation.effectiveTime on a component result SHALL imply that
the effective time of the result equals the effective time of the outer Observation.
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4.10.3
Extensions
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4.10.4
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Table 1. ASTM CCR TABLE A2.13 <Result> Object Type Definition Table
There are no extensions to the CDA R2 model for results.
ASTM CCR Mapping
CCR data element
<Results>
<Result>
<DateTime>
<IDs>
<Type>
CDA R2 correspondence
Section
Observation
Observation.effectiveTime
Observation.id
-no correspondence-
Comments
ASTM: Values include: Hematology, Chemistry,
Serology, Virology, Toxicology, Microbiology,
Imaging - X-ray, Ultrasound, CT, MRI, Angiography,
Cardiac Echo, Nuclear Medicine, Pathology,
Procedure.
HL7: Infer values from observation.code (e.g. by
looking at the LOINC class for a LOINC code).
<Description>
<Status>
<Procedure>
Observation.code
Observation.statusCode
Observation.methodCode;
Procedure
ASTM: The use of <Procedure> under <Result>
should be reserved for instances where listing the
<Procedure> has direct clinical relevance to the
<Result> or when the <Procedure> used to obtain the
<Result> is not obvious or is atypical or specialized.
HL7: Can potentially map to Observation.methodCode
or to a related Procedure that is linked via an
entryRelationship.
<Substance>
<Test>
Observation.specimen
Observation
HL7: An observation can have nested component
observations.
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Table 2. ASTM CCR TABLE A2.14 TestType Definition Table
CCR data element
<Test>
<DateTime>
<IDs>
<Type>
CDA R2 correspondence
Observation
Observation.effectiveTime
Observation.id
Observation.moodCode
Comments
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CCR data element
<Description>
<Status>
<Method>
<Agent>
CDA R2 correspondence
Observation.code
Observation.statusCode
Observation.methodCode
Observation.participant
Comments
<TestResult>
<NormalResult>
<Flag>
<ConfidenceValue>
Observation.value
Observation.referenceRange
Observation.interpretationCode
Observation.value
ASTM: Used to define a specific agent in
relation to a <Test>, such as a drug name for
microbiology/culture sensitivities.
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4.10.5
Example
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4.10.5.1
Rendered
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This example shows how the results of a Complete Blood Count and Chemistry Panel might be rendered.
RESULTS
April 07, 2000
Hematology
HGB (M 13-18 g/dl; F 12-16 g/dl)
WBC (4.3-10.8 10+3/ul)
PLT (150-350 10+3/ul)
Chemistry
NA (135-145meq/l)
K (3.5-5.0 meq/l)
CL (98-106 meq/l)
HCO3 (18-23 meq/l)
May 10, 2000
13.2
6.7
123*
140
4.0
102
35*
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CDA-encoded
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This example shows how the rendered results above can be represented in CDA R2.
<section>
<code code="30954-2" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC"/>
<title>RESULTS</title>
<text>
<table border="1">
<thead>
<tr><th> </th><th>April 07, 2000</th><th>May 10, 2000</th></tr>
</thead>
<tbody>
<tr><td colspan="3">Hematology</td></tr>
<tr><td>HGB (M 13-18 g/dl; F 12-16 g/dl)</td><td>13.2</td><td> </td></tr>
<tr><td>WBC (4.3-10.8 10+3/ul)</td><td>6.7</td><td> </td></tr>
<tr><td>PLT (135-145 meq/l)</td><td>123*</td><td> </td></tr>
<tr><td colspan="3">Chemistry</td></tr>
<tr><td>NA (135-145meq/l)</td><td> </td><td>140</td></tr>
<tr><td>K (3.5-5.0 meq/l)</td><td> </td><td>4.0</td></tr>
<tr><td>CL (98-106 meq/l)</td><td> </td><td>102</td></tr>
<tr><td>HCO3 (18-23 meq/l)</td><td> </td><td>35*</td></tr>
</tbody>
</table>
</text>
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<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
<id root="2.16.840.1.113883.19" extension="1"/>
<code code="43789009" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="CBC WO DIFFERENTIAL"/>
<statusCode code="completed"/>
<effectiveTime value="200004071430"/>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<id root="2.16.840.1.113883.19" extension="2"/>
<code code="30313-1" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="HGB"/>
<value xsi:type="PQ" value="13.2" unit="g/dl"/>
<referenceRange>
<observationRange>
<code code="30313-1" codeSystem="2.16.840.1.113883.6.1"/>
<text>M 13-18 g/dl; F 12-16 g/dl</text>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<id root="2.16.840.1.113883.19" extension="3"/>
<code code="33765-9" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="WBC"/>
<value xsi:type="PQ" value="6.7" unit="10+3/ul"/>
<referenceRange>
<observationRange>
<code code="33765-9" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="4.3" unit="10+3/ul"/>
<high value="10.8" unit="10+3/ul"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<id root="2.16.840.1.113883.19" extension="4"/>
<code code="26515-7" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="PLT"/>
<value xsi:type="PQ" value="123" unit="10+3/ul"/>
<interpretationCode code="L" codeSystem="2.16.840.1.113883.5.83"/>
<referenceRange>
<observationRange>
<code code="26515-7" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="150" unit="10+3/ul"/>
<high value="350" unit="10+3/ul"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
</observation>
</entry>
<entry typeCode="DRIV">
<observation classCode="OBS" moodCode="EVN">
<code code="20109005" codeSystem="2.16.840.1.113883.6.96"
codeSystemName="SNOMED CT" displayName="LYTES"/>
<statusCode code="completed"/>
<effectiveTime value="200005101430"/>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<code code="2951-2" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="NA"/>
<value xsi:type="PQ" value="140" unit="meq/l"/>
<referenceRange>
<observationRange>
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<code code="2951-2" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="135" unit="meq/l"/>
<high value="145" unit="meq/l"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<code code="2823-3" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="K"/>
<value xsi:type="PQ" value="4.0" unit="meq/l"/>
<referenceRange>
<observationRange>
<code code="2823-2" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="3.5" unit="meq/l"/>
<high value="5.0" unit="meq/l"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<code code="2075-0" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="CL"/>
<value xsi:type="PQ" value="102" unit="meq/l"/>
<referenceRange>
<observationRange>
<code code="2075-0" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="98" unit="meq/l"/>
<high value="106" unit="meq/l"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
<entryRelationship typeCode="COMP">
<observation classCode="OBS" moodCode="EVN">
<code code="1963-8" codeSystem="2.16.840.1.113883.6.1"
codeSystemName="LOINC" displayName="HCO3"/>
<value xsi:type="PQ" value="35" unit="meq/l"/>
<interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>
<referenceRange>
<observationRange>
<code code="1963-8" codeSystem="2.16.840.1.113883.6.1"/>
<value xsi:type="IVL_PQ"/>
<low value="18" unit="meq/l"/>
<high value="23" unit="meq/l"/>
</value>
</observationRange>
</referenceRange>
</observation>
</entryRelationship>
</observation>
</entry>
</section>
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This example shows how the rendered results above can be represented in ASTM CCR XML markup.
CCR-encoded
<Results>
<Result>
<CCRDataObjectID>2.16.840.1.113883.19.1</CCRDataObjectID>
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<DateTime>
<Type>
<Text>Assessment Time</Text>
</Type>
<ExactDateTime>2000-04-07T14:30Z</ExactDateTime>
</DateTime>
<Type>
<Text>Hematology</Text>
</Type>
<Description>
<Text>CBC WO DIFFERENTIAL</Text>
<Code>
<Value>43789009</Value>
<CodingSystem>SNOMED CT</CodingSystem>
</Code>
</Description>
<Status>
<Text>Final Results</Text>
</Status>
<Source/>
<Test>
<CCRDataObjectID>2.16.840.1.113883.19.2</CCRDataObjectID>
<Type>
<Text>Result</Text>
</Type>
<Description>
<Text>HGB</Text>
<Code>
<Value>30313-1</Value>
<CodingSystem>LOINC</CodingSystem>
</Code>
</Description>
<Source/>
<TestResult>
<Value>13.2</Value>
<Units>
<Unit>g/dl</Unit>
</Units>
</TestResult>
<NormalResult>
<Normal>
<Description>
<Text>M 13-18 g/dl; F 12-16 g/dl</Text>
</Description>
<Source/>
</Normal>
</NormalResult>
</Test>
<Test>
<CCRDataObjectID>2.16.840.1.113883.19.2</CCRDataObjectID>
<Type>
<Text>Result</Text>
</Type>
<Description>
<Text>WBC</Text>
<Code>
<Value>33765-9</Value>
<CodingSystem>LOINC</CodingSystem>
</Code>
</Description>
<Source/>
<TestResult>
<Value>6.7</Value>
<Units>
<Unit>10+3/ul</Unit>
</Units>
</TestResult>
<NormalResult>
<Normal>
<Value>4.3</Value>
<Units>
14
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2
3
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5
6
7
8
9
10
11
12
13
14
15
16
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18
19
20
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<Unit>10+3/ul</Unit>
</Units>
<ValueSequencePosition>1</ValueSequencePosition>
<Source/>
</Normal>
<Normal>
<Value>10.8</Value>
<Units>
<Unit>10+3/ul</Unit>
</Units>
<ValueSequencePosition>2</ValueSequencePosition>
<VariableNormalModifier>
<Text>TO</Text>
</VariableNormalModifier>
<Source/>
</Normal>
</NormalResult>
</Test>
<Test>
<CCRDataObjectID>2.16.840.1.113883.19.2</CCRDataObjectID>
<Type>
<Text>Result</Text>
</Type>
<Description>
<Text>PLT</Text>
<Code>
<Value>123</Value>
<CodingSystem>LOINC</CodingSystem>
</Code>
</Description>
<Source/>
<TestResult>
<Value>153</Value>
<Units>
<Unit>10+3/ul</Unit>
</Units>
</TestResult>
<NormalResult>
<Normal>
<Value>150</Value>
<Units><Unit>10+3/ul</Unit></Units>
<ValueSequencePosition>1</ValueSequencePosition>
<Source/>
</Normal>
<Normal>
<Value>350</Value>
<Units><Unit>10+3/ul</Unit></Units>
<ValueSequencePosition>2</ValueSequencePosition>
<VariableNormalModifier>
<Text>TO</Text>
</VariableNormalModifier>
<Source/>
</Normal>
</NormalResult>
<Flag>
<Text>LOW</Text>
</Flag>
</Test>
</Result>
</Results>
62
4.11 Procedures
63
64
4.12 Encounters
65
15
1
4.13 Plan of Care
2
16
1
2
3
4
5
6
7
8
9
10
11
12
13
5 References
1.
2.
3.
4.
5.
6.
7.
8.
ASTM CCR
Primary HL7 Domain Committee(s) models (e.g. Orders/Observation lab model).
HL7 Care Record Summary
IHE PCC Technical Framework Volume 3 (available at www.ihe.net)
HL7 CDA R2
HL7 V3 reference material (e.g. RIM, datatypes, vocabulary)
HL7 Claims attachments documents
HL7 Clinical Statement Model
17
1
6 Appendix
2
3
4
5
18