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The Results domain in Clinical Data Spaces (CDS) collates information from both Results and Vital Signs sections in a CCD. There are two separate validation checklists, one for Results and another for Vital Signs, to align with the two separate CCD sections.

The Results section contains observations of results generated by laboratories, imaging procedures, and other procedures. The scope includes observations such as hematology, chemistry, virology, plain x-ray, CT, MRI, and procedure observations. The section often includes notable results such as abnormal values or relevant trends, and could contain all results for the period of time being documented. There is a separate Entry section for each result organizer and a Component section for each result observation.

This topic details the data elements that must be present in the Results section of a Continuity of Care Document (CCD) for it to be processed in the Clinical:ResultsCcda data space (hosted in Data Engine).

(R) - Required elements for the Results section and its sub-sections to be processed correctly in the Clinical:ResultsCCDA data space.

(O) - Optional elements that are processed if provided in correct format.

Required  (R)  elements that are children of an Optional  (O)  element are only required for the immediate parent element to be processed.

Results Section Details

Results Section Template ID

component/section/templateId

Specifies which CCDA R2.1 template is being used to determine the requirements, format and structure of the information this subsection.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.3.1”/>
	</section>
</component>
...
SectionElementAttributeValueNotes
ResultstemplateIdrootMust be 2.16.840.1.113883.10.20.22.2.3.1The unique identifier for the CCDA R2.1 template that defines the requirements, format and structure for the entire Results section in Continuity of Care Documents (CCDs).

Results Section Code

component/section/code

Indicates that this section is detailing results information.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.3.1”/>
		<code code=”30954-2” codeSystem=”2.16.840.1.113883.6.1” codeSystemName=”LOINC” displayName=”RESULTS”/>
	</section>
</component>
...
SectionElementAttributeValueNotes
ResultscodecodeMust be 30954-2In the Logical Observation Identifiers Names and Codes (LOINC) coding system this alphanumeric string (or 'code') represents the Results document.
codeSystemMust be 2.16.840.1.113883.6.1The unique numerical identifier for the Logical Observation Identifiers Names and Codes (LOINC) coding system. This system will be used to resolve the value in the code attribute.
codeSystemNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the code system.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the template section.

Results Section Confidentiality Code

component/section/confidentialityCode

Indicates the level of security that should be applied to this Results section. The level of security that should be applied is typically driven by the guidelines of the system that generated the CCD.

...
<component>
	<section>
		<templateId root=”2.16.840.1.113883.10.20.22.2.3.1”/>
		<confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25"/>
	</section>
</component>
...
SectionElementAttributeValueNotes
Results
confidentialityCode
codeMust include an alphanumeric string of any length. The HL7-supported confidentiality coding system is typically used, where security levels are indicated as:
  • U - unrestricted
  • L - low
  • N - normal
  • - moderate
  • R - restricted
  • V - very restricted

If no code attribute is present, a nullFlavor attribute MUST be present instead. Otherwise, the code element will not be processed. Refer to How nullFlavor Values are Processed in Coded Elements for details on nullFlavor attributes.

codeSystemMust include an alphanumeric string of any length, typically in the following format: 2.16.840.1.113883.X.XX.X. The HL7-supported confidentiality coding system is indicated by 2.16.840.1.113883.5.25A numerical string that specifies which system will be used to translate the identifier provided in the code attribute.

Result Organizer

component/section/entry/organizer

This sub-section provides a structure for grouping result observations. It contains information applicable to all of the observations in the results section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				...
			</organizer>
		</entry>
	</section>
</component>
...
SectionElementAttributeValueNotes
Result Organizer

organizer

classCode

Must be one of the following:

  • BATTERY
  • CLUSTER
  • The value "BATTERY' is used when the contents of the organizer are a group of related clinical acts (typically, observations) in a flat list, as would be the case in a battery of tests.
  • The value "CLUSTER" is used for more complex organizer constructs with nested organizer elements.
moodCodeMust be EVNIndicates that this entry is an event (EVN) that has happened or is an ongoing act, or was documented from a past act.

Result Organizer Template ID

component/section/entry/organizer/templateId

Specifies which CCDA R2.1 template is being used to structure the results organizer sub-section. R2.1 templates define the requirements, format, and structure of a CCD section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Organizer

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.1

Uniquely identifies the results organizer sub-section.

Result Organizer ID

component/section/entry/organizer/id

Specifies the unique identifier for the organization responsible for organizing the results contained within this sub-section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<id root="7d5a02b0-67a4-11db-bd13-0800200c9a66" extension="4562-123"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Organizer

id

root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example:

  • OID: 2.16.840.1.113883.x.xx.x or 
  • UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4

Uniquely identifies the results organizer sub-section.

extension Can be an alphanumeric string of any length.This attribute is optional. Part of the information that uniquely identifies the organization.

Result Organizer Code

component/section/entry/organizer/code

Categorizes the results contained in the Results Observation sub-section into one of several commonly accepted values.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<code code="43789009" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="CBC WO DIFFERENTIAL"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Organizer

code

codeMust be an alphanumeric string that represents the procedure activity from various coding systems (such as SNOMED CT or LOINC). 
codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.
codeSystemNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the code system.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name of the category for the grouped results.

Result Organizer Status Code

component/section/entry/organizer/statusCode

Indicates the current status of the results grouping.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<statusCode code="active"/>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Organizer

statusCode

code

Must be one of the following:

  • aborted
  • active
  • cancelled
  • completed
  • held
  • suspended
 

Result Organizer Effective Time

component/section/entry/organizer/effectiveTime

Specifies the date and time the group of results was obtained. Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<effectiveTime xsi:type="IVL_TS">
					<low value="200803190830-0800"/>
					<high value="200803190830-0800"/>
				</effectiveTime>
			</organizer>
		</entry>
	</section>
</component>
...

Result Organizer Author

component/section/entry/organizer/author

Specifies information of the person responsible for grouping the result observation. Refer to Assigned Author Element for more details on what information can be available for the author section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<author>
					<assignedAuthor>
						<id root="1.3.6.1.4.1.22812.4.10025422.0" extension="10007"/>
					</assignedAuthor>
					<time value="200803190830-0800"/>
				</author>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Organizer
  • author
    • assignedAuthor
      • id
root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example:

  • OID: 2.16.840.1.113883.x.xx.x or 
  • UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4
 
extensionCan be an alphanumeric string of any length.This attribute is optional. Part of the information that uniquely identifies the person documenting the Result Organizer section.
  • author
    • time
valueMust be populated with a date in the format YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] where +/-ZZZZ specifies the offset from Coordinated Universal Time.Indicates the specific time the author grouped the results.

Result Observation

component/section/entry/organizer/component/observation

This sub-section represents the result of a laboratory, radiology or other study performed on a patient.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						...
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

observation

classCode

Must be OBS

Specifies the general nature of the entry, which in this case is an observation (OBS).
moodCodeMust be EVNIndicates that this entry is an event (EVN) that has happened or is an ongoing activity, or was documented from a past activity.

Result Observation Template ID

component/section/entry/organizer/component/observation/templateId

Specifies which CCDA R2.1 template is being used to structure the result observation sub-section. R2.1 templates define the requirements, format, and structure of a CCD section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

templateId

root

Must be 2.16.840.1.113883.10.20.22.4.2

Uniquely identifies the result observation sub-section.

Result Observation Code

component/section/entry/organizer/component/observation/code

Specifies the type of result observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<code code="30313-1" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="HGB"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

code

code

Must be an alphanumerical value.

Must be a code from the Logical Observation Identifiers Names and Codes (LOINC) code system that identifies the result observation.
codeSystemMust be 2.16.840.1.113883.6.1The unique numerical identifier for the LOINC coding system. This system will be used to resolve the value in the code attribute.
codeSystemNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the code system.
displayNameCan be an alphanumerical string of any lengthThis attribute is optional. A human readable display name for the template section.

Result Observation Status Code

component/section/entry/organizer/component/observation/statusCode

Indicates the current status of the result observation.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<statusCode code="completed"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

statusCode

code

Must be one of the following:

  • aborted
  • active
  • cancelled
  • completed
  • held
  • suspended
 

Result Observation Effective Time

component/section/entry/organizer/component/observation/effectiveTime

Specifies the date and time the result observation was obtained. Represents the biologically relevant time of the measurement (for example, the time a blood pressure reading was obtained or the time a blood sample was obtained). Refer to How Effective Time values are processed for details on the different ways effectiveTime information can be processed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<effectiveTime value="200803190830-0800"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...

Result Observation Value

component/section/entry/organizer/component/observation/value

Indicates the value of the result observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<value xsi:type="PQ" value="13.2" unit="g/dl"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

value

xsi:type

Must be one of the following:

  • IVL_PQ
  • CD
  • SC
  • ST
  • PQ
  • INT
  • REAL
  • RTO_PQ_PQ
  • ED
  • IVL_TS
  • TS

 

Result Observation ID

component/section/entry/organizer/component/observation/id

Specifies the unique identifier for the organization responsible for the result observation contained within this sub-section.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<id root="107c2dc0-67a5-11db-bd13-0800200c9a66" extension="89371"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

id

root

Must be an alphanumeric string in an OID (object identifier) or UUID (universally unique identifier) format. 

For example:

  • OID: 2.16.840.1.113883.x.xx.x or 
  • UUID: 53459040-b1b4-49ed-ae1f-a52c8c502df4
 
extensionCan be an alphanumerical string of any lengthUniquely identifies the organization responsible for the result observation contained within this sub-section.

Result Observation Interpretation Code

component/section/entry/organizer/component/observation/interpretationCode

Indicates how the observed result was interpreted.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

interpretationCode

code

Must be an alphanumeric string from ValueSet Observation Interpretation (HL7). For example:

  • A - abnormal
  • B - better
  • C - carrier
  • D - decreased
  • HX - above high threshold
  • IND - indeterminate
  • MS - moderately susceptible

 

codeSystemMust be an alphanumeric string of any length in the following format:  2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Result Observation Method Code

component/section/entry/organizer/component/observation/methodCode

Indicates the method used to observe the result.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<methodCode code="1404" codeSystem="2.16.840.1.113883.5.84"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

methodCode

code

Must be an alphanumeric string of any length.

 

codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Result Observation Target Site Code

component/section/entry/organizer/component/observation/targetSiteCode

Indicates the specific site where the result was observed.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<targetSiteCode code="302539009" codeSystem="2.16.840.1.113883.6.96"/>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation

targetSiteCode

code

Must be an alphanumeric string of any length.

 

codeSystemMust be an alphanumeric string of any length in the following format: 2.16.840.1.113883.X.XXUnique identifier for the Coding System that should be used to resolve the value specified in the code attribute.

Result Observation Author

component/section/entry/organizer/component/observation/author

Details the information of the person documenting the result observation. Refer to Assigned Author Element for more details on what information can be available for the author section. 

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<author>
							<assignedAuthor>
								...
							</assignedAuthor>
						</author>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...

Result Observation Reference Range

component/section/entry/organizer/component/observation/referenceRange/observationRange

Indicates the range of values for the observed result if applicable.

...
<component>
	<section>
		...
		<entry typeCode=”DRIV”>
			<organizer classCode="BATTERY" moodCode="EVN">
				<templateId root="2.16.840.1.113883.10.20.22.4.1"/>
				<component>
					<observation classCode="OBS" moodCode="EVN">
						<templateId root="2.16.840.1.113883.10.20.22.4.2"/>
						<referenceRange>
							<observationRange>
								<text>M 13-18 g/dl; F 12-16 g/dl</text>
							</observationRange>
						</referenceRange>
					</observation>
				</component>
			</organizer>
		</entry>
	</section>
</component>
...
SubsectionElementAttributeValueNotes
Result Observation
  • referenceRange
    • observationRange
      • text
N/A

Can contain text of any type or length

This attribute is optional. The specification suggests value is an acceptable child element (with low and high values) however for the purposes of correct processing in Clinical Data Spaces, we accept a completed text element instead.



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