3.13 Results

The template identifier for the results section is 2.16.840.1.113883.10.20.1.14.

This section contains the results of observations generated by laboratories, imaging procedures, and other procedures. The scope includes hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, cardiac echo, nuclear medicine, pathology, and procedure observations. The section may contain all results for the period of time being summarized, but should include notable results such as abnormal values or relevant trends.

Lab results are 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.

Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echo.

Procedure results are typically generated by a clinician wanting to provide more granular information about component observations made during the performance of a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy.

CONF-388: CCDSHOULD 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).

3.13.1 Section conformance

CONF-389: The result section SHALL contain Section / code.
CONF-390: 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.
CONF-391: The results section SHALL contain Section / title.
CONF-392: Section / titleSHOULD be valued with a case-insensitive language-insensitive text string containing “results”.

3.13.2 Clinical statement conformance

The following figure shows a subset of the CDA Clinical Statement model containing those classes being constrained or referred to in the conformance statements that follow.

Figure 12. CDA R2 clinical statement model for results

3.13.2.1 Results representation

The template identifier for a result organizer is 2.16.840.1.113883.10.20.1.32.
The template identifier for a result observation is 2.16.840.1.113883.10.20.1.31.

Results in ASTM CCR and CCD are structured similarly to the HL7 Version 2 ORU Observation message, where there is an outer result organizer (templateId 2.16.840.1.113883.10.20.1.32), analogous to the HL7 Version 2 OBR Observation Result Segment, which contains one or more result observations (templateId 2.16.840.1.113883.10.20.1.31), analogous to the HL7 Version 2 OBX Observation/Result Segment.

3.13.2.1.1 Result organizer

The result organizer identifies an observation set, contained with the result organizer as a set of result observations. It contains information applicable to all of the contained result observations.

CONF-393: A result organizer (templateId 2.16.840.1.113883.10.20.1.32) SHALL be represented with Organizer.
CONF-394: The value for “Organizer / @moodCode” in a result organizer SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-395: A result organizer SHALL contain at least one Organizer / id.
CONF-396: A result organizer SHALL contain exactly one Organizer / statusCode.
CONF-397: A result organizer SHALL contain exactly one Organizer / code.

ASTM CCR defines a restricted set of required result Type codes (see ResultTypeCode in section 7.3 Summary of CCD value sets), used to categorize a result into one of several commonly accepted values (e.g. “Hematology”, “Chemistry”, “Nuclear Medicine”). These values are often implicit in the Organizer / code (e.g. an Organizer / code of “complete blood count” implies a ResultTypeCode of “Hematology”). To better support translations between CCD and ASTM’s XML CCR format, CCD requires Organizer / code to include a ResultTypeCode either directly or as a translation of a code from some other code system.

CONF-398: 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.
CONF-399: A result organizer SHOULD include one or more Organizer / specimen if the specimen isn't inherent in Organizer / code.
CONF-400: Organizer / specimenSHALL NOT conflict with the specimen inherent in Organizer / code.
CONF-401: Organizer / specimen / specimenRole / idSHOULD 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.
CONF-402: A result organizer SHALL contain one or more Organizer / component.
CONF-403: 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.
CONF-404: A result organizer Organizer / component / procedureMAY be a reference to a procedure described in the Procedure section. (See section 5.3 InternalCCRLink for more on referencing within CCD).
CONF-405: The target of one or more result organizer Organizer / component relationships SHALL be a result observation.
CONF-406: A result organizer SHALL contain one or more sources of information, as defined in section 5.2 Source.

3.13.2.1.2 Result observation

CONF-407: A result observation (templateId 2.16.840.1.113883.10.20.1.31) SHALL be represented with Observation.
CONF-408: The value for “Observation / @moodCode” in a result observation SHALL be “EVN” 2.16.840.1.113883.5.1001 ActMood STATIC.
CONF-409: A result observation SHALL contain at least one Observation / id.
CONF-410: A result observation SHALL contain exactly one Observation / statusCode.
CONF-411: 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).
CONF-412: A result observation SHALL contain exactly one Observation / code.
CONF-413: 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).
CONF-414: 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.
CONF-415: Observation / methodCodeSHALL NOT conflict with the method inherent in Observation / code.
CONF-416: A result observation SHALL contain exactly one Observation / value.
CONF-417: 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.
CONF-418: 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.
CONF-419: A result observation SHOULD contain one or more Observation / referenceRange to show the normal range of values for the observation result.
CONF-420: 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.
CONF-421: A result observation SHALL contain one or more sources of information, as defined in section 5.2 Source.