US Core Implementation Guide
7.0.0 - STU7 United States of America flag

This page is part of the US Core (v7.0.0: STU7) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions. Page versions: STU6.1 STU6 STU5 STU4 STU3

Resource Profile: US Core Laboratory Result Observation Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab Version: 7.0.0
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreLaboratoryResultObservationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.37

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Laboratory Result Observation Profile is based upon the US Core Observation Clinical Result Profile and, along with the US Core DiagnosticReport Profile for Laboratory Results Reporting, meets the U.S. Core Data for Interoperability (USCDI) Laboratory requirements. Laboratory results are grouped and summarized using the DiagnosticReport resource, which references Observation resources. Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) that references other observations, or rarely a laboratory test with component result values. The US Core Laboratory Result Observation Profile sets minimum expectations for the Observation resource to record, search, and fetch laboratory test results associated with a patient to promote interoperability and adoption through common implementation. It identifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

  • Query for lab results belonging to a Patient
  • Record or update lab results belonging to a Patient

Mandatory and Must Support Data Elements

In addition to the Mandatory and Must Support data elements in the US Core Observation Clinical Result Profile, the following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views section below provides the formal summary, definitions, and terminology requirements. Note that the “Differential Table” displays elements unique to this profile and the “Key Elements Table” displays a combined view of elements for this profile and the US Core Observation Clinical Result Profile.

Each Observation Must Have:

  1. a category code of ‘laboratory’
  2. a laboratory LOINC code, if available, which tells you what is being measured

Each Observation Must Support:

  1. a timestamp when the resource last changed*
  2. a result value*
    • if the result value is a numeric quantity, a standard UCUM unit
    • if the result value is a coded quantity, a standard SNOMED CT
  3. result interpretation
    • if the result value is a numeric quantity, a standard UCUM unit
  4. result reference range
  5. a specimen type (e.g., blood, serum, urine)

* see guidance below

Profile Specific Implementation Guidance:

  • For USCDI, systems are required to use SNOMED CT for coded results if the SCT code exists.
  • The specimen type can be communicated in the mandatory Observation.code (e.g., Blood Glucose), the Must Support Observation.specimen element, or through both elements.
  • The Observation.category element provides an efficient way of restricting search on observations to a given context such as laboratory observations. Example searches are shown in the Quick Start section below. However, clients need to understand that data categorization is somewhat subjective. The categorization applied by the source may not align with the client’s expectations. Clients may find it more useful to use queries based on a specific code or set of codes or to perform additional client-side filtering of query results.
  • Additional codes that translate or map to the Observation code or category codes are allowed. For example:
    • providing both a local code and a LOINC code
    • providing a more specific code such as ‘chemistry’, a SNOMED CT concept, or a system-specific code
  • Systems SHOULD support Observation.effectivePeriod to accurately represent measurements over time (for example, a 24-Hour Urine Collection test).
  • *An Observation without a value, SHALL include a reason why the data is absent unless there are 1) component observations, or 2) reporting panel observations using Observation.hasMember.
    • For further guidance, see the Observation Grouping section in FHIR Specification.
    • Systems that never provide an observation without a value are not required to support Observation.dataAbsentReason.
  • *An Observation.component without a value, SHALL include a reason why the data is absent.
    • Systems that never provide a component observation without a component value are not required to support Observation.component.dataAbsentReason.
  • See the General Guidance page for further guidance on SNOMED and UCUM.
  • See the LOINC scale type to FHIR data type mapping for guidance on which Observation.value[x] data type to use based on the LOINC Type of Scale.
  • *This profile inherits the invariant “us-core-3” from the US Core Observation Clinical Result Profile that requires UCUM to be used as a unit type for Observation.valeQuantity.code.
  • * See the US Core General Guidance page for Searching Using lastUpdated. Updates to Meta.lastUpdated SHOULD reflect:
    • New laboratory observations
    • Changes in the status of laboratory observations, including events that trigger the same status (e.g., amended → amended).

Based upon additional testing, we intend to to upgrade the Meta.lastUpdated guidance (SHOULD) to requirements (SHALL) in the next version of US Core

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from USCoreObservationClinicalResultProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation USCoreObservationClinicalResultProfile
... meta S 0..1 Meta Metadata about the resource
.... lastUpdated S 0..1 instant When the resource last changed
... category:us-core S 1..1 CodeableConcept Classification of type of observation
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
... code S 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... value[x] SC 0..1 Result Value
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes

... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
us-core-22: SHALL use UCUM for coded quantity units.

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreObservationClinicalResultProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S 1..1 CodeableConcept Classification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets



Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
... code SΣ 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... value[x] SΣC 0..1 Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
from this IG
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreObservationClinicalResultProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S 1..1 CodeableConcept Classification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets



Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
... code SΣ 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity Low Range, if relevant
.... high C 0..1 SimpleQuantity High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Observation.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
from this IG
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

This structure is derived from USCoreObservationClinicalResultProfile

Summary

Mandatory: 1 element
Must-Support: 8 elements

Structures

This structure refers to these other structures:

Maturity: 3

Differential View

This structure is derived from USCoreObservationClinicalResultProfile

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation USCoreObservationClinicalResultProfile
... meta S 0..1 Meta Metadata about the resource
.... lastUpdated S 0..1 instant When the resource last changed
... category:us-core S 1..1 CodeableConcept Classification of type of observation
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
... code S 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... value[x] SC 0..1 Result Value
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes

... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
us-core-22: SHALL use UCUM for coded quantity units.

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreObservationClinicalResultProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S 1..1 CodeableConcept Classification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets



Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
... code SΣ 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... value[x] SΣC 0..1 Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
from this IG
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreObservationClinicalResultProfile Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S 1..1 CodeableConcept Classification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets



Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
... code SΣ 1..1 CodeableConcept Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

... subject SΣ 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
.... valueString string S
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation S 0..* CodeableConcept Result interpretation
Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity Low Range, if relevant
.... high C 0..1 SimpleQuantity High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Observation.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
from this IG
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
from this IG
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard
Observation.bodySiteexampleSNOMEDCTBodyStructures
http://hl7.org/fhir/ValueSet/body-site
from the FHIR Standard
Observation.methodexampleObservationMethods
http://hl7.org/fhir/ValueSet/observation-methods
from the FHIR Standard
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
http://hl7.org/fhir/ValueSet/referencerange-meaning
from the FHIR Standard
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
http://hl7.org/fhir/ValueSet/referencerange-appliesto
from the FHIR Standard
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
http://hl7.org/fhir/ValueSet/observation-codes
from the FHIR Standard
Observation.component.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.component.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
: (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

This structure is derived from USCoreObservationClinicalResultProfile

Summary

Mandatory: 1 element
Must-Support: 8 elements

Structures

This structure refers to these other structures:

Maturity: 3

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Quick Start

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile’s information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

  • See the Scopes Format section for a description of the SMART scopes syntax.
  • See the Search Syntax section for a description of the US Core search syntax.
  • See the General Requirements section for additional rules and expectations when a server requires status parameters.
  • See the General Guidance section for additional guidance on searching for multiple patients.

US Core Scopes

Servers providing access to laboratory data SHALL support these US Core SMART Scopes:

  • resource level scopes: <patient|user|system>/Observation.rs

  • granular scopes: <patient|user|system>.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported:

  1. SHALL support searching using the combination of the patient and category search parameters:

    GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

    Example:

    1. GET [base]/Observation?patient=1134281&amp;category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = laboratory (how to search by reference and how to search by token)

  2. SHALL support searching using the combination of the patient and code search parameters:
    • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)

    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}

    Example:

    1. GET [base]/Observation?patient=1134281&amp;code=http://loinc.org|2339-0
    2. GET [base]/Observation?patient=1134281&amp;code=http://loinc.org|2339-0,http://loinc.org|25428-4,http://loinc.org|2514-8

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and observation code(s). SHOULD support search by multiple report codes. The Observation code parameter searches `Observation.code only. (how to search by reference and how to search by token)

  3. SHALL support searching using the combination of the patient and category and date search parameters:
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

    GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&date=ge2018-03-14T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and a category code = laboratory (how to search by reference and how to search by token and how to search by date)

Optional Search Parameters:

The following search parameter combinations SHOULD be supported:

  1. SHOULD support searching using the combination of the patient and category and status search parameters:
    • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

    GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&status={system|}[code]{,{system|}[code],...}

    Example:

    1. GET [base]/Observation?patient=1134281&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&status=final

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category = laboratory and status (how to search by reference and how to search by token)

  2. SHOULD support searching using the combination of the patient and category and _lastUpdated search parameters:
    • including support for these _lastUpdated comparators: gt,lt,ge,le
    • including optional support for AND search on _lastUpdated (e.g._lastUpdated=[date]&_lastUpdated=[date]]&...)

    GET [base]/Observation?patient={Type/}[id]&category={system|}[code]&_lastUpdated={gt|lt|ge|le}[date]{&_lastUpdated={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&http://terminology.hl7.org/CodeSystem/observation-category|laboratory&_lastUpdated=ge2024-01-01T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category and _lastUpdated. See the US Core General Guidance page for Searching Using lastUpdated. (how to search by reference and how to search by token and how to search by date)

  3. SHOULD support searching using the combination of the patient and code and date search parameters:
    • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)
    • including support for these date comparators: gt,lt,ge,le
    • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

    GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&code=http://loinc.org|2339-0&date=ge2019-01-01T00:00:00Z

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token and how to search by date)