US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab | Version: 8.0.0-ballot | |||
Standards status: Trial-use | Maturity Level: 3 | Computable Name: USCoreLaboratoryResultObservationProfile | ||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.42 | ||||
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:
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:
Each Observation Must Support:
* see guidance below
Profile Specific Implementation Guidance:
Observation.code
(e.g., Blood Glucose), the Must Support Observation.specimen
element, or through both elements.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.Observation.effectivePeriod
to accurately represent measurements over time (for example, a 24-Hour Urine Collection test).Observation.hasMember
.
Observation.dataAbsentReason
.Observation.component
without a value, SHALL include a reason why the data is absent.
Observation.component.dataAbsentReason
.Observation.value[x]
data type to use based on the LOINC Type of Scale.Observation.valeQuantity.code
.Meta.lastUpdated
SHOULD reflect:
Usage:
Changes since version 7.0.0:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USCoreObservationClinicalResultProfile
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | USCoreObservationClinicalResultProfile | |||
meta | S | 0..1 | Meta | Metadata about the resource |
lastUpdated | S | 0..1 | instant | When the resource last changed |
Slices for category | Content/Rules for all slices | |||
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. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | |
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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') |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | C | 0..* | USCoreObservationClinicalResultProfile | Measurements and simple assertions dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management 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 ele-1: All FHIR elements must have a @value or children |
lastUpdated | SΣ | 0..1 | instant | When the resource last changed ele-1: All FHIR elements must have a @value or children |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. ele-1: All FHIR elements must have a @value or children |
Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children |
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 ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children |
subject | SΣ | 1..1 | Reference(US Core Patient Profile) | Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children |
encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation ele-1: All FHIR elements must have a @value or children |
effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children us-core-1: Datetime must be at least to day. | |
effectiveDateTime | dateTime | |||
performer | SΣ | 0..* | Reference(US Core Practitioner Profile) | Who is responsible for the observation ele-1: All FHIR elements must have a @value or children |
value[x] | SΣC | 0..1 | Result Value ele-1: All FHIR elements must have a @value or children 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. ele-1: All FHIR elements must have a @value or children |
interpretation | S | 0..* | CodeableConcept | Result interpretation Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes ele-1: All FHIR elements must have a @value or children |
specimen | S | 0..1 | Reference(US Core Specimen Profile) | Specimen used for this observation ele-1: All FHIR elements must have a @value or children |
referenceRange | SC | 0..* | BackboneElement | Result reference range ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard | |
Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard | |
Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category from this IG | |
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | |
Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | |
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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') |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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 value:$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 | SΣ | 0..* | Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | 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 | |||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI | |||
Observation.meta.security | extensible | All Security Labelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | ||||
Observation.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | ||||
Observation.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard | ||||
Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard | ||||
Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category from this IG | ||||
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | ||||
Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | ||||
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard | ||||
Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site from the FHIR Standard | ||||
Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard | ||||
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard | ||||
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard | ||||
Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard | ||||
Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | ||||
Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | USCoreObservationClinicalResultProfile | |||
meta | S | 0..1 | Meta | Metadata about the resource |
lastUpdated | S | 0..1 | instant | When the resource last changed |
Slices for category | Content/Rules for all slices | |||
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. |
Documentation for this format |
Path | Conformance | ValueSet | URI |
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | |
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Observation | C | 0..* | USCoreObservationClinicalResultProfile | Measurements and simple assertions dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management 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 ele-1: All FHIR elements must have a @value or children |
lastUpdated | SΣ | 0..1 | instant | When the resource last changed ele-1: All FHIR elements must have a @value or children |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
status | ?!SΣ | 1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. ele-1: All FHIR elements must have a @value or children |
Slices for category | S | 1..* | CodeableConcept | Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. ele-1: All FHIR elements must have a @value or children |
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 ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children |
subject | SΣ | 1..1 | Reference(US Core Patient Profile) | Who and/or what the observation is about ele-1: All FHIR elements must have a @value or children |
encounter | SΣ | 0..1 | Reference(US Core Encounter Profile) | Encounter associated with Observation ele-1: All FHIR elements must have a @value or children |
effective[x] | SΣC | 0..1 | Clinically relevant time/time-period for observation ele-1: All FHIR elements must have a @value or children us-core-1: Datetime must be at least to day. | |
effectiveDateTime | dateTime | |||
performer | SΣ | 0..* | Reference(US Core Practitioner Profile) | Who is responsible for the observation ele-1: All FHIR elements must have a @value or children |
value[x] | SΣC | 0..1 | Result Value ele-1: All FHIR elements must have a @value or children 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. ele-1: All FHIR elements must have a @value or children |
interpretation | S | 0..* | CodeableConcept | Result interpretation Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes ele-1: All FHIR elements must have a @value or children |
specimen | S | 0..1 | Reference(US Core Specimen Profile) | Specimen used for this observation ele-1: All FHIR elements must have a @value or children |
referenceRange | SC | 0..* | BackboneElement | Result reference range ele-1: All FHIR elements must have a @value or children 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 ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard | |
Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard | |
Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category from this IG | |
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | |
Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | |
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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 value:$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 | SΣ | 0..* | Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) | 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 | |||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI | |||
Observation.meta.security | extensible | All Security Labelshttp://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard | ||||
Observation.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | ||||
Observation.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languages from the FHIR Standard
| ||||
Observation.status | required | ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard | ||||
Observation.category | preferred | ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard | ||||
Observation.category:us-core | required | Pattern: laboratoryhttp://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category from this IG | ||||
Observation.code | extensible | USCoreLaboratoryTestCodeshttp://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes from this IG | ||||
Observation.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | ||||
Observation.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard | ||||
Observation.bodySite | example | SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site from the FHIR Standard | ||||
Observation.method | example | ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard | ||||
Observation.referenceRange.type | preferred | ObservationReferenceRangeMeaningCodeshttp://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard | ||||
Observation.referenceRange.appliesTo | example | ObservationReferenceRangeAppliesToCodeshttp://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard | ||||
Observation.component.code | example | LOINCCodes (a valid code from LOINC)http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard | ||||
Observation.component.dataAbsentReason | extensible | DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard | ||||
Observation.component.interpretation | extensible | ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
us-core-4 | best practice | Observation.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-22 | error | Observation.referenceRange | SHALL 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
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.
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
The following search parameters and search parameter combinations SHALL be supported:
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:
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)
patient
and code
search parameters:
code
(e.g.code={system|}[code],{system|}[code],...
)GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}
Example:
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)
patient
and category
and date
search parameters:
date
comparators: gt,lt,ge,le
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:
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)
The following search parameter combinations SHOULD be supported:
patient
and category
and status
search parameters:
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:
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)
patient
and category
and _lastUpdated
search parameters:
_lastUpdated
comparators: gt,lt,ge,le
_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:
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)
patient
and code
and date
search parameters:
code
(e.g.code={system|}[code],{system|}[code],...
)date
comparators: gt,lt,ge,le
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:
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)