CIBMTR Reporting Implementation Guide
0.1.11 - Trial Use 1

This page is part of the CIBMTR Reporting Implementation Guide (v0.1.11: Release) 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

Resource Profile: CIBMTR Observation Laboratory Results Profile (us-core)

Official URL: http://fhir.nmdp.org/ig/cibmtr-reporting/StructureDefinition/cibmtr-observation-lab Version: 0.1.11
Draft as of 2026-06-25 Computable Name: CIBMTRObservationLab

Overview

Laboratory Observation FHIR resources may be submitted to the CIBMTR Direct FHIR API (see the R4 Connection Guide). These profiles are derived from profiles defined in the US Core Implementation Guide. The CIBMTR profiles extend the base profiles by requiring the meta.security element to identify the submitting center and by applying bindings to CIBMTR-defined or laboratory-specific ValueSets where applicable. The Laboratory Observation resource is patient-specific and represents laboratory test results and related laboratory observations for an individual subject.

Mandatory and Must Support Data Elements

The following data elements must always be present (Must Have) or must be supported if the data is present in the sending system (Must Support).

Each Laboratory Observation Must Have:

  • security label
  • status
  • laboratory test code (code)
  • patient reference (subject)
  • effective date/time

Each Laboratory Observation Must Support:

  • encounter reference
  • specimen reference
  • reference range
  • interpretation
  • performer
  • note

Profile-specific Implementation Guidance (CIBMTR)

Security label requirement (meta.security)
The CIBMTR observation laboratory results profile requires a meta.security label identifying the Transplant Center context (e.g., rc_<CCN>). This security tag is used as part of the query pattern for searching and for access scoping.

subject
The subject element is mandatory and must contain a reference to a Patient resource identifying the subject of the laboratory result.

code
The code element identifies the laboratory test or observation being reported. Laboratory test codes are typically represented using LOINC codes or CIBMTR-defined laboratory ValueSets where applicable.

value[x]
Observation result values may be represented in multiple forms. CIBMTR currently supports only valueQuantity for numeric results and valueCodeableConcept for categorical results. For valueCodeableConcept, only coded values are supported. Other value types, such as valueString, are not currently supported.

valueQuantity.comparator
There are cases where the laboratory result exceeds the measurable limits of the test and a comparator such as < or > is required. In these cases, the valueQuantity.comparator element MUST be used.

referenceRange
For CMV LOINC codes that use valueQuantity, a corresponding referenceRange element MUST also be provided.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
Constraints: obs-6, obs-7, us-core-2
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... Slices for security Σ 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
..... security:TransplantCenter SΣ 1..1 Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... code ΣC 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... 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(8.0.0) S | Group | Device | US Core Location Profile(8.0.0)) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(US Core Encounter Profile(8.0.0)) Encounter associated with Observation
... effective[x] SΣC 1..1 Clinically relevant time/time-period for observation
Constraints: us-core-1
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer SΣ 0..* Reference(US Core Practitioner Profile(8.0.0) S | US Core Organization Profile(8.0.0) | US Core Patient Profile(8.0.0) | PractitionerRole | US Core CareTeam Profile(8.0.0) | US Core RelatedPerson Profile(8.0.0)) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
Constraints: us-core-3, us-core-4
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
... 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(8.0.0)) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
Constraints: obs-3, us-core-22
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.security:TransplantCenter Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Clinical Result Observation Category 📦8.0.0 US Core v8.0
Observation.code Base extensible US Core Laboratory Test Codes 📦8.0.0 US Core v8.0
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')
us-core-1 error Observation.effective[x] Datetime must be at least to day. $this is dateTime implies $this.toString().length() >= 10
us-core-2 error Observation If there is no component or hasMember element then either a value[x] or a data absent reason must be present (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3 error Observation.value[x] SHALL use UCUM for coded quantity units. ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
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 USCoreLaboratoryResultObservationProfile

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
... meta
.... Slices for security 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
..... security:TransplantCenter S 1..1 Coding Security Labels applied to this resource
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... code C 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
... effective[x] 1..1 dateTime, Period, Timing, instant Clinically relevant time/time-period for observation
... value[x] 0..1 Result Value
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
Constraints: obs-6, obs-7, us-core-2
... 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
.... Slices for security Σ 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
..... security:TransplantCenter SΣ 1..1 Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... 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
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The name of the test that was performed.
... subject SΣ 1..1 Reference(US Core Patient Profile(8.0.0) S | Group | Device | US Core Location Profile(8.0.0)) 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(8.0.0)) Encounter associated with Observation
... effective[x] SΣC 1..1 Clinically relevant time/time-period for observation
Constraints: us-core-1
.... 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(8.0.0) S | US Core Organization Profile(8.0.0) | US Core Patient Profile(8.0.0) | PractitionerRole | US Core CareTeam Profile(8.0.0) | US Core RelatedPerson Profile(8.0.0)) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
Constraints: us-core-3, us-core-4
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
... 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(8.0.0)) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
Constraints: obs-3, us-core-22
.... 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

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.security:TransplantCenter Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📦4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Clinical Result Observation Category 📦8.0.0 US Core v8.0
Observation.code Base extensible US Core Laboratory Test Codes 📦8.0.0 US Core v8.0
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📦4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📦4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📦4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📦4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')
us-core-1 error Observation.effective[x] Datetime must be at least to day. $this is dateTime implies $this.toString().length() >= 10
us-core-2 error Observation If there is no component or hasMember element then either a value[x] or a data absent reason must be present (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3 error Observation.value[x] SHALL use UCUM for coded quantity units. ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
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 USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 1 element(4 nested mandatory elements)
Must-Support: 1 element

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.meta.security

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
Constraints: obs-6, obs-7, us-core-2
... meta SΣ 0..1 Meta Metadata about the resource
.... lastUpdated SΣ 0..1 instant When the resource last changed
.... Slices for security Σ 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
..... security:TransplantCenter SΣ 1..1 Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... code ΣC 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... 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(8.0.0) S | Group | Device | US Core Location Profile(8.0.0)) Who and/or what the observation is about
... encounter SΣ 0..1 Reference(US Core Encounter Profile(8.0.0)) Encounter associated with Observation
... effective[x] SΣC 1..1 Clinically relevant time/time-period for observation
Constraints: us-core-1
.... effectiveDateTime dateTime S
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... performer SΣ 0..* Reference(US Core Practitioner Profile(8.0.0) S | US Core Organization Profile(8.0.0) | US Core Patient Profile(8.0.0) | PractitionerRole | US Core CareTeam Profile(8.0.0) | US Core RelatedPerson Profile(8.0.0)) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
Constraints: us-core-3, us-core-4
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
... 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(8.0.0)) Specimen used for this observation
... referenceRange SC 0..* BackboneElement Result reference range
Constraints: obs-3, us-core-22
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.security:TransplantCenter Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Clinical Result Observation Category 📦8.0.0 US Core v8.0
Observation.code Base extensible US Core Laboratory Test Codes 📦8.0.0 US Core v8.0
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')
us-core-1 error Observation.effective[x] Datetime must be at least to day. $this is dateTime implies $this.toString().length() >= 10
us-core-2 error Observation If there is no component or hasMember element then either a value[x] or a data absent reason must be present (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3 error Observation.value[x] SHALL use UCUM for coded quantity units. ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
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')

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
... meta
.... Slices for security 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
..... security:TransplantCenter S 1..1 Coding Security Labels applied to this resource
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... code C 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
... effective[x] 1..1 dateTime, Period, Timing, instant Clinically relevant time/time-period for observation
... value[x] 0..1 Result Value
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile(8.0.0) Measurements and simple assertions
Constraints: obs-6, obs-7, us-core-2
... 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
.... Slices for security Σ 1..* Coding Security Labels applied to this resource
Slice: Unordered, Open by pattern:system
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
..... security:TransplantCenter SΣ 1..1 Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://terminology.cibmtr.org/codesystem/transplant-center
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
Constraints: sec-rc
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... 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
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
.... text Σ 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The name of the test that was performed.
... subject SΣ 1..1 Reference(US Core Patient Profile(8.0.0) S | Group | Device | US Core Location Profile(8.0.0)) 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(8.0.0)) Encounter associated with Observation
... effective[x] SΣC 1..1 Clinically relevant time/time-period for observation
Constraints: us-core-1
.... 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(8.0.0) S | US Core Organization Profile(8.0.0) | US Core Patient Profile(8.0.0) | PractitionerRole | US Core CareTeam Profile(8.0.0) | US Core RelatedPerson Profile(8.0.0)) Who is responsible for the observation
... value[x] SΣC 0..1 Result Value
Constraints: us-core-3, us-core-4
.... valueQuantity Quantity S
.... valueCodeableConcept CodeableConcept S
... 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(8.0.0)) Specimen used for this observation
... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
... referenceRange SC 0..* BackboneElement Result reference range
Constraints: obs-3, us-core-22
.... 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

Path Status Usage ValueSet Version Source
Observation.meta.security Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.security:TransplantCenter Base extensible SecurityLabels 📦4.0.1 FHIR Std.
Observation.meta.tag Base example Common Tags 📦4.0.1 FHIR Std.
Observation.language Base preferred Common Languages 📦4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📦4.0.1 FHIR Std.
Observation.category:us-core Base required US Core Clinical Result Observation Category 📦8.0.0 US Core v8.0
Observation.code Base extensible US Core Laboratory Test Codes 📦8.0.0 US Core v8.0
Observation.dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📦4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📦4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📦4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📦4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📦4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📦4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Observation If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
sec-rc error Observation.meta.security:TransplantCenter.code Use transplant center identifier for security tag matches('^rc_[0-9]{5}$')
us-core-1 error Observation.effective[x] Datetime must be at least to day. $this is dateTime implies $this.toString().length() >= 10
us-core-2 error Observation If there is no component or hasMember element then either a value[x] or a data absent reason must be present (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3 error Observation.value[x] SHALL use UCUM for coded quantity units. ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
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 USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 1 element(4 nested mandatory elements)
Must-Support: 1 element

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Observation.meta.security

 

Other representations of profile: CSV, Excel, Schematron

Notes:

Value[x]

Observation result values may be represented in multiple forms. CIBMTR currently supports only the following value types:

"valueQuantity" : {
  "value" : 5,
  "unit" : "gram per deciliter",
  "system" : "http://unitsofmeasure.org",
  "code" : "g/dL"
}

"valueCodeableConcept" : {
  "coding" : [
    {
      "system" : "http://snomed.info/sct",
      "code" : "10828004",
      "display" : "Positive (qualifier value)"
    }
  ]
}

CIBMTR does NOT currently support any other value types, such as valueString.

Using comparators in valueQuantity

In some cases, the laboratory result exceeds the measurable limits of the test and requires a comparator such as < or >. In these cases, the valueQuantity.comparator MUST be used. For example:

"valueQuantity" : {
  "value" : 13700,
  "comparator" : "<",
  "unit" : "international unit per milliliter",
  "system" : "http://unitsofmeasure.org",
  "code" : "[IU]/mL"
}

Special rules:

  • For CMV LOINC codes that use valueQuantity, a corresponding referenceRange element MUST also be provided. For example:
"referenceRange" : [
  {
    "low" : {
      "value" : 13700,
      "unit" : "international unit per milliliter",
      "system" : "http://unitsofmeasure.org",
      "code" : "[IU]/mL"
    },
    "high" : {
      "value" : 9000000,
      "unit" : "international unit per milliliter",
      "system" : "http://unitsofmeasure.org",
      "code" : "[IU]/mL"
    }
  }
]