HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.1

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.1 FHIR Profiles - Local Development build (v0.9.1). See the Directory of published versions

TNMClinicalStageGroup

Definitions for onco-core-TNMClinicalStageGroup.

1. Observation
Definition

The extent of the cancer in the body, according to the TNM classification system, based on information obtained prior to neoadjuvant treatment and surgery, e.g. based on evidence such as physical examination, imaging, and/or biopsy.

Control0..*
Alternate NamesVital Signs, Measurement, Results, Tests
Comments

Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as lab reports, etc.

InvariantsDefined on this element
obs-6: SHALL only be present if Observation.value[x] is not present (: )
obs-7: Component code SHALL not be same as observation code (: )
2. Observation.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Bundles always have an id, though it is usually a generated UUID.

3. Observation.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

Control0..1
TypeMeta
4. Observation.meta.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
5. Observation.meta.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingThis element introduces a set of slices on Observation.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
6. sourcesystem
SliceNamesourcesystem
Definition

FHIR: This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. FHIM: Identifies the computer system that created the medical record. This optional field may also be used to indicate that the medical record was originally created by a different organization from the one that is currently storing or utilizing the record in that the assigning authority of the Id could be set to that originating organization. This property is optional, as some systems will assume that all records that it contains originated in that system, however it is anticipated that it will become increasingly commonplace for records from multiple systems and organizations will be comingled in order to provide a complete picture of the patient's health record.

Control0..1
TypeExtension(SourceSystem) (Extension Type: uri)
7. Observation.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This values changes when the resource is created, updated, or deleted.

Control0..1
Typeid
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

8. Observation.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

Control0..1
Typeinstant
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant.

9. Observation.meta.profile
Definition

A list of profiles StructureDefinitions that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Control0..*
Typeuri
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

10. Observation.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Control0..*
BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
The codes SHALL be taken from All Security Labels; other codes may be used where these codes are not suitable
TypeCoding
Comments

The security labels can be updated without changing the stated version of the resource The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

11. Observation.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Control0..*
BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones"
TypeCoding
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

12. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

Control0..1
Typeuri
Is Modifiertrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element as much as possible.

13. Observation.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from http://tools.ietf.org/html/bcp47
Typecode
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

14. Observation.text
Definition

A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.

15. Observation.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

16. Observation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingThis element introduces a set of slices on Observation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
17. observationbasedon
SliceNameobservationbasedon
Definition

The plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

Control0..*
TypeExtension(ObservationBasedOn) (Extension Type: Reference(ProcedureRequest | ReferralRequest))
18. observationpartof
SliceNameobservationpartof
Definition

A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

Control0..*
TypeExtension(ObservationPartOf) (Extension Type: Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure))
19. annotation
SliceNameannotation
Definition

An added or follow-up note, often after the fact, that contains metadata about who made the statement and when.

Control0..*
TypeExtension(Annotation) (Extension Type: Annotation(Annotation))
20. observationderivedfrom
SliceNameobservationderivedfrom
Definition

The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

Control0..*
TypeExtension(ObservationDerivedFrom) (Extension Type: Reference(DocumentReference | Media | QuestionnaireResponse | Observation))
21. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • exists @ url
22. focalsubject
SliceNamefocalsubject
Definition

The person or entity that the information in this resource relates to, if different than the person of record. The subject of information can be a reference or a code, the latter when the subject is described generically, for example, in terms of a relationship to the subject of record (e.g., wife).

Control0..*
TypeExtension(FocalSubject) (Extension Type: Choice of: Reference(Resource), CodeableConcept)
Is Modifiertrue
Must Supporttrue
23. Observation.modifierExtension-focalsubject.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
24. Observation.modifierExtension-focalsubject.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

25. Observation.modifierExtension-focalsubject.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #.

Fixed Valuehttp://mcodeinitiative.org/us/mcode/StructureDefinition/obf-FocalSubject-extension
26. Observation.modifierExtension-focalsubject.valueReference
Definition

Records the history of the primary cancer condition, the original or first tumor in the body (reference https://www.cancer.gov/publications/dictionaries/cancer-terms/def/primary-tumor). Cancers that are not clearly secondary (i.e., of uncertain origin or behavior) should be documented as primary.

Cancer staging information summarized in this profile should reflect the most recent staging assessment on the patient, and should be updated if and when there is a new staging assessment. Past staging assessments will be preserved in instances of the TNMClinicalStageGroup and/or TNMPathologicalStageGroup, which refer back to PrimaryCancerCondition.

Conformance note: For the code attribute, to be compliant with US Core Profiles, SNOMED CT must be used unless there is no suitable code, in which case ICD-10-CM can be used.

Control1..1
TypeReference(PrimaryCancerCondition)
27. Observation.identifier
Definition

A unique identifier for the simple observation instance.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Requirements

Allows observations to be distinguished and referenced.

28. Observation.status
Definition

The status of the result value.

Control1..1
BindingCodes providing the status of an observation.
The codes SHALL be taken from ObservationStatus
Typecode
Is Modifiertrue
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

29. Observation.category
Definition

A code that classifies the general type of observation being made. This is used for searching, sorting and display purposes.

Control0..1
BindingCodes for high level observation categories .
The codes SHALL be taken from Observation Category Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Comments

The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Observation.code.

30. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name".

Control1..1
BindingCodes identifying names of simple observations.
For example codes, see LOINC Codes
TypeCodeableConcept
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

31. Observation.code.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
32. Observation.code.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

33. Observation.code.coding
Definition

A reference to a code defined by a terminology system.

Control1..*
TypeCoding
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

SlicingThis element introduces a set of slices on Observation.code.coding. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ code
34. Fixed_21908-9
SliceNameFixed_21908-9
Definition

Stage group.clinical Cancer

Control1..1
TypeCoding
35. Observation.code.coding-Fixed-21908-9.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
36. Observation.code.coding-Fixed-21908-9.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

37. Observation.code.coding-Fixed-21908-9.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Fixed Valuehttp://loinc.org
38. Observation.code.coding-Fixed-21908-9.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

39. Observation.code.coding-Fixed-21908-9.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Requirements

Need to refer to a particular code in the system.

Fixed Value21908-9
40. Observation.code.coding-Fixed-21908-9.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

41. Observation.code.coding-Fixed-21908-9.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

42. Observation.code.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

43. Observation.subject
Definition

The subject of an observation.

Control1..1
TypeReference(Patient)
Requirements

Observations have no value if you don't know who or what they're about.

Comments

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

If the target of the observation is different than the subject, the general extension observation-focal-subject. may be used. However, the distinction between the patient's own value for an observation versus that of the fetus, or the donor or blood product unit, etc., are often specified in the observation code.

44. Observation.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

Control0..1
TypeReference(Encounter)
Requirements

For some observations it may be important to know the link between an observation and a particular encounter.

45. Observation.effectivex
Definition

The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

Control0..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

Knowing when an observation was deemed true is important to its relevance as well as determining trends.

Comments

At least a date should be present unless this observation is a historical report.

46. Observation.issued
Definition

The date and time this observation was made available to providers, typically after the results have been reviewed and verified.

Control0..1
Typeinstant
Comments

Updated when the result is updated.

47. Observation.performer
Definition

Who was responsible for asserting the observed value as "true".

Control0..*
TypeReference(Practitioner)
Requirements

May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

48. Observation.valueCodeableConcept
Definition

The information determined as a result of making the observation, if the information has a simple value.

Control1..1
BindingThe codes SHOULD be taken from TNMStageGroupVS
TypeCodeableConcept
Must Supporttrue
Requirements

An observation exists to have a value, though it may not if it is in error, or it represents a group of observations.

Comments

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. This element has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueString, valueRange, valueRatio, valueSampledData, valueAttachment, valueTime, valueDateTime, or valuePeriod. (The name format is "'value' + the type name" with a capital on the first letter of the type).

If the data element is usually coded or if the type associated with the Observation.value defines a coded value, use CodeableConcept instead of string datatype even if the value is uncoded text. A value set is bound to the ValueCodeableConcept element. For boolean values use valueCodeableConcept and select codes from HL7 Version 2 Table 0136. These "yes/no" concepts can be mapped to the display name "true/false" or other mutually exclusive terms that may be needed. For further discussion and examples see the notes section below.

49. Observation.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.value[x] is missing.

Control0..0 This element is affected by the following invariants: obs-6
BindingCodes specifying why the result (Observation.value[x]) is missing.
The codes SHALL be taken from Observation Value Absent Reason; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

For many results it is necessary to handle exceptional values in measurements.

Comments

Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

50. Observation.interpretation
Definition

The assessment made based on the result of the observation. Intended as a simple compact code often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. Otherwise known as abnormal flag.

Control0..1
BindingCodes identifying interpretations of observations.
The codes SHALL be taken from Observation Interpretation Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

Alternate NamesAbnormal Flag
51. Observation.comments
Definition

May include statements about significant, unexpected or unreliable values, or information about the source of the value where this may be relevant to the interpretation of the result.

Control0..1
Typestring
Requirements

Need to be able to provide free text additional information.

52. Observation.bodySite
Definition

Indicates the site on the subject's body where the observation was made (i.e. the target site).

Control0..0
BindingCodes describing anatomical locations. May include laterality.
The codes SHOULD be taken from SNOMED CT Body Structures
TypeCodeableConcept
Requirements

Knowing where the observation is made is important for tracking if multiple sites are possible.

Comments

Only used if not implicit in code found in Observation.code. If the use case requires BodySite to be handled as a separate resource instead of an inline coded element (e.g. to identify and track separately) then use the standard extension body-site-instance.

53. Observation.method
Definition

Method or staging system used to stage the cancer.

Control0..1
BindingThe codes SHALL be taken from CancerStagingSystemVS; other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
Requirements

In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

Comments

Only used if not implicit in code for Observation.code.

54. Observation.specimen
Definition

The specimen that was used when this observation was made.

Control0..0
TypeReference(Specimen)
Comments

Observations are not made on specimens themselves; they are made on a subject, but usually by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

55. Observation.device
Definition

The device used to generate the observation data.

Control0..0
TypeReference(http://fhir.org/guides/argonaut/StructureDefinition/argo-device)
Comments

An extension should be used if further typing of the device is needed. Devices used to support obtaining an observation can be represented using either extension or through the Observation.related element.

56. Observation.referenceRange
Definition

Guidance on how to interpret the value by comparison to a normal or recommended range.

Control0..0
TypeBackboneElement
Requirements

Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g. specific to the patient's age, gender, weight and other factors), but this may not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

InvariantsDefined on this element
obs-3: Must have at least a low or a high or text (: )
57. Observation.referenceRange.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
58. Observation.referenceRange.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

59. Observation.referenceRange.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

60. Observation.referenceRange.low
Definition

The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
61. Observation.referenceRange.high
Definition

The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
62. Observation.referenceRange.meaning
Definition

Code for the meaning of the reference range.

Control0..1
BindingCode for the meaning of a reference range.
The codes SHALL be taken from Observation Reference Range Meaning Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, or perhaps what state this reference range applies to (i.e. age, hormonal cycles, etc.).

Comments

This SHOULD be populated if there is more than one range.

63. Observation.referenceRange.age
Definition

The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

64. Observation.referenceRange.text
Definition

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of 'normals'.

Control0..1
Typestring
65. Observation.related
Definition

A reference to another resource (usually another Observation but could also be a QuestionnaireAnswer) whose relationship is defined by the relationship type code.

Control0..1
TypeBackboneElement
Requirements

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and a set of related observations or sometimes QuestionnaireResponse from which the measure is derived.

Comments

For a discussion on the ways Observations can assembled in groups together see Notes below.

SlicingThis element introduces a set of slices on Observation.related. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • profile @ target.reference
66. Observation.related.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
67. Observation.related.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

68. Observation.related.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

69. Observation.related.type
Definition

A code specifying the kind of relationship that exists with the target resource.

Control0..1
BindingCodes specifying how two observations are related.
The codes SHALL be taken from ObservationRelationshipType
Typecode
Requirements

A relationship type SHOULD be provided.

Comments

"derived-from" is only logical choice when referencing QuestionnaireAnswer resource.

Fixed Valuehas-member
70. Observation.related.target
Definition

A reference to the observation or QuestionnaireResponse resource that is related to this observation.

Control1..1
TypeReference(Observation)
71. onco-core-TNMClinicalPrimaryTumorCategory
SliceNameonco-core-TNMClinicalPrimaryTumorCategory
Definition

Category of the primary tumor, based on its size and extent, assessed prior to surgery, based on evidence such as physical examination, imaging, and/or biopsy.

Control0..1
TypeBackboneElement
72. Observation.related-TNMClinicalPrimaryTumorCategory.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
73. Observation.related-TNMClinicalPrimaryTumorCategory.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

74. Observation.related-TNMClinicalPrimaryTumorCategory.mod
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

75. Observation.related-TNMClinicalPrimaryTumorCategory.type
Definition

A code specifying the kind of relationship that exists with the target resource.

Control0..1
BindingCodes specifying how two observations are related.
The codes SHALL be taken from ObservationRelationshipType
Typecode
Requirements

A relationship type SHOULD be provided.

Comments

"derived-from" is only logical choice when referencing QuestionnaireAnswer resource.

Fixed Valuehas-member
76. Observation.related-TNMClinicalPrimaryTumorCategory.target
Definition

A reference to the observation or QuestionnaireResponse resource that is related to this observation.

Control1..1
TypeReference(TNMClinicalPrimaryTumorCategory)
77. onco-core-TNMClinicalRegionalNodesCategory
SliceNameonco-core-TNMClinicalRegionalNodesCategory
Definition

Category of the presence or absence of metastases in regional lymph nodes, assessed using tests that are done before surgery. These include physical exams, imaging tests, laboratory tests (such as blood tests), and biopsies (definition adapted from NCI Dictionary of Cancer Terms).

Control0..1
TypeBackboneElement
78. Observation.related-TNMClinicalRegionalNodesCategory.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
79. Observation.related-TNMClinicalRegionalNodesCategory.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

80. Observation.related-TNMClinicalRegionalNodesCategory.mod
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

81. Observation.related-TNMClinicalRegionalNodesCategory.type
Definition

A code specifying the kind of relationship that exists with the target resource.

Control0..1
BindingCodes specifying how two observations are related.
The codes SHALL be taken from ObservationRelationshipType
Typecode
Requirements

A relationship type SHOULD be provided.

Comments

"derived-from" is only logical choice when referencing QuestionnaireAnswer resource.

Fixed Valuehas-member
82. Observation.related-TNMClinicalRegionalNodesCategory.target
Definition

A reference to the observation or QuestionnaireResponse resource that is related to this observation.

Control1..1
TypeReference(TNMClinicalRegionalNodesCategory)
83. onco-core-TNMClinicalDistantMetastasesCategory
SliceNameonco-core-TNMClinicalDistantMetastasesCategory
Definition

Category describing the presence or absence of metastases in remote anatomical locations, assessed using tests that are done before surgery. These include physical exams, imaging tests, laboratory tests (such as blood tests), and biopsies (definition adapted from NCI Dictionary of Cancer Terms).

Control0..1
TypeBackboneElement
84. Observation.related-TNMClinicalDistantMetastasesCategory.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
85. Observation.related-TNMClinicalDistantMetastasesCategory.ext
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

86. Observation.related-TNMClinicalDistantMetastasesCategory.mod
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

87. Observation.related-TNMClinicalDistantMetastasesCategory.type
Definition

A code specifying the kind of relationship that exists with the target resource.

Control0..1
BindingCodes specifying how two observations are related.
The codes SHALL be taken from ObservationRelationshipType
Typecode
Requirements

A relationship type SHOULD be provided.

Comments

"derived-from" is only logical choice when referencing QuestionnaireAnswer resource.

Fixed Valuehas-member
88. Observation.related-TNMClinicalDistantMetastasesCategory.target
Definition

A reference to the observation or QuestionnaireResponse resource that is related to this observation.

Control1..1
TypeReference(TNMClinicalDistantMetastasesCategory)
89. Observation.component
Definition

Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

Control0..0
TypeBackboneElement
Requirements

Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

Comments

For a discussion on the ways Observations can assembled in groups together see Notes below.

90. Observation.component.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
91. Observation.component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

92. Observation.component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

93. Observation.component.code
Definition

Describes what was observed. Sometimes this is called the observation "code".

Control1..1 This element is affected by the following invariants: obs-7
BindingCodes identifying names of simple observations.
For example codes, see LOINC Codes
TypeCodeableConcept
Requirements

Knowing what kind of observation is being made is essential to understanding the observation.

94. Observation.component.valuex
Definition

The information determined as a result of making the observation, if the information has a simple value.

Control0..1
TypeChoice of: Quantity, CodeableConcept, string, Range, Ratio, SampledData, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

An observation exists to have a value, though it may not if it is in error, or it represents a group of observations.

Comments

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For boolean values use valueCodeableConcept and select codes from <http://hl7.org/fhir/ValueSet/v2-0136> (These "yes/no" concepts can be mapped to the display name "true/false" or other mutually exclusive terms that may be needed"). The element, Observation.value[x], has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueRatio, valueChoice, valuePeriod, valueSampleData, or valueString (The name format is "'value' + the type name" with a capital on the first letter of the type).

95. Observation.component.dataAbsentReason
Definition

Provides a reason why the expected value in the element Observation.value[x] is missing.

Control0..1 This element is affected by the following invariants: obs-6
BindingCodes specifying why the result (Observation.value[x]) is missing.
The codes SHALL be taken from Observation Value Absent Reason; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

For many results it is necessary to handle exceptional values in measurements.

Comments

"Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

96. Observation.component.referenceRange
Definition

Guidance on how to interpret the value by comparison to a normal or recommended range.

Control0..*
TypeBackboneElement
Requirements

Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g. specific to the patient's age, gender, weight and other factors), but this may not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

97. Observation.component.referenceRange.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
98. Observation.component.referenceRange.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

99. Observation.component.referenceRange.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

100. Observation.component.referenceRange.low
Definition

The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
101. Observation.component.referenceRange.high
Definition

The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
102. Observation.component.referenceRange.meaning
Definition

Code for the meaning of the reference range.

Control0..1
BindingCode for the meaning of a reference range.
The codes SHALL be taken from Observation Reference Range Meaning Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, or perhaps what state this reference range applies to (i.e. age, hormonal cycles, etc.).

Comments

This SHOULD be populated if there is more than one range.

103. Observation.component.referenceRange.age
Definition

The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

104. Observation.component.referenceRange.text
Definition

Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of 'normals'.

Control0..1
Typestring