minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions
Active as of 2024-04-09 | Maturity Level: 4 |
Definitions for the mcode-tnm-primary-tumor-category resource profile.
Guidance on how to interpret the contents of this table can be found here
0. Observation | |||||
2. Observation.code | |||||
Binding | The codes SHOULD be taken from TNM Primary Tumor Staging Type Value Set (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-staging-type-vs )
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4. Observation.value[x] | |||||
Binding | The codes SHOULD be taken from TNM Primary Tumor Category Value Set (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-category-vs )
| ||||
[x] Note | See Choice of Data Types for further information about how to use [x] |
Guidance on how to interpret the contents of this table can be found here
0. Observation | |||||
Definition | Measurements and simple assertions made about a patient, device or other subject. | ||||
Short | Measurements and simple assertions | ||||
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 laboratory reports, etc. | ||||
Control | 0..* | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | Vital Signs, Measurement, Results, Tests | ||||
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present ( dataAbsentReason.empty() or value.empty() )obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present ( value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() )obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty()) obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()) | ||||
2. 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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||||
Short | A set of rules under which this content was created | ||||
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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
4. 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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Short | Extensions that cannot be ignored | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
Summary | false | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) | ||||
6. Observation.status | |||||
Definition | The status of the result value. | ||||
Short | registered | preliminary | final | amended + | ||||
Comments | This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1 (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1 )Codes providing the status of an observation. | ||||
Type | code | ||||
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Need to track the status of individual results. Some results are finalized before the whole report is finalized. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
8. Observation.code | |||||
Definition | Describes what was observed. Sometimes this is called the observation "name". | ||||
Short | Type of observation (code / type) | ||||
Comments | All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. | ||||
Control | 1..1 | ||||
Binding | The codes SHOULD be taken from For example codes, see TNM Primary Tumor Staging Type Value Sethttp://hl7.org/fhir/ValueSet/observation-codes (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-staging-type-vs )
| ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. | ||||
Alternate Names | Name | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
10. Observation.subject | |||||
Definition | The patient associated with TNM category. The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the | ||||
Short | Who and/or what the observation is 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. | ||||
Control | 0..1 | ||||
Type | Reference(Cancer Patient Profile, Patient, Group, Device, Location) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Observations have no value if you don't know who or what they're about. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
12. Observation.focus | |||||
Definition | Staging is associated with a particular primary cancer condition. Observation.focus is used to point back to that condition. The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus. | ||||
Short | The cancer condition associated with TNM category.What the observation is about, when it is not about the subject of record | ||||
Comments | Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use | ||||
Control | 0..* | ||||
Type | Reference(Primary Cancer Condition Profile, Resource) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
14. Observation.effective[x] | |||||
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. | ||||
Short | Clinically relevant time/time-period for observation | ||||
Comments | At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events. | ||||
Control | 0..1 | ||||
Type | Choice of: dateTime, Period, Timing, instant | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Must Support Types | No must-support rules about the choice of types/profiles | ||||
Summary | true | ||||
Requirements | Knowing when an observation was deemed true is important to its relevance as well as determining trends. | ||||
Alternate Names | Occurrence | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
16. Observation.value[x] | |||||
Definition | The information determined as a result of making the observation, if the information has a simple value. | ||||
Short | Actual result | ||||
Comments | An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. 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 additional guidance, see the Notes section below. | ||||
Control | 0..1 This element is affected by the following invariants: obs-7 | ||||
Binding | The codes SHOULD be taken from For codes, see TNM Primary Tumor Category Value Set (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-category-vs )
| ||||
Type | CodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
18. Observation.method | |||||
Definition | The staging system or protocol used to determine the category of the cancer based on its extent. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method. Indicates the mechanism used to perform the observation. | ||||
Short | The staging system used.How it was done | ||||
Comments | Only used if not implicit in code for Observation.code. | ||||
Control | 10..1 | ||||
Binding | Unless not suitable, these codes SHALL be taken from For example codes, see TNM Staging Method Value Sethttp://hl7.org/fhir/ValueSet/observation-methods (extensible to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-staging-method-vs ) | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | false | ||||
Requirements | In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here
0. Observation | |||||
Definition | Measurements and simple assertions made about a patient, device or other subject. | ||||
Short | Measurements and simple assertions | ||||
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 laboratory reports, etc. | ||||
Control | 0..* | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | Vital Signs, Measurement, Results, Tests | ||||
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty() )dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() )obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present ( dataAbsentReason.empty() or value.empty() )obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present ( value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty() ) | ||||
2. Observation.id | |||||
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
Short | Logical id of this artifact | ||||
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. | ||||
Control | 0..1 | ||||
Type | id | ||||
Is Modifier | false | ||||
Summary | true | ||||
4. Observation.meta | |||||
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
Short | Metadata about the resource | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
6. 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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||||
Short | A set of rules under which this content was created | ||||
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. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
8. Observation.language | |||||
Definition | The base language in which the resource is written. | ||||
Short | Language of the resource content | ||||
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). | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages (preferred to http://hl7.org/fhir/ValueSet/languages )A human language.
| ||||
Type | code | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
10. Observation.text | |||||
Definition | A human-readable narrative that contains a summary of the resource and can 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. | ||||
Short | Text summary of the resource, for human interpretation | ||||
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
12. 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. | ||||
Short | Contained, inline 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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | inline resources, anonymous resources, contained resources | ||||
14. Observation.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the resource. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Short | Additional content defined by implementations | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
16. 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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Short | Extensions that cannot be ignored | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
Summary | false | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
18. Observation.identifier | |||||
Definition | A unique identifier assigned to this observation. | ||||
Short | Business Identifier for observation | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows observations to be distinguished and referenced. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
20. Observation.basedOn | |||||
Definition | A 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. | ||||
Short | Fulfills plan, proposal or order | ||||
Control | 0..* | ||||
Type | Reference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. | ||||
Alternate Names | Fulfills | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
22. Observation.partOf | |||||
Definition | A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. | ||||
Short | Part of referenced event | ||||
Comments | To link an Observation to an Encounter use | ||||
Control | 0..* | ||||
Type | Reference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Alternate Names | Container | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
24. Observation.status | |||||
Definition | The status of the result value. | ||||
Short | registered | preliminary | final | amended + | ||||
Comments | This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ObservationStatus (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1 )Codes providing the status of an observation. | ||||
Type | code | ||||
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Need to track the status of individual results. Some results are finalized before the whole report is finalized. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
26. Observation.category | |||||
Definition | A code that classifies the general type of observation being made. | ||||
Short | Classification of type of observation | ||||
Comments | In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set. | ||||
Control | 0..* | ||||
Binding | The codes SHOULD be taken from ObservationCategoryCodes (preferred to http://hl7.org/fhir/ValueSet/observation-category )Codes for high level observation categories. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | Used for filtering what observations are retrieved and displayed. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
28. Observation.code | |||||
Definition | Describes what was observed. Sometimes this is called the observation "name". | ||||
Short | Type of observation (code / type) | ||||
Comments | All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. | ||||
Control | 1..1 | ||||
Binding | The codes SHOULD be taken from TNM Primary Tumor Staging Type Value Set (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-staging-type-vs )
| ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. | ||||
Alternate Names | Name | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
30. Observation.subject | |||||
Definition | The patient associated with TNM category. | ||||
Short | Who and/or what the observation is 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. | ||||
Control | 0..1 | ||||
Type | Reference(Cancer Patient Profile) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | Observations have no value if you don't know who or what they're about. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
32. Observation.focus | |||||
Definition | Staging is associated with a particular primary cancer condition. Observation.focus is used to point back to that condition. | ||||
Short | The cancer condition associated with TNM category. | ||||
Comments | Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use | ||||
Control | 0..* | ||||
Type | Reference(Primary Cancer Condition Profile) | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
34. Observation.encounter | |||||
Definition | The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. | ||||
Short | Healthcare event during which this observation is made | ||||
Comments | This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests). | ||||
Control | 0..1 | ||||
Type | Reference(Encounter) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | For some observations it may be important to know the link between an observation and a particular encounter. | ||||
Alternate Names | Context | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
36. Observation.effective[x] | |||||
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. | ||||
Short | Clinically relevant time/time-period for observation | ||||
Comments | At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events. | ||||
Control | 0..1 | ||||
Type | Choice of: dateTime, Period, Timing, instant | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Must Support | true | ||||
Must Support Types | No must-support rules about the choice of types/profiles | ||||
Summary | true | ||||
Requirements | Knowing when an observation was deemed true is important to its relevance as well as determining trends. | ||||
Alternate Names | Occurrence | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
38. Observation.issued | |||||
Definition | The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. | ||||
Short | Date/Time this version was made available | ||||
Comments | For Observations that don’t require review and verification, it may be the same as the | ||||
Control | 0..1 | ||||
Type | instant | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
40. Observation.performer | |||||
Definition | Who was responsible for asserting the observed value as "true". | ||||
Short | Who is responsible for the observation | ||||
Control | 0..* | ||||
Type | Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
42. Observation.value[x] | |||||
Definition | The information determined as a result of making the observation, if the information has a simple value. | ||||
Short | Actual result | ||||
Comments | An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. 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 additional guidance, see the Notes section below. | ||||
Control | 0..1 This element is affected by the following invariants: obs-7 | ||||
Binding | The codes SHOULD be taken from TNM Primary Tumor Category Value Set (preferred to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-primary-tumor-category-vs )
| ||||
Type | CodeableConcept | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | true | ||||
Requirements | An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
44. Observation.dataAbsentReason | |||||
Definition | Provides a reason why the expected value in the element Observation.value[x] is missing. | ||||
Short | Why the result is missing | ||||
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. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values. | ||||
Control | 0..1 This element is affected by the following invariants: obs-6 | ||||
Binding | Unless not suitable, these codes SHALL be taken from DataAbsentReason (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason )Codes specifying why the result ( | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | For many results it is necessary to handle exceptional values in measurements. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
46. Observation.interpretation | |||||
Definition | A categorical assessment of an observation value. For example, high, low, normal. | ||||
Short | High, low, normal, etc. | ||||
Comments | Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. | ||||
Control | 0..* | ||||
Binding | Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation )Codes identifying interpretations of observations. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. | ||||
Alternate Names | Abnormal Flag | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
48. Observation.note | |||||
Definition | Comments about the observation or the results. | ||||
Short | Comments about the observation | ||||
Comments | May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation. | ||||
Control | 0..* | ||||
Type | Annotation | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | Need to be able to provide free text additional information. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
50. Observation.bodySite | |||||
Definition | Indicates the site on the subject's body where the observation was made (i.e. the target site). | ||||
Short | Observed body part | ||||
Comments | Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite. | ||||
Control | 0..1 | ||||
Binding | For example codes, see SNOMEDCTBodyStructures (example to http://hl7.org/fhir/ValueSet/body-site )Codes describing anatomical locations. May include laterality. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
52. Observation.method | |||||
Definition | The staging system or protocol used to determine the category of the cancer based on its extent. When the staging system is implied by Observation.code, Observation.method is not required. However, when Observation.code does not imply a staging system (for example, if the code is SNOMED CT 385388004 Lymphoma stage), then the staging system must be specified in Observation.method. | ||||
Short | The staging system used. | ||||
Comments | Only used if not implicit in code for Observation.code. | ||||
Control | 1..1 | ||||
Binding | Unless not suitable, these codes SHALL be taken from TNM Staging Method Value Set (extensible to http://hl7.org/fhir/us/mcode/ValueSet/mcode-tnm-staging-method-vs ) | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Must Support | true | ||||
Summary | false | ||||
Requirements | In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
54. Observation.specimen | |||||
Definition | The specimen that was used when this observation was made. | ||||
Short | Specimen used for this observation | ||||
Comments | Should only be used if not implicit in code found in | ||||
Control | 0..1 | ||||
Type | Reference(Specimen) | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
56. Observation.device | |||||
Definition | Not used in this profile | ||||
Short | Not used in this profile | ||||
Comments | Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant. | ||||
Control | 0..1 | ||||
Type | Reference(Device, DeviceMetric) | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
58. Observation.referenceRange | |||||
Definition | Not used in this profile | ||||
Short | Not used in this profile | ||||
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 might 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. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Summary | false | ||||
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. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )obs-3: Must have at least a low or a high or text ( low.exists() or high.exists() or text.exists() ) | ||||
60. Observation.referenceRange.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
62. Observation.referenceRange.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Short | Additional content defined by implementations | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
64. 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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Short | Extensions that cannot be ignored even if unrecognized | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
66. 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). | ||||
Short | Low Range, if relevant | ||||
Control | 0..1 This element is affected by the following invariants: obs-3 | ||||
Type | Quantity(SimpleQuantity) | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
68. 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). | ||||
Short | High Range, if relevant | ||||
Control | 0..1 This element is affected by the following invariants: obs-3 | ||||
Type | Quantity(SimpleQuantity) | ||||
Is Modifier | false | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
70. Observation.referenceRange.type | |||||
Definition | Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. | ||||
Short | Reference range qualifier | ||||
Comments | This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from ObservationReferenceRangeMeaningCodes (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning )Code for the meaning of a reference range. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
72. Observation.referenceRange.appliesTo | |||||
Definition | Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple | ||||
Short | Reference range population | ||||
Comments | This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. | ||||
Control | 0..* | ||||
Binding | For example codes, see ObservationReferenceRangeAppliesToCodes (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto )Codes identifying the population the reference range applies to. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | Need to be able to identify the target population for proper interpretation. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
74. 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. | ||||
Short | Applicable age range, if relevant | ||||
Control | 0..1 | ||||
Type | Range | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | Some analytes vary greatly over age. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
76. 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". | ||||
Short | Text based reference range in an observation | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
78. Observation.hasMember | |||||
Definition | Not used in this profile | ||||
Short | Not used in this profile | ||||
Comments | When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation. | ||||
Control | 0..* | ||||
Type | Reference(Observation, QuestionnaireResponse, MolecularSequence) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
80. Observation.derivedFrom | |||||
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. | ||||
Short | Related measurements the observation is made from | ||||
Comments | All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below. | ||||
Control | 0..* | ||||
Type | Reference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence) | ||||
Is Modifier | false | ||||
Summary | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
82. 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. | ||||
Short | Component results | ||||
Comments | For a discussion on the ways Observations can be assembled in groups together see Notes below. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Is Modifier | false | ||||
Summary | true | ||||
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. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
84. Observation.component.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Short | Unique id for inter-element referencing | ||||
Control | 0..1 | ||||
Type | string | ||||
Is Modifier | false | ||||
XML Format | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
86. Observation.component.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Short | Additional content defined by implementations | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | false | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
88. 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 in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 can 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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Short | Extensions that cannot be ignored even if unrecognized | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) | ||||
90. Observation.component.code | |||||
Definition | Describes what was observed. Sometimes this is called the observation "code". | ||||
Short | Type of component observation (code / type) | ||||
Comments | All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. | ||||
Control | 1..1 | ||||
Binding | For example codes, see LOINCCodes (example to http://hl7.org/fhir/ValueSet/observation-codes )Codes identifying names of simple observations. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | true | ||||
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
92. Observation.component.value[x] | |||||
Definition | The information determined as a result of making the observation, if the information has a simple value. | ||||
Short | Actual component result | ||||
Comments | Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was 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 additional guidance, see the Notes section below. | ||||
Control | 0..1 | ||||
Type | Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Is Modifier | false | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Requirements | An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
94. Observation.component.dataAbsentReason | |||||
Definition | Provides a reason why the expected value in the element Observation.component.value[x] is missing. | ||||
Short | Why the component result is missing | ||||
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. | ||||
Control | 0..1 This element is affected by the following invariants: obs-6 | ||||
Binding | Unless not suitable, these codes SHALL be taken from DataAbsentReason (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason )Codes specifying why the result ( | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | For many results it is necessary to handle exceptional values in measurements. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
96. Observation.component.interpretation | |||||
Definition | A categorical assessment of an observation value. For example, high, low, normal. | ||||
Short | High, low, normal, etc. | ||||
Comments | Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. | ||||
Control | 0..* | ||||
Binding | Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation )Codes identifying interpretations of observations. | ||||
Type | CodeableConcept | ||||
Is Modifier | false | ||||
Summary | false | ||||
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. | ||||
Alternate Names | Abnormal Flag | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) | ||||
98. Observation.component.referenceRange | |||||
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range. | ||||
Short | Provides guide for interpretation of component result | ||||
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 might 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. | ||||
Control | 0..* | ||||
Type | See ttp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange | ||||
Is Modifier | false | ||||
Summary | false | ||||
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. | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |