This page is part of the Genetic Reporting Implementation Guide (v0.3.0: STU 1 Ballot 2) based on FHIR R4. The current version which supercedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions
Definitions for the obs-efficacy Profile.
Observation | |
Definition | Finding of the expected impact of a particular genotype on the efficacy of a particular medication for the subject. |
Control | 0..* |
Alternate Names | Vital 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 laboratory reports, etc. |
Invariants | Defined on this element 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.code = %resource.code.coding.code) and (coding.system = %resource.code.coding.system)).empty()) |
Observation.id | |
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
Control | 0..1 |
Type | id |
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. |
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. |
Control | 0..1 |
Type | Meta |
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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
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. |
Observation.language | |
Definition | The base language in which the resource is written. |
Control | 0..1 |
Binding | A human language. The codes SHOULD be taken from CommonLanguages |
Type | code |
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). |
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. |
Control | 0..1 |
Type | Narrative |
Alternate Names | narrative, html, xhtml, display |
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. |
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. |
Control | 0..* |
Type | Resource |
Alternate Names | inline 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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. |
Observation.extension | |
Definition | An Extension |
Control | 0..* |
Type | Extension |
Observation.extension ([CanonicalType[http://hl7.org/fhir/StructureDefinition/bodySite]]) | |
Definition | Allows associating observations to a particular portion of the patient - a fetus, a tumor, a lesion, etc. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(BodyStructure Reference) (Extension Type: Reference(BodyStructure)) |
Invariants | Defined on this element 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()) |
Observation.extension ([CanonicalType[http://hl7.org/fhir/StructureDefinition/observation-secondaryFinding]]) | |
Definition | Allows flagging observations that should be considered secondary findings. |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | Extension(secondaryFinding) (Extension Type: CodeableConcept) |
Invariants | Defined on this element 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()) |
Observation.extension ([CanonicalType[http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/dr-relatedArtifact]]) | |
Definition | References to literature that supports the impact assertion. |
Control | 0..* |
Type | Extension(Related Artifact) (Extension Type: RelatedArtifact) |
Must Support | true |
Observation.extension.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Control | 0..1 |
Type | string |
Observation.extension.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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
Observation.extension.url | |
Definition | Source of the definition for the extension code - a logical name or a URL. |
Control | 1..1 |
Type | uri |
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 SHALL be a URI for the Structure Definition defining the extension. |
Fixed Value | http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/dr-relatedArtifact |
Observation.extension.valueRelatedArtifact | |
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
Control | 0..1 |
Type | RelatedArtifact |
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). |
Control | 0..* |
Type | Extension |
Is Modifier | 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 |
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. |
Observation.identifier | |
Definition | A unique identifier assigned to this observation. |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 0..* |
Type | Identifier |
Requirements | Allows observations to be distinguished and referenced. |
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. |
Control | 0..* |
Type | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) |
Must Support | true |
Requirements | Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. |
Alternate Names | Fulfills |
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. |
Control | 0..* |
Type | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) |
Alternate Names | Container |
Comments | To link an Observation to an Encounter use |
Observation.status | |
Definition | The status of the result value. |
Control | 1..1 |
Binding | Codes providing the status of an observation. The codes SHALL be taken from ObservationStatus |
Type | code |
Is Modifier | true |
Must Support | true |
Requirements | Need to track the status of individual results. Some results are finalized before the whole report is finalized. |
Comments | … This should generally be 'completed' or 'revised'. |
Observation.category | |
Definition | A code that classifies the general type of observation being made. |
Control | 1..* |
Binding | Codes for high level observation categories. The codes SHOULD be taken from ObservationCategoryCodes |
Type | CodeableConcept |
Must Support | true |
Requirements | Used for filtering what observations are retrieved and displayed. |
Comments | … This should be populated with 'lab'. |
Pattern Value | <valueCodeableConcept xmlns="http://hl7.org/fhir"> <coding> <system value="http://terminology.hl7.org/CodeSystem/observation-category"/> <code value="laboratory"/> </coding> </valueCodeableConcept> |
Observation.code | |
Definition | Predicted phenotype for ability of drug to bind to intended site in order to deliver intended affect. A single marker interpretation value known to allow (responsive) or prevent (resistant) the drug to perform. |
Control | 1..1 |
Binding | Codes identifying names of simple observations. For example codes, see LOINCCodes |
Type | CodeableConcept |
Must Support | true |
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. |
Alternate Names | Name |
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. |
Pattern Value | <valueCodeableConcept xmlns="http://hl7.org/fhir"> <coding> <system value="http://loinc.org"/> <code value="51961-1"/> </coding> </valueCodeableConcept> |
Observation.subject | |
Definition | 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 |
Control | 0..1 |
Type | Reference(Patient | Group | Location) |
Must Support | true |
Requirements | Observations have no value if you don't know who or what they're about. |
Comments | … This must be the same patient as on the DiagnosticReport unless combining data from multiple fetuses or family members in a single report. |
Observation.focus | |
Definition | 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. |
Control | 0..* |
Type | Reference(Resource) |
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 |
Observation.encounter | |
Definition | The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. |
Control | 0..1 |
Type | Reference(Encounter) |
Requirements | For some observations it may be important to know the link between an observation and a particular encounter. |
Alternate Names | Context |
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). |
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. |
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] |
Must Support | true |
Requirements | Knowing when an observation was deemed true is important to its relevance as well as determining trends. |
Alternate Names | Occurrence |
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. |
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. |
Control | 0..1 |
Type | instant |
Must Support | true |
Comments | For Observations that don’t require review and verification, it may be the same as the |
Observation.performer | |
Definition | Who was responsible for asserting the observed value as "true". |
Control | 0..1 |
Type | Reference(Practitioner | Organization | Patient | RelatedPerson) |
Must Support | true |
Requirements | May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. |
Observation.valueCodeableConcept | |
Definition | Drug efficacy marker interpretation, based on LOINC LL539-8. Look to Medication Usage Implication for guidance. If the variant is predicted to not have an effect then Responsive is the proper choice. Non-responsive implies complete resistance, whereas Resistant indicates residual drug efficacy. |
Control | 1..1 This element is affected by the following invariants: obs-7 |
Type | CodeableConcept |
Must Support | 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. |
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. |
Observation.dataAbsentReason | |
Definition | Provides a reason why the expected value in the element Observation.value[x] is missing. |
Control | 0..1 This element is affected by the following invariants: obs-6 |
Binding | Codes specifying why the result (`Observation.value[x]`) is missing. The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
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. 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. |
Observation.interpretation | |
Definition | A categorical assessment of an observation value. For example, high, low, normal. |
Control | 0..0 |
Binding | Codes identifying interpretations of observations. The codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. |
Alternate Names | Abnormal Flag |
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. |
Observation.note | |
Definition | Additional commentary, qualification or other information about the genetic impact. |
Control | 0..* |
Type | Annotation |
Must Support | true |
Requirements | Need to be able to provide free text additional information. |
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. |
Observation.bodySite | |
Definition | Indicates the site on the subject's body where the observation was made (i.e. the target site). |
Control | 0..1 |
Binding | Codes describing anatomical locations. May include laterality. For example codes, see SNOMEDCTBodyStructures |
Type | CodeableConcept |
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. |
Observation.method | |
Definition | Indicates the mechanism used to perform the observation. |
Control | 0..1 |
Binding | Methods for simple observations. For example codes, see ObservationMethods |
Type | CodeableConcept |
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. |
Observation.specimen | |
Definition | The specimen that was used when this observation was made. |
Control | 0..1 |
Type | Reference(Specimen) |
Comments | Should only be used if not implicit in code found in |
Observation.device | |
Definition | The device used to generate the observation data. |
Control | 0..1 |
Type | Reference(Device | DeviceMetric) |
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. |
Observation.referenceRange | |
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two |
Control | 0..* |
Type | BackboneElement |
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 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. |
Invariants | Defined on this element 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()) |
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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
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). |
Control | 0..* |
Type | Extension |
Is Modifier | 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 |
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. |
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). |
Control | 0..1 This element is affected by the following invariants: obs-3 |
Type | Quantity(SimpleQuantity) |
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). |
Control | 0..1 This element is affected by the following invariants: obs-3 |
Type | Quantity(SimpleQuantity) |
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. |
Control | 0..1 |
Binding | Code for the meaning of a reference range. The codes SHOULD be taken from ObservationReferenceRangeMeaningCodes |
Type | CodeableConcept |
Requirements | Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. |
Comments | This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. |
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 |
Control | 0..* |
Binding | Codes identifying the population the reference range applies to. For example codes, see ObservationReferenceRangeAppliesToCodes |
Type | CodeableConcept |
Requirements | Need to be able to identify the target population for proper interpretation. |
Comments | This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. |
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. |
Control | 0..1 |
Type | Range |
Requirements | Some analytes vary greatly over age. |
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". |
Control | 0..1 |
Type | string |
Observation.hasMember | |
Definition | This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group. |
Control | 0..* |
Type | Reference(Observation | QuestionnaireResponse | MolecularSequence) |
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. |
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. |
Control | 0..* |
Type | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) |
Must Support | true |
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. |
Observation.derivedFrom(finding) | |
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. |
Control | 1..* |
Type | Reference(Genotype | Haplotype | Described Variant | Complex variation) |
Must Support | true |
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. |
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. |
Control | 0..* |
Type | BackboneElement |
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 be assembled in groups together see Notes below. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
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). |
Control | 0..* |
Type | Extension |
Is Modifier | 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 |
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. |
Observation.component.code | |
Definition | Describes what was observed. Sometimes this is called the observation "code". |
Control | 1..1 |
Binding | Codes identifying names of simple observations. For example codes, see LOINCCodes |
Type | CodeableConcept |
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. |
Comments | All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. |
Observation.component.value[x] | |
Definition | The information determined as a result of making the observation, if the information has a simple value. |
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] |
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. |
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. |
Observation.component.dataAbsentReason | |
Definition | Provides a reason why the expected value in the element Observation.component.value[x] is missing. |
Control | 0..1 This element is affected by the following invariants: obs-6 |
Binding | Codes specifying why the result (`Observation.value[x]`) is missing. The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
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. |
Observation.component.interpretation | |
Definition | A categorical assessment of an observation value. For example, high, low, normal. |
Control | 0..0 |
Binding | Codes identifying interpretations of observations. The codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. |
Alternate Names | Abnormal Flag |
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. |
Observation.component.referenceRange | |
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range. |
Control | 0..* |
Type | See Observation.referenceRange |
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 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. |
Observation.component(evidence-level) | |
Definition | Indicates the quality and type of evidence supporting this assertion. E.g. Tier I - Level A, Tier I - Level B, Tier II - Level C, Tier II - Level D, Tier III, Tier IV, Not Applicable. |
Control | 0..1 |
Type | BackboneElement |
Must Support | 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. |
Comments | For a discussion on the ways Observations can be assembled in groups together see Notes below. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
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). |
Control | 0..* |
Type | Extension |
Is Modifier | 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 |
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. |
Observation.component.code | |
Definition | Describes what was observed. Sometimes this is called the observation "code". |
Control | 1..1 |
Binding | Codes identifying names of simple observations. For example codes, see LOINCCodes |
Type | CodeableConcept |
Must Support | true |
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. |
Comments | All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. |
Pattern Value | <valueCodeableConcept xmlns="http://hl7.org/fhir"> <coding> <system value="http://loinc.org"/> <code value="TBD-Level-of-Evidence"/> </coding> </valueCodeableConcept> |
Observation.component.valueCodeableConcept | |
Definition | The information determined as a result of making the observation, if the information has a simple value. |
Control | 1..1 |
Binding | Binding not yet defined |
Type | CodeableConcept |
Must Support | 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. |
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. |
Observation.component.dataAbsentReason | |
Definition | Provides a reason why the expected value in the element Observation.component.value[x] is missing. |
Control | 0..1 This element is affected by the following invariants: obs-6 |
Binding | Codes specifying why the result (`Observation.value[x]`) is missing. The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
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. |
Observation.component.interpretation | |
Definition | A categorical assessment of an observation value. For example, high, low, normal. |
Control | 0..0 |
Binding | Codes identifying interpretations of observations. The codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. |
Alternate Names | Abnormal Flag |
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. |
Observation.component.referenceRange | |
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range. |
Control | 0..* |
Type | See Observation.referenceRange |
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 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. |
Observation.component(medication-assessed) | |
Definition | The medication whose impact is being described. |
Control | 1..* |
Type | BackboneElement |
Must Support | 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. |
Comments | For a discussion on the ways Observations can be assembled in groups together see Notes below. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
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. |
Control | 0..1 |
Type | string |
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. |
Control | 0..* |
Type | Extension |
Alternate Names | extensions, 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. |
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). |
Control | 0..* |
Type | Extension |
Is Modifier | 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 |
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. |
Observation.component.code | |
Definition | Describes what was observed. Sometimes this is called the observation "code". |
Control | 1..1 |
Binding | Codes identifying names of simple observations. For example codes, see LOINCCodes |
Type | CodeableConcept |
Must Support | true |
Requirements | Knowing what kind of observation is being made is essential to understanding the observation. |
Comments | All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. |
Pattern Value | <valueCodeableConcept xmlns="http://hl7.org/fhir"> <coding> <system value="http://loinc.org"/> <code value="51963-7"/> </coding> </valueCodeableConcept> |
Observation.component.valueCodeableConcept | |
Definition | The information determined as a result of making the observation, if the information has a simple value. |
Control | 1..1 |
Binding | Binding not yet defined |
Type | CodeableConcept |
Must Support | 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. |
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. |
Observation.component.dataAbsentReason | |
Definition | Provides a reason why the expected value in the element Observation.component.value[x] is missing. |
Control | 0..1 This element is affected by the following invariants: obs-6 |
Binding | Codes specifying why the result (`Observation.value[x]`) is missing. The codes SHALL be taken from DataAbsentReason; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
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. |
Observation.component.interpretation | |
Definition | A categorical assessment of an observation value. For example, high, low, normal. |
Control | 0..0 |
Binding | Codes identifying interpretations of observations. The codes SHALL be taken from ObservationInterpretationCodes; other codes may be used where these codes are not suitable |
Type | CodeableConcept |
Requirements | For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. |
Alternate Names | Abnormal Flag |
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. |
Observation.component.referenceRange | |
Definition | Guidance on how to interpret the value by comparison to a normal or recommended range. |
Control | 0..* |
Type | See Observation.referenceRange |
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 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. |