ObservationMicrobiology

Introduction

The ObservationMicrobiology profile represents the result information of a microbiology request and is a profile created from the resource Observation. The Resistance results will not be shown using this Observation profile, only the results of other microbiology examinations done on the sample of the patient. The data available from COSMIC to this profile is only starting from R8.3.03 COSMIC release, information created before this release cannot be taken from this API.

Intended Use

The profile ObservationMicrobiology is used for communicating an entry of a result of a microbiology test done by sending a value in the element observation.value. This profile is referenced in the basedOn field of DiagnosticReport FHIR profile. The API can be used to read result information for a specific microbiology test done as a part of a microbiology.

Organization profile used for performer supports requesting PDL hierarchy details as well, it will have the full hierarchy of units related to performer.

Profile Overview

ObservationMicrobiology

ObservationMicrobiology (Observation)	I		Observation	There are no (further) constraints on this element Element id Observation Short description Measurements and simple assertions Alternate names Vital Signs, Measurement, Results, Tests Definition Measurements and simple assertions made about a patient, device or other subject. 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. Data type Observation Constraints 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()` Mappings rim: Entity. Role, or Act workflow: Event sct-concept: < 363787002 \|Observable entity\| v2: OBX rim: Observation[classCode=OBS, moodCode=EVN]
id	Σ	1..1	string	There are no (further) constraints on this element Element id Observation.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. 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. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Observation.meta Short description Metadata about the resource 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Observation.implicitRules Short description A set of rules under which this content was created 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. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id Observation.language Short description Language of the resource content Definition The base language in which the resource is written. 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id Observation.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display 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. 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Observation.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources 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. 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. Data type Resource Mappings rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id Observation.identifier Short description Business Identifier for observation Definition A unique identifier assigned to this observation. Requirements Allows observations to be distinguished and referenced. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.identifier w5: FiveWs.identifier v2: OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4. rim: id
basedOn	Σ	0..*	Reference(ServiceRequest)	Element id Observation.basedOn Short description Fulfills plan, proposal or order Alternate names Fulfills 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. Requirements Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. Data type Reference(ServiceRequest) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.basedOn v2: ORC rim: .inboundRelationship[typeCode=COMP].source[moodCode=EVN]
partOf	Σ	0..0	Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy)	There are no (further) constraints on this element Element id Observation.partOf Short description Part of referenced event Alternate names Container Definition A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. Comments To link an Observation to an Encounter use `encounter`. See the Notes below for guidance on referencing another Observation. Data type Reference(MedicationAdministration \| MedicationDispense \| MedicationStatement \| Procedure \| Immunization \| ImagingStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.partOf v2: Varies by domain rim: .outboundRelationship[typeCode=FLFS].target
status	Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id Observation.status Short description registered \| preliminary \| final \| amended + Definition The status of the result value. Requirements Need to track the status of individual results. Some results are finalized before the whole report is finalized. Comments This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Data type code Binding Codes providing the status of an observation. ObservationStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.status w5: FiveWs.status sct-concept: < 445584004 \|Report by finality status\| v2: OBX-11 rim: status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
category		1..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.category Short description Classification of type of observation Definition A code that classifies the general type of observation being made. Requirements Used for filtering what observations are retrieved and displayed. 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. Data type CodeableConcept Binding Codes for high level observation categories. ObservationCategoryCodes (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.class rim: .outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
code	Σ	1..1	CodeableConcept	There are no (further) constraints on this element Element id Observation.code Short description Type of observation (code / type) Alternate names Name Definition Describes what was observed. Sometimes this is called the observation "name". Requirements Knowing what kind of observation is being made is essential to understanding the observation. 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. Data type CodeableConcept Binding Codes identifying names of simple observations. LOINCCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.code w5: FiveWs.what[x] sct-concept: < 363787002 \|Observable entity\| OR < 386053000 \|Evaluation procedure\| v2: OBX-3 rim: code sct-attr: 116680003 \|Is a\|
subject	Σ	0..1	Reference(Patient)	Element id Observation.subject Short description Who and/or what the observation is about 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 `focus` element or the `code` itself specifies the actual focus of the observation. Requirements Observations have no value if you don't know who or what they're about. Comments One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated. Data type Reference(Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.subject w5: FiveWs.subject[x] v2: PID-3 rim: participation[typeCode=RTGT] w5: FiveWs.subject
focus	Σ	0..0	Reference(Resource)	There are no (further) constraints on this element Element id Observation.focus Short description What the observation is about, when it is not about the subject of record 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. 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 `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension focusCode. Data type Reference(Resource) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.subject[x] v2: OBX-3 rim: participation[typeCode=SBJ] w5: FiveWs.subject
encounter	Σ	0..1	Reference(Encounter)	There are no (further) constraints on this element Element id Observation.encounter Short description Healthcare event during which this observation is made Alternate names Context Definition The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. Requirements For some observations it may be important to know the link between an observation and a particular encounter. 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). Data type Reference(Encounter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.context w5: FiveWs.context v2: PV1 rim: inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
effective[x]	Σ	0..1		Element id Observation.effective[x] Short description Clinically relevant time/time-period for observation Alternate names Occurrence 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. Using to commnicate the specimen collection date time Requirements Knowing when an observation was deemed true is important to its relevance as well as determining trends. Comments At least a date should be present unless this observation is a historical report. 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. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.occurrence[x] w5: FiveWs.done[x] v2: OBX-14, and/or OBX-19 after v2.4 (depends on who observation made) rim: effectiveTime
effectiveDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
effectivePeriod			Period	There are no (further) constraints on this element Data type Period
effectiveTiming			Timing	There are no (further) constraints on this element Data type Timing
effectiveInstant			instant	There are no (further) constraints on this element Data type instant
issued	Σ	0..1	instant	There are no (further) constraints on this element Element id Observation.issued Short description Date/Time this version was made available Definition The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. Comments For Observations that don’t require review and verification, it may be the same as the `lastUpdated` time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the `lastUpdated` time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.recorded v2: OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made) rim: participation[typeCode=AUT].time
performer	Σ	0..*	Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson)	There are no (further) constraints on this element Element id Observation.performer Short description Who is responsible for the observation Definition Who was responsible for asserting the observed value as "true". Requirements May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. Data type Reference(Practitioner \| PractitionerRole \| Organization \| CareTeam \| Patient \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings workflow: Event.performer.actor w5: FiveWs.actor v2: OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO' rim: participation[typeCode=PRF]
value[x]	Σ I	0..1		There are no (further) constraints on this element Element id Observation.value[x] Short description Actual result Definition The information determined as a result of making the observation, if the information has a simple value. 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. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 441742003 \|Evaluation finding\| v2: OBX.2, OBX.5, OBX.6 rim: value sct-attr: 363714003 \|Interprets\|
valueQuantity			Quantity	There are no (further) constraints on this element Data type Quantity
valueCodeableConcept			CodeableConcept	There are no (further) constraints on this element Data type CodeableConcept
valueString			string	There are no (further) constraints on this element Data type string
valueBoolean			boolean	There are no (further) constraints on this element Data type boolean
valueInteger			integer	There are no (further) constraints on this element Data type integer
valueRange			Range	There are no (further) constraints on this element Data type Range
valueRatio			Ratio	There are no (further) constraints on this element Data type Ratio
valueSampledData			SampledData	There are no (further) constraints on this element Data type SampledData
valueTime			time	There are no (further) constraints on this element Data type time
valueDateTime			dateTime	There are no (further) constraints on this element Data type dateTime
valuePeriod			Period	There are no (further) constraints on this element Data type Period
dataAbsentReason	I	0..0	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.dataAbsentReason Short description Why the result is missing Definition Provides a reason why the expected value in the element Observation.value[x] is missing. 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. Data type CodeableConcept Binding Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: value.nullFlavor
interpretation		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.interpretation Short description High, low, normal, etc. Alternate names Abnormal Flag Definition A categorical assessment of an observation value. For example, high, low, normal. Requirements For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Data type CodeableConcept Binding Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| v2: OBX-8 rim: interpretationCode sct-attr: 363713009 \|Has interpretation\|
note		0..*	Annotation	There are no (further) constraints on this element Element id Observation.note Short description Comments about the observation Definition Comments about the observation or the results. 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. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX) rim: subjectOf.observationEvent[code="annotation"].value
bodySite		0..1	CodeableConcept	There are no (further) constraints on this element Element id Observation.bodySite Short description Observed body part Definition Indicates the site on the subject's body where the observation was made (i.e. the target site). 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. Data type CodeableConcept Binding Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 123037004 \|Body structure\| v2: OBX-20 rim: targetSiteCode sct-attr: 718497002 \|Inherent location\|
method		0..0	CodeableConcept	There are no (further) constraints on this element Element id Observation.method Short description How it was done Definition Indicates the mechanism used to perform the observation. 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. Data type CodeableConcept Binding Methods for simple observations. ObservationMethods (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-17 rim: methodCode
specimen		0..1	Reference(Specimen)	There are no (further) constraints on this element Element id Observation.specimen Short description Specimen used for this observation Definition The specimen that was used when this observation was made. Comments Should only be used if not implicit in code found in `Observation.code`. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report). Data type Reference(Specimen) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 123038009 \|Specimen\| v2: SPM segment rim: participation[typeCode=SPC].specimen sct-attr: 704319004 \|Inherent in\|
device		0..0	Reference(Device \| DeviceMetric)	There are no (further) constraints on this element Element id Observation.device Short description (Measurement) Device Definition The device used to generate the observation data. 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. Data type Reference(Device \| DeviceMetric) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 49062001 \|Device\| v2: OBX-17 / PRT -10 rim: participation[typeCode=DEV] sct-attr: 424226004 \|Using device\|
referenceRange	I	0..*	BackboneElement	There are no (further) constraints on this element Element id Observation.referenceRange Short description Provides guide for interpretation 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 `referenceRange` elements would be used. 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. Data type BackboneElement Constraints 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()` Mappings v2: OBX.7 rim: outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
id		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Observation.referenceRange.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
low	I	0..1	SimpleQuantity	There are no (further) constraints on this element Element id Observation.referenceRange.low Short description Low Range, if relevant 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). Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:IVL_PQ.low
high	I	0..1	SimpleQuantity	There are no (further) constraints on this element Element id Observation.referenceRange.high Short description High Range, if relevant 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). Data type SimpleQuantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:IVL_PQ.high
type		0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Observation.referenceRange.type Short description Reference range qualifier Definition Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. 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. Data type CodeableConcept Binding Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| OR < 365860008 \|General clinical state finding\| OR < 250171008 \|Clinical history or observation findings\| OR < 415229000 \|Racial group\| OR < 365400002 \|Finding of puberty stage\| OR < 443938003 \|Procedure carried out on subject\| v2: OBX-10 rim: interpretationCode
appliesTo		0..*	CodeableConcept	There are no (further) constraints on this element Element id Observation.referenceRange.appliesTo Short description Reference range population 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 `appliesTo` are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used. 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. Data type CodeableConcept Binding Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings sct-concept: < 260245000 \|Findings values\| OR < 365860008 \|General clinical state finding\| OR < 250171008 \|Clinical history or observation findings\| OR < 415229000 \|Racial group\| OR < 365400002 \|Finding of puberty stage\| OR < 443938003 \|Procedure carried out on subject\| v2: OBX-10 rim: interpretationCode
age		0..1	Range	There are no (further) constraints on this element Element id Observation.referenceRange.age Short description Applicable age range, if relevant 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. Requirements Some analytes vary greatly over age. Data type Range Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: outboundRelationship[typeCode=PRCN].targetObservationCriterion[code="age"].value
text		0..1	string	There are no (further) constraints on this element Element id Observation.referenceRange.text Short description Text based reference range in an observation 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". Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: OBX-7 rim: value:ST
hasMember	Σ	0..*	Reference(Observation)	Element id Observation.hasMember Short description Related resource that belongs to the Observation group 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. 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. Data type Reference(Observation) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Relationships established by OBX-4 usage rim: outBoundRelationship
derivedFrom	Σ	0..0	Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence)	There are no (further) constraints on this element Element id Observation.derivedFrom Short description Related measurements the observation is made from 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. 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. Data type Reference(DocumentReference \| ImagingStudy \| Media \| QuestionnaireResponse \| Observation \| MolecularSequence) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Relationships established by OBX-4 usage rim: .targetObservation
component	Σ	0..0	BackboneElement	There are no (further) constraints on this element Element id Observation.component Short description Component results 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. 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: containment by OBX-4? rim: outBoundRelationship[typeCode=COMP]

COS version	Profile version	Required COSMIC version	Date	Description
3.0.0	1.0.0	R8.3.05	May 2022	initial version

Statuses

FHIR status	Status in COSMIC
Preliminary	Preliminary
Amended	Additional
Final	Final
Any other status	Unknown

ValueSet

The profile includes bindings to the following FHIR defined value set:

ValueSet

id : observation-category

meta

extension

url : http://hl7.org/fhir/ValueSet/observation-category

identifier

version : 4.0.1

name : ObservationCategoryCodes

title : Observation Category Codes

status : draft

experimental : False

date : 2019-11-01T09:29:23+11:00

publisher : FHIR Project team

contact

description : Observation Category codes.

compose