LaboratoryTestResult
Profile | Description | Status | URL |
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HdBe-LaboratoryTestResult | A laboratory result describes the result of a laboratory analysis. These are specimen-oriented tests as performed in laboratories such as Clinical Chemistry, Serology, Microbiology, etc. In addition to the results of tests with a singular result, this concept can also contain the results of more complex tests with multiple results or a ‘panel’. | draft | https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult |
HdBe-LaboratoryTestResult.Specimen | Specimen contains all details regarding the specimen on which the test was carried out. | draft | https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen |
UML overview profiles
HdBe-LaboratoryTestResult
Instructions |
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The CBB LaboratoryTestResult captures both singular laboratory tests and panels/clusters of multiple related tests requested together (e.g. blood gases and EBV serology)*. This profile should be used slightly different in these two situations:
*) Please note the the CBB also recognizes the related_result concept. This is unrelated to the use of panels/clusters. This concept is represented either using |
Observation | I | Observation | Element IdObservation LaboratoryTestResult / LaboratoryTest Alternate namesVital Signs, Measurement, Results, Tests, LaboratoriumUitslag, LaboratoriumTest DefinitionAn instance of CBB LaboratoryTestResult or of a single LaboratoryTest within this CBB. The CBB LaboratoryTestResult captures both singular laboratory tests and panels/clusters of multiple related tests requested together (e.g. blood gases and EBV serology)*. This profile should be used slightly different in these two situations:
*) Please note the the CBB also recognizes the related_result concept. This is unrelated to the use of panels/clusters. This concept is represented either using
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extension | I | 0..* | Extension | Element IdObservation.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Constraints
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relatedResult | I | 0..* | Extension(Reference(Observation)) | Element IdObservation.extension:relatedResult Sequel to referenced Observation Alternate namesextensions, user content DefinitionThis observation follows the target observation (e.g. timed tests such as Glucose Tolerance Test). 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. Extension(Reference(Observation)) Extension URLhttp://hl7.org/fhir/StructureDefinition/observation-sequelTo Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdObservation.extension:relatedResult.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. 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. System.String Fixed Valuehttp://hl7.org/fhir/StructureDefinition/observation-sequelTo
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value[x] | 1..1 | Element IdObservation.extension:relatedResult.value[x] RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures
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valueReference | Reference(Observation| HdBe LaboratoryTestResult) | Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdObservation.identifier Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced.
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basedOn | Σ I | 0..* | Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) | There are no (further) constraints on this element Element IdObservation.basedOn Fulfills plan, proposal or order Alternate namesFulfills DefinitionA 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. Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) Constraints
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partOf | Σ I | 0..* | Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) | There are no (further) constraints on this element Element IdObservation.partOf Part of referenced event Alternate namesContainer DefinitionA larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. To link an Observation to an Encounter use Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) Constraints
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status | Σ ?! | 1..1 | codeBinding | Element IdObservation.status ResultStatus / TestResultStatus Alternate namesTestUitslagStatus DefinitionThe status of the laboratory test result or test result panel/cluster. Need to track the status of individual results. Some results are finalized before the whole report is finalized. If this resource represents a singular test result or a single test in a cluster/panel, this will be the status of this particular test result. However, if it represents the overall result of a panel/cluster, this status should represent the status of the panel/cluster and should be in accordance with the test result statuses of the individual tests. Use ConceptMap 'TestResultStatus-to-ObservationStatus' to translate CBB terminology to profile terminology in ValueSet 'ObservationStatus' ObservationStatus (required)Permitted Values TestResultStatus_to_ObservationStatus Constraints
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category | 0..* | CodeableConceptBinding | Element IdObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Unordered, Open, by $this(Value) BindingCodes for high level observation categories. ObservationCategoryCodes (preferred)Constraints
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resultType | 0..1 | CodeableConceptBinding | Element IdObservation.category:resultType Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Codes for high level observation categories. ResultType (required)Constraints
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code | Σ | 1..1 | CodeableConceptBinding | Element IdObservation.code PanelOrBattery / TestCode Alternate namesName, Onderzoek, TestCode DefinitionThe name and code of the executed test. For laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name and code of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology. Knowing what kind of observation is being made is essential to understanding the observation. When this resource represents a singular laboratory test result, a code MUST come from NHG Tabel 45 http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.16--20200901000000 or the Nederlandse Labcodeset http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.3--20200901000000. When this resource represent the overall result of a panel/cluster, a code MUST be a LOINC code. See the root of this profile for guidance. TO-DO: Change to ReTam Codes identifying names of simple observations. https://fhir.healthdata.be/ValueSet/TO-DO (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Location| HdBe Patient) | Element IdObservation.subject Who and/or what the observation is about DefinitionThe 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 Observations have no value if you don't know who or what they're about. 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. Reference(Patient| Group| Device| Location| HdBe Patient) Constraints
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focus | Σ I | 0..* | Reference(Resource) | There are no (further) constraints on this element Element IdObservation.focus What the observation is about, when it is not about the subject of record DefinitionThe 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. 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
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encounter | Σ I | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element IdObservation.encounter Healthcare event during which this observation is made Alternate namesContext DefinitionThe healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. For some observations it may be important to know the link between an observation and a particular encounter. 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).
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effective[x] | Σ | 0..1 | Element IdObservation.effective[x] Clinically relevant time/time-period for observation Alternate namesOccurrence DefinitionThe 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. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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. Unordered, Open, by $this(Type) Constraints
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effectivePeriod | Period | There are no (further) constraints on this element Data Type | ||
effectiveTiming | Timing | There are no (further) constraints on this element Data Type | ||
effectiveInstant | instant | There are no (further) constraints on this element Data Type | ||
effectiveDateTime | Σ | 0..1 | dateTime | Element IdObservation.effective[x]:effectiveDateTime TestDateTime Alternate namesOccurrence, TestDatumTijd DefinitionThe date and if possible the time at which the test was carried out. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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.
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issued | Σ | 0..1 | instant | There are no (further) constraints on this element Element IdObservation.issued Date/Time this version was made available DefinitionThe date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. For Observations that don’t require review and verification, it may be the same as the
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performer | Σ I | 0..1 | Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) | Element IdObservation.performer Performer Alternate namesUitvoerder DefinitionThe healthcare provider and/or organization where or by whom the LaboratoryTestResult was performed. May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) Constraints
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value[x] | Σ I | 0..1 | Element IdObservation.value[x] TestResult Alternate namesTestUitslag DefinitionThe test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal). An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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 quantitative results, it is mandatory to provide an unit. For additional guidance, see the Notes section below.
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valueQuantity | Quantity | Data Type | ||
valueCodeableConcept | CodeableConcept | Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.dataAbsentReason Why the result is missing DefinitionProvides a reason why the expected value in the element Observation.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. 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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | Element IdObservation.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Unordered, Open, by coding(Exists) BindingCodes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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resultFlags | 0..* | CodeableConceptBinding | Element IdObservation.interpretation:resultFlags ResultFlags Alternate namesAbnormal Flag, InterpretatieVlaggen DefinitionAttention codes indicating whether the result of a quantitative test is above or below certain reference values or interpreting the result otherwise.(Resistent). The values Resistant, Intermediate en Susceptible are used with microbiological test results. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Use ConceptMap 'ResultFlags-to-ObservationInterpretation' to translate CBB terminology to profile terminology in ValueSet 'Observation-interpretation' ObservationInterpretationCodes (extensible)Permitted Values ResultFlags_to_ObservationInterpretationCodes Constraints
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coding | Σ | 1..* | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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resultInterpretation | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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coding | Σ | 0..0 | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | Element IdObservation.interpretation:resultInterpretation.text ResultInterpretation Alternate namesUitslagInterpretatie DefinitionComment of the laboratory specialist regarding the interpretation of the results The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdObservation.note Comments about the observation DefinitionComments about the observation or the results. Need to be able to provide free text additional information. 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.
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdObservation.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdObservation.note.text Comment Alternate namesToelichting DefinitionComments, such as a textual interpretation or advice accompanying the result, for example. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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bodySite | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.bodySite Observed body part DefinitionIndicates the site on the subject's body where the observation was made (i.e. the target site). 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. Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example)Constraints
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method | 0..1 | CodeableConceptBinding | Element IdObservation.method TestMethod Alternate namesTestmethode DefinitionThe test method used to obtain the result. In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Only used if not implicit in code for Observation.code. Methods for simple observations. TestMethod (required)Constraints
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specimen | I | 0..1 | Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) | Element IdObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. The Specimen concept of the CCB defines either the collected source material without further processing, or a microorganism, optionally including the source material from which it whas isolated.
Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) Constraints
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device | I | 0..1 | Reference(Device| DeviceMetric) | There are no (further) constraints on this element Element IdObservation.device (Measurement) Device DefinitionThe device used to generate the observation data. 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. Reference(Device| DeviceMetric) Constraints
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referenceRange | I | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.referenceRange Provides guide for interpretation DefinitionGuidance 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 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. 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.
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low | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.low ReferenceRangeLowerLimit Alternate namesReferentieOndergrens DefinitionThe lower reference limit for the patient of the value measured with the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.high ReferenceRangeUpperLimit Alternate namesReferentieBovengrens DefinitionThe upper reference limit for the patient of the value measured in the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred)Constraints
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdObservation.referenceRange.appliesTo Reference range population DefinitionCodes 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 Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example)Constraints
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age | I | 0..1 | Range | There are no (further) constraints on this element Element IdObservation.referenceRange.age Applicable age range, if relevant DefinitionThe 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. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element IdObservation.referenceRange.text Text based reference range in an observation DefinitionText 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". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 0..* | Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.hasMember Related resource that belongs to the Observation group DefinitionThis 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. When this resource is used to represent the overall result of a panel/cluster of laboratory tests, the individual test results SHOULD be referenced here. See the root of this profile for guidance. Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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derivedFrom | Σ I | 0..* | Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.derivedFrom RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures 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. Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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component | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.component Component results DefinitionSome 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. 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. For a discussion on the ways Observations can be assembled in groups together see Notes below.
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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.component.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Codes identifying names of simple observations. LOINCCodes (example)Constraints
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value[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.component.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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.
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valueQuantity | Quantity | There are no (further) constraints on this element Data Type | ||
valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
valueString | string | There are no (further) constraints on this element Data Type | ||
valueBoolean | boolean | There are no (further) constraints on this element Data Type | ||
valueInteger | integer | There are no (further) constraints on this element Data Type | ||
valueRange | Range | There are no (further) constraints on this element Data Type | ||
valueRatio | Ratio | There are no (further) constraints on this element Data Type | ||
valueSampledData | SampledData | There are no (further) constraints on this element Data Type | ||
valueTime | time | There are no (further) constraints on this element Data Type | ||
valueDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
valuePeriod | Period | There are no (further) constraints on this element Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. "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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element IdObservation.component.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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. 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.
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Observation | I | Observation | Element IdObservation LaboratoryTestResult / LaboratoryTest Alternate namesVital Signs, Measurement, Results, Tests, LaboratoriumUitslag, LaboratoriumTest DefinitionAn instance of CBB LaboratoryTestResult or of a single LaboratoryTest within this CBB. The CBB LaboratoryTestResult captures both singular laboratory tests and panels/clusters of multiple related tests requested together (e.g. blood gases and EBV serology)*. This profile should be used slightly different in these two situations:
*) Please note the the CBB also recognizes the related_result concept. This is unrelated to the use of panels/clusters. This concept is represented either using
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extension | I | 0..* | Extension | Element IdObservation.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Constraints
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relatedResult | I | 0..* | Extension(Reference(Observation)) | Element IdObservation.extension:relatedResult Sequel to referenced Observation Alternate namesextensions, user content DefinitionThis observation follows the target observation (e.g. timed tests such as Glucose Tolerance Test). 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. Extension(Reference(Observation)) Extension URLhttp://hl7.org/fhir/StructureDefinition/observation-sequelTo Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdObservation.extension:relatedResult.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. 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. System.String Fixed Valuehttp://hl7.org/fhir/StructureDefinition/observation-sequelTo
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value[x] | 1..1 | Element IdObservation.extension:relatedResult.value[x] RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures
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valueReference | Reference(Observation| HdBe LaboratoryTestResult) | Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdObservation.identifier Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced.
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basedOn | Σ I | 0..* | Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) | There are no (further) constraints on this element Element IdObservation.basedOn Fulfills plan, proposal or order Alternate namesFulfills DefinitionA 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. Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) Constraints
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partOf | Σ I | 0..* | Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) | There are no (further) constraints on this element Element IdObservation.partOf Part of referenced event Alternate namesContainer DefinitionA larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. To link an Observation to an Encounter use Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) Constraints
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status | Σ ?! | 1..1 | codeBinding | Element IdObservation.status ResultStatus / TestResultStatus Alternate namesTestUitslagStatus DefinitionThe status of the laboratory test result or test result panel/cluster. Need to track the status of individual results. Some results are finalized before the whole report is finalized. If this resource represents a singular test result or a single test in a cluster/panel, this will be the status of this particular test result. However, if it represents the overall result of a panel/cluster, this status should represent the status of the panel/cluster and should be in accordance with the test result statuses of the individual tests. Use ConceptMap 'TestResultStatus-to-ObservationStatus' to translate CBB terminology to profile terminology in ValueSet 'ObservationStatus' ObservationStatus (required)Permitted Values TestResultStatus_to_ObservationStatus Constraints
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category | 0..* | CodeableConceptBinding | Element IdObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Unordered, Open, by $this(Value) BindingCodes for high level observation categories. ObservationCategoryCodes (preferred)Constraints
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resultType | 0..1 | CodeableConceptBinding | Element IdObservation.category:resultType Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Codes for high level observation categories. ResultType (required)Constraints
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code | Σ | 1..1 | CodeableConceptBinding | Element IdObservation.code PanelOrBattery / TestCode Alternate namesName, Onderzoek, TestCode DefinitionThe name and code of the executed test. For laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name and code of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology. Knowing what kind of observation is being made is essential to understanding the observation. When this resource represents a singular laboratory test result, a code MUST come from NHG Tabel 45 http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.16--20200901000000 or the Nederlandse Labcodeset http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.3--20200901000000. When this resource represent the overall result of a panel/cluster, a code MUST be a LOINC code. See the root of this profile for guidance. TO-DO: Change to ReTam Codes identifying names of simple observations. https://fhir.healthdata.be/ValueSet/TO-DO (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Location| HdBe Patient) | Element IdObservation.subject Who and/or what the observation is about DefinitionThe 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 Observations have no value if you don't know who or what they're about. 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. Reference(Patient| Group| Device| Location| HdBe Patient) Constraints
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focus | Σ I | 0..* | Reference(Resource) | There are no (further) constraints on this element Element IdObservation.focus What the observation is about, when it is not about the subject of record DefinitionThe 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. 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
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encounter | Σ I | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element IdObservation.encounter Healthcare event during which this observation is made Alternate namesContext DefinitionThe healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. For some observations it may be important to know the link between an observation and a particular encounter. 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).
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effective[x] | Σ | 0..1 | Element IdObservation.effective[x] Clinically relevant time/time-period for observation Alternate namesOccurrence DefinitionThe 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. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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. Unordered, Open, by $this(Type) Constraints
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effectivePeriod | Period | There are no (further) constraints on this element Data Type | ||
effectiveTiming | Timing | There are no (further) constraints on this element Data Type | ||
effectiveInstant | instant | There are no (further) constraints on this element Data Type | ||
effectiveDateTime | Σ | 0..1 | dateTime | Element IdObservation.effective[x]:effectiveDateTime TestDateTime Alternate namesOccurrence, TestDatumTijd DefinitionThe date and if possible the time at which the test was carried out. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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.
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issued | Σ | 0..1 | instant | There are no (further) constraints on this element Element IdObservation.issued Date/Time this version was made available DefinitionThe date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. For Observations that don’t require review and verification, it may be the same as the
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performer | Σ I | 0..1 | Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) | Element IdObservation.performer Performer Alternate namesUitvoerder DefinitionThe healthcare provider and/or organization where or by whom the LaboratoryTestResult was performed. May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) Constraints
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value[x] | Σ I | 0..1 | Element IdObservation.value[x] TestResult Alternate namesTestUitslag DefinitionThe test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal). An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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 quantitative results, it is mandatory to provide an unit. For additional guidance, see the Notes section below.
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valueQuantity | Quantity | Data Type | ||
valueCodeableConcept | CodeableConcept | Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.dataAbsentReason Why the result is missing DefinitionProvides a reason why the expected value in the element Observation.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. 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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | Element IdObservation.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Unordered, Open, by coding(Exists) BindingCodes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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resultFlags | 0..* | CodeableConceptBinding | Element IdObservation.interpretation:resultFlags ResultFlags Alternate namesAbnormal Flag, InterpretatieVlaggen DefinitionAttention codes indicating whether the result of a quantitative test is above or below certain reference values or interpreting the result otherwise.(Resistent). The values Resistant, Intermediate en Susceptible are used with microbiological test results. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Use ConceptMap 'ResultFlags-to-ObservationInterpretation' to translate CBB terminology to profile terminology in ValueSet 'Observation-interpretation' ObservationInterpretationCodes (extensible)Permitted Values ResultFlags_to_ObservationInterpretationCodes Constraints
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coding | Σ | 1..* | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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resultInterpretation | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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coding | Σ | 0..0 | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | Element IdObservation.interpretation:resultInterpretation.text ResultInterpretation Alternate namesUitslagInterpretatie DefinitionComment of the laboratory specialist regarding the interpretation of the results The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdObservation.note Comments about the observation DefinitionComments about the observation or the results. Need to be able to provide free text additional information. 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.
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdObservation.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdObservation.note.text Comment Alternate namesToelichting DefinitionComments, such as a textual interpretation or advice accompanying the result, for example. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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bodySite | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.bodySite Observed body part DefinitionIndicates the site on the subject's body where the observation was made (i.e. the target site). 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. Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example)Constraints
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method | 0..1 | CodeableConceptBinding | Element IdObservation.method TestMethod Alternate namesTestmethode DefinitionThe test method used to obtain the result. In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Only used if not implicit in code for Observation.code. Methods for simple observations. TestMethod (required)Constraints
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specimen | I | 0..1 | Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) | Element IdObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. The Specimen concept of the CCB defines either the collected source material without further processing, or a microorganism, optionally including the source material from which it whas isolated.
Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) Constraints
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device | I | 0..1 | Reference(Device| DeviceMetric) | There are no (further) constraints on this element Element IdObservation.device (Measurement) Device DefinitionThe device used to generate the observation data. 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. Reference(Device| DeviceMetric) Constraints
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referenceRange | I | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.referenceRange Provides guide for interpretation DefinitionGuidance 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 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. 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.
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low | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.low ReferenceRangeLowerLimit Alternate namesReferentieOndergrens DefinitionThe lower reference limit for the patient of the value measured with the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.high ReferenceRangeUpperLimit Alternate namesReferentieBovengrens DefinitionThe upper reference limit for the patient of the value measured in the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred)Constraints
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdObservation.referenceRange.appliesTo Reference range population DefinitionCodes 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 Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example)Constraints
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age | I | 0..1 | Range | There are no (further) constraints on this element Element IdObservation.referenceRange.age Applicable age range, if relevant DefinitionThe 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. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element IdObservation.referenceRange.text Text based reference range in an observation DefinitionText 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". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 0..* | Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.hasMember Related resource that belongs to the Observation group DefinitionThis 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. When this resource is used to represent the overall result of a panel/cluster of laboratory tests, the individual test results SHOULD be referenced here. See the root of this profile for guidance. Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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derivedFrom | Σ I | 0..* | Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.derivedFrom RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures 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. Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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component | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.component Component results DefinitionSome 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. 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. For a discussion on the ways Observations can be assembled in groups together see Notes below.
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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.component.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Codes identifying names of simple observations. LOINCCodes (example)Constraints
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value[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.component.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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.
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valueQuantity | Quantity | There are no (further) constraints on this element Data Type | ||
valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
valueString | string | There are no (further) constraints on this element Data Type | ||
valueBoolean | boolean | There are no (further) constraints on this element Data Type | ||
valueInteger | integer | There are no (further) constraints on this element Data Type | ||
valueRange | Range | There are no (further) constraints on this element Data Type | ||
valueRatio | Ratio | There are no (further) constraints on this element Data Type | ||
valueSampledData | SampledData | There are no (further) constraints on this element Data Type | ||
valueTime | time | There are no (further) constraints on this element Data Type | ||
valueDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
valuePeriod | Period | There are no (further) constraints on this element Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. "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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element IdObservation.component.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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. 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.
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Observation | I | Observation | Element IdObservation LaboratoryTestResult / LaboratoryTest Alternate namesVital Signs, Measurement, Results, Tests, LaboratoriumUitslag, LaboratoriumTest DefinitionAn instance of CBB LaboratoryTestResult or of a single LaboratoryTest within this CBB. The CBB LaboratoryTestResult captures both singular laboratory tests and panels/clusters of multiple related tests requested together (e.g. blood gases and EBV serology)*. This profile should be used slightly different in these two situations:
*) Please note the the CBB also recognizes the related_result concept. This is unrelated to the use of panels/clusters. This concept is represented either using
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extension | I | 0..* | Extension | Element IdObservation.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Constraints
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relatedResult | I | 0..* | Extension(Reference(Observation)) | Element IdObservation.extension:relatedResult Sequel to referenced Observation Alternate namesextensions, user content DefinitionThis observation follows the target observation (e.g. timed tests such as Glucose Tolerance Test). 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. Extension(Reference(Observation)) Extension URLhttp://hl7.org/fhir/StructureDefinition/observation-sequelTo Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdObservation.extension:relatedResult.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. 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. System.String Fixed Valuehttp://hl7.org/fhir/StructureDefinition/observation-sequelTo
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value[x] | 1..1 | Element IdObservation.extension:relatedResult.value[x] RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures
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valueReference | Reference(Observation| HdBe LaboratoryTestResult) | Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdObservation.identifier Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced.
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basedOn | Σ I | 0..* | Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) | There are no (further) constraints on this element Element IdObservation.basedOn Fulfills plan, proposal or order Alternate namesFulfills DefinitionA 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. Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(CarePlan| DeviceRequest| ImmunizationRecommendation| MedicationRequest| NutritionOrder| ServiceRequest) Constraints
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partOf | Σ I | 0..* | Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) | There are no (further) constraints on this element Element IdObservation.partOf Part of referenced event Alternate namesContainer DefinitionA larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure. To link an Observation to an Encounter use Reference(MedicationAdministration| MedicationDispense| MedicationStatement| Procedure| Immunization| ImagingStudy) Constraints
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status | Σ ?! | 1..1 | codeBinding | Element IdObservation.status ResultStatus / TestResultStatus Alternate namesTestUitslagStatus DefinitionThe status of the laboratory test result or test result panel/cluster. Need to track the status of individual results. Some results are finalized before the whole report is finalized. If this resource represents a singular test result or a single test in a cluster/panel, this will be the status of this particular test result. However, if it represents the overall result of a panel/cluster, this status should represent the status of the panel/cluster and should be in accordance with the test result statuses of the individual tests. Use ConceptMap 'TestResultStatus-to-ObservationStatus' to translate CBB terminology to profile terminology in ValueSet 'ObservationStatus' ObservationStatus (required)Permitted Values TestResultStatus_to_ObservationStatus Constraints
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category | 0..* | CodeableConceptBinding | Element IdObservation.category Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Unordered, Open, by $this(Value) BindingCodes for high level observation categories. ObservationCategoryCodes (preferred)Constraints
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resultType | 0..1 | CodeableConceptBinding | Element IdObservation.category:resultType Classification of type of observation DefinitionA code that classifies the general type of observation being made. Used for filtering what observations are retrieved and displayed. 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. Codes for high level observation categories. ResultType (required)Constraints
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code | Σ | 1..1 | CodeableConceptBinding | Element IdObservation.code PanelOrBattery / TestCode Alternate namesName, Onderzoek, TestCode DefinitionThe name and code of the executed test. For laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name and code of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology. Knowing what kind of observation is being made is essential to understanding the observation. When this resource represents a singular laboratory test result, a code MUST come from NHG Tabel 45 http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.16--20200901000000 or the Nederlandse Labcodeset http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.13.1.3--20200901000000. When this resource represent the overall result of a panel/cluster, a code MUST be a LOINC code. See the root of this profile for guidance. TO-DO: Change to ReTam Codes identifying names of simple observations. https://fhir.healthdata.be/ValueSet/TO-DO (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Location| HdBe Patient) | Element IdObservation.subject Who and/or what the observation is about DefinitionThe 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 Observations have no value if you don't know who or what they're about. 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. Reference(Patient| Group| Device| Location| HdBe Patient) Constraints
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focus | Σ I | 0..* | Reference(Resource) | There are no (further) constraints on this element Element IdObservation.focus What the observation is about, when it is not about the subject of record DefinitionThe 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. 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
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encounter | Σ I | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element IdObservation.encounter Healthcare event during which this observation is made Alternate namesContext DefinitionThe healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made. For some observations it may be important to know the link between an observation and a particular encounter. 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).
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effective[x] | Σ | 0..1 | Element IdObservation.effective[x] Clinically relevant time/time-period for observation Alternate namesOccurrence DefinitionThe 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. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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. Unordered, Open, by $this(Type) Constraints
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effectivePeriod | Period | There are no (further) constraints on this element Data Type | ||
effectiveTiming | Timing | There are no (further) constraints on this element Data Type | ||
effectiveInstant | instant | There are no (further) constraints on this element Data Type | ||
effectiveDateTime | Σ | 0..1 | dateTime | Element IdObservation.effective[x]:effectiveDateTime TestDateTime Alternate namesOccurrence, TestDatumTijd DefinitionThe date and if possible the time at which the test was carried out. Knowing when an observation was deemed true is important to its relevance as well as determining trends. 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.
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issued | Σ | 0..1 | instant | There are no (further) constraints on this element Element IdObservation.issued Date/Time this version was made available DefinitionThe date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified. For Observations that don’t require review and verification, it may be the same as the
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performer | Σ I | 0..1 | Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) | Element IdObservation.performer Performer Alternate namesUitvoerder DefinitionThe healthcare provider and/or organization where or by whom the LaboratoryTestResult was performed. May give a degree of confidence in the observation and also indicates where follow-up questions should be directed. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole| Patient| Organization| CareTeam| RelatedPerson| HdBe HealthProfessional PractitionerRole| HdBe HealthProfessional Practitioner) Constraints
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value[x] | Σ I | 0..1 | Element IdObservation.value[x] TestResult Alternate namesTestUitslag DefinitionThe test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal). An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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 quantitative results, it is mandatory to provide an unit. For additional guidance, see the Notes section below.
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valueQuantity | Quantity | Data Type | ||
valueCodeableConcept | CodeableConcept | Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.dataAbsentReason Why the result is missing DefinitionProvides a reason why the expected value in the element Observation.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. 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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | Element IdObservation.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Unordered, Open, by coding(Exists) BindingCodes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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resultFlags | 0..* | CodeableConceptBinding | Element IdObservation.interpretation:resultFlags ResultFlags Alternate namesAbnormal Flag, InterpretatieVlaggen DefinitionAttention codes indicating whether the result of a quantitative test is above or below certain reference values or interpreting the result otherwise.(Resistent). The values Resistant, Intermediate en Susceptible are used with microbiological test results. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Use ConceptMap 'ResultFlags-to-ObservationInterpretation' to translate CBB terminology to profile terminology in ValueSet 'Observation-interpretation' ObservationInterpretationCodes (extensible)Permitted Values ResultFlags_to_ObservationInterpretationCodes Constraints
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coding | Σ | 1..* | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element IdObservation.interpretation:resultFlags.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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resultInterpretation | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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coding | Σ | 0..0 | Coding | There are no (further) constraints on this element Element IdObservation.interpretation:resultInterpretation.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for alternative encodings within a code system, and translations to other code systems. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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text | Σ | 0..1 | string | Element IdObservation.interpretation:resultInterpretation.text ResultInterpretation Alternate namesUitslagInterpretatie DefinitionComment of the laboratory specialist regarding the interpretation of the results The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdObservation.note Comments about the observation DefinitionComments about the observation or the results. Need to be able to provide free text additional information. 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.
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdObservation.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdObservation.note.text Comment Alternate namesToelichting DefinitionComments, such as a textual interpretation or advice accompanying the result, for example. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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bodySite | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.bodySite Observed body part DefinitionIndicates the site on the subject's body where the observation was made (i.e. the target site). 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. Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example)Constraints
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method | 0..1 | CodeableConceptBinding | Element IdObservation.method TestMethod Alternate namesTestmethode DefinitionThe test method used to obtain the result. In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results. Only used if not implicit in code for Observation.code. Methods for simple observations. TestMethod (required)Constraints
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specimen | I | 0..1 | Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) | Element IdObservation.specimen Specimen used for this observation DefinitionThe specimen that was used when this observation was made. The Specimen concept of the CCB defines either the collected source material without further processing, or a microorganism, optionally including the source material from which it whas isolated.
Reference(Specimen| HdBe LaboratoryTestResult.Specimen| https://fhir.healthdata.be/StructureDefinition/HdBe-LaboratoryTestResult.Specimen.Microorganism) Constraints
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device | I | 0..1 | Reference(Device| DeviceMetric) | There are no (further) constraints on this element Element IdObservation.device (Measurement) Device DefinitionThe device used to generate the observation data. 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. Reference(Device| DeviceMetric) Constraints
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referenceRange | I | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.referenceRange Provides guide for interpretation DefinitionGuidance 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 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. 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.
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low | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.low ReferenceRangeLowerLimit Alternate namesReferentieOndergrens DefinitionThe lower reference limit for the patient of the value measured with the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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high | I | 0..1 | SimpleQuantity | Element IdObservation.referenceRange.high ReferenceRangeUpperLimit Alternate namesReferentieBovengrens DefinitionThe upper reference limit for the patient of the value measured in the test. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.referenceRange.type Reference range qualifier DefinitionCodes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range. Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed. Code for the meaning of a reference range. ObservationReferenceRangeMeaningCodes (preferred)Constraints
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appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdObservation.referenceRange.appliesTo Reference range population DefinitionCodes 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 Need to be able to identify the target population for proper interpretation. This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed. Codes identifying the population the reference range applies to. ObservationReferenceRangeAppliesToCodes (example)Constraints
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age | I | 0..1 | Range | There are no (further) constraints on this element Element IdObservation.referenceRange.age Applicable age range, if relevant DefinitionThe 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. Some analytes vary greatly over age. The stated low and high value are assumed to have arbitrarily high precision when it comes to determining which values are in the range. I.e. 1.99 is not in the range 2 -> 3.
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text | 0..1 | string | There are no (further) constraints on this element Element IdObservation.referenceRange.text Text based reference range in an observation DefinitionText 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". Note that FHIR strings SHALL NOT exceed 1MB in size
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hasMember | Σ I | 0..* | Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.hasMember Related resource that belongs to the Observation group DefinitionThis 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. When this resource is used to represent the overall result of a panel/cluster of laboratory tests, the individual test results SHOULD be referenced here. See the root of this profile for guidance. Reference(Observation| QuestionnaireResponse| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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derivedFrom | Σ I | 0..* | Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) | Element IdObservation.derivedFrom RelatedResult Alternate namesGerelateerdeUitslag DefinitionReference to related tests, e.g. paired tests or sequential tests like gram staining and microbiological cultures 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. Reference(DocumentReference| ImagingStudy| Media| QuestionnaireResponse| Observation| MolecularSequence| HdBe LaboratoryTestResult) Constraints
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component | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element IdObservation.component Component results DefinitionSome 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. 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. For a discussion on the ways Observations can be assembled in groups together see Notes below.
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code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdObservation.component.code Type of component observation (code / type) DefinitionDescribes what was observed. Sometimes this is called the observation "code". Knowing what kind of observation is being made is essential to understanding the observation. All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. Codes identifying names of simple observations. LOINCCodes (example)Constraints
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value[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdObservation.component.value[x] Actual component result DefinitionThe information determined as a result of making the observation, if the information has a simple value. An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations. 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.
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valueQuantity | Quantity | There are no (further) constraints on this element Data Type | ||
valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
valueString | string | There are no (further) constraints on this element Data Type | ||
valueBoolean | boolean | There are no (further) constraints on this element Data Type | ||
valueInteger | integer | There are no (further) constraints on this element Data Type | ||
valueRange | Range | There are no (further) constraints on this element Data Type | ||
valueRatio | Ratio | There are no (further) constraints on this element Data Type | ||
valueSampledData | SampledData | There are no (further) constraints on this element Data Type | ||
valueTime | time | There are no (further) constraints on this element Data Type | ||
valueDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
valuePeriod | Period | There are no (further) constraints on this element Data Type | ||
dataAbsentReason | I | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.dataAbsentReason Why the component result is missing DefinitionProvides a reason why the expected value in the element Observation.component.value[x] is missing. For many results it is necessary to handle exceptional values in measurements. "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. Codes specifying why the result (`Observation.value[x]`) is missing. DataAbsentReason (extensible)Constraints
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interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdObservation.component.interpretation High, low, normal, etc. Alternate namesAbnormal Flag DefinitionA categorical assessment of an observation value. For example, high, low, normal. For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result. 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. Codes identifying interpretations of observations. ObservationInterpretationCodes (extensible)Constraints
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referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element IdObservation.component.referenceRange Provides guide for interpretation of component result DefinitionGuidance on how to interpret the value by comparison to a normal or recommended range. 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. 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.
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Mapping FHIR profile to CBB
Path | map |
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Observation | laboratory_test_result |
Observation | laboratory_test |
Observation.extension:relatedResult.value[x] | related_result |
Observation.status | result_status |
Observation.status | laboratory_test.test_result_status |
Observation.category:resultType | result_type |
Observation.code | panel_or_battery |
Observation.code | laboratory_test.test_code |
Observation.effective[x]:effectiveDateTime | laboratory_test.test_date_time |
Observation.performer | performer.healthcare_provider |
Observation.value[x] | laboratory_test.test_result |
Observation.interpretation:resultFlags | laboratory_test.result_flags |
Observation.interpretation:resultInterpretation.text | laboratory_test.result_interpretation |
Observation.note.text | laboratory_test.comment |
Observation.method | laboratory_test.test_method |
Observation.specimen | specimen |
Observation.referenceRange.low | laboratory_test.reference_range_lower_limit |
Observation.referenceRange.high | laboratory_test.reference_range_upper_limit |
Observation.derivedFrom | related_result |
zib LaboratoryTestResult difference
Concept | Category | Description |
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code |
terminology | Removed bound valuesets. Need to be replaced by a ReTam valueset. (TO-DO) |
performer |
reference | Added reference to HdBe-HealthcareProvider-Organization (seems missing in the current zib profile implementation). |
performer |
slicing | Removed slicing because this caused an error in the FHIR validator. |
value[x] |
textual | Added textual guidance to include the unit for quantitative results. |
interpretation.resultFlags |
terminology | Added ConceptMap ResultFlagsCodelist-to-ObservationInterpretation (seems missing in the currenct zib profile implementation). |
test_method |
terminology | TO-DO: Check if the ValueSet needs to be replaced with the SNOMED-CT code for Procedure. |
has_member |
reference | Added reference to HdBe-LaboratoryTestResult.Specimen (seems missing in the current zib profile implementation). |
derived_from |
reference | Added reference to HdBe-LaboratoryTestResult (seems missing in the current zib profile implementation). |
HdBe-LaboratoryTestResult.Specimen
Instructions |
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The Specimen concept from the CCB HdBe-LaboratoryTestResult contains a concept for SpecimenMaterial and for Microorganism. These two concepts cannot be represented in the same Specimen resources; if there's a need to communicate both the microorganism and the sample material from which it was isolated, two instances need to be used. The instance representing the microorganism should refer to the instance respresenting the sample material using |
Specimen | I | Specimen | Element IdSpecimen Specimen Alternate namesMonster DefinitionThe Specimen concept from the CCB HdBe-LaboratoryTestResult contains a concept for SpecimenMaterial and for Microorganism. These two concepts cannot be represented in the same Specimen resources; if there's a need to communicate both the microorganism and the sample material from which it was isolated, two instances need to be used. The instance representing the microorganism should refer to the instance respresenting the sample material using
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.identifier SpecimenId Alternate namesMonsternummer DefinitionIdentification number of the material obtained, as a reference for inquiries to the source organization. In a transmural setting, this number will consist of a specimen number including the identification of the issuing organization, to be unique outside of the borders of an organization.
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accessionIdentifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element IdSpecimen.accessionIdentifier Identifier assigned by the lab DefinitionThe identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures.
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdSpecimen.status available | unavailable | unsatisfactory | entered-in-error DefinitionThe availability of the specimen. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes providing the status/availability of a specimen. SpecimenStatus (required)Constraints
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type | Σ | 0..1 | CodeableConceptBinding | Element IdSpecimen.type SpecimenMaterial / Microorganism Alternate namesMicroorganisme Definition
This Specimen resource can represent either a specimen material or a microorganism. Which of these two types is represented, is determined by this element. If there's a need to represent both the microorganism isolate and the specimen material from which it was derived, two separte resources are to be used, where the microorganism resource refers to the material resource using Specimen.parent. If this resource represents material and is carried out on derived material (such as plasma), this element will still contain the material drawn (in this case, blood). In this case, the LOINC code will generally refer to plasma. The type of the specimen. SpecimenMaterial-and-Microorganism (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Substance| Location) | There are no (further) constraints on this element Element IdSpecimen.subject Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device DefinitionWhere the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device. Must know the subject context. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient| Group| Device| Substance| Location) Constraints
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receivedTime | Σ | 0..1 | dateTime | Element IdSpecimen.receivedTime ReceivedDateTime Alternate namesAannameDatumTijd DefinitionDate and time that the material is handed over at the laboratory or specimen collection center.
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parent | I | 0..* | Reference(HdBe LaboratoryTestResult.Specimen) | Element IdSpecimen.parent Specimen from which this specimen originated DefinitionReference to the parent (source) specimen which is used when the specimen was either derived from or a component of another specimen. When this resource represents a microorganism (that is, Reference(HdBe LaboratoryTestResult.Specimen) Constraints
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request | I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdSpecimen.request Why the specimen was collected DefinitionDetails concerning a service request that required a specimen to be collected. The request may be explicit or implied such with a ServiceRequest that requires a blood draw.
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collection | 0..1 | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.collection Collection details DefinitionDetails concerning the specimen collection.
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collector | Σ I | 0..1 | Reference(Practitioner| PractitionerRole) | There are no (further) constraints on this element Element IdSpecimen.collection.collector Who collected the specimen DefinitionPerson who collected the specimen. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole) Constraints
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collected[x] | Σ | 0..1 | Element IdSpecimen.collection.collected[x] Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time. Unordered, Open, by $this(Type) Constraints
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collectedDateTime | Σ | 0..1 | dateTime | Element IdSpecimen.collection.collected[x]:collectedDateTime Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time.
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collectedPeriod | Σ | 0..1 | Period | Element IdSpecimen.collection.collected[x]:collectedPeriod CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine.
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duration | Σ I | 0..1 | DurationBinding | Element IdSpecimen.collection.duration CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Appropriate units for Duration. CommonUCUMCodesForDuration (extensible)Constraints
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quantity | I | 0..1 | SimpleQuantity | Element IdSpecimen.collection.quantity CollectedVolume Alternate namesVerzamelvolume DefinitionTotal volume of the collected material. If it is necessary to determine the absolute amount of a particular substance in the collected material, the volume thereof must be given. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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method | 0..1 | CodeableConceptBinding | Element IdSpecimen.collection.method CollectionMethod Alternate namesAfnameprocedure DefinitionIf relevant for the results, the method of obtaining the specimen can be entered as well. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The technique that is used to perform the procedure. CollectionMethod (required)Constraints
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bodySite | 0..1 | HdBe AnatomicalLocationBinding | Element IdSpecimen.collection.bodySite AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionAnatomic location where the material is collected, e.g. elbow Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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fastingStatus[x] | Σ | 0..1 | Binding | There are no (further) constraints on this element Element IdSpecimen.collection.fastingStatus[x] Whether or how long patient abstained from food and/or drink DefinitionAbstinence or reduction from some or all food, drink, or both, for a period of time prior to sample collection. Many diagnostic tests require fasting to facilitate accurate interpretation. Representing fasting status using this element is preferred to representing it with an observation using a 'pre-coordinated code' such as LOINC 2005-7 (Calcium [Moles/time] in 2 hour Urine --12 hours fasting), or using a component observation Codes describing the fasting status of the patient. v2.0916 (extensible)Constraints
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fastingStatusCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
fastingStatusDuration | Duration | There are no (further) constraints on this element Data Type | ||
processing | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.processing Processing and processing step details DefinitionDetails concerning processing and processing steps for the specimen.
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.processing.description Textual description of procedure DefinitionTextual description of procedure. Note that FHIR strings SHALL NOT exceed 1MB in size
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procedure | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdSpecimen.processing.procedure Indicates the treatment step applied to the specimen DefinitionA coded value specifying the procedure used to process the specimen. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type indicating the technique used to process the specimen. SpecimenProcessingProcedure (example)Constraints
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additive | I | 0..* | Reference(Substance) | There are no (further) constraints on this element Element IdSpecimen.processing.additive Material used in the processing step DefinitionMaterial used in the processing step. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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time[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.processing.time[x] Date and time of specimen processing DefinitionA record of the time or period when the specimen processing occurred. For example the time of sample fixation or the period of time the sample was in formalin.
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timeDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timePeriod | Period | There are no (further) constraints on this element Data Type | ||
container | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.container Direct container of specimen (tube/slide, etc.) DefinitionThe container holding the specimen. The recursive nature of containers; i.e. blood in tube in tray in rack is not addressed here.
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.container.identifier SpecimenNumberExtension Alternate namesMonstervolgnummer DefinitionThe specimen number extension is used when the collected material is distributed from the original tube or container across multiple tubes. In combination with the specimen Id the extension yield a unique identification of the tube or container
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.container.description Textual description of the container DefinitionTextual description of the container. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 0..1 | CodeableConceptBinding | Element IdSpecimen.container.type Kind of container directly associated with specimen DefinitionThe type of container associated with the specimen (e.g. slide, aliquot, etc.). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type of specimen container. ContainerType (preferred)Constraints
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capacity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.capacity Container volume or size DefinitionThe capacity (volume or other measure) the container may contain. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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specimenQuantity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.specimenQuantity Quantity of specimen within container DefinitionThe quantity of specimen in the container; may be volume, dimensions, or other appropriate measurements, depending on the specimen type. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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additive[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.container.additive[x] Additive associated with container DefinitionIntroduced substance to preserve, maintain or enhance the specimen. Examples: Formalin, Citrate, EDTA. Substance added to specimen container. v2.0371 (example)Constraints
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additiveCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
additiveReference | Reference(Substance) | There are no (further) constraints on this element Data Type | ||
condition | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdSpecimen.condition State of the specimen DefinitionA mode or state of being that describes the nature of the specimen. The specimen condition can be used to assess its quality or appropriateness for a specific test. Specimen condition is an observation made about the specimen. It's a point-in-time assessment. It can be used to assess its quality or appropriateness for a specific test. Codes describing the state of the specimen. v2.0493 (extensible)Constraints
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note | 0..* | Annotation | There are no (further) constraints on this element Element IdSpecimen.note Comments DefinitionTo communicate any details or issues about the specimen or during the specimen collection. (for example: broken vial, sent with patient, frozen). For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdSpecimen.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdSpecimen.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdSpecimen.note.text Comment Alternate namesToelichting DefinitionComments on the specimen , such as drawing material after a (glucose) stimulus or taking medicine. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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Specimen | I | Specimen | Element IdSpecimen Specimen Alternate namesMonster DefinitionThe Specimen concept from the CCB HdBe-LaboratoryTestResult contains a concept for SpecimenMaterial and for Microorganism. These two concepts cannot be represented in the same Specimen resources; if there's a need to communicate both the microorganism and the sample material from which it was isolated, two instances need to be used. The instance representing the microorganism should refer to the instance respresenting the sample material using
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.identifier SpecimenId Alternate namesMonsternummer DefinitionIdentification number of the material obtained, as a reference for inquiries to the source organization. In a transmural setting, this number will consist of a specimen number including the identification of the issuing organization, to be unique outside of the borders of an organization.
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accessionIdentifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element IdSpecimen.accessionIdentifier Identifier assigned by the lab DefinitionThe identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures.
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdSpecimen.status available | unavailable | unsatisfactory | entered-in-error DefinitionThe availability of the specimen. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes providing the status/availability of a specimen. SpecimenStatus (required)Constraints
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type | Σ | 0..1 | CodeableConceptBinding | Element IdSpecimen.type SpecimenMaterial / Microorganism Alternate namesMicroorganisme Definition
This Specimen resource can represent either a specimen material or a microorganism. Which of these two types is represented, is determined by this element. If there's a need to represent both the microorganism isolate and the specimen material from which it was derived, two separte resources are to be used, where the microorganism resource refers to the material resource using Specimen.parent. If this resource represents material and is carried out on derived material (such as plasma), this element will still contain the material drawn (in this case, blood). In this case, the LOINC code will generally refer to plasma. The type of the specimen. SpecimenMaterial-and-Microorganism (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Substance| Location) | There are no (further) constraints on this element Element IdSpecimen.subject Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device DefinitionWhere the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device. Must know the subject context. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient| Group| Device| Substance| Location) Constraints
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receivedTime | Σ | 0..1 | dateTime | Element IdSpecimen.receivedTime ReceivedDateTime Alternate namesAannameDatumTijd DefinitionDate and time that the material is handed over at the laboratory or specimen collection center.
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parent | I | 0..* | Reference(HdBe LaboratoryTestResult.Specimen) | Element IdSpecimen.parent Specimen from which this specimen originated DefinitionReference to the parent (source) specimen which is used when the specimen was either derived from or a component of another specimen. When this resource represents a microorganism (that is, Reference(HdBe LaboratoryTestResult.Specimen) Constraints
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request | I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdSpecimen.request Why the specimen was collected DefinitionDetails concerning a service request that required a specimen to be collected. The request may be explicit or implied such with a ServiceRequest that requires a blood draw.
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collection | 0..1 | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.collection Collection details DefinitionDetails concerning the specimen collection.
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collector | Σ I | 0..1 | Reference(Practitioner| PractitionerRole) | There are no (further) constraints on this element Element IdSpecimen.collection.collector Who collected the specimen DefinitionPerson who collected the specimen. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole) Constraints
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collected[x] | Σ | 0..1 | Element IdSpecimen.collection.collected[x] Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time. Unordered, Open, by $this(Type) Constraints
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collectedDateTime | Σ | 0..1 | dateTime | Element IdSpecimen.collection.collected[x]:collectedDateTime Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time.
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collectedPeriod | Σ | 0..1 | Period | Element IdSpecimen.collection.collected[x]:collectedPeriod CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine.
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duration | Σ I | 0..1 | DurationBinding | Element IdSpecimen.collection.duration CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Appropriate units for Duration. CommonUCUMCodesForDuration (extensible)Constraints
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quantity | I | 0..1 | SimpleQuantity | Element IdSpecimen.collection.quantity CollectedVolume Alternate namesVerzamelvolume DefinitionTotal volume of the collected material. If it is necessary to determine the absolute amount of a particular substance in the collected material, the volume thereof must be given. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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method | 0..1 | CodeableConceptBinding | Element IdSpecimen.collection.method CollectionMethod Alternate namesAfnameprocedure DefinitionIf relevant for the results, the method of obtaining the specimen can be entered as well. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The technique that is used to perform the procedure. CollectionMethod (required)Constraints
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bodySite | 0..1 | HdBe AnatomicalLocationBinding | Element IdSpecimen.collection.bodySite AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionAnatomic location where the material is collected, e.g. elbow Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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fastingStatus[x] | Σ | 0..1 | Binding | There are no (further) constraints on this element Element IdSpecimen.collection.fastingStatus[x] Whether or how long patient abstained from food and/or drink DefinitionAbstinence or reduction from some or all food, drink, or both, for a period of time prior to sample collection. Many diagnostic tests require fasting to facilitate accurate interpretation. Representing fasting status using this element is preferred to representing it with an observation using a 'pre-coordinated code' such as LOINC 2005-7 (Calcium [Moles/time] in 2 hour Urine --12 hours fasting), or using a component observation Codes describing the fasting status of the patient. v2.0916 (extensible)Constraints
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fastingStatusCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
fastingStatusDuration | Duration | There are no (further) constraints on this element Data Type | ||
processing | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.processing Processing and processing step details DefinitionDetails concerning processing and processing steps for the specimen.
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.processing.description Textual description of procedure DefinitionTextual description of procedure. Note that FHIR strings SHALL NOT exceed 1MB in size
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procedure | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdSpecimen.processing.procedure Indicates the treatment step applied to the specimen DefinitionA coded value specifying the procedure used to process the specimen. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type indicating the technique used to process the specimen. SpecimenProcessingProcedure (example)Constraints
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additive | I | 0..* | Reference(Substance) | There are no (further) constraints on this element Element IdSpecimen.processing.additive Material used in the processing step DefinitionMaterial used in the processing step. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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time[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.processing.time[x] Date and time of specimen processing DefinitionA record of the time or period when the specimen processing occurred. For example the time of sample fixation or the period of time the sample was in formalin.
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timeDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timePeriod | Period | There are no (further) constraints on this element Data Type | ||
container | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.container Direct container of specimen (tube/slide, etc.) DefinitionThe container holding the specimen. The recursive nature of containers; i.e. blood in tube in tray in rack is not addressed here.
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.container.identifier SpecimenNumberExtension Alternate namesMonstervolgnummer DefinitionThe specimen number extension is used when the collected material is distributed from the original tube or container across multiple tubes. In combination with the specimen Id the extension yield a unique identification of the tube or container
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.container.description Textual description of the container DefinitionTextual description of the container. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 0..1 | CodeableConceptBinding | Element IdSpecimen.container.type Kind of container directly associated with specimen DefinitionThe type of container associated with the specimen (e.g. slide, aliquot, etc.). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type of specimen container. ContainerType (preferred)Constraints
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capacity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.capacity Container volume or size DefinitionThe capacity (volume or other measure) the container may contain. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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specimenQuantity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.specimenQuantity Quantity of specimen within container DefinitionThe quantity of specimen in the container; may be volume, dimensions, or other appropriate measurements, depending on the specimen type. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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additive[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.container.additive[x] Additive associated with container DefinitionIntroduced substance to preserve, maintain or enhance the specimen. Examples: Formalin, Citrate, EDTA. Substance added to specimen container. v2.0371 (example)Constraints
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additiveCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
additiveReference | Reference(Substance) | There are no (further) constraints on this element Data Type | ||
condition | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdSpecimen.condition State of the specimen DefinitionA mode or state of being that describes the nature of the specimen. The specimen condition can be used to assess its quality or appropriateness for a specific test. Specimen condition is an observation made about the specimen. It's a point-in-time assessment. It can be used to assess its quality or appropriateness for a specific test. Codes describing the state of the specimen. v2.0493 (extensible)Constraints
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note | 0..* | Annotation | There are no (further) constraints on this element Element IdSpecimen.note Comments DefinitionTo communicate any details or issues about the specimen or during the specimen collection. (for example: broken vial, sent with patient, frozen). For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdSpecimen.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdSpecimen.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdSpecimen.note.text Comment Alternate namesToelichting DefinitionComments on the specimen , such as drawing material after a (glucose) stimulus or taking medicine. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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Specimen | I | Specimen | Element IdSpecimen Specimen Alternate namesMonster DefinitionThe Specimen concept from the CCB HdBe-LaboratoryTestResult contains a concept for SpecimenMaterial and for Microorganism. These two concepts cannot be represented in the same Specimen resources; if there's a need to communicate both the microorganism and the sample material from which it was isolated, two instances need to be used. The instance representing the microorganism should refer to the instance respresenting the sample material using
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.identifier SpecimenId Alternate namesMonsternummer DefinitionIdentification number of the material obtained, as a reference for inquiries to the source organization. In a transmural setting, this number will consist of a specimen number including the identification of the issuing organization, to be unique outside of the borders of an organization.
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accessionIdentifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element IdSpecimen.accessionIdentifier Identifier assigned by the lab DefinitionThe identifier assigned by the lab when accessioning specimen(s). This is not necessarily the same as the specimen identifier, depending on local lab procedures.
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdSpecimen.status available | unavailable | unsatisfactory | entered-in-error DefinitionThe availability of the specimen. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes providing the status/availability of a specimen. SpecimenStatus (required)Constraints
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type | Σ | 0..1 | CodeableConceptBinding | Element IdSpecimen.type SpecimenMaterial / Microorganism Alternate namesMicroorganisme Definition
This Specimen resource can represent either a specimen material or a microorganism. Which of these two types is represented, is determined by this element. If there's a need to represent both the microorganism isolate and the specimen material from which it was derived, two separte resources are to be used, where the microorganism resource refers to the material resource using Specimen.parent. If this resource represents material and is carried out on derived material (such as plasma), this element will still contain the material drawn (in this case, blood). In this case, the LOINC code will generally refer to plasma. The type of the specimen. SpecimenMaterial-and-Microorganism (required)Constraints
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subject | Σ I | 0..1 | Reference(Patient| Group| Device| Substance| Location) | There are no (further) constraints on this element Element IdSpecimen.subject Where the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device DefinitionWhere the specimen came from. This may be from patient(s), from a location (e.g., the source of an environmental sample), or a sampling of a substance or a device. Must know the subject context. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient| Group| Device| Substance| Location) Constraints
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receivedTime | Σ | 0..1 | dateTime | Element IdSpecimen.receivedTime ReceivedDateTime Alternate namesAannameDatumTijd DefinitionDate and time that the material is handed over at the laboratory or specimen collection center.
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parent | I | 0..* | Reference(HdBe LaboratoryTestResult.Specimen) | Element IdSpecimen.parent Specimen from which this specimen originated DefinitionReference to the parent (source) specimen which is used when the specimen was either derived from or a component of another specimen. When this resource represents a microorganism (that is, Reference(HdBe LaboratoryTestResult.Specimen) Constraints
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request | I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdSpecimen.request Why the specimen was collected DefinitionDetails concerning a service request that required a specimen to be collected. The request may be explicit or implied such with a ServiceRequest that requires a blood draw.
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collection | 0..1 | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.collection Collection details DefinitionDetails concerning the specimen collection.
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collector | Σ I | 0..1 | Reference(Practitioner| PractitionerRole) | There are no (further) constraints on this element Element IdSpecimen.collection.collector Who collected the specimen DefinitionPerson who collected the specimen. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Practitioner| PractitionerRole) Constraints
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collected[x] | Σ | 0..1 | Element IdSpecimen.collection.collected[x] Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time. Unordered, Open, by $this(Type) Constraints
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collectedDateTime | Σ | 0..1 | dateTime | Element IdSpecimen.collection.collected[x]:collectedDateTime Collection time DefinitionTime when specimen was collected from subject - the physiologically relevant time.
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collectedPeriod | Σ | 0..1 | Period | Element IdSpecimen.collection.collected[x]:collectedPeriod CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine.
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duration | Σ I | 0..1 | DurationBinding | Element IdSpecimen.collection.duration CollectionPeriod Alternate namesVerzamelperiode DefinitionIf the material has not been collected at a single point in time but over a certain period, this period can be captured in this concept. An example is 24 hour urine. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Appropriate units for Duration. CommonUCUMCodesForDuration (extensible)Constraints
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quantity | I | 0..1 | SimpleQuantity | Element IdSpecimen.collection.quantity CollectedVolume Alternate namesVerzamelvolume DefinitionTotal volume of the collected material. If it is necessary to determine the absolute amount of a particular substance in the collected material, the volume thereof must be given. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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method | 0..1 | CodeableConceptBinding | Element IdSpecimen.collection.method CollectionMethod Alternate namesAfnameprocedure DefinitionIf relevant for the results, the method of obtaining the specimen can be entered as well. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The technique that is used to perform the procedure. CollectionMethod (required)Constraints
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bodySite | 0..1 | HdBe AnatomicalLocationBinding | Element IdSpecimen.collection.bodySite AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionAnatomic location where the material is collected, e.g. elbow Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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fastingStatus[x] | Σ | 0..1 | Binding | There are no (further) constraints on this element Element IdSpecimen.collection.fastingStatus[x] Whether or how long patient abstained from food and/or drink DefinitionAbstinence or reduction from some or all food, drink, or both, for a period of time prior to sample collection. Many diagnostic tests require fasting to facilitate accurate interpretation. Representing fasting status using this element is preferred to representing it with an observation using a 'pre-coordinated code' such as LOINC 2005-7 (Calcium [Moles/time] in 2 hour Urine --12 hours fasting), or using a component observation Codes describing the fasting status of the patient. v2.0916 (extensible)Constraints
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fastingStatusCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
fastingStatusDuration | Duration | There are no (further) constraints on this element Data Type | ||
processing | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.processing Processing and processing step details DefinitionDetails concerning processing and processing steps for the specimen.
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.processing.description Textual description of procedure DefinitionTextual description of procedure. Note that FHIR strings SHALL NOT exceed 1MB in size
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procedure | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdSpecimen.processing.procedure Indicates the treatment step applied to the specimen DefinitionA coded value specifying the procedure used to process the specimen. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type indicating the technique used to process the specimen. SpecimenProcessingProcedure (example)Constraints
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additive | I | 0..* | Reference(Substance) | There are no (further) constraints on this element Element IdSpecimen.processing.additive Material used in the processing step DefinitionMaterial used in the processing step. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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time[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.processing.time[x] Date and time of specimen processing DefinitionA record of the time or period when the specimen processing occurred. For example the time of sample fixation or the period of time the sample was in formalin.
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timeDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timePeriod | Period | There are no (further) constraints on this element Data Type | ||
container | 0..* | BackboneElement | There are no (further) constraints on this element Element IdSpecimen.container Direct container of specimen (tube/slide, etc.) DefinitionThe container holding the specimen. The recursive nature of containers; i.e. blood in tube in tray in rack is not addressed here.
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identifier | Σ | 0..* | Identifier | Element IdSpecimen.container.identifier SpecimenNumberExtension Alternate namesMonstervolgnummer DefinitionThe specimen number extension is used when the collected material is distributed from the original tube or container across multiple tubes. In combination with the specimen Id the extension yield a unique identification of the tube or container
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description | 0..1 | string | There are no (further) constraints on this element Element IdSpecimen.container.description Textual description of the container DefinitionTextual description of the container. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 0..1 | CodeableConceptBinding | Element IdSpecimen.container.type Kind of container directly associated with specimen DefinitionThe type of container associated with the specimen (e.g. slide, aliquot, etc.). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Type of specimen container. ContainerType (preferred)Constraints
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capacity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.capacity Container volume or size DefinitionThe capacity (volume or other measure) the container may contain. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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specimenQuantity | I | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element IdSpecimen.container.specimenQuantity Quantity of specimen within container DefinitionThe quantity of specimen in the container; may be volume, dimensions, or other appropriate measurements, depending on the specimen type. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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additive[x] | 0..1 | There are no (further) constraints on this element Element IdSpecimen.container.additive[x] Additive associated with container DefinitionIntroduced substance to preserve, maintain or enhance the specimen. Examples: Formalin, Citrate, EDTA. Substance added to specimen container. v2.0371 (example)Constraints
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additiveCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data Type | ||
additiveReference | Reference(Substance) | There are no (further) constraints on this element Data Type | ||
condition | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdSpecimen.condition State of the specimen DefinitionA mode or state of being that describes the nature of the specimen. The specimen condition can be used to assess its quality or appropriateness for a specific test. Specimen condition is an observation made about the specimen. It's a point-in-time assessment. It can be used to assess its quality or appropriateness for a specific test. Codes describing the state of the specimen. v2.0493 (extensible)Constraints
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note | 0..* | Annotation | There are no (further) constraints on this element Element IdSpecimen.note Comments DefinitionTo communicate any details or issues about the specimen or during the specimen collection. (for example: broken vial, sent with patient, frozen). For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdSpecimen.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner| Patient| RelatedPerson| Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner| Patient| RelatedPerson| Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdSpecimen.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdSpecimen.note.text Comment Alternate namesToelichting DefinitionComments on the specimen , such as drawing material after a (glucose) stimulus or taking medicine. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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Mapping FHIR profile to CBB
Path | map |
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Specimen | specimen |
Specimen.identifier | specimen.specimen_id |
Specimen.type | specimen.specimen_material |
Specimen.type | specimen_microorganism |
Specimen.receivedTime | specimen.received_date_time |
Specimen.collection.collected[x]:collectedDateTime | specimen.collection_date_time |
Specimen.collection.collected[x]:collectedPeriod | specimen.collection_period |
Specimen.collection.duration | specimen.collection_period |
Specimen.collection.quantity | specimen.collected_volume |
Specimen.collection.method | specimen.collection_method |
Specimen.collection.bodySite | specimen.anatomical_location |
Specimen.container.identifier | specimen.specimen_number_extension |
Specimen.container.type | specimen.container_type |
Specimen.note.text | specimen.comment |
zib LaboratoryTestResult-Specimen difference
Concept | Category | Description |
---|---|---|
type |
terminology | Replaced SpecimenMaterial valueset values from a SNOMED descendent-of 105590001 (Substance) to a descendent-of 123038009 (Specimen). |
type |
terminology | Replaced Dutch reference set for Microorganism by changing the SNOMED hierarchy 2581000146104 (Dutch microorganism simple reference set) to 410607006 (Organism). |
type |
terminology | Combined ValueSet for SpecimenMaterial and Microorganism in new ValueSet SpecimenMaterial-and-Microorganism. |
receivedTime |
textual | Removed sentence 'This is the issue...' (zib ticket #1551) |
container.type |
terminology | Relaxed binding from required to preferred. (zib ticket #1552) |