Base Profile for Lab Observations
EHRtoRegistryLaboratoryResultObservationProfile
This profile definition contains the formal specification requirements for representing laboratory observations (derived from the U.S. Core Implementation Guide).
To summarize (for human readers), the following data elements are mandatory (i.e data SHALL be present) or must be supported if the data is present in the sending system:
Each Observation must have:
- a
status - a
categorycode of laboratory - a LOINC code, if available, which tells you what is being measured
- a patient
Each Observation must support:
- a time indicating when the measurement was taken
- a result value or a reason why the data is absent
- if the result value is a numeric quantity, a standard UCUM unit
Other implementation guidance:
- Additional codes that translate or map to the Observation code or category codes are allowed. For example:
- providing both a local code and LOINC code
- providing a more specific
categorycodes such as chemistry, or system specific codes in addition to the laboratorycategorycode.
- An Observation without a value SHALL include a reason why the data is absent unless there are component observations, or references to other observations that are grouped within it.
- See the definition of Must Support for clarification on its meaning in this context.
Profile Specification
| EHRtoRegistryLaboratoryResultObservationProfile (Observation) | C | USCoreLaboratoryResultObservationProfile | Element idObservationShort description Measurements and simple assertions Alternate namesVital Signs, Measurement, Results, Tests DefinitionThis profile was originally created to meet the 2015 Edition Common Clinical Data Set 'Laboratory test(s) and Laboratory value(s)/result(s)' requirements. It has been (lightly) updated for our EHR to registry exchange use case. Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc. USCoreLaboratoryResultObservationProfile Constraints
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| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idObservation.idShort description Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||
| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idObservation.metaShort description Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idObservation.implicitRulesShort description A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idObservation.languageShort description Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human language.
The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| text | 0..1 | Narrative | There are no (further) constraints on this element Element idObservation.textShort description Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idObservation.containedShort description Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.extensionShort description 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) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.modifierExtensionShort description Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. 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) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element idObservation.identifierShort description Business Identifier for observation DefinitionA unique identifier assigned to this observation. Allows observations to be distinguished and referenced. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| basedOn | Σ C | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | There are no (further) constraints on this element Element idObservation.basedOnShort description 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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| partOf | Σ C | 0..* | Reference(ImagingStudy | Immunization | MedicationAdministration | MedicationDispense | MedicationStatement | Procedure) | There are no (further) constraints on this element Element idObservation.partOfShort description 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(ImagingStudy | Immunization | MedicationAdministration | MedicationDispense | MedicationStatement | Procedure) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idObservation.statusShort description registered | preliminary | final | amended + DefinitionThe status of the result value. Need to track the status of individual results. Some results are finalized before the whole report is finalized. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes providing the status of an observation. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| category | S | 1..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.categoryShort description 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(Pattern) BindingCodes for high level observation categories. ObservationCategoryCodes (preferred) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| Laboratory | S | 1..1 | CodeableConceptBindingPattern | There are no (further) constraints on this element Element idObservation.category:LaboratoryShort description 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. ObservationCategoryCodes (preferred) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
{
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/observation-category",
"code": "laboratory"
}
]
}Mappings
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| code | S Σ | 1..1 | CodeableConceptBinding | Element idObservation.codeShort description Laboratory Test Name Alternate namesName, Test Name, Observation Identifer DefinitionThe test that was performed. A LOINC SHALL be used if the concept is present in LOINC. Knowing the kind of observation is essential to understanding the observation. The typical patterns for codes are:
Systems SHALL be capable of sending the local code if one exists. When using LOINC, use either the SHORTNAME or LONG_COMMON_NAME field for the display. LOINC codes The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| subject | S Σ C | 1..1 | Reference(USCorePatientProfile) | There are no (further) constraints on this element Element idObservation.subjectShort description 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(USCorePatientProfile) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| focus | Σ C | 0..* | Reference(Resource) | There are no (further) constraints on this element Element idObservation.focusShort description 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 The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| encounter | Σ C | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element idObservation.encounterShort description 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). The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| effective[x] | S Σ C | 0..1 | There are no (further) constraints on this element Element idObservation.effective[x]Short description Clinically relevant time/time-period for observation Alternate namesOccurrence DefinitionFor lab tests this is the specimen collection date. For Ask at Order Entry Questions (AOE)'s this is the date the question was asked. 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. The cardinality or value of this element may be affected by these constraints: ele-1, us-core-1 Constraints
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| effectiveDateTime | dateTime | There are no (further) constraints on this element Data type | ||||
| effectivePeriod | Period | There are no (further) constraints on this element Data type | ||||
| issued | Σ | 0..1 | instant | There are no (further) constraints on this element Element idObservation.issuedShort description 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 The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| performer | Σ C | 0..* | Reference(CareTeam | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson) | There are no (further) constraints on this element Element idObservation.performerShort description Who is responsible for the observation DefinitionWho was responsible for asserting the observed value as "true". 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(CareTeam | Organization | Patient | Practitioner | PractitionerRole | RelatedPerson) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| value[x] | S Σ C | 0..1 | There are no (further) constraints on this element Element idObservation.value[x]Short description Result Value DefinitionThe Laboratory result value. If a coded value, the valueCodeableConcept.code SHOULD be selected from SNOMED CT. If a numeric value, valueQuantity.code SHALL be selected from UCUM. A FHIR UCUM Codes value set that defines all UCUM codes is in the FHIR specification. 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 additional guidance, see the Notes section below. The cardinality or value of this element may be affected by these constraints: ele-1, obs-7, us-core-2, us-core-3, us-core-4 Constraints
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| valueBoolean | boolean | There are no (further) constraints on this element Data type | ||||
| valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data type | ||||
| valueDateTime | dateTime | There are no (further) constraints on this element Data type | ||||
| valueInteger | integer | There are no (further) constraints on this element Data type | ||||
| valuePeriod | Period | There are no (further) constraints on this element Data type | ||||
| valueQuantity | Quantity | 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 | ||||
| valueString | string | There are no (further) constraints on this element Data type | ||||
| valueTime | time | There are no (further) constraints on this element Data type | ||||
| dataAbsentReason | S C | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.dataAbsentReasonShort description 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 ( The cardinality or value of this element may be affected by these constraints: ele-1, obs-6, us-core-2 Constraints
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| interpretation | 0..* | CodeableConceptBinding | Element idObservation.interpretationShort description 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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| note | 0..* | Annotation | There are no (further) constraints on this element Element idObservation.noteShort description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| bodySite | 0..1 | CodeableConcept | Element idObservation.bodySiteShort description 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 extensionbodySite. Codes describing anatomical locations. May include laterality. SNOMEDCTBodyStructures (example) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| method | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.methodShort description How it was done DefinitionIndicates the mechanism used to perform the observation. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| specimen | C | 0..1 | Reference(Specimen) | There are no (further) constraints on this element Element idObservation.specimenShort description Specimen used for this observation DefinitionThe specimen that was used when this observation was made. Should only be used if not implicit in code found in The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| device | C | 0..1 | Reference(Device | DeviceMetric) | There are no (further) constraints on this element Element idObservation.deviceShort description (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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| referenceRange | C | 0..* | BackboneElement | There are no (further) constraints on this element Element idObservation.referenceRangeShort description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.referenceRange.extensionShort description 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 element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.referenceRange.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| low | C | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.lowShort description Low Range, if relevant DefinitionThe value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3). 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. The cardinality or value of this element may be affected by these constraints: ele-1, obs-3 Constraints
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| high | C | 0..1 | SimpleQuantity | There are no (further) constraints on this element Element idObservation.referenceRange.highShort description High Range, if relevant DefinitionThe value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3). 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. The cardinality or value of this element may be affected by these constraints: ele-1, obs-3 Constraints
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| type | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.referenceRange.typeShort description 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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| appliesTo | 0..* | CodeableConcept | There are no (further) constraints on this element Element idObservation.referenceRange.appliesToShort description 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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| age | C | 0..1 | Range | There are no (further) constraints on this element Element idObservation.referenceRange.ageShort description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| text | 0..1 | string | There are no (further) constraints on this element Element idObservation.referenceRange.textShort description 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 The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| hasMember | Σ C | 0..* | Reference(MolecularSequence | Observation | QuestionnaireResponse) | There are no (further) constraints on this element Element idObservation.hasMemberShort description 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 using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation. Reference(MolecularSequence | Observation | QuestionnaireResponse) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| derivedFrom | Σ C | 0..* | Reference(DocumentReference | ImagingStudy | Media | MolecularSequence | Observation | QuestionnaireResponse) | There are no (further) constraints on this element Element idObservation.derivedFromShort description Related measurements the observation is made from DefinitionThe target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image. 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 | MolecularSequence | Observation | QuestionnaireResponse) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| component | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idObservation.componentShort description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idObservation.component.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.component.extensionShort description 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 element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idObservation.component.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| code | Σ | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idObservation.component.codeShort description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| value[x] | Σ | 0..1 | There are no (further) constraints on this element Element idObservation.component.value[x]Short description 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| valueBoolean | boolean | There are no (further) constraints on this element Data type | ||||
| valueCodeableConcept | CodeableConcept | There are no (further) constraints on this element Data type | ||||
| valueDateTime | dateTime | There are no (further) constraints on this element Data type | ||||
| valueInteger | integer | There are no (further) constraints on this element Data type | ||||
| valuePeriod | Period | There are no (further) constraints on this element Data type | ||||
| valueQuantity | Quantity | 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 | ||||
| valueString | string | There are no (further) constraints on this element Data type | ||||
| valueTime | time | There are no (further) constraints on this element Data type | ||||
| dataAbsentReason | C | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.dataAbsentReasonShort description 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 ( The cardinality or value of this element may be affected by these constraints: ele-1, obs-6 Constraints
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| interpretation | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idObservation.component.interpretationShort description 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) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| referenceRange | 0..* | see (referenceRange) | There are no (further) constraints on this element Element idObservation.component.referenceRangeShort description 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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