CDC National Healthcare Safety Network (NHSN) Digital Quality Measures (dQM) Content Package IG
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CDC National Healthcare Safety Network (NHSN) Digital Quality Measures (dQM) Content Package IG - Local Development build (v2.0.0-cibuild) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: LongTermCareMonthlyEventLabObservation - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the ltc-monthly-observation-lab resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. Observation
Definition

-


Measurements and simple assertions made about a patient, device or other subject.

Short Measurements and simple assertions
Comments

-


Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control 0..*
Is Modifier false
Must Support false
Summary false
Alternate Names Vital Signs, Measurement, Results, Tests
Invariants dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present ((component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()))
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Short (NHSN-MS) Logical id of this artifactLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control 10..1
Type idstring
Is Modifier false
Summary true
4. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Short A set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control 0..1
Type uri
Is Modifier true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Short Extensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary false
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Observation.status
Definition

The status of the result value.

Short (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknownregistered | preliminary | final | amended +
Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control 1..1
Binding The codes SHALL be taken from Non-Negative Observation Statushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
(required to http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status)
Type code
Is Modifier true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Must Support true
Summary true
Requirements

Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.category
Definition

A code that classifies the general type of observation being made.

Short (QI-Core)(USCDI) Classification of type of observationClassification of type of observation
Comments

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control 10..*
Binding The codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/observation-category)

Codes for high level observation categories.

Type CodeableConcept
Is Modifier false
Must Support true
Summary false
Requirements

Used for filtering what observations are retrieved and displayed.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing This element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
  • 12. Observation.category:us-core
    Slice Name us-core
    Definition

    A code that classifies the general type of observation being made.

    Short (QI-Core)(USCDI) Classification of type of observationClassification of type of observation
    Comments

    In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

    Control 10..1*
    Binding The codes SHALL be taken from The codes SHOULD be taken from US Core Clinical Result Observation Categoryhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
    (required to http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category)

    Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


    Codes for high level observation categories.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Requirements

    Used for filtering what observations are retrieved and displayed.

    Pattern Value {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
        "code" : "laboratory"
      }]
    }
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Observation.code
    Definition

    The name of the clinical test or procedure performed on a patient. A LOINC SHALL be used if the concept is present in LOINC.


    Describes what was observed. Sometimes this is called the observation "name".

    Short (QI-Core)(USCDI) Laboratory Test NameType of observation (code / type)
    Comments

    The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. 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.


    All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

    Control 1..1
    Binding Unless not suitable, these codes SHALL be taken from For example codes, see US Core Laboratory Test Codeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
    (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

    Laboratory LOINC Codes


    Codes identifying names of simple observations.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary true
    Requirements

    Knowing what kind of observation is being made is essential to understanding the observation.

    Alternate Names Name
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Observation.subject
    Definition

    The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

    Short (QI-Core)(USCDI) Who and/or what the observation is aboutWho and/or what the observation is about
    Comments

    One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

    Control 10..1
    Type Reference(QICore Patient, Patient, Group, Device, Location)
    Is Modifier false
    Must Support true
    Summary true
    Requirements

    Observations have no value if you don't know who or what they're about.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Observation.subject.reference
    Definition

    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

    Short Literal reference, Relative, internal or absolute URL
    Comments

    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control 10..1
    This element is affected by the following invariants: ref-1
    Type string
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Summary true
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. Observation.encounter
    Definition

    The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

    Short Healthcare event during which this observation is made
    Comments

    This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

    Control 0..1
    Type Reference(Encounter, Encounter)
    Is Modifier false
    Must Support true
    Summary true
    Requirements

    For some observations it may be important to know the link between an observation and a particular encounter.

    Alternate Names Context
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Observation.encounter.reference
    Definition

    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

    Short Literal reference, Relative, internal or absolute URL
    Comments

    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control 10..1
    This element is affected by the following invariants: ref-1
    Type string
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Summary true
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Observation.effective[x]
    Definition

    The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

    Short (QI-Core)(USCDI) Clinically relevant time/time-period for observationClinically relevant time/time-period for observation
    Comments

    At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

    Control 10..1
    This element is affected by the following invariants: us-core-1
    Type Choice of: dateTime, Period, Timing, instant
    [x] Note SeeChoice of Data Typesfor further information about how to use [x]
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Must Support Types dateTime
    Summary true
    Requirements

    Knowing when an observation was deemed true is important to its relevance as well as determining trends.

    Alternate Names Occurrence
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    us-core-1: Datetime must be at least to day. ($this is DateTime implies $this.toString().length() >= 10)
    26. Observation.issued
    Definition

    The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

    Short (QI-Core) Date/Time this version was made availableDate/Time this version was made available
    Comments

    For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

    Control 0..1
    Type instant
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Summary true
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Observation.value[x]
    Definition

    The Laboratory result value. If a coded value, the valueCodeableConcept.code SHOULD be selected from SNOMED CT if the concept exists. 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.


    The information determined as a result of making the observation, if the information has a simple value.

    Short (QI-Core)(USCDI) Result ValueActual result
    Comments

    An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

    Control 0..1
    This element is affected by the following invariants: obs-7, us-core-2, us-core-3, us-core-4
    Type Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, SampledData
    [x] Note SeeChoice of Data Typesfor further information about how to use [x]
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Must Support Types Choice of: Quantity, CodeableConcept, string, SampledData
    Summary true
    Requirements

    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    us-core-3: SHALL use UCUM for coded quantity units. (value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org')
    us-core-4: SHOULD use Snomed CT for coded Results (value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct')
    30. Observation.dataAbsentReason
    Definition

    Provides a reason why the expected value in the element Observation.value[x] is missing.

    Short (USCDI) Why the result is missingWhy the result is missing
    Comments

    Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

    The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

    Control 0..1
    This element is affected by the following invariants: obs-6, us-core-2
    Binding Unless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

    Codes specifying why the result (Observation.value[x]) is missing.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Requirements

    For many results it is necessary to handle exceptional values in measurements.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Observation.interpretation
    Definition

    A categorical assessment of an observation value. For example, high, low, normal.

    Short (QI-Core) High, low, normal, etc.High, low, normal, etc.
    Comments

    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

    Control 0..*
    Binding Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

    Codes identifying interpretations of observations.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Requirements

    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

    Alternate Names Abnormal Flag
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Observation.bodySite
    Definition

    Indicates the site on the subject's body where the observation was made (i.e. the target site).

    Short Observed body part
    Comments

    Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

    If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

    Control 0..1
    Binding For example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site|4.0.1
    (example to http://hl7.org/fhir/ValueSet/body-site)

    Codes describing anatomical locations. May include laterality.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. Observation.method
    Definition

    Indicates the mechanism used to perform the observation.

    Short How it was done
    Comments

    Only used if not implicit in code for Observation.code.

    Control 0..1
    Binding Unless not suitable, these codes SHALL be taken from For example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/observation-methods)
    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Requirements

    In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    38. Observation.specimen
    Definition

    The specimen that was used when this observation was made.

    Short (USCDI) Specimen used for this observationSpecimen used for this observation
    Comments

    Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

    Control 0..1
    Type Reference(US Core Specimen Profile, Specimen)
    Is Modifier false
    Must Support true
    Summary false
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    40. Observation.specimen.reference
    Definition

    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

    Short Literal reference, Relative, internal or absolute URL
    Comments

    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

    Control 10..1
    This element is affected by the following invariants: ref-1
    Type string
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Summary true
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. Observation.component
    Definition

    Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

    Short Component results
    Comments

    For a discussion on the ways Observations can be assembled in groups together see Notes below.

    Control 0..*
    Type BackboneElement
    Is Modifier false
    Must Support true
    Summary true
    Requirements

    Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. Observation.component.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    Short Extensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control 0..*
    Type Extension
    Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summary true
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Names extensions, user content, modifiers
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    46. Observation.component.code
    Definition

    Describes what was observed. Sometimes this is called the observation "code".

    Short Type of component observation (code / type)
    Comments

    All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

    Control 1..1
    Binding Unless not suitable, these codes SHALL be taken from For example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/observation-codes)
    Type CodeableConcept
    Is Modifier false
    Summary true
    Requirements

    Knowing what kind of observation is being made is essential to understanding the observation.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. Observation.component.value[x]
    Definition

    The information determined as a result of making the observation, if the information has a simple value.

    Short Actual component result
    Comments

    Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

    Control 0..1
    Type Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
    [x] Note SeeChoice of Data Typesfor further information about how to use [x]
    Is Modifier false
    Primitive Value This primitive element may be present, or absent, or replaced by an extension
    Must Support true
    Must Support Types No must-support rules about the choice of types/profiles
    Summary true
    Requirements

    An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    50. Observation.component.interpretation
    Definition

    A categorical assessment of an observation value. For example, high, low, normal.

    Short High, low, normal, etc.
    Comments

    Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

    Control 0..*
    Binding Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

    Codes identifying interpretations of observations.

    Type CodeableConcept
    Is Modifier false
    Must Support true
    Summary false
    Requirements

    For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

    Alternate Names Abnormal Flag
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

    Guidance on how to interpret the contents of this table can be foundhere

    0. Observation
    2. Observation.id
    Short (NHSN-MS) Logical id of this artifact
    Control 1..?
    4. Observation.meta
    6. Observation.meta.extension:link-received-date-extension
    Slice Name link-received-date-extension
    Control 0..1
    Type Extension(Received Date) (Extension Type: dateTime)
    8. Observation.subject
    10. Observation.subject.reference
    Control 1..?
    Must Support true
    12. Observation.encounter
    Must Support true
    14. Observation.encounter.reference
    Control 1..?
    Must Support true
    16. Observation.effective[x]
    Control 1..?
    [x] Note SeeChoice of Data Typesfor further information about how to use [x]
    18. Observation.issued
    Must Support true
    20. Observation.interpretation
    Must Support true
    22. Observation.bodySite
    Must Support true
    24. Observation.method
    Binding Unless not suitable, these codes SHALL be taken from ObservationMethods
    (extensible to http://hl7.org/fhir/ValueSet/observation-methods)
    Must Support true
    26. Observation.specimen
    28. Observation.specimen.reference
    Control 1..?
    Must Support true
    30. Observation.component
    Must Support true
    32. Observation.component.code
    Binding Unless not suitable, these codes SHALL be taken from LOINCCodes
    (extensible to http://hl7.org/fhir/ValueSet/observation-codes)
    34. Observation.component.value[x]
    [x] Note SeeChoice of Data Typesfor further information about how to use [x]
    Must Support true
    36. Observation.component.interpretation
    Must Support true

    Guidance on how to interpret the contents of this table can be foundhere

    0. Observation
    Definition

    -

    Short Measurements and simple assertions
    Comments

    -

    Control 0..*
    Is Modifier false
    Must Support false
    Summary false
    Alternate Names Vital Signs, Measurement, Results, Tests
    Invariants dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
    dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
    obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
    us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present ((component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists()))
    2. Observation.id
    Definition

    The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

    Short (NHSN-MS) Logical id of this artifact
    Comments

    The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

    Control 1..1
    Type id
    Is Modifier false
    Summary true
    4. Observation.meta
    Definition

    The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

    Short Metadata about the resource
    Control 0..1
    Type Meta
    Is Modifier false
    Summary true
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. Observation.meta.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    Short Unique id for inter-element referencing
    Control 0..1
    Type string
    Is Modifier false
    XML Format In the XML format, this property is represented as an attribute.
    Summary false
    8. Observation.meta.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    Short Additional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control 0..*
    Type Extension
    Is Modifier false
    Summary false
    Alternate Names extensions, user content
    Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    Slicing This element introduces a set of slices on Observation.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 10. Observation.meta.extension:link-received-date-extension
      Slice Name link-received-date-extension
      Definition

      This extension stores the date and time a Resource was received by the processing system (e.g. NHSNLink).

      Short Received Date
      Control 0..1
      Type Extension(Received Date) (Extension Type: dateTime)
      Is Modifier false
      Summary false
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      12. Observation.meta.versionId
      Definition

      The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

      Short Version specific identifier
      Comments

      The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

      Control 0..1
      Type id
      Is Modifier false
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. Observation.meta.lastUpdated
      Definition

      When the resource last changed - e.g. when the version changed.

      Short When the resource version last changed
      Comments

      This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

      Control 0..1
      Type instant
      Is Modifier false
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      16. Observation.meta.source
      Definition

      A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

      Short Identifies where the resource comes from
      Comments

      In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

      This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

      Control 0..1
      Type uri
      Is Modifier false
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. Observation.meta.profile
      Definition

      A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

      Short Profiles this resource claims to conform to
      Comments

      It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

      Control 0..*
      Type canonical(StructureDefinition)
      Is Modifier false
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.meta.security
      Definition

      Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

      Short Security Labels applied to this resource
      Comments

      The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

      Control 0..*
      Binding Unless not suitable, these codes SHALL be taken from All Security Labels
      (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

      Security Labels from the Healthcare Privacy and Security Classification System.

      Type Coding
      Is Modifier false
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Observation.meta.tag
      Definition

      Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

      Short Tags applied to this resource
      Comments

      The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

      Control 0..*
      Binding For example codes, see CommonTags
      (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

      Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

      Type Coding
      Is Modifier false
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. Observation.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      Short A set of rules under which this content was created
      Comments

      Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

      Control 0..1
      Type uri
      Is Modifier true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary true
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. Observation.language
      Definition

      The base language in which the resource is written.

      Short Language of the resource content
      Comments

      Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

      Control 0..1
      Binding The codes SHOULD be taken from CommonLanguages
      (preferred to http://hl7.org/fhir/ValueSet/languages)

      A human language.

      Additional Bindings Purpose
      AllLanguages Max Binding
      Type code
      Is Modifier false
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Summary false
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. Observation.text
      Definition

      A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

      Short Text summary of the resource, for human interpretation
      Comments

      Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

      Control 0..1
      Type Narrative
      Is Modifier false
      Summary false
      Alternate Names narrative, html, xhtml, display
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. Observation.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

      Short Contained, inline Resources
      Comments

      This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

      Control 0..*
      Type Resource
      Is Modifier false
      Summary false
      Alternate Names inline resources, anonymous resources, contained resources
      32. Observation.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      Short Additional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control 0..*
      Type Extension
      Is Modifier false
      Summary false
      Alternate Names extensions, user content
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      34. Observation.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      Short Extensions that cannot be ignored
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control 0..*
      Type Extension
      Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Summary false
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Names extensions, user content
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      36. Observation.identifier
      Definition

      A unique identifier assigned to this observation.

      Short Business Identifier for observation
      Note This is a business identifier, not a resource identifier (see discussion)
      Control 0..*
      Type Identifier
      Is Modifier false
      Summary true
      Requirements

      Allows observations to be distinguished and referenced.

      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. Observation.basedOn
      Definition

      A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

      Short Fulfills plan, proposal or order
      Control 0..*
      Type Reference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
      Is Modifier false
      Summary true
      Requirements

      Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

      Alternate Names Fulfills
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. Observation.partOf
      Definition

      A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

      Short Part of referenced event
      Comments

      To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

      Control 0..*
      Type Reference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
      Is Modifier false
      Summary true
      Alternate Names Container
      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. Observation.status
      Definition

      The status of the result value.

      Short (QI-Core)(USCDI) registered | prliminary | final | amended | corrected | entered-in-error | unknown
      Comments

      This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

      Control 1..1
      Binding The codes SHALL be taken from Non-Negative Observation Status
      (required to http://hl7.org/fhir/us/qicore/ValueSet/qicore-non-negative-observation-status)
      Type code
      Is Modifier true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
      Primitive Value This primitive element may be present, or absent, or replaced by an extension
      Must Support true
      Summary true
      Requirements

      Need to track the status of individual results. Some results are finalized before the whole report is finalized.

      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. Observation.category
      Definition

      A code that classifies the general type of observation being made.

      Short (QI-Core)(USCDI) Classification of type of observation
      Comments

      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

      Control 1..*
      Binding The codes SHOULD be taken from ObservationCategoryCodes
      (preferred to http://hl7.org/fhir/ValueSet/observation-category)

      Codes for high level observation categories.

      Type CodeableConcept
      Is Modifier false
      Must Support true
      Summary false
      Requirements

      Used for filtering what observations are retrieved and displayed.

      Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      Slicing This element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • pattern @ $this
      • 46. Observation.category:us-core
        Slice Name us-core
        Definition

        A code that classifies the general type of observation being made.

        Short (QI-Core)(USCDI) Classification of type of observation
        Comments

        In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

        Control 1..1
        Binding The codes SHALL be taken from US Core Clinical Result Observation Category
        (required to http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category)

        Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

        Type CodeableConcept
        Is Modifier false
        Must Support true
        Summary false
        Requirements

        Used for filtering what observations are retrieved and displayed.

        Pattern Value {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
            "code" : "laboratory"
          }]
        }
        Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. Observation.code
        Definition

        The name of the clinical test or procedure performed on a patient. A LOINC SHALL be used if the concept is present in LOINC.

        Short (QI-Core)(USCDI) Laboratory Test Name
        Comments

        The typical patterns for codes are: 1) a LOINC code either as a translation from a "local" code or as a primary code, or 2) a local code only if no suitable LOINC exists, or 3) both the local and the LOINC translation. 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.

        Control 1..1
        Binding Unless not suitable, these codes SHALL be taken from US Core Laboratory Test Codes
        (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

        Laboratory LOINC Codes

        Type CodeableConcept
        Is Modifier false
        Must Support true
        Summary true
        Requirements

        Knowing what kind of observation is being made is essential to understanding the observation.

        Alternate Names Name
        Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        50. Observation.subject
        Definition

        The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

        Short (QI-Core)(USCDI) Who and/or what the observation is about
        Comments

        One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

        Control 1..1
        Type Reference(QICore Patient)
        Is Modifier false
        Must Support true
        Summary true
        Requirements

        Observations have no value if you don't know who or what they're about.

        Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        52. Observation.subject.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        Short Unique id for inter-element referencing
        Control 0..1
        Type string
        Is Modifier false
        XML Format In the XML format, this property is represented as an attribute.
        Summary false
        54. Observation.subject.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        Short Additional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control 0..*
        Type Extension
        Is Modifier false
        Summary false
        Alternate Names extensions, user content
        Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        Slicing This element introduces a set of slices on Observation.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 56. Observation.subject.reference
          Definition

          A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

          Short Literal reference, Relative, internal or absolute URL
          Comments

          Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

          Control 1..1
          This element is affected by the following invariants: ref-1
          Type string
          Is Modifier false
          Primitive Value This primitive element may be present, or absent, or replaced by an extension
          Must Support true
          Summary true
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. Observation.subject.type
          Definition

          The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

          The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

          Short Type the reference refers to (e.g. "Patient")
          Comments

          This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

          Control 0..1
          Binding Unless not suitable, these codes SHALL be taken from ResourceType
          (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

          Aa resource (or, for logical models, the URI of the logical model).

          Type uri
          Is Modifier false
          Primitive Value This primitive element may be present, or absent, or replaced by an extension
          Summary true
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. Observation.subject.identifier
          Definition

          An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

          Short Logical reference, when literal reference is not known
          Comments

          When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

          When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

          Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

          Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

          Note This is a business identifier, not a resource identifier (see discussion)
          Control 0..1
          Type Identifier
          Is Modifier false
          Summary true
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          62. Observation.subject.display
          Definition

          Plain text narrative that identifies the resource in addition to the resource reference.

          Short Text alternative for the resource
          Comments

          This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

          Control 0..1
          Type string
          Is Modifier false
          Primitive Value This primitive element may be present, or absent, or replaced by an extension
          Summary true
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          64. Observation.focus
          Definition

          The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

          Short What the observation is about, when it is not about the subject of record
          Comments

          Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

          Control 0..*
          Type Reference(Resource)
          Is Modifier false
          Summary true
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. Observation.encounter
          Definition

          The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

          Short Healthcare event during which this observation is made
          Comments

          This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

          Control 0..1
          Type Reference(Encounter)
          Is Modifier false
          Must Support true
          Summary true
          Requirements

          For some observations it may be important to know the link between an observation and a particular encounter.

          Alternate Names Context
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. Observation.encounter.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          Short Unique id for inter-element referencing
          Control 0..1
          Type string
          Is Modifier false
          XML Format In the XML format, this property is represented as an attribute.
          Summary false
          70. Observation.encounter.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          Short Additional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control 0..*
          Type Extension
          Is Modifier false
          Summary false
          Alternate Names extensions, user content
          Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          Slicing This element introduces a set of slices on Observation.encounter.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 72. Observation.encounter.reference
            Definition

            A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

            Short Literal reference, Relative, internal or absolute URL
            Comments

            Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

            Control 1..1
            This element is affected by the following invariants: ref-1
            Type string
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Must Support true
            Summary true
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. Observation.encounter.type
            Definition

            The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

            The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

            Short Type the reference refers to (e.g. "Patient")
            Comments

            This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

            Control 0..1
            Binding Unless not suitable, these codes SHALL be taken from ResourceType
            (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

            Aa resource (or, for logical models, the URI of the logical model).

            Type uri
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Summary true
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. Observation.encounter.identifier
            Definition

            An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

            Short Logical reference, when literal reference is not known
            Comments

            When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

            When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

            Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

            Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

            Note This is a business identifier, not a resource identifier (see discussion)
            Control 0..1
            Type Identifier
            Is Modifier false
            Summary true
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. Observation.encounter.display
            Definition

            Plain text narrative that identifies the resource in addition to the resource reference.

            Short Text alternative for the resource
            Comments

            This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

            Control 0..1
            Type string
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Summary true
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            80. Observation.effective[x]
            Definition

            The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

            Short (QI-Core)(USCDI) Clinically relevant time/time-period for observation
            Comments

            At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

            Control 1..1
            This element is affected by the following invariants: us-core-1
            Type Choice of: dateTime, Period, Timing, instant
            [x] Note SeeChoice of Data Typesfor further information about how to use [x]
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Must Support true
            Must Support Types dateTime
            Summary true
            Requirements

            Knowing when an observation was deemed true is important to its relevance as well as determining trends.

            Alternate Names Occurrence
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            us-core-1: Datetime must be at least to day. ($this is DateTime implies $this.toString().length() >= 10)
            82. Observation.issued
            Definition

            The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

            Short (QI-Core) Date/Time this version was made available
            Comments

            For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

            Control 0..1
            Type instant
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Must Support true
            Summary true
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. Observation.performer
            Definition

            Who was responsible for asserting the observed value as "true".

            Short Who is responsible for the observation
            Control 0..*
            Type Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
            Is Modifier false
            Summary true
            Requirements

            May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            86. Observation.value[x]
            Definition

            The Laboratory result value. If a coded value, the valueCodeableConcept.code SHOULD be selected from SNOMED CT if the concept exists. 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.

            Short (QI-Core)(USCDI) Result Value
            Comments

            An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

            Control 0..1
            This element is affected by the following invariants: obs-7, us-core-2, us-core-3, us-core-4
            Type Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period
            [x] Note SeeChoice of Data Typesfor further information about how to use [x]
            Is Modifier false
            Primitive Value This primitive element may be present, or absent, or replaced by an extension
            Must Support true
            Must Support Types Choice of: Quantity, CodeableConcept, string
            Summary true
            Requirements

            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            us-core-3: SHALL use UCUM for coded quantity units. (value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org')
            us-core-4: SHOULD use Snomed CT for coded Results (value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct')
            88. Observation.dataAbsentReason
            Definition

            Provides a reason why the expected value in the element Observation.value[x] is missing.

            Short (USCDI) Why the result is missing
            Comments

            Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

            The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

            Control 0..1
            This element is affected by the following invariants: obs-6, us-core-2
            Binding Unless not suitable, these codes SHALL be taken from DataAbsentReason
            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

            Codes specifying why the result (Observation.value[x]) is missing.

            Type CodeableConcept
            Is Modifier false
            Must Support true
            Summary false
            Requirements

            For many results it is necessary to handle exceptional values in measurements.

            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. Observation.interpretation
            Definition

            A categorical assessment of an observation value. For example, high, low, normal.

            Short (QI-Core) High, low, normal, etc.
            Comments

            Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

            Control 0..*
            Binding Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

            Codes identifying interpretations of observations.

            Type CodeableConcept
            Is Modifier false
            Must Support true
            Summary false
            Requirements

            For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

            Alternate Names Abnormal Flag
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            92. Observation.note
            Definition

            Comments about the observation or the results.

            Short Comments about the observation
            Comments

            May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

            Control 0..*
            Type Annotation
            Is Modifier false
            Summary false
            Requirements

            Need to be able to provide free text additional information.

            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            94. Observation.bodySite
            Definition

            Indicates the site on the subject's body where the observation was made (i.e. the target site).

            Short Observed body part
            Comments

            Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

            If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

            Control 0..1
            Binding For example codes, see SNOMEDCTBodyStructures
            (example to http://hl7.org/fhir/ValueSet/body-site)

            Codes describing anatomical locations. May include laterality.

            Type CodeableConcept
            Is Modifier false
            Must Support true
            Summary false
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            96. Observation.method
            Definition

            Indicates the mechanism used to perform the observation.

            Short How it was done
            Comments

            Only used if not implicit in code for Observation.code.

            Control 0..1
            Binding Unless not suitable, these codes SHALL be taken from ObservationMethods
            (extensible to http://hl7.org/fhir/ValueSet/observation-methods)
            Type CodeableConcept
            Is Modifier false
            Must Support true
            Summary false
            Requirements

            In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            98. Observation.specimen
            Definition

            The specimen that was used when this observation was made.

            Short (USCDI) Specimen used for this observation
            Comments

            Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

            Control 0..1
            Type Reference(US Core Specimen Profile)
            Is Modifier false
            Must Support true
            Summary false
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            100. Observation.specimen.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            Short Unique id for inter-element referencing
            Control 0..1
            Type string
            Is Modifier false
            XML Format In the XML format, this property is represented as an attribute.
            Summary false
            102. Observation.specimen.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            Short Additional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control 0..*
            Type Extension
            Is Modifier false
            Summary false
            Alternate Names extensions, user content
            Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            Slicing This element introduces a set of slices on Observation.specimen.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 104. Observation.specimen.reference
              Definition

              A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

              Short Literal reference, Relative, internal or absolute URL
              Comments

              Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

              Control 1..1
              This element is affected by the following invariants: ref-1
              Type string
              Is Modifier false
              Primitive Value This primitive element may be present, or absent, or replaced by an extension
              Must Support true
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              106. Observation.specimen.type
              Definition

              The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

              The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

              Short Type the reference refers to (e.g. "Patient")
              Comments

              This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

              Control 0..1
              Binding Unless not suitable, these codes SHALL be taken from ResourceType
              (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

              Aa resource (or, for logical models, the URI of the logical model).

              Type uri
              Is Modifier false
              Primitive Value This primitive element may be present, or absent, or replaced by an extension
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              108. Observation.specimen.identifier
              Definition

              An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

              Short Logical reference, when literal reference is not known
              Comments

              When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

              When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

              Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

              Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

              Note This is a business identifier, not a resource identifier (see discussion)
              Control 0..1
              Type Identifier
              Is Modifier false
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              110. Observation.specimen.display
              Definition

              Plain text narrative that identifies the resource in addition to the resource reference.

              Short Text alternative for the resource
              Comments

              This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

              Control 0..1
              Type string
              Is Modifier false
              Primitive Value This primitive element may be present, or absent, or replaced by an extension
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              112. Observation.device
              Definition

              The device used to generate the observation data.

              Short (Measurement) Device
              Comments

              Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

              Control 0..1
              Type Reference(Device, DeviceMetric)
              Is Modifier false
              Summary false
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              114. Observation.referenceRange
              Definition

              Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

              Short Provides guide for interpretation
              Comments

              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

              Control 0..*
              Type BackboneElement
              Is Modifier false
              Summary false
              Requirements

              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
              116. Observation.referenceRange.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              Short Unique id for inter-element referencing
              Control 0..1
              Type string
              Is Modifier false
              XML Format In the XML format, this property is represented as an attribute.
              Summary false
              118. Observation.referenceRange.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              Short Additional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control 0..*
              Type Extension
              Is Modifier false
              Summary false
              Alternate Names extensions, user content
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              120. Observation.referenceRange.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              Short Extensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control 0..*
              Type Extension
              Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summary true
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Names extensions, user content, modifiers
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              122. Observation.referenceRange.low
              Definition

              The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

              Short Low Range, if relevant
              Control 0..1
              This element is affected by the following invariants: obs-3
              Type Quantity(SimpleQuantity)
              Is Modifier false
              Summary false
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              124. Observation.referenceRange.high
              Definition

              The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

              Short High Range, if relevant
              Control 0..1
              This element is affected by the following invariants: obs-3
              Type Quantity(SimpleQuantity)
              Is Modifier false
              Summary false
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              126. Observation.referenceRange.type
              Definition

              Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

              Short Reference range qualifier
              Comments

              This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

              Control 0..1
              Binding The codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
              (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning)

              Code for the meaning of a reference range.

              Type CodeableConcept
              Is Modifier false
              Summary false
              Requirements

              Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              128. Observation.referenceRange.appliesTo
              Definition

              Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

              Short Reference range population
              Comments

              This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

              Control 0..*
              Binding For example codes, see ObservationReferenceRangeAppliesToCodes
              (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto)

              Codes identifying the population the reference range applies to.

              Type CodeableConcept
              Is Modifier false
              Summary false
              Requirements

              Need to be able to identify the target population for proper interpretation.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              130. Observation.referenceRange.age
              Definition

              The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

              Short Applicable age range, if relevant
              Control 0..1
              Type Range
              Is Modifier false
              Summary false
              Requirements

              Some analytes vary greatly over age.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              132. Observation.referenceRange.text
              Definition

              Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

              Short Text based reference range in an observation
              Control 0..1
              Type string
              Is Modifier false
              Primitive Value This primitive element may be present, or absent, or replaced by an extension
              Summary false
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              134. Observation.hasMember
              Definition

              This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

              Short Related resource that belongs to the Observation group
              Comments

              When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

              Control 0..*
              Type Reference(Observation, QuestionnaireResponse, MolecularSequence)
              Is Modifier false
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              136. Observation.derivedFrom
              Definition

              The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

              Short Related measurements the observation is made from
              Comments

              All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

              Control 0..*
              Type Reference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
              Is Modifier false
              Summary true
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              138. Observation.component
              Definition

              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

              Short Component results
              Comments

              For a discussion on the ways Observations can be assembled in groups together see Notes below.

              Control 0..*
              Type BackboneElement
              Is Modifier false
              Must Support true
              Summary true
              Requirements

              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              140. Observation.component.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              Short Unique id for inter-element referencing
              Control 0..1
              Type string
              Is Modifier false
              XML Format In the XML format, this property is represented as an attribute.
              Summary false
              142. Observation.component.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              Short Additional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control 0..*
              Type Extension
              Is Modifier false
              Summary false
              Alternate Names extensions, user content
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              144. Observation.component.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              Short Extensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control 0..*
              Type Extension
              Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summary true
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Names extensions, user content, modifiers
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              146. Observation.component.code
              Definition

              Describes what was observed. Sometimes this is called the observation "code".

              Short Type of component observation (code / type)
              Comments

              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

              Control 1..1
              Binding Unless not suitable, these codes SHALL be taken from LOINCCodes
              (extensible to http://hl7.org/fhir/ValueSet/observation-codes)
              Type CodeableConcept
              Is Modifier false
              Summary true
              Requirements

              Knowing what kind of observation is being made is essential to understanding the observation.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              148. Observation.component.value[x]
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              Short Actual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control 0..1
              Type Choice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
              [x] Note SeeChoice of Data Typesfor further information about how to use [x]
              Is Modifier false
              Primitive Value This primitive element may be present, or absent, or replaced by an extension
              Must Support true
              Must Support Types No must-support rules about the choice of types/profiles
              Summary true
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              150. Observation.component.dataAbsentReason
              Definition

              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

              Short Why the component result is missing
              Comments

              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

              Control 0..1
              This element is affected by the following invariants: obs-6
              Binding Unless not suitable, these codes SHALL be taken from DataAbsentReason
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

              Codes specifying why the result (Observation.value[x]) is missing.

              Type CodeableConcept
              Is Modifier false
              Summary false
              Requirements

              For many results it is necessary to handle exceptional values in measurements.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              152. Observation.component.interpretation
              Definition

              A categorical assessment of an observation value. For example, high, low, normal.

              Short High, low, normal, etc.
              Comments

              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

              Control 0..*
              Binding Unless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

              Codes identifying interpretations of observations.

              Type CodeableConcept
              Is Modifier false
              Must Support true
              Summary false
              Requirements

              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

              Alternate Names Abnormal Flag
              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              154. Observation.component.referenceRange
              Definition

              Guidance on how to interpret the value by comparison to a normal or recommended range.

              Short Provides guide for interpretation of component result
              Comments

              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

              Control 0..*
              Type Seettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
              Is Modifier false
              Summary false
              Requirements

              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

              Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))