STU 3 Candidate

This page is part of the FHIR Specification (v1.4.0: STU 3 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

A.7.2.0.4 StructureDefinition: USLab-ObsCode - Detailed Descriptions

Definitions for the uslab-obscode Profile.

Observation(USLab-ObsCode)
Definition

US Realm laboratory result using CodeableConcept Data Type for non-numeric results. Laboratory results to ordering providers in the ambulatory care setting and "reportable" laboratory test results to local public health agencies.

Control0..*
TypeObservation
Alternate NamesVital Signs, Measurement, Results, Tests, Obs
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 lab reports, etc.

InvariantsDefined on this element
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (xpath: not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')]))))
obs-7: Component code SHALL not be same as observation code (xpath: not(exists(f:component/f:code)) or count(for $coding in f:code/f:coding return parent::*/f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value and f:system/@value=$coding/f:system/@value])=0)
Observation.id
Definition

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

Control0..1
Typeid
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. Bundles always have an id, though it is usually a generated UUID.

Observation.meta
Definition

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

Control0..1
TypeMeta
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.

Control0..1
Typeuri
Is Modifiertrue
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 as much as possible.

Observation.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from http://tools.ietf.org/html/bcp47
Typecode
Comments

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

Observation.text
Definition

A human-readable narrative that contains a summary of the resource, and may 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.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.

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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

Observation.extension
Definition

An Extension

Control0..*
TypeExtension
SlicingThis element introduces a set of slices. The slicing rules are:
  • unordered
  • Open
  • discriminators: url
Observation.extension (http://hl7.org/fhir/StructureDefinition/uslab-specimenrejectreason)
Definition

This extension describes the reason if a test is cancelled for specimen related reason.

Control0..*
TypeExtension (Extension Type: CodeableConcept)
Observation.extension.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.extension.extension(extension)
Definition

An Extension

Control0..0
TypeExtension
Observation.extension.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition should be version specific. This will ideally be the URI for the Resource Profile defining the extension, with the code for the extension after a #.

Fixed Valuehttp://hl7.org/fhir/StructureDefinition/uslab-specimenrejectreason
Observation.extension.valueCodeableConcept
Definition

Value of extension - may be a resource or one of a constrained set of the data types (see Extensibility in the spec for list).

Control1..1
BindingSpecimen Rejection Reasons codes for identifying why a test was not performed.
The codes SHALL be taken from US Laboratory Observation Specimen Rejection Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
Observation.extension.valueCodeableConcept.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.extension.valueCodeableConcept.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.extension.valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Must Supporttrue
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

Observation.extension.valueCodeableConcept.coding.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.extension.valueCodeableConcept.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.extension.valueCodeableConcept.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control1..1
Typeuri
Must Supporttrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Observation.extension.valueCodeableConcept.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

Observation.extension.valueCodeableConcept.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Must Supporttrue
Requirements

Need to refer to a particular code in the system.

Observation.extension.valueCodeableConcept.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Must Supporttrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Observation.extension.valueCodeableConcept.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Observation.extension.valueCodeableConcept.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Must Supporttrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

Observation.extension (http://hl7.org/fhir/StructureDefinition/uslab-observationkind)
Definition

This extension is used to classify the kind of observation in Observation.value for laboratory reporting and to differentiate between actual test results, responses to filler questions when ordering tests and other unsolicted responses. This may be required to drive operational functionality.

Control1..1
TypeExtension (Extension Type: code)
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. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

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

Observation.identifier
Definition

A unique identifier for the simple observation instance.

Control1..*
TypeIdentifier
Must Supporttrue
Requirements

Allows observations to be distinguished and referenced.

Observation.identifier.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.identifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.identifier.use
Definition

The purpose of this identifier.

Control1..1
BindingIdentifies the purpose for this identifier, if known .
The codes SHALL be taken from IdentifierUse
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Observation.identifier.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Control0..1
BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
The codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Observation.identifier.system
Definition

Establishes the namespace in which set of possible id values is unique.

Control1..1
Typeuri
Must Supporttrue
Requirements

There are many sequences of identifiers. To perform matching, we need to know what sequence we're dealing with. The system identifies a particular sequence or set of unique identifiers.

Examplehttp://www.acme.com/identifiers/patient or urn:ietf:rfc:3986 if the Identifier.value itself is a full uri
Observation.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Control1..1
Typestring
Must Supporttrue
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

Example123456
Observation.identifier.period
Definition

Time period during which identifier is/was valid for use.

Control0..1
TypePeriod
Observation.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..1
TypeReference(Organization)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Observation.status
Definition

The status of the result value.

Control1..1
BindingCodes providing the status of an observation.
The codes SHALL be taken from ObservationStatus
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

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

Observation.category
Definition

A code that classifies the general type of observation being made. This is used for searching, sorting and display purposes.

Control0..1
BindingCodes for high level observation categories .
For example codes, see Observation Category Codes
TypeCodeableConcept
Comments

The level of granularity is defined by the category concepts in the value set. More fine-grained filtering can be performed using the metadata and/or terminology hierarchy in Observation.code.

Observation.code
Definition

The laboratory test that was performed. This is element is bound to LOINC.

Control1..1
BindingLOINC codes
The codes SHALL be taken from US Laboratory Observation Profile Observation Name Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
Requirements

The use of the Logical Observation Identifiers Names and Codes (LOINC) code system is required where a LOINC code is available for the Observation.code, i.e. the being resulted.

Alternate NamesTest Name, Observation Identifer
Comments

UsageNote= 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.

Observation.code.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.code.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.code.coding
Definition

A reference to a code defined by a terminology system.

Control1..*
TypeCoding
Must Supporttrue
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

Observation.code.coding.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.code.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.code.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control1..1
Typeuri
Must Supporttrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Observation.code.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

Observation.code.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Must Supporttrue
Requirements

Need to refer to a particular code in the system.

Comments

Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations.

Observation.code.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Must Supporttrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Comments

When using LOINC 'long common name' is preferred although the LOINC 'short name' or the LOINC 'fully-specified name can also be used. ( http://lionc.org.terms-of-use).

Observation.code.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Observation.code.text
Definition

This is the laboratory defined display text for the lab test if different from the code display text(s).

Control0..1
Typestring
Must Supporttrue
Requirements

Used when the laboratory define how the dsplay text if different from the code display text.

Comments

If this exists, this is the text to be used for display.

Observation.subject
Definition

The patient, or group of patients, location, or device whose characteristics (direct or indirect) are described by the observation and into whose record the observation is placed. Comments: Indirect characteristics may be those of a specimen, fetus, donor, other observer (for example a relative or EMT), or any observation made about the subject.

Control1..1
TypeChoice of: Reference(US Laboratory Patient Profile), Reference(US Laboratory Patient Profile)
Must Supporttrue
Requirements

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

Comments

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

If the target of the observation is different than the subject, the general extension observation-focal-subject. may be used. However, the distinction between the patient's own value for an observation versus that of the fetus, or the donor or blood product unit, etc., are often specified in the observation code.

Observation.encounter
Definition

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

Control0..1
TypeReference(Encounter)
Requirements

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

Observation.effective[x]
Definition

For lab tests this is the specimen collection date. For Ask at Order Entry Questions (AOE)'s this is the date the question was asked.

Control0..1
TypeChoice of: dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

Minimum Precision to Day.

Comments

At least a date should be present unless this observation is a historical report.

InvariantsDefined on this element
inv-1: Datetime must be at least to day. (xpath: f:matches(./\d{4}-[01]\d-[0-3]\dT[0-2]\d:[0-5]\d([+-][0-2]\d:[0-5]\d|Z)/))
Observation.issued
Definition

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

Control0..1
Typeinstant
Must Supporttrue
Requirements

Minimum Precision to Day.

Comments

Updated when the result is updated.

InvariantsDefined on this element
inv-4: Datetime must be at least to day. (xpath: f:matches(./\d{4}-[01]\d-[0-3]\dT[0-2]\d:[0-5]\d([+-][0-2]\d:[0-5]\d|Z)/))
Observation.performer
Definition

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

Control0..1
TypeChoice of: Reference(Practitioner), Reference(Organization), Reference(Patient), Reference(RelatedPerson)
Requirements

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

SlicingThis element introduces a set of slices. The slicing rules are:
  • ordered
  • Open at End
  • discriminators: type@profile
Observation.performer(USLabPerformingLabSlice)
Definition

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

Control1..1
TypeReference(US Laboratory Organization Profile)
Must Supporttrue
Requirements

If lab generated results need organization.

Observation.value[x]
Definition

This is the actual coded result.

Control0..1
BindingSNOMED CT for coded results
The codes SHALL be taken from SNOMED CT Codes; other codes may be used where these codes are not suitable
TypeChoice of: Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

The use of the SNOMED-CT code system is required where a SNOMED-CT concept code is available for Observation.valueCodeableConcept, i.e. the actual coded result.

Alternate Namescoded result
Comments

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is derived). If a value is present, the datatype for this element should be determined by Observation.code. This element has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueString, valueRange, valueRatio, valueSampledData, valueAttachment, valueTime, valueDateTime, or valuePeriod. (The name format is "'value' + the type name" with a capital on the first letter of the type).

If the data element is usually coded or if the type associated with the Observation.value defines a coded value, use CodeableConcept instead of string datatype even if the value is uncoded text. A value set is bound to the ValueCodeableConcept element. For boolean values use valueCodeableConcept and select codes from HL7 Version 2 Table 0136. These "yes/no" concepts can be mapped to the display name "true/false" or other mutually exclusive terms that may be needed. For further discussion and examples see the notes section below.

Observation.dataAbsentReason
Definition

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

Control0..1 This element is affected by the following invariants: obs-6
BindingCodes specifying why the result (Observation.value[x]) is missing.
The codes SHALL be taken from Observation Value Absent Reason; other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
Requirements

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

Comments

Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

Observation.interpretation
Definition

The assessment made based on the result of the observation. Intended as a simple compact code often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result. Otherwise known as abnormal flag.

Control0..1
BindingCodes identifying interpretations of observations
The codes SHALL be taken from US Laboratory Observation Profile Interpretation Codes
TypeCodeableConcept
Must Supporttrue
Requirements

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

Alternate NamesAbnormal Flag
Observation.interpretation.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.interpretation.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.interpretation.coding
Definition

A reference to a code defined by a terminology system.

Control1..*
TypeCoding
Must Supporttrue
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

Observation.interpretation.coding.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.interpretation.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.interpretation.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control1..1
Typeuri
Must Supporttrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Observation.interpretation.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Control0..1
Typestring
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

Observation.interpretation.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control1..1
Typecode
Must Supporttrue
Requirements

Need to refer to a particular code in the system.

Observation.interpretation.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Observation.interpretation.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Observation.interpretation.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

Observation.comment
Definition

May include statements about significant, unexpected or unreliable values, or information about the source of the value where this may be relevant to the interpretation of the result.

Control0..1
Typestring
Requirements

Need to be able to provide free text additional information.

Observation.bodySite
Definition

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

Control0..0
BindingCodes describing anatomical locations. May include laterality.
For example codes, see SNOMED CT Body Structures
TypeCodeableConcept
Requirements

Knowing where the observation is made is important for tracking if multiple sites are possible.

Comments

Only used if not implicit in code found in Observation.code. If the use case requires BodySite to be handled as a separate resource instead of an inline coded element (e.g. to identify and track separately) then use the standard extension body-site-instance.

Observation.method
Definition

Indicates the mechanism used to perform the observation.

Control0..1
BindingMethods for simple observations.
For example codes, see Observation Methods
TypeCodeableConcept
Requirements

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

Comments

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

Observation.specimen
Definition

The specimen that was used when this observation was made.

Control0..1
TypeReference(US Laboratory Specimen Profile)
Must Supporttrue
Comments

Observations are not made on specimens themselves; they are made on a subject, but usually 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).

Observation.device
Definition

The device used to generate the observation data.

Control0..1
TypeChoice of: Reference(Device), Reference(DeviceMetric)
Comments

An extension should be used if further typing of the device is needed. Devices used to support obtaining an observation can be represented using either extension or through the Observation.related element.

Observation.referenceRange
Definition

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

Control0..*
TypeBackboneElement
Requirements

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

Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g. specific to the patient's age, gender, weight and other factors), but this may 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.

InvariantsDefined on this element
obs-3: Must have at least a low or a high or text (xpath: (exists(f:low) or exists(f:high)or exists(f:text)))
Observation.referenceRange.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.referenceRange.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.referenceRange.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

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

Observation.referenceRange.low
Definition

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

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Observation.referenceRange.high
Definition

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

Control0..1 This element is affected by the following invariants: obs-3
TypeQuantity(SimpleQuantity)
Observation.referenceRange.meaning
Definition

Code for the meaning of the reference range.

Control0..1
BindingCode for the meaning of a reference range.
For example codes, see Observation Reference Range Meaning Codes
TypeCodeableConcept
Requirements

Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, or perhaps what state this reference range applies to (i.e. age, hormonal cycles, etc.).

Comments

This SHOULD be populated if there is more than one range.

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.

Control0..1
TypeRange
Requirements

Some analytes vary greatly over age.

Observation.referenceRange.text
Definition

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

Control0..1
Typestring
Observation.related
Definition

A reference to another resource (usually another Observation but could also be a QuestionnaireAnswer) whose relationship is defined by the relationship type code.

Control0..0
TypeBackboneElement
Requirements

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and a set of related observations or sometimes QuestionnaireResponse from which the measure is derived.

Comments

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

Observation.related.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.related.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.related.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 that contains it. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

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

Observation.related.type
Definition

A code specifying the kind of relationship that exists with the target resource.

Control0..1
BindingCodes specifying how two observations are related.
The codes SHALL be taken from ObservationRelationshipType
Typecode
Requirements

A relationship type SHOULD be provided.

Comments

"derived-from" is only logical choice when referencing QuestionnaireAnswer resource.

Observation.related.target
Definition

A reference to the observation or QuestionnaireResponse resource that is related to this observation.

Control1..1
TypeChoice of: Reference(Observation), Reference(QuestionnaireResponse)
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.

Control0..*
TypeBackboneElement
Requirements

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

Comments

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

Observation.component.id
Definition

unique id for the element within a resource (for internal references).

Control0..1
Typeid
Observation.component.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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

Observation.component.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

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

Observation.component.code
Definition

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

Control1..1 This element is affected by the following invariants: obs-7
BindingCodes identifying names of simple observations.
For example codes, see LOINC Codes
TypeCodeableConcept
Requirements

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

Observation.component.value[x]
Definition

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

Control0..1
TypeChoice of: Quantity, CodeableConcept, string, Range, Ratio, SampledData, Attachment, time, dateTime, Period
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

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

Comments

Normally, an observation will have either a value or a set of related observations. A few observations (e.g. Apgar score) may have both a value and related observations (for an Apgar score, the observations from which the measure is 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 boolean values use valueCodeableConcept and select codes from <http://hl7.org/fhir/ValueSet/v2-0136> (These "yes/no" concepts can be mapped to the display name "true/false" or other mutually exclusive terms that may be needed"). The element, Observation.value[x], has a variable name depending on the type as follows: valueQuantity, valueCodeableConcept, valueRatio, valueChoice, valuePeriod, valueSampleData, or valueString (The name format is "'value' + the type name" with a capital on the first letter of the type).

Observation.component.dataAbsentReason
Definition

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

Control0..1 This element is affected by the following invariants: obs-6
BindingCodes specifying why the result (Observation.value[x]) is missing.
The codes SHALL be taken from Observation Value Absent Reason; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

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

Comments

"Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done". The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

Observation.component.referenceRange
Definition

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

Control0..*
TypeSee referenceRange
Requirements

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

Comments

Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g. specific to the patient's age, gender, weight and other factors), but this may 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.