QI-Core Implementation Guide
7.0.0 - STU7 United States of America flag

QI-Core Implementation Guide, published by HL7 International / Clinical Quality Information. This guide is not an authorized publication; it is the continuous build for version 7.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-qi-core/ and changes regularly. See the Directory of published versions

Resource Profile: QICoreLaboratoryResultObservation - Detailed Descriptions

Active as of 2022-05-31

Definitions for the qicore-observation-lab resource profile.

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

0. Observation
Definition

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

ShortMeasurements 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.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-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.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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.meta.lastUpdated
Definition

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

ShortWhen the resource last changedWhen 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.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. 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.

ShortA 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.

Control0..1
Typeuri
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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 Namesextensions, user content
Invariantsele-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())
10. Observation.status
Definition

The status of the result value.

Short(QI) registered | prliminary | final | amended | corrected | cancelled | 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.

Control1..1
BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

Codes providing the status of an observation.

Typecode
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

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

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

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

Short(QI) 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.

Control10..*
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category
(preferred to http://hl7.org/fhir/ValueSet/observation-category)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

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

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

    Short(QI) 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.

    Control10..1*
    BindingThe codes SHALL be taken from The codes SHOULD be taken from US Core Clinical Result Observation Categoryhttp://hl7.org/fhir/ValueSet/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


    Codes for high level observation categories.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

    Used for filtering what observations are retrieved and displayed.

    Pattern Value{
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
        "code" : "laboratory"
      }]
    }
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. 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) 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.

    Control1..1
    BindingUnless not suitable, these codes SHALL be taken from For example codes, see US Core Laboratory Test Codeshttp://hl7.org/fhir/ValueSet/observation-codes
    (extensible to http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes)

    Laboratory LOINC Codes


    Codes identifying names of simple observations.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

    Alternate NamesName
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. 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) 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.

    Control10..1
    TypeReference(QICore Patient, Patient, Group, Device, Location)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

    Invariantsele-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(QI) Encounter associated with ObservationHealthcare 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).

    Control0..1
    TypeReference(QICore Encounter, Encounter)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Requirements

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

    Alternate NamesContext
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. 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) 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.

    Control0..1
    This element is affected by the following invariants: us-core-1
    TypeChoice of: dateTime, Period, Timing, instant
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesdateTime
    Summarytrue
    Requirements

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

    Alternate NamesOccurrence
    Invariantsele-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)
    24. 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) 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.

    Control0..1
    Typeinstant
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. 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) 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.

    Control0..1
    This element is affected by the following invariants: obs-7, us-core-2, us-core-3, us-core-4
    TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Must Support TypesChoice of: Quantity, CodeableConcept, string
    Summarytrue
    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.

    Invariantsele-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. (ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org')
    us-core-4: SHOULD use Snomed CT for coded Results (ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct'))
    28. Observation.dataAbsentReason
    Definition

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

    ShortWhy 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.

    Control0..1
    This element is affected by the following invariants: obs-6, us-core-2
    BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
    (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

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

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

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

    Short(QI) 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.

    Control0..*
    BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation
    (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

    Codes identifying interpretations of observations.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Requirements

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

    Alternate NamesAbnormal Flag
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Observation.specimen
    Definition

    The specimen that was used when this observation was made.

    ShortSpecimen 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).

    Control0..1
    TypeReference(US Core Specimen Profile, Specimen)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. 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.

    ShortResult reference rangeProvides guide for interpretation
    Comments

    Upper and lower limit of test values expected for a designated population of individuals. Reference range values may differ by patient characteristics, laboratory test manufacturer and laboratory test performer.


    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.

    Control0..*
    This element is affected by the following invariants: us-core-22
    TypeBackboneElement
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    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.

    Invariantsele-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())
    us-core-22: SHALL use UCUM for coded quantity units. ((low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org'))
    obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
    36. 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).

    ShortExtensions 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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    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 Namesextensions, user content, modifiers
    Invariantsele-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())