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: QICore Laboratory Result Observation

Official URL: http://hl7.org/fhir/us/qicore/StructureDefinition/qicore-observation-lab Version: 7.0.0
Active as of 2022-05-31 Computable Name: QICoreLaboratoryResultObservation

The QI-Core Laboratory Result Observation Profile is based upon the US Laboratory Result Observation Resource. Defines the core set of elements and extensions for quality rule and measure authors.

"Must Have", "QI Elements" and "primary code path" are defined in the QI-Core Must Support section.
Must Have:
  • status: (QI) registered | prliminary | final | amended | corrected | cancelled | entered-in-error | unknown
  • category: (QI) Classification of type of observation
  • category(us-core): (QI) Classification of type of observation
  • code: (QI) Laboratory Test Name
  • subject: (QI) Who and/or what the observation is about
QI Elements:
  • encounter: (QI) Encounter associated with Observation
  • effective[x]: (QI) Clinically relevant time/time-period for observation
  • issued: (QI) Date/Time this version was made available
  • value[x]: (QI) Result Value
  • interpretation: (QI) High, low, normal, etc.
Primary code path: code
(PCPath) This element is the primary code path for this resource CQL Retrieve


NOTE TO BALLOT REVIEWERS:
  • US Core 7.0, and thus QI-Core 7.0, has a new approach to USCDI requirements.
    • As noted in the US Core 7.0 Must Support section, US Core 7.0 no longer highlights mandatory (cardinality 1..* or 1..1) and Must Support elements with a (USCDI) indicator as such items must be supported for interoperability.
    • Those USCDI elements that are not mandatory or Must Support now include an indicator (ADDITIONAL USCDI) in US Core. QI-Core 7.0 does not reference USCDI elements; rather, users should access US Core 7.0 to understand its implementation of USCDI version 4.
  • We invite comments about the approach and suggestions for other options that would also avoid unnecessary noise or reading load to the QI-Core profile representation.
  • Further, QI-Core 7.0 does not discuss USCDI+Quality because at the time of ballot preparation, no published version of USCDI+Quality is available. We seek reviewer advice regarding how QI-Core might address future USCDI+Quality.

Usage

See the patterns page for implementation and usage patterns.

Examples

Glucose Laboratory Result Observation Example

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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
us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
... meta SΣ 0..1 Meta Metadata about the resource
ele-1: All FHIR elements must have a @value or children
.... lastUpdated SΣ 0..1 instant When the resource last changed
ele-1: All FHIR elements must have a @value or children
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for category S 1..* CodeableConcept (QI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ele-1: All FHIR elements must have a @value or children
.... category:us-core S 1..1 CodeableConcept (QI) Classification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


ele-1: All FHIR elements must have a @value or children

Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
... code SΣ 1..1 CodeableConcept (QI) Laboratory Test Name
Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes


ele-1: All FHIR elements must have a @value or children
... subject SΣ 1..1 Reference(QICore Patient) (QI) Who and/or what the observation is about
ele-1: All FHIR elements must have a @value or children
... encounter SΣ 0..1 Reference(QICore Encounter) (QI) Encounter associated with Observation
ele-1: All FHIR elements must have a @value or children
... effective[x] SΣC 0..1 (QI) Clinically relevant time/time-period for observation
ele-1: All FHIR elements must have a @value or children
us-core-1: Datetime must be at least to day.
.... effectiveDateTime dateTime
... issued Σ 0..1 instant (QI) Date/Time this version was made available
ele-1: All FHIR elements must have a @value or children
... value[x] SΣC 0..1 (QI) Result Value
ele-1: All FHIR elements must have a @value or children
us-core-3: SHALL use UCUM for coded quantity units.
us-core-4: SHOULD use Snomed CT for coded Results
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


ele-1: All FHIR elements must have a @value or children
... interpretation S 0..* CodeableConcept (QI) High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


ele-1: All FHIR elements must have a @value or children
... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
ele-1: All FHIR elements must have a @value or children
... referenceRange SC 0..* BackboneElement Result reference range
ele-1: All FHIR elements must have a @value or children
obs-3: Must have at least a low or a high or text
us-core-22: SHALL use UCUM for coded quantity units.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:us-corerequiredPattern: laboratory
http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
Observation.codeextensibleUSCoreLaboratoryTestCodes
http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
Observation.dataAbsentReasonextensibleDataAbsentReason
http://hl7.org/fhir/ValueSet/data-absent-reason
from the FHIR Standard
Observation.interpretationextensibleObservationInterpretationCodes
http://hl7.org/fhir/ValueSet/observation-interpretation
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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())
us-core-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
: ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
us-core-22errorObservation.referenceRangeSHALL 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')

 

Other representations of profile: CSV, Excel, Schematron