Generated Narrative: StructureDefinition ch-lab-observation-cbc Name Flags Card. Type Description & Constraints Observation 0..* ChLabObservationSingleTest Laboratory result for a simple test or for a panel/study This profile also imposes the profile Observation Results: laboratory Slices for category Content/Rules for all slices category:studyType 0..* CodeableConcept The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 18723-7 category:specialty 0..* CodeableConcept The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) 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://snomed.info/sct code 1..1 code Symbol in syntax defined by the system Fixed Value: 394916005 code 1..1 CodeableConcept Type of observation (code / type) 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 58410-2 method 0..1 CodeableConcept How it was done 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://snomed.info/sct code 1..1 code Symbol in syntax defined by the system Fixed Value: 702659008 Slices for component S 8..12 BackboneElement Component observations Slice: Unordered, Open by value:code component:WhiteBloodCellCount S 1..1 BackboneElement Leucocyte count Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept Leucocyte count code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 6690-2 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: 10*9/L component:RedBloodCellCount S 1..1 BackboneElement Erythrocyte count Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept Leucocyte count code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 789-8 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: 10*12/L component:Hemoglobin S 1..1 BackboneElement Hemoglobin Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept Hemoglobin code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 718-7 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: g/dL component:Hematocrit S 1..1 BackboneElement Hematocrit Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept Hematocrit code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 4544-3 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: % component:MeanCorpuscularVolume S 1..1 BackboneElement Mean Corpuscular Volume Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept MeanCorpuscularVolume code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 787-2 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: fL component:MeanCorpuscularHemoglobin S 1..1 BackboneElement Mean Corpuscular Hemoglobin Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept MeanCorpuscularHemoglobin code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 785-6 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: pg component:MeanCorpuscularHemoglobinConcentration S 1..1 BackboneElement Mean Corpuscular Hemoglobin Concentration Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept MeanCorpuscularHemoglobinConcentration code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 786-4 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: g/dL component:ErythrocyteDistWidth S 0..1 BackboneElement Erythrocyte distribution width Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept ErythrocyteDistWidth code Binding: CH LAB-Report Codes for Erythrocyte Distribuiton Width Test (required) Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: fL component:PlateletCount S 1..1 BackboneElement Platelet Count Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept PlateletCount code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 777-3 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: 10^9/L component:PlateletDistWidth S 0..1 BackboneElement Platelet Distribution Width Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept Platelet distribution width [Entitic volume] in Blood by Automated count 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 32207-3 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: fL component:PlateletMeanVolume S 0..1 BackboneElement Platelet Mean Volume Slices for extension Content/Rules for all slices extension:value-r5 0..1 R5 Observation.value%5Bx%5D Extension code S 1..1 CodeableConcept PlateletMeanVolume code 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://loinc.org code 1..1 code Symbol in syntax defined by the system Fixed Value: 32623-1 Slices for value[x] Content/Rules for all slices value[x]:valueQuantity S 0..1 QuantityEuLab automated CBC Profile component value value S 1..1 decimal Numerical value (with implicit precision) unit S 1..1 string Unit representation code 1..1 code Coded form of the unit Fixed Value: fL Documentation for this format
CH LAB-Report Observation Results CBC Panel - Blood by Automated count, Results in sliced component
Profile for observation laboratory result of automated Count of Blood Cells. We choose as Unit 10⁹/L or 10¹²/L for Cell Count.
This profile constrains the ChLabObservationResultsLaboratoryt profile to represent results produced by automated CBC (count of Blood-Cells) for the HL7 Swiss project.
Used by permission of HL7 Switzerland, all rights reserved Creative Commons License
Laboratory result for a simple test or for a panel/study
This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and references the atomic results of the study as "has-member" child observations
Represents either a lab simple observation or the group of observations produced by a laboratory study.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
dataAbsentReason SHALL only be present if Observation.value[x] is not present
dataAbsentReason.empty() or value.empty()
not(exists(f:dataAbsentReason)) or (not(exists(*[starts-with(local-name(.), 'value')])))
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()
not(f:*[starts-with(local-name(.), 'value')] and (for $coding in f:code/f:coding return f:component/f:code/f:coding[f:code/@value=$coding/f:code/@value] [f:system/@value=$coding/f:system/@value]))
If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"
(status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
Observation[classCode=OBS, moodCode=EVN]
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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.
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.
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
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
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.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
The laboratory test kit used for this test.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Other information that may be relevant to this event.
Other resources *from the patient record* that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension **should not** be used if more specific inline elements or extensions are available. For example, use `Observation.hasMember` instead of supportingInformation for representing the members of an Observation panel.
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Optional Extension Element - found in all resources.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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.
Source of the definition for the extension code - a logical name or a URL.
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 SHALL be a URI for the Structure Definition defining the extension.
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
Certified Reference Material: CodeableConcept
This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].
Certified Reference Material: Identifier
This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].
This extension links this observation with the laboratory test kit used for this test. Usually only one laboratory test kit is referred
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).
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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
A unique identifier assigned to this observation.
Allows observations to be distinguished and referenced.
OBX.21 For OBX segments from systems without OBX-21 support a combination of ORC/OBR and OBX must be negotiated between trading partners to uniquely identify the OBX segment. Depending on how V2 has been implemented each of these may be an option: 1) OBR-3 + OBX-3 + OBX-4 or 2) OBR-3 + OBR-4 + OBX-3 + OBX-4 or 2) some other way to uniquely ID the OBR/ORC + OBX-3 + OBX-4.
A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.
Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.
A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.
To link an Observation to an Encounter use `encounter`. See the [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below for guidance on referencing another Observation.
Status of this observation (e.g. preliminary, final,...)
This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.
Need to track the status of individual results. Some results are finalized before the whole report is finalized.
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Codes providing the status of an observation.
status Amended & Final are differentiated by whether it is the subject of a ControlAct event with a type of "revise"
A code that classifies the general type of observation being made. In this profile, fixed to "laboratory".
"laboratory" includes laboratory medicine and pathology
Used for filtering what observations are retrieved and displayed.
Codes for high level observation categories.
.outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
A code that classifies the general type of observation being made.
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.
The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations
In the context of this Observation-laboratory-uv-ips profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.
Knowing what kind of observation is being made is essential to understanding the observation.
< 363787002 |Observable entity| OR < 386053000 |Evaluation procedure|
Who and/or what the observation is about
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.
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.
Observations have no value if you don't know who or what they're about.
Literal reference, Relative, internal or absolute URL
A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
Type the reference refers to (e.g. "Patient")
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
Plain text narrative that identifies the resource in addition to the resource reference.
This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
What the observation is about, when it is not about the subject of record
The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.
Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use `specimen` if a reference to a specimen is required. If a code is required instead of a resource use either `bodysite` for bodysites or the standard extension [focusCode](http://hl7.org/fhir/R4/extension-observation-focuscode.html).
Healthcare event during which this observation is made
The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.
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).
For some observations it may be important to know the link between an observation and a particular encounter.
inboundRelationship[typeCode=COMP].source[classCode=ENC, moodCode=EVN]
Clinically relevant time/time-period for observation
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.
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](http://hl7.org/fhir/R4/datatypes.html#timing) datatype which allow the measurement to be tied to regular life events.
Knowing when an observation was deemed true is important to its relevance as well as determining trends.
OBX-14, and/or OBX-19 after v2.4 (depends on who observation made)
Provides a reason why the effectiveTime is missing.
Date/Time this result was made available
The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.
For Observations that don’t require review and verification, it may be the same as the [`lastUpdated` ](http://hl7.org/fhir/R4/resource-definitions.html#Meta.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.
OBR.22 (or MSH.7), or perhaps OBX-19 (depends on who observation made)
Who was responsible for asserting the observed value as "true".
May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.
OBX.15 / (Practitioner) OBX-16, PRT-5:PRT-4='RO' / (Device) OBX-18 , PRT-10:PRT-4='EQUIP' / (Organization) OBX-23, PRT-8:PRT-4='PO'
Distinguishes the type of involvement of the performer in the event. For example, 'author', 'verifier' or 'responsible party'.
The information determined as a result of making the observation, if the information has a simple value.
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](http://hl7.org/fhir/R4/observation.html#notes) below.
An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.
Provides a reason why the expected value is missing.
Provides a reason why the expected value in the element Observation.value[x] is missing.
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.
For many results it is necessary to handle exceptional values in measurements.
Codes specifying why the result (`Observation.value[x]`) is missing.
A categorical assessment of an observation value. For example, high, low, normal.
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.
For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.
Codes identifying interpretations of observations.
Comments about the observation or the results.
May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.
Need to be able to provide free text additional information.
NTE.3 (partner NTE to OBX, or sometimes another (child?) OBX)
Indicates the site on the subject's body where the observation was made (i.e. the target site).
Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component. If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension[ bodySite](http://hl7.org/fhir/R4/extension-bodysite.html).
Codes describing anatomical locations. May include laterality.
Laboratory technique (method of measurement) are integral parts of the test specification of some laboratory test coding systems (e.g. NPU), in LOINC hovewer measurement principle is not always present in the test definition. In some cases however knowledge of the used measurment techique is important for proper interpretation of the test result. That's why it is important to explicitly include informaiton about measurement method is such cases.
In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.
The specimen that was used when this observation was made.
When the specimen is applicable and known it shall be documented
The device used to generate the observation data.
Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.
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.
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.
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.
Must have at least a low or a high or text
low.exists() or high.exists() or text.exists()
(exists(f:low) or exists(f:high)or exists(f:text))
outboundRelationship[typeCode=REFV]/target[classCode=OBS, moodCode=EVN]
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
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).
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).
Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.
This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.
Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.
Code for the meaning of a reference range.
< 260245000 |Findings values| OR < 365860008 |General clinical state finding| OR < 250171008 |Clinical history or observation findings| OR < 415229000 |Racial group| OR < 365400002 |Finding of puberty stage| OR < 443938003 |Procedure carried out on subject|
Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple `appliesTo` are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.
This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.
Need to be able to identify the target population for proper interpretation.
Codes identifying the population the reference range applies to.
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.
Text based reference range in an observation
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".
Related resource that belongs to the Observation group
A reference to another Observation profiled by ch-lab-observation-results-laboratory. The target observation (for instance an individual test member of a panel) is considered as a sub-observation of the current one, which plays the role of a grouper.
This element is used in the context of international patient summary when there is a need to group a collection of observations, because they belong to the same panel, or because they share a common interpretation comment, or a common media attachment (illustrative image or graph). In these cases, the current observation is the grouper, and its set of sub-observations are related observations using the type "has-member". For a discussion on the ways Observations can be assembled in groups together see [Observation Grouping](http://hl7.org/fhir/observation.html#obsgrouping).
Relationships established by OBX-4 usage
Related measurements the observation is made from
The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.
All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see [Notes](http://hl7.org/fhir/R4/observation.html#obsgrouping) below.
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.
For a discussion on the ways Observations can be assembled in groups together see [Notes](http://hl7.org/fhir/R4/observation.html#notes) below.
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.
Type of component observation (code / type)
Describes what was observed. Sometimes this is called the observation "code".
*All* code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.
Codes identifying names of simple observations.
Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the [Notes section](http://hl7.org/fhir/R4/observation.html#notes) below.
363714003 |Interprets| < 441742003 |Evaluation finding|
Provides a reason why the expected value in the element Observation.component.value[x] is missing.
"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.
Provides guide for interpretation of component result
Guidance on how to interpret the value by comparison to a normal or recommended range.
Standard Deviation (same units as the quantity)
The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).
standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.
Probability Distribution Type for uncertainty
A code specifying the type of probability distribution for the uncertainty.
This is only meaningful if there is also an uncertainty extension. If there is an uncertainty extension with no type, this means that the probability distribution type is unknown. In that case, the uncertainty has the meaning of an informal guess.
Numerical value (with implicit precision)
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Precision is handled implicitly in almost all cases of measurement.
PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
< | <= | >= | > - how to understand the value
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
If there is no comparator, then there is no modification of the value
This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
How the Quantity should be understood and represented.
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
The identification of the system that provides the coded form of the unit.
Need to know the system that defines the coded form of the unit.
CO.codeSystem, PQ.translation.codeSystem
A computer processable form of the unit in some unit representation system.
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
PQ.code, MO.currency, PQ.translation.code
Mean Corpuscular Hemoglobin Concentration
MeanCorpuscularHemoglobinConcentration code
Platelet distribution width [Entitic volume] in Blood by Automated count