It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

A reference to a code defined by a terminology system. The effective system is the NHG Tabel 45 Diagnostische bepalingen

It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

A laboratory result describes the result of a laboratory analysis. These are specimen-oriented tests as performed in laboratories such as Clinical Chemistry, Serology, Microbiology, etc. In addition to the results of tests with a singular result, this concept can also contain the results of more complex tests with multiple results or a ‘panel’.

This profile is used for two concepts of the HCIM LaboratoryTestResult at the same time: the root concept (NL-CM:13.1.1) and the LaboratoryTest concept (NL-CM:13.1.3). A LaboratoryTestResult can consist of just one LaboratoryTest or can be a panel of multiple LaboratoryTests. If there's just one LaboratoryTest, a single instance of this profile may be used to represent both concepts, but if there are multiple LaboratoryTests, there should be one parent instance representing the LaboratoryTestResult that uses Observation.related to link child instances representing individual LaboratoryTests.

Note that the Observation.related field in is also used for a third case where there are multiple related LaboratoryTestResults (RelatedResult, NL-CM:13.1.33).

The list below summarizes the different situations: 1. Single LaboratoryTestResult with single LaboratoryTest: * single instance of this profile * .code represents the HCIM concept TestCode (NL-CM:13.1.8) 2. Single LaboratoryTestResult with multiple LaboratoryTests * parent instance with child instances in .related.target * .code of parent represents the HCIM concept PanelOrBattery (NL-CM:13.1.4) * .code of child represents the HCIM concept TestCode (NL-CM:13.1.8) * .related.type of parent set to "has-member" 3. Multiple related LaboratoryTestResults * multiple instances representing the root concept * .code represents the HCIM concept TestCode (NL-CM:13.1.8) * .related.target references the related instances * .related.type set to whichever value is appropriate

Also note that there is the additional profile zib-LaboratoryTestResult-DiagnosticReport, which is used for (textual) reports on individual (panels of) observations, like conclusions. The DiagnosticReport contains references to instances of this profile and can be used in all three the situations described above.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

An Extension

It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

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.

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.

The status of the test result of this test. If the laboratory test is an panel/cluster, the overall status is given in the status of the panel/cluster.

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

Codes providing the status of an observation.

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

Provides the specific HCIM code for TestResultStatus or ResultStatus.

The status of the laboratory test result. If the laboratory test is an panel/cluster, this status reflects the status of the whole panel/cluster. If the status item per subtest is used too, this status must be in accordance with these status values.

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

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

TestResultStatusCodelist

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.

Codes for high level observation categories.

Used for filtering what observations are retrieved and displayed.

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.

Codes for high level observation categories.

Used for filtering what observations are retrieved and displayed.

The type of result defines the laboratory specialty under which the test is categorized.

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.

ResultaatTypeCodelijst

Used for filtering what observations are retrieved and displayed.

The name and code of the executed test or for laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology.

This can either be the HCIM concept PanelOrBattery (NL-CM:13.1.4) or TestCode (NL-CM:13.1.8) depending on the use case. See the documentation on the root of this profile for guidance on implementing the different uses cases.

Codes identifying names of simple observations.

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

A reference to a code defined by a terminology system.

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 labeled as UserSelected = true.

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

A reference to a code defined by a terminology system. The effective system is the NHG Tabel 45 Diagnostische bepalingen

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 labeled as UserSelected = true.

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

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

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.

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

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.

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.

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

The encounter during which this journal entry was made.

It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

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

A laboratory result describes the result of a laboratory analysis. These are specimen-oriented tests as performed in laboratories such as Clinical Chemistry, Serology, Microbiology, etc. In addition to the results of tests with a singular result, this concept can also contain the results of more complex tests with multiple results or a ‘panel’.

This profile is used for two concepts of the HCIM LaboratoryTestResult at the same time: the root concept (NL-CM:13.1.1) and the LaboratoryTest concept (NL-CM:13.1.3). A LaboratoryTestResult can consist of just one LaboratoryTest or can be a panel of multiple LaboratoryTests. If there's just one LaboratoryTest, a single instance of this profile may be used to represent both concepts, but if there are multiple LaboratoryTests, there should be one parent instance representing the LaboratoryTestResult that uses Observation.related to link child instances representing individual LaboratoryTests.

Note that the Observation.related field in is also used for a third case where there are multiple related LaboratoryTestResults (RelatedResult, NL-CM:13.1.33).

The list below summarizes the different situations: 1. Single LaboratoryTestResult with single LaboratoryTest: * single instance of this profile * .code represents the HCIM concept TestCode (NL-CM:13.1.8) 2. Single LaboratoryTestResult with multiple LaboratoryTests * parent instance with child instances in .related.target * .code of parent represents the HCIM concept PanelOrBattery (NL-CM:13.1.4) * .code of child represents the HCIM concept TestCode (NL-CM:13.1.8) * .related.type of parent set to "has-member" 3. Multiple related LaboratoryTestResults * multiple instances representing the root concept * .code represents the HCIM concept TestCode (NL-CM:13.1.8) * .related.target references the related instances * .related.type set to whichever value is appropriate

Also note that there is the additional profile zib-LaboratoryTestResult-DiagnosticReport, which is used for (textual) reports on individual (panels of) observations, like conclusions. The DiagnosticReport contains references to instances of this profile and can be used in all three the situations described above.

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 may not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

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.

This element is labelled 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).

A human language.

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.

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 in formation 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.

An Extension

An Extension

It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

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.

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.

A unique identifier assigned to this observation.

Allows observations to be distinguished and referenced.

A plan, proposal or order that is fulfilled in whole or in part by this event.

Requester information should be captured and exchanged in the resource ProcedureRequest referenced by basedOn. Requester is the healthcare provider and/or organization where or by whom the LaboratoryTestResult was requested. There are a few required elements in ProcedureRequest: * ProcedureRequest.status (use fixed value active, unless you know what the actual value is) * ProcedureRequest.intent (use fixed value order, unless you know what the actual value is) * ProcedureRequest.code (use extension http://hl7.org/fhir/STU3/extension-iso21090-nullflavor.html with valueCode UNK, unless you know what the actual value is) * ProcedureRequest.subject (equal to Observation.subject) * ProcedureRequest.requester.agent (contains the requesting HealthProfessional)

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

The status of the test result of this test. If the laboratory test is an panel/cluster, the overall status is given in the status of the panel/cluster.

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

Codes providing the status of an observation.

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

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

An Extension

Provides the specific HCIM code for TestResultStatus or ResultStatus.

The status of the laboratory test result. If the laboratory test is an panel/cluster, this status reflects the status of the whole panel/cluster. If the status item per subtest is used too, this status must be in accordance with these status values.

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

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.

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

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

TestResultStatusCodelist

Primitive value for 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.

Codes for high level observation categories.

Used for filtering what observations are retrieved and displayed.

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.

Codes for high level observation categories.

Used for filtering what observations are retrieved and displayed.

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

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.

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.

A reference to a code defined by a terminology system.

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 labeled as UserSelected = true.

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

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

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.

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.

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

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.

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

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.

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.

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).

Need to refer to a particular code in the system.

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

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

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

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.

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.

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.

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

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.

The type of result defines the laboratory specialty under which the test is categorized.

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.

ResultaatTypeCodelijst

Used for filtering what observations are retrieved and displayed.

The name and code of the executed test or for laboratory tests comprising multiple subtests and often requested together as a whole, this concept contains the name of the compound request (often indicated as a ‘panel’, ‘battery’ or ‘cluster’). Examples include: blood gases and EBV serology.

This can either be the HCIM concept PanelOrBattery (NL-CM:13.1.4) or TestCode (NL-CM:13.1.8) depending on the use case. See the documentation on the root of this profile for guidance on implementing the different uses cases.

Codes identifying names of simple observations.

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

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

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.

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.

A reference to a code defined by a terminology system.

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 labeled as UserSelected = true.

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

A reference to a code defined by a terminology system. The effective system is the NHG Tabel 45 Diagnostische bepalingen

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 labeled as UserSelected = true.

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

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

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.

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.

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

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.

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

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.

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.

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).

Need to refer to a particular code in the system.

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

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

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

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.

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.

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.

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

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.

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.

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.

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

The encounter during which this journal entry was made.

It is recommended to use the nl-core-episodeofcare extension to reference nl-core-episodeofcare (EpisodeOfCare) instances rather than the context element, as this approach will be enforced in FHIR R4.

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

The date and if possible the time at which the test was carried out.

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

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

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

Updated when the result is updated.

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.

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

An Extension

Optional Extension Element - found in all resources.

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.

An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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.

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.

The test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal).

Normally, an observation will have either a single 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, valueBoolean, 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 further discussion and examples see the notes section below.

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

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.

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

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

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.

Codes identifying interpretations of observations.

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

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

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.

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.

A reference to a code defined by a terminology system.

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 labeled as UserSelected = true.

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

A reference to a code defined by a terminology system.

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 labeled as UserSelected = true.

Observation Interpretation Codes

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

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

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.

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.

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

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.

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

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.

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.

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).

Need to refer to a particular code in the system.

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

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

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

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.

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.

Attention codes indicating whether the result is above or below certain reference values or interpreting the result otherwise. (Resistent)

This slice binds the ValueSet from the HCIM, which overlaps the ValueSet from the core FHIR Observation. To satisfy the FHIR profiling rules, the code from the core FHIR ValueSet SHOULD be included as well if a code from this ValueSet is included. A ConceptMap (https://simplifier.net/resolve?canonical=http://nictiz.nl/fhir/ConceptMap/InterpretatieVlaggenCodelijst-to-observation-interpretation) is available that explains the relationship between the FHIR observation-interpretation value set and the HCIM ResultFlagsCodelist.

InterpretatieVlaggenCodelijst

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

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

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.

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.

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

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.

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

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.

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.

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).

Need to refer to a particular code in the system.

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

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

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

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.

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.

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.

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

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, such as a textual interpretation or advice accompanying the result, for example or a comment of the laboratory specialist regarding the interpretation of the results.

Need to be able to provide free text additional information.

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 body-site-instance.

Codes describing anatomical locations. May include laterality.

The test method used to obtain the result.

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

SNOMED CT (2.16.840.1.113883.6.96): All values

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.

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).

The device used to generate the observation data.

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 an extension or through the Observation.related element.

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

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.

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.

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

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.

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.

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.

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.

The lower reference limit for the patient of the value measured with the test.

The upper reference limit for the patient of the value measured in the test.

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.

Code for the meaning of a reference range.

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

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.

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

Codes identifying the population the reference range applies to.

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

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.

Some analytes vary greatly over age.

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'.

Reference to related LaboratoryTestResult instances, or to the LaboratoryTest concept if this is a grouping Observation.

The Observation.related field is used for two different HCIM use cases: 1. The LaboratoryTestResult can reference other, related LaboratoryTestResults (RelatedResult, NL-CM:13.1.33). 2. The LaboratoryTestResult can consist of multiple LaboratoryTest concepts (NL-CM:13.1.3)

See the documentation on the root if this profile for guidance on implementing these use cases.

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 a QuestionnaireResponse from which the measure is derived.

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

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.

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.

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.

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.

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

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

Codes specifying how two observations are related.

A relationship type SHOULD be provided.

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

Container of the LaboratoryTest concept. This container contains all data elements of the LaboratoryTest concept.

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

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

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.

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.

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.

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.

The TestCode is the name of the executed test.

LOINC (2.16.840.1.113883.6.1): All values

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

The test result. Depending on the type of test, the result will consist of a value with a unit or a coded value (ordinal or nominal).

Normally, an observation will have either a single 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).

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

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 "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.

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

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

Attention codes indicating whether the result is above or below certain reference values or interpreting the result otherwise. (Resistent)

A ConceptMap (https://simplifier.net/resolve?canonical=http://nictiz.nl/fhir/ConceptMap/InterpretatieVlaggenCodelijst-to-observation-interpretation) is available that maps ResultFlagsCodelist to the observation-interpretation value set.

InterpretatieVlaggenCodelijst

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

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

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.

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.