Lab:Vdraft FHIR Lab2zorg: verschil tussen versies
(Copy from published page) |
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(2 tussenliggende versies door 2 gebruikers niet weergegeven) | |||
Regel 1: | Regel 1: | ||
__NOINDEX__ | __NOINDEX__ | ||
− | {{DISPLAYTITLE:FHIR Lab2zorg V3.0.0}} | + | {{DISPLAYTITLE:FHIR Lab2zorg V3.0.0-beta.1}} |
{{underconstruction}} | {{underconstruction}} | ||
Regel 35: | Regel 35: | ||
Each transaction starts with links to the functional definition in an ART-DECOR publication and references one or several FHIR profiles. Where the functional definition contains all specific data elements for the transaction (prefixed with ‘lu-concept-v2’), the FHIR profiles only contain a mapping to these data elements that do not have a dependency on a zib counterpart. For example: ‘lu-concept-v2-4266’ (Specimen) has a relation with the zib element with id ‘NL-CM-13.1.2’, therefore no mapping with ‘lu-concept-v2-4266’ can be found in the profiles. On the other hand, ‘lu-concept-v2-4296’ (LaboratoryResultIdentification) has no relation with a zib element, therefore a mapping can be found in the relevant FHIR profile. | Each transaction starts with links to the functional definition in an ART-DECOR publication and references one or several FHIR profiles. Where the functional definition contains all specific data elements for the transaction (prefixed with ‘lu-concept-v2’), the FHIR profiles only contain a mapping to these data elements that do not have a dependency on a zib counterpart. For example: ‘lu-concept-v2-4266’ (Specimen) has a relation with the zib element with id ‘NL-CM-13.1.2’, therefore no mapping with ‘lu-concept-v2-4266’ can be found in the profiles. On the other hand, ‘lu-concept-v2-4296’ (LaboratoryResultIdentification) has no relation with a zib element, therefore a mapping can be found in the relevant FHIR profile. | ||
− | Because of [[FHIR:V1.0_FHIR_Profiling_Guidelines_R4#Open_vs._closed_world_modeling|open world | + | Because of [[FHIR:V1.0_FHIR_Profiling_Guidelines_R4#Open_vs._closed_world_modeling|open world modeling]], the cardinality of elements in the FHIR profiles can be less strict than the cardinalities in the ART-DECOR transactions. However, the latter cardinality is leading when it comes to exchanging building blocks in the context of a specific transaction. For example: in the nl-core-LaboratoryTestResult profile, {{fhir|.performer}} has a core cardinality of 0..*, while in both the 'Send laboratory results' and ‘Serve laboratory results’ ART-DECOR transactions, the Performer element has a cardinality of 1..1 M. Therefore, {{fhir|.performer}} is expected to be filled with either a reference to an nl-core-HealthcareProvider-Organization resource. |
− | Each transaction contains a Patient building block with cardinality 1..1 M. This patient is the subject of all | + | Each transaction contains a Patient building block with cardinality 1..1 M. This patient is the subject of all other building blocks in the transaction, although no explicit relation exists in the data set. Therefore, a reference to a Patient resource conforming to the nl-core-Patient profile is expected in {{fhir|.subject}} of each FHIR instance of each building block. |
[[Bestand:LaboratoryInFHIRR4Overview.png|miniatuur|Laboratory results in FHIR R4 overview]] | [[Bestand:LaboratoryInFHIRR4Overview.png|miniatuur|Laboratory results in FHIR R4 overview]] | ||
The single zib LaboratoryTestResult consists of objects that in FHIR are represented using different (instances of) resources: | The single zib LaboratoryTestResult consists of objects that in FHIR are represented using different (instances of) resources: | ||
− | * ''NL-CM:13.1.1 LaboratoryTestResult'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4.nl-core|pkgVersion= | + | * ''NL-CM:13.1.1 LaboratoryTestResult'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult}} {{fhir|Observation}} and has {{fhir|.hasMember}} relationships with individual ''NL-CM:13.1.3 LaboratoryTests''. |
** Note that this level only exists when LaboratoryTestResult contains ''NL-CM:13.1.4 PanelOrBattery''. The concepts ''NL-CM:13.1.7 ResultType'', ''NL-CM:13.1.5 Comment'', and ''NL-CM:13.1.6 ResultStatus'' are not mapped in the absence of ''NL-CM:13.1.4 PanelOrBattery''. | ** Note that this level only exists when LaboratoryTestResult contains ''NL-CM:13.1.4 PanelOrBattery''. The concepts ''NL-CM:13.1.7 ResultType'', ''NL-CM:13.1.5 Comment'', and ''NL-CM:13.1.6 ResultStatus'' are not mapped in the absence of ''NL-CM:13.1.4 PanelOrBattery''. | ||
− | * ''NL-CM:13.1.3 LaboratoryTest'' also maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4.nl-core|pkgVersion= | + | * ''NL-CM:13.1.3 LaboratoryTest'' also maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult}} {{fhir|Observation}} and MAY be referenced by a different {{fhir|Observation.hasMember}} containing ''NL-CM:13.1.1 LaboratoryTestResult''. |
− | * ''NL-CM:13.1.2 Specimen'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen|nictiz.fhir.nl.r4.nl-core|pkgVersion= | + | * ''NL-CM:13.1.2 Specimen'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult.Specimen}} {{fhir|Specimen}}. |
− | ** Note that there could be multiple instances of Specimen: one for the main ''NL-CM:13.1.16 SpecimenMaterial'', and one per isolated ''NL-CM:13.1.22 Microorganism'' with a {{fhir|.parent}} relationship to the main | + | ** Note that there could be multiple instances of Specimen: one for the main ''NL-CM:13.1.16 SpecimenMaterial'', and one per isolated ''NL-CM:13.1.22 Microorganism'' with a {{fhir|.parent}} relationship to the main specimen. |
− | * ''NL-CM:13.1.29 SpecimenSource'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen.Source|nictiz.fhir.nl.r4.nl-core|pkgVersion= | + | * ''NL-CM:13.1.29 SpecimenSource'' maps into profile {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen.Source|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult.Specimen.Source}} {{fhir|Device}}. This is a special case where the specimen did not come from the Patient directly. |
==Patient identification== | ==Patient identification== | ||
Regel 62: | Regel 62: | ||
==Resource identification== | ==Resource identification== | ||
− | All profiles used within the information standard contain {{fhir|.identifier}} elements with a cardinality of 0..* because of open world | + | All profiles used within the information standard contain {{fhir|.identifier}} elements with a cardinality of 0..* because of open world modeling. However, all ART-DECOR transactions referenced within this IG assign a 1..1 R cardinality, meaning a stable identifier SHOULD be provided, or [[FHIR:V0.9_FHIR_IG_R4#Missing_information|the DataAbsentReason extension if a value is missing]]. Identifiers SHALL contain both a {{fhir|.system}} and a {{fhir|.value}}. |
Because in HL7v3 (CDA) an identifier can only be composed using [[Hoofdpagina#Object_IDentifiers_.28OIDs.29|OIDs]], the {{fhir|.system}} SHALL be an OID to accommodate compatibility in transformations to and from FHIR. The [https://www.hl7.nl/wiki/index.php?title=DatatypesR1:II Netherlands HL7v3 datatype II] also defines additional restrictions on the maximum length of both <code>@root</code> and <code>@extension</code> (equivalent to respectively {{fhir|.system}} and {{fhir|.value}} in FHIR). For the same compatibility reasons, {{fhir|.system}} SHALL have a maximum of 128 characters and {{fhir|.value}} SHALL have a maximum of 64 characters. | Because in HL7v3 (CDA) an identifier can only be composed using [[Hoofdpagina#Object_IDentifiers_.28OIDs.29|OIDs]], the {{fhir|.system}} SHALL be an OID to accommodate compatibility in transformations to and from FHIR. The [https://www.hl7.nl/wiki/index.php?title=DatatypesR1:II Netherlands HL7v3 datatype II] also defines additional restrictions on the maximum length of both <code>@root</code> and <code>@extension</code> (equivalent to respectively {{fhir|.system}} and {{fhir|.value}} in FHIR). For the same compatibility reasons, {{fhir|.system}} SHALL have a maximum of 128 characters and {{fhir|.value}} SHALL have a maximum of 64 characters. | ||
− | Systems that encounter or resolve references, either logical or literal, in resources they receive, SHALL NOT rewrite these references to a copy of these resources (with {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/ext-CopyIndicator|nictiz.fhir.nl.r4.nl-core|pkgVersion= | + | Systems that encounter or resolve references, either logical or literal, in resources they receive, SHALL NOT rewrite these references to a copy of these resources (with {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/ext-CopyIndicator|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2}} present) they may store. This means that [https://hl7.org/fhir/r4/references.html relative literal references] may need to be rewritten to absolute ones. This also goes for [[FHIR:V1.0_FHIR_IG_R4#Including_.22secondary.22_resources_when_sending_information|included secondary resources in transactions]]. |
==FHIR Profile Package== | ==FHIR Profile Package== | ||
All use cases in this specification depend on the same set of FHIR profiles. The table below lists profiles that represent applicable zibs for laboratory result information exchange. | All use cases in this specification depend on the same set of FHIR profiles. The table below lists profiles that represent applicable zibs for laboratory result information exchange. | ||
− | {{NoteBoxNictizR4Package|p1=nictiz.fhir.nl.r4.labexchange|v1=3.0.0-beta.1|p2=nictiz.fhir.nl.r4.zib2020| | + | {{NoteBoxNictizR4Package|p1=nictiz.fhir.nl.r4.labexchange|v1=3.0.0-beta.1|p2=nictiz.fhir.nl.r4.nl-core|v2=0.6.0-beta.2|p3=nictiz.fhir.nl.r4.zib2020|v3=0.6.0-beta.2}} |
{| class="wikitable" style="min-width:90%;" | {| class="wikitable" style="min-width:90%;" | ||
Regel 79: | Regel 79: | ||
|style="min-width:150px;"|Based on zib (EN) | |style="min-width:150px;"|Based on zib (EN) | ||
|- | |- | ||
− | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4. | + | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult}} |
| Observation | | Observation | ||
| rowspan="3" | LaboratoryResult | | rowspan="3" | LaboratoryResult | ||
|- | |- | ||
− | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen|nictiz.fhir.nl.r4. | + | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult.Specimen}} |
| Specimen | | Specimen | ||
|- | |- | ||
− | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen.Source|nictiz.fhir.nl.r4. | + | | {{Simplifier|http://nictiz.nl/fhir/StructureDefinition/nl-core-LaboratoryTestResult.Specimen.Source|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-LaboratoryTestResult.Specimen.Source}} |
| Device | | Device | ||
|- | |- | ||
− | | {{Simplifier|http://fhir.nl/fhir/StructureDefinition/nl-core-patient|nictiz.fhir.nl.r4. | + | | {{Simplifier|http://fhir.nl/fhir/StructureDefinition/nl-core-patient|nictiz.fhir.nl.r4.nl-core|pkgVersion=0.6.0-beta.2|title=nl-core-Patient}} |
|Patient | |Patient | ||
|Patient | |Patient | ||
|- | |- | ||
− | | {{Simplifier|http://fhir.nl/fhir/StructureDefinition/nl-core-HealthcareProvider-Organization | + | | {{Simplifier|http://fhir.nl/fhir/StructureDefinition/nl-core-HealthcareProvider-Organization|nictiz.fhir.nl.r4.nl-core|title=nl-core-HealthcareProvider-Organization}} |
|Organization | |Organization | ||
|HealthcareProvider | |HealthcareProvider | ||
Regel 115: | Regel 115: | ||
| rowspan="2" | LIS | | rowspan="2" | LIS | ||
| rowspan="2" | Laboratory information system | | rowspan="2" | Laboratory information system | ||
− | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-RetrieveServe|nictiz.fhir.nl.r4. | + | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-RetrieveServe|nictiz.fhir.nl.r4.labexchange|pkgVersion=3.0.0-beta.1|title=CapabilityStatement: Lab2Healthcare-Results-RetrieveServe}} |
| Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A LIS is only expected to serve results in the context of Lab2zorg. | | Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A LIS is only expected to serve results in the context of Lab2zorg. | ||
|- | |- | ||
− | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-SendReceive|nictiz.fhir.nl.r4. | + | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-SendReceive|nictiz.fhir.nl.r4.labexchange|pkgVersion=3.0.0-beta.1|title=CapabilityStatement: Lab2Healthcare-Results-SendReceive}} |
| Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A LIS is only expected to send results in the context of Lab2zorg. | | Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A LIS is only expected to send results in the context of Lab2zorg. | ||
|- | |- | ||
Regel 125: | Regel 125: | ||
| rowspan="2" | XIS | | rowspan="2" | XIS | ||
| rowspan="2" | (Any) Healthcare information system | | rowspan="2" | (Any) Healthcare information system | ||
− | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-RetrieveServe|nictiz.fhir.nl.r4. | + | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-RetrieveServe|nictiz.fhir.nl.r4.labexchange|pkgVersion=3.0.0-beta.1|title=CapabilityStatement: Lab2Healthcare-Results-RetrieveServe}} |
− | | Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A XIS may both retrieve | + | | Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A XIS may both retrieve results and serve copies of results in the context of Lab2zorg. |
|- | |- | ||
− | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-SendReceive|nictiz.fhir.nl.r4. | + | | [[Bestand: Verwijzing.png| 20px]] {{Simplifier|http://nictiz.nl/fhir/CapabilityStatement/Lab2Healthcare-Results-SendReceive|nictiz.fhir.nl.r4.labexchange|pkgVersion=3.0.0-beta.1|title=CapabilityStatement: Lab2Healthcare-Results-SendReceive}} |
| Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A XIS may both send copies of results and receive (copies of) results in the context of Lab2zorg. | | Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A XIS may both send copies of results and receive (copies of) results in the context of Lab2zorg. | ||
|} | |} | ||
Regel 146: | Regel 146: | ||
* Get results on/before/after date X for one or more specific {{fhir|Observation.code}}s | * Get results on/before/after date X for one or more specific {{fhir|Observation.code}}s | ||
− | Each server SHALL perform filtering based on the patient and request context, so only the records are returned that the requesting party is authorized for. Example expectations are that any ordering provider will have access to results related to his orders, and any requesting party interested in medication related results only has access to those. | + | Each server SHALL perform filtering based on the patient, and results associated with the request context and patient identification search parameters, so only the records are returned that the requesting party is authorized for. Example expectations are that any ordering provider will have access to results related to his orders, and any requesting party interested in medication related results only has access to those. |
A special word of caution about volume. It has been proven hard to impossible to define an optimum on how much history should be supported. For example some genetic tests are done once at age 15, and are still valid at age 80. Returning ''all'' results for someone age 80 could take an enormous toll on both server and client and is seldom relevant. Clients are therefore encouraged to be as specific as possible, by using both {{fhir|code}} and/or {{fhir|date}} and/or [https://www.hl7.org/fhir/search.html#count {{fhir|_count}}] whenever possible. Servers SHOULD implement [https://www.hl7.org/fhir/search.html#count {{fhir|_count}}], and SHOULD implement an OperationOutcome that informs the client of a partial result set when the total number exceeds what a server will handle. | A special word of caution about volume. It has been proven hard to impossible to define an optimum on how much history should be supported. For example some genetic tests are done once at age 15, and are still valid at age 80. Returning ''all'' results for someone age 80 could take an enormous toll on both server and client and is seldom relevant. Clients are therefore encouraged to be as specific as possible, by using both {{fhir|code}} and/or {{fhir|date}} and/or [https://www.hl7.org/fhir/search.html#count {{fhir|_count}}] whenever possible. Servers SHOULD implement [https://www.hl7.org/fhir/search.html#count {{fhir|_count}}], and SHOULD implement an OperationOutcome that informs the client of a partial result set when the total number exceeds what a server will handle. | ||
Regel 157: | Regel 157: | ||
! style="text-align:left;"| '''Role''' | ! style="text-align:left;"| '''Role''' | ||
|- | |- | ||
− | |style="background-color: white;vertical-align:top;" rowspan="2"|Retrieve | + | |style="background-color: white;vertical-align:top;" rowspan="2"|Retrieve laboratory results (PULL) |
− | |style="background-color: white;vertical-align:top;"|Retrieve laboratory results | + | |style="background-color: white;vertical-align:top;"|Retrieve laboratory results request |
|style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatRaadplegend Systeem [LAB-LRR] | |style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatRaadplegend Systeem [LAB-LRR] | ||
|style="background-color: white;vertical-align:top;"|Send a query to the LAB-LRB to retrieve lab results | |style="background-color: white;vertical-align:top;"|Send a query to the LAB-LRB to retrieve lab results | ||
|- | |- | ||
− | |style="background-color: white;vertical-align:top;"| | + | |style="background-color: white;vertical-align:top;"|Retrieve laboratory results response |
|style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatBeschikbaarstellend Systeem [LAB-LRB] | |style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatBeschikbaarstellend Systeem [LAB-LRB] | ||
|style="background-color: white;vertical-align:top;"|Respond to a query from the LAB-LRR to retrieve lab results | |style="background-color: white;vertical-align:top;"|Respond to a query from the LAB-LRR to retrieve lab results | ||
Regel 378: | Regel 378: | ||
! style="text-align:left;"| '''Role''' | ! style="text-align:left;"| '''Role''' | ||
|- | |- | ||
− | |style="background-color: white;vertical-align:top;" rowspan="2"|Send | + | |style="background-color: white;vertical-align:top;" rowspan="2"|Send laboratory results (PUSH) |
|style="background-color: white;vertical-align:top;"|Send laboratory results | |style="background-color: white;vertical-align:top;"|Send laboratory results | ||
|style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatSturend Systeem [LAB-LRS] | |style="background-color: white;vertical-align:top;"|LaboratoriumresultaatResultaatSturend Systeem [LAB-LRS] | ||
Regel 454: | Regel 454: | ||
The XIS (LAB-LRO) may be unable to accept a Bundle due to errors or because of technical or business rules. Refer to the [[FHIR:V1.0_FHIR_IG_R4#Handling_errors#Handling_errors|Handling Errors section]] in the FHIR IG for more information. | The XIS (LAB-LRO) may be unable to accept a Bundle due to errors or because of technical or business rules. Refer to the [[FHIR:V1.0_FHIR_IG_R4#Handling_errors#Handling_errors|Handling Errors section]] in the FHIR IG for more information. | ||
− | + | ==Health professional reports result leading into a notification "new lab results" for subscribed healthcare professional(s)== | |
− | ''This use case will be added in a future release.'' | + | ''This use case will be added in a future release.'' |
Huidige versie van 26 aug 2022 om 12:39
This article or section is in the middle of an expansion or major restructuring and is not yet ready for use. |
1 Introduction
This page describes the technical design of Lab2zorg (Lab2healthcare) as a subset of the Information standard lab exchange. This technical specification is implementer centric and complements the functional design. This page uses various terms as defined in the glossary (Dutch: Begrippenlijst). This page implements general principles applicable to FHIR as outlined by a central FHIR IG for R4. Please make sure you familiarize yourself with both the functional design and the FHIR IG for full appreciation of the context of this page.
Many laboratory results have important relationships to other observations and need to be grouped together. The FHIR specification defines several structures to do this:
Observation
and one or moreObservation.hasMember
elements.- Each
.hasMember
element references another Observation and the Observation with.hasMember
elements thus serves as grouper for all Observations it references. Each Observation can be accessed individually. This is useful for panels and/or batteries of tests. This is what NL-CM:13.1.3 LaboratoryTest maps into. - Note that while FHIR Observation also allows references to resource types MolecularSequence and QuestionnaireResponse, there is no identified use case for that at time of writing.
- An Observation without
.hasMember
elements is expected to be an individual result and has a value when one can be/is determined.
- Each
Observation
and one or moreObservation.derivedFrom
elements.- Each
.derivedFrom
element references another Observation references related measurements the observation is made from. This is what NL-CM:13.1.33 RelatedResult::LaboratoryTestResult maps into. - Note that while FHIR Observation also allows references to resource types DocumentReference, ImagingStudy, Media, QuestionnaireResponse and MolecularSequence, there is no identified use case for those at time of writing.
- Each
Observation
and one or moreObservation.component
elements..component
s of an Observation are not accessible individually. Whenever you access the Observation, you also access all its components. This is mostly useful when certain context is provided around the result. For lab observations this is expected to be less common. An example outside of the lab realm could be BloodPressure where systolic, diastolic, and cuff size are all in one Observation with 3 components.
This FHIR implementation guide assumes that systems (XIS) are able to make a connection to the right systems. It does not provide information on finding the right XIS nor does it provide information about security including authentication and authorization. Finding the right system, and security aspects of the connection, are dealt with by the infrastructure. Any relevant infrastructure is expected to have a framework in place to deal with this. The only assumption/requirement for an infrastructure is that this allows RESTful FHIR-based exchange as specified here.
2 Boundaries and relationships
2.1 Mappings between profiles and data set
Each transaction starts with links to the functional definition in an ART-DECOR publication and references one or several FHIR profiles. Where the functional definition contains all specific data elements for the transaction (prefixed with ‘lu-concept-v2’), the FHIR profiles only contain a mapping to these data elements that do not have a dependency on a zib counterpart. For example: ‘lu-concept-v2-4266’ (Specimen) has a relation with the zib element with id ‘NL-CM-13.1.2’, therefore no mapping with ‘lu-concept-v2-4266’ can be found in the profiles. On the other hand, ‘lu-concept-v2-4296’ (LaboratoryResultIdentification) has no relation with a zib element, therefore a mapping can be found in the relevant FHIR profile.
Because of open world modeling, the cardinality of elements in the FHIR profiles can be less strict than the cardinalities in the ART-DECOR transactions. However, the latter cardinality is leading when it comes to exchanging building blocks in the context of a specific transaction. For example: in the nl-core-LaboratoryTestResult profile, .performer
has a core cardinality of 0..*, while in both the 'Send laboratory results' and ‘Serve laboratory results’ ART-DECOR transactions, the Performer element has a cardinality of 1..1 M. Therefore, .performer
is expected to be filled with either a reference to an nl-core-HealthcareProvider-Organization resource.
Each transaction contains a Patient building block with cardinality 1..1 M. This patient is the subject of all other building blocks in the transaction, although no explicit relation exists in the data set. Therefore, a reference to a Patient resource conforming to the nl-core-Patient profile is expected in .subject
of each FHIR instance of each building block.
The single zib LaboratoryTestResult consists of objects that in FHIR are represented using different (instances of) resources:
- NL-CM:13.1.1 LaboratoryTestResult maps into profile nl-core-LaboratoryTestResult
Observation
and has.hasMember
relationships with individual NL-CM:13.1.3 LaboratoryTests.- Note that this level only exists when LaboratoryTestResult contains NL-CM:13.1.4 PanelOrBattery. The concepts NL-CM:13.1.7 ResultType, NL-CM:13.1.5 Comment, and NL-CM:13.1.6 ResultStatus are not mapped in the absence of NL-CM:13.1.4 PanelOrBattery.
- NL-CM:13.1.3 LaboratoryTest also maps into profile nl-core-LaboratoryTestResult
Observation
and MAY be referenced by a differentObservation.hasMember
containing NL-CM:13.1.1 LaboratoryTestResult. - NL-CM:13.1.2 Specimen maps into profile nl-core-LaboratoryTestResult.Specimen
Specimen
.- Note that there could be multiple instances of Specimen: one for the main NL-CM:13.1.16 SpecimenMaterial, and one per isolated NL-CM:13.1.22 Microorganism with a
.parent
relationship to the main specimen.
- Note that there could be multiple instances of Specimen: one for the main NL-CM:13.1.16 SpecimenMaterial, and one per isolated NL-CM:13.1.22 Microorganism with a
- NL-CM:13.1.29 SpecimenSource maps into profile nl-core-LaboratoryTestResult.Specimen.Source
Device
. This is a special case where the specimen did not come from the Patient directly.
2.2 Patient identification
This implementation guide assumes that the client system is able to make a connection to the right server that contains the patient's information. It does not provide information on finding the right server nor does it provide information about security. Moreover, each transaction is performed in the context of a specific (authenticated) patient, whose context might have been established using the authentication mechanisms described in external specifications such as the MedMij 'Afsprakenstelsel' or through the usage of search parameters for patient identification. Each server is required to perform filtering based on the patient associated with the context for the request or based on the patient identification search parameters, so only the records associated with the authenticated patient are returned.
When patient identification requires the use of search parameters, the following search parameters SHALL be supported:
- Patient:
identifier
- Observation:
patient
An example of a request that retrieves all Observation resources of a patient with a fake BSN of 11122233:
GET [base]/Observation?patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333
2.3 Resource identification
All profiles used within the information standard contain .identifier
elements with a cardinality of 0..* because of open world modeling. However, all ART-DECOR transactions referenced within this IG assign a 1..1 R cardinality, meaning a stable identifier SHOULD be provided, or the DataAbsentReason extension if a value is missing. Identifiers SHALL contain both a .system
and a .value
.
Because in HL7v3 (CDA) an identifier can only be composed using OIDs, the .system
SHALL be an OID to accommodate compatibility in transformations to and from FHIR. The Netherlands HL7v3 datatype II also defines additional restrictions on the maximum length of both @root
and @extension
(equivalent to respectively .system
and .value
in FHIR). For the same compatibility reasons, .system
SHALL have a maximum of 128 characters and .value
SHALL have a maximum of 64 characters.
Systems that encounter or resolve references, either logical or literal, in resources they receive, SHALL NOT rewrite these references to a copy of these resources (with http://nictiz.nl/fhir/StructureDefinition/ext-CopyIndicator present) they may store. This means that relative literal references may need to be rewritten to absolute ones. This also goes for included secondary resources in transactions.
2.4 FHIR Profile Package
All use cases in this specification depend on the same set of FHIR profiles. The table below lists profiles that represent applicable zibs for laboratory result information exchange.
Nictiz uses the FHIR Packaging mechanism. This conveniently bundles all profiles, terminology, example material and other conformance resources you need into a single archive, which can be downloaded or installed using the appropriate FHIR tooling. This version of the information standard uses the following packages:
Note: packages use Semantic Versioning. Other versions can be used at will as long as they have the same major.minor number or a minor number higher than the stated version. |
FHIR Profile | FHIR Resource | Based on zib (EN) |
nl-core-LaboratoryTestResult | Observation | LaboratoryResult |
nl-core-LaboratoryTestResult.Specimen | Specimen | |
nl-core-LaboratoryTestResult.Specimen.Source | Device | |
nl-core-Patient | Patient | Patient |
nl-core-HealthcareProvider-Organization | Organization | HealthcareProvider |
3 Actors involved
Persons | Systems | FHIR Capability Statements | |||
---|---|---|---|---|---|
Name | Description | Name | Description | Name | Description |
Lab Professional | The user of a LIS | LIS | Laboratory information system | CapabilityStatement: Lab2Healthcare-Results-RetrieveServe | Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A LIS is only expected to serve results in the context of Lab2zorg. |
CapabilityStatement: Lab2Healthcare-Results-SendReceive | Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A LIS is only expected to send results in the context of Lab2zorg. | ||||
Healthcare professional | The user of a XIS | XIS | (Any) Healthcare information system | CapabilityStatement: Lab2Healthcare-Results-RetrieveServe | Retrieve [LAB-LRR]/serve [LAB-LRB] lab results requirements. A XIS may both retrieve results and serve copies of results in the context of Lab2zorg. |
CapabilityStatement: Lab2Healthcare-Results-SendReceive | Send [LAB-LRS]/receive [LAB-LRO] lab results requirements. A XIS may both send copies of results and receive (copies of) results in the context of Lab2zorg. |
4 Use cases
4.1 Health professional orders lab tests and receives results
This use case will be added in a future release.
4.2 Health professional retrieves lab results
4.2.1 Introduction
Healthcare professionals need to be able to retrieve laboratory results directly from a lab (LIS) or a secondary healthcare provider (XIS). Different healthcare professionals may have different needs and/or authorizations. The core FHIR specification offers support for a lot of use cases. This specification only outlines options for the identified scope and associated minimal expectations. As such it is not intended to be limiting to said expectations. Servers SHALL use the CapabilityStatement to advertise their implementation and clients SHOULD use this as means to discover the servers capabilities as per the FHIR specification, as well as publish their own capabilities. [FHIR RESTful] / [CapabilityStatement].
The identified use cases within the scope of this implementation guide are very broad:
- Get latest X results for one or more specific
Observation.code
s - Get latest X results for any
Observation.code
s - Get results on/before/after date X
- Get results on/before/after date X for one or more specific
Observation.code
s
Each server SHALL perform filtering based on the patient, and results associated with the request context and patient identification search parameters, so only the records are returned that the requesting party is authorized for. Example expectations are that any ordering provider will have access to results related to his orders, and any requesting party interested in medication related results only has access to those.
A special word of caution about volume. It has been proven hard to impossible to define an optimum on how much history should be supported. For example some genetic tests are done once at age 15, and are still valid at age 80. Returning all results for someone age 80 could take an enormous toll on both server and client and is seldom relevant. Clients are therefore encouraged to be as specific as possible, by using both code
and/or date
and/or _count
whenever possible. Servers SHOULD implement _count
, and SHOULD implement an OperationOutcome that informs the client of a partial result set when the total number exceeds what a server will handle.
4.2.2 Actors
Transaction group | Transaction | Actor | Role |
---|---|---|---|
Retrieve laboratory results (PULL) | Retrieve laboratory results request | LaboratoriumresultaatResultaatRaadplegend Systeem [LAB-LRR] | Send a query to the LAB-LRB to retrieve lab results |
Retrieve laboratory results response | LaboratoriumresultaatResultaatBeschikbaarstellend Systeem [LAB-LRB] | Respond to a query from the LAB-LRR to retrieve lab results |
4.2.3 Invocations
4.2.3.1 LAB-LRR: request message
The request message represents an HTTP GET parameterized query from the XIS (LAB-LRR) to the XIS/LIS (LAB-LRB).
4.2.3.1.1 Trigger events
When the healthcare professional wants to obtain laboratory results, it issues a retrieve laboratory results request message.
4.2.3.1.2 Message semantics
The XIS (LAB-LRR) executes an HTTP GET conforming to the FHIR RESTful and search specification against the XIS/LIS's Observation endpoint.
- Laboratory results are all under the
.category
observation, using query parametercategory
as token. - Requesting data for a specific
.subject
is done using query parameterpatient
as reference, or on some network infrastructures with an authorization token. The FHIR query parameter type reference can take on many forms.- If you know what the
Patient.id
is, e.g. from previous interactions with the same endpoint, you may use:patient=[id]
patient=[type]/[id]
patient=[url]
- If you don't know what the
Patient.id
is, but you know thePatient.identifier
, e.g. the Burgerservicenummer (BSN), you may use:patient:identifier=[system]|[value]
- If you know what the
- Requesting laboratory results of a specific type is done using query parameter
code
as token. - Requesting laboratory results of a specific date (range) is done using query parameter
date
as token.
Basic query syntax
GET [base]/Observation?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory{&patient=Patient/[id] | &patient:identifier=[system]|[value]}{&[parameter(s)]&_include=[resource(s)]}
Examples
Parameter values have not been uri escaped in these examples for readability. This is likely necessary in practice.
Get all lab results of type 14683-7 (LOINC) for patient with BSN 111222333 |
---|
GET [base]/Observation?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7 |
Get all lab results of type 14683-7 (LOINC) for patient with BSN 111222333 since March 12, 2022 |
---|
GET [base]/Observation?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7&date=gt2022-03-12 |
Get all lab results of type 14683-7 (LOINC) for patient with BSN 111222333 since March 12, 2022 but before June 7, 2022 |
---|
GET [base]/Observation?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7&date=gt2022-03-12&date=lt2022-06-07 |
Get all lab results of type 14683-7 (LOINC) and/or 3583 (NHG) for patient with BSN 111222333 |
---|
GET [base]/Observation?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7,https://referentiemodel.nhg.org/tabellen/nhg-tabel-45-diagnostische-bepalingen|3583 |
Get latest lab result of type 14683-7 (LOINC) for patient with BSN 111222333 |
---|
GET [base]/Observation/$lastn?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7 |
Get latest 5 lab results of type 14683-7 (LOINC) for patient with BSN 111222333 |
---|
GET [base]/Observation/$lastn?max=5&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7 |
Get latest lab result of any type for patient with BSN 111222333 |
---|
GET [base]/Observation/$lastn?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333 |
Query parameters overview
Servers SHALL at minimum support all stated parameters and modifiers, and MAY support additional parameters and modifiers. Clients SHALL support required parameters, and MAY support optional parameters.
category
- token - 1..1 required - fixed value http://terminology.hl7.org/CodeSystem/observation-category|laboratorypatient
- token - 0..1 conditional - required if not solved using an alternative method like an authorization token- Modifier
:identifier
- 0..1 optional - required when searching by identifier
- Modifier
code
- token - 0..1 optionaldate
- date - 0..1 optional- Prefix
eq
- 0..1 optional - required when searching for results with.effective
on exact date - Prefix
lt
- 0..1 optional - required when searching for results with.effective
before date - Prefix
le
- 0..1 optional - required when searching for results with.effective
on or before date - Prefix
gt
- 0..1 optional - required when searching for results with.effective
after date - Prefix
ge
- 0..1 optional - required when searching for results with.effective
on or after date
- Prefix
_count
- positiveInt - 0..1 optional_include
- reference - 0..* optional - useful for request to include secondary related resources, e.g.:_include=Observation:patient,Observation:performer,Observation:has-member,Observation:specimen
- Note that servers MAY, depending on their read capabilities, choose to implement inclusion of resources regardless of a client requesting this to satisfy the generic requirement that references SHALL be resolvable.
Operations
lastn
- shortcut FHIR core operation for getting the latest X results of specified types, or 'any' type- Parameter
max
- positiveInt - optional - default ismax=1
- Parameter
4.2.3.1.2.1 Expected actions
The XIS/LIS (LAB-LRB) SHALL process the query to retrieve laboratory results.
4.2.3.2 LAB-LRB: response message
The XIS/LIS (LAB-LRB) returns an HTTP Status code appropriate to the processing as well as a FHIR Bundle including the matching information. Refer to the generic FHIR IG for more information on handling errors and status codes. Not finding a match based on stated parameters does not constitute an error.
4.2.3.2.1 Trigger events
The XIS/LIS (LAB-LRB) completed the processing of the retrieve laboratory results request message.
4.2.3.2.2 Message semantics
The XIS/LIS (LAB-LRB) SHALL process the request and, unless an error is found, respond with a Bundle resource of type searchset. Each Observation matching the request SHALL be marked with .entry.search.mode
=match. Each otherwise included resource SHALL be marked with .entry.search.mode
=include. If the searchset bundle contains less matching resources than the actual total set, then:
- the
Bundle.link
that holds the self link, SHOULD include the_count
parameter to inform the client of what max was applied - an OperationOutcome SHOULD be included marked with
.entry.search.mode
=outcome.
The resources in the response Bundle SHALL be a valid instance of their stated profile. All resources SHALL include their related profile canonical URL in the .meta.profile
element in order to show compliance. The exception is the OperationOutcome resource for which there is no profile in this specification.
Example searchset Bundle
XML contents for searchset Bundle |
---|
<Bundle xmlns="http://hl7.org/fhir">
<id value="1"/>
<type value="searchset"/>
<total value="3"/>
<link>
<relation value="self"/>
<url value="http://example.org/fhir?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory&patient:identifier=http://fhir.nl/fhir/NamingSystem/bsn|111222333&code=http://loinc.org|14683-7"/>
</link>
<entry>
<fullUrl value="https://example.org/fhir/Observation/1"/>
<resource>
<Observation>
<!-- -->
</Observation>
</resource>
<search>
<mode value="match"/>
</search>
</entry>
<entry>
<fullUrl value="https://example.org/fhir/Observation/2"/>
<resource>
<Observation>
<!-- -->
</Observation>
</resource>
<search>
<mode value="match"/>
</search>
</entry>
<entry>
<fullUrl value="https://example.org/fhir/Observation/3"/>
<resource>
<resource>
<Observation>
<!-- -->
</Observation>
</resource>
</resource>
<search>
<mode value="match"/>
</search>
</entry>
<entry>
<fullUrl value="https://example.org/fhir/Specimen/1"/>
<resource>
<Specimen>
<!-- -->
</Specimen>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
<entry>
<fullUrl value="https://example.org/fhir/Patient/1"/>
<resource>
<Patient>
<!-- -->
</Patient>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
<entry>
<fullUrl value="https://example.org/fhir/Organization/1"/>
<resource>
<Organization>
<!-- -->
</Organization>
</resource>
<search>
<mode value="include"/>
</search>
</entry>
</Bundle>
|
Example OperationOutcome
XML contents for OperationOutcome |
---|
<OperationOutcome xmlns="http://hl7.org/fhir">
<id value="size-exceeded-1"/>
<issue>
<severity value="warning"/>
<code value="too-costly"/>
<details>
<text value="Resultaat was 3000, wat meer is dan het maximum van 1000"/>
</details>
</issue>
</OperationOutcome>
|
4.2.3.2.3 LAB-LRR: Expected actions
The XIS/LIS (LAB-LRR) SHALL process the response Bundle in accordance with the intentions of the trigger event that caused the retrieve. Actions may include discrete rendering on screen or in context with other information, triggering alerts on trends, ordering of (other) tests and more.
4.3 Health professional sends lab results to other health professional
4.3.1 Introduction
The functional design distinguishes two use cases where lab results may be sent with something else or separate. The process of 'sending' things in FHIR works by means of a RESTful 'create' action. You could create a single Observation on another system using POST Observation
and the appropriate Observation in the request body. When you have multiple Observations to create, you could do that for every single Observation, or by means of a Bundle with all resources. This same Bundle approach works for one Observation too.
The added benefit of a Bundle lies in having a solution for all other resources you may want to send, e.g. MedicationRequest, and referenced resources like Patient, PractitionerRole, Practitioner and Organization. Sending the Observation without the resources it references would only work if the receiving server can resolve those. They should then already exist on that server, with references to them or they should be accessible on the source. Without access to the references in the Observation, the target server may not know which patient is involved or what lab this result came from.
4.3.2 Actors
Transaction group | Transaction | Actor | Role |
---|---|---|---|
Send laboratory results (PUSH) | Send laboratory results | LaboratoriumresultaatResultaatSturend Systeem [LAB-LRS] | Send lab results to the LAB-LRO |
Receive laboratory results | LaboratoriumresultaatResultaatOntvangend Systeem [LAB-LRO] | Respond to received lab results from the LAB-LRS |
4.3.3 Invocations
4.3.3.1 LAB-LRS: request message
The XIS/LIS (LAB-LRS) sends lab results using the HTTP POST method on the target XIS's (LAB-LRO) base. Note that lab results may or may not be sent in tandem with other resources like MedicationRequest. The same principles apply with or without these other resources. The server can only process the incoming request correctly if it understands what is being sent which includes being able to resolve references.
4.3.3.1.1 Trigger Events
This message is invoked when the XIS needs to send one or more laboratory results to another XIS.
4.3.3.1.2 Message Semantics
Because sending laboratory results will most likely consist of multiple Observations, a transaction interaction is used. This allows for creating a set of resources in a single interaction and makes it possible to include referenced secondary resources if needed.
A transaction interaction is performed by an HTTP POST command as shown:
POST [base]
The body of the post submission is a Bundle with Bundle.type
=transaction. Each entry carries request details (Bundle.entry.request
) that provides the HTTP details of the action in order to inform the system processing the transaction of what to do for the entry. (Note: .request
SHALL be present, even for the resources which aren't Observations. See the overarching principles for more information.)
Identification
Resources SHALL have a stable identifier in the .identifier
element for all resources if such an identifier exists in the underlying data. Not all data, like individual results, are currently known to have identifiers in all source systems, but when they exist they are essential and where they do not exist yet they SHOULD be considered. Having stable identification is essential in detection of duplicates and potential clinical decision making issues deriving from duplicates. For more information on dealing with identifiers, see the general FHIR IG.
Read more
The laboratory result data sent to the XIS SHALL conform to the matching profile(s) listed in the profile table. That table contains profiles that represent applicable zibs for laboratory result information exchange.
4.3.3.1.2.1 Expected Actions
On receipt of the submission, the XIS (LAB-LRO) SHALL:
- process all contained requests successfully or process nothing.
- process creation of or updating all Observation resources.
- Updating might be in order e.g. when corrections are sent or when previously pending tests have been updated with results.
- match Patient, Practitioner(Role), Organization to pre-existing resources on its server.
- The server MAY update pre-existing information with the incoming information.
- The server MAY keep its pre-existing matching resources as-is.
- The server SHALL create new resources if no matching resource is found (unknown patient, new physician in otherwise known organization, etc.).
- decide if any available Specimen and/or Device resources are relevant.
- If the server decides to ignore Specimen or Device information, it SHALL not keep the references to them.
- respond using HTTP 200 and a Bundle with detail in case of success. See FHIR IG Handling Errors for response options in case of errors.
- Note that the response Bundle with type transaction-response SHALL be specific about how the server handled the request Bundle.
4.3.3.2 LAB-LRO: response message
The XIS (LAB-LRO) returns an HTTP Status code appropriate to the processing outcome and returns a Bundle with Bundle.type
=batch-response, that contains one entry for each entry in the request, in the same order, with the outcome of processing the entry.
4.3.3.2.1 Trigger Events
The XIS (LAB-LRO) completed processing of the send laboratory results message.
4.3.3.2.2 Message Semantics
The XIS (LAB-LRO) SHALL return a Bundle with Bundle.type
=batch-response that contains one entry for each entry in the request, in the same order, with the outcome of processing the entry.
A client may use the returned Bundle to track the outcomes of processing the entry, and the identities assigned to the resources by the server. Each entry element SHALL contain a response element which details the outcome of processing the entry - the HTTP status code, and the location and ETag
header values, which are used for identifying and versioning the resources. In addition, a resource may be included in the entry, as specified by the Prefer
header sent by the LAB-LRS.
Read more:
4.3.3.2.3 Expected Actions
The XIS/LIS (LAB-LRS) processes the results according to application-defined rules. The most basic of those rules would include marking the transaction as sent/processed successfully or flag a need for action like resending or contacting the LAB-LRO.
4.3.3.2.4 Handling Errors
The XIS (LAB-LRO) may be unable to accept a Bundle due to errors or because of technical or business rules. Refer to the Handling Errors section in the FHIR IG for more information.
4.4 Health professional reports result leading into a notification "new lab results" for subscribed healthcare professional(s)
This use case will be added in a future release.