Boundaries and Relationships

Diagram of functional layering

The below diagram offers an overview of the layering of CBBs. A description of the diagram and it's three used colors:

  • The blue boxes represent projects that form the basis for this implementation guide. More information is given in the general guidance page of the CBB implementation guide.
  • The green box indicates this implementation guide that contains all the definitions for exchanging LaboratoryTestResult.
  • All the grey boxes represent projects and use cases based on the CBBs and/or the LaboratoryTestResult specs.



Boundaries and Relationships

Laboratory examination is an essential part of healthcare. Laboratory results serve a variety of goals, such as determining diseases and correct medication administration doses. Information standards describe how laboratory results can be exchanged safely and unambiguously between the relevant stakeholders. This implementation guide aims to establish this within the research domain of Sciensano. It has essential relations and differences with other (international) standards that may concern the implementer. Therefore, the following sections identify related standards and try to give a high-over view of similarities and differences with this implementation guide.

Netherlands

Nictiz maintains the information standard 'Labuitwisseling'. It specifies four domains, namely the exchange of LaboratoryTestResults between a laboratory organization and:

  • another laboratory organization,
  • a research center,
  • a healthcare organization,
  • the patient.

In the Netherlands, LaboratoryTestResult exchange happens primarily using HL7v2 and HL7v3. The development of FHIR implementation starts with the domains of the patient and healthcare organization.

  • Exchange with patients was the first described in FHIR and is wholly based on zibs. It is being used and implemented within the MedMij framework. The described scenario is based on a search/retrieve principle by the patient.
  • Exchange with healthcare organizations in FHIR is in active development. Although the functional design and zib-based data model have been published, the technical design based on FHIR is still in draft status. It defines both a scenario for sending and searching/retrieval of LaboratoryTestresults.

These 'Labuitwisseling' standards align well with this implementation guide, starting with the zibs as the base data model. The respective CBB and CBB-profile changelog describes the precise changes. Also, just like this implementation guide the focus is solely LaboratoryTestResults, and no DiagnosticReport is defined.

Belgium

In Belgium, the HL7 BE Laboratory WG Implementation Guide, published by eHealth Platform, aims to clarify the definition of the Belgian laboratory result. It concerns the construction of a laboratory report pertaining to a patient in the Belgian context. For many elements, the HL7 BE profiles are compatible with the CBB profiles defined in this guide, especially regarding guidance on referencing and (ReTaM) codes and values in the Observation resource. There are, however, also noteworthy differences:

  • The HL7 BE implementation guide does not contain a logical data model definition. It uses the profiles, in combination with MustSupport flags, and the guidance page to specify the focal information.
  • HL7 BE defines a report using the DiagnosticReport as the central resource. The DiagnosticReport functions as the 'organizer' of the report. It includes supporting resources such as the Media resource.
  • The document exchange paradigm requires the Composition resource to structure the document. This implementation guide does not specify an exchange paradigm or method yet.
  • Narratives must be set 'empty,' thereby encouraging (or trying to enforce) all information exchange to be structured. This implementation guide does not adjust the base FHIR definition for the narrative. It does, however, allow the narrative to be empty.
  • Performer information is mainly handled through the DiagnosticReport. A mandatory results interpreter (biologist) is defined that is not defined within the CBB profiles. In the CBB LaboratoryTestResult profile, the performer is a lab and represented in the `Observation.performer element. The PractitionerRole is not defined in the HL7 BE guide, but this resource is essential to fully communicate the CBB HealthProfessional information.

Some minor incompatibilities after testing the HL7 BE Laboratory examples against this implementation guide profiles:

  • All HumanName.given are invalid because of missing givenOrInitial extension, which is required by the CBB NameInformation profile. The extension is necessary to determine if the .given element contains a given name or an initial.
  • All Addresses are invalid because of a missing language extension. The language extension has a cardinality of 1..1, but the HL7 BE core profile makes it 0..1. (Raised a ticket - https://github.com/hl7-be/core/issues/31)

Germany

The German Medizininformatik Initiative has published the 'Modul Laborbefund Implementation Guide'. It contains an extensive logical information model which is also represented in FHIR. No exchange paradigm is defined yet. The language is German. Some noteworthy observations and differences:

  • A DiagnosticReport is defined.
  • Specimen information is not defined in FHIR on this level but may be described in use-case guides.
  • Observation.value[x] supports only datatypes Quantity (using mandatory UCUM) and CodeableConcept.
  • A ServiceRequest is defined but does not contain guidance for exchanging requester information.
  • Observation.performer is not specified. Instead, a mandatory Observation.identifier of a particular type needs to be present that contains a reference to the identifier assigning organization.
  • MustSupport flags are set.
  • Refers to International Patient Summary IG (IPS) for must-support definition and LOINC codes.

Other initiatives

Other (international) initiatives that use LaboratoryTestResults in some way. This list is far from extensive and may be enriched at a later moment.