HL7 Europe Laboratory Report
0.1.1 - trial-use 150

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## Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

### eHN Laboratory Guidelines (Informative)

Logical models representing the eHN Laboratory Guidelines. This is informative material.

A - Laboratory Report | Laboratory Report. eHN guideline model.
A.1.1, A.1.2 - Subject of care | Patient or Subject of care. Sections A.1.1 and A.1.2 of the eHN guideline.
A.1.3 - Health insurance and payment information | Health insurance and payment information. Section A1.3 of the eHN guideline.
A.1.4 - Information recipient | Information recipient (intended recipient or recipients of the report, additional recipients might be identified by the ordering party, e.g. GP, other specialist), if applicable. Section A1.4 of the eHN guideline.
A.1.5 - Author | Author (by whom the Laboratory result report or a subset of its results was authored). Section A1.5 of the eHN guideline.
A.1.6 - Legal authenticator | Legal authenticator (The person taking responsibility for the medical content of the document). Section A1.6 of the eHN guideline.
A.1.7 - Result validator | Result validator. Section A1.7 of the eHN guideline.
A.2, A.3 - Order | Order information and reason. Sections A.2 and A.3 of the eHN guideline.
A.4 - Specimen information | Specimen information. Section A4 of the eHN guideline.
A.5 - Results data elements | Results data elements. Section A5 of the eHN guideline.

### eHN Logical Model mappings (Informative)

Concept Maps describing how the data set specified by the eHN Laboratory Guidelines is supposed to be implemented by using this guide. Informative for this version of the guide.

A - Laboratory Report model to this guide | It shows how the Laboratory Report data set defined by the EU eHN guidelines is mapped into this guide.
A.1.1, A.1.2 - Subject of care model to this guide | It shows how the Subject data set defined by the EU eHN guidelines is mapped into this guide.
A.1.3 - Health insurance and payment information model to this guide | It shows how the A.1.3 - Health insurance and payment information data set defined by the EU eHN guidelines is mapped into this guide.
A.1.4 - Information recipient model to this guide | It shows how the A.1.4 - Information recipient data set defined by the EU eHN guidelines is mapped into this guide.
A.1.5 - Author model to this guide | It shows how the A.1.5 - Author data set defined by the EU eHN guidelines is mapped into this guide.
A.1.6 - Legal authenticator model to this guide | It shows how the A.1.6 - Legal authenticator data set defined by the EU eHN guidelines is mapped into this guide.
A.1.7 - Result validator model to this guide | It shows how the A.1.7 - Result validator data set defined by the EU eHN guidelines is mapped into this guide.
A.2, A.3 - Order model to this guide | It shows how the Order data set defined by the EU eHN guidelines is mapped into this guide.
A.4 - Specimen information model to this guide | It shows how the A.4 - Specimen information data set defined by the EU eHN guidelines is mapped into this guide.
A.5 - Results data elements model to this guide | It shows how the A.5 - Results data elements data set defined by the EU eHN guidelines is mapped into this guide.

### Actors and Obligations (Informative)

Actors and Obligations used to describe the Laboratory Report functional requirements for the specified data elements. Informative for this version of the guide.

Actor Laboratory Report Consumer | Laboratory Report Report Consumer: a system receiving/querying and using a Laboratory Report.
Actor Laboratory Report Creator | Laboratory Report Creator: a system generating and sending/providing a Laboratory Report to a Consumer or to a Repository for report storage and sharing.
Actor Laboratory Report Repository | Laboratory Report Report Repository: a system maintaining a copy of the received Laboratory Report, to store and make it available for the consumers.
Human Name Obligations | Specify the functional capabilities that the defined actors may, should or shall applied to the Human Name profile elements.
Observation Obligations | Specify the functional capabilities that the defined actors may, should or shall applied to the Observation profile elements.
Patient Obligations | Specify the functional capabilities that the defined actors may, should or shall applied to the Patient EU Lab profile elements.
ServiceRequest Obligations | Specify the functional capabilities that the defined actors may, should or shall applied to the ServiceRequest profile elements.
Specimen Obligations | Specify the functional capabilities that the defined actors may, should or shall applied to the Specimen profile elements.

### Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Body structure: Laboratory | This profile defines how to represent Body Structure in HL7 FHIR for the purpose of this guide.
Bundle: Laboratory Report | Clinical document used to represent a Laboratory Report for the scope of the HL7 Europe project.
Composition: Laboratory Report | Clinical document used to represent a Laboratory Report for the scope of the HL7 Europe project.
DiagnosticReport: Laboratory Report | DiagnosticReport used to represent an entry of a Laboratory Report, including its context, for the scope of the HL7 Europe project.
Observation Results: laboratory | This profile constrains the Observation resource to represent results produced by laboratory tests or panels/studies for the HL7 Europe project. This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and or a global interpretation by the producer of the study, in the comment element; and references the atomic results of the study as "has-member" child observations.
Patient: Animal | This profile defines how to represent an Animal as subject of care in FHIR for the purpose of this guide. This is used to identify the species when a specimen is collected from an animal
Patient: Person | This profile defines how to represent a human Patient in FHIR for the purpose of this guide. When the ips-pat-1 invariant is satisfied (Patient.name.given, Patient.name.family or Patient.name.text SHALL be present) then this profile complies with the IPS patient profile.
Practitioner: Laboratory Report | This profile defines how to represent Practitioners in FHIR for the purpose of the HL7 Europe project.
PractitionerRole: Laboratory Report | This profile defines how to represent Practitioners (with their roles) in FHIR for the purpose of the HL7 Europe project.
ServiceRequest: Laboratory Order | This profile defines how to represent an laboratory orders using the HL7 FHIR ServiceRequest for the purpose of this guide.
Specimen: Laboratory | This profile defines how to represent Specimens in HL7 FHIR for the purpose of this guide.
Substance: Specimen Additive Substance | This profile defines how to represent Specimen Additive Substances in HL7 FHIR for the purpose of this guide.

### Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

Address (EU) | This profile extends the Address data type to support streetname, housenumber and postal box.
HumanName (Eu) | This profile extends the HumanName data type for supporting multiple family names.
Quantity (Eu Lab) | This profile constrains the Quantity data type to use UCUM as the code system for units and optionally share measurement uncertainty
Ratio (Eu Lab) | This profile constrains the Ratio data type to use UCUM as the code system for units and optionally share measurement uncertainty

### Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Certified Reference Material: CodeableConcept | This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].
Certified Reference Material: Identifier | This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].
Device Laboratory Test Kit | This extension links this observation with the laboratory test kit used for this test. Usually only one laboratory test kit is referred
Document DiagnosticReport Reference | This extension provides a reference to the DiagnosticReport instance that is associated with this Composition.

### Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Body Structure Laterality | Body Structure site laterality qualifier. It indicates the body site laterality from which a laboratory specimen is collected. (based on SNOMED CT)
Body Structure Qualifier | Body Structure site qualifier. It indicates the body site qualifier from which a laboratory specimen is collected. (based on SNOMED CT)
Laboratory Certified Reference Material | List of the coded concepts describing the certified reference material used for the calibration, typically used when the unit of the result is UCUM [IU].
Laboratory Code | Laboratory observation codes. List of Laboratory observation codes derived from the LOINC and NPU code systems.
Laboratory Code: LOINC | Laboratory observation codes based on the LOINC code system.
Laboratory Code: NPU | Laboratory observation codes based on the NPU code system.
Laboratory Order | List of LOINC Laboratory codes of type 'Order' or 'Both. This value set is built upon the IPS value set 'Results Laboratory Observation - IPS'
Laboratory Report Types | Laboratory Report Types. This version includes only one code as suggested by the eHN guideline. Category can be used for filtering per study type or specialty.
Laboratory Specialty | Laboratory Specialties. Notes: Note 1: This value set is based on analysis of national coding practices in 8 European countries (AT, CZ, DE, FR, IE, IT, PT, SE) and agreed by involved lab experts as a common lab specialty value set. Note 2: Many European countries are using additional laboratory specialty types, which should be mapped towards this value set. Note 3: In case of documented need, this value set could be extended.
Laboratory Study Types | Laboratory Study Types Notes: Note 1:26436-6 (Laboratory studies) enables issuing a report putting together observations from multiple specialties (disciplines) in the same text block, allowing delivery of a global interpretation comment at the end of the text block that will be rendered at the end of the report. Note 2:Mycology and parasitology, as well as bacteriology, are part of the 18725-2 (Microbiology studies (set)) studies. Note 3:Virology MAY be included in 18725-2 (MICROBIOLOGY STUDIES) or 18727-8 (SEROLOGY STUDIES) or split between both study types, depending upon the Content Creator Actor’s choice.
Laboratory Techniques | Laboratory technique (method of measurement) used for the result measurement (based on SNOMED CT).
Specimen Additive | List of the specimen additives. Additives are commonly added to the vacutainer tubes to preserve the specimen for laboratory analysis
Specimen Container | List of the containers commonly used to collect specimens (e.g. urine, blood,..).
Specimen Types | Laboratory Specimen Types
Types of species | Types of animal species for non-human subjects

### Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Laboratory Code: example | List of local coded concepts used for supporting the examples defined in this guide.

### Terminology: Concept Maps

These define transformations to convert between codes by systems conforming with this implementation guide.

DiagnosticReport to Composition status | Proposed relationship between the statuses used in the DiagnosticReport resource and that used for the Composition.

### Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Bundle: Hepatitis Panel | Example of Laboratory Report (Bundle) including a Hepatitis Panel
Bundle: Microbiology Culture + Susceptibility | Example of Laboratory Report (Bundle) with Microbiology Culture plus Susceptibility Results
Bundle: MyHealth@EU Proof Of Concept | Example of Laboratory Report (Bundle) used in the MyHealth@EU Proof Of Concept.
Bundle: converted from CDA | Example of Laboratory Report (Bundle) converted from a CDA report
Bundle: two sections | Example of Laboratory Report (Bundle) including two sections with a single observations expressed in LOINC and with Czech national codes. Note: this example merges results from a Czech report example with header information from an Italian one, please do not focus on possible inconsistencies between these two parts.
Composition: example | Example of Composition conforming this guide.
DiagnosticReport: example | Example of DiagnosticReport conforming this guide.
Observation: Aerobic Culture example | Example of Aerobic Culture Observation conforming this guide.
Observation: Anaerobic Culture example | Example of Anaerobic Culture Observation conforming this guide.
Observation: Gram Staining example | Example of Gram Staining result Observation conforming this guide.
Observation: Gram-positive cocci example | Example of Gram-positive cocci in clusters by gram staining Observation conforming this guide.
Observation: Gram-positive cocci, observed quantity, example | Example of Gram-positive cocci in clusters by gram staining, observed quantity, Observation conforming this guide.
Observation: Leukocytes Presence example | Example of Leukocytes Presence by gram staining Observation conforming this guide.
Observation: Staphylococcus aureus Cephalothin susceptibility example | Example of Staphylococcus aureus Cephalothin susceptibility Observation conforming this guide.
Observation: Staphylococcus aureus Growth example | Example of Staphylococcus aureus Growth Observation conforming this guide.
Observation: Staphylococcus aureus Oxacillin susceptibility example | Example of Staphylococcus aureus Oxacillin susceptibility Observation conforming this guide.
Observation: Staphylococcus aureus Vancomycin susceptibility example | Example of Staphylococcus aureus Vancomycin susceptibility Observation conforming this guide.
Observation: Staphylococcus aureus identified example | Example of Staphylococcus aureus identified by Aerobe culture Observation conforming this guide.
Observation: Staphylococcus aureus levoFLOXacin susceptibility example | Example of Staphylococcus aureus levoFLOXacin susceptibility Observation conforming this guide.
Observation: Staphylococcus aureus susceptibility panel example | Example of Staphylococcus aureus susceptibility panel Observation conforming this guide.
Observation: certified reference material | Example of Observation with a concentration of insulin of 50 mIU/L, using as certified reference material https://www.nibsc.org/documents/ifu/66-304.pdf
Observation: ratio example | Example of Observation with ratio result
Patient: Dutch complete name | Example of Patient including a complete Dutch name.
Patient: animal example | Example of Patient resource used for indicating an animal (cat) conforming this guide.
Patient: example | Example of Patient conforming this guide.
Practitioner: example | Example of Practitioner conforming this guide.
PractitionerRole: example | Example of PractitionerRole conforming this guide.
ServiceRequest: example | Example of ServiceRequest conforming this guide.
Specimen: animal example | Example of Specimen collected from an animal.