HL7 Austria ELGA Laboratory Report R4 Implementation Guide
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HL7 Austria ELGA Laboratory Report R4 Implementation Guide, published by HL7 Austria. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/gabriel0316/test-laboratory/ and changes regularly. See the Directory of published versions

Implementation Guidance

Implementation Guidance

This page provides practical guidance for implementing the AT ELGA Laboratory Report IG.

1. Document Structure

An ELGA laboratory report is a FHIR document Bundle containing exactly one Composition and one DiagnosticReport, plus all referenced resources.

Bundle (ATELGALabBundle)
├── Composition (ATELGALabComposition)       ← document header, sections
├── DiagnosticReport (ATELGALabDiagnosticReport) ← results container
├── Patient (ATELGALabPatient)
├── Organization (ATELGALabOrganization)     ← performing laboratory
├── Practitioner / PractitionerRole          ← ordering physician, signing pathologist
├── ServiceRequest (ATELGALabServiceRequest) ← laboratory order
├── Specimen (ATELGALabSpecimen)
└── Observation(s) (ATELGALabObservation)    ← individual results

The Bundle is the unit of exchange to and from the ELGA infrastructure.

2. Patient Identification

Austrian patients SHOULD be identified by at least one of the following:

Identifier System OID When to use
SVNR (Sozialversicherungsnummer) urn:oid:1.2.40.0.10.1.4.3.1 Always preferred; uniquely identifies the patient in the Austrian social insurance system
bPK (bereichsspezifisches Personenkennzeichen) urn:oid:1.2.40.0.10.2.1.1.149 When ELGA bPK-GH is available (health sector bPK)
Lokale Patientennummer GDA-specific OID URI Always include local ID alongside national identifiers

SVNR format: 10 digits — 3-digit sequence number + 6-digit birthdate (DDMMYY) + 1 check digit.

Example:

{
  "identifier": [
    {
      "type": { "coding": [{ "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "SS" }] },
      "system": "urn:oid:1.2.40.0.10.1.4.3.1",
      "value": "1234240195",
      "assigner": { "display": "Dachverband der österreichischen Sozialversicherungsträger" }
    }
  ]
}

3. Organization (GDA) Identification

Every laboratory MUST be identified by its GDA-OID — the Object Identifier assigned by ELGA GmbH or the registering authority.

Identifier System Note
GDA-OID urn:ietf:rfc:3986 Value is a URN OID, e.g., urn:oid:1.2.40.0.34.99.x.y.z
KANR (Krankenanstaltennummer) urn:oid:1.2.40.0.34.4.10 Hospital labs only
VPNR (Vertragspartnernummer) urn:oid:1.2.40.0.10.1.4.3.2 Contracted labs

4. Laboratory Test Codes

Test codes SHALL be provided using LOINC as the primary coding system for interoperability with the EU Lab IG and MyHealth@EU.

Additional local codes MAY be provided as supplementary codings:

{
  "code": {
    "coding": [
      {
        "system": "http://loinc.org",
        "code": "718-7",
        "display": "Hemoglobin [Mass/volume] in Blood"
      },
      {
        "system": "https://fhir.hl7.at/elga-labor/CodeSystem/at-lab-local-cs",
        "code": "AT-LAB-001",
        "display": "Hämoglobin (lokal)"
      }
    ],
    "text": "Hämoglobin"
  }
}

5. Units of Measure

All quantitative results SHALL use UCUM codes for units. Common Austrian laboratory units:

Unit UCUM Code Example
g/dL g/dL Hemoglobin
10⁹/L 10*9/L Leukocytes, Thrombocytes
10¹²/L 10*12/L Erythrocytes
% % Hematocrit
µmol/L umol/L Bilirubin
U/L U/L Enzymes (ALT, AST, GGT)
mg/dL mg/dL Glucose, Creatinine
mmol/L mmol/L Electrolytes

6. Result Status

The status element on Observation SHALL reflect the lifecycle of the result:

Status German When
preliminary Vorläufig Result available but not yet verified
final Endgültig Result verified and signed off
corrected Korrigiert Previously final result has been corrected
cancelled Storniert Result cancelled (e.g., invalid specimen)

In ELGA, only final or corrected results SHOULD be submitted to the ELGA infrastructure.

7. Reference Ranges

Reference ranges SHALL be provided for all quantitative results where applicable. They SHOULD be patient-context-specific (age, sex, unit), not universal.

{
  "referenceRange": [
    {
      "low": { "value": 4.0, "unit": "10*9/L", "system": "http://unitsofmeasure.org", "code": "10*9/L" },
      "high": { "value": 10.5, "unit": "10*9/L", "system": "http://unitsofmeasure.org", "code": "10*9/L" },
      "appliesTo": [{ "coding": [{ "system": "http://snomed.info/sct", "code": "248153007", "display": "Male" }] }],
      "text": "4,0 – 10,5 × 10⁹/L (Männer, Erwachsene)"
    }
  ]
}

8. Language and Localisation

  • All report text fields (titles, conclusions, notes) SHOULD use Austrian German (de-AT)
  • Set Bundle.language = #de-AT and Composition.language = #de-AT
  • The Composition.title SHOULD be a human-readable German title, e.g., "Laboratoriumsbefund — Großes Blutbild"
  • Use Austrian number formatting in text: decimal comma (,), thousands separator (.)

9. Human-Readable PDF

ELGA requires that laboratory reports include a human-readable representation. Provide a PDF as:

{
  "presentedForm": [
    {
      "contentType": "application/pdf",
      "language": "de-AT",
      "data": "<base64-encoded-PDF>",
      "title": "Laboratoriumsbefund"
    }
  ]
}

10. Terminology Servers

Austrian terminology resources are managed via the Austrian Terminology Server (using TerminoloGit):

  • Austrian Terminology Server: contact HL7 Austria or ELGA GmbH for access details
  • International codes (LOINC, SNOMED CT, UCUM): use the FHIR R4 terminology server or the EU Lab expansion parameters

11. Conformance Checklist

Before submitting an ELGA laboratory report:

  • Bundle has exactly one Composition and one DiagnosticReport
  • Patient has at least one Austrian identifier (SVNR preferred)
  • Organization has a GDA-OID identifier
  • All Observations have status = #final (or #corrected)
  • All quantitative values use UCUM codes
  • All test codes use LOINC (primary)
  • A PDF representation is included in DiagnosticReport.presentedForm
  • Bundle language is set to de-AT
  • Bundle identifier uses the laboratory's GDA OID namespace