Populate a Questionnaire with pre-existing data or AI-extracted values from clinical documents. Extends SDC Questionnaire/$populate with the contextual-populate mode and a provenance output parameter.

Graph to retrieve Patient with most recent Task of type 'complete-questionnaire'.

Graph to retrieve Task of type 'complete-questionnaire' with Questionnaire, QuestionnaireResponse

Use to record a single value laboratory analyte result, commonly found in clinical pathology testing such as medical biochemistry, haematology, immunology and transfusion medicine. These results may also appear in anatomical pathology reports as ‘ancillary tests', for example flow cytometry. One or more instances of this archetype may be nested within the 'Test result' SLOT in the OBSERVATION.laboratory_test_result. In some circumstances this archetype may be carried within a CLUSTER.laboratory_test_panel archetype, together with other analytes which are normally tested and/or reported as part of a battery, panel or profile. This archetype may be used within the setting of more complex laboratory/pathology reporting such as anatomical pathology reports where quantitative results such as cytometric flow studies are often reported alongside conventional macroscopic and microscopic reporting.

To record laboratory test results in a panel/battery structure common to clinical pathology testing biochemistry, haematology and immunology. Normally used in conjunction with a parent OBSERVATION.laboratory_test_result. Where other more complex result patterns are required it may be helpful to specialise this archetype or substitute another.

Use to record the result, including findings and the laboratory's interpretation, of an investigation performed on specimens collected from an individual or related to that individual. This is typically done in a laboratory, but may be done in other environments such as at the point of care. This archetype is intended to cover the result of a single ordered investigation where the specimen(s) are collected as a single procedure, and may include multiple analyte results or other components. Examples of this could include 'Full blood count', which would yield a separate analyte result for the count of each type of blood cell, or 'kidney biopsy non-neoplastic', which would yield findings from microscopy, immunohistochemistry and electron microscopy. This archetype has been designed to be a framework that will usually be extended with CLUSTER archetypes to enable appropriate recording of specific laboratory test result patterns. This includes, but is not limited to, tests for biochemistry, haematology, immunology and transfusion services etc and specific patterns for the unique requirements for microbiology and anatomical pathology. If the ordered tests or investigations do not commonly belong together in a named group or panel, each test result would normally be represented using separate instances of this archetype. There is, however, considerable variation in actual reporting/messaging practice and this archetype/related archetypes are designed to handle such variation. This archetype supports multiple approaches to recording of specimen, reflecting current practice which varies enormously. A Laboratory test result has a high degree of alignment to an HL7 FHIR Diagnostic Report resource. It is anticipated that one or more instances of this archetype, or archetype family, will be sent back to a requesting clinician within a laboratory report document comprising COMPOSITION.report_result archetype, or similar, and other relevant ENTRY archetypes. The recording of confounding factors may be inconsistent, often depending on the analysing laboratory and on clinical information sent by the requester. In the State section of the archetype there is a simple 'Confounding factors' data element that is optional and can be repeated as one way to record a variety of simple factors that need to be made explicit as they may influence interpretation of the results. If the confounding factors are more complex, it may be appropriate to create a local/shared CLUSTER archetype that can be nested in the 'Confounding factors details' SLOT. Note 1: Known or required pre-conditions, such as 'fasting' or 'Day 1 of menstrual cycle', should be reported in the 'Sampling conditions' data element in the CLUSTER.specimen archetype, nested within this OBSERVATION archetype. Note 2: Known issues with specimen collection or handling, such as 'sample haemolysed' or 'prolonged use of tourniquet' should be reported within 'Specimen quality' in the CLUSTER.specimen archetype, nested within this OBSERVATION archetype. Where 'reflex tests' are performed by the laboratory, these may be handled as per US/FHIR guidance (see https://www.hl7.org/fhir/2015may/uslabreport-guide.html) or other local policy. For example, one of the following …

1. Record the reflex test results additional 'Test findings' within the same 'openEHR-EHR-OBSERVATION.laboratory_test_result'
2. Record the reflex test results as 'Test findings' within a new 'openEHR-EHR-OBSERVATION.laboratory_test_result' but refer to the original lab test request via 'Test request details'.
3. Record the reflex test results as 'Test findings' within a new 'openEHR-EHR-OBSERVATION.laboratory_test_result' but reference a new lab test request as well as the original lab test request via 'Test request details'.

Model resembling the OMOP-CDM 5.4 Observation table.

Model resembling the OMOP-CDM 5.4 Person table.

Model resembling the OMOP-CDM 5.4 Provider table.

Base model for a OMOP-CDM 5.4.

FHIR Observation profile for measurements and findings derived from a cardiac diagnostic procedure such as a resting 12-lead ECG or an ambulatory (Holter) recording.

Examples include resting heart rate, the standard ECG intervals (PR, QRS, QT, QTc Bazett / Fridericia, P duration), the cardiologist's overall ECG impression, and Holter-derived summaries (24h heart rate min/avg/max, atrial fibrillation burden and episode statistics, sinus pauses, ventricular and supraventricular ectopy).

Design notes

• category is fixed to procedure. The HL7 observation-category CodeSystem has no cardiac code; cardiology measurements are classified as procedure per the FHIR Vital Signs and ECG guidance.
• Panel grouper on Observation.code. When related metrics are recorded over the same period (AFib burden + episodes + longest episode, sinus pause count + longest pause, …) the parent Observation.code carries a panel grouper code and each metric is carried on a separate component. The parent code is never reused on a component. Where LOINC has no panel concept, a Tiro local code from TiroCardiacMetric is used.
• LOINC-first coding. Individual ECG intervals and 24h heart rate min/max use the verified LOINC concepts (see the LOINC table on issue #11). Metrics with no LOINC equivalent fall back to TiroCardiacMetric.

FHIR Observation profile for cardiac measurements that flow into a vital-signs / flowsheet stream rather than into a final cardiology report. Typical use case: a Holter device emits a rolling average heart rate every hour and those values are written as discrete vital-signs Observations.

category is fixed to vital-signs (the HL7 observation-category code) — this is the distinguishing constraint from CardiacMeasurement, which fixes category to procedure. Use CardiacMeasurement for the cardiologist's final report and panel-style summaries; use this profile for individual real-time measurements.

Profile for tracking the origin and method of data entry for form fields to support audit trails and transparency. One FormProvenance resource is created per populated QuestionnaireResponse item.

FHIR Observation profile representing a single dimensional measurement (diameter, length, area, volume, circumference, angle, thickness, …) of an anatomical structure or lesion derived from an imaging study.

Typical use cases include tumor diameter on CT (RECIST), aortic annulus diameter on cardiac MRI (pre-TAVR sizing), and prostate volume on TRUS. The category slice is fixed to imaging, locking the profile to image-derived measurements; non-imaging measurements of the same structures (e.g. DRE-estimated prostate volume, physical-exam head circumference) belong on a sibling profile.

openEHR alignment

This profile is mapped against two openEHR archetypes because openEHR aggregates imaging data differently than FHIR:

• openEHR-EHR-OBSERVATION.imaging_exam_result.v1 — report-level archetype (analogous to FHIR DiagnosticReport). Carries study-wide context: modality, study date, status, source image references.
• openEHR-EHR-CLUSTER.imaging_exam.v1 — per-body-structure findings archetype, plus its specialisations (e.g. imaging_exam-lymph_node.v0) which add structure-specific quantitative ELEMENTs such as at0.2 Diameter (DV_QUANTITY, mm, up to 3 occurrences for 3 axes).

Inverted aggregation: openEHR nests measurements under a body-structure cluster under a report; FHIR (this profile) keeps one Observation per measurement and uses bodySite/focus to record the structure. The two forms are semantically equivalent — component here corresponds to the multi-occurrence ELEMENT pattern in the openEHR specialisations (e.g. three Diameter occurrences for three axes).

The actual measurement quantity has no node in the base CLUSTER.imaging_exam.v1 — it lives in body-structure specialisations (imaging_exam-lymph_node.v0/items[at0.2], …) — so value[x] maps to the specialisation node, not the base archetype.

A measurement of a laboratory test.

FHIR Observation profile representing a single laboratory analyte result.

Designed to be semantically interoperable with the openEHR openEHR-EHR-CLUSTER.laboratory_test_analyte.v1 archetype. Every constrained element below carries an explicit mapping entry pointing at the equivalent archetype node path. Four archetype elements have no idiomatic FHIR equivalent on Observation and are documented as additional mapping rows (with "(not represented)"): at0027 (Analyte result sequence), at0014 (Analyte result detail), at0006 (Result status time), at0032 (Accredited).

Multi-disciplinary team (MDT) meeting for prostate cancer.

A Quality Indicator is a measure of the clinical quality of a service or intervention. Typically it is part of the nominator in Value-Based Healthcare model.

A question tree is a template block that contains a tree of questions. Each question may have one or more answers and may have one or more child questions.

FHIR Document Bundle with a Composition and a list of resources that describe the clinical report.

A table is a template block that contains a repeating set of rows with a uniform set of columns.

A template block is a section of a template that defines a block of content that can be included in a document.

Profile for a Tiro Questionnaire

The OperationOutcome returned by the Tiro.health FHIR API for error responses (and some validation outcomes). Every issue carries a human-readable details.text and a standard FHIR issue.code; some issues additionally carry a Tiro detail code in issue.details.coding (see the OperationOutcomeIssueDetail code system). Branch on issue.code and the coded issue.details.coding, never on details.text. Documentation: https://docs.tiro.health/fhir/errors

Tumor staging is the process of determining the extent of a cancer's spread from the original site of the tumor to other parts of the body. The staging system used most often in the United States is the TNM system. The T stands for tumor, the N stands for nodes, and the M stands for metastasis. The T describes the size and extent of the primary tumor. The N describes the size and extent of the lymph nodes involved. The M describes whether the cancer has spread to other parts of the body. The TNM system is used to stage many types of cancer, including breast cancer, colon cancer, lung cancer, and prostate cancer. The TNM system is also used to stage other types of cancer, such as melanoma, lymphoma, and leukemia. The TNM system is used to stage many types of cancer, including breast cancer, colon cancer, lung cancer, and prostate cancer. The TNM system is also used to stage other types of cancer, such as melanoma, lymphoma, and leukemia.

Extension to add a comment to an answer in a QuestionnaireResponse

A bookmark extension

List of bookmarks that must be available in the launch context.

Enable suggestions for inline mentions in text fields

ID of a labeled HTML element (e.g. a span with a data-label attribute) within a DocumentReference attachment that the AI used as source text when extracting a field value. Multiple occurrences indicate multiple contributing spans. Enables UI source-highlighting.

Set of initial values for a questionnaire

A separator character for input groups.

Orientation of the items in the Questionnaire

Provides the narrative content in an alternative format such as RTF or plain text.

This extension is used to define the narrative generation based on the QuestionnaireResponse.

FHIR Extension for narrative templates used in Questionnaires. This extension contains a template that is used to dynamically generate the narrative content of a Questionnaire based on provided data.

FHIR Extension for narrative snippets used in narrative templates within Questionnaires. These snippets are loaded into the rendering environment and can be referenced by narrative templates or by other snippets to generate dynamic content.

Conditionally restricts answer options based on FHIRPath expressions that evaluate other answers in the questionnaire. When the expression evaluates to true, the specified option is restricted (hidden or disabled).

Flag to indicate that the value set has been pre-expanded.

Pre-adoption of R6 Provenance.why — describes why the event recorded in this provenance occurred in textual form. For AI-populated fields this captures the model's reasoning. Note: the backend currently stores reasoning in activity.text; ProvenanceWhy is the intended field going forward.

Indicates whether the question is included in the summary of the parent group.

Pre-configured questionnaireresponses.

Reference to an element defined inside the SVG document referenced by the itemMedia extension.

Regular expression to validate the answer to a question

Render Type extension for the FHIR Questionnaire resource which indicates the layout preference for the Questionnaire

This extension adds a score to each code in the expansion of a value set. The score is used to sort the codes in the expansion.

Retired. Use ProvenanceAgentTypeVS instead.

Clinical M-Stage for Lung Cancer with REO Addendum

AJCC 8th Edition Clinical MStage for Lung Cancer

AJCC 8th Edition Clinical NStage for Lung Cancer

AJCC 8th Edition Clinical TStage for Lung Cancer

Activities that can be performed on form fields

SNOMED-CT codes for 'ja' and 'nee'

All available bookmarks for Questionnaire population.

Diagnosis of Lung Cancer

Location of metastasis for Lung Cancer

MIME types supported for narrative alternative formats

All Tiro.health OperationOutcome issue-detail codes. Bound (example strength) to OperationOutcome.issue.details in the Tiro.health OperationOutcome profile.

ValueSet for The status of the laboratory test result as a whole.

Positive Negative from LOINC Answer List LL360-9

Standard FHIR agent type codes used in FormProvenance.agent.type. Automated Atticus engines use #assembler; source document authors use #author.

The type of an answer in a question tree.

Orientation of the items in the Questionnaire

ValueSet for The status of the analyte result value.

Available template languages to generate a narrative for a Questionnaire item

Publication statuses for questionnaire templates.

SNOMED-CT bevindingen functioneringsniveau volgens Wereldgezondheidsorganisatie

Extra codes for the REO Multidisciplinary Discussion at UZ Leuven

Retired. Agent type codes previously used in Provenance.agent.type. Use http://terminology.hl7.org/CodeSystem/provenance-participant-type (code: assembler) instead.

Tiro.health Auto Generate Codes in case common standard CodeSystems are insufficïent.

Example code for use in examples.

Activities that can be performed on form fields and which will be tracked through provenance

A bookmark for KWS resources.

Additional launch context for FHIR Questionnaires launched from KWS.

Tiro.health detail codes carried in OperationOutcome.issue.details.coding. They give a stable, machine-readable classification of an issue beyond the standard FHIR issue-type (OperationOutcome.issue.code). Consumers should branch on these codes rather than on the free-text issue.details.text. Documentation: https://docs.tiro.health/fhir/errors

CodeSystem for The status of the laboratory test result as a whole.

Orientation of the items in the Questionnaire

This CodeSystem defines the sections of a report as they are coded in the EHR of ExampleHospital.

CodeSystem for The status of the analyte result value.

SNOMED CT

Supported inputs for Tiro.health tasks.

Supported outputs for Tiro.health tasks.

Supported task types by Tiro.health

Available template languages to generate a narrative for a Questionnaire item

Publication status codes for Tiro.health questionnaire templates.

Local codes for cardiac monitoring metrics that have no equivalent in LOINC or SNOMED CT. The set is deliberately small: each Tiro code documents a genuine terminology gap (AFib burden / episode statistics, sinus pause counts and longest pause, ventricular- and supraventricular-tachycardia run counts and longest runs, and per-panel Holter grouper codes that LOINC does not currently provide).

Codes covered by LOINC or SNOMED CT are NOT duplicated here — see the example instances for the chosen LOINC/SCT codes (PVC count LOINC#76126-2, premature atrial contractions LOINC#8615-7, atrial fibrillation SCT#49436004, …).

These codes are a stopgap. Each entry should be replaced with a LOINC or SNOMED CT code as soon as a suitable concept becomes available.

Custom Questionnaire Item Control codes by Tiro Health for rendering FHIR Questionnaire items.

UCUM

Provenance for a field extracted by AI from a clinical document (contextual-populate). The entity carries the source DocumentReference and html-element-id extensions identifying the specific labeled spans used for extraction.

A practitioner role for an abdominal surgeon

AI engine that labels and marks clinical document HTML content for extraction. Backend reference: Device/4.

AI engine that extracts answer values from labeled clinical document content (contextual-populate). Backend reference: Device/5.

FHIRPath expression evaluation engine. Referenced as Provenance.agent.who when initialExpression or calculatedExpression is evaluated. Backend reference: Device/1.

Population engine that applies initial values, evaluates definitions, and handles repopulation. Backend reference: Device/2.

Preset engine that loads saved preset configurations onto form fields. Backend reference: Device/3.

Text field for Blood Pressure which decomposes automatically into Systolic and Diastolic components

Blood Pressure with Systolic and Diastolic components

A snapshot of KWS bookmarks

CM Stage Observation.

CN Stage Observation.

CT Stage Observation.

Example questionnaire demonstrating calculated expressions for automatic BMI computation.

Library to calculate the Charlson Comorbidity Index

Clinical TNM Stage

A questionnaire to conclude the report.

Example contextual-populate request supplying a clinical DocumentReference as AI context. The AI marking pipeline extracts field values and returns one FormProvenance per populated item.

Example $populate response for contextual-populate mode. Includes the populated QuestionnaireResponse and one FormProvenance entry per populated field. In practice, provenance is repeated once per field.

Provenance for a field populated by matching Questionnaire.item.definition to a FHIR Observation. The backend sends both #definition and #data-import as tiroActivity codings.

Patiënt for illustration purposes.

Datum waarop de diagnose is gesteld.

Example medical doctor specialized in urology/oncology

A practitioner named Dr. Pauwels

Example medical doctor specialized in urology/oncology

Example questionnaire demonstrating dynamic answer options populated from a FHIR server using x-fhir-query.

Stub DocumentReference representing a referral letter, referenced by the AI clipboard provenance example

Shared example patient used as the subject for every Observation example in this file.

This is an example hospital.

Sample LabResult instance demonstrating archetype-compatible population of every mapped element.

Stub Practitioner referenced by provenance examples

Stub QuestionnaireResponse referenced by provenance examples

Report Template represented as FHIR Questionnaire with references to sub-questionnaires that represent building blocks of the report.

An example table.

Aortic annulus mean diameter measured on cardiac MRI for pre-TAVR sizing, with long and short axes captured as components.

P wave duration from a 12-lead ECG.

PR interval from a 12-lead ECG.

QRS complex duration from a 12-lead ECG.

QT interval from a 12-lead ECG (uncorrected).

QT interval corrected by Bazett's formula.

QT interval corrected by Fridericia's formula.

Resting heart rate from a 12-lead ECG.

Cardiologist's overall impression of a 12-lead ECG. Uses LOINC 8601-7 (EKG impression) — not LOINC 2230-1, which codes epinephrine in plasma.

Note: issue #11's table cites 8601-0, but the LOINC concept for "EKG impression" is actually 8601-7 (verified on loinc.org and used by HL7 US Core). 8601-0 does not exist.

24h heart rate summary from a Holter recording, with min / mean / max on components. Parent code is LOINC 43149-4 "Heart rate device panel" — the closest LOINC panel concept; its defined members only cover the mean-by-time-window side (41924-2 is one of them), so code.text clarifies that this instance also carries 24h max and 24h min. Component codes use the verified LOINC 24h-HR concepts (min 8883-1, mean 41924-2, max 8873-2).

Corrected QT interval derived from a 24h Holter recording.

Atrial fibrillation summary from a 24h Holter recording: burden, episode count, longest episode. Parent code is SCT#49436004 Atrial fibrillation — the clinical finding being characterized — and each metric is carried on a component. None of the metrics has a LOINC equivalent today, so component codes come from TiroCardiacMetric.

A single rolling-window average heart rate from a Holter monitor landing on the patient's flowsheet. Represents the case where a Holter implementation emits recurring HR averages with category = vital-signs rather than the panel-style procedure Observations on CardiacMeasurement.

Sinus pause summary from a 24h Holter recording: pause count and longest pause duration. Parent code is a Tiro panel grouper (LOINC has no pause panel); components use Tiro local codes.

Supraventricular ectopy summary from a 24h Holter recording: total SVEB count (a supraventricular ectopic beat is, clinically, a premature atrial contraction) and SVT run statistics. The SVEB count uses LOINC 8615-7 "Premature atrial contractions". The SVT run statistics and the panel grouper have no LOINC equivalents and come from TiroCardiacMetric.

Ventricular ectopy summary from a 24h Holter recording: total PVC count and VT run statistics. PVC count uses LOINC 76126-2 "Premature ventricular contractions [#]". The VT run statistics and the panel grouper have no LOINC equivalents, so those come from TiroCardiacMetric.

Prostate volume estimated from transrectal ultrasound using the ellipsoid formula.

Long-axis diameter of a hepatic target lesion measured on a contrast-enhanced CT, per RECIST 1.1.

Provenance for a field computed by the FHIRPath engine from a calculatedExpression

A filled report.

Percentage of patients with a TURB procedure for bladder cancer who have a MOC or Follow-up containing anatomical pathology report with a diagnosis of bladder cancer within 6 months after the TURB procedure.

An initial report to be filled in.

Library of reusable input controls and input groups for FHIR Questionnaire items

A patient named Jan Jansens

An ongoing encounter with Jan Jansens

Composition containing the Lung Cancer Staging Report.

Questionnaire for Lung Cancer Staging.

QuestionnaireResponse for Lung Cancer Staging.

Example patient that is diagnosed with lung cancer.

Lung Cancer Staging Condition.

Example encounter where a patient has a lung cancer level.

Bundle containing the Lung Cancer Staging Report including the QuestionnaireResponse and related resources.

Metastasis Observation.

Questionnaire demonstrating the use of multiple choice questions defined as seperate items.

Questionnaire response demonstrating the use of multiple choice questions defined as seperate items.

This is an example of a nested answer horizontal question.

PSA Measurement observation

PSA Measurement observation

EAU Risk Group observation of the prostate tumor.

Gleason Score observatoin

Clinical T Stage observation of the prostate tumor.

PD-L1 Expression Observation.

PSA is a measurement of the prostate specific antigen in a blood sample.

A system for identifying patients in the ReportServer.

Example pre-populate request: evaluates initialExpression and item.initial at form launch.

Example questionnaire demonstrating pre-population of patient data using FHIRPath expressions and variables.

Provenance for fields populated from a saved preset configuration. The backend sends both #preset and #static as tiroActivity codings.

Patient is diagnosed with prostate cancer.

Defines the set of resources to created during the MDT Prostate Cancer.

Example patient that is diagnosed with prostate cancer.

Example of a Composition from a Prostate Cancer Staging report.

FHIR Document containing all resources related to the Prostate Cancer diagnosis for PCaPatient by Dr. Hause.

A basic questionnaire with launch context referring to bookmarks.

Previous problems overview for REO Multidisplincary Discussion

Previous therapies overview for REO Multidisplincary Discussion

Example encounter where a patient has a raised PSA level.

Patient is diagnosed with raised PSA.

A bundle containing a resources to populate the report.

A response to the questionnaire.

Self Administered Comorbidty Questionnaire

A session to launch a questionnaire.

Smoking Status

This subscription triggers an event when a report is updated and the extraction of FHIR resources has completed.

This subscription triggers an event when a specific report is updated and the extraction of FHIR resources has completed.

TNM Stage Group Observation.

Render library to render a FHIR Questionnaire in a table layout

Render library to render a FHIR Questionnaire in a tree like question-answer layout

Ureterenoscopie because of a TCC

Ureterenoscopie because of a TCC

Uretorenoscopy because of a TCC

Uretorenoscopy because of a TCC

Provenance for a field manually entered by the treating clinician

Example questionnaire demonstrating validation extensions: entryFormat, minValue, maxValue, maxDecimalPlaces, and regex.

This value set has an expansion with scores for each code.

This value set has a flag to indicate that it has been pre-expanded.

Functioneringsniveau volgens Wereldgezondheidsorganisatie

This topic triggers an event when a report is updated and the extraction of FHIR resources has completed.