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Laboratory Test / Analysis

vr.wm-mat-007 · wm-mat-007-laboratory-test-analysis

Describe one identifiable laboratory test instance through method selection, specimen use, run evidence and qualified result revisions.

World Models Physical world and living systems PHY.MAT.LAB
Bundle → Layer → Finding → QuestionsClassifiersWhat it isWhy it existsDistinguishing featuresWhat robots and AI may and may not doMoral aspectsOwnersLinks to other meta-modelsIdentity and identifiersDirect propertiesRecognitionCapabilities and actionsHazards and failure modesStandards and interfacesContext of useSources

Bundle → Layer → Finding → Questions Filled

3 bundles · 3 layers · 5 findings · 10 questions

Method Which procedure produces the result.

Test method

The analytical method and its validation.

Method identity

The method, its version and what it measures.

  1. Which method and version was used, and which quantity does it measure?
  2. Is the method validated or accredited for this specimen type?

Performance characteristics

Detection limits, range and uncertainty of the method.

  1. What are the limit of detection and the measuring range of the method?
  2. How is measurement uncertainty estimated for the result?
Run The execution of the method on specimens.

Analytical run

Instrument, operator, calibration and controls of one run.

Run control

Calibration and quality control status of the run.

  1. Which instrument and calibration were used in the run?
  2. Did the quality control samples in the run pass their acceptance criteria?

Specimen linkage

The specimen analysed and its condition on receipt.

  1. Which specimen was analysed, and was its chain of custody intact?
  2. Was the specimen within its stability limits when analysed?
Result What was reported and its status.

Reported result

The value, unit, uncertainty and release status.

Result release

A result validated and released by an authorised person.

  1. What value and unit were reported, with which uncertainty or reference interval?
  2. Was the result released as final, or later corrected or amended?

Classifiers Filled

Family
World Models
Category
Physical world and living systems
Entry kind
entity
Navigation path
NAV.PHY.MAT.LAB
Domain
PHY.MAT.LAB
Industry
Cross-industry
Tags
laboratorytestanalysisphy.mat.lab

What it is Filled

A laboratory test or analysis is the application of a defined method to a specimen in a laboratory run to produce a result for a measured quantity. It covers the method, the run and the reported result with its uncertainty, while the specimen itself and the general observation record are separate subjects.

In scope

  • Test identity, intent, profile, responsible roles and test-specific lifecycle
  • Revision-pinned specimen and method bindings, suitability assessments and run participation
  • Typed result assertions, quality limitations, release evidence, corrections and controlled projections

Out of scope

  • Specimen collection, custody, storage and disposal masters; patient, material and instrument masters
  • Method development and validation studies, shared batch management, calibration execution and accreditation decisions
  • Clinical diagnosis, product conformity decisions, legal conclusions, physical laboratory operations and hazardous procedural instructions

Why it exists Filled

Describe one identifiable laboratory test instance through method selection, specimen use, run evidence and qualified result revisions.

Distinguishing features Filled

  • It is the act of testing with a method and run, distinct from the specimen it consumes.
  • Its result carries method, run controls and uncertainty, unlike a bare measurement record.
  • Results pass through validation and release by authorised staff before they count as final.
  • Distinct from field measurement by instruments in place, which has no laboratory run.

What robots and AI may and may not do Filled

Must not

  • Release a result that an authorised person has not validated.
  • Alter a released result without issuing a recorded correction.
  • Interpret results clinically or legally in place of a qualified professional.
  • Report a value without its unit and method.
  • Disclose personal results to anyone not entitled to receive them.

Only with a human decision

  • Validating and releasing results.
  • Accepting a run despite a quality control failure.
  • Communicating critical results that need urgent action.

May

  • Report released results with their method, unit, uncertainty and status.
  • Flag results from runs with failed quality control or expired calibration.
  • Check that specimen stability and chain of custody were within limits.
  • Convert units between documented systems when the conversion is unambiguous.

Moral aspects Filled

  • Medical, forensic and safety decisions depend on correct results; errors can harm people directly.
  • Results about persons are sensitive personal data and need strict confidentiality.
  • Laboratory staff and others can be exposed to hazardous specimens and reagents.

Who is affected

  • Persons whose specimens are tested
  • Clinicians and other result users
  • Laboratory staff
  • Regulators and accreditation bodies

Owners Filled

Steward

The laboratory director or quality manager answers for methods, runs and released results.

Roles

Test record steward
Own record identity, profile bindings and disputed associations.
Analyst
Contribute attributed method, attempt and result evidence within competence.
Technical reviewer
Assess fitness and quality evidence; preserve unresolved issues.
Release authority
Authorize exact result and report revisions under the local policy.
Records custodian
Control purpose-based access, retention holds and lawful disposition.
Integration maintainer
Validate mapping fidelity and preserve external master identities.

Master systems

  • Laboratory information management systems
  • Laboratory information systems in clinical settings

Links to other meta-models Filled

references

  • WM-MAT-005 Lab Sample / Specimen - Proposed binding replaces any inference that the registry parent means a test inherits specimen identity. Reference specimen and custody evidence without owning it.
  • WM-LIV-023 Clinical / Biological Specimen - Optional proposed reciprocal binding for a clinical profile; the existing incoming candidate REFERENCE remains intact. No transfer of clinical specimen ownership.
  • Controlled method and validation evidence - Pin actual method revision and applicability evidence; target model/version remains an adoption binding to resolve.
  • Shared run, equipment and calibration records - Link attempt participation and applicable evidence without operating or mastering the shared assets.

aligned

  • FHIR R4 Observation, Specimen and DiagnosticReport - Clinical exchange concepts only. Mapping, terminology licensing and conformance fixtures remain incomplete; this is not a universal laboratory representation.
  • PROV-O - Conceptual mapping for activity attribution, derivation and revision; no claim of metrological traceability follows from a provenance graph.

neighbor

  • WM-MAT-005 Lab Sample / Specimen - Registry parent is contextual, not inheritance: a test is not a specimen. Reference the specimen master and its revision; own only the assessment of suitability for this test and participation links. Do not copy its custody or disposal lifecycle.
  • WM-LIV-023 Clinical / Biological Specimen - The registry has an incoming candidate REFERENCE from the clinical specimen to this model. Preserve that direction. A reciprocal clinical specimen binding is proposed only when needed; clinical identity and consent remain external.
  • Method definition and validation study - Own the selected method revision and its applicability assertion, not the method master or its validation lifecycle. Laboratory accreditation and method fitness are separate claims.
  • Shared analytical run, instrument and calibration - A run can serve many test instances. Own participation and evidence references, not the shared run or instrument lifecycle. Repeating acquisition differs from reprocessing existing data.
  • Observation and report records - The test persists before results exist. An observation is a result assertion and a report is a released presentation or collection. External records keep authoritative identity; local assertions name the master and revision.
  • Field observation and hazardous work - Laboratory-governed field testing can use this model when a qualified method and test identity exist. Location alone is not an exclusion. General telemetry and hazardous execution procedures are outside this model.

parent

  • WM-MAT-005

What else AI and robots need to interact with it Filled

Identity and identifiers required Filled

  • A test request and its result are identified by the laboratory's accession or sample number and test code.
  • Tests are often coded with LOINC in clinical settings, and runs carry batch identifiers.

Direct properties required Filled

  • The measured quantity with its value and unit, preferably expressed in UCUM or SI units.
  • Measurement uncertainty and the limits of detection and quantification.
  • Analytical conditions such as temperature in degrees Celsius where the method specifies them.
  • Specimen age and storage temperature at the time of analysis.

Recognition required Filled

  • A laboratory test record names a method, a specimen, a run and a result with its status.
  • Often confused with the specimen record, a point-of-care reading or a general observation.

Capabilities and actions required Filled

  • Results can be repeated, corrected, amended and traced back to run and method.
  • Methods can be validated, verified and accredited for defined scopes.

Hazards and failure modes required Filled

  • Specimen mix-up leading to results attributed to the wrong person or sample.
  • Exposure to biological or chemical hazards when handling specimens and reagents.
  • Use of results from a failed or uncalibrated run.

Standards and interfaces required Filled

  • HL7 FHIR Observation and DiagnosticReport resources.
  • LOINC for test codes and UCUM for units.
  • ISO/IEC 17025 and ISO 15189 accreditation scopes.

Context of use required Filled

  • Used in clinical, environmental, food, forensic and industrial testing laboratories.
  • Accredited laboratories work under ISO/IEC 17025 or, in medicine, ISO 15189.

Sources Filled

  1. ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories - International Organization for Standardization
  2. NIST Policy on Metrological Traceability - National Institute of Standards and Technology
  3. FHIR R4 Observation - Health Level Seven International
  4. FHIR R4 Specimen - Health Level Seven International
  5. FHIR R4 DiagnosticReport - Health Level Seven International
  6. PROV-O: The PROV Ontology - World Wide Web Consortium
  7. The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics - Eurachem
  8. Laboratory Quality Management System Training Toolkit - World Health Organization
  9. ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (ISO/IEC)
  10. ISO 15189 Medical laboratories - Requirements for quality and competence (ISO)
  11. LOINC Logical Observation Identifiers Names and Codes (Regenstrief Institute)

Open questions

  • Verify source versions and licensing, read applicable normative texts and restore an independent external review before canonical promotion.
  • Develop qualified industrial, environmental and clinical profiles, including qualitative performance validation and local retention and disclosure requirements.
  • Build executable schemas and mapping fixtures for wrong specimens, pools, partial panels, failed controls, absent and below-limit results, reprocessing, corrections and lawful disposal.
  • Full ISO normative text and medical laboratory accreditation requirements have not been reviewed.
  • Qualitative method performance validation, sector-specific sampling rules and specialized assay profiles need dedicated sources and qualified review.
  • Nested instance schemas, status-transition tables, terminology pins, neighbour versions and executable mapping fixtures are not supplied.
  • No direct HTTP status or response hash was measured in this sandbox; the coordinator must run check_sources.py externally.
  • Independent external review remains absent under the single-provider waiver.

Machine files

Card as JSON Specification AGENTS.md Source Card backlog vercy.card/1

Provenance

world-models research · reviewable-draft

Built from: models/wm-mat-007-laboratory-test-analysis/spec.yaml, ver-cy/world-models/card-supplements/wm-mat-007-laboratory-test-analysis.json