# Vercy AI instruction - YAML 1.2 (JSON-compatible) { "vercy": "1.0-draft", "publication": { "status": "published", "adjudicationStatus": "reviewable-draft", "publishableCanonical": false, "generatedAt": "2026-10-06T21:44:33Z", "synthesisSha256": "36b3daad86dfb7e94658c9b7f1c90fa214a480262f9f8966ec47f69c0d59cfa2", "providerMode": "single-provider-waiver", "providers": [ "Codex" ], "waivedProviders": [ "Claude", "Grok" ] }, "metaModel": { "id": "WM-MAT-007", "registryId": "vr.wm-mat-007", "name": "Laboratory Test / Analysis", "version": "0.1.0", "previousVersions": [], "entryKind": "entity", "family": "World Models", "category": "Physical world and living systems", "industry": [ "Cross-industry" ], "domain": [ "PHY.MAT.LAB" ], "tags": [ "laboratory", "test", "analysis", "phy.mat.lab" ], "status": "published" }, "canonicalUrl": "https://ver.cy/models/wm-mat-007-laboratory-test-analysis/", "sourceUrl": "https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/research/runs/wm-mat-007", "model": { "registry_id": "vr.wm-mat-007", "model_id": "WM-MAT-007", "name": "Laboratory Test / Analysis", "entry_kind": "entity", "purpose": "Describe one identifiable laboratory test instance through method selection, specimen use, run evidence and qualified result revisions.", "scope_statement": "A persistent test instance governed by a laboratory or material authority. It carries test-specific assertions and references from initiation through cancellation, release or correction. It may link multiple execution attempts and results. This is a proposed information model, not a laboratory procedure, clinical interpretation engine or authority to release results.", "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" ], "boundary_notes": [ { "neighbor": "WM-MAT-005 Lab Sample / Specimen", "distinction": "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.", "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ] }, { "neighbor": "WM-LIV-023 Clinical / Biological Specimen", "distinction": "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.", "source_refs": [ "SRC-003", "SRC-004", "SRC-005" ] }, { "neighbor": "Method definition and validation study", "distinction": "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.", "source_refs": [ "SRC-001", "SRC-007" ] }, { "neighbor": "Shared analytical run, instrument and calibration", "distinction": "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.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007" ] }, { "neighbor": "Observation and report records", "distinction": "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.", "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ] }, { "neighbor": "Field observation and hazardous work", "distinction": "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.", "source_refs": [ "SRC-001", "SRC-007", "SRC-008" ] } ] }, "sources": [ { "id": "SRC-001", "title": "ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories", "organization": "International Organization for Standardization", "url": "https://www.iso.org/standard/66912.html", "version_or_date": "Edition 3, 2017-11; public catalogue says confirmed 2023; full standard not reviewed", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Public scope and competence context only; no clause-level compliance claim." }, { "id": "SRC-002", "title": "NIST Policy on Metrological Traceability", "organization": "National Institute of Standards and Technology", "url": "https://www.nist.gov/calibrations/traceability", "version_or_date": "Policy page updated 2024-06-17", "source_type": "public-authority", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Result-specific traceability evidence and limits of fitness-for-purpose inference." }, { "id": "SRC-003", "title": "FHIR R4 Observation", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R4/observation.html", "version_or_date": "FHIR R4 4.0.1", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Clinical profile alignment for typed values, missingness, method, device, specimen and component links." }, { "id": "SRC-004", "title": "FHIR R4 Specimen", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R4/specimen.html", "version_or_date": "FHIR R4 4.0.1", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Separate specimen identifiers, parent links and collection/processing context; not a universal custody schema." }, { "id": "SRC-005", "title": "FHIR R4 DiagnosticReport", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R4/diagnosticreport.html", "version_or_date": "FHIR R4 4.0.1", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Report identity, result references, status, performer and issued-time distinctions in a clinical profile." }, { "id": "SRC-006", "title": "PROV-O: The PROV Ontology", "organization": "World Wide Web Consortium", "url": "https://www.w3.org/TR/prov-o/", "version_or_date": "W3C Recommendation 2013-04-30", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Activities, entities, agents, derivation and revisions; provenance is not a truth or compliance certificate." }, { "id": "SRC-007", "title": "The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics", "organization": "Eurachem", "url": "https://eurachem.org/images/stories/Guides/pdf/MV_guide_3rd_ed_V1_EN.pdf", "version_or_date": "Third edition 2025; quantitative method focus", "source_type": "first-party-doc", "primary_source": true, "authority_tier": 2, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Selected sections 3, 4.7, 5, 7 and 9 inform fitness, sampling boundary, performance and quality evidence. Qualitative validation is deferred." }, { "id": "SRC-008", "title": "Laboratory Quality Management System Training Toolkit", "organization": "World Health Organization", "url": "https://extranet.who.int/hslp/content/LQMS-training-toolkit", "version_or_date": "Toolkit landing page accessed 2026-10-07; module revision dates unpinned", "source_type": "public-authority", "primary_source": true, "authority_tier": 2, "accessed_at": "2026-10-06T21:43:08Z", "relevance": "Module summaries for sample management, quality control, occurrence management, records and information management. Linked handbook was not retrieved." } ], "structure": { "bundles": [ { "id": "bundle-test-context", "name": "Test context", "description": "Stable identity and accountable intent.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-008" ], "layers": [ { "id": "layer-identity", "name": "Test identity", "description": "Context required to answer test identity questions for this test.", "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ], "findings": [ { "id": "finding-identity", "name": "Test identity", "description": "One test persists across attempts and report revisions. Accession, specimen, test code and run IDs are related identifiers, not interchangeable keys.", "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ], "questions": [ { "id": "finding-identity-q1", "kind": "identity", "text": "Which master identifier and namespace distinguish this test from its specimen and accession?", "answer_data": [ "test_identifier", "master_namespace", "accession_reference" ] }, { "id": "finding-identity-q2", "kind": "classification", "text": "Which test code and profile version describe the requested analysis?", "answer_data": [ "test_code", "code_system_version", "profile_reference" ] }, { "id": "finding-identity-q3", "kind": "composition", "text": "Which parent panel or related tests exist without merging their identities?", "answer_data": [ "panel_reference", "related_test_references", "relation_kind" ] }, { "id": "finding-identity-q4", "kind": "lifecycle", "text": "Which test state applies when no run or result exists yet?", "answer_data": [ "test_state", "state_reason", "state_effective_time" ] } ], "data_elements": [ { "id": "finding-identity-data-test-identifier", "name": "test-identifier", "description": "Master-issued test identity plus issuer namespace.", "value_kind": "identifier", "cardinality": "1", "required": true, "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ] }, { "id": "finding-identity-data-test-context", "name": "test-context", "description": "Code, profile, accession and related test references with independent states.", "value_kind": "object", "cardinality": "1", "required": true, "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ] } ], "artifacts": [ { "id": "finding-identity-artifact", "name": "Test registration snapshot", "description": "Proposed evidence-bearing representation of test identity. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-003", "SRC-005", "SRC-006" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-intent", "name": "Intent and responsibility", "description": "Context required to answer intent and responsibility questions for this test.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ], "findings": [ { "id": "finding-intent", "name": "Intent and responsibility", "description": "Record the requested use, accountable laboratory role and acceptance basis. A request does not establish method fitness or release authority.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ], "questions": [ { "id": "finding-intent-q1", "kind": "definition", "text": "What analytical question and intended use does this test address?", "answer_data": [ "analytical_question", "intended_use", "request_reference" ] }, { "id": "finding-intent-q2", "kind": "ownership", "text": "Which role stewards this test record and resolves ownership disputes?", "answer_data": [ "record_steward", "responsible_laboratory_reference", "dispute_route" ] }, { "id": "finding-intent-q3", "kind": "authority", "text": "What evidence authorizes accepting or cancelling this test?", "answer_data": [ "authority_reference", "decision_actor", "decision_basis" ] }, { "id": "finding-intent-q4", "kind": "constraint", "text": "What urgency, scope or subcontracting restrictions qualify the request?", "answer_data": [ "priority_basis", "scope_limits", "referral_reference" ] } ], "data_elements": [ { "id": "finding-intent-data-intent-record", "name": "intent-record", "description": "Intended use, accountable role and request or internal initiation basis.", "value_kind": "object", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] }, { "id": "finding-intent-data-acceptance-evidence", "name": "acceptance-evidence", "description": "Versioned acceptance, cancellation or referral decisions.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] } ], "artifacts": [ { "id": "finding-intent-artifact", "name": "Test intent and acceptance record", "description": "Proposed evidence-bearing representation of intent and responsibility. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "bundle-specimen-use", "name": "Specimen use", "description": "Test-specific material bindings and suitability.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-004", "SRC-006", "SRC-007", "SRC-008" ], "layers": [ { "id": "layer-specimen-binding", "name": "Specimen binding", "description": "Context required to answer specimen binding questions for this test.", "source_refs": [ "SRC-004", "SRC-006", "SRC-008" ], "findings": [ { "id": "finding-specimen-binding", "name": "Specimen binding", "description": "Bind the material actually used, including aliquot or pool provenance, without taking control of the specimen master.", "source_refs": [ "SRC-004", "SRC-006", "SRC-008" ], "questions": [ { "id": "finding-specimen-binding-q1", "kind": "relationship", "text": "Which specimen or aliquot master revisions were used for each attempt?", "answer_data": [ "specimen_references", "revision_pins", "attempt_references" ] }, { "id": "finding-specimen-binding-q2", "kind": "composition", "text": "How are pooled or derived inputs linked to their contributing specimens?", "answer_data": [ "input_lineage", "pool_reference", "contribution_reference" ] }, { "id": "finding-specimen-binding-q3", "kind": "provenance", "text": "Which source asserts the material-to-test association and with what confidence?", "answer_data": [ "assertion_source", "asserted_at", "association_status" ] }, { "id": "finding-specimen-binding-q4", "kind": "exception", "text": "How is a disputed or unresolved specimen match prevented from appearing confirmed?", "answer_data": [ "mismatch_status", "hold_reason", "resolution_reference" ] } ], "data_elements": [ { "id": "finding-specimen-binding-data-specimen-bindings", "name": "specimen-bindings", "description": "Referenced specimen identities and revisions for executed attempts; planned tests may defer population until execution.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-004", "SRC-006", "SRC-008" ] }, { "id": "finding-specimen-binding-data-binding-evidence", "name": "binding-evidence", "description": "Master evidence for identity matching and input lineage.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-004", "SRC-006", "SRC-008" ] } ], "artifacts": [ { "id": "finding-specimen-binding-artifact", "name": "Specimen participation map", "description": "Proposed evidence-bearing representation of specimen binding. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-004", "SRC-006", "SRC-008" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-suitability", "name": "Suitability for this test", "description": "Context required to answer suitability for this test questions for this test.", "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ], "findings": [ { "id": "finding-suitability", "name": "Suitability for this test", "description": "Preserve the assessment against this test method and intended use. Specimen availability alone is not acceptance.", "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ], "questions": [ { "id": "finding-suitability-q1", "kind": "quality", "text": "What specimen condition evidence supports suitability for the selected method?", "answer_data": [ "condition_evidence", "method_revision", "assessment_status" ] }, { "id": "finding-suitability-q2", "kind": "temporal", "text": "Which collection, receipt and analysis times support the applicable stability assessment?", "answer_data": [ "collection_time", "receipt_time", "analysis_time", "stability_rule_reference" ] }, { "id": "finding-suitability-q3", "kind": "decision", "text": "Who accepted, rejected or qualified this input for this particular test?", "answer_data": [ "disposition", "reviewer", "decision_time", "exception_basis" ] }, { "id": "finding-suitability-q4", "kind": "constraint", "text": "Which missing sampling context limits inference beyond the submitted material?", "answer_data": [ "sampling_scope", "representativeness_limit", "customer_supplied_information" ] } ], "data_elements": [ { "id": "finding-suitability-data-suitability-assessment", "name": "suitability-assessment", "description": "Assessment, evidence, reviewer and scope-specific limitations; unknown is explicit.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ] }, { "id": "finding-suitability-data-sampling-context", "name": "sampling-context", "description": "Sampling and custody evidence mastered outside the test.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ] } ], "artifacts": [ { "id": "finding-suitability-artifact", "name": "Test-specific suitability assessment", "description": "Proposed evidence-bearing representation of suitability for this test. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "bundle-method-fitness", "name": "Method fitness", "description": "Pinned method and applicability evidence.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ], "layers": [ { "id": "layer-method-selection", "name": "Method selection", "description": "Context required to answer method selection questions for this test.", "source_refs": [ "SRC-003", "SRC-007" ], "findings": [ { "id": "finding-method-selection", "name": "Method selection", "description": "Select a controlled method revision and intended property or measurand. Changed revisions require an explicit applicability review.", "source_refs": [ "SRC-003", "SRC-007" ], "questions": [ { "id": "finding-method-selection-q1", "kind": "definition", "text": "Which property or measurand and matrix define the selected analysis?", "answer_data": [ "property_definition", "matrix", "measurement_basis" ] }, { "id": "finding-method-selection-q2", "kind": "identity", "text": "Which method identifier, revision and local procedure binding were actually used?", "answer_data": [ "method_reference", "method_revision", "procedure_binding" ] }, { "id": "finding-method-selection-q3", "kind": "validation", "text": "What validation or verification evidence covers this method in the actual setting?", "answer_data": [ "fitness_evidence_reference", "covered_scope", "uncovered_scope" ] }, { "id": "finding-method-selection-q4", "kind": "exception", "text": "Which deviations or method changes require a qualified disposition?", "answer_data": [ "deviation_reference", "change_reason", "disposition" ] } ], "data_elements": [ { "id": "finding-method-selection-data-method-binding", "name": "method-binding", "description": "Controlled method revision selected for this test; required before admitted execution evidence.", "value_kind": "reference", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-007" ] }, { "id": "finding-method-selection-data-fitness-assertion", "name": "fitness-assertion", "description": "Scope comparison and review evidence; not an accreditation certificate.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-003", "SRC-007" ] } ], "artifacts": [ { "id": "finding-method-selection-artifact", "name": "Method applicability record", "description": "Proposed evidence-bearing representation of method selection. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-003", "SRC-007" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-performance", "name": "Performance limitations", "description": "Context required to answer performance limitations questions for this test.", "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ], "findings": [ { "id": "finding-performance", "name": "Performance limitations", "description": "Attach applicable performance evidence without treating every analysis as quantitative or equating detection limits with a zero result.", "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ], "questions": [ { "id": "finding-performance-q1", "kind": "measurement", "text": "Which quantitative range, detection or quantification limits apply to this result type?", "answer_data": [ "working_range", "detection_limit", "quantification_limit", "applicability" ] }, { "id": "finding-performance-q2", "kind": "quality", "text": "Which matrix effects, selectivity or precision limitations qualify the analysis?", "answer_data": [ "performance_evidence", "matrix_effects", "limitations" ] }, { "id": "finding-performance-q3", "kind": "requirement", "text": "How is method fitness compared with the intended decision need?", "answer_data": [ "fitness_requirement", "assessment_reference", "acceptance_basis" ] }, { "id": "finding-performance-q4", "kind": "exception", "text": "What evidence is still needed for a qualitative method or an unsupported matrix?", "answer_data": [ "qualitative_profile_gap", "unsupported_scope", "review_hold" ] } ], "data_elements": [ { "id": "finding-performance-data-performance-context", "name": "performance-context", "description": "Profile-dependent limits, scope and units or explicit non-applicability.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ] }, { "id": "finding-performance-data-performance-evidence", "name": "performance-evidence", "description": "Versioned external method evidence supporting the applicable limitations.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ] } ], "artifacts": [ { "id": "finding-performance-artifact", "name": "Performance evidence index", "description": "Proposed evidence-bearing representation of performance limitations. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-002", "SRC-003", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "bundle-execution-evidence", "name": "Execution evidence", "description": "Attempt lineage and observed quality context.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-002", "SRC-003", "SRC-006", "SRC-007", "SRC-008" ], "layers": [ { "id": "layer-attempts", "name": "Attempt and run participation", "description": "Context required to answer attempt and run participation questions for this test.", "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ], "findings": [ { "id": "finding-attempts", "name": "Attempt and run participation", "description": "Record local attempt identity and shared run references. Acquisition and reprocessing remain distinct, with failed attempts visible.", "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ], "questions": [ { "id": "finding-attempts-q1", "kind": "process", "text": "Which run participation or processing activity produced each test output?", "answer_data": [ "attempt_identifier", "run_reference", "activity_kind", "output_references" ] }, { "id": "finding-attempts-q2", "kind": "temporal", "text": "When did acquisition and processing occur, and when was each event recorded?", "answer_data": [ "start_time", "end_time", "recorded_at", "time_precision" ] }, { "id": "finding-attempts-q3", "kind": "spatial", "text": "Where was the test performed and what relevant conditions were recorded?", "answer_data": [ "site_reference", "field_or_lab_context", "condition_evidence" ] }, { "id": "finding-attempts-q4", "kind": "provenance", "text": "Which operator, instrument and software revisions contributed to the attempt?", "answer_data": [ "operator_reference", "instrument_reference", "software_revision", "raw_data_reference" ] } ], "data_elements": [ { "id": "finding-attempts-data-attempts", "name": "attempts", "description": "Attempt IDs, activity kinds, run pins, event times, location and contributors.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ] }, { "id": "finding-attempts-data-raw-evidence", "name": "raw-evidence", "description": "Immutable raw data and processing evidence references with integrity metadata.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ] } ], "artifacts": [ { "id": "finding-attempts-artifact", "name": "Attempt evidence manifest", "description": "Proposed evidence-bearing representation of attempt and run participation. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-run-quality", "name": "Run quality and traceability", "description": "Context required to answer run quality and traceability questions for this test.", "source_refs": [ "SRC-002", "SRC-007", "SRC-008" ], "findings": [ { "id": "finding-run-quality", "name": "Run quality and traceability", "description": "Link control and calibration evidence to the affected attempt. Custody history and an instrument label do not establish metrological traceability.", "source_refs": [ "SRC-002", "SRC-007", "SRC-008" ], "questions": [ { "id": "finding-run-quality-q1", "kind": "evidence", "text": "Which controls and calibration evidence apply to this test attempt?", "answer_data": [ "control_evidence", "calibration_reference", "applicability_interval" ] }, { "id": "finding-run-quality-q2", "kind": "validation", "text": "Who assessed the run evidence against the specified acceptance criteria?", "answer_data": [ "criteria_reference", "assessment_actor", "assessment_result" ] }, { "id": "finding-run-quality-q3", "kind": "measurement", "text": "What documented reference chain supports any metrological traceability assertion?", "answer_data": [ "reference_chain", "uncertainty_contributions", "claim_scope" ] }, { "id": "finding-run-quality-q4", "kind": "exception", "text": "Which failed controls or later-discovered issues place this result under review?", "answer_data": [ "nonconformity_reference", "affected_results", "hold_status" ] } ], "data_elements": [ { "id": "finding-run-quality-data-run-quality-context", "name": "run-quality-context", "description": "Applicable controls, review states and unresolved failures.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-002", "SRC-007", "SRC-008" ] }, { "id": "finding-run-quality-data-traceability-claim", "name": "traceability-claim", "description": "Result-specific claim, references and limitations; absent claim is not inferred as conformity.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-002", "SRC-007", "SRC-008" ] } ], "artifacts": [ { "id": "finding-run-quality-artifact", "name": "Run quality evidence index", "description": "Proposed evidence-bearing representation of run quality and traceability. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-002", "SRC-007", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "bundle-result-meaning", "name": "Result meaning", "description": "Typed assertions and bounded interpretation.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ], "layers": [ { "id": "layer-result-values", "name": "Typed result assertions", "description": "Context required to answer typed result assertions questions for this test.", "source_refs": [ "SRC-003", "SRC-005", "SRC-007" ], "findings": [ { "id": "finding-result-values", "name": "Typed result assertions", "description": "Represent quantities, categorical outcomes and unavailable results explicitly. A missing value, below-limit report and zero are different assertions.", "source_refs": [ "SRC-003", "SRC-005", "SRC-007" ], "questions": [ { "id": "finding-result-values-q1", "kind": "measurement", "text": "What typed value, comparator and unit or coded outcome was produced?", "answer_data": [ "value_kind", "value", "comparator", "unit", "coded_outcome" ] }, { "id": "finding-result-values-q2", "kind": "exception", "text": "Why is an expected result absent, invalid or limited rather than numerically zero?", "answer_data": [ "absence_reason", "invalid_reason", "limit_qualifier" ] }, { "id": "finding-result-values-q3", "kind": "composition", "text": "Which result components or replicates belong to the reported test outcome?", "answer_data": [ "component_references", "replicate_references", "aggregation_basis" ] }, { "id": "finding-result-values-q4", "kind": "provenance", "text": "Which raw inputs and processing revision support each derived value?", "answer_data": [ "raw_input_references", "processing_revision", "derivation_reference" ] } ], "data_elements": [ { "id": "finding-result-values-data-result-assertions", "name": "result-assertions", "description": "Result identity, revision, status, type and value-or-absence reason per assertion.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-005", "SRC-007" ] }, { "id": "finding-result-values-data-derivation-links", "name": "derivation-links", "description": "Referenced raw evidence and transformation provenance; preserve original representation.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-003", "SRC-005", "SRC-007" ] } ], "artifacts": [ { "id": "finding-result-values-artifact", "name": "Versioned result assertion set", "description": "Proposed evidence-bearing representation of typed result assertions. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-003", "SRC-005", "SRC-007" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-interpretation", "name": "Uncertainty and interpretation context", "description": "Context required to answer uncertainty and interpretation context questions for this test.", "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ], "findings": [ { "id": "finding-interpretation", "name": "Uncertainty and interpretation context", "description": "Keep uncertainty, reference intervals and decision thresholds distinguishable. Record qualified interpretations without making clinical or product decisions.", "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ], "questions": [ { "id": "finding-interpretation-q1", "kind": "measurement", "text": "What uncertainty expression and coverage basis apply to a quantitative result?", "answer_data": [ "uncertainty_value", "uncertainty_kind", "coverage_basis", "applicability" ] }, { "id": "finding-interpretation-q2", "kind": "classification", "text": "Which reference interval or decision threshold is applicable and to what population or material?", "answer_data": [ "reference_interval", "threshold_reference", "applicable_population", "material_scope" ] }, { "id": "finding-interpretation-q3", "kind": "decision", "text": "Who supplied the interpretation and which separate decision does it support?", "answer_data": [ "interpretation_author", "interpretation_reference", "decision_reference" ] }, { "id": "finding-interpretation-q4", "kind": "constraint", "text": "Which caveats prevent extrapolating this result to an untested item or different use?", "answer_data": [ "scope_caveats", "sampling_limit", "fitness_limit" ] } ], "data_elements": [ { "id": "finding-interpretation-data-interpretation-context", "name": "interpretation-context", "description": "Qualified uncertainty, ranges, thresholds and their distinct roles.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ] }, { "id": "finding-interpretation-data-interpretation-evidence", "name": "interpretation-evidence", "description": "Attributed interpretation and downstream decision references.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ] } ], "artifacts": [ { "id": "finding-interpretation-artifact", "name": "Qualified interpretation record", "description": "Proposed evidence-bearing representation of uncertainty and interpretation context. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-002", "SRC-003", "SRC-005", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "bundle-release-continuity", "name": "Release and continuity", "description": "Accountable report revisions and restricted reuse.", "rationale": "Groups test-owned assertions while leaving referenced masters independently governed.", "source_refs": [ "SRC-001", "SRC-005", "SRC-006", "SRC-008" ], "layers": [ { "id": "layer-release", "name": "Review and release evidence", "description": "Context required to answer review and release evidence questions for this test.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ], "findings": [ { "id": "finding-release", "name": "Review and release evidence", "description": "Keep technical review, authorization, publication of a report and delivery acknowledgement distinct. A completed run is not an authorized release.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ], "questions": [ { "id": "finding-release-q1", "kind": "authority", "text": "What evidence authorizes release of these exact result revisions?", "answer_data": [ "authorizer", "authorization_basis", "result_revision_pins" ] }, { "id": "finding-release-q2", "kind": "state", "text": "Is this report preliminary, partial, final or otherwise qualified under the chosen profile?", "answer_data": [ "report_status", "profile_status_mapping", "unresolved_items" ] }, { "id": "finding-release-q3", "kind": "temporal", "text": "When was the approved report issued and what test-effective time does it describe?", "answer_data": [ "issued_at", "test_effective_time", "authorization_time" ] }, { "id": "finding-release-q4", "kind": "access", "text": "Which recipients may receive the report and what delivery evidence exists?", "answer_data": [ "recipient_scope", "disclosure_basis", "delivery_reference", "acknowledgement" ] } ], "data_elements": [ { "id": "finding-release-data-release-evidence", "name": "release-evidence", "description": "Authorization and report revision bindings; mandatory for a release assertion.", "value_kind": "object", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] }, { "id": "finding-release-data-report-reference", "name": "report-reference", "description": "Master report ID and revision or locally mastered issued presentation.", "value_kind": "reference", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] } ], "artifacts": [ { "id": "finding-release-artifact", "name": "Release evidence and report manifest", "description": "Proposed evidence-bearing representation of review and release evidence. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-001", "SRC-005", "SRC-008" ] } ], "inline_only_rationale": null } ] }, { "id": "layer-correction", "name": "Correction and controlled reuse", "description": "Context required to answer correction and controlled reuse questions for this test.", "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ], "findings": [ { "id": "finding-correction", "name": "Correction and controlled reuse", "description": "A correction preserves attribution to the superseded assertion while identifying the current view. A retest is a linked attempt or new test under an explicit rule, never a silent edit.", "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ], "questions": [ { "id": "finding-correction-q1", "kind": "lifecycle", "text": "Which revision supersedes or withdraws a prior result and why?", "answer_data": [ "prior_revision", "new_revision", "change_kind", "change_reason" ] }, { "id": "finding-correction-q2", "kind": "event", "text": "Which affected recipients require correction notification and what is its recorded status?", "answer_data": [ "affected_release_references", "notification_obligation", "notification_status" ] }, { "id": "finding-correction-q3", "kind": "retention", "text": "Which policy governs retention or lawful disposal of test records and referenced evidence?", "answer_data": [ "retention_policy", "hold_reference", "disposition_authority", "external_owner" ] }, { "id": "finding-correction-q4", "kind": "interoperability", "text": "Which profile mapping preserves identity, missingness and revision meaning during exchange?", "answer_data": [ "mapping_version", "loss_report", "external_identifiers", "round_trip_evidence" ] } ], "data_elements": [ { "id": "finding-correction-data-revision-chain", "name": "revision-chain", "description": "Supersession or withdrawal assertions, author, reason and affected releases.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] }, { "id": "finding-correction-data-reuse-controls", "name": "reuse-controls", "description": "Disclosure, retention and mapping restrictions; no automatic remote correction or deletion.", "value_kind": "object", "cardinality": "0..1", "required": false, "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] } ], "artifacts": [ { "id": "finding-correction-artifact", "name": "Correction and reuse record", "description": "Proposed evidence-bearing representation of correction and controlled reuse. May be a structured record or a reference to an existing authoritative record; format does not determine ownership.", "media_or_form": [ "structured record", "evidence manifest" ], "serial": true, "identity_strategy": "Authoritative master-system ID and issuer namespace, then governed IRI, then Dimension UUID/ULID; retain distinct revision identity and content digest. Never use a date, filename or digest alone as the master identity.", "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] } ], "inline_only_rationale": null } ] } ] } ] }, "functions": [ { "id": "function-register-test", "name": "Register a local test record", "description": "Proposed, unimplemented local operation. Create stable test identity and intent without creating a specimen or authorizing work.", "inputs": [ "master namespace", "initiation evidence", "intended use" ], "outputs": [ "test reference", "registration evidence" ], "preconditions": [ "Authorized record steward", "No conflicting master identity" ], "effects": [ "Create local test identity and explicit planned state" ], "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] }, { "id": "function-bind-inputs", "name": "Bind specimen and method evidence", "description": "Proposed, unimplemented local operation. Attach revision-pinned inputs and suitability assertions without changing specimen custody or method definitions.", "inputs": [ "test reference", "specimen and method revision pins", "suitability evidence" ], "outputs": [ "binding revision", "unresolved-binding report" ], "preconditions": [ "Authorized analyst", "Expected current test revision", "Resolve identity conflicts or record an unresolved hold" ], "effects": [ "Append test-specific bindings and their provenance" ], "source_refs": [ "SRC-003", "SRC-004", "SRC-007" ] }, { "id": "function-record-attempt", "name": "Record attempt evidence", "description": "Proposed, unimplemented local operation. Register run participation and outputs from an already performed activity; does not operate instruments.", "inputs": [ "test revision", "run reference", "raw evidence", "actor and time assertions" ], "outputs": [ "attempt reference", "evidence integrity report" ], "preconditions": [ "Authorized evidence contributor", "Master links and units preserved", "No overwrite of admitted raw evidence" ], "effects": [ "Append acquisition or reprocessing activity and related result references" ], "source_refs": [ "SRC-003", "SRC-006", "SRC-007" ] }, { "id": "function-assess-readiness", "name": "Assess release record readiness", "description": "Proposed, unimplemented local operation. Check record completeness and surface missing authority or quality evidence; not a scientific validator or release decision.", "inputs": [ "result revision pins", "required profile", "quality and review references" ], "outputs": [ "readiness report", "blocking or unknown items" ], "preconditions": [ "Authorized reviewer scope", "Pinned profile rules available" ], "effects": [ "Produce local report; failed or unknown gates cannot become pass by default" ], "source_refs": [ "SRC-001", "SRC-005", "SRC-007", "SRC-008" ] }, { "id": "function-record-release", "name": "Record an authorized release", "description": "Proposed, unimplemented local operation. Record evidence that a qualified authority approved specified revisions; does not itself issue or transmit a report.", "inputs": [ "authorization evidence", "result and report revision pins", "recipient scope" ], "outputs": [ "local release evidence reference", "refusal reasons" ], "preconditions": [ "Authority evidence verified under adoption policy", "No unresolved blocking quality issue", "Expected current revision matches" ], "effects": [ "Append release assertion for exact revisions or refuse without state change" ], "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] }, { "id": "function-record-correction", "name": "Record a correction or withdrawal", "description": "Proposed, unimplemented local operation. Link attributed revisions and affected releases while retaining lawful history and external notification tasks.", "inputs": [ "prior revision", "replacement or withdrawal evidence", "reason", "affected releases" ], "outputs": [ "revision chain update", "notification task references", "refusal reasons" ], "preconditions": [ "Authorized correction reviewer", "No supersession cycle", "Known current revision and retention policy" ], "effects": [ "Append supersession or withdrawal without silently replacing historical values; no external notification is sent" ], "source_refs": [ "SRC-005", "SRC-006", "SRC-008" ] } ], "composition": [ { "target": "WM-MAT-005 Lab Sample / Specimen", "relation": "REFERENCE", "purpose": "Proposed binding replaces any inference that the registry parent means a test inherits specimen identity. Reference specimen and custody evidence without owning it.", "required": false, "source_refs": [ "SRC-004", "SRC-007", "SRC-008" ] }, { "target": "WM-LIV-023 Clinical / Biological Specimen", "relation": "REFERENCE", "purpose": "Optional proposed reciprocal binding for a clinical profile; the existing incoming candidate REFERENCE remains intact. No transfer of clinical specimen ownership.", "required": false, "source_refs": [ "SRC-003", "SRC-004" ] }, { "target": "Controlled method and validation evidence", "relation": "REFERENCE", "purpose": "Pin actual method revision and applicability evidence; target model/version remains an adoption binding to resolve.", "required": false, "source_refs": [ "SRC-007" ] }, { "target": "Shared run, equipment and calibration records", "relation": "REFERENCE", "purpose": "Link attempt participation and applicable evidence without operating or mastering the shared assets.", "required": false, "source_refs": [ "SRC-002", "SRC-006", "SRC-007" ] }, { "target": "FHIR R4 Observation, Specimen and DiagnosticReport", "relation": "ALIGN", "purpose": "Clinical exchange concepts only. Mapping, terminology licensing and conformance fixtures remain incomplete; this is not a universal laboratory representation.", "required": false, "source_refs": [ "SRC-003", "SRC-004", "SRC-005" ] }, { "target": "PROV-O", "relation": "ALIGN", "purpose": "Conceptual mapping for activity attribution, derivation and revision; no claim of metrological traceability follows from a provenance graph.", "required": false, "source_refs": [ "SRC-002", "SRC-006" ] } ], "serviceLayers": { "dimension": { "owner_package_requirements": [ "Identify the adopting laboratory or material authority by governed identifier and role, without a brand as owner.", "Declare master namespaces, profile version, intended uses and qualified review authority.", "Supply approved retention, confidentiality, safety and release policies plus storage and interface bindings." ], "namespace_guidance": "Use stable owner-governed namespaces for tests, attempts, result assertions and revisions. Keep specimen, report and instrument namespaces distinct; aliases do not silently merge masters.", "registry_links": [ "vr.wm-mat-007", "WM-MAT-005", "WM-LIV-023" ] }, "canon_and_patch": { "canonicalization_rules": [ "Preserve source values, code system versions, comparators, units and uncertainty representations. Derived normalization carries its own provenance.", "Stable identity is distinct from revision and report presentation. Unknown, absent, invalid and not-applicable must not collapse to one value." ], "patch_rules": [ "Use expected revision, authorized actor, reason and evidence for each patch; reject stale writes.", "Released assertion content is corrected by explicit successor or withdrawal with affected-release links. A retest does not overwrite a prior attempt." ], "compatibility_rules": [ "Require a versioned migration and loss report when changing value types, status meanings, units or specimen linkage semantics.", "Profile requirements may narrow the model but must not silently impose clinical fields on industrial tests." ] }, "artifact_rules": { "identity_priority": [ "Authoritative master-system identifier with issuer namespace", "Governed global identifier or IRI", "UUID or ULID assigned by the adopting Dimension" ], "timestamp_rule": "Use RFC 3339 with seconds and explicit offset or Z for known instants. Keep acquisition/event time, report issue time and observation/ingestion time separate. Preserve original precision and unknown zone; do not fabricate seconds for a date-only source, instead retain the partial source representation and its precision.", "serial_naming_rule": "Use stable artifact identity plus revision and sequence for serial outputs; dates and filenames are labels only. Keep original and rendered report identities linked.", "integrity_rule": "Record media type, size and digest for evidence bytes and any transformation. A matching hash establishes byte integrity, not scientific validity, identity or authority." }, "policies": [ "Service rules are proposed adoption governance informed by sources and the repository contract, not claims that an external standard mandates this exact design.", "Scientific release, exceptional quality acceptance and interpretation require qualified authority under a pinned profile. Agents may prepare evidence but cannot infer authority from data availability.", "Restrict patient-linked, proprietary and legally sensitive data by purpose and role. Hazardous subjects remain policy references without operational procedures.", "Do not infer accreditation, conformity, safety or clinical diagnosis from a valid model record, a traceability claim or a final status." ], "crud": { "read": [ "Resolve requested revision and access scope; expose qualifiers, current/superseded state and gaps alongside values." ], "create": [ "Create test identity from authorized initiation with explicit intent; planned or cancelled tests need not yet have specimen, run or result." ], "update": [ "Append evidence and qualified state changes under concurrency control. Never silently replace raw data, identifiers or released result values." ], "delete": [ "Apply the adopting records policy, retention periods and holds before disposition. Retain minimal lawful tombstones and revision relationships where permitted; do not promise indefinite sensitive-data retention.", "The records custodian executes approved local payload deletion. Specimen disposal and deletion of referenced external masters belong to their custodians; a local retirement never executes those actions." ] }, "roles": [ { "name": "Test record steward", "responsibilities": [ "Own record identity, profile bindings and disputed associations." ] }, { "name": "Analyst", "responsibilities": [ "Contribute attributed method, attempt and result evidence within competence." ] }, { "name": "Technical reviewer", "responsibilities": [ "Assess fitness and quality evidence; preserve unresolved issues." ] }, { "name": "Release authority", "responsibilities": [ "Authorize exact result and report revisions under the local policy." ] }, { "name": "Records custodian", "responsibilities": [ "Control purpose-based access, retention holds and lawful disposition." ] }, { "name": "Integration maintainer", "responsibilities": [ "Validate mapping fidelity and preserve external master identities." ] } ], "access": { "default_rule": "Deny by default; grant only purpose-bound role access to needed test content and revisions. Catalogue publication does not authorize disclosure of instance results.", "scopes": [ "bundle", "layer", "finding", "artifact" ], "exceptions": [ "Emergency or mandated disclosure requires documented basis, minimal scope, authorizer and subsequent review; it does not silently change the default policy." ], "audit_requirements": [ "Record reads where required, evidence imports, release assertions, corrections, exports and disposition with actor, purpose, revision and time.", "Reference the authoritative audit service; this model records linkage without owning its enforcement or tamper-resistance guarantees." ] }, "agents_bootstrap": { "filename": "AGENTS.md", "required_fields": [ "Name", "Type", "Specification URL", "Storage type URL", "Interface URL", "Processes URL" ], "read_order": [ "AGENTS.md and adopting Dimension authority/access policies", "spec.yaml including publication holds and boundaries", "Pinned profile, referenced masters and evidence before any proposed mutation" ] } }, "coverage": { "claim": "Source-grounded proposed structure for one persistent laboratory test instance, with external specimen, method and shared-run masters. A separate local no-tools self-audit is complete. Independent review, source/version verification, sector profiles and executable conformance remain holds. This is a noncanonical reviewable draft, not an accredited laboratory system or scientific release authority.", "confidence": "medium", "checklist": [ { "dimension": "identity", "status": "covered", "notes": "Stable test, attempt, result and revision identities are distinct." }, { "dimension": "lifecycle", "status": "covered", "notes": "Planned, cancelled, attempted, released and corrected records do not imply one universal state machine." }, { "dimension": "relationships", "status": "covered", "notes": "Specimen, method, run and report masters remain separate; registry candidates are qualified." }, { "dimension": "temporal", "status": "covered", "notes": "Event, record and issue time are separate with precision preserved." }, { "dimension": "provenance", "status": "covered", "notes": "Input and revision lineage supports attribution, not truth." }, { "dimension": "ownership", "status": "covered", "notes": "Generic laboratory roles govern local assertions and external masters retain ownership." }, { "dimension": "validation", "status": "covered", "notes": "Evidence gates and scientific review are distinct from structural schema validation." }, { "dimension": "access", "status": "covered", "notes": "Purpose-bound access covers all hierarchy levels and artifacts." }, { "dimension": "retention and deletion", "status": "covered", "notes": "Profile-dependent disposition and minimal tombstones; physical sample disposal is external." }, { "dimension": "interoperability", "status": "gap", "notes": "FHIR R4 and PROV-O are conceptual alignments; executable mappings remain a gap." }, { "dimension": "measurement", "status": "covered", "notes": "Typed values, absence, limits, uncertainty and interpretation are separated." }, { "dimension": "safety", "status": "covered", "notes": "Hazardous operations and regulated-use decisions require external policies and qualified authority." } ], "known_omissions": [ "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." ], "conflicts": [], "regional_assumptions": [ "No jurisdiction or retention duration is universal. The adopting laboratory supplies applicable law, competence, privacy and reporting rules.", "Clinical FHIR examples are profile-specific; industrial and environmental tests need separate mappings." ], "adversarial_checks": [ "Reject test/sample identity collapse and panel-wide finality inferred from one component.", "Keep below-limit, zero, missing, invalid and categorical outcomes distinct.", "Reject traceability inferred solely from custody, instrument calibration label or a provenance graph.", "A failed control or wrong specimen binding must not disappear through retesting or correction.", "Reprocessing existing bytes is distinct from a new acquisition; corrected results do not silently authorize external notifications." ] }, "researchAdjudication": { "providerMode": "single-provider-waiver", "activeProviders": [ "codex" ], "waivedProviders": [ "claude", "grok" ], "providerPolicy": { "contract_version": "1.0.0", "mode": "single-provider-waiver", "effective_at": "2026-09-06T00:00:00Z", "scope": "Canonical single-stream subject-model research after the six-workstream consolidation", "active_providers": [ "codex" ], "waived_providers": [ { "provider": "claude", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "Claude produced no result on prior 1800-second and 900-second attempts and again timed out on bounded 600-second Sonnet and 300-second Haiku passes. The owner prioritized completion over provider availability." }, { "provider": "grok", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "The repository owner authorized completion without Grok when Grok is unavailable, slow or schema-invalid. Grok may still be attempted as a bounded supplemental reviewer, but its failure never blocks a valid Claude plus no-tools result." } ], "review_rule": "Codex may complete source-grounded fallback research after bounded Claude and Grok attempts fail. It requires a separate no-tools adversarial audit and remains reviewable-draft with a visible absence-of-external-review hold.", "supplemental_provider_attempts": [ { "provider": "claude", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." }, { "provider": "grok", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." } ] }, "boundaryDecision": { "entry_kind": "entity", "status": "accepted", "rationale": "The root retains identity through initiation, multiple attempts and result revisions. Individual executions are events and reports are representations or linked records. Registry standalone-mm is a record-plane value; the sample parent is contextual placement, not proof that the test inherits specimen identity or custody." }, "decisions": [ { "concept": "Persistent test root", "disposition": "accepted", "rationale": "Identity, lifecycle questions and local functions consistently describe one test instance rather than a method definition, specimen or single execution event." }, { "concept": "Specimen parent as inheritance", "disposition": "rejected", "rationale": "A test is not a specimen subtype. The proposal qualifies contextual registry placement and uses external specimen bindings without taking custody or disposal ownership." }, { "concept": "Clinical specimen relationship direction", "disposition": "qualified", "rationale": "The frozen ledger contains an incoming candidate REFERENCE. It is retained as incoming; a reciprocal binding is proposed only for an adopting clinical profile and does not edit the ledger." }, { "concept": "Mandatory completed evidence at creation", "disposition": "rejected", "rationale": "A planned or cancelled test can lack specimen, method, run and result. Conditional execution and release requirements belong to the adopting profile, not universal root creation." }, { "concept": "Accession and test code identity", "disposition": "qualified", "rationale": "The admitted result keeps accession, specimen, test, run and panel identifiers distinct and does not assume an accession/code pair is globally unique." }, { "concept": "Method validation and accreditation", "disposition": "separated", "rationale": "Method revisions and applicability assertions are local bindings. Validation studies, accreditation determinations and method development remain externally mastered." }, { "concept": "Field testing exclusion", "disposition": "rejected", "rationale": "The source review supports laboratory-governed testing outside laboratory premises. The frozen scope uses responsibility and method context instead of location alone." }, { "concept": "Shared run ownership", "disposition": "qualified", "rationale": "The attempt manifest stores participation and references. It does not manage a shared batch, operate an instrument or replace external calibration records." }, { "concept": "Custody as metrological traceability", "disposition": "rejected", "rationale": "Quality questions require a result-specific reference chain and uncertainty context; custody, instrument labels and provenance graphs are explicitly insufficient." }, { "concept": "Typed results and missingness", "disposition": "accepted", "rationale": "Questions preserve quantitative and coded values, absence, invalidity and below-limit qualifiers. Numerical uncertainty and units are conditional; zero is not a missing-value default." }, { "concept": "Qualitative performance coverage", "disposition": "deferred", "rationale": "The admitted method guide focuses on quantitative analysis. The result represents qualitative outcomes but does not claim complete qualitative method validation evidence." }, { "concept": "Release authority and local functions", "disposition": "accepted as proposed only", "rationale": "Readiness assessment checks evidence completeness. Release recording requires authority and exact revision pins; none of the six operations performs scientific execution, transmission or independent clinical interpretation." }, { "concept": "Corrections and retention", "disposition": "accepted with policy dependency", "rationale": "Supersession preserves attribution and affected releases without equating correction to retest. Lawful disposition can remove payloads under policy while retaining permitted minimal continuity records." }, { "concept": "Source and executable assurance", "disposition": "limited", "rationale": "Selected web content is available but ISO full text, linked WHO files, current adoption applicability and nested executable schemas are incomplete. No direct HTTP status or response hash was measured." }, { "concept": "Independent review", "disposition": "waived and held", "rationale": "Claude and Grok were skipped with zero attempts by owner instruction. This separate Codex no-tools self-audit cannot be represented as an independent second-provider review." } ], "publicationHolds": [ "Independent external review is absent under the owner-authorized single-provider waiver. Claude and Grok were skipped with zero attempts; the separate local Codex no-tools self-audit is not an independent provider review.", "Live source and version verification remains incomplete. Eight admitted URLs supplied selected readable web-tool content, but direct HTTP checks were not attempted under the owner-reported sandbox restriction. No direct status or response hash was measured. The coordinator must run check_sources.py externally. ISO full text and linked WHO files were not reviewed.", "Sector, jurisdiction, qualified authority, clinical privacy, retention, accreditation scope, qualitative method validation and hazardous-work policy require adopting-profile review. No scientific validity, clinical decision authority or accreditation is certified.", "Nested instance schemas, conditional completeness rules, state transitions, pinned neighbor bindings, terminology versions, FHIR/PROV mappings and adversarial conformance fixtures remain incomplete. Local functions are proposed and unimplemented.", "Independent external review was explicitly waived by the repository owner; this codex-only result remains a reviewable draft." ], "deferredResearch": [ "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." ] }, "statistics": { "sources": 8, "bundles": 6, "layers": 12, "findings": 12, "questions": 48, "artifacts": 12, "functions": 6 } }