CLIA — US Clinical Laboratory Improvement Amendments (42 CFR Part 493)

CLIA — US Clinical Laboratory Improvement Amendments (42 CFR Part 493) — 88% of in-scope requirements covered.

6 requirements · 4 in scope (3 enforced · 1 designed) · 2 out-of-scope (outside KYE™’s authority layer). The 88% is weighted over the in-scope base.

CLIA: requirement → the KYE™ artefact that enforces it

Demo data

You learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.

  1. 1291-report-integrity · enforced

    493.1291 — Reported test results are attributable, accurate, and any correction is traceable

    Audit events: kye.evidence.decision_map.v1, kye.replay.context_seal.v1 · Constitution: 13 resilience loop

  2. audit-trail · enforced

    Electronic test records carry a tamper-evident audit trail of every AI-driven change

    Audit events: kye.evidence.pack.v1 · Worm tables: evidence_events · Constitution: 30 audit worm retention

  3. 1445-ai-oversight · enforced

    Subpart M — A qualified, named individual authorises AI-supported result generation before it is reported

    Audit events: kye.purpose.request.v1, kye.purpose.admissibility.v1 · Constitution: 12 purpose permission

  4. 1105-record-retention · designed

    493.1105 — Test records and reports are retained and remain retrievable for the required period

    R2 buckets: kye-evidence-archive · Constitution: 30 audit worm retention

  5. 493-subpart-k-analytic-systems · out-of-scope

    Subpart K — Analytic-system quality control and method validation

    (no enforcement cited)

  6. 493-pt-competency · out-of-scope

    Subparts H & M — Proficiency testing and personnel competency assessment

    (no enforcement cited)

How this widget is built
Demonstrates
KYE™ Compliance Mapping Rail™
Components
  • Framework requirement (clause)
  • Coverage status
  • KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)
Flow
Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram
Used on

Source: The Clinical Laboratory Improvement Amendments (CLIA), implemented at 42 CFR Part 493, set US federal quality standards for laboratory testing performed on human specimens for diagnosis, prevention or treatment. KYE Protocol™ governs the test-record and result-reporting integrity slices (Subpart J recordkeeping), the audit-trail/electronic-records slice, and the authority slice where an AI-supported algorithm contributes to a reportable result. KYE™ does not perform testing, run proficiency testing, validate analytical performance, or assess personnel competency. · License: 42 CFR Part 493 is US federal regulation in the public domain; KYE™ registry paraphrases each requirement's intent and cites the official identifier for mapping purposes only.

By category

CategoryReqsEnforcedDesignedAdvisoryDeferredCoverage
Test records & result-report integrity (Subpart J, 493.1105/1291)2110075%
Audit trail for electronic test records11000100%
Authority & oversight of AI-supported result generation (Subpart M)11000100%
Analytic systems quality & validation (Subpart K)100000%
Proficiency testing & personnel competency (Subparts H, M)100000%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
clia.493.1105-record-retention493.1105 — Test records and reports are retained and remain retrievable for the required perioddesignedengines: internal
r2_buckets: kye-evidence-archive
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
clia.493.1291-report-integrity493.1291 — Reported test results are attributable, accurate, and any correction is traceableenforcedaudit_events: kye.evidence.decision_map.v1, kye.replay.context_seal.v1
engines: internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
clia.audit-trailElectronic test records carry a tamper-evident audit trail of every AI-driven changeenforcedaudit_events: kye.evidence.pack.v1
engines: internal
worm_tables: evidence_events
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
clia.493.1445-ai-oversightSubpart M — A qualified, named individual authorises AI-supported result generation before it is reportedenforcedaudit_events: kye.purpose.request.v1, kye.purpose.admissibility.v1
engines: internal
constitution_refs: constitution/12-PURPOSE-PERMISSION.md
clia.493-subpart-k-analytic-systemsSubpart K — Analytic-system quality control and method validationout-of-scope(no enforcement cited)
clia.493-pt-competencySubparts H & M — Proficiency testing and personnel competency assessmentout-of-scope(no enforcement cited)

Canonical KYE™ surfaces referenced on this page: KYE Protocol™.