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

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

CLIA — US Clinical Laboratory Improvement Amendments (42 CFR Part 493) — 58% covered.

6 requirements · 3 enforced · 1 designed · 0 advisory · 0 deferred.

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) 2 1 1 0 0 75%
Audit trail for electronic test records 1 1 0 0 0 100%
Authority & oversight of AI-supported result generation (Subpart M) 1 1 0 0 0 100%
Analytic systems quality & validation (Subpart K) 1 0 0 0 0 0%
Proficiency testing & personnel competency (Subparts H, M) 1 0 0 0 0 0%

Every requirement → the KYE™ artefact that enforces it

IDTitleStatusKYE™ enforcement
clia.493.1105-record-retention 493.1105 — Test records and reports are retained and remain retrievable for the required period designed engines: internal
r2_buckets: kye-evidence-archive
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
clia.493.1291-report-integrity 493.1291 — Reported test results are attributable, accurate, and any correction is traceable enforced audit_events: kye.evidence.decision_map.v1, kye.replay.context_seal.v1
engines: internal
constitution_refs: constitution/13-RESILIENCE-LOOP.md
clia.audit-trail Electronic test records carry a tamper-evident audit trail of every AI-driven change enforced audit_events: kye.evidence.pack.v1
engines: internal
worm_tables: evidence_events
constitution_refs: constitution/30-AUDIT-WORM-RETENTION.md
clia.493.1445-ai-oversight Subpart M — A qualified, named individual authorises AI-supported result generation before it is reported enforced audit_events: kye.purpose.request.v1, kye.purpose.admissibility.v1
engines: internal
constitution_refs: constitution/12-PURPOSE-PERMISSION.md
clia.493-subpart-k-analytic-systems Subpart K — Analytic-system quality control and method validation out-of-scope (no enforcement cited)
clia.493-pt-competency Subparts H & M — Proficiency testing and personnel competency assessment out-of-scope (no enforcement cited)