🇺🇸 Live Medical Devices & Diagnostics

CLIA Lab Standards (42 CFR 493)

Establishes quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. Applies to all facilities performing clinical laboratory testing on human specimens in the United States.

View official source document

104

Rules extracted

1,119

Obligations decomposed

10.8x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

What AuditDSS covers

Source

Regulation

Extracted

104

Rules

Decomposed

1,119

Obligations

10.8x

Decomposition ratio

Each rule is decomposed into an average of 10.8 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 1,119 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in CLIA Lab Standards is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: CLIA Lab Standards (42 CFR 493)
Regulatory body: Centers for Medicare & Medicaid Services
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: September 1, 1992
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

clinical laboratorieshospital laboratoriesphysician office laboratoriesreference laboratories

Key requirements

laboratory certification
proficiency testing
quality control procedures
personnel qualifications
patient test management
quality assurance

Frequently asked questions about CLIA Lab Standards

What is CLIA Lab Standards?

Who does CLIA Lab Standards apply to?

CLIA Lab Standards applies to clinical laboratories, hospital laboratories, physician office laboratories, reference laboratories.

How many obligations does CLIA Lab Standards contain?

AuditDSS has decomposed CLIA Lab Standards into 1,119 atomic obligations from 104 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of CLIA Lab Standards?

The key requirements include: laboratory certification, proficiency testing, quality control procedures, personnel qualifications, patient test management, quality assurance.

How can I assess my CLIA Lab Standards compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 1,119 CLIA Lab Standards obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces CLIA Lab Standards?

CLIA Lab Standards is enforced in United States by Centers for Medicare & Medicaid Services.

When did CLIA Lab Standards come into effect?

CLIA Lab Standards became effective on September 1, 1992.

What industry does CLIA Lab Standards apply to?

CLIA Lab Standards is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a CLIA Lab Standards compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for CLIA Lab Standards — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering CLIA Lab Standards requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine CLIA Lab Standards with other regulations into a single unified compliance pack for your business.

Build CLIA Lab Standards compliance pack

Already have a policy? Assess it against CLIA Lab Standards

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 1,119 obligations

Your document is scored against every obligation in CLIA Lab Standards. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.