CLIA - 42 CFR 493

Below are select sections from the Clinical Laboratory Improvement Act (CLIA). The sections below are provided as a quick reference for moderate complexity labs. For the full text of CLIA please visit 42 CFR 493.

Personnel

Lab Director Qualifications

Subpart M

42 CFR 493.1405

Lab Director Responsibilities

Subpart M

42 CFR 493.1407

Technical Consultant Qualifications

Subpart M

42 CFR 493.1411

Technical Consultant Responsibilities

Subpart M

42 CFR 493.1413

Clinical Consultant Qualifications

Subpart M

42 CFR 493.1417

Clinical Consultant Responsibilities

Subpart M

42 CFR 493.1419

Testing Personnel Qualifications

Subpart M

42 CFR 493.1423

Testing Personnel Responsibilities

Subpart M

42 CFR 493.1425

Quality Systems

General Laboratory Systems

Subpart K

42 CFR 493.1230

Test Requisition

Subpart K

42 CFR 493.1241

Specimen Collection and Handling

Subpart K

42 CFR 493.1242

Procedure Manual

Subpart K

42 CFR 493.1251

Test Systems and Equipment

Subpart K

42 CFR 493.1252

Performance Verification

Subpart K

42 CFR 493.1253

Maintenance and Function Checks

Subpart K

42 CFR 493.1254

Calibration

Subpart K

42 CFR 493.1255

Quality Control

Subpart K

42 CFR 493.1256

Instrument Comparison

Subpart K

42 CFR 493.1281

Corrective Actions

Subpart K

42 CFR 493.1282

Lab Report

Subpart K

42 CFR 493.1291

Proficiency Testing

Enrollment

Subpart H

42 CFR 493.801

Successful Participation

Subpart H

42 CFR 493.803

Reinstatement

Subpart H

42 CFR 493.807

Miscellaneous

Facilities

Subpart J

42 CFR 493.1101

Record Retention

Subpart J

42 CFR 493.1105

Accreditation

Subpart E

42 CFR 493.551

Inspection

Subpart Q

42 CFR 493.1773