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Current CLIA Regulations
(including all changes through 01/24/2004)


Subpart A--General Provisions
493.1 Basis and scope
493.2 Definitions
493.3 Applicability
493.5 Categories of tests by complexity
493.15 Laboratories performing waived tests
493.17 Test categorization
493.19 Provider-performed microscopy (PPM) procedures
493.20 Laboratories performing tests of moderate complexity
493.25 Laboratories performing tests of high complexity
Subpart B--Certificate of Waiver
493.35 Application for a certificate of waiver
493.37 Requirements for a certificate of waiver
493.39 Notification requirements for laboratories issued a certificate of waiver
Subpart C--Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance
493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance
493.45 Requirements for a registration certificate
493.47 Requirements for a certificate for provider-performed microscopy (PPM) procedures
493.49 Requirements for a certificate of compliance.
493.51 Notification requirements for laboratories issued a certificate of compliance
493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures
Subpart D--Certificate of Accreditation
493.55 Application for registration certificate and certificate of accreditation
493.57 Requirements for a registration certificate
493.61 Requirements for a certificate of accreditation
493.63 Notification requirements for laboratories issued a certificate of accreditation
Subpart E--Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
493.551 General requirements for laboratories
493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs
493.555 Federal review of laboratory requirements
493.557 Additional submission requirements
493.559 Publication of approval of deeming authority or CLIA exemption
493.561 Denial of application or reapplication
493.563 Validation inspections--Basis and focus
493.565 Selection for validation inspection--laboratory responsibilities
493.567 Refusal to cooperate with validation inspection
493.569 Consequences of a finding of noncompliance as a result of a validation inspection
493.571 Disclosure of accreditation, State and CMS validation inspection results
493.573 Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs
493.575 Removal of deeming authority or CLIA exemption and final determination review
Subpart F--General Administration
493.602 Scope of subpart
493.606 Applicability of subpart
493.638 Certificate fees
493.639 Fee for revised certificate
493.643 Fee for determination of program compliance
493.645 Additional fee(s) applicable to approved State laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedure
493.646 Payment of fees
493.649 Methodology for determining fee amount
Subpart G [Reserved]
Subpart H--Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing
493.801 Condition: Enrollment and testing of samples
493.803 Condition: Successful participation
493.807 Condition: Reinstatement of laboratories performing nonwaived testing
  • Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests
493.821  Condition: Microbiology
493.823 Standard; Bacteriology
493.825 Standard; Mycobacteriology
493.827 Standard; Mycology
493.829 Standard; Parasitology
493.831 Standard; Virology
493.833 Condition: Diagnostic immunology
493.835 Standard; Syphilis serology
493.837 Standard; General immunology
493.839 Condition: Chemistry
493.841 Standard; Routine chemistry
493.843 Standard; Endocrinology
493.845 Standard; Toxicology
493.849 Condition: Hematology
493.851 Standard; Hematology
493.853 Condition: Pathology
493.855 Standard; Cytology: gynecologic examinations
493.857 Condition: Immunohematology
493.859  Standard; ABO group and D (Rho) typing
493.861 Standard; Unexpected antibody detection
493.863 Standard; Compatibility testing
493.865 Standard; Antibody identification
Subpart I--Proficiency Testing Programs for Nonwaived Testing
493.901 Approval of proficiency testing programs
493.903 Administrative responsibilities
493.905 Nonapproved proficiency testing programs
  • Proficiency Testing Programs by Specialty and Subspecialty
493.909 Microbiology
493.911 Bacteriology
493.913  Mycobacteriology
493.915 Mycology
493.917  Parasitology
493.919 Virology
493.921 Diagnostic immunology
493.923 Syphilis serology
493.927  General immunology
493.929 Chemistry
493.931 Routine chemistry
493.933  Endocrinology
493.937  Toxicology
493.941 Hematology (including routine hematology and coagulation)
493.945 Cytology; gynecologic examinations
493.959 Immunohematology
Subpart J-- Facility Administration for Nonwaived Testing
493.1100 Condition: Facility administration
493.1101 Standards:  Facilities
493.1103 Standard: Requirements for transfusion services
493.1105 Standard:  Retention requirements
Subpart K--Quality Systems for Nonwaived Testing
493.1200 Introduction
493.1201  Condition Bacteriology
493.1202 Condition: Mycobacteriology
493.1203 Condition: Mycology
493.1204 Condition: Parasitology
493.1205 Condition: Virology  
493.1207 Condition: Syphilis serology
493.1208 Condition: General immunology
493.1210 Condition: Routine chemistry
493.1211 Condition:  Urinalysis 
493.1212 Condition: Endocrinology
493.1213 Condition:  Toxicology
493.1215 Condition:  Hematology
493.1217 Condition:  Immunohematology
493.1219 Condition:  Histopathology
493.1220 Condition: Oral pathology
493.1221 Condition:  Cytology
493.1225 Condition: Clinical cytogenetics   
493.1226 Condition: Radiobioassay
493.1227 Condition: Histocompatibility
General Laboratory Systems
493.1230 Condition: General laboratory systems
493.1231 Standard: Confidentiality of patient information
493.1232 Standard: Specimen identification and integrity
493.1233 Standard:  Complaint investigations  
493.1234 Standard: Communications
493.1235 Standard:  Personnel competency assessment policies
493.1236 Standard:  Evaluation of proficiency testing performance
493.1239 Standard:  General laboratory systems assessment
Preanalytic Systems
493.1240 Condition: Preanalytic systems
493.1241 Standard:  Test request
493.1242 Standard:  Specimen submission, handling, and referral
493.1249 Standard:  Preanalytic systems assessment  
Analytic Systems
 493.1250 Condition: Analytic Systems
 493.1251 Standard:  Procedure manual   
493.1252 Standard:  Test systems, equipment, instruments, reagents, materials, and supplies
493.1253 Standard: Establishment and verification of performance specifications
493.1254  Standard: Maintenance and function checks
493.1255 Standard:  Calibration and calibration verification procedures
493.1256 Standard:  Control procedures
493.1261 Standard:  Bacteriology
493.1262 Standard:  Mycobacteriology
493.1263 Standard:  Mycology  
493.1264 Standard:  Parasitology
493.1265 Standard: Virology
493.1267 Standard:  Routine chemistry
493.1269 Standard:  Hematology
493.1271 Standard:  Immunohematology
493.1273 Standard:  Histopathology
493.1274 Standard: Cytology
493.1276 Standard:  Clinical cytogenetics
493.1278 Standard:  Histocompatibility
493.1281 Standard:  Comparison of test results
493.1282 Standard: Corrective actions
493.1283 Standard:  Test records
493.1289 Standard:  Analytic systems assessment
Post Analytic Systems
493.1290 Condition:  Postanalytic systems
493.1291 Standard:  Test report
493.1299 Standard: Postanalytic systems assessment
Subpart L [Reserved]
Subpart M--Personnel for Nonwaived Testing
493.1351 General
  • Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
493.1353 Scope
493.1355 Condition: Laboratories performing PPM procedures; laboratory  director
493.1357 Standard; laboratory director qualifications
493.1359 Standard; PPM laboratory director responsibilities
493.1361 Condition: Laboratories performing PPM procedures; testing personnel
 493.1363 Standard; PPM testing personnel qualifications
493.1365 Standard; PPM testing personnel responsibilities
  • Laboratories Performing Moderate Complexity Testing
493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director
493.1405  Standard; Laboratory director qualifications
493.1406 Standard; Laboratory director qualifications on or before February 28, 1992
493.1407 Standard; Laboratory director responsibilities
493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant
493.1411 Standard; Technical consultant qualifications
493.1413 Standard; Technical consultant responsibilities
493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant
493.1417 Standard; Clinical consultant qualifications
493.1419 Standard; Clinical consultant responsibilities
493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel
493.1423  Standard; Testing personnel qualifications
493.1425 Standard; Testing personnel responsibilities
  • Laboratories Performing High Complexity Testing
493.1441 Condition: Laboratories performing high complexity testing; laboratory director
493.1443 Standard; Laboratory director qualifications
493.1445 Standard; Laboratory director responsibilities
493.1447 Condition: Laboratories performing high complexity testing; technical supervisor
493.1449 Standard; Technical supervisor qualifications
493.1451 Standard; Technical supervisor responsibilities
493.1453 Condition: Laboratories performing high complexity testing; clinical consultant
493.1455 Standard; Clinical consultant qualifications
493.1457 Standard; Clinical consultant responsibilities
493.1459 Condition: Laboratories performing high complexity testing; general supervisor
493.1461 Standard; General supervisor qualifications
493.1462 General supervisor qualifications on or before February 28, 1992
493.1463 Standard; General supervisor responsibilities
493.1467 Condition: Laboratories performing high complexity testing; cytology general supervisor
493.1469 Standard; Cytology general supervisor qualifications
493.1471 Standard; Cytology general supervisor responsibilities
493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist
493.1483 Standard; Cytotechnologist qualifications
493.1485 Standard; Cytotechnologist responsibilities
493.1487 Condition: Laboratories performing high complexity testing; testing personnel
493.1489 Standard; Testing personnel qualifications
493.1491 Technologist qualifications on or before February 28, 1992
493.1495  Standard; Testing personnel responsibilities
Subparts N-O [Reserved]
Subparts P [Reserved]
Subpart Q--Inspection
493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories
493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories
493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures
493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance
493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation
Subpart R--Enforcement Procedures
493.1800 Basis and scope
493.1804  General considerations
493.1806 Available sanctions: All laboratories
493.1807 Additional sanctions: Laboratories that participate in Medicare
493.1808  Adverse action on any type of CLIA certificate: Effect on Medicare approval
493.1809 Limitation on Medicaid payment
493.1810 Imposition and lifting of alternative sanctions
493.1812 Action when deficiencies pose immediate jeopardy
493.1814 Action when deficiencies are at the condition level but do not pose immediate jeopardy
493.1816 Action when deficiencies are not at the condition level
493.1820 Ensuring timely correction of deficiencies
493.1826 Suspension of part of Medicare payments
493.1828 Suspension of all Medicare payments
493.1832 Directed plan of correction and directed portion of a plan of correction
493.1834 Civil money penalty
493.1836  State onsite monitoring
493.1838 Training and technical assistance for unsuccessful participation in proficiency testing
493.1840 Suspension, limitation, or revocation of any type of CLIA certificate
493.1842 Cancellation of Medicare approval
493.1844 Appeals procedures
493.1846 Civil action
493.1850 Laboratory registry
Subpart S [Reserved]
Subpart T--Consultations
493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee
Authority: Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16))
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted

This page last reviewed: 7/7/2004
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