Home/CFR/Title 42/Part 493
FEDERAL · 42 CFR

Part 493 — Laboratory Requirements

220 sections · Title 42: Public Health

§ 493.1Basis and scope.
§ 493.2Definitions.
§ 493.3Applicability.
§ 493.5Categories of tests by complexity.
§ 493.15Laboratories performing waived tests.
§ 493.17Test categorization.
§ 493.19Provider-performed microscopy (PPM) procedures.
§ 493.20Laboratories performing tests of moderate complexity.
§ 493.25Laboratories performing tests of high complexity.
§ 493.35Application for a certificate of waiver.
§ 493.37Requirements for a certificate of waiver.
§ 493.39Notification requirements for laboratories issued a certificate of waiver.
§ 493.41Condition: Reporting of SARS-CoV-2 test results.
§ 493.43Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.
§ 493.45Requirements for a registration certificate.
§ 493.47Requirements for a certificate for provider-performed microscopy (PPM) procedures.
§ 493.49Requirements for a certificate of compliance.
§ 493.51Notification requirements for laboratories issued a certificate of compliance.
§ 493.53Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
§ 493.55Application for registration certificate and certificate of accreditation.
§ 493.57Requirements for a registration certificate.
§ 493.61Requirements for a certificate of accreditation.
§ 493.63Notification requirements for laboratories issued a certificate of accreditation.
§ 493.551General requirements for laboratories.
§ 493.553Approval process (application and reapplication) for accreditation organizations and State licensure programs.
§ 493.555Federal review of laboratory requirements.
§ 493.557Additional submission requirements.
§ 493.559Publication of approval of deeming authority or CLIA exemption.
§ 493.561Denial of application or reapplication.
§ 493.563Validation inspections—Basis and focus.
§ 493.565Selection for validation inspection—laboratory responsibilities.
§ 493.567Refusal to cooperate with validation inspection.
§ 493.569Consequences of a finding of noncompliance as a result of a validation inspection.
§ 493.571Disclosure of accreditation, State and CMS validation inspection results.
§ 493.573Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
§ 493.575Removal of deeming authority or CLIA exemption and final determination review.
§ 493.602Scope of subpart.
§ 493.606Applicability of subpart.
§ 493.638Certificate fees.
§ 493.639Fees for revised and replacement certificates.
§ 493.643Additional fees applicable to laboratories issued a certificate of compliance.
§ 493.645Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
§ 493.649Additional fees applicable to approved State laboratory programs.
§ 493.655Payment of fees.
§ 493.680Methodology for determining the biennial fee increase.
§ 493.801Condition: Enrollment and testing of samples.
§ 493.803Condition: Successful participation.
§ 493.807Condition: Reinstatement of laboratories performing nonwaived testing.
§ 493.821Condition: Microbiology.
§ 493.823Standard; Bacteriology.
§ 493.825Standard; Mycobacteriology.
§ 493.827Standard; Mycology.
§ 493.829Standard; Parasitology.
§ 493.831Standard; Virology.
§ 493.833Condition: Diagnostic immunology.
§ 493.835Standard; Syphilis serology.
§ 493.837Standard; General immunology.
§ 493.839Condition: Chemistry.
§ 493.841Standard; Routine chemistry.
§ 493.843Standard; Endocrinology.
§ 493.845Standard; Toxicology.
§ 493.849Condition: Hematology.
§ 493.851Standard; Hematology.
§ 493.853Condition: Pathology.
§ 493.855Standard; Cytology: gynecologic examinations.
§ 493.857Condition: Immunohematology.
§ 493.859Standard; ABO group and D (Rho) typing.
§ 493.861Standard; Unexpected antibody detection.
§ 493.863Standard; Compatibility testing.
§ 493.865Standard; Antibody identification.
§ 493.901Approval of proficiency testing programs.
§ 493.903Administrative responsibilities.
§ 493.905Nonapproved proficiency testing programs.
§ 493.909Microbiology.
§ 493.911Bacteriology.
§ 493.913Mycobacteriology.
§ 493.915Mycology.
§ 493.917Parasitology.
§ 493.919Virology.
§ 493.921Diagnostic immunology.
§ 493.923Syphilis serology.
§ 493.927General immunology.
§ 493.929Chemistry.
§ 493.931Routine chemistry.
§ 493.933Endocrinology.
§ 493.937Toxicology.
§ 493.941Hematology (including routine hematology and coagulation).
§ 493.945Cytology; gynecologic examinations.
§ 493.959Immunohematology.
§ 493.1100Condition: Facility administration.
§ 493.1101Standard: Facilities.
§ 493.1103Standard: Requirements for transfusion services.
§ 493.1105Standard: Retention requirements.
§ 493.1200Introduction.
§ 493.1201Condition: Bacteriology.
§ 493.1202Condition: Mycobacteriology.
§ 493.1203Condition: Mycology.
§ 493.1204Condition: Parasitology.
§ 493.1205Condition: Virology.
§ 493.1207Condition: Syphilis serology.
§ 493.1208Condition: General immunology.
§ 493.1210Condition: Routine chemistry.
§ 493.1211Condition: Urinalysis.
§ 493.1212Condition: Endocrinology.
§ 493.1213Condition: Toxicology.
§ 493.1215Condition: Hematology.
§ 493.1217Condition: Immunohematology.
§ 493.1219Condition: Histopathology.
§ 493.1220Condition: Oral pathology.
§ 493.1221Condition: Cytology.
§ 493.1225Condition: Clinical cytogenetics.
§ 493.1226Condition: Radiobioassay.
§ 493.1227Condition: Histocompatibility.
§ 493.1230Condition: General laboratory systems.
§ 493.1231Standard: Confidentiality of patient information.
§ 493.1232Standard: Specimen identification and integrity.
§ 493.1233Standard: Complaint investigations.
§ 493.1234Standard: Communications.
§ 493.1235Standard: Personnel competency assessment policies.
§ 493.1236Standard: Evaluation of proficiency testing performance.
§ 493.1239Standard: General laboratory systems quality assessment.
§ 493.1240Condition: Preanalytic systems.
§ 493.1241Standard: Test request.
§ 493.1242Standard: Specimen submission, handling, and referral.
§ 493.1249Standard: Preanalytic systems quality assessment.
§ 493.1250Condition: Analytic systems.
§ 493.1251Standard: Procedure manual.
§ 493.1252Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
§ 493.1253Standard: Establishment and verification of performance specifications.
§ 493.1254Standard: Maintenance and function checks.
§ 493.1255Standard: Calibration and calibration verification procedures.
§ 493.1256Standard: Control procedures.
§ 493.1261Standard: Bacteriology.
§ 493.1262Standard: Mycobacteriology.
§ 493.1263Standard: Mycology.
§ 493.1264Standard: Parasitology.
§ 493.1265Standard: Virology.
§ 493.1267Standard: Routine chemistry.
§ 493.1269Standard: Hematology.
§ 493.1271Standard: Immunohematology.
§ 493.1273Standard: Histopathology.
§ 493.1274Standard: Cytology.
§ 493.1276Standard: Clinical cytogenetics.
§ 493.1278Standard: Histocompatibility.
§ 493.1281Standard: Comparison of test results.
§ 493.1282Standard: Corrective actions.
§ 493.1283Standard: Test records.
§ 493.1289Standard: Analytic systems quality assessment.
§ 493.1290Condition: Postanalytic systems.
§ 493.1291Standard: Test report.
§ 493.1299Standard: Postanalytic systems quality assessment.
§ 493.1351General.
§ 493.1353Scope.
§ 493.1355Condition: Laboratories performing PPM procedures; laboratory director.
§ 493.1357Standard; laboratory director qualifications.
§ 493.1359Standard; PPM laboratory director responsibilities.
§ 493.1361Condition: Laboratories performing PPM procedures; testing personnel.
§ 493.1363Standard: PPM testing personnel qualifications.
§ 493.1365Standard; PPM testing personnel responsibilities.
§ 493.1403Condition: Laboratories performing moderate complexity testing; laboratory director.
§ 493.1405Standard; Laboratory director qualifications.
§ 493.1407Standard; Laboratory director responsibilities.
§ 493.1409Condition: Laboratories performing moderate complexity testing; technical consultant.
§ 493.1411Standard; Technical consultant qualifications.
§ 493.1413Standard; Technical consultant responsibilities.
§ 493.1415Condition: Laboratories performing moderate complexity testing; clinical consultant.
§ 493.1417Standard; Clinical consultant qualifications.
§ 493.1419Standard; Clinical consultant responsibilities.
§ 493.1421Condition: Laboratories performing moderate complexity testing; testing personnel.
§ 493.1423Standard; Testing personnel qualifications.
§ 493.1425Standard; Testing personnel responsibilities.
§ 493.1441Condition: Laboratories performing high complexity testing; laboratory director.
§ 493.1443Standard; Laboratory director qualifications.
§ 493.1445Standard; Laboratory director responsibilities.
§ 493.1447Condition: Laboratories performing high complexity testing; technical supervisor.
§ 493.1449Standard; Technical supervisor qualifications.
§ 493.1451Standard: Technical supervisor responsibilities.
§ 493.1453Condition: Laboratories performing high complexity testing; clinical consultant.
§ 493.1455Standard; Clinical consultant qualifications.
§ 493.1457Standard; Clinical consultant responsibilities.
§ 493.1459Condition: Laboratories performing high complexity testing; general supervisor.
§ 493.1461Standard: General supervisor qualifications.
§ 493.1463Standard: General supervisor responsibilities.
§ 493.1467Condition: Laboratories performing high complexity testing; cytology general supervisor.
§ 493.1469Standard: Cytology general supervisor qualifications.
§ 493.1471Standard: Cytology general supervisor responsibilities.
§ 493.1481Condition: Laboratories performing high complexity testing; cytotechnologist.
§ 493.1483Standard: Cytotechnologist qualifications.
§ 493.1485Standard; Cytotechnologist responsibilities.
§ 493.1487Condition: Laboratories performing high complexity testing; testing personnel.
§ 493.1489Standard; Testing personnel qualifications.
§ 493.1495Standard; Testing personnel responsibilities.
§ 493.1771Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
§ 493.1773Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
§ 493.1775Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
§ 493.1777Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
§ 493.1780Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
§ 493.1800Basis and scope.
§ 493.1804General considerations.
§ 493.1806Available sanctions: All laboratories.
§ 493.1807Additional sanctions: Laboratories that participate in Medicare.
§ 493.1808Adverse action on any type of CLIA certificate: Effect on Medicare approval.
§ 493.1809Limitation on Medicaid payment.
§ 493.1810Imposition and lifting of alternative sanctions.
§ 493.1812Action when deficiencies pose immediate jeopardy.
§ 493.1814Action when deficiencies are at the condition level but do not pose immediate jeopardy.
§ 493.1816Action when deficiencies are not at the condition level.
§ 493.1820Ensuring timely correction of deficiencies.
§ 493.1826Suspension of part of Medicare payments.
§ 493.1828Suspension of all Medicare payments.
§ 493.1832Directed plan of correction and directed portion of a plan of correction.
§ 493.1834Civil money penalty.
§ 493.1836State onsite monitoring.
§ 493.1838Training and technical assistance for unsuccessful participation in proficiency testing.
§ 493.1840Suspension, limitation, or revocation of any type of CLIA certificate.
§ 493.1842Cancellation of Medicare approval.
§ 493.1844Appeals procedures.
§ 493.1846Civil action.
§ 493.1850Laboratory registry.
§ 493.2001Establishment and function of the Clinical Laboratory Improvement Advisory Committee.