Part 493 — Laboratory Requirements
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
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
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— Fees for revised and replacement certificates.
- § 493.643— Additional fees applicable to laboratories issued a certificate of compliance.
- § 493.645— Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
- § 493.649— Additional fees applicable to approved State laboratory programs.
- § 493.655— Payment of fees.
- § 493.680— Methodology for determining the biennial fee increase.
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.
- § 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.
- § 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
Subpart K — Quality System 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.
- § 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 quality assessment.
- § 493.1240— Condition: Preanalytic systems.
- § 493.1241— Standard: Test request.
- § 493.1242— Standard: Specimen submission, handling, and referral.
- § 493.1249— Standard: Preanalytic systems quality assessment.
- § 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 quality assessment.
- § 493.1290— Condition: Postanalytic systems.
- § 493.1291— Standard: Test report.
- § 493.1299— Standard: Postanalytic systems quality assessment.
Subpart M — Personnel for Nonwaived Testing
- § 493.1351— General.
- § 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.
- § 493.1403— Condition: Laboratories performing moderate complexity testing; laboratory director.
- § 493.1405— Standard; Laboratory director qualifications.
- § 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.
- § 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.
- § 493.1463— 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.
- § 493.1495— Standard; Testing personnel responsibilities.
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.