42 CFR Part 493
PART 493—LABORATORY REQUIREMENTS
- PART 493—LABORATORY REQUIREMENTS
- Chapter IV—Centers for Medicare & Medicaid Services, Department of Health and Human Services › Subchapter G—Standards and Certification
- 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.
- § 493.41 Condition: Reporting of SARS-CoV-2 test results.
- 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 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 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 Standard: Facilities.
- § 493.1103 Standard: Requirements for transfusion services.
- § 493.1105 Standard: Retention requirements.
- 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.
- 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 quality 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 quality 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 quality assessment.
- Postanalytic Systems
- § 493.1290 Condition: Postanalytic systems.
- § 493.1291 Standard: Test report.
- § 493.1299 Standard: Postanalytic systems quality 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.
- § 493.1407 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.
- § 493.1463 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.
- Subparts N-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.
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