Title 42, Part 493 — Laboratory Requirements

Basis and scope.

Definitions.

Applicability.

Categories of tests by complexity.

Laboratories performing waived tests.

Test categorization.

Provider-performed microscopy (PPM) procedures.

Laboratories performing tests of moderate complexity.

Laboratories performing tests of high complexity.

Application for a certificate of waiver.

Requirements for a certificate of waiver.

Notification requirements for laboratories issued a certificate of waiver.

Condition: Reporting of SARS-CoV-2 test results.

Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.

Requirements for a registration certificate.

Requirements for a certificate for provider-performed microscopy (PPM) procedures.

Requirements for a certificate of compliance.

Notification requirements for laboratories issued a certificate of compliance.

Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.

Application for registration certificate and certificate of accreditation.

Requirements for a registration certificate.

Requirements for a certificate of accreditation.

Notification requirements for laboratories issued a certificate of accreditation.

General requirements for laboratories.

Approval process (application and reapplication) for accreditation organizations and State licensure programs.

Federal review of laboratory requirements.

Additional submission requirements.

Publication of approval of deeming authority or CLIA exemption.

Denial of application or reapplication.

Validation inspections—Basis and focus.

Selection for validation inspection—laboratory responsibilities.

Refusal to cooperate with validation inspection.

Consequences of a finding of noncompliance as a result of a validation inspection.

Disclosure of accreditation, State and CMS validation inspection results.

Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.

Removal of deeming authority or CLIA exemption and final determination review.

Scope of subpart.

Applicability of subpart.

Certificate fees.

Fees for revised and replacement certificates.

Additional fees applicable to laboratories issued a certificate of compliance.

Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.

Additional fees applicable to approved State laboratory programs.

Payment of fees.

Methodology for determining the biennial fee increase.

Condition: Enrollment and testing of samples.

Condition: Successful participation.

Condition: Reinstatement of laboratories performing nonwaived testing.

Condition: Microbiology.

Standard; Bacteriology.

Standard; Mycobacteriology.

Standard; Mycology.

Standard; Parasitology.

Standard; Virology.

Condition: Diagnostic immunology.

Standard; Syphilis serology.

Standard; General immunology.

Condition: Chemistry.

Standard; Routine chemistry.

Standard; Endocrinology.

Standard; Toxicology.

Condition: Hematology.

Standard; Hematology.

Condition: Pathology.

Standard; Cytology: gynecologic examinations.

Condition: Immunohematology.

Standard; ABO group and D (Rho) typing.

Standard; Unexpected antibody detection.

Standard; Compatibility testing.

Standard; Antibody identification.

Approval of proficiency testing programs.

Administrative responsibilities.

Nonapproved proficiency testing programs.

Microbiology.

Bacteriology.

Mycobacteriology.

Mycology.

Parasitology.

Virology.

Diagnostic immunology.

Syphilis serology.

General immunology.

Chemistry.

Routine chemistry.

Endocrinology.

Toxicology.

Hematology (including routine hematology and coagulation).

Cytology; gynecologic examinations.

Immunohematology.

Condition: Facility administration.

Standard: Facilities.

Standard: Requirements for transfusion services.

Standard: Retention requirements.

Introduction.

Condition: Bacteriology.

Condition: Mycobacteriology.

Condition: Mycology.

Condition: Parasitology.

Condition: Virology.

Condition: Syphilis serology.

Condition: General immunology.

Condition: Routine chemistry.

Condition: Urinalysis.

Condition: Endocrinology.

Condition: Toxicology.

Condition: Hematology.

Condition: Immunohematology.

Condition: Histopathology.

Condition: Oral pathology.

Condition: Cytology.

Condition: Clinical cytogenetics.

Condition: Radiobioassay.

Condition: Histocompatibility.

Condition: General laboratory systems.

Standard: Confidentiality of patient information.

Standard: Specimen identification and integrity.

Standard: Complaint investigations.

Standard: Communications.

Standard: Personnel competency assessment policies.

Standard: Evaluation of proficiency testing performance.

Standard: General laboratory systems quality assessment.

Condition: Preanalytic systems.

Standard: Test request.

Standard: Specimen submission, handling, and referral.

Standard: Preanalytic systems quality assessment.

Condition: Analytic systems.

Standard: Procedure manual.

Standard: Test systems, equipment, instruments, reagents, materials, and supplies.

Standard: Establishment and verification of performance specifications.

Standard: Maintenance and function checks.

Standard: Calibration and calibration verification procedures.

Standard: Control procedures.

Standard: Bacteriology.

Standard: Mycobacteriology.

Standard: Mycology.

Standard: Parasitology.

Standard: Virology.

Standard: Routine chemistry.

Standard: Hematology.

Standard: Immunohematology.

Standard: Histopathology.

Standard: Cytology.

Standard: Clinical cytogenetics.

Standard: Histocompatibility.

Standard: Comparison of test results.

Standard: Corrective actions.

Standard: Test records.

Standard: Analytic systems quality assessment.

Condition: Postanalytic systems.

Standard: Test report.

Standard: Postanalytic systems quality assessment.

General.

Scope.

Condition: Laboratories performing PPM procedures; laboratory director.

Standard; laboratory director qualifications.

Standard; PPM laboratory director responsibilities.

Condition: Laboratories performing PPM procedures; testing personnel.

Standard: PPM testing personnel qualifications.

Standard; PPM testing personnel responsibilities.

Condition: Laboratories performing moderate complexity testing; laboratory director.

Standard; Laboratory director qualifications.

Standard; Laboratory director responsibilities.

Condition: Laboratories performing moderate complexity testing; technical consultant.

Standard; Technical consultant qualifications.

Standard; Technical consultant responsibilities.

Condition: Laboratories performing moderate complexity testing; clinical consultant.

Standard; Clinical consultant qualifications.

Standard; Clinical consultant responsibilities.

Condition: Laboratories performing moderate complexity testing; testing personnel.

Standard; Testing personnel qualifications.

Standard; Testing personnel responsibilities.

Condition: Laboratories performing high complexity testing; laboratory director.

Standard; Laboratory director qualifications.

Standard; Laboratory director responsibilities.

Condition: Laboratories performing high complexity testing; technical supervisor.

Standard; Technical supervisor qualifications.

Standard: Technical supervisor responsibilities.

Condition: Laboratories performing high complexity testing; clinical consultant.

Standard; Clinical consultant qualifications.

Standard; Clinical consultant responsibilities.

Condition: Laboratories performing high complexity testing; general supervisor.

Standard: General supervisor qualifications.

Standard: General supervisor responsibilities.

Condition: Laboratories performing high complexity testing; cytology general supervisor.

Standard: Cytology general supervisor qualifications.

Standard: Cytology general supervisor responsibilities.

Condition: Laboratories performing high complexity testing; cytotechnologist.

Standard: Cytotechnologist qualifications.

Standard; Cytotechnologist responsibilities.

Condition: Laboratories performing high complexity testing; testing personnel.

Standard; Testing personnel qualifications.

Standard; Testing personnel responsibilities.

Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.

Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.

Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.

Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.

Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.

Basis and scope.

General considerations.

Available sanctions: All laboratories.

Additional sanctions: Laboratories that participate in Medicare.

Adverse action on any type of CLIA certificate: Effect on Medicare approval.

Limitation on Medicaid payment.

Imposition and lifting of alternative sanctions.

Action when deficiencies pose immediate jeopardy.

Action when deficiencies are at the condition level but do not pose immediate jeopardy.

Action when deficiencies are not at the condition level.

Ensuring timely correction of deficiencies.

Suspension of part of Medicare payments.

Suspension of all Medicare payments.

Directed plan of correction and directed portion of a plan of correction.

Civil money penalty.

State onsite monitoring.

Training and technical assistance for unsuccessful participation in proficiency testing.

Suspension, limitation, or revocation of any type of CLIA certificate.

Cancellation of Medicare approval.

Appeals procedures.

Civil action.

Laboratory registry.

Establishment and function of the Clinical Laboratory Improvement Advisory Committee.