42 C.F.R. PART 493--LABORATORY REQUIREMENTS
TITLE 42--Public Health
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER G--STANDARDS AND CERTIFICATION
PART 493--LABORATORY REQUIREMENTS
Subpart A--GENERAL PROVISIONS
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| Categories of tests by complexity.
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| Laboratories performing waived tests.
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| Provider-performed microscopy (PPM) procedures.
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| Laboratories performing tests of moderate complexity.
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| Laboratories performing tests of high complexity.
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Subpart B--CERTIFICATE OF WAIVER
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| Application for a certificate of waiver.
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| Requirements for a certificate of waiver.
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| Notification requirements for laboratories issued a certificate of waiver.
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Subpart C--REGISTRATION CERTIFICATE, CERTIFICATE FOR PROVIDER-PERFORMED MICROSCOPY PROCEDURES, AND CERTIFICATE OF COMPLIANCE
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| Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.
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| Requirements for a registration certificate.
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| Requirements for a certificate for provider-performed microscopy (PPM) procedures.
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| Requirements for a certificate of compliance.
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| Notification requirements for laboratories issued a certificate of compliance.
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| Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
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Subpart D--CERTIFICATE OF ACCREDITATION
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| Application for registration certificate and certificate of accreditation.
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| Requirements for a registration certificate.
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| Requirements for a certificate of accreditation.
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| Notification requirements for laboratories issued a certificate of accreditation.
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Subpart E--ACCREDITATION BY A PRIVATE, NONPROFIT ACCREDITATION ORGANIZATION OR EXEMPTION UNDER AN APPROVED STATE LABORATORY PROGRAM
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| General requirements for laboratories.
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| Approval process (application and reapplication) for accreditation organizations and State licensure programs.
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| Federal review of laboratory requirements.
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| Additional submission requirements.
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| Publication of approval of deeming authority or CLIA exemption.
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| Denial of application or reapplication.
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| Validation inspections--Basis and focus.
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| Selection for validation inspection--laboratory responsibilities.
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| Refusal to cooperate with validation inspection.
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| Consequences of a finding of noncompliance as a result of a validation inspection.
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| Disclosure of accreditation, State and CMS validation inspection results.
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| Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
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| Removal of deeming authority or CLIA exemption and final determination review.
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Subpart F--GENERAL ADMINISTRATION
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| Applicability of subpart.
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| Fee for revised certificate.
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| Fee for determination of program compliance.
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| Additional fee(s) applicable to approved State laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
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| Methodology for determining fee amount.
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Subpart G--[RESERVED]
Subpart H--PARTICIPATION IN PROFICIENCY TESTING FOR LABORATORIES PERFORMING NONWAIVED TESTING
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| Condition: Enrollment and testing of samples.
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| Condition: Successful participation.
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| Condition: Reinstatement of laboratories performing nonwaived testing.
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| Standard; Mycobacteriology.
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| Condition: Diagnostic immunology.
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| Standard; Syphilis serology.
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| Standard; General immunology.
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| Standard; Routine chemistry.
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| Standard; Cytology: gynecologic examinations.
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| Condition: Immunohematology.
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| Standard; ABO group and D (Rho) typing.
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| Standard; Unexpected antibody detection.
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| Standard; Compatibility testing.
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| Standard; Antibody identification.
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Subpart I--PROFICIENCY TESTING PROGRAMS FOR NONWAIVED TESTING
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| Approval of proficiency testing programs.
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| Administrative responsibilities.
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| Nonapproved proficiency testing programs.
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| Hematology (including routine hematology and coagulation).
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| Cytology; gynecologic examinations.
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Subpart J--FACILITY ADMINISTRATION FOR NONWAIVED TESTING
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| Condition: Facility administration.
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| Standard: Requirements for transfusion services.
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| Standard: Retention requirements.
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Subpart K--QUALITY SYSTEM FOR NONWAIVED TESTING
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| Condition: Mycobacteriology.
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| Condition: Syphilis serology.
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| Condition: General immunology.
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| Condition: Routine chemistry.
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| Condition: Endocrinology.
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| Condition: Immunohematology.
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| Condition: Histopathology.
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| Condition: Oral pathology.
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| Condition: Clinical cytogenetics.
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| Condition: Radiobioassay.
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| Condition: Histocompatibility.
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| Condition: General laboratory systems.
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| Standard: Confidentiality of patient information.
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| Standard: Specimen identification and integrity.
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| Standard: Complaint investigations.
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| Standard: Communications.
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| Standard: Personnel competency assessment policies.
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| Standard: Evaluation of proficiency testing performance.
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| Standard: General laboratory systems quality assessment.
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| Condition: Preanalytic systems.
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| Standard: Specimen submission, handling, and referral.
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| Standard: Preanalytic systems quality assessment.
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| Condition: Analytic systems.
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| Standard: Procedure manual.
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| Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
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| Standard: Establishment and verification of performance specifications.
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| Standard: Maintenance and function checks.
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| Standard: Calibration and calibration verification procedures.
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| Standard: Control procedures.
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| Standard: Mycobacteriology.
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| Standard: Routine chemistry.
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| Standard: Immunohematology.
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| Standard: Histopathology.
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| Standard: Clinical cytogenetics.
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| Standard: Histocompatibility.
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| Standard: Comparison of test results.
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| Standard: Corrective actions.
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| Standard: Analytic systems quality assessment.
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| Condition: Postanalytic systems.
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| Standard: Postanalytic systems quality assessment.
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Subpart L--[RESERVED]
Subpart M--PERSONNEL FOR NONWAIVED TESTING
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| Condition: Laboratories performing PPM procedures; laboratory director.
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| Standard; laboratory director qualifications.
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| Standard; PPM laboratory director responsibilities.
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| Condition: Laboratories performing PPM procedures; testing personnel.
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| Standard: PPM testing personnel qualifications.
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| Standard; PPM testing personnel responsibilities.
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| Condition: Laboratories performing moderate complexity testing; laboratory director.
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| Standard; Laboratory director qualifications.
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| Standard; Laboratory director qualifications on or before February 28, 1992.
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| Standard; Laboratory director responsibilities.
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| Condition: Laboratories performing moderate complexity testing; technical consultant.
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| Standard; Technical consultant qualifications.
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| Standard; Technical consultant responsibilities.
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| Condition: Laboratories performing moderate complexity testing; clinical consultant.
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| Standard; Clinical consultant qualifications.
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| Standard; Clinical consultant responsibilities.
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| Condition: Laboratories performing moderate complexity testing; testing personnel.
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| Standard; Testing personnel qualifications.
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| Standard; Testing personnel responsibilities.
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| Condition: Laboratories performing high complexity testing; laboratory director.
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| Standard; Laboratory director qualifications.
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| Standard; Laboratory director responsibilities.
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| Condition: Laboratories performing high complexity testing; technical supervisor.
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| Standard; Technical supervisor qualifications.
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| Standard: Technical supervisor responsibilities.
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| Condition: Laboratories performing high complexity testing; clinical consultant.
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| Standard; Clinical consultant qualifications.
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| Standard; Clinical consultant responsibilities.
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| Condition: Laboratories performing high complexity testing; general supervisor.
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| Standard: General supervisor qualifications.
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| General supervisor qualifications on or before February 28, 1992.
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| Standard: General supervisor responsibilities.
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| Condition: Laboratories performing high complexity testing; cytology general supervisor.
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| Standard: Cytology general supervisor qualifications.
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| Standard: Cytology general supervisor responsibilities.
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| Condition: Laboratories performing high complexity testing; cytotechnologist.
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| Standard: Cytotechnologist qualifications.
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| Standard; Cytotechnologist responsibilities.
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| Condition: Laboratories performing high complexity testing; testing personnel.
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| Standard; Testing personnel qualifications.
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| Technologist qualifications on or before February 28, 1992.
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| Standard; Testing personnel responsibilities.
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Subparts N-P--[RESERVED]
Subpart Q--INSPECTION
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| Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
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| Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
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| Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
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| Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
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| Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
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Subpart R--ENFORCEMENT PROCEDURES
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| Available sanctions: All laboratories.
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| Additional sanctions: Laboratories that participate in Medicare.
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| Adverse action on any type of CLIA certificate: Effect on Medicare approval.
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| Limitation on Medicaid payment.
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| Imposition and lifting of alternative sanctions.
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| Action when deficiencies pose immediate jeopardy.
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| Action when deficiencies are at the condition level but do not pose immediate jeopardy.
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| Action when deficiencies are not at the condition level.
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| Ensuring timely correction of deficiencies.
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| Suspension of part of Medicare payments.
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| Suspension of all Medicare payments.
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| Directed plan of correction and directed portion of a plan of correction.
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| Training and technical assistance for unsuccessful participation in proficiency testing.
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| Suspension, limitation, or revocation of any type of CLIA certificate.
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| Cancellation of Medicare approval.
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Subpart S--[RESERVED]
Subpart T--CONSULTATIONS
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| Establishment and function of the Clinical Laboratory Improvement Advisory Committee.
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