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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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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