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Section 493.1
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Definitions |
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Section 493.2
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Applicability |
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Section 493.3
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Categories of tests by complexity |
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Section 493.5
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Laboratories performing waived tests |
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Section 493.15
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Test categorization |
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Section 493.17
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Provider-performed microscopy (PPM) procedures |
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Section 493.19
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Laboratories performing tests of moderate complexity |
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Section 493.20
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Laboratories performing tests of high complexity |
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Section 493.25
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Application for a certificate of waiver |
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Section 493.35
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Requirements for a certificate of waiver |
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Section 493.37
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Notification requirements for laboratories issued a certificate of waiver |
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Section 493.39
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Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate |
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Section 493.43
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Requirements for a registration certificate |
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Section 493.45
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Requirements for a certificate for provider-performed microscopy (PPM) procedures |
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Section 493.47
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Requirements for a certificate of compliance |
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Section 493.49
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Notification requirements for laboratories issued a certificate of compliance |
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Section 493.51
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Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures |
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Section 493.53
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Application for registration certificate and certificate of accreditation |
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Section 493.55
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Requirements for a registration certificate |
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Section 493.57
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Requirements for a certificate of accreditation |
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Section 493.61
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Notification requirements for laboratories issued a certificate of accreditation |
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Section 493.63
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General requirements for laboratories |
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Section 493.551
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Approval process (application and reapplication) for accreditation organizations and State licensure programs |
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Section 493.553
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Federal review of laboratory requirements |
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Section 493.555
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Additional submission requirements |
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Section 493.557
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Publication of approval of deeming authority or CLIA exemption |
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Section 493.559
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Denial of application or reapplication |
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Section 493.561
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Validation inspections--Basis and focus |
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Section 493.563
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Selection for validation inspection--laboratory responsibilities |
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Section 493.565
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Refusal to cooperate with validation inspection |
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Section 493.567
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Consequences of a finding of noncompliance as a result of a validation inspection |
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Section 493.569
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Disclosure of accreditation, State and CMS validation inspection results |
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Section 493.571
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Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs |
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Section 493.573
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Removal of deeming authority or CLIA exemption and final determination review |
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Section 493.575
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Scope of subpart |
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Section 493.602
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Applicability of subpart |
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Section 493.606
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Certificate fees |
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Section 493.638
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Fee for revised certificate |
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Section 493.639
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Fee for determination of program compliance |
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Section 493.643
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Additional fee(s) applicable to approved State laboratory programs and laboratories issued a certificate of |
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Section 493.645
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Payment of fees |
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Section 493.646
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Methodology for determining fee amount |
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Section 493.649
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Condition: Enrollment and testing of samples |
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Section 493.801
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Condition: Successful participation |
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Section 493.803
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Condition: Reinstatement of laboratories performing nonwaived testing |
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Section 493.807
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Condition: Microbiology |
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Section 493.821
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Standard; Bacteriology |
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Section 493.823
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Standard; Mycobacteriology |
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Section 493.825
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Standard; Mycology |
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Section 493.827
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Standard; Parasitology |
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Section 493.829
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Standard; Virology |
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Section 493.831
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Condition: Diagnostic immunology |
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Section 493.833
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Standard; Syphilis serology |
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Section 493.835
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Standard; General immunology |
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Section 493.837
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Condition: Chemistry |
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Section 493.839
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Standard; Routine chemistry |
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Section 493.841
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Standard; Endocrinology |
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Section 493.843
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Standard; Toxicology |
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Section 493.845
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Condition: Hematology |
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Section 493.849
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Standard; Hematology |
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Section 493.851
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Condition: Pathology |
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Section 493.853
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Standard; Cytology: gynecologic examinations |
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Section 493.855
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Condition: Immunohematology |
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Section 493.857
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Standard; ABO group and D (Rho) typing |
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Section 493.859
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Standard; Unexpected antibody detection |
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Section 493.861
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Standard; Compatibility testing |
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Section 493.863
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Standard; Antibody identification |
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Section 493.865
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Approval of proficiency testing programs |
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Section 493.901
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Administrative responsibilities |
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Section 493.903
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Nonapproved proficiency testing programs |
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Section 493.905
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Microbiology |
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Section 493.909
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Bacteriology |
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Section 493.911
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Mycobacteriology |
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Section 493.913
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Mycology |
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Section 493.915
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Parasitology |
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Section 493.917
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Virology |
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Section 493.919
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Diagnostic immunology |
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Section 493.921
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Syphilis serology |
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Section 493.923
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General immunology |
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Section 493.927
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Chemistry |
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Section 493.929
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Routine chemistry |
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Section 493.931
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Endocrinology |
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Section 493.933
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Toxicology |
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Section 493.937
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Hematology (including routine hematology and coagulation) |
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Section 493.941
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Cytology; gynecologic examinations |
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Section 493.945
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Immunohematology |
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Section 493.959
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Condition: Facility administration |
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Section 493.1100
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Standard: Facilities |
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Section 493.1101
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Standard: Requirements for transfusion services |
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Section 493.1103
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Standard: Retention requirements |
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Section 493.1105
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Introduction |
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Section 493.1200
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Condition: Bacteriology |
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Section 493.1201
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Condition: Mycobacteriology |
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Section 493.1202
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Condition: Mycology |
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Section 493.1203
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Condition: Parasitology |
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Section 493.1204
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Condition: Virology |
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Section 493.1205
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Condition: Syphilis serology |
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Section 493.1207
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Condition: General immunology |
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Section 493.1208
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Condition: Routine chemistry |
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Section 493.1210
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Condition: Urinalysis |
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Section 493.1211
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Condition: Endocrinology |
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Section 493.1212
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Condition: Toxicology |
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Section 493.1213
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Condition: Hematology |
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Section 493.1215
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Condition: Immunohematology |
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Section 493.1217
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Condition: Histopathology |
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Section 493.1219
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Condition: Oral pathology |
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Section 493.1220
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Condition: Cytology |
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Section 493.1221
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Condition: Clinical cytogenetics |
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Section 493.1225
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Condition: Radiobioassay |
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Section 493.1226
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Condition: Histocompatibility |
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Section 493.1227
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Condition: General laboratory systems |
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Section 493.1230
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Standard: Confidentiality of patient information |
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Section 493.1231
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Standard: Specimen identification and integrity |
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Section 493.1232
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Standard: Complaint investigations |
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Section 493.1233
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Standard: Communications |
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Section 493.1234
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Standard: Personnel competency assessment policies |
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Section 493.1235
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Standard: Evaluation of proficiency testing performance |
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Section 493.1236
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Standard: General laboratory systems quality assessment |
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Section 493.1239
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Condition: Preanalytic systems |
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Section 493.1240
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Standard: Test request |
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Section 493.1241
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Standard: Specimen submission, handling, and referral |
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Section 493.1242
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Standard: Preanalytic systems quality assessment |
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Section 493.1249
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Condition: Analytic systems |
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Section 493.1250
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Standard: Procedure manual |
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Section 493.1251
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Standard: Test systems, equipment, instruments, reagents, materials, and supplies |
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Section 493.1252
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Standard: Establishment and verification of performance specifications |
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Section 493.1253
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Standard: Maintenance and function checks |
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Section 493.1254
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Standard: Calibration and calibration verification procedures |
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Section 493.1255
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Standard: Control procedures |
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Section 493.1256
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Standard: Bacteriology |
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Section 493.1261
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Standard: Mycobacteriology |
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Section 493.1262
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Standard: Mycology |
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Section 493.1263
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Standard: Parasitology |
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Section 493.1264
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Standard: Virology |
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Section 493.1265
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Standard: Routine chemistry |
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Section 493.1267
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Standard: Hematology |
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Section 493.1269
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Standard: Immunohematology |
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Section 493.1271
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Standard: Histopathology |
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Section 493.1273
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Standard: Cytology |
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Section 493.1274
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Standard: Clinical cytogenetics |
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Section 493.1276
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Standard: Histocompatibility |
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Section 493.1278
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Standard: Comparison of test results |
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Section 493.1281
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Standard: Corrective actions |
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Section 493.1282
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Standard: Test records |
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Section 493.1283
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Standard: Analytic systems quality assessment |
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Section 493.1289
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Condition: Postanalytic systems |
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Section 493.1290
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Standard: Test report |
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Section 493.1291
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Standard: Postanalytic systems quality assessment |
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Section 493.1299
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General |
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Section 493.1351
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Scope |
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Section 493.1353
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Condition: Laboratories performing PPM procedures; laboratory director |
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Section 493.1355
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Standard; laboratory director qualifications |
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Section 493.1357
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Standard; PPM laboratory director responsibilities |
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Section 493.1359
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Condition: Laboratories performing PPM procedures; testing personnel |
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Section 493.1361
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Standard: PPM testing personnel qualifications |
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Section 493.1363
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Standard; PPM testing personnel responsibilities |
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Section 493.1365
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Condition: Laboratories performing moderate complexity testing; laboratory director |
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Section 493.1403
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Standard; Laboratory director qualifications |
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Section 493.1405
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Standard; Laboratory director qualifications on or before February 28, 1992 |
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Section 493.1406
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Standard; Laboratory director responsibilities |
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Section 493.1407
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Condition: Laboratories performing moderate complexity testing; technical consultant |
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Section 493.1409
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Standard; Technical consultant qualifications |
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Section 493.1411
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Standard; Technical consultant responsibilities |
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Section 493.1413
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Condition: Laboratories performing moderate complexity testing; clinical consultant |
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Section 493.1415
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Standard; Clinical consultant responsibilities |
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Section 493.1419
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Condition: Laboratories performing moderate complexity testing; testing personnel |
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Section 493.1421
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Standard; Testing personnel qualifications |
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Section 493.1423
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Standard; Testing personnel responsibilities |
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Section 493.1425
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Condition: Laboratories performing high complexity testing; laboratory director |
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Section 493.1441
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Standard; Laboratory director qualifications |
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Section 493.1443
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Standard; Laboratory director responsibilities |
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Section 493.1445
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Condition: Laboratories performing high complexity testing; technical supervisor |
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Section 493.1447
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Standard; Technical supervisor qualifications |
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Section 493.1449
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Standard: Technical supervisor responsibilities |
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Section 493.1451
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Condition: Laboratories performing high complexity testing; clinical consultant |
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Section 493.1453
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Standard; Clinical consultant qualifications |
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Section 493.1455
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Standard; Clinical consultant responsibilities |
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Section 493.1457
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Condition: Laboratories performing high complexity testing; general supervisor |
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Section 493.1459
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Standard: General supervisor qualifications |
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Section 493.1461
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General supervisor qualifications on or before February 28, 1992 |
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Section 493.1462
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Standard: General supervisor responsibilities |
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Section 493.1463
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Condition: Laboratories performing high complexity testing; cytology general supervisor |
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Section 493.1467
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Standard: Cytology general supervisor qualifications |
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Section 493.1469
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Standard: Cytology general supervisor responsibilities |
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Section 493.1471
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Condition: Laboratories performing high complexity testing; cytotechnologist |
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Section 493.1481
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Standard: Cytotechnologist qualifications |
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Section 493.1483
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Standard; Cytotechnologist responsibilities |
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Section 493.1485
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Condition: Laboratories performing high complexity testing; testing personnel |
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Section 493.1487
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Standard; Testing personnel qualifications |
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Section 493.1489
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Technologist qualifications on or before February 28, 1992 |
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Section 493.1491
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Standard; Testing personnel responsibilities |
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Section 493.1495
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Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories |
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Section 493.1771
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Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories |
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Section 493.1773
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Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed |
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Section 493.1775
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Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance |
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Section 493.1777
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Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation |
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Section 493.1780
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Basis and scope |
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Section 493.1800
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General considerations |
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Section 493.1804
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Available sanctions: All laboratories |
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Section 493.1806
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Additional sanctions: Laboratories that participate in Medicare |
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Section 493.1807
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Adverse action on any type of CLIA certificate: Effect on Medicare approval |
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Section 493.1808
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Limitation on Medicaid payment |
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Section 493.1809
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Imposition and lifting of alternative sanctions |
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Section 493.1810
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Action when deficiencies pose immediate jeopardy |
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Section 493.1812
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Action when deficiencies are at the condition level but do not pose immediate jeopardy |
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Section 493.1814
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Action when deficiencies are not at the condition level |
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Section 493.1816
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Ensuring timely correction of deficiencies |
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Section 493.1820
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Suspension of part of Medicare payments |
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Section 493.1826
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Suspension of all Medicare payments |
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Section 493.1828
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Directed plan of correction and directed portion of a plan of correction |
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Section 493.1832
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Civil money penalty |
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Section 493.1834
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State onsite monitoring |
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Section 493.1836
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Training and technical assistance for unsuccessful participation in proficiency testing |
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Section 493.1838
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Suspension, limitation, or revocation of any type of CLIA certificate |
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Section 493.1840
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Cancellation of Medicare approval |
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Section 493.1842
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Appeals procedures |
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Section 493.1844
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Civil action |
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Section 493.1846
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Laboratory registry |
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Section 493.1850
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Establishment and function of the Clinical Laboratory Improvement Advisory Committee |
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Section 493.2001
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Basis and scope |