Current CLIA Regulations
(including all changes through
01/24/2004)
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|
While every effort is made to ensure the accuracy of this
hyperlinked version of the regulations, the 2004
Codification is the definitive document. A
linked version of the offical regulation may be found on the Government
Printing Office (GPO) site.
Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory
Services (Appendix C)
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PART 493--LABORATORY REQUIREMENTS
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| Subpart A--General Provisions
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|
Section |
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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 |
|
Section |
|
|
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 |
| |
| Subpart C--Registration
Certificate, Certificate for Provider-performed Microscopy Procedures, and
Certificate of Compliance |
|
Section |
|
|
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 |
|
Section |
|
|
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 |
|
Section |
|
|
493.551 |
General requirements for laboratories |
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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 |
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493.565
|
Selection for validation
inspection--laboratory responsibilities |
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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 |
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493.575
|
Removal of deeming authority or CLIA
exemption and final determination review |
| |
| Subpart F--General Administration |
|
Section
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493.602
|
Scope of subpart |
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493.606
|
Applicability of subpart |
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493.638
|
Certificate fees |
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493.639
|
Fee for revised certificate |
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493.643
|
Fee for determination of program
compliance |
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493.645
|
Additional fee(s) applicable to approved State
laboratory programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM procedure |
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493.646
|
Payment of fees |
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493.649
|
Methodology for determining fee
amount |
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| Subpart G [Reserved] |
| |
| Subpart H--Participation in
Proficiency Testing for Laboratories Performing
Nonwaived Testing |
|
Section
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493.801
|
Condition: Enrollment and testing of
samples |
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493.803
|
Condition: Successful participation |
|
493.807
|
Condition: Reinstatement of
laboratories performing
nonwaived testing |
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|
-
Proficiency Testing by Specialty and Subspecialty for Laboratories Performing
Tests of Moderate Complexity (Including the Subcategory), High Complexity, or
Any Combination of These Tests
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|
Section
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493.821
|
Condition: Microbiology |
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493.823
|
Standard; Bacteriology |
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493.825
|
Standard; Mycobacteriology |
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493.827
|
Standard; Mycology |
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493.829
|
Standard; Parasitology |
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493.831
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Standard; Virology |
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493.833
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Condition: Diagnostic immunology |
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493.835
|
Standard; Syphilis serology |
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493.837
|
Standard; General immunology |
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493.839
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Condition: Chemistry |
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493.841
|
Standard; Routine chemistry |
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493.843
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Standard; Endocrinology |
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493.845
|
Standard; Toxicology |
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493.849
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Condition: Hematology |
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493.851
|
Standard; Hematology |
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493.853
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Condition: Pathology |
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493.855
|
Standard; Cytology: gynecologic
examinations |
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493.857
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Condition: Immunohematology |
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493.859
|
Standard; ABO group and D (Rho)
typing |
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493.861
|
Standard; Unexpected antibody
detection |
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493.863
|
Standard; Compatibility testing |
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493.865
|
Standard; Antibody identification |
| |
| Subpart I--Proficiency Testing
Programs for
Nonwaived Testing |
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Section
|
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493.901
|
Approval of proficiency testing
programs |
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493.903
|
Administrative responsibilities |
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493.905
|
Nonapproved proficiency testing
programs |
| |
-
Proficiency Testing Programs by Specialty and Subspecialty
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Section
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493.909
|
Microbiology |
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493.911
|
Bacteriology |
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493.913
|
Mycobacteriology |
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493.915
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Mycology |
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493.917
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Parasitology |
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493.919
|
Virology |
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493.921
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Diagnostic immunology |
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493.923
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Syphilis serology |
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493.927
|
General immunology |
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493.929
|
Chemistry |
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493.931
|
Routine chemistry |
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493.933
|
Endocrinology |
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493.937
|
Toxicology |
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493.941
|
Hematology (including routine
hematology and coagulation) |
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493.945
|
Cytology; gynecologic examinations |
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493.959
|
Immunohematology |
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| Subpart J--
Facility Administration for Nonwaived Testing |
|
Section
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493.1100
|
Condition: Facility
administration |
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493.1101
|
Standards:
Facilities
|
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493.1103
|
Standard: Requirements for
transfusion services |
|
493.1105
|
Standard: Retention
requirements |
| |
| Subpart K--Quality
Systems for Nonwaived Testing |
|
Section
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493.1200 |
Introduction |
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493.1201
|
Condition Bacteriology
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493.1202
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Condition: Mycobacteriology
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493.1203
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Condition: Mycology
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493.1204
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Condition: Parasitology |
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493.1205
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Condition: Virology |
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493.1207
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Condition: Syphilis serology
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493.1208
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Condition: General immunology |
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493.1210
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Condition: Routine chemistry |
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493.1211
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Condition: Urinalysis
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493.1212
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Condition: Endocrinology |
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493.1213
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Condition: Toxicology
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493.1215
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Condition: Hematology
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493.1217
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Condition: Immunohematology
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493.1219
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Condition: Histopathology
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493.1220
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Condition: Oral pathology |
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493.1221
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Condition: Cytology
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493.1225
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Condition: Clinical cytogenetics
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493.1226
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Condition: Radiobioassay |
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493.1227
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Condition: Histocompatibility |
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General Laboratory Systems
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493.1230
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Condition: General laboratory
systems
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493.1231
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Standard: Confidentiality of patient
information
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493.1232
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Standard: Specimen identification
and integrity |
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493.1233
|
Standard: Complaint
investigations |
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493.1234
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Standard: Communications |
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493.1235
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Standard: Personnel competency
assessment policies |
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493.1236
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Standard: Evaluation of
proficiency testing performance
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493.1239
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Standard: General laboratory
systems assessment
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Preanalytic Systems |
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493.1240
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Condition: Preanalytic systems |
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493.1241
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Standard: Test request |
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493.1242
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Standard: Specimen submission,
handling, and referral
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493.1249
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Standard: Preanalytic systems
assessment
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Analytic Systems |
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493.1250
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Condition: Analytic Systems |
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493.1251
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Standard: Procedure manual
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493.1252
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Standard: Test systems,
equipment, instruments, reagents, materials, and supplies
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493.1253
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Standard: Establishment and
verification of performance specifications
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493.1254
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Standard: Maintenance and
function checks |
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493.1255
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Standard: Calibration and
calibration verification procedures
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493.1256
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Standard: Control procedures
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493.1261
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Standard: Bacteriology
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493.1262
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Standard: Mycobacteriology
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493.1263
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Standard: Mycology
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493.1264
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Standard: Parasitology
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493.1265
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Standard: Virology |
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493.1267
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Standard: Routine chemistry
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493.1269
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Standard: Hematology
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493.1271
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Standard: Immunohematology
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493.1273
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Standard: Histopathology
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493.1274 |
Standard: Cytology
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493.1276 |
Standard: Clinical
cytogenetics |
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493.1278 |
Standard: Histocompatibility
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493.1281
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Standard: Comparison of test
results |
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493.1282
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Standard: Corrective actions |
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493.1283
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Standard: Test records |
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493.1289
|
Standard: Analytic systems
assessment
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Post Analytic Systems |
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493.1290 |
Condition: Postanalytic
systems |
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493.1291 |
Standard: Test report
|
|
493.1299 |
Standard: Postanalytic systems
assessment |
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| Subpart L [Reserved] |
| |
| Subpart M--Personnel for
Nonwaived Testing |
|
Section
|
|
|
493.1351
|
General |
| |
-
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
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|
Section
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|
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493.1353
|
Scope |
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493.1355
|
Condition: Laboratories performing
PPM procedures; laboratory director |
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493.1357
|
Standard; laboratory director
qualifications |
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493.1359
|
Standard; PPM laboratory director
responsibilities |
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493.1361
|
Condition: Laboratories performing
PPM procedures; testing personnel |
|
493.1363
|
Standard; PPM testing personnel
qualifications |
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493.1365
|
Standard; PPM testing personnel
responsibilities |
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-
Laboratories Performing Moderate Complexity Testing
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|
Section
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|
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493.1403
|
Condition: Laboratories performing
moderate complexity testing; laboratory director |
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493.1405
|
Standard; Laboratory director
qualifications |
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493.1406
|
Standard; Laboratory director
qualifications on or before February 28, 1992 |
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493.1407
|
Standard; Laboratory director
responsibilities |
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493.1409
|
Condition: Laboratories performing
moderate complexity testing; technical consultant |
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493.1411
|
Standard; Technical consultant
qualifications |
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493.1413
|
Standard; Technical consultant
responsibilities
|
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493.1415
|
Condition: Laboratories performing
moderate complexity testing; clinical consultant |
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493.1417
|
Standard; Clinical consultant
qualifications |
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493.1419
|
Standard; Clinical consultant
responsibilities |
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493.1421
|
Condition: Laboratories performing
moderate complexity testing; testing personnel |
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493.1423
|
Standard; Testing personnel
qualifications |
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493.1425
|
Standard; Testing personnel
responsibilities |
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-
Laboratories Performing High Complexity Testing
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|
Section
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|
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493.1441
|
Condition: Laboratories performing
high complexity testing; laboratory director |
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493.1443
|
Standard; Laboratory director
qualifications |
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493.1445
|
Standard; Laboratory director
responsibilities |
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493.1447
|
Condition: Laboratories performing
high complexity testing; technical supervisor |
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493.1449
|
Standard; Technical supervisor
qualifications |
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493.1451
|
Standard; Technical supervisor
responsibilities |
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493.1453
|
Condition: Laboratories performing
high complexity testing; clinical consultant |
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493.1455
|
Standard; Clinical consultant
qualifications |
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493.1457
|
Standard; Clinical consultant
responsibilities |
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493.1459
|
Condition: Laboratories performing
high complexity testing; general supervisor |
|
493.1461
|
Standard; General supervisor
qualifications |
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493.1462
|
General supervisor qualifications on
or before February 28, 1992 |
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493.1463
|
Standard; General supervisor
responsibilities |
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[[Page881]]
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|
493.1467
|
Condition: Laboratories performing
high complexity testing; cytology general supervisor |
|
493.1469
|
Standard; Cytology general
supervisor qualifications |
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493.1471
|
Standard; Cytology general
supervisor responsibilities |
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493.1481
|
Condition: Laboratories performing
high complexity testing; cytotechnologist |
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493.1483
|
Standard; Cytotechnologist
qualifications |
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493.1485
|
Standard; Cytotechnologist
responsibilities |
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493.1487
|
Condition: Laboratories performing
high complexity testing; testing personnel |
|
493.1489
|
Standard; Testing personnel
qualifications |
|
493.1491
|
Technologist qualifications on or
before February 28, 1992 |
|
493.1495
|
Standard; Testing personnel
responsibilities |
| |
| Subparts N-O [Reserved] |
| |
| Subparts
P
[Reserved] |
| |
| Subpart Q--Inspection |
|
Section
|
|
|
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 |
|
Section
|
|
|
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 |
|
Section
|
|
|
493.2001
|
Establishment and function of the Clinical
Laboratory Improvement Advisory Committee |
| |
| Authority: Sec. 353 of the Public Health Service Act,
secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the
sentence following 1395x(s)(11) through 1395x(s)(16)) |
| |
| Source: 55 FR 9576, Mar. 14, 1990, unless otherwise
noted
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