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Electronic Code of Federal Regulations

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e-CFR Data is current as of December 18, 2014

Title 42Chapter IVSubchapter GPart 493


TITLE 42—Public Health

CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER G—STANDARDS AND CERTIFICATION

PART 493—LABORATORY REQUIREMENTS

rule

Subpart A—GENERAL PROVISIONS

§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.
rule

Subpart B—CERTIFICATE OF WAIVER

§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.
rule

Subpart C—REGISTRATION CERTIFICATE, CERTIFICATE FOR PROVIDER-PERFORMED MICROSCOPY PROCEDURES, AND CERTIFICATE OF COMPLIANCE

§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.
rule

Subpart D—CERTIFICATE OF ACCREDITATION

§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.
rule

Subpart E—ACCREDITATION BY A PRIVATE, NONPROFIT ACCREDITATION ORGANIZATION OR EXEMPTION UNDER AN APPROVED STATE LABORATORY PROGRAM

§493.551
General requirements for laboratories.
§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.
§493.565
Selection for validation inspection—laboratory responsibilities.
§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.
§493.575
Removal of deeming authority or CLIA exemption and final determination review.
rule

Subpart F—GENERAL ADMINISTRATION

§493.602
Scope of subpart.
§493.606
Applicability of subpart.
§493.638
Certificate fees.
§493.639
Fee for revised certificate.
§493.643
Fee for determination of program compliance.
§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 procedures.
§493.646
Payment of fees.
§493.649
Methodology for determining fee amount.
rule

Subpart G—[RESERVED]

rule

Subpart H—PARTICIPATION IN PROFICIENCY TESTING FOR LABORATORIES PERFORMING NONWAIVED TESTING

§493.801
Condition: Enrollment and testing of samples.
§493.803
Condition: Successful participation.
§493.807
Condition: Reinstatement of laboratories performing nonwaived testing.

Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests

§493.821
Condition: Microbiology.
§493.823
Standard; Bacteriology.
§493.825
Standard; Mycobacteriology.
§493.827
Standard; Mycology.
§493.829
Standard; Parasitology.
§493.831
Standard; Virology.
§493.833
Condition: Diagnostic immunology.
§493.835
Standard; Syphilis serology.
§493.837
Standard; General immunology.
§493.839
Condition: Chemistry.
§493.841
Standard; Routine chemistry.
§493.843
Standard; Endocrinology.
§493.845
Standard; Toxicology.
§493.849
Condition: Hematology.
§493.851
Standard; Hematology.
§493.853
Condition: Pathology.
§493.855
Standard; Cytology: gynecologic examinations.
§493.857
Condition: Immunohematology.
§493.859
Standard; ABO group and D (Rho) typing.
§493.861
Standard; Unexpected antibody detection.
§493.863
Standard; Compatibility testing.
§493.865
Standard; Antibody identification.
rule

Subpart I—PROFICIENCY TESTING PROGRAMS FOR NONWAIVED TESTING

§493.901
Approval of proficiency testing programs.
§493.903
Administrative responsibilities.
§493.905
Nonapproved proficiency testing programs.

Proficiency Testing Programs by Specialty and Subspecialty

§493.909
Microbiology.
§493.911
Bacteriology.
§493.913
Mycobacteriology.
§493.915
Mycology.
§493.917
Parasitology.
§493.919
Virology.
§493.921
Diagnostic immunology.
§493.923
Syphilis serology.
§493.927
General immunology.
§493.929
Chemistry.
§493.931
Routine chemistry.
§493.933
Endocrinology.
§493.937
Toxicology.
§493.941
Hematology (including routine hematology and coagulation).
§493.945
Cytology; gynecologic examinations.
§493.959
Immunohematology.
rule

Subpart J—FACILITY ADMINISTRATION FOR NONWAIVED TESTING

§493.1100
Condition: Facility administration.
§493.1101
Standard: Facilities.
§493.1103
Standard: Requirements for transfusion services.
§493.1105
Standard: Retention requirements.
rule

Subpart K—QUALITY SYSTEM FOR NONWAIVED TESTING

§493.1200
Introduction.
§493.1201
Condition: Bacteriology.
§493.1202
Condition: Mycobacteriology.
§493.1203
Condition: Mycology.
§493.1204
Condition: Parasitology.
§493.1205
Condition: Virology.
§493.1207
Condition: Syphilis serology.
§493.1208
Condition: General immunology.
§493.1210
Condition: Routine chemistry.
§493.1211
Condition: Urinalysis.
§493.1212
Condition: Endocrinology.
§493.1213
Condition: Toxicology.
§493.1215
Condition: Hematology.
§493.1217
Condition: Immunohematology.
§493.1219
Condition: Histopathology.
§493.1220
Condition: Oral pathology.
§493.1221
Condition: Cytology.
§493.1225
Condition: Clinical cytogenetics.
§493.1226
Condition: Radiobioassay.
§493.1227
Condition: Histocompatibility.

General Laboratory Systems

§493.1230
Condition: General laboratory systems.
§493.1231
Standard: Confidentiality of patient information.
§493.1232
Standard: Specimen identification and integrity.
§493.1233
Standard: Complaint investigations.
§493.1234
Standard: Communications.
§493.1235
Standard: Personnel competency assessment policies.
§493.1236
Standard: Evaluation of proficiency testing performance.
§493.1239
Standard: General laboratory systems quality assessment.

Preanalytic Systems

§493.1240
Condition: Preanalytic systems.
§493.1241
Standard: Test request.
§493.1242
Standard: Specimen submission, handling, and referral.
§493.1249
Standard: Preanalytic systems quality assessment.

Analytic Systems

§493.1250
Condition: Analytic systems.
§493.1251
Standard: Procedure manual.
§493.1252
Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
§493.1253
Standard: Establishment and verification of performance specifications.
§493.1254
Standard: Maintenance and function checks.
§493.1255
Standard: Calibration and calibration verification procedures.
§493.1256
Standard: Control procedures.
§493.1261
Standard: Bacteriology.
§493.1262
Standard: Mycobacteriology.
§493.1263
Standard: Mycology.
§493.1264
Standard: Parasitology.
§493.1265
Standard: Virology.
§493.1267
Standard: Routine chemistry.
§493.1269
Standard: Hematology.
§493.1271
Standard: Immunohematology.
§493.1273
Standard: Histopathology.
§493.1274
Standard: Cytology.
§493.1276
Standard: Clinical cytogenetics.
§493.1278
Standard: Histocompatibility.
§493.1281
Standard: Comparison of test results.
§493.1282
Standard: Corrective actions.
§493.1283
Standard: Test records.
§493.1289
Standard: Analytic systems quality assessment.

Postanalytic Systems

§493.1290
Condition: Postanalytic systems.
§493.1291
Standard: Test report.
§493.1299
Standard: Postanalytic systems quality assessment.
rule

Subpart L—[RESERVED]

rule

Subpart M—PERSONNEL FOR NONWAIVED TESTING

§493.1351
General.

Laboratories Performing Provider-Performed Microscopy (PPM) Procedures

§493.1353
Scope.
§493.1355
Condition: Laboratories performing PPM procedures; laboratory director.
§493.1357
Standard; laboratory director qualifications.
§493.1359
Standard; PPM laboratory director responsibilities.
§493.1361
Condition: Laboratories performing PPM procedures; testing personnel.
§493.1363
Standard: PPM testing personnel qualifications.
§493.1365
Standard; PPM testing personnel responsibilities.

Laboratories Performing Moderate Complexity Testing

§493.1403
Condition: Laboratories performing moderate complexity testing; laboratory director.
§493.1405
Standard; Laboratory director qualifications.
§493.1406
Standard; Laboratory director qualifications on or before February 28, 1992.
§493.1407
Standard; Laboratory director responsibilities.
§493.1409
Condition: Laboratories performing moderate complexity testing; technical consultant.
§493.1411
Standard; Technical consultant qualifications.
§493.1413
Standard; Technical consultant responsibilities.
§493.1415
Condition: Laboratories performing moderate complexity testing; clinical consultant.
§493.1417
Standard; Clinical consultant qualifications.
§493.1419
Standard; Clinical consultant responsibilities.
§493.1421
Condition: Laboratories performing moderate complexity testing; testing personnel.
§493.1423
Standard; Testing personnel qualifications.
§493.1425
Standard; Testing personnel responsibilities.

Laboratories Performing High Complexity Testing

§493.1441
Condition: Laboratories performing high complexity testing; laboratory director.
§493.1443
Standard; Laboratory director qualifications.
§493.1445
Standard; Laboratory director responsibilities.
§493.1447
Condition: Laboratories performing high complexity testing; technical supervisor.
§493.1449
Standard; Technical supervisor qualifications.
§493.1451
Standard: Technical supervisor responsibilities.
§493.1453
Condition: Laboratories performing high complexity testing; clinical consultant.
§493.1455
Standard; Clinical consultant qualifications.
§493.1457
Standard; Clinical consultant responsibilities.
§493.1459
Condition: Laboratories performing high complexity testing; general supervisor.
§493.1461
Standard: General supervisor qualifications.
§493.1462
General supervisor qualifications on or before February 28, 1992.
§493.1463
Standard: General supervisor responsibilities.
§493.1467
Condition: Laboratories performing high complexity testing; cytology general supervisor.
§493.1469
Standard: Cytology general supervisor qualifications.
§493.1471
Standard: Cytology general supervisor responsibilities.
§493.1481
Condition: Laboratories performing high complexity testing; cytotechnologist.
§493.1483
Standard: Cytotechnologist qualifications.
§493.1485
Standard; Cytotechnologist responsibilities.
§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.
rule

Subparts N-P [Reserved]

rule

Subpart Q—INSPECTION

§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.
rule

Subpart R—ENFORCEMENT PROCEDURES

§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.
rule

Subpart S—[RESERVED]

rule

Subpart T—CONSULTATIONS

§493.2001
Establishment and function of the Clinical Laboratory Improvement Advisory Committee.


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