Title 42

PART 493

Part 493 - Laboratory Requirements

PART 493 - LABORATORY REQUIREMENTS Authority: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.

42:5.0.1.1.9.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.9.1.32.1SECTION 493.1
   493.1 Basis and scope.
42:5.0.1.1.9.1.32.2SECTION 493.2
   493.2 Definitions.
42:5.0.1.1.9.1.32.3SECTION 493.3
   493.3 Applicability.
42:5.0.1.1.9.1.32.4SECTION 493.5
   493.5 Categories of tests by complexity.
42:5.0.1.1.9.1.32.5SECTION 493.15
   493.15 Laboratories performing waived tests.
42:5.0.1.1.9.1.32.6SECTION 493.17
   493.17 Test categorization.
42:5.0.1.1.9.1.32.7SECTION 493.19
   493.19 Provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.1.32.8SECTION 493.20
   493.20 Laboratories performing tests of moderate complexity.
42:5.0.1.1.9.1.32.9SECTION 493.25
   493.25 Laboratories performing tests of high complexity.
42:5.0.1.1.9.2SUBPART B
Subpart B - Certificate of Waiver
42:5.0.1.1.9.2.32.1SECTION 493.35
   493.35 Application for a certificate of waiver.
42:5.0.1.1.9.2.32.2SECTION 493.37
   493.37 Requirements for a certificate of waiver.
42:5.0.1.1.9.2.32.3SECTION 493.39
   493.39 Notification requirements for laboratories issued a certificate of waiver.
42:5.0.1.1.9.2.32.4SECTION 493.41
   493.41 Condition: Reporting of SARS-CoV-2 test results.
42:5.0.1.1.9.3SUBPART C
Subpart C - Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance
42:5.0.1.1.9.3.32.1SECTION 493.43
   493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.
42:5.0.1.1.9.3.32.2SECTION 493.45
   493.45 Requirements for a registration certificate.
42:5.0.1.1.9.3.32.3SECTION 493.47
   493.47 Requirements for a certificate for provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.3.32.4SECTION 493.49
   493.49 Requirements for a certificate of compliance.
42:5.0.1.1.9.3.32.5SECTION 493.51
   493.51 Notification requirements for laboratories issued a certificate of compliance.
42:5.0.1.1.9.3.32.6SECTION 493.53
   493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.4SUBPART D
Subpart D - Certificate of Accreditation
42:5.0.1.1.9.4.32.1SECTION 493.55
   493.55 Application for registration certificate and certificate of accreditation.
42:5.0.1.1.9.4.32.2SECTION 493.57
   493.57 Requirements for a registration certificate.
42:5.0.1.1.9.4.32.3SECTION 493.61
   493.61 Requirements for a certificate of accreditation.
42:5.0.1.1.9.4.32.4SECTION 493.63
   493.63 Notification requirements for laboratories issued a certificate of accreditation.
42:5.0.1.1.9.5SUBPART E
Subpart E - Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
42:5.0.1.1.9.5.32.1SECTION 493.551
   493.551 General requirements for laboratories.
42:5.0.1.1.9.5.32.2SECTION 493.553
   493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs.
42:5.0.1.1.9.5.32.3SECTION 493.555
   493.555 Federal review of laboratory requirements.
42:5.0.1.1.9.5.32.4SECTION 493.557
   493.557 Additional submission requirements.
42:5.0.1.1.9.5.32.5SECTION 493.559
   493.559 Publication of approval of deeming authority or CLIA exemption.
42:5.0.1.1.9.5.32.6SECTION 493.561
   493.561 Denial of application or reapplication.
42:5.0.1.1.9.5.32.7SECTION 493.563
   493.563 Validation inspections - Basis and focus.
42:5.0.1.1.9.5.32.8SECTION 493.565
   493.565 Selection for validation inspection - laboratory responsibilities.
42:5.0.1.1.9.5.32.9SECTION 493.567
   493.567 Refusal to cooperate with validation inspection.
42:5.0.1.1.9.5.32.10SECTION 493.569
   493.569 Consequences of a finding of noncompliance as a result of a validation inspection.
42:5.0.1.1.9.5.32.11SECTION 493.571
   493.571 Disclosure of accreditation, State and CMS validation inspection results.
42:5.0.1.1.9.5.32.12SECTION 493.573
   493.573 Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
42:5.0.1.1.9.5.32.13SECTION 493.575
   493.575 Removal of deeming authority or CLIA exemption and final determination review.
42:5.0.1.1.9.6SUBPART F
Subpart F - General Administration
42:5.0.1.1.9.6.32.1SECTION 493.602
   493.602 Scope of subpart.
42:5.0.1.1.9.6.32.2SECTION 493.606
   493.606 Applicability of subpart.
42:5.0.1.1.9.6.32.3SECTION 493.638
   493.638 Certificate fees.
42:5.0.1.1.9.6.32.4SECTION 493.639
   493.639 Fee for revised certificate.
42:5.0.1.1.9.6.32.5SECTION 493.643
   493.643 Fee for determination of program compliance.
42:5.0.1.1.9.6.32.6SECTION 493.645
   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.
42:5.0.1.1.9.6.32.7SECTION 493.646
   493.646 Payment of fees.
42:5.0.1.1.9.6.32.8SECTION 493.649
   493.649 Methodology for determining fee amount.
42:5.0.1.1.9.7SUBPART G
Subpart G [Reserved]
42:5.0.1.1.9.8SUBPART H
Subpart H - Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing
42:5.0.1.1.9.8.32SUBJGRP 32
   Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests
42:5.0.1.1.9.8.32.1SECTION 493.801
   493.801 Condition: Enrollment and testing of samples.
42:5.0.1.1.9.8.32.2SECTION 493.803
   493.803 Condition: Successful participation.
42:5.0.1.1.9.8.32.3SECTION 493.807
   493.807 Condition: Reinstatement of laboratories performing nonwaived testing.
42:5.0.1.1.9.8.32.4SECTION 493.821
   493.821 Condition: Microbiology.
42:5.0.1.1.9.8.32.5SECTION 493.823
   493.823 Standard; Bacteriology.
42:5.0.1.1.9.8.32.6SECTION 493.825
   493.825 Standard; Mycobacteriology.
42:5.0.1.1.9.8.32.7SECTION 493.827
   493.827 Standard; Mycology.
42:5.0.1.1.9.8.32.8SECTION 493.829
   493.829 Standard; Parasitology.
42:5.0.1.1.9.8.32.9SECTION 493.831
   493.831 Standard; Virology.
42:5.0.1.1.9.8.32.10SECTION 493.833
   493.833 Condition: Diagnostic immunology.
42:5.0.1.1.9.8.32.11SECTION 493.835
   493.835 Standard; Syphilis serology.
42:5.0.1.1.9.8.32.12SECTION 493.837
   493.837 Standard; General immunology.
42:5.0.1.1.9.8.32.13SECTION 493.839
   493.839 Condition: Chemistry.
42:5.0.1.1.9.8.32.14SECTION 493.841
   493.841 Standard; Routine chemistry.
42:5.0.1.1.9.8.32.15SECTION 493.843
   493.843 Standard; Endocrinology.
42:5.0.1.1.9.8.32.16SECTION 493.845
   493.845 Standard; Toxicology.
42:5.0.1.1.9.8.32.17SECTION 493.849
   493.849 Condition: Hematology.
42:5.0.1.1.9.8.32.18SECTION 493.851
   493.851 Standard; Hematology.
42:5.0.1.1.9.8.32.19SECTION 493.853
   493.853 Condition: Pathology.
42:5.0.1.1.9.8.32.20SECTION 493.855
   493.855 Standard; Cytology: gynecologic examinations.
42:5.0.1.1.9.8.32.21SECTION 493.857
   493.857 Condition: Immunohematology.
42:5.0.1.1.9.8.32.22SECTION 493.859
   493.859 Standard; ABO group and D (Rho) typing.
42:5.0.1.1.9.8.32.23SECTION 493.861
   493.861 Standard; Unexpected antibody detection.
42:5.0.1.1.9.8.32.24SECTION 493.863
   493.863 Standard; Compatibility testing.
42:5.0.1.1.9.8.32.25SECTION 493.865
   493.865 Standard; Antibody identification.
42:5.0.1.1.9.9SUBPART I
Subpart I - Proficiency Testing Programs for Nonwaived Testing
42:5.0.1.1.9.9.33SUBJGRP 33
   Proficiency Testing Programs by Specialty and Subspecialty
42:5.0.1.1.9.9.33.1SECTION 493.901
   493.901 Approval of proficiency testing programs.
42:5.0.1.1.9.9.33.2SECTION 493.903
   493.903 Administrative responsibilities.
42:5.0.1.1.9.9.33.3SECTION 493.905
   493.905 Nonapproved proficiency testing programs.
42:5.0.1.1.9.9.33.4SECTION 493.909
   493.909 Microbiology.
42:5.0.1.1.9.9.33.5SECTION 493.911
   493.911 Bacteriology.
42:5.0.1.1.9.9.33.6SECTION 493.913
   493.913 Mycobacteriology.
42:5.0.1.1.9.9.33.7SECTION 493.915
   493.915 Mycology.
42:5.0.1.1.9.9.33.8SECTION 493.917
   493.917 Parasitology.
42:5.0.1.1.9.9.33.9SECTION 493.919
   493.919 Virology.
42:5.0.1.1.9.9.33.10SECTION 493.921
   493.921 Diagnostic immunology.
42:5.0.1.1.9.9.33.11SECTION 493.923
   493.923 Syphilis serology.
42:5.0.1.1.9.9.33.12SECTION 493.927
   493.927 General immunology.
42:5.0.1.1.9.9.33.13SECTION 493.929
   493.929 Chemistry.
42:5.0.1.1.9.9.33.14SECTION 493.931
   493.931 Routine chemistry.
42:5.0.1.1.9.9.33.15SECTION 493.933
   493.933 Endocrinology.
42:5.0.1.1.9.9.33.16SECTION 493.937
   493.937 Toxicology.
42:5.0.1.1.9.9.33.17SECTION 493.941
   493.941 Hematology (including routine hematology and coagulation).
42:5.0.1.1.9.9.33.18SECTION 493.945
   493.945 Cytology; gynecologic examinations.
42:5.0.1.1.9.9.33.19SECTION 493.959
   493.959 Immunohematology.
42:5.0.1.1.9.10SUBPART J
Subpart J - Facility Administration for Nonwaived Testing
42:5.0.1.1.9.10.34.1SECTION 493.1100
   493.1100 Condition: Facility administration.
42:5.0.1.1.9.10.34.2SECTION 493.1101
   493.1101 Standard: Facilities.
42:5.0.1.1.9.10.34.3SECTION 493.1103
   493.1103 Standard: Requirements for transfusion services.
42:5.0.1.1.9.10.34.4SECTION 493.1105
   493.1105 Standard: Retention requirements.
42:5.0.1.1.9.11SUBPART K
Subpart K - Quality System for Nonwaived Testing
42:5.0.1.1.9.11.34SUBJGRP 34
   General Laboratory Systems
42:5.0.1.1.9.11.34.1SECTION 493.1200
   493.1200 Introduction.
42:5.0.1.1.9.11.34.2SECTION 493.1201
   493.1201 Condition: Bacteriology.
42:5.0.1.1.9.11.34.3SECTION 493.1202
   493.1202 Condition: Mycobacteriology.
42:5.0.1.1.9.11.34.4SECTION 493.1203
   493.1203 Condition: Mycology.
42:5.0.1.1.9.11.34.5SECTION 493.1204
   493.1204 Condition: Parasitology.
42:5.0.1.1.9.11.34.6SECTION 493.1205
   493.1205 Condition: Virology.
42:5.0.1.1.9.11.34.7SECTION 493.1207
   493.1207 Condition: Syphilis serology.
42:5.0.1.1.9.11.34.8SECTION 493.1208
   493.1208 Condition: General immunology.
42:5.0.1.1.9.11.34.9SECTION 493.1210
   493.1210 Condition: Routine chemistry.
42:5.0.1.1.9.11.34.10SECTION 493.1211
   493.1211 Condition: Urinalysis.
42:5.0.1.1.9.11.34.11SECTION 493.1212
   493.1212 Condition: Endocrinology.
42:5.0.1.1.9.11.34.12SECTION 493.1213
   493.1213 Condition: Toxicology.
42:5.0.1.1.9.11.34.13SECTION 493.1215
   493.1215 Condition: Hematology.
42:5.0.1.1.9.11.34.14SECTION 493.1217
   493.1217 Condition: Immunohematology.
42:5.0.1.1.9.11.34.15SECTION 493.1219
   493.1219 Condition: Histopathology.
42:5.0.1.1.9.11.34.16SECTION 493.1220
   493.1220 Condition: Oral pathology.
42:5.0.1.1.9.11.34.17SECTION 493.1221
   493.1221 Condition: Cytology.
42:5.0.1.1.9.11.34.18SECTION 493.1225
   493.1225 Condition: Clinical cytogenetics.
42:5.0.1.1.9.11.34.19SECTION 493.1226
   493.1226 Condition: Radiobioassay.
42:5.0.1.1.9.11.34.20SECTION 493.1227
   493.1227 Condition: Histocompatibility.
42:5.0.1.1.9.11.34.21SECTION 493.1230
   493.1230 Condition: General laboratory systems.
42:5.0.1.1.9.11.34.22SECTION 493.1231
   493.1231 Standard: Confidentiality of patient information.
42:5.0.1.1.9.11.34.23SECTION 493.1232
   493.1232 Standard: Specimen identification and integrity.
42:5.0.1.1.9.11.34.24SECTION 493.1233
   493.1233 Standard: Complaint investigations.
42:5.0.1.1.9.11.34.25SECTION 493.1234
   493.1234 Standard: Communications.
42:5.0.1.1.9.11.34.26SECTION 493.1235
   493.1235 Standard: Personnel competency assessment policies.
42:5.0.1.1.9.11.34.27SECTION 493.1236
   493.1236 Standard: Evaluation of proficiency testing performance.
42:5.0.1.1.9.11.34.28SECTION 493.1239
   493.1239 Standard: General laboratory systems quality assessment.
42:5.0.1.1.9.11.35SUBJGRP 35
   Preanalytic Systems
42:5.0.1.1.9.11.35.29SECTION 493.1240
   493.1240 Condition: Preanalytic systems.
42:5.0.1.1.9.11.35.30SECTION 493.1241
   493.1241 Standard: Test request.
42:5.0.1.1.9.11.35.31SECTION 493.1242
   493.1242 Standard: Specimen submission, handling, and referral.
42:5.0.1.1.9.11.35.32SECTION 493.1249
   493.1249 Standard: Preanalytic systems quality assessment.
42:5.0.1.1.9.11.36SUBJGRP 36
   Analytic Systems
42:5.0.1.1.9.11.36.33SECTION 493.1250
   493.1250 Condition: Analytic systems.
42:5.0.1.1.9.11.36.34SECTION 493.1251
   493.1251 Standard: Procedure manual.
42:5.0.1.1.9.11.36.35SECTION 493.1252
   493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
42:5.0.1.1.9.11.36.36SECTION 493.1253
   493.1253 Standard: Establishment and verification of performance specifications.
42:5.0.1.1.9.11.36.37SECTION 493.1254
   493.1254 Standard: Maintenance and function checks.
42:5.0.1.1.9.11.36.38SECTION 493.1255
   493.1255 Standard: Calibration and calibration verification procedures.
42:5.0.1.1.9.11.36.39SECTION 493.1256
   493.1256 Standard: Control procedures.
42:5.0.1.1.9.11.36.40SECTION 493.1261
   493.1261 Standard: Bacteriology.
42:5.0.1.1.9.11.36.41SECTION 493.1262
   493.1262 Standard: Mycobacteriology.
42:5.0.1.1.9.11.36.42SECTION 493.1263
   493.1263 Standard: Mycology.
42:5.0.1.1.9.11.36.43SECTION 493.1264
   493.1264 Standard: Parasitology.
42:5.0.1.1.9.11.36.44SECTION 493.1265
   493.1265 Standard: Virology.
42:5.0.1.1.9.11.36.45SECTION 493.1267
   493.1267 Standard: Routine chemistry.
42:5.0.1.1.9.11.36.46SECTION 493.1269
   493.1269 Standard: Hematology.
42:5.0.1.1.9.11.36.47SECTION 493.1271
   493.1271 Standard: Immunohematology.
42:5.0.1.1.9.11.36.48SECTION 493.1273
   493.1273 Standard: Histopathology.
42:5.0.1.1.9.11.36.49SECTION 493.1274
   493.1274 Standard: Cytology.
42:5.0.1.1.9.11.36.50SECTION 493.1276
   493.1276 Standard: Clinical cytogenetics.
42:5.0.1.1.9.11.36.51SECTION 493.1278
   493.1278 Standard: Histocompatibility.
42:5.0.1.1.9.11.36.52SECTION 493.1281
   493.1281 Standard: Comparison of test results.
42:5.0.1.1.9.11.36.53SECTION 493.1282
   493.1282 Standard: Corrective actions.
42:5.0.1.1.9.11.36.54SECTION 493.1283
   493.1283 Standard: Test records.
42:5.0.1.1.9.11.36.55SECTION 493.1289
   493.1289 Standard: Analytic systems quality assessment.
42:5.0.1.1.9.11.37SUBJGRP 37
   Postanalytic Systems
42:5.0.1.1.9.11.37.56SECTION 493.1290
   493.1290 Condition: Postanalytic systems.
42:5.0.1.1.9.11.37.57SECTION 493.1291
   493.1291 Standard: Test report.
42:5.0.1.1.9.11.37.58SECTION 493.1299
   493.1299 Standard: Postanalytic systems quality assessment.
42:5.0.1.1.9.12SUBPART L
Subpart L [Reserved]
42:5.0.1.1.9.13SUBPART M
Subpart M - Personnel for Nonwaived Testing
42:5.0.1.1.9.13.38SUBJGRP 38
   Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
42:5.0.1.1.9.13.38.1SECTION 493.1351
   493.1351 General.
42:5.0.1.1.9.13.38.2SECTION 493.1353
   493.1353 Scope.
42:5.0.1.1.9.13.38.3SECTION 493.1355
   493.1355 Condition: Laboratories performing PPM procedures; laboratory director.
42:5.0.1.1.9.13.38.4SECTION 493.1357
   493.1357 Standard; laboratory director qualifications.
42:5.0.1.1.9.13.38.5SECTION 493.1359
   493.1359 Standard; PPM laboratory director responsibilities.
42:5.0.1.1.9.13.38.6SECTION 493.1361
   493.1361 Condition: Laboratories performing PPM procedures; testing personnel.
42:5.0.1.1.9.13.38.7SECTION 493.1363
   493.1363 Standard: PPM testing personnel qualifications.
42:5.0.1.1.9.13.38.8SECTION 493.1365
   493.1365 Standard; PPM testing personnel responsibilities.
42:5.0.1.1.9.13.39SUBJGRP 39
   Laboratories Performing Moderate Complexity Testing
42:5.0.1.1.9.13.39.9SECTION 493.1403
   493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director.
42:5.0.1.1.9.13.39.10SECTION 493.1405
   493.1405 Standard; Laboratory director qualifications.
42:5.0.1.1.9.13.39.11SECTION 493.1406
   493.1406 Standard; Laboratory director qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.39.12SECTION 493.1407
   493.1407 Standard; Laboratory director responsibilities.
42:5.0.1.1.9.13.39.13SECTION 493.1409
   493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant.
42:5.0.1.1.9.13.39.14SECTION 493.1411
   493.1411 Standard; Technical consultant qualifications.
42:5.0.1.1.9.13.39.15SECTION 493.1413
   493.1413 Standard; Technical consultant responsibilities.
42:5.0.1.1.9.13.39.16SECTION 493.1415
   493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant.
42:5.0.1.1.9.13.39.17SECTION 493.1417
   493.1417 Standard; Clinical consultant qualifications.
42:5.0.1.1.9.13.39.18SECTION 493.1419
   493.1419 Standard; Clinical consultant responsibilities.
42:5.0.1.1.9.13.39.19SECTION 493.1421
   493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel.
42:5.0.1.1.9.13.39.20SECTION 493.1423
   493.1423 Standard; Testing personnel qualifications.
42:5.0.1.1.9.13.39.21SECTION 493.1425
   493.1425 Standard; Testing personnel responsibilities.
42:5.0.1.1.9.13.40SUBJGRP 40
   Laboratories Performing High Complexity Testing
42:5.0.1.1.9.13.40.22SECTION 493.1441
   493.1441 Condition: Laboratories performing high complexity testing; laboratory director.
42:5.0.1.1.9.13.40.23SECTION 493.1443
   493.1443 Standard; Laboratory director qualifications.
42:5.0.1.1.9.13.40.24SECTION 493.1445
   493.1445 Standard; Laboratory director responsibilities.
42:5.0.1.1.9.13.40.25SECTION 493.1447
   493.1447 Condition: Laboratories performing high complexity testing; technical supervisor.
42:5.0.1.1.9.13.40.26SECTION 493.1449
   493.1449 Standard; Technical supervisor qualifications.
42:5.0.1.1.9.13.40.27SECTION 493.1451
   493.1451 Standard: Technical supervisor responsibilities.
42:5.0.1.1.9.13.40.28SECTION 493.1453
   493.1453 Condition: Laboratories performing high complexity testing; clinical consultant.
42:5.0.1.1.9.13.40.29SECTION 493.1455
   493.1455 Standard; Clinical consultant qualifications.
42:5.0.1.1.9.13.40.30SECTION 493.1457
   493.1457 Standard; Clinical consultant responsibilities.
42:5.0.1.1.9.13.40.31SECTION 493.1459
   493.1459 Condition: Laboratories performing high complexity testing; general supervisor.
42:5.0.1.1.9.13.40.32SECTION 493.1461
   493.1461 Standard: General supervisor qualifications.
42:5.0.1.1.9.13.40.33SECTION 493.1462
   493.1462 General supervisor qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.40.34SECTION 493.1463
   493.1463 Standard: General supervisor responsibilities.
42:5.0.1.1.9.13.40.35SECTION 493.1467
   493.1467 Condition: Laboratories performing high complexity testing; cytology general supervisor.
42:5.0.1.1.9.13.40.36SECTION 493.1469
   493.1469 Standard: Cytology general supervisor qualifications.
42:5.0.1.1.9.13.40.37SECTION 493.1471
   493.1471 Standard: Cytology general supervisor responsibilities.
42:5.0.1.1.9.13.40.38SECTION 493.1481
   493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist.
42:5.0.1.1.9.13.40.39SECTION 493.1483
   493.1483 Standard: Cytotechnologist qualifications.
42:5.0.1.1.9.13.40.40SECTION 493.1485
   493.1485 Standard; Cytotechnologist responsibilities.
42:5.0.1.1.9.13.40.41SECTION 493.1487
   493.1487 Condition: Laboratories performing high complexity testing; testing personnel.
42:5.0.1.1.9.13.40.42SECTION 493.1489
   493.1489 Standard; Testing personnel qualifications.
42:5.0.1.1.9.13.40.43SECTION 493.1491
   493.1491 Technologist qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.40.44SECTION 493.1495
   493.1495 Standard; Testing personnel responsibilities.
42:5.0.1.1.9.14SUBPART N
Subparts N-P [Reserved]
42:5.0.1.1.9.15SUBPART Q
Subpart Q - Inspection
42:5.0.1.1.9.15.41.1SECTION 493.1771
   493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
42:5.0.1.1.9.15.41.2SECTION 493.1773
   493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
42:5.0.1.1.9.15.41.3SECTION 493.1775
   493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
42:5.0.1.1.9.15.41.4SECTION 493.1777
   493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
42:5.0.1.1.9.15.41.5SECTION 493.1780
   493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
42:5.0.1.1.9.16SUBPART R
Subpart R - Enforcement Procedures
42:5.0.1.1.9.16.41.1SECTION 493.1800
   493.1800 Basis and scope.
42:5.0.1.1.9.16.41.2SECTION 493.1804
   493.1804 General considerations.
42:5.0.1.1.9.16.41.3SECTION 493.1806
   493.1806 Available sanctions: All laboratories.
42:5.0.1.1.9.16.41.4SECTION 493.1807
   493.1807 Additional sanctions: Laboratories that participate in Medicare.
42:5.0.1.1.9.16.41.5SECTION 493.1808
   493.1808 Adverse action on any type of CLIA certificate: Effect on Medicare approval.
42:5.0.1.1.9.16.41.6SECTION 493.1809
   493.1809 Limitation on Medicaid payment.
42:5.0.1.1.9.16.41.7SECTION 493.1810
   493.1810 Imposition and lifting of alternative sanctions.
42:5.0.1.1.9.16.41.8SECTION 493.1812
   493.1812 Action when deficiencies pose immediate jeopardy.
42:5.0.1.1.9.16.41.9SECTION 493.1814
   493.1814 Action when deficiencies are at the condition level but do not pose immediate jeopardy.
42:5.0.1.1.9.16.41.10SECTION 493.1816
   493.1816 Action when deficiencies are not at the condition level.
42:5.0.1.1.9.16.41.11SECTION 493.1820
   493.1820 Ensuring timely correction of deficiencies.
42:5.0.1.1.9.16.41.12SECTION 493.1826
   493.1826 Suspension of part of Medicare payments.
42:5.0.1.1.9.16.41.13SECTION 493.1828
   493.1828 Suspension of all Medicare payments.
42:5.0.1.1.9.16.41.14SECTION 493.1832
   493.1832 Directed plan of correction and directed portion of a plan of correction.
42:5.0.1.1.9.16.41.15SECTION 493.1834
   493.1834 Civil money penalty.
42:5.0.1.1.9.16.41.16SECTION 493.1836
   493.1836 State onsite monitoring.
42:5.0.1.1.9.16.41.17SECTION 493.1838
   493.1838 Training and technical assistance for unsuccessful participation in proficiency testing.
42:5.0.1.1.9.16.41.18SECTION 493.1840
   493.1840 Suspension, limitation, or revocation of any type of CLIA certificate.
42:5.0.1.1.9.16.41.19SECTION 493.1842
   493.1842 Cancellation of Medicare approval.
42:5.0.1.1.9.16.41.20SECTION 493.1844
   493.1844 Appeals procedures.
42:5.0.1.1.9.16.41.21SECTION 493.1846
   493.1846 Civil action.
42:5.0.1.1.9.16.41.22SECTION 493.1850
   493.1850 Laboratory registry.
42:5.0.1.1.9.17SUBPART S
Subpart S [Reserved]
42:5.0.1.1.9.18SUBPART T
Subpart T - Consultations
42:5.0.1.1.9.18.41.1SECTION 493.2001
   493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee.