Title 42

PART 493

Part 493 - Laboratory Requirements

PART 493 - LABORATORY REQUIREMENTS 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)), and the Pub. L. 112-202 amendments to 42 U.S.C. 263a. 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.
42:5.0.1.1.9.3SUBPART 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.