Title 42--Public Health
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 493--LABORATORY REQUIREMENTS
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| 493.1 |
Basis and scope. |
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| 493.2 |
Definitions.
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| 493.3 |
Applicability.
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| 493.5 |
Categories of tests by complexity. |
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| 493.15 |
Laboratories performing waived tests. |
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| 493.17 |
Test categorization. |
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| 493.19 |
Provider-performed microscopy (PPM) procedures.
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| 493.20 |
Laboratories performing tests of moderate complexity.
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| 493.25 |
Laboratories performing tests of high complexity.
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| 493.35 |
Application for a certificate of waiver. |
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| 493.37 |
Requirements for a certificate of waiver. |
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| 493.39 |
Notification requirements for laboratories issued a certificate of waiver. |
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| 493.43 |
Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance. |
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| 493.45 |
Requirements for a registration certificate.
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| 493.47 |
Requirements for a certificate for provider-performed microscopy (PPM) procedures.
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| 493.49 |
Requirements for a certificate of compliance.
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| 493.51 |
Notification requirements for laboratories issued a certificate of compliance. |
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| 493.53 |
Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures. |
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| 493.55 |
Application for registration certificate and certificate of accreditation. |
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| 493.57 |
Requirements for a registration certificate. |
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| 493.61 |
Requirements for a certificate of accreditation. |
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| 493.63 |
Notification requirements for laboratories issued a certificate of accreditation. |
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| 493.551 |
General requirements for laboratories. |
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| 493.553 |
Approval process (application and reapplication) for accreditation organizations and State licensure programs. |
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| 493.555 |
Federal review of laboratory requirements. |
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| 493.557 |
Additional submission requirements. |
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| 493.559 |
Publication of approval of deeming authority or CLIA exemption. |
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| 493.561 |
Denial of application or reapplication. |
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| 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. |
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| 493.569 |
Consequences of a finding of noncompliance as a result of a validation inspection. |
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| 493.571 |
Disclosure of accreditation, State and CMS validation inspection results. |
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| 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. |
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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 procedures. |
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| 493.646 |
Payment of fees. |
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| 493.649 |
Methodology for determining fee amount. |
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| 493.801 |
Condition: Enrollment and testing of samples.
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| 493.803 |
Condition: Successful participation.
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| 493.807 |
Condition: Reinstatement of laboratories performing nonwaived testing. |
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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 |
Standard; Virology. |
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| 493.833 |
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 |
Condition: Chemistry. |
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| 493.841 |
Standard; Routine chemistry. |
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| 493.843 |
Standard; Endocrinology. |
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| 493.845 |
Standard; Toxicology. |
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| 493.849 |
Condition: Hematology. |
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| 493.851 |
Standard; Hematology. |
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| 493.853 |
Condition: Pathology. |
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| 493.855 |
Standard; Cytology: gynecologic examinations. |
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| 493.857 |
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. |
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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. |
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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 |
Mycology.
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| 493.917 |
Parasitology.
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| 493.919 |
Virology.
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| 493.921 |
Diagnostic immunology. |
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| 493.923 |
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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| 493.1100 |
Condition: Facility administration. |
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| 493.1101 |
Standard: Facilities. |
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| 493.1103 |
Standard: Requirements for transfusion services. |
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| 493.1105 |
Standard: Retention requirements.
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| 493.1200 |
Introduction.
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| 493.1201 |
Condition: Bacteriology. |
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| 493.1202 |
Condition: Mycobacteriology. |
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| 493.1203 |
Condition: Mycology. |
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| 493.1204 |
Condition: Parasitology. |
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| 493.1205 |
Condition: Virology. |
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| 493.1207 |
Condition: Syphilis serology. |
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| 493.1208 |
Condition: General immunology.
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| 493.1210 |
Condition: Routine chemistry. |
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| 493.1211 |
Condition: Urinalysis. |
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| 493.1212 |
Condition: Endocrinology. |
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| 493.1213 |
Condition: Toxicology. |
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| 493.1215 |
Condition: Hematology. |
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| 493.1217 |
Condition: Immunohematology. |
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| 493.1219 |
Condition: Histopathology. |
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| 493.1220 |
Condition: Oral pathology. |
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| 493.1221 |
Condition: Cytology. |
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| 493.1225 |
Condition: Clinical cytogenetics. |
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| 493.1226 |
Condition: Radiobioassay. |
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| 493.1227 |
Condition: Histocompatibility. |
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| 493.1230 |
Condition: General laboratory systems. |
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| 493.1231 |
Standard: Confidentiality of patient information. |
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| 493.1232 |
Standard: Specimen identification and integrity. |
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| 493.1233 |
Standard: Complaint investigations. |
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| 493.1234 |
Standard: Communications.
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| 493.1235 |
Standard: Personnel competency assessment policies. |
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| 493.1236 |
Standard: Evaluation of proficiency testing performance. |
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| 493.1239 |
Standard: General laboratory systems quality assessment.
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| 493.1240 |
Condition: Preanalytic systems. |
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| 493.1241 |
Standard: Test request. |
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| 493.1242 |
Standard: Specimen submission, handling, and referral. |
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| 493.1249 |
Standard: Preanalytic systems quality assessment.
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| 493.1250 |
Condition: Analytic systems. |
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| 493.1251 |
Standard: Procedure manual.
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| 493.1252 |
Standard: Test systems, equipment, instruments, reagents, materials, and supplies. |
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| 493.1253 |
Standard: Establishment and verification of performance specifications.
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| 493.1254 |
Standard: Maintenance and function checks. |
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| 493.1255 |
Standard: Calibration and calibration verification procedures. |
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| 493.1256 |
Standard: Control procedures.
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| 493.1261 |
Standard: Bacteriology. |
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| 493.1262 |
Standard: Mycobacteriology. |
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| 493.1263 |
Standard: Mycology. |
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| 493.1264 |
Standard: Parasitology. |
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| 493.1265 |
Standard: Virology. |
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| 493.1267 |
Standard: Routine chemistry. |
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| 493.1269 |
Standard: Hematology. |
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| 493.1271 |
Standard: Immunohematology.
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| 493.1273 |
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 |
Standard: Comparison of test results. |
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| 493.1282 |
Standard: Corrective actions. |
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| 493.1283 |
Standard: Test records. |
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| 493.1289 |
Standard: Analytic systems quality assessment.
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| 493.1290 |
Condition: Postanalytic systems. |
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| 493.1291 |
Standard: Test report.
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| 493.1299 |
Standard: Postanalytic systems quality assessment.
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| 493.1351 |
General. |
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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. |
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| 493.1363 |
Standard: PPM testing personnel qualifications. |
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| 493.1365 |
Standard; PPM testing personnel responsibilities. |
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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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| 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. |
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| 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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| 493.1467 |
Condition: Laboratories performing high complexity testing; cytology general supervisor. |
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| 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. |
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| 493.1489 |
Standard; Testing personnel qualifications. |
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| 493.1491 |
Technologist qualifications on or before February 28, 1992. |
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| 493.1495 |
Standard; Testing personnel responsibilities. |
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| 493.1771 |
Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories. |
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| 493.1773 |
Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories. |
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| 493.1775 |
Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures. |
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| 493.1777 |
Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance. |
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| 493.1780 |
Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation. |
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| 493.1800 |
Basis and scope. |
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| 493.1804 |
General considerations. |
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| 493.1806 |
Available sanctions: All laboratories. |
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| 493.1807 |
Additional sanctions: Laboratories that participate in Medicare. |
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| 493.1808 |
Adverse action on any type of CLIA certificate: Effect on Medicare approval. |
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| 493.1809 |
Limitation on Medicaid payment. |
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| 493.1810 |
Imposition and lifting of alternative sanctions. |
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| 493.1812 |
Action when deficiencies pose immediate jeopardy. |
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| 493.1814 |
Action when deficiencies are at the condition level but do not pose immediate jeopardy. |
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| 493.1816 |
Action when deficiencies are not at the condition level. |
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| 493.1820 |
Ensuring timely correction of deficiencies. |
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| 493.1826 |
Suspension of part of Medicare payments. |
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| 493.1828 |
Suspension of all Medicare payments. |
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| 493.1832 |
Directed plan of correction and directed portion of a plan of correction. |
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| 493.1834 |
Civil money penalty. |
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| 493.1836 |
State onsite monitoring. |
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| 493.1838 |
Training and technical assistance for unsuccessful participation in proficiency testing. |
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| 493.1840 |
Suspension, limitation, or revocation of any type of CLIA certificate. |
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| 493.1842 |
Cancellation of Medicare approval. |
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| 493.1844 |
Appeals procedures.
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| 493.1846 |
Civil action. |
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| 493.1850 |
Laboratory registry. |
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| 493.2001 |
Establishment and function of the Clinical Laboratory Improvement Advisory Committee.
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