2001 CFR Title 47, Volume 1

Title 42--Public Health CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 493--LABORATORY REQUIREMENTS
	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.
	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.
	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.
	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.
	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.
	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.
	493.801	Condition: Enrollment and testing of samples.
	493.803	Condition: Successful participation.
	493.807	Condition: Reinstatement of laboratories performing tests of moderate complexity (including the subcategory), high complexity, or any combination of these tests, after failure to participate successfully.
	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.
	493.901	Approval of proficiency testing programs.
	493.903	Administrative responsibilities.
	493.905	Nonapproved proficiency testing programs.
	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.
	493.1101	Condition: Patient test management; moderate complexity (including the subcategory), or high complexity testing, or any combination of these tests.
	493.1103	Standard; Procedures for specimen submission and handling.
	493.1105	Standard; Test requisition.
	493.1107	Standard; Test records.
	493.1109	Standard; Test report.
	493.1111	Standard; Referral of specimens.
	493.1201	Condition: General quality control; moderate complexity (including the subcategory) or high complexity testing, or any combination of these tests.
	493.1202	Standard; Moderate or high complexity testing, or both: Effective from September 1, 1992 to December 31, 2002.
	493.1203	Standard; Moderate or high complexity testing, or both: Effective beginning December 31, 2002.
	493.1204	Standard; Facilities.
	493.1205	Standard; Test methods, equipment, instrumentation, reagents, materials, and supplies.
	493.1211	Standard; Procedure manual.
	493.1213	Standard; Establishment and verification of method performance specifications.
	493.1215	Standard; Equipment maintenance and function checks.
	493.1217	Standard; Calibration and calibration verification procedures.
	493.1218	Standard; Control procedures.
	493.1219	Standard; Remedial actions.
	493.1221	Standard; Quality control records.
	493.1223	Condition: Quality control--specialties and subspecialties for tests of moderate or high complexity, or both.
	493.1225	Condition: Microbiology.
	493.1227	Condition: Bacteriology.
	493.1229	Condition: Mycobacteriology.
	493.1231	Condition: Mycology.
	493.1233	Condition: Parasitology.
	493.1235	Condition: Virology.
	493.1237	Condition: Diagnostic immunology.
	493.1239	Condition: Syphilis serology.
	493.1241	Condition: General immunology.
	493.1243	Condition: Chemistry.
	493.1245	Condition: Routine chemistry.
	493.1247	Condition: Endocrinology.
	493.1249	Condition: Toxicology.
	493.1251	Condition: Urinalysis.
	493.1253	Condition: Hematology.
	493.1255	Condition: Pathology.
	493.1257	Condition: Cytology.
	493.1259	Condition: Histopathology.
	493.1261	Condition: Oral pathology.
	493.1263	Condition: Radiobioassay.
	493.1265	Condition: Histocompatibility.
	493.1267	Condition: Clinical cytogenetics.
	493.1269	Condition: Immunohematology.
	493.1271	Condition: Transfusion services and bloodbanking.
	493.1273	Standard; Immunohematological collection, processing, dating periods, labeling and distribution of blood and blood products.
	493.1275	Standard; Blood and blood products storage facilities.
	493.1277	Standard; Arrangement for services.
	493.1279	Standard; Provision of testing.
	493.1283	Standard; Retention of samples of transfused blood.
	493.1285	Standard; Investigation of transfusion reactions.
	493.1351	General.
	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.
	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.
	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.
	493.1701	Condition: Quality assurance; moderate complexity (including the subcategory) or high complexity testing, or any combination of these tests.
	493.1703	Standard; Patient test management assessment.
	493.1705	Standard; Quality control assessment.
	493.1707	Standard; Proficiency testing assessment.
	493.1709	Standard; Comparison of test results.
	493.1711	Standard; Relationship of patient information to patient test results.
	493.1713	Standard; Personnel assessment.
	493.1715	Standard; Communications.
	493.1717	Standard; Complaint investigations.
	493.1719	Standard; Quality assurance review with staff.
	493.1721	Standard; Quality assurance records.
	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.
	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.
	493.2001	Establishment and function of the Clinical Laboratory Improvement Advisory Committee.