Title 42

PART 493 SUBPART K

Subpart K - Quality System for Nonwaived Testing Source:68 FR 3703, Jan. 24, 2003, unless otherwise noted.

• 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.

42:5.0.1.1.9.11.34	SUBJGRP 34	General Laboratory Systems
42:5.0.1.1.9.11.34.1	SECTION 493.1200	493.1200 Introduction.
42:5.0.1.1.9.11.34.2	SECTION 493.1201	493.1201 Condition: Bacteriology.
42:5.0.1.1.9.11.34.3	SECTION 493.1202	493.1202 Condition: Mycobacteriology.
42:5.0.1.1.9.11.34.4	SECTION 493.1203	493.1203 Condition: Mycology.
42:5.0.1.1.9.11.34.5	SECTION 493.1204	493.1204 Condition: Parasitology.
42:5.0.1.1.9.11.34.6	SECTION 493.1205	493.1205 Condition: Virology.
42:5.0.1.1.9.11.34.7	SECTION 493.1207	493.1207 Condition: Syphilis serology.
42:5.0.1.1.9.11.34.8	SECTION 493.1208	493.1208 Condition: General immunology.
42:5.0.1.1.9.11.34.9	SECTION 493.1210	493.1210 Condition: Routine chemistry.
42:5.0.1.1.9.11.34.10	SECTION 493.1211	493.1211 Condition: Urinalysis.
42:5.0.1.1.9.11.34.11	SECTION 493.1212	493.1212 Condition: Endocrinology.
42:5.0.1.1.9.11.34.12	SECTION 493.1213	493.1213 Condition: Toxicology.
42:5.0.1.1.9.11.34.13	SECTION 493.1215	493.1215 Condition: Hematology.
42:5.0.1.1.9.11.34.14	SECTION 493.1217	493.1217 Condition: Immunohematology.
42:5.0.1.1.9.11.34.15	SECTION 493.1219	493.1219 Condition: Histopathology.
42:5.0.1.1.9.11.34.16	SECTION 493.1220	493.1220 Condition: Oral pathology.
42:5.0.1.1.9.11.34.17	SECTION 493.1221	493.1221 Condition: Cytology.
42:5.0.1.1.9.11.34.18	SECTION 493.1225	493.1225 Condition: Clinical cytogenetics.
42:5.0.1.1.9.11.34.19	SECTION 493.1226	493.1226 Condition: Radiobioassay.
42:5.0.1.1.9.11.34.20	SECTION 493.1227	493.1227 Condition: Histocompatibility.
42:5.0.1.1.9.11.34.21	SECTION 493.1230	493.1230 Condition: General laboratory systems.
42:5.0.1.1.9.11.34.22	SECTION 493.1231	493.1231 Standard: Confidentiality of patient information.
42:5.0.1.1.9.11.34.23	SECTION 493.1232	493.1232 Standard: Specimen identification and integrity.
42:5.0.1.1.9.11.34.24	SECTION 493.1233	493.1233 Standard: Complaint investigations.
42:5.0.1.1.9.11.34.25	SECTION 493.1234	493.1234 Standard: Communications.
42:5.0.1.1.9.11.34.26	SECTION 493.1235	493.1235 Standard: Personnel competency assessment policies.
42:5.0.1.1.9.11.34.27	SECTION 493.1236	493.1236 Standard: Evaluation of proficiency testing performance.
42:5.0.1.1.9.11.34.28	SECTION 493.1239	493.1239 Standard: General laboratory systems quality assessment.
42:5.0.1.1.9.11.35	SUBJGRP 35	Preanalytic Systems
42:5.0.1.1.9.11.35.29	SECTION 493.1240	493.1240 Condition: Preanalytic systems.
42:5.0.1.1.9.11.35.30	SECTION 493.1241	493.1241 Standard: Test request.
42:5.0.1.1.9.11.35.31	SECTION 493.1242	493.1242 Standard: Specimen submission, handling, and referral.
42:5.0.1.1.9.11.35.32	SECTION 493.1249	493.1249 Standard: Preanalytic systems quality assessment.
42:5.0.1.1.9.11.36	SUBJGRP 36	Analytic Systems
42:5.0.1.1.9.11.36.33	SECTION 493.1250	493.1250 Condition: Analytic systems.
42:5.0.1.1.9.11.36.34	SECTION 493.1251	493.1251 Standard: Procedure manual.
42:5.0.1.1.9.11.36.35	SECTION 493.1252	493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
42:5.0.1.1.9.11.36.36	SECTION 493.1253	493.1253 Standard: Establishment and verification of performance specifications.
42:5.0.1.1.9.11.36.37	SECTION 493.1254	493.1254 Standard: Maintenance and function checks.
42:5.0.1.1.9.11.36.38	SECTION 493.1255	493.1255 Standard: Calibration and calibration verification procedures.
42:5.0.1.1.9.11.36.39	SECTION 493.1256	493.1256 Standard: Control procedures.
42:5.0.1.1.9.11.36.40	SECTION 493.1261	493.1261 Standard: Bacteriology.
42:5.0.1.1.9.11.36.41	SECTION 493.1262	493.1262 Standard: Mycobacteriology.
42:5.0.1.1.9.11.36.42	SECTION 493.1263	493.1263 Standard: Mycology.
42:5.0.1.1.9.11.36.43	SECTION 493.1264	493.1264 Standard: Parasitology.
42:5.0.1.1.9.11.36.44	SECTION 493.1265	493.1265 Standard: Virology.
42:5.0.1.1.9.11.36.45	SECTION 493.1267	493.1267 Standard: Routine chemistry.
42:5.0.1.1.9.11.36.46	SECTION 493.1269	493.1269 Standard: Hematology.
42:5.0.1.1.9.11.36.47	SECTION 493.1271	493.1271 Standard: Immunohematology.
42:5.0.1.1.9.11.36.48	SECTION 493.1273	493.1273 Standard: Histopathology.
42:5.0.1.1.9.11.36.49	SECTION 493.1274	493.1274 Standard: Cytology.
42:5.0.1.1.9.11.36.50	SECTION 493.1276	493.1276 Standard: Clinical cytogenetics.
42:5.0.1.1.9.11.36.51	SECTION 493.1278	493.1278 Standard: Histocompatibility.
42:5.0.1.1.9.11.36.52	SECTION 493.1281	493.1281 Standard: Comparison of test results.
42:5.0.1.1.9.11.36.53	SECTION 493.1282	493.1282 Standard: Corrective actions.
42:5.0.1.1.9.11.36.54	SECTION 493.1283	493.1283 Standard: Test records.
42:5.0.1.1.9.11.36.55	SECTION 493.1289	493.1289 Standard: Analytic systems quality assessment.
42:5.0.1.1.9.11.37	SUBJGRP 37	Postanalytic Systems
42:5.0.1.1.9.11.37.56	SECTION 493.1290	493.1290 Condition: Postanalytic systems.
42:5.0.1.1.9.11.37.57	SECTION 493.1291	493.1291 Standard: Test report.
42:5.0.1.1.9.11.37.58	SECTION 493.1299	493.1299 Standard: Postanalytic systems quality assessment.

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