U.S. Code of Federal Regulations

Regulations most recently checked for updates: Nov 22, 2025

All TitlesTitle 42Chapter IVPart 493Subpart K - Subpart K—Quality System for Nonwaived Testing

GENERAL LABORATORY SYSTEMS
§ 493.1230 - Condition: General laboratory systems.
§ 493.1231 - Standard: Confidentiality of patient information.
§ 493.1232 - Standard: Specimen identification and integrity.
§ 493.1233 - Standard: Complaint investigations.
§ 493.1234 - Standard: Communications.
§ 493.1235 - Standard: Personnel competency assessment policies.
§ 493.1236 - Standard: Evaluation of proficiency testing performance.
§ 493.1239 - Standard: General laboratory systems quality assessment.
§ 493.1200 - Introduction.
§ 493.1201 - Condition: Bacteriology.
§ 493.1202 - Condition: Mycobacteriology.
§ 493.1203 - Condition: Mycology.
§ 493.1204 - Condition: Parasitology.
§ 493.1205 - Condition: Virology.
§ 493.1207 - Condition: Syphilis serology.
§ 493.1208 - Condition: General immunology.
§ 493.1210 - Condition: Routine chemistry.
§ 493.1211 - Condition: Urinalysis.
§ 493.1212 - Condition: Endocrinology.
§ 493.1213 - Condition: Toxicology.
§ 493.1215 - Condition: Hematology.
§ 493.1217 - Condition: Immunohematology.
§ 493.1219 - Condition: Histopathology.
§ 493.1220 - Condition: Oral pathology.
§ 493.1221 - Condition: Cytology.
§ 493.1225 - Condition: Clinical cytogenetics.
§ 493.1226 - Condition: Radiobioassay.
§ 493.1227 - Condition: Histocompatibility.

PREANALYTIC SYSTEMS
§ 493.1240 - Condition: Preanalytic systems.
§ 493.1241 - Standard: Test request.
§ 493.1242 - Standard: Specimen submission, handling, and referral.
§ 493.1249 - Standard: Preanalytic systems quality assessment.

ANALYTIC SYSTEMS
§ 493.1250 - Condition: Analytic systems.
§ 493.1251 - Standard: Procedure manual.
§ 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
§ 493.1253 - Standard: Establishment and verification of performance specifications.
§ 493.1254 - Standard: Maintenance and function checks.
§ 493.1255 - Standard: Calibration and calibration verification procedures.
§ 493.1256 - Standard: Control procedures.
§ 493.1261 - Standard: Bacteriology.
§ 493.1262 - Standard: Mycobacteriology.
§ 493.1263 - Standard: Mycology.
§ 493.1264 - Standard: Parasitology.
§ 493.1265 - Standard: Virology.
§ 493.1267 - Standard: Routine chemistry.
§ 493.1269 - Standard: Hematology.
§ 493.1271 - Standard: Immunohematology.
§ 493.1273 - Standard: Histopathology.
§ 493.1274 - Standard: Cytology.
§ 493.1276 - Standard: Clinical cytogenetics.
§ 493.1278 - Standard: Histocompatibility.
§ 493.1281 - Standard: Comparison of test results.
§ 493.1282 - Standard: Corrective actions.
§ 493.1283 - Standard: Test records.
§ 493.1289 - Standard: Analytic systems quality assessment.

POSTANALYTIC SYSTEMS
§ 493.1290 - Condition: Postanalytic systems.
§ 493.1291 - Standard: Test report.
§ 493.1299 - Standard: Postanalytic systems quality assessment.
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