Subpart K. Subpart K—Quality System for Nonwaived Testing
- § 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.
General Laboratory Systems
- SECTION § 493.1230 - Condition: General laboratory systems.
- SECTION § 493.1231 - Standard: Confidentiality of patient information.
- SECTION § 493.1232 - Standard: Specimen identification and integrity.
- SECTION § 493.1233 - Standard: Complaint investigations.
- SECTION § 493.1234 - Standard: Communications.
- SECTION § 493.1235 - Standard: Personnel competency assessment policies.
- SECTION § 493.1236 - Standard: Evaluation of proficiency testing performance.
- SECTION § 493.1239 - Standard: General laboratory systems quality assessment.
Preanalytic Systems
Analytic Systems
- SECTION § 493.1250 - Condition: Analytic systems.
- SECTION § 493.1251 - Standard: Procedure manual.
- SECTION § 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
- SECTION § 493.1253 - Standard: Establishment and verification of performance specifications.
- SECTION § 493.1254 - Standard: Maintenance and function checks.
- SECTION § 493.1255 - Standard: Calibration and calibration verification procedures.
- SECTION § 493.1256 - Standard: Control procedures.
- SECTION § 493.1261 - Standard: Bacteriology.
- SECTION § 493.1262 - Standard: Mycobacteriology.
- SECTION § 493.1263 - Standard: Mycology.
- SECTION § 493.1264 - Standard: Parasitology.
- SECTION § 493.1265 - Standard: Virology.
- SECTION § 493.1267 - Standard: Routine chemistry.
- SECTION § 493.1269 - Standard: Hematology.
- SECTION § 493.1271 - Standard: Immunohematology.
- SECTION § 493.1273 - Standard: Histopathology.
- SECTION § 493.1274 - Standard: Cytology.
- SECTION § 493.1276 - Standard: Clinical cytogenetics.
- SECTION § 493.1278 - Standard: Histocompatibility.
- SECTION § 493.1281 - Standard: Comparison of test results.
- SECTION § 493.1282 - Standard: Corrective actions.
- SECTION § 493.1283 - Standard: Test records.
- SECTION § 493.1289 - Standard: Analytic systems quality assessment.
Postanalytic Systems