42 CFR Subpart K - Subpart K—Quality System for Nonwaived Testing
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- § 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.
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General Laboratory Systems (§§ 493.1230 - 493.1239)
- § 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.
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Analytic Systems (§§ 493.1250 - 493.1289)
- § 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.
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Postanalytic Systems (§§ 493.1290 - 493.1299)
Source:
68 FR 3703, Jan. 24, 2003, unless otherwise noted.