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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 42 - Public Health |
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Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
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SubChapter G - Standards and Certification |
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Part 493 - Laboratory Requirements |
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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. |
| § 493.1218 - Standard; Control procedures. |
| § 493.1219 - Condition: Histopathology. |
| § 493.1220 - Condition: Oral pathology. |
| § 493.1221 - Condition: Cytology. |
| § 493.1223 - Condition: Quality control—specialties and subspecialties for tests of moderate or high complexity, or both. |
| § 493.1225 - Condition: Clinical cytogenetics. |
| § 493.1226 - Condition: Radiobioassay. |
| § 493.1227 - Condition: Histocompatibility. |
| § 493.1229 - Condition: Mycobacteriology. |
| § 493.1237 - Condition: Diagnostic immunology. |
| § 493.1243 - Condition: Chemistry. |
| § 493.1245 - Condition: Routine chemistry. |
| § 493.1247 - Condition: Endocrinology. |
| § 493.1257 - Condition: Cytology. |
| § 493.1259 - Condition: Histopathology. |
| § 493.1275 - Standard; Blood and blood products storage facilities. |
| § 493.1277 - Standard; Arrangement for services. |
| § 493.1279 - Standard; Provision of testing. |
| § 493.1285 - Standard; Investigation of transfusion reactions. |
| Postanalytic Systems |
| § 493.1290 - Condition: Postanalytic systems. |
| § 493.1291 - Standard: Test report. |
| § 493.1299 - Standard: Postanalytic systems quality assessment. |
| 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. |
| 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. |
| 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. |