SUBPART K—Quality System for Nonwaived Testing (§493.1200 to §493.1299)
- 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.
- 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.
- 493.1240—Condition: Preanalytic systems.
- 493.1241—Standard: Test request.
- 493.1242—Standard: Specimen submission, handling, and referral.
- 493.1249—Standard: Preanalytic systems quality assessment.
- 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.
- 493.1290—Condition: Postanalytic systems.
- 493.1291—Standard: Test report.
- 493.1299—Standard: Postanalytic systems quality assessment.