Laboratory manager
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REAGENT AND TEST KITS QUALITY CONTROLREGISTERATION OF REAGENT AND TEST KITS: Date all reagents and test kits on receipt. Register them into LIS and leave the "Active" flag as "N" if the reagent or test kit is not being used immediately. When reagent or test kit is being placed for use, date the in-use vial with the date it is opened. If this is a new lot, change the LIS the "Active" flag to "Y" and change the previous lot "Active" flag to "N". FREQUENCY OF TESTING: All required QC for reagents and test kits will be alerted to the technologist by the LIS when working up through bench WORKLIST. Daily QC: Catalase (all benches) Gram stain (Microscopy) Oxidase (all benches) Staph latex (all benches) Tube Coagulase (Infection Control bench) Weekly QC: Arabinose (QC bench) Bile solubility (QC bench) Cephalosporin for Campylobacter ID (QC bench) MUG (QC bench) Nalidixic acid for Campylobacter ID (QC bench) Optochin (QC bench) Prolex Streptococcus Grouping (QC bench) Tributyrin (QC bench) Xylose (QC bench) QC When Test is performed: Cetrimide agar Cryptococcal Antigen Eosinophil stain Thermonuclease (Blood Culture bench) Germ tube Infrequently used reagents and stains
See Appendix IX (REAGENTS FOR QC BENCH ON RECEIPT) PROCEDURE: For kits which require freshly subcultured control organisms to be QC namely API, Rapid ANA, and Vitek cards: In SOFT, 1 (Receiving Work List) F5 (marking) Using the “Kit QC on Receipt” template, wand the appropriate organisms for each type of Kit to be QC. F7 R Choose a label printer. Enter. Labels can be used for subculture of organisms from freezer stocks, the test itself, API/ Rapid ANA code sheets, and purity plates as required. For kits that have their own internal controls, follow procedure described in the Technical section of the lab manual. Enter the results into the LIS.
EQUIPMENT QC & MAINTENANCEA. Refrigerators, Freezers, Incubators, Heating Blocks, Centrifuges 1. Temperature and CO2 levels is checked and recorded daily by the wash-up technician. Report all out-of-range readings to the QA technologist for corrective action. 2. Maintenance such as cleaning and defrosting are done every 3 months or semi-annually. Record all maintenance performed on charts in Equipment Maintenance binder. B. Instruments (e.g. Architect, BacT/Alert): See the appropriate sections of the manual for QC items. Record all results into the LIS. C. Deionized Water: Resistivity reading is recorded daily by the wash-up technician. Culture for bacterial count is done weekly. Report all out-of-range readings to the QA technologist for corrective action.
Record cleaning and disinfection of cabinet work area on chart as scheduled. All biosafety cabinets are certified annually by CONTEST. Certificates are filed in the QA section in the store room.
Daily – random streaking check, 5 times daily; daily carry-over check; daily cleaning; daily loop checking; Weekly – loop filing
Eppendorff pipettes are checked semi-annually by an outside contractor. Records are kept in the Pipette Check folder in the QA section. Pipette Calibration Acceptance Criteria:
Match the label of the jar and the lid. Include the following in each anaerobic jar set up:
Enter results into Softmicqc. * Not required for 24 hours throat culture jars.
Match the label of the jar and the lid. Include the following in each anaerobic jar set up:
Enter results into Softmicqc. Records of all preventive maintenance and repair work performed by maintenance companies are filed in each of the equipment binders. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||