Laboratory manager
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QUALITY CONTROL MANUAL TABLE OF CONTENTS MAINTENANCE OF ISOLATES FOR QUALITY CONTROL 3 QUALITY CONTROL OF CULTURE MEDIA 4 SHEEP/HORSE BLOOD STERILITY TESTING 10 KIRBY BAUER QUALITY CONTROL 11 E-TEST QUALITY CONTROL 17 ROSCO Diagnostica Tablets QC 19 TREK Sensititre Weekly QC 20 HIGH LEVEL AMINOGLYCOSIDE RESISTANCE SCREEN PLATE (QUAD) QC 21 REAGENT AND TEST KITS QUALITY CONTROL 22 EQUIPMENT QC & MAINTENANCE 24 SEROLOGY QC 26 QUALITY CONTROL REVIEW 27 APPENDIX II - Bacteriology QC Bench Workflow 29 APPENDIX III - Ordering New QC ORGANISMS in Soft 35 APPENDIX IV - Order Entry for New QC TESTS 37 APPENDIX V - Printing QC Labels Procedure 38 APPENDIX VI - Bench Quality Control Documentation in LIS 39 APPENDIX VII - SOFT for micqc 46 APPENDIX VIII - Media for QC Bench On-Receipt 48 APPENDIX IX - Reagents for QC Bench On-Receipt 50 APPENDIX X - Registering Antibiotics 52 APPENDIX XI - Weekly Susceptibility QC 54 APPENDIX XII - Rarely Used Antibiotic Discs 57 APPENDIX XIII - QC Antibiotic Inventory 58 Record of Edited Revisions 59
VITEK QUALITY CONTROL See Vitek Manual MAINTENANCE OF ISOLATES FOR QUALITY CONTROLSTOCK CULTURES Reference strains for quality control are originally obtained from ATCC, Microbiologicals or other commercial sources as lyophilised cultures. Follow manufacturer's instructions and subculture these lyophilised cultures. Upon receipt, each new strain will be will be entered in Soft like a patients specimen (see order entry instructions Appendix III - Ordering New QC Organisms in Soft) and then frozen in triplicate in the appropriate QC storage box. See Laboratory Information Systems for Freezing QC Strains in SoftStore. Store the sub-cultured isolates in trisodium citrate glycerol at -70oC. These frozen cultures are used as STOCK CULTURES and should be replaced annually. Viruses are kept in DMSO in liquid nitrogen. WORKING CULTURES Working cultures are stored on TSB agar slants at 4o to 8oC or on Chocolate agar or Blood Agar for fastidious organism. See the working List of Quality Control Organisms for storage requirements and freezer location. These cultures are replaced monthly by sub-culturing twice to the appropriate solid media from the frozen Stock Cultures. The fresh subcultures are then placed in the appropriate racks and the previous months cultures are discarded. Virus working cultures are propagated in the appropriate tube culture cell lines. BEFORE TESTING Before testing, cultures are sub-cultured from the working cultures onto solid media before use. Not applicable for viruses QUALITY CONTROL OF CULTURE MEDIAPROCEDURE FOR QC ON COMMERCIALLY PREPARED MEDIA: All prepared media received will be examined visually for colour change, precipitate, lysis of blood, contamination etc. Any atypical observation should be brought to the attention of the QA technologist. An incident report form will then be filled out and faxed to the supplier. Performance quality control testing for routine media supplied by OXOID / BIOMEDIA is not required except the following:
On receipt of these media, a sufficient amount of each lot (see Appendix VIII - MEDIA FOR QC BENCH ON RECEIPT) for amount will be set aside for performance testing.
Prepare a saline suspension of all required isolates to a turbidity to match 0.5 McFarland Standard. Inoculate media using a calibrated 1µL (0.001 mL) loop. Incubate as required and inspect cultures at 24 and 48 hours.
Prepare a saline suspension of all required isolates to a turbidity to match 0.5 McFarland Standard. Make a 1:10 dilution; remove 300ul from a standard blank Vitek saline tube (3.0mL) and pipette 300uL of the 0.5 McFarland suspension into the saline.
ORGANISMS FOR MEDIA QC
* Use the 1:10 dilution of the 0.5 McFarland suspensions for inoculation.
PROCEDURE FOR QC ON MEDIA PREPARED IN-HOUSE: Visual inspection includes observing the media for colour change, precipitate, lysis of blood, etc. Any atypical observation should be brought to the attention of the QA technologist. If the medium is visually satisfactory, write "OK" in the space provided. pH testing will be performed on the final medium after it has solidified and cooled to room temperature. Record the value obtained in micqc Results Entry List “Procedure Actions” Comment (F7). For blood that has been added to freshly prepared agar, one drop is put onto BA and incubated at 35oC for 48 hours and then at RT for a further 48 hours. Sterility testing will be performed on all media prepared in our laboratory. One plate or tube from each batch will be incubated at 35oC for 48 hours, one at room temperature for 48 hours. Performance testing will be done using the Standard Loop method. One plate from each batch will be tested when first prepared and again on each successive 7 days until the supply in the refrigerator is depleted or the expiry date is reached. If expected results are not attained, the QA technologist or Charge technologist must be informed. QA technologist or Charge technologist will implement appropriate corrective action. The lab will be notified through LIS e-mail if needed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
