each other at least twice a year for correlation of results? Are there defined tolerance limits for result 5.9 agreement of inter-instrument assays? Does the laboratory have a procedure for 5.10 evaluating automatic pipette systems for carryover? Are pipettors, microtiter or automatic dispensers 5.11 checked at annually for accuracy and reproducibility, and results recorded? Is the temperature of baths and/or heat 5.12 blocks checked on days of use? Is the temperature of refrigerators and other 5.13 temperature dependent equipment documented daily: Room temperature 5.13.1 Freezer 5.13.2 Refrigerator 5.13.3 Incubators 5.13.4 Is there evidence of active review of 5.14 temperature records? Are reviews documented? 5.15 Is there a procedure available if acceptable 5.16 temperature ranges are exceeded? Is there documentation that anaerobic systems 5.17 (eg. jars, chambers, bags) are checked for adequate anaerobic conditions with: indicator strips 5.17.1 fastidious anaerobic organisms 5.17.2 Are CO2 incubators checked daily for adequate 5.17.3 CO2 levels, with recording of results 5.18 Biological Safety Cabinets Is a biological safety cabinet used for handling 5.18.1 all specimens or organisms considered to be contagious by airborne routes? Does the biological safety cabinet meet minimum requirements for the work performed 5.18.2 in it, as described in the Health Canada Laboratory Biosafety Guidelines? Type of biological safety cabinet used: Class I – 5.18.3 protect operator Class II protect operator plus specimen 5.18.4 – Class III protect operator plus specimen, – 5.18.5 airtight Is the biological safety cabinet certified annually 5.18.6 (and documented)? Is the cabinet appropriately situated to 5.18.7 avoid/minimize air turbulence?
each other at least twice a year for correlation of results? 5.9 Are there defined tolerance limits for result agreement of inter-instrument assays? 5.10 Does the laboratory have a procedure for evaluating automatic pipette systems for carryover? 5.11 Are pipettors, microtiter or automatic dispensers checked at annually for accuracy and reproducibility, and results recorded? 5.12 Is the temperature of baths and/or heat blocks checked on days of use? 5.13 Is the temperature of refrigerators and other temperature dependent equipment documented daily: 5.13.1 Room temperature 5.13.2 Freezer 5.13.3 Refrigerator 5.13.4 Incubators 5.14 Is there evidence of active review of temperature records? 5.15 Are reviews documented? 5.16 Is there a procedure available if acceptable temperature ranges are exceeded? 5.17 Is there documentation that anaerobic systems (eg. jars, chambers, bags) are checked for adequate anaerobic conditions with: 5.17.1 indicator strips 5.17.2 fastidious anaerobic organisms 5.17.3 Are CO2 incubators checked daily for adequate CO2 levels, with recording of results 5.18 Biological Safety Cabinets 5.18.1 Is a biological safety cabinet used for handling all specimens or organisms considered to be contagious by airborne routes? 5.18.2 Does the biological safety cabinet meet minimum requirements for the work performed in it, as described in the Health Canada Laboratory Biosafety Guidelines? 5.18.3 Type of biological safety cabinet used: Class I – protect operator 5.18.4 Class II – protect operator plus specimen 5.18.5 Class III – protect operator plus specimen, airtight 5.18.6 Is the biological safety cabinet certified annually (and documented)? 5.18.7 Is the cabinet appropriately situated to avoid/minimize air turbulence?
CRA-F-05-15189-S-08-Microbiology%20Inspection%20Checklist.docx