accuracy and reproducibility, and results recorded? Is the temperature of water baths and/or heat 6.12 blocks checked on days of use? Is the temperature of refrigerators and 6.13 temperature dependent equipment documented daily: Room temperature 6.13.1 Freezer 6.13.2 Refrigerator 6.13.3 Is there evidence of active review of results of 6.14 instrument maintenance and temperature? Is there a procedure available if acceptable 6.15 temperature ranges are exceeded? Is this review documented? 6.16 Glassware 6.17 Are there appropriate documented procedures 6.17.1 for handling and cleaning glassware, including methods for testing for detergent removal? Microscopes 6.18 Are there an adequate number of microscopes 6.18.1 for the workload? Are all microscopes clean, well maintained and 6.18.2 suitable for their intended use? Is there an adequate selection of objective lenses 6.18.3 for the specimens examined? Is there a procedure for Koehler illumination? 6.18.4 Centrifuges 6.19 Is there a schedule for maintenance of all 6.19.1 centrifuges? Are operating speeds checked and documented? 6.19.2 Balances 6.20 Are balances mounted on vibration-free 6.20.1 benches? Are balances and regularly serviced? 6.20.2 Are NIST/Equivalent reference weights 6.20.3 available and used for checking accuracy? Autoclaves 6.21 Is the autoclave monitored weekly for proper 6.21.1 functioning? Pipettes 6.22 Does your laboratory check pipettes for 6.22.1 calibration? Thermometers 6.23
accuracy and reproducibility, and results recorded? 6.12 Is the temperature of water baths and/or heat blocks checked on days of use? 6.13 Is the temperature of refrigerators and temperature dependent equipment documented daily: 6.13.1 Room temperature 6.13.2 Freezer 6.13.3 Refrigerator 6.14 Is there evidence of active review of results of instrument maintenance and temperature? 6.15 Is there a procedure available if acceptable temperature ranges are exceeded? 6.16 Is this review documented? 6.17 Glassware 6.17.1 Are there appropriate documented procedures for handling and cleaning glassware, including methods for testing for detergent removal? 6.18 Microscopes 6.18.1 Are there an adequate number of microscopes for the workload? 6.18.2 Are all microscopes clean, well maintained and suitable for their intended use? 6.18.3 Is there an adequate selection of objective lenses for the specimens examined? 6.18.4 Is there a procedure for Koehler illumination? 6.19 Centrifuges 6.19.1 Is there a schedule for maintenance of all centrifuges? 6.19.2 Are operating speeds checked and documented? 6.20 Balances 6.20.1 Are balances mounted on vibration-free benches? 6.20.2 Are balances and regularly serviced? 6.20.3 Are NIST/Equivalent reference weights available and used for checking accuracy? 6.21 Autoclaves 6.21.1 Is the autoclave monitored weekly for proper functioning? 6.22 Pipettes 6.22.1 Does your laboratory check pipettes for calibration? 6.23 Thermometers
CRA-F-05-15189-S-04-Molecular%20Diagnostics%20Inspection%20Checklist.docx