Does the laboratory have a procedure for 5.8 evaluating automatic pipette systems for carryover? Are pipettors and dilutors (fixed volume or adjustable) checked at least annually for 5.9 accuracy and reproducibility, and results recorded? Is the temperature of water baths and/or heat 5.10 blocks checked on days of use? Is the temperature of refrigerators and other 5.11 temperature dependent equipment documented daily: Room temperature 5.11.1 Freezer(s) 5.11.2 Refrigerator(s) 5.11.3 Is there evidence of review of instrument 5.12 maintenance and temperature by a supervisor? Is this review documented? 5.13 Is there a procedure available if acceptable 5.14 temperature ranges are exceeded? 6.0 Testing Calibration Verification is the process of – 6.1 confirming that the current calibration settings remain valid for a method. Is there documentation of calibration as 6.1.1 recommended by the manufacturer? At change of reagent, is your calibration 6.1.2 verified by performing QC? Are criteria established for frequency of 6.1.3 calibration verification? Linearity is the range of analyte values that – a method can directly measure on the 6.2 specimen without any dilution, concentration or other pre-treatment not part of the usual assay process. Is linearity validated initially as part of the 6.2.1 instrument validation prior to putting into service? Is there documentation of linearity? 6.2.2 7.0 Specimen Handling
5.8 Does the laboratory have a procedure for evaluating automatic pipette systems for carryover? 5.9 Are pipettors and dilutors (fixed volume or adjustable) checked at least annually for accuracy and reproducibility, and results recorded? 5.10 Is the temperature of water baths and/or heat blocks checked on days of use? 5.11 Is the temperature of refrigerators and other temperature dependent equipment documented daily: 5.11.1 Room temperature 5.11.2 Freezer(s) 5.11.3 Refrigerator(s) 5.12 Is there evidence of review of instrument maintenance and temperature by a supervisor? 5.13 Is this review documented? 5.14 Is there a procedure available if acceptable temperature ranges are exceeded? 6.0 Testing 6.1 Calibration Verification – is the process of confirming that the current calibration settings remain valid for a method. 6.1.1 Is there documentation of calibration as recommended by the manufacturer? 6.1.2 At change of reagent, is your calibration verified by performing QC? 6.1.3 Are criteria established for frequency of calibration verification? 6.2 Linearity – is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration or other pre-treatment not part of the usual assay process. 6.2.1 Is linearity validated initially as part of the instrument validation prior to putting into service? 6.2.2 Is there documentation of linearity? 7.0 Specimen Handling