PEPFAR Quality Control and Method Validation Activity 9 Worksheet 2: QC Investigation

96 Worksheet 2: QC Investigation 907* Analyte Under Investigation Instrument XYZ Chemistry Analyzer Date June 20XX Controls Affected: Level 1 Level 2 Level 3 Other QC Flags : 1:2S 1:2.5S 1:38 .:4S (Random or Systematic) 2:2S 4:1S 10x 3:1s (Systematic) R:4S (Random) The change began: suddenly or gradually at run# on date Recent data are distributed: above below or evenly about the mean. The % of data prior to the change within +1 SD is: approximately 68% < 68% > 68% A new lot number of reagent was started at run # on A new bottle of reagent was started at run # on A new lot number of calibrator was started at run # on - A new bottle of calibrator was started at run # on A new box of controls was started at run # on A new bottle of control was started at run # on 1 Instrument maintenance occurred at run # on A change in the analytical process occurred at run # on Other test(s) affected: The common Instrument Wavelength Reagent Calibrator denominator is: Dispenser Test Principle Supply Shipment Other: Information The QC chart mean is assigned: Correctly Too high Too Low The QC chart SD is assigned: Correctly Too high Too Low Probable error type is: Systematic Random Either Random or Systematic Patient results may be erroneously: High Low Imprecise The change in method accuracy or precision Coincides with a change in: Reagent Calibration Instrumentation Controls Process Action: Repeat Controls (and All patient samples or Borderline patient samples ) with: Fresh Reagent New Lot of Fresh Calibrator New Lot of Fresh Controls Alternate Controls Reagent Calibrator Clean or maintain instrument Arrange instrument service from manufacturer Consult with supervisor, director, or technical specialist Temporarily discontinue reporting patient results Refer patient samples to another laboratory Assess current mean and SD against target and TEa If change not corrected with action above and TE