The following are desired criteria for IQC material EXCEPT:

• Levels of IQC should span the clinically relevant concentrations of the analyte.

• Convenient size of aliquots/vials can be prepared.

•    IQC material should NOT mimic the composition of patient samples.

• Ready to use and require minimum preparation

The following are true regarding assigning an IQC range EXCEPT:

• Initially, a minimum of 20 data points, ideally from 20 separate days should be used.

• Values should be reviewed once data from longer-term stable operation has been obtained

• The acceptable range of IQC values (2SD/3SD, etc) should be determined based on the required quality of the assay

• Failed IQC values should be excluded from the cumulative data.

  The following are examples of RANDOM error EXCEPT:

•       Pipetting error

• Reagent lot bias

• Electrical interference

• Detector variation

The 2015 Milan Mandated Quality Hierarchy includes which of the following:

• Goals based on analytical performance related to clinical outcomes

•   Goals based on biological variation

•      Expert group opinions

•    EQA/PT goals

      What is the formula for calculating sigma metric?

•   (TEa/Bias) – CV

• (TEa – CV) / Bias

•     TEa / (Bias –CV)

•    (TEa – Bias) / CV

    The sigma metric can be used to:

•   Identify assays that require improvement (and those that do not)

• Define the required quality of an assay

•   Determine the optimal IQC rules for an assay

• Provide guidance on the frequency of IQC required

     The appropriate reaction to an IQC rejection should be to:

• stop analysis & troubleshoot the problem

•    correct the error

• document the error that occurred and the corrective actions taken

• document the error that occurred and the corrective actions taken

     The formula for Reference Change Value (RCV) is:

• 2^1/2 Z (CVA² + CVI²)^1/2

•    3.77 * (CVA² + CVI²)^1/2

•   2^1/2 Z (CVA₁² + CVA₂²)^1/2

• 3.77 * (CVA₁² + CVA₂²)^1/2

      The following are characteristics of Moving Average QC:

• Continuous QC monitoring

• Risk of non-commutability

•     Multiple QC levels

• Controls pre-analytical & analytical phases

     The following are TRUE regarding IQC within a laboratory network:

•     Protocols need to be standardised, including IQC material used, frequency of IQC and how target and range values are assigned.

• Liaison with the manufacturer is required to coordinate reagent and IQC lot changes across sites

•     Variation in assay performance is completely eliminated when the same analysers and methods are used across different sites.

•      Regular review of assay performance across the network is required to ensure assay quality classifications remain appropriate.