QUALITY CONTROL

Quality control is an aspect of quality assessment used to maintain the quality in the laboratory.

True or False?

• TRUE

• FALSE

It is recommended to use at least one level of control for each analyte to monitor daily IQC performance.

Tru or False?

• TRUE

• FLASE

The following statements are TRUE regarding L-J chart EXCEPT:

• The most commonly used charts to monitor quality control results.

• The deviation of the results from the mean, especially when the results are greater than mean±2SD from the mean, indicates the rejection of the run.

• If the plot trend shows bias within 1SD after 10 runs, we have to establish the mean and SD.

• L-J chart should be monitored daily and periodically to assess the analyzer performance.

This rule should only be interpreted within-run, not between-run.

TRUE or FALSE?

• TRUE

• FALSE

This rule is used as a warning rule to trigger careful inspection of the control data.

The mentioned rule is referring to ___________.

• 
• 

The following issues can be suspected to be the root cause of the 1 3S rule violation EXCEPT:

• QC material is not mixed well before analysis.

• The operator used the wrong reagents.

• The user has not performed daily maintenance.

• The QC material is deteriorated.

Laboratory X has TWO coagulation analyzers. As shown in the picture, one of the analyzers has an issue with the IQC performance. Which of the following could be suspected as the root cause?

• Stability of reagents

• The reagent was not calibrated.

• Systematic error

Situation A: David has performed the IQC for PT and PTT on Analyzer A and Analyzer B. Both analyzers were the same brand and used the same reagents and QC material. The IQC results are as follows:

Analyzer A: Both PT and PTT QC results were in.

Analyzer B: The PT QC was in, but the PTT QC result was out.

Which of the following statements is the BEST answer to explain the root cause?

• Stability of the PTT reagent

• PTT QC material has deteriorated.

• Systematic error of Analyzer B

• The PTT reagent was not calibrated correctly.

Situation B: Laura has performed the IQC for Fibrinogen on Analyzer X and Analyzer Y. Both analyzers were the same brand and used the same reagents and QC material. The IQC results are as follows:

Analyzer X: QC Level 1 & Level 2 results were out.

Analyzer Y: QC Level 1 & Level 2 results were in.

Which of the following statements is the BEST answer to explain the root cause?

• Stability of the reagent

• Both QC material have deteriorated.

• Insufficient reagent

• The assigned mean for both IQC in analyzer A were incorrect.

Choose the BEST answer to explain the correct practice in quality control management.

• The main purpose of IQC is the precision

  (repeatability or reproducibility) of the method.

• Maintenance of analyzer should be done before performing the IQC and tests.

• Corrective action and preventive action are required to stop and prevent the non-conformities.

• All answers are correct