Quality Control

Definition
• Laboratory quality control is designed to detect , reduce, and correct
deficiencies in a laboratory internal analytical process prior to release
of patient results and improve the quality of the results reported by
the laboratory.
• QC emphasizes statistical control procedures and nonstatistical check
procedures such as linearity checks, reagent, standard checks and
temperature monitors
• QA measures and monitor the lab. Performance based on turnaround
time, specimen identification , patient identification
Technical procedure
• Pre- analytical variables – Test request , Patient preparation , Patient
identification , Specimen acquisition , Specimen transport, Specimen
processing, Specimen distribution , preparation of work lists and logs
• Analytical variables – Analytical methodology ,standardization and
calibration procedures , documentation of analytical protocols and
procedures and monitoring of critical equipment and materials.
• Monitoring of analytical quality by the use of statistical methods and
control charts
Laboratory testing process and Errors
Levey – Jennings Control Chart
• It is a graph that QC data is plotted on to give a visual indication
whether a laboratory test is working well
• Analyze the control material by the analytical method to be controlled
on at least 20 different days.
• Calculate the mean and SD
Levey – Jennings Control Chart
• Construct a control chart
Y –axis – control value
X- axis - Time
• Introduce control into each analytical run ( 50 samples or every 12
hours ), record the values and plot each value on the control chart
Levey – Jennings Control Chart
• If values within control limits, we can report the patient results
• When a single control value exceeds the control limit , stop process of
patient samples , do not report the patient results
• Find out error and resolve the problem , then repeat the entire run
control and patient samples
Westgard Multirule chart
Level 2
Level 1
Interpretation of control date using westgard
rules
Control material
• They should have the same matrix as patient specimens, including
viscosity , turbidity, composition and color
• Simple to use
• Minimal vial to vial variability
• Stable for long periods of time in large enough quantities to last at least
one year and liquid controls are more convenient than lyophilized
controls.
• Concentration of analyte should be in normal and abnormal ranges
• lyophilized controls are reconstituted by adding distilled water or diluents
• Internal QA-daily monitoring of the precision and accuracy of
analytical method
• Systematic error- occurs when results fall one direction , due to
calibration problem.
• Random error – due to lack of reproducibility in the pipetting ,
preparation of reagents, mixing , lack of stability of temp, photometric
and sesors
External Quality Assurance Scheme
• External QA – Long-term accuracy of analytical method.
• External Quality assessment in which patient specimen made from a
common pool are analyzed by laboratories enrolled in the program
• The results are returned to a central facility and evaluated to
determine the quality of each lab performance
Thank you