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Quality Control

This document defines quality control and quality assurance procedures for laboratories. It discusses how quality control aims to detect, reduce, and correct issues before releasing patient results. This includes using statistical process control, quality checks of reagents and equipment, and monitoring turnaround times and specimen handling. The document then describes analytical quality control procedures involving pre-analytical, analytical, and post-analytical variables. It introduces Levey-Jennings and Westgard control charts for monitoring quality using control samples, and discusses interpreting control data using Westgard rules. Finally, it discusses best practices for control materials and internal and external quality assurance schemes.

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200 views19 pages

Quality Control

This document defines quality control and quality assurance procedures for laboratories. It discusses how quality control aims to detect, reduce, and correct issues before releasing patient results. This includes using statistical process control, quality checks of reagents and equipment, and monitoring turnaround times and specimen handling. The document then describes analytical quality control procedures involving pre-analytical, analytical, and post-analytical variables. It introduces Levey-Jennings and Westgard control charts for monitoring quality using control samples, and discusses interpreting control data using Westgard rules. Finally, it discusses best practices for control materials and internal and external quality assurance schemes.

Uploaded by

Rsrao
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

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

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