Quality Control
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Is a complete system of creating and following procedures and policies
Quality Assurance (QA)
What is the aim of quality assurance?
To provide the most reliable patient laboratory result To minimize errors in the pre-analytical, analytical, and postanalytical phases
A system of ensuring accuracy and precision in the laboratory by using quality control materials in every series of measurement
Quality Control (QC)
Testing of patient samples can proceed even without performing QC first. True or false?
False; before you run patient samples, you have to run quality control testing first
Overall process used to ensure that laboratory results meet the requirements for healthcare services to patients
Quality Management (QM)
Quality Management is otherwise known as
TQM (Total Quality Management)
Intervals of acceptable values with upper and lower limits
Control limits
Most commercially prepared QC materials are lyophilized. What does lyophilized means?
They come in powdered or pulverized form
Ideal control limit
± 2SD
Who applied the principles of analyzing QC in the laboratory? When?
Levey & Jennings, 1950s
These are specimens analyzed for QC purposes
Quality Control Materials/ Control Solutions
Control level with concentrations above or below the normal range of the analyte being tested
Level 2 (Abnormal Control)
A sample taken from the total volume of the quality control material
Aliquot
Level of control that contains normal levels for the analyte being tested
Level 1 (Normal Control)
Level of controls commonly used in immunoassays:
Level 1 (Low Control) Level 2 (Normal Control) Level 3 (High Control)
What to do if a quality control result shows that one/some values are out of control?
Find the error → take corrective measures → repeat quality control testing = if the control results are within the control limits, you can now proceed testing patient samples
What are the objectives of performing Quality Control?
To check the stability of the machine/analyzers utilized in the Chemistry Laboratory To check the quality of the reagents To check technical (operator) errors
The errors we encounter in the laboratory from the pre-analytical, analytical and post-analytical phases of testing
Variation/Variables
In the operation of a QC system, is it allowed to accept errors?
Errors are acceptable BUT WITH LIMIT
The standard confidence limit in Clinical Chemistry is set at
± 2SD
If the error repeatedly occurred (even if corrective actions are already made). Reject or Accept?
Reject
If an error occurred, but it was corrected thru corrective actions. Reject or Accept?
Accept
Involves the analyses of control samples and the patient specimen; use for the daily monitoring of accuracy and precision of analytical methods
Intralab Quality Control (Internal QC)
How often should we perform QC within a clinical laboratory?
Daily