Quality Assurance in Laboratory Results

Quality Assurance

• Focuses on non-statistical procedures to ensure quality results, including:
  • Expiry dates of reagents
  • Temperature control
  • Human error
• Is a proactive process that provides confidence in the results produced

Quality Control vs. Quality Assurance

• Quality control is product-orientated, focusing on the patient's result
• Quality assurance is process-orientated, considering all processes and elements that may influence the outcome, such as:
  • Human error

Quality Control in a Medical Laboratory

• Quality control is a statistical method to monitor and evaluate the process that produces patient results.
• It involves reviewing and analyzing data using mathematical concepts such as mean, range, and standard deviation.
• The goal is to determine whether a patient's result produced by an instrument accurately reflects the patient's condition.
• Quality control involves testing quality control material to measure actual performance.

Control Samples

• Are commercially produced and similar in nature to human body fluids, such as serum
• Are inoculated (spiked) with a known concentration of a particular constituent
• Can be liquid or freeze-dried in nature

Use of Control Samples

• Are run on an instrument just like a patient's sample would be processed
• Can have concentrations of the substance to be tested at normal range, above normal range, or below normal range
• Are run at a frequency determined by the laboratory, typically:
  • Once a day
  • Following a service or repair procedure
  • When a new batch of reagent is used