Quality Control and Quality Assurance

What is quality control?

A method that ensures laboratories and automated instruments are producing reliable test results

___________ + ____________ = Reliability

Precision + accuracy

What 3 things does quality control test?

Instruments, reagents, and you (it’s a domino effect)

What is precision?

How close the measurements are to each other

What is accuracy?

How close a given set of measurements are to their true value

How often should a quality control be done?

Depends on the analyzer being used and how often it is being used

What is the difference between quality control and maintenance?

Quality control identifies problems, defects, and cracks in the system while maintenance keeps all systems a go

Quality control is _________ while maintenance is ________

Reactive, proactive

What equipment is required for monthly maintenance for the Sedi vue and Catalyst One machines?

Powderless gloves, optical tissues and alcohol prep pads

How long can extra quality control solution be saved for and re-used?

14 days

What should you do for monthly maintenance with a Procyte DX and Procyte One machine?

Bleach rinse 1x a month

What are random errors in quality control?

Unstable temperature, bubble in reagent, inadequately mixing reagent

What are 3 systemic errors in quality control?

Bad calibration, deterioration of reagent, and change in reagent lot number

What is quality assurance?

Long term monitoring of the entire laboratory or automated analyzer process

What kind of approach is needed for quality assurance?

A proactive approach