[1S] UNIT 5: Quality Management

Coordinated activities to implement the quality policy

Pre/Post/Analytical Quality assurance

Pre/Post/Analytical Quality planning

Pre/Post/Analytical Quality control

Pre/Post/Analytical Quality improvement

A planned and systematic set of quality activities focused on providing confidence that quality requirements will be fulfilled

Uses Quality indicators which is an established measure used to determine how well an organization meets needs and operational and performance expectations

Verifying the acceptability of methods prior to reporting patient results

T/F: Method should remain valid over time

Method validation is validated by the?

The laboratory can be validated by their?

ability of a test to detect a given disease or condition

ability of a test to correctly identify the absence of a given disease or condition

chance of an individual having a given or condition if the test is abnormal

chance of an individual does not have a given disease or condition if the test is within the reference interval

closeness of a measure to the true value or target value

LAB ERRORS ○ Mislabelling ○ Transcription ○ Delay transportation

refers to the results being as close as possible to the true value on a consistent basis

amount of variation in a series of repeated measurements

LAB ERRORS ○ Delay turn around time ○ Failure to release results

LAB ERRORS Highest frequency of errors especially with the use of handwritten labels and request forms

LAB ERRORS Errors of accuracy

LAB ERRORS Can either be an increase or decrease but never both

LAB ERRORS Common cause is reagent instability / inaccurate control samples