QA and QC

Nonanalytical factors in quality assessment include

Both qualified personnel and established laboratory policies.

An example of a preanalytical error is

specimen obtained from the wrong patient

Clinical sensitivity is defined as the

proportion of subjects with the specific disease or condition who have a positive test result.

Clinical specificity is defined as the

proportion of subjects without the specific disease or condition who have a negative test result.

Accuracy

How close a test result is to the true value

Precision

How close the test results are to one another when repeated analyses of the same material are performed

Standard

Highly purified substances of a known composition

A new test kit must be validated for accuracy and precision that can be done by:

validated for accuracy and precision

Quality assessment programs include

patient identification.

specimen procurement.

specimen transportation and processing procedures.

For testing of moderate complexity, quality control requires

performing control procedures using at least two levels of control material for each day of testing.