Quality Control Laboratory Operations Review 47
TERM EXPLANATION
Quality control (QC)
Control
External QC
Internal monitoring systems
Equivalent QC
Part of analytical phase of quality assurance; process of monitoring results from control samples to
verify accuracy of patient results.
Sample that is chemically & physically similar to unknown specimen & is tested in exactly the same
manner. Monitors precision of test system. For nonwaived quantitative tests, CLIA requires at least
2 levels of controls each day test is performed. (See “Equivalent QC” below.) For qualitative tests,
pos & neg controls must be included with each run.
Testing control material not built into test system. Term also used for QC that extends beyond lab,
e.g., participation in proficiency testing program.
Electronic, internal, or procedural controls that are built into test system.
Labs may reduce frequency of testing external QC materials for certain test systems if they can
demonstrate through a CMS-approved QC evaluation process that test system is stable.