What is Quality Control?

Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process producing patient results. The statistical process requires:

• Regular testing of quality control products along with patient samples.

  Good laboratory practice requires testing normal and abnormal controls at least once a day when patient testing is performed. If the test is stable for less than 24 hours or some change has occurred that could potentially affect the test stability, controls should be tested more frequently. All laboratories in the United States must comply with CLIA Requirements (see CLIA Requirements for more information).

• Generation of QC results for evaluation.

  When performing a diagnostic test in the medical laboratory, the outcome of the test is a result. The result may be a patient result or a quality control (QC) result. The result may be quantitative (a number), qualitative (positive or negative), or semi-quantitative (limited to a few different values).

Note: Unity Real Time™ online currently provides QC rule evaluation only for quantitative tests. You may enter data from qualitative and semi-quantitative tests; however, the data is not evaluated against any rules.