Quality control (QC) is a dynamic process that ensures reliable test results. Reliability takes into consideration many types of information, including manufactures' recommendations, regulatory requirements, environmental considerations (eg, reagent and specimen storage temperatures, instrument maintenance) and the medical significance of the test result.
A Quality Control Plan developed by the laboratory should discuss the procedures that are necessary to be sure all laboratory testing is being monitored. A QC Plan may include the following:
- a list of variables within the laboratory that may affect test results and need to be monitored, such as water quality, pipette calibration, and instrument calibration;
- defined protocols for performing QC testing;
- proficiency testing guidelines and requirements;
- a method for presenting QC test results so that results can be easily evaluated;
- frequency for evaluation of QC data;
- procedures for troubleshooting QC errors;
- corrective actions that need to be taken to address QC errors, including the steps taken to resolve the problem and verification of success;
- a schedule for routine maintenance of laboratory instruments; and
- record keeping and QC record retention requirements.