Laboratory Guidelines

CLIA '88 Guidelines

Based on CLIA '88 guidelines regarding the selection of quality control material and use, there are several main objectives for internal quality control:

• The basic composition of quality control material needs to be the same as patient samples.
• The mean and standard deviation must be established or verified for all control material before quality control use.
• Laboratories are responsible for having procedures that monitor the complete analytical process, include the method performance specifications, detect immediate errors, and monitor long term precision and accuracy.
• The laboratory must establish written QC procedures to evaluate the quality of the analytical process of each method to assure the accuracy and reliability of patient test results.