1. The laboratory will, at minimum, follow the manufacturer's instructions for quality control or those set by CLIA (whichever are more stringent) for all test
(waived & non-waived). Individualized Quality Control Plan (IQCP) is an option to traditional QC and can be found in section 493.1250 of the CLIA regulations.
This is an option to traditional QC but not required.
2. For qualitative tests, the laboratory must run a positive and negative control. The frequency would be set by the individual test.
3. For quantitative tests, the laboratory must run at least two appropriate samples (e.g., normal and abnormal). The frequency and amount of controls would be set by the individual test.
4. All new controls will be validated for use prior to changing lot number of controls or discarding due to expiration date. (see page 4-4 for information)
5. Date received, lot numbers, expiration date, date opened, control range, mean and control results will all be documented.
6. If control material is not available for a test an alternate method (comparison study - i.e. send to reference lab) will be developed to assure accuracy of results.
7. If the laboratory uses two methods for the same in-house test, a comparison testing will be performed by comparing results from the same specimen. The frequency would be set by CLIA or outside surveying agency.
8. QC materials will be tested in the same manner as patient samples.
9. All QC results (good and bad) will be recorded.
10. Computer generated results must be saved and easy to retrieve.