For laboratories in the United States that perform nonwaived testing and must adhere to the CLIA regulations, an IQCP that is based on risk management is now accepted as an alternate QC option in specifically defined circumstances. Until recently, the two QC options that were acceptable for CLIA-certified laboratories were:
- Two or more levels of external liquid controls per test per day (depending on the specialty/subspecialty)
- Equivalent quality control (EQC). EQC refers to the test manufacturers’ built-in quality assessments, which are intended to provide the equivalent quality information provided by external controls (EQC could be used after it was confirmed by the test site to be equivalent to external control).
However, EQC is no longer an acceptable QC option for nonwaived tests. (The QC requirement for waived testing remains the same-- follow the manufacturer's instructions).
A laboratory may decide to develop an IQCP if it wants to rely on manufacturers' built-in assessments for daily QC. It is important to note that the IQCP is not mandatory. If desired, laboratories can analyze external QC at the appropriate levels and frequency.
In any case, a laboratory may not implement an IQCP that allows for quality control to be performed less frequently than indicated in the manufacturer's instructions.
