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IQCP and the Clinical Laboratory Improvement Amendments (CLIA) for Laboratories Operation in the United States

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. 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 now being phased out as a CLIA-accepted QC option for nonwaived testing. After January 1, 2016, EQC will no longer be a QC option. The QC requirement for waived testing remains the same-- follow 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.
The IQCP Education and Transition Period began on January 1, 2014 and will conclude on January 1, 2016. This education and transition period gives laboratories the opportunity to learn about IQCP and implement their chosen QC policies and procedures.