New Option for Laboratories to Meet CLIA Quality Control Requirements: Individualized Quality Control Plan

CMS has approved a new quality control option for laboratories to meet the Quality Control (QC) requirements of the Clinical Laboratory Improvement Amendments (CLIA), the Individualized Quality Control Plan (IQCP). This plan uses a risk management approach. Laboratories may begin using IQCP on January 1, 2014. Currently, laboratories have the option of following the CLIA QC regulations or using Equivalent Quality Control (EQC). Laboratories may continue to use these options during the Education and Transition period of January 1, 2014 through December 31, 2015. IQCP will give laboratories the opportunity to tailor a QC plan that is customized to their unique testing environment, while giving them the ability to adapt to new and future technologies. Laboratories can use the retrospective data and information gathered during routine operations to meet portions of the IQCP requirement. EQC will no longer be an acceptable QC option as of January 1, 2016. After the Education and Transition Period, any laboratory using a QC plan less stringent than the CLIA QC regulations must perform an IQCP, or the laboratory will be cited for non-compliance. Regardless of the option chosen, the instructions and recommendations in the manufacturer’s test package insert must continue to be followed.

Beginning January 1, 2016, laboratories must use one of the following to be in compliance with CLIA:

• Follow the CLIA QC regulations;  or
• IQCP