The Centers for Medicare & Medicaid Services (CMS), Baltimore, which is implementing a new quality control option for labs based on risk management, has provided interpretive guidelines.
The Individualized Quality Control Plan (IQCP) will give labs flexibility in customizing Quality Control (QC) policies and procedures depending on the test systems they are using and the individual characteristics of the labs themselves.
IQCP is voluntary.
Click here for the IQCP Interpretive Guidelines, which provide procedures for labs that wish to use IQCP to meet CLIA QC requirements for equivalent quality testing.
Labs will continue to have the option of gaining compliance by following all Clinical Laboratory Improvement Amendments (CLIA) QC regulations as written.
The lab director is responsible for ensuring that QC programs are established and maintained to guarantee the quality of lab services provided, and to identify failures in quality as they occur.
An IQCP Education and Transition Period will allow labs to learn about IQCP and implement the labs’ chosen QC policies and procedures. The period will begin on January 1, 2014 and end on January 1, 2016. Before it begins, training will be provided to CLIA surveyors.