The Centers for Medicare and Medicaid Services (CMS) released a Survey and Certification letter in August announcing a new policy regarding quality control under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). For over a decade, clinical laboratories have been permitted to use alternative quality control procedures, known as Equivalent Quality Control (EQC), to allow for a more flexible response to rapid changes in technology. Since it has proven difficult for laboratories to customize their individual circumstances to EQC, CMS has developed a more customizable process called IQCP (Individualized Quality Control Plans).
IQCP is a risk management-based system that allows the laboratory to customize its quality control plan according to the test method and use, environment, and personnel competency. IQCP will consider the entire testing process – from pre-analytic to analytic to post-analytic – and will assess risks and requirements in each of these phases.
IQCP will replace EQC as an alternative procedure for quality control. Laboratories must still review manufacturer’s instructions for quality control, but if those instructions do not meet the CLIA requirements of two levels of quality control each day of patient testing, then IQCP must be used. IQCP is considered a voluntary alternative for CMS-certified laboratories performing two levels of external quality controls on each test system for each day of testing.
There will be an education and transition period for laboratories to acclimate to IQCP from January 1, 2014 to January 1, 2016.
CMS issued Interpretive Guidelines on IQCP as part of the Survey and Certification letter.