Joint Commission Clarifies Stance on IQCP

The Joint Commission has published a list of frequently asked questions (FAQs) to address its expectations related to the Individualized Quality Control Plan (IQCP) for clinical laboratories. On Jan. 1, 2014, the Centers for Medicare and Medicaid Services (CMS) began a two-year education and transition period for the IQCP, a new quality control option for clinical laboratories. The IQCP Interpretive Guidelines outline a risk assessment model for establishing a quality control frequency that will replace the current Equivalent Quality Control (EQC). EQC must be phased out by Jan. 1, 2016. To assess the CMS revisions, the Joint Commission changed the Quality System Assessment for Nonwaived Testing (QSA) chapter of the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing. Note 2 was added to the Rationale for Standard QSA (02.04.01) to explain the commission’s expectations during the education and transition period and was communicated in the March 2014 Joint Commission Perspectives. However, this note raised more questions. To minimize confusion, Note 2 has been removed and the commission has issued a FAQ to answer additional questions (see below). FAQs on IQCP Must my laboratory continue to perform quality control for any test system(s) being considered for an IQCP? During CMS’s IQCP education and transition period, laboratories must continue to maintain compliance with existing Joint Commission requirements and Clinical Laboratory Improvement Amendments (CLIA) regulations related to quality control for all test systems. What if my laboratory fails to perform quality control for any test system under consideration for an IQCP? Failure to maintain compliance with Joint Commission requirements or existing CLIA regulations related to quality control will result in citation for quality control noncompliance. Does the education and transition period apply to all quality control for all test systems? The education and transition period applies only to test system(s) being investigated by the laboratory for inclusion in an IQCP. Takeaway: Laboratories must continue to comply with existing requirements for quality control during CMS’s education and transition period for IQCP.