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Individualized Quality Control Plan – Hardy Diagnostics

Individualized Quality Control Plan After January 1, 2016, the Centers for Medicare and Medicaid Services (CMS) will require clinical labs to revise their QC procedures on CLIA non-waived tests. After this date, labs will be required to choose between performing CMS/CLIA default guidelines or they must implement an Individualized Quality Control Plan (IQCP).

An IQCP consists of three key parts: (1) a Risk Assessment (RA) which identifies areas where errors or failures could occur in entire workflow path (pre-analytical, analytical, post-analytical); and assesses risk for harm to the patient if an error would occur and be reported; (2) a Quality Control Plan (QCP) which defines the control mechanisms in place for detecting or preventing errors; and finally (3) a Quality Assessment (QA), a process to continually monitor the efficacy of the QCP.

Resources such as frequently asked questions (FAQs) on how to set-up an IQCP can be found at CMS, College of American Pathologists (CAP) and additional resource materials are available through the American Society for Microbiology (ASM). In addition, a CAP IQCP eligibility determination flowchart as well as a CAP checklist for IQCP requirements are also available. Below are additional Hardy resources on IQCP FAQs from an interview with Dr. Susan E. Sharp and a customer notification letter on how these changes will affect Hardy’s CLSI M22 exempt media.

For additional questions, please contact our Hardy Technical Services Department and 800-266-2222, option 2 or via email at [email protected].