title: Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?
abstract: The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use "equivalent QC" (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown.
authors.affiliation: Kaiser Permanente, Department of Pathology, Portland, Oregon, USA susan.e.sharp@kp.org.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Sharp
authors.affiliation: University of North Carolina, School of Medicine, Pathology and Laboratory Medicine, Chapel Hill, North Carolina, USA.
authors.forename: Melissa B
authors.initials: MB
authors.lastname: Miller
authors.affiliation: University of California, Clinical Microbiology, Los Angeles, California, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Hindler
mesh_terms: D003955:Diagnostic Tests, Routine / Q000379:methods* / Q000592:standards*; D006801:Humans; D008828:Microbiological Techniques / Q000379:methods* / Q000592:standards*; D011786:Quality Control