Individualized Quality Control Plan: 3 Years Later

Abstract

Each year, clinical laboratories must review and reapprove their individualized quality control plans (IQCPs). In doing so, laboratories must question if they are successfully meeting the IQCP compliance mandates set forth by the Center for Medicare and Medicaid Services (CMS) Clinical Laboratories Improvement Amendments (CLIA), the College of American Pathologists (CAP), or other accrediting agencies. Laboratory audits are a way to evaluate how well all IQCP requirements are being met and to understand if they are addressing the continuous monitoring aspects associated with the IQCP Quality Assessment. Data from three sources were reviewed to better understand ongoing compliance with, and potential pitfalls of, local IQCPs. The sources that were reviewed included CAP 2016 on-site survey checklist question deficiencies, CMS CLIA October 2018 Top 10 Deficiencies in the Nation-CMS Surveys, and a Survey Monkey created by the author of this article and distributed through the American Society for Microbiology Division C e-mail listserve.