The Clinical and Laboratory Standards Institute (CLSI) has published Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.

This guide converts the requirement complexities of US Food and Drug Administration (FDA) regulations into plain language, offering intuitive assistance on how to conform to the Quality System Regulation (QSReg), 21 CFR 820, when creating laboratory-developed tests (LDTs). This CLSI practical guide can help laboratorians learn how to address the new demands, beyond the Clinical Laboratory Improvement Amendments (CLIA) regulations, within their unique laboratory settings. 

LDTs are in vitro diagnostic devices that are intended for clinical use and are designed, manufactured, and used within a single laboratory. This practical guide is intended to clarify how to implement the QSReg that may be required for some classifications of LDTs. On October 3, 2014, the FDA issued draft guidance for regulating LDTs that includes notification or registration of LDTs with the FDA, reporting adverse events, and other requirements. This document only addresses the QSReg that is currently applicable to manufacturers and is expected to become applicable for some classifications of LDTs when the final guidance is published.

“Changes are coming for institutions offering LDTs,” notes James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Associate Medical Director for Clinical Operations, and Medical Director of Clinical Chemistry, at Vanderbilt University School of Medicine, in Nashville, Tennessee, USA. “This guide by CLSI will help CLIA-certified laboratories understand the Federal Food, Drug, and Cosmetic Act regulations and prepare for the proposed changes to the enforcement of the FDA LDT regulations. Laboratories will learn the intent of the FDA QSReg and how these requirements differ from quality under CLIA and CMS.”

CLSI solicited the help of experts from the in vitro diagnostics industry to develop this practical guide, as well as representatives from FDA and Centers for Medicare & Medicaid Services (CMS)/CLIA. These experts have many years of experience in complying with FDA regulations and succeeding with FDA inspections. This document translates the FDA proposed requirements for high-risk LDTs into intuitive, actionable steps to prepare for the change. The guide helps users to learn where the QSReg differs from current CLIA requirements, and how it affects protocols. The document also aids users in finding the tips and hints on methods for complying that have proven to be effective. 

David G. Grenache, PhD, Associate Professor of Pathology at the University of Utah and Medical Director of the Chemistry Division at ARUP Laboratories in Salt Lake City, Utah, USA, highlights, “To many clinical laboratorians, the FDA QSReg is uncharted territory. I applaud CLSI for providing a well-written guide that brings clarity to a set of complicated regulations.”

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