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CLSI brings together the worldwide laboratory community to advance a common cause.
CLSI is excited to share a new report, entitled “The FDA Ruling on Laboratory Developed Tests: Taking Control of What’s in Your Control.” This free resource aggregates helpful CLSI guidance and materials that can also serve as an “LDT Toolkit” for the laboratory community.
CLSI and CAP 2024 Webinar: Identification and Methicillin Resistance Testing for Staphylococci other than S. aureus (SOSA) – What to Do Now?
Date: Thursday, 5 December 2024 | 1:00 – 2:00 PM ET
Learning Objectives:
CLSI C34 describes methods for all aspects of sweat testing, including collection and analysis, results evaluation and reporting, and quality control.
CLSI QMS14 presents concepts and information to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory that are critical to managing and sustaining quality.
CLSI AUTO11 provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization.
This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part
CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs.
CLSI C38 provides guidelines for patient preparation, specimen collection, transport, and processing for the measurement of trace elements in a variety of biological matrixes.
CLSI and our volunteer members actively identify and develop new guidance on standards that raise laboratory testing quality, safety, and efficiency. We are setting the bar for how that guidance is delivered.
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