CLSI EP23

Laboratory Quality Control Based on Risk Management, 2nd Edition

This guideline provides recommendations based on risk management for laboratories to develop quality control plans tailored to the combination of measuring system, laboratory setting, and clinical application of the test.

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Chairholder: James H. Nichols, PhD, DABCC, FACB

Date of Publication: August 15, 2023

Order Code PDF: CLSI EP23Ed2E
ISBN Number: 978-1-68440-201-4

Order Code Print: CLSI EP23Ed2
ISBN Number: 978-1-68440-200-7

Edition: Second

Pages: 126

CLSI EP23 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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CLSI EP23 Abstract

Clinical and Laboratory Standards Institute guideline EP23—Laboratory Quality Control Based on Risk Management provides recommendations based on risk management for laboratories to develop quality control plans (QCPs) tailored to the combination of measuring system, laboratory setting, and clinical application of the test. Regulatory requirements, information provided by the developer, information pertaining to the laboratory environment, and medical requirements for the test results are evaluated, using risk-management principles, to develop a QCP tailored to the combination of measuring system, laboratory environment, and clinical application. The effectiveness of the laboratory QCP is monitored to detect trends, identify corrective actions, and provide continual quality improvement opportunities. The advantages and limitations of various QC processes are discussed.