CLSI EP23-P

Clinical and Laboratory Standards Institute document EP23-P–Laboratory Quality Control Based on Risk Management;Proposed Guideline provides guidance to laboratories on the development of quality control plans for measuring systems.Regulatory requirements, information provided by the manufacturer, information pertaining to the laboratory environment, andmedical requirements for the test results are evaluated using risk management principles to develop a quality control plan tailoredto the particular combination of measuring system, laboratory environment, and clinical application. The effectiveness of thelaboratory quality control plan is monitored to detect trends, identify corrective actions, and provide continuous qualityimprovement. The advantages and limitations of various quality control processes are considered.Clinical and Laboratory Standards Institute (CLSI). Laboratory Quality Control Based on Risk

Published:

01/01/2010

ISBN(s):

1562387189

Number of Pages:

102