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Clinical and Laboratory Standards Institute

FDA Compliance

CLSI Publishes New Proposed Guidelines

For manufacturers, clinic labs, and patient-care facility management

Published: Wednesday, December 9, 2009 - 15:26

(CLSI: Wayne, PA) -- Clinical and Laboratory Standards Institute (CLSI) recently published new proposed-level guidelines.

“How to Construct and Interpret an Error Grid for Diagnostic Assays”—Proposed Guideline (EP27-P) describes what an error grid is, why it is useful, and how to go about constructing and interpreting the information. Guidance is provided for manufacturers and for the clinical laboratory.

“Selection Criteria for Point-of-Care Testing Devices”—Proposed Guideline (POCT09-P) provides guidance on selection of point-of-care testing devices based on the patient care setting and clinical needs. It is designed as an aid to laboratory and facility management to simplify and facilitate the selection process but also allows evaluation of devices to identify those that are optimal to the patient care setting and population served.

The proposed documents are made available for review and comment to achieve a broad consensus so an approved document can be distributed for use to the health care community. This review is intended to ensure the utility and readability of CLSI’s approved consensus documents. Any comments received on a document as a result of CLSI member delegate voting and review will be addressed by the committee during the document’s advancement.

If you have technical questions regarding the content of CLSI standards and guidelines please e-mail standard@clsi.org. Visit www.clsi.org.




About The Author

Clinical and Laboratory Standards Institute

The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community. CLSI develops best practices in clinical and laboratory testings and promotes their use throughout the world, using a consensus-driven process that balances the viewpoints of industry, government, and the health care professions. Our documents provide invaluable tools that allow distinct—yet inseparable—constituencies to meet their health care responsibilities with www.clsi.org.