CLSI POCT08-A-2010
Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline

Standard No.

CLSI POCT08-A-2010

Release Date

2010

Published By

US-CLSI

Scope

This document is designed to provide education in basic concepts of good laboratory practice to a wide audience; to provide tools, protocols, and examples to illustrate and assist in the implementation of good laboratory practices; and to provide templates and other resources to make it easier to build a high-quality point-of-care testing (POCT) program. The intended audience includes: ? Medical technologists and other laboratory professionals engaged in noninstrumented POCT ? Nurses and other medical personnel without laboratory training or specialization who perform such testing ? Nonmedically trained workers performing such testing ? Laboratory professionals and others engaged in oversight or consultation ? Manufacturers and distributors of noninstrumented point-of-care tests Organizations that may engage in noninstrumented POCT and that might use this guideline include, but are not limited to: ? Physician office and group practices ? Hospitals and other acute-care facilities ? Long-term care facilities ? Home care organizations ? Outreach and community organizations providing testing ? Other settings where simple laboratory tests may improve disease detection or management Aspects of good laboratory practice addressed include: ? Roles and responsibilities of the people involved in the testing system ? Selecting, learning, proving, and implementing new tests ? Avoiding errors before, during, and after testing ? Building systems and procedures to maintain test quality ? Recordkeeping to limit risk and document performance