scope:

This document is designed as an aid for laboratory and facility management to simplify and facilitate the point-of-care testing (POCT) device selection process and allow evaluation of these devices to identify those that are optimal for the patient care setting and population served. The device evaluation process will lead to an increased awareness of the device's testing process and risk associated with use of the device. In addition, long-term benefits can be achieved with improved operational and compliance processes. Thus, patient care, quality, and compliance will be maximized.

This guidance document is intended to reflect the selection process of instrumented diagnostic systems that can be used at or near the site of patient care. Purposely excluded from this discussion are large central laboratory analyzers, noninstrumented testing (eg, dip sticks, visual read lateral flow devices), and handheld glucose meters, which are the subject of other CLSI guidance documents, either already existing (eg, CLSI document C301) or in development. Although these classes of diagnostics devices are excluded from specific discussion, many of the processes and concepts discussed herein have widespread utility across device classes.