Clinical and Laboratory Standards Institute (CLSI) recently published “Selection Criteria for Point-of-Care Testing Devices; Approved Guideline” (POCT09-A).
This document provides guidance on selection of point-of-care testing (POCT) 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.
With a more thorough understanding of the implications, limitations, and overall components involved in POCT device selection, the process can be shortened significantly. In addition, long-term benefits can be achieved with improved operational and compliance processes. Thus, patient care, quality, and compliance will be maximized.
Marcia L. Zucker, PhD, Director of Clinical Support, Response Biomedical Corporation, chairholder of the committee that developed the document, says, “The POCT09 guideline was developed to give a step-by-step procedure by which people can determine whether a particular device is right for them. They will understand the pitfalls, understand how to make implementation of the system as smooth as possible, and have evidence that implementation will likely improve patient care. This document really gets to the critical issue behind implementing a point-of-care test.”
This guidance document is directed toward assisting and benefiting personnel responsible for the evaluation, negotiation, and selection process, including laboratory, management, information technology, and end users of the POCT system. Because some vendor sales representatives do not have a laboratory background, the in vitro diagnostic industry would also benefit from having a consensus guideline that would assist the sales force with product presentation and the encouragement of customer feedback.