New CLSI Point-of-Care In Vitro Testing Guideline Provides Information on How to Effectively Assess, Evaluate, and Implement POCT.

WAYNE, Pa. -- Advances in technology and the implementation of microtechniques and portable instruments have made it possible to expedite treatment decisions and move laboratory testing closer to the patient/client. Point-of-care testing (POCT), also known as bedside testing or near-patient testing, is intended to provide more rapid test results than can be achieved in central or satellite laboratory settings. This is important particularly in critical care areas, such as the intensive care unit, emergency rooms, burn units, emergency transport vehicles, and operating rooms, as well as in skilled nursing facilities and hospices.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new edition of the document, Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline--Second Edition (POCT4-A2), which provides users of in vitro diagnostic (IVD) devices outside the clinical laboratory with easy-to-follow information and suggestions for good laboratory practice and for producing reliable test results regardless of where the test is performed.

This document provides guidance on how to assess POCT needs, how to evaluate and implement POCT, and how to ensure reliable results comparable to those obtained within the clinical laboratory.

It replaces the approved guideline, AST2-A, which was published in 1995. Changes that have been made in this edition include:

--introduction of the concept of Alternative Quality Control (AQC) for point-of-care testing sites;

--guidance for point-of-care programs outside the US, as well as updated regulatory recommendations for US-based programs;

--recommendations regarding patient/specimen collection and identification; and,

--a newly developed training checklist.

Ellis Jacobs, PhD, DABCC, FACB, New York State Department of Health, comments, "The revised POCT4-A2 will be of value to anyone interested in implementing or improving the performance of point-of-care testing, regardless of the testing location. It explains in easy to understand terms the entire process for establishing a POCT program, from assessing the need(s), through development of an organizational structure with roles and accountability, to instrument selection and evaluation. It provides valuable information and suggestions for good laboratory practices and for the production of reliable results. Of interest to new programs will be the example forms and log sheets that are included in the document."

For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call 610-688-0100.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.