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CLSI Releases Standards on Point-of-Care Testing

Wayne, Pennsylvania, USA—July 2015—CLSI recently released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. Effects of Different Sample Types on Glucose Measurements, 1st Edition (POCT06-Ed1), provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition (POCT13-Ed3), focuses on performance of point-of-care glucose monitoring systems, with an emphasis on safety practices, quality control, training, and administrative responsibility.

POCT06 suggests ways to optimize laboratory and hospital staff efficiency, minimize patient discomfort, and help to ensure the quality and accuracy of glucose results. The new document aids in identifying the possible causes of differences in glucose test results when different measurement technologies, sampling sites, and/or sample types are used. This document is intended for use by clinicians, point-of-care teams, pathologists, laboratory directors, and manufacturers of glucose testing devices.

“Patients requiring glucose testing often are tested with different methodologies and sample types that have different accuracy challenges. Physicians and health care providers are forced to determine if differences in glucose test results are caused by the patient’s physiology or are due to different test methodologies and their accuracy challenges. This document can provide manufacturers and health care providers insight into properly comparing glucose results from different testing technologies, sampling sites, and/or sample types,” highlighted Document Development Committee Co-Chairholders Mary C. Coyle, MS, MT(ASCP), PMP, Director Marketing Healthcare Software at Roche Diagnostics Corporation, and Ellis Jacobs, PhD, DABCC, FACB, Director of Scientific Affairs at Alere Inc.

POCT13 contains a question and answer format that provides recommendations related to administrative structure, operator authorization, test system selection, quality assurance, and test procedure. The revised document includes samples of meter maintenance and quality control logs, and includes updates to information about safety, training, and alternate site testing that have changed since the document’s previous release in 2005. This document is intended for use by personnel monitoring glucose levels at sites other than a hospital laboratory.

“Establishing and maintaining a robust glucose monitoring program is a multifaceted task, which includes 1) personnel training and certification, 2) equipment selection and quality control, 3) testing procedure development and compliance, and 4) patient safety and equipment disinfection. Since representatives from industry, academia, clinical laboratories, and the FDA provided significant input into the development of this document, its end-users will find it a useful blueprint regardless of their level of experience or expertise in glucose monitoring,” noted Document Development Committee Chairholder James R. Petisce, PhD, Principal Scientist at BD Medical – Diabetes Care.

These documents, including their sample pages, can be found on the CLSI Shop at shop.clsi.org/point-of-care-documents/.

 

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