CLSI POCT09

Selection Criteria for Point-of-Care Testing Devices, 1st Edition

This document provides guidance on selection of point-of-care testing 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.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of January 2017. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Marcia L. Zucker, PhD

Date of Publication: April 30, 2010

Order Code PDF: CLSI POCT09AE
ISBN Number: 1-56238-722-7

Order Code Print: print not available

Edition: First

Pages: 72

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CLSI POCT09 Abstract

Clinical and Laboratory Standards Institute document POCT09-A—Selection Criteria for Point-of-Care Testing Devices; Approved Guideline provides guidance on selection of point-of-care testing (POCT) devices based on the patient care setting and clinical needs. 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. Overall, this guidance document is designed to assist and benefit personnel responsible for the evaluation, negotiation, and selection process including laboratory, management, and information technology. It includes discussions on important factors when considering POCT through clinical and operational needs assessment. In addition, regulatory and accreditation requirements on various POCT or devices are explained, along with the various appendices that serve as a tool for POCT device implementation.