CLSI POCT09-A (R2018)

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.