Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new document, Implementation Guide of POCT01 for Health Care Providers; Approved Guideline (POCT02-A), which identifies and describes the particular features of a connectivity-compliant device for health care providers or end users responsible for instrumented point-of-care testing (POCT). This guideline gives clear and concise information for users to address questions with the vendor of a compliant device; allows providers to acquire the device with a connectivity solution best suited to their needs; and includes practical advice on how to permit error-free point-of-care testing and result reporting along with optimal data capture for quality assurance purposes.
Patrick St. Louis, PhD, DipCC, Department of Clinical Biochemistry, Sainte Justine Hospital, explains, “POCT02 is an essential, understandable guideline for health care providers and end users. This resource provides an explanation of the requirements for a connectivity-compliant device, describes how users can approach suppliers, and outlines practical ways to implement the POCT process. A key focus of the document is to explain how true connectivity can enhance data transfer and, among other things, permit proper attribution of test results.”
POCT02-A presents some background on the rationale behind CLSI document POCT01, and describes the practical manner in which application of the standard to the POCT device/system should permit the flow of data among the testing system, the data manager, and the LIS/HIS.
For additional information on CLSI or for further information regarding this release, visit our website at www.clsi.org or call +610.688.0100.
CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care 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.
Contacts:
Amanda Holm,
Marketing Manager
+ 610-688-0100 ext. 129
aholm@clsi.org
