Press Releases
- Verification of Comparability of Patient Results Within One Health Care System (C54-A)
- One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test (H47-A2)
- Diagnosis of Mycobacterial Infections (M48-A)
- Implementation Guide of POCT01 for Health Care Providers (POCT02-A)
CLSI Publishes Guideline for Verification of Comparability of Patient Results Within One Health Care System
Wayne, Pennsylvania, USA—June 2008—Clinical and Laboratory Standards Institute has recently published a new document, Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline (C54-A), which provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system. Patients may get laboratory testing at multiple locations within a health care system. Comparable results within this health care system, using the different measurement systems, and/or multiple instruments within one location (eg, backup instruments, point-of-care [POC] instruments) are necessary to provide optimal patient care. The document reviews the salient issues surrounding verification of comparability of patient results among measurement procedures, and provides a practical, statistically valid approach that laboratories of varying size and resources can use to satisfy this quality requirement.
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CLSI Publishes Guideline for One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test
Wayne, Pennsylvania, USA—June 2008—The PT and APTT are important screening tests used in laboratory evaluation of patients suspected to have disorders of blood coagulation, including the presence of circulating coagulation inhibitors. Clinical and Laboratory Standards Institute (CLSI) recently published an updated document, One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition (H47-A2), which provides guidelines for performing the PT and APTT tests in the clinical laboratory, for reporting results, and for identifying sources of error. Read full press release.
CLSI Publishes New Guideline for Diagnosis of Mycobacterial Infections
Wayne, Pennsylvania, USA—June 2008—The enormous global problem of tuberculosis (with roughly one-third of the world’s population infected with Mycobacterium tuberculosis), coupled with an increasing incidence of infections caused by nontuberculous mycobacteria, present unique challenges for the laboratory diagnosis of mycobacterial infections. The diagnosis of M. tuberculosis needs to be optimized and expedited for good patient management and appropriate control measures need to be implemented to prevent transmission of tuberculosis. There are similar demands for accurate identification of the ever-increasing numbers of species of nontuberculous mycobacteria.
In light of these issues, Clinical and Laboratory Standards Institute (CLSI) has recently published
Laboratory Detection and Identification of Mycobacteria; Approved Guideline (M48-A).
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CLSI Publishes New Implementation Guide of POCT01 for Health Care Providers
Wayne, Pennsylvania, USA—June 2008—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.
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