A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition
This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests (LDTs).
Planning for Laboratory Operations During a Disaster, 1st Edition
This document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.
Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition
This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.
Microarrays for Diagnosis and Monitoring of Infectious Diseases, 1st Edition
This document provides guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results.
Quality Management: Approaches to Reducing Errors at the Point of Care, 1st Edition
This document presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.