CLSI H57-A

Clinical and Laboratory Standards Institute document H57-A-Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline provides guidance and procedures to the end user and manufacturer for the selection, evaluation, validation, and implementation of a laboratory coagulometer. Guidelines are given on the information that should be sought by the end user and manufacturer before acquisition. Included are guidelines for the procedures, specimens, reagents, and data analysis that may be used in the assessment of a coagulometer. This document addresses the differences in workload and range of tests offered by different laboratories, and this is reflected in the user assessment guidelines. Finally, guidance is given on implementation, including training, education, and interfacing.