CLSI H57-A PDF

CLSI H57-A – Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline, H57-A

Clinical and Laboratory Standards Institute document H57-A-Protocol for the Evaluation, Validation, and Implementation ofCoagulometers; 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 besought by the end user and manufacturer before acquisition. Included are guidelines for the procedures, specimens, reagents, anddata analysis that may be used in the assessment of a coagulometer. This document addresses the differences in workload andrange of tests offered by different laboratories, and this is reflected in the user assessment guidelines. Finally, guidance is givenon implementation, including training, education, and interfacing.