CLSI H57

Protocol for the Evaluation, Validation, and Implementation of Coagulometers, 1st Edition

This document provides guidance and procedures to the end user and manufacturer for the selection, evaluation, validation, and implementation of a laboratory coagulometer.

This document is available in electronic format only.

More Details

Member price:

List Price:

PDF Add to Cart

Details

Chairholder: Chris Gardiner, FIBMS, MSc, PhD

Date of Publication: January 23, 2008

Order Code PDF: CLSI H57AE
ISBN Number: 1-56268-656-5

Order Code Print: print not available

Edition: First

Pages: 48

CLSI H57 Additional Details

If interested in ordering larger quantities of this document in print, please contact us here.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of August 2021. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI H57 Abstract

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.