Jan 7 2010
Clinical and Laboratory Standards Institute
(CLSI) recently published "Validation of Automated Systems for
Immunohematological Testing Before Implementation; Approved Guideline"
(I/LA33-A). This document provides guidance to laboratory personnel for
validating an automated system for immunohematological testing before
implementation.
Immunohematological laboratory testing has evolved from test tube-based
methods to automated systems that employ a variety of techniques and
methods. Automated systems for such testing may bring potential advantages
to a laboratory, such as improvements in turnaround time, standardized
interpretation of reactions, and positive sample identification using
bar-code technology. Increasing use of automated systems in
immunohematological testing necessitates the development of a guideline for
laboratories for validation of these automated systems.
Katharine Appleton Downes, MD, chairholder of the committee that developed
the document, says, "I/LA33-A is beneficial to the laboratory because it is
comprehensive in design and was developed based on input from a variety of
stakeholders. It includes the key elements and tasks of the validation
process, including installation qualification, operational qualification,
and performance qualification. The appendix is especially practical because
it contains easy-to-use templates for the laboratory to apply to meet its
needs for data gathering, statistical calculations, and testing of
materials."
SOURCE: Clinical and Laboratory Standards Institute