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: CLSI
