CLSI I/LA33

Validation of Automated Systems for Immunohematological Testing Before Implementation, 1st Edition

This document provides guidance to the end user and laboratory for validation of automated systems used in immunohematological testing before implementation.

This document is available in electronic format only.

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Chairholder: Katharine Appleton Downes, MD

Date of Publication: December 30, 2009

Order Code PDF: CLSI ILA33AE
ISBN Number: 1-56238-714-6

Order Code Print: print not available

Edition: First

Pages: 100

CLSI I/LA33 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI I/LA33 Abstract

Clinical and Laboratory Standards Institute document I/LA33-A—Validation of Automated Systems for Immunohematological Testing Before Implementation; Approved Guideline provides guidance to the user and laboratory for validating an automated system for immunohematological testing. Current automated system methodologies are discussed. This document addresses the development of a validation plan and the information required for its creation. It includes guidelines for elements and tasks of the validation process, including installation qualification, operational qualification, and performance qualification. For each of these qualifications, the purpose, prerequisites, responsibilities, considerations for and examples of test cases, and activities performed are included. The Appendix contains templates that may be used by the laboratory for development of test cases related to and for different aspects of installation qualification, operational qualification, and performance qualification.