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.

This guideline focuses on the validation of automated systems for immunohematological testing in the laboratory. This document assumes that the vendor of the immunohematological automated system (or systems) developed and validated performance claims using protocols in accordance with regulatory requirements. The elements of this document include immunohematology tests and automated systems, validation process, materials, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). The intended audience of this guideline is any laboratory that performs immunohematological testing. 

This document addresses the validation of automated systems for immunohematological testing before implementation. It is applicable to situations in which validation should be performed before implementation; for example, when changing from a manual platform for immunohematological testing to an automated system, adding an automated system, or changing from one automated system to another automated system. Although this guideline focuses on preimplementation validation, it may also provide useful information for validation postimplementation, such as when adding new intended uses or tests, relocating equipment, or changing reagents and critical materials; when upgrading an existing automated system (eg, new software, hardware, firmware); when a component is modified; when new quality control (QC) material or new or revised software is implemented; or when the laboratory acquires a new laboratory information system (LIS) or Blood Establishment Computer Software (BECS). 

The exclusions and limitations of this document include selection of automated systems, prevalidation, manual immunohematological testing, validation of LIS or BECS (refer to CLSI document AUTO08),1 implementation or postimplementation of automated systems, validation of off-label usage, and validation of a bar-code system (refer to CLSI document AUTO02).2