Abstract:

The automated system for immunohematological testing should be validated before its routine implement. First, the laboratory should establish the required performance for the automated system according to the clinical application. Then the risk assessment should be conducted for those critical control points, including hazard identification, root cause analysis, risk estimation, and the risk acceptability evaluation. The validation plan should cover the installation qualification, operational qualification, and performance qualification. Only upon the validation of the automated systems for immunohematological testing is successful, can the automated system be introduced into the routine implement.

Key words: Automated system, Immunohematological testing, Validation