Validation of the Laboratory Information System

Abstract

The use of computer systems and computerized devices in the laboratory is becoming nearly universal, and increasingly processes once performed by people are being transferred to machines, the inner workings of which may be only dimly understood. The task of the people managing the work of the laboratory is to comprehend the processes by which the computerized laboratory information system (LIS) in use, usually acquired as a package from a vendor, may be shown to be doing the job it is expected to do. The functions of the system must be validated. Useful discussions of regulation¹ and inspection and accreditation² of laboratory information systems are available. However, despite its importance there is remarkably little published outside the blood bank literature about the validation of laboratory information systems that is accessible to general users of the systems, that is, addresses specifically laboratory issues in terms and concepts familiar to the laboratorian. Our intention here is to discuss LIS validation as it applies in the laboratory in general, to define the issues related to validation, and to suggest an approach to dealing with them.