Clinical and Laboratory Standards Institute (CLSI) document AUTO08-A—Managing and Validating Laboratory Information Systems; Approved Guideline identifies important factors that laboratory managers should consider when developing a protocol for the validation of the laboratory information systems (LIS). Also included are recommendations to help prepare validation protocols for assessing the accuracy and dependability of the LIS in storing, retrieving, and transmitting data.

The laboratory industry is quickly moving into the era of electronic reports, transmission of information via the Internet, etc., and there is a need to develop guidelines that can provide consistency in the industry. The purpose of this guideline is to address the validation of LIS systems and any interface to an external system (e.g., electronic health record system [EHRS], formerly known as a hospital information system [HIS], point-of-care device [POCD], reference laboratory, data repository, instrumentation, laboratory automation system [LAS], or financial system) to ensure that information is accurate and reliable during sample accessioning, transmittal of test results, and throughout the system’s intended use. 

This guideline addresses the validation process as it relates to: 

• data entry; 

• data analysis; 

• data verification; 

• data transmission; 

• data storage; and 

• data retrieval. 

The primary focus of AUTO08-A is on the software within the clinical laboratory environment. Therefore, the recommendations presented in AUTO08-A are not directly applicable to over-the-counter devices or software on instruments. The document is intended for use by: laboratory compliance officers, laboratory LIS staff (e.g., LIS coordinator, system administrator), vendors of LIS and associated hardware, IT staff responsible for LIS, and network administrators.