CLSI Publishes New Guideline for Managing and Validating Laboratory Information Systems.

WAYNE, Pa. -- 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. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new document, Managing and Validating Laboratory Information Systems; Approved Guideline (AUTO8-A), to provide necessary guidance for developing a protocol for validation of the laboratory information system (LIS), as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data.

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.

AUTO8-A 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.

AUTO8-A is one of a series of eleven different CLSI-approved documents that address individual portions of an automated laboratory system. For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.