CLSI Protocols for Lab Instrument Implementation, Verification, and Maintenance

Today's clinical Laboratory is challenged to provide accurate, precise, and high-quality data for patient care at a reasonable cost. Laboratory directors and managers must make appropriate decisions in selection of instrumentation, and once that decision has been made, these persons must, with their chosen instrumentation, adequately and efficiently verify and maintain performance.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has recently published a new guideline, Laboratory Instrument Implementation, Verification, and Maintenance; Proposed Guideline (GP31-P), which provides a basic understanding of the considerations for the implementation, verification, and maintenance of generic laboratory and pathology equipment in a systematic and easy-to-use format to ensure quality results.

The document provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing. Issues ranging from manufacturer relationships, initial verification of functionality, and ongoing operational assessment are discussed. It includes recommended instrument performance criteria that should be considered; discussion of proper functioning of instrumentation based on theory or experience, when necessary; and references for further information.


The new, proposed guideline was developed by CLSI as a joint project with the College of American Pathologists (CAP), click here for ordering details.