Autoverification of Clinical Laboratory Test Results; Approved Guideline
|Publication Date:||1 October 2006|
This guideline specifies recommendations for the design, building, implementation, validation, and compliance of the algorithms used for autoverification of laboratory results.
The intended users of this guideline are information system vendors; hospital, reference, independent, and physician office laboratories; data management vendors; instrument manufacturers; and those involved in point-of-care testing.
This guideline is not intended to provide test parameter rules or limits for practicing medicine or methods for confirmation of result delivery. This guideline does not address hardware specifications, interface specifications, connectivity, or software configuration. Security measures are beyond the scope of this document and are assumed to be covered by country-specific policies. For additional information, refer to the current edition of CLSI document AUTO11-IT Security of In Vitro Diagnostic Instruments and Software Systems.