Press Releases
Autoverification of Clinical Laboratory Test Results (AUTO10-P); IT Security of In Vitro Diagnostic Instruments and Software Systems (AUTO11-P); Evaluating Dehydrated Mueller-Hinton Agar (M6-A2); Viral Culture (M41-P)

New CLSI Document Provides Proposed Guidelines for Next Generation Autoverification of Clinical Laboratory Test Results
Wayne, Pennsylvania, USA—1 February 2006—Newly proposed Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document Autoverification of Clinical Laboratory Test Results; Proposed Guideline (AUTO10-P) is designed to provide laboratorians with a tool set consisting of basic and complex Boolean logic to develop algorithms that can be used to make result verification decisions based upon available medical data. This document provides a general framework that will allow laboratories to design, implement, validate, and customize rules for autoverification based on the needs of its own patient population.
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New CLSI Document Provides Proposed Standard for IT Security of In Vitro Diagnostic Instruments and Software Systems
Wayne, Pennsylvania, USA—1 February 2006—Newly proposed Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document IT Security of In Vitro Diagnostic Instruments and Software Systems; Proposed Standard (AUTO11-P) specifies technical and operational requirements, as well as technical implementation procedures related to security of IVD systems (devices, analytical instruments, data management systems, etc.) installed at a healthcare organization.  This document provides a framework for communication of IT security issues between the IVD system vendor and the healthcare organization.
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New CLSI Document Provides Replacement Reference Standards for Evaluating Dehydrated Mueller-Hinton Agar
Wayne, Pennsylvania, USA—1 February 2006—A newly approved document from Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) titled Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition (M6-A2) is now available. It provides three protocols for evaluating dehydrated Mueller-Hinton agar in the disk diffusion procedure for antimicrobial susceptibility testing. 
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New CLSI Document Guides Viral Culture, Addresses Recent Safety Concerns, Biologic Threats
Wayne, Pennsylvania, USA—1 February 2006—Comprehensive diagnostic virology laboratories typically employ a combination of culture and nonculture techniques for the detection of viral agents in clinical samples.  The commercial availability of high quality cell cultures, culture media, and culture confirmation reagents has served to expand the availability of viral cultures.  Newly proposed Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document Viral Culture; Proposed Guideline (M41-P) provides recommendations for optimizing culture results.
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