12 January 2005   
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Standards Status

Notice of Vote and Comment Deadlines for Consensus Documents
LIS Validation (AUTO8-P); Remote Access (AUTO9-P); Glucose Monitoring (AST4-A2)

Clinical and Laboratory Standards Institute (CLSI) announces that the following documents are submitted for vote as candidate-for-advancement consensus documents.

The documents and ballots are posted on Forums to delegates of Active and Associate Active member organizations. If you are a voting delegate or alternate, we request that you access Forums to obtain the candidate-for-advancement document. Login to access Forums.

The deadline for the completed ballots for AUTO8-P and AUTO9-P to be received in the Executive Offices is 12 April 2005.

AUTO8-PProtocols to Validate Laboratory Information Systems; Proposed Guideline
This document provides 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.

AUTO9-PRemote Access to Clinical Laboratory Diagnostic Devices via the Internet; Proposed Standard
This document provides a standard communication protocol for instrument system vendors, device manufacturers, and hospital administrators to allow remote connections to laboratory diagnostic devices.  The remote connections can be used to monitor instruments’ subsystems; collect diagnostics data for remote system troubleshooting; and collect data for electronic inventory management.

-Second Notice-

The deadline for the completed ballot for AST4-A2 to be received in the Executive Offices is 7 February 2005.

AST4-A2Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline–Second Edition
This document contains guidelines for performance of point-of-care (POC) glucose monitoring systems; the guidelines stress quality control, training, and administrative responsibility.


Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the Executive Offices by the above deadline.

In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.

Find out more about Active and Associate Active membership. [ return to top ]

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©2005 Clinical and Laboratory Standards Institute