2 April 2008   
 

CLSI 2008 Leadership Conference
2 – 4 April 2008
Renaissance Harborplace Hotel
Baltimore, Maryland USA

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To Your Good Health Workshop and Awards Celebration Dinner Highlight 2008 CLSI Leadership Conference
CLSI Project Proposal: Meeting the Needs for Standardization
New Guideline Supports the Development and Evaluation of Continuous Interstitial Glucose Monitoring Devices
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Standards Status
Vote and Deadlines
  • (C28-P3) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory 
  • (POCT5-P) Performance Metrics for Continuous Interstitial Glucose Monitoring 
  • (GP15-A3) Papanicolaou Technique
  • (H4-A6) Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens 


CLSI submits the following for vote as a candidate-for-advancement consensus documents.  The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums.  

C28-P3Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Proposed Guideline—Third Edition
This document provides guidance for determining reference values and reference intervals for quantitative clinical laboratory tests. The deadline for the completed ballot for C28-P3 to be received at the CLSI offices is 26 May 2008.

POCT5-PPerformance Metrics for Continuous Interstitial Glucose Monitoring; Proposed Guideline
This document provides consensus guidelines for health care professionals, IVD and medical device manufacturers, and regulatory agencies on how continuous glucose monitor (CGM) data should be; 1) presented; 2) compared between devices; and 3) compared between measurement technologies. The deadline for the completed ballot for POCT5-P to be received at the CLSI offices is 26 May 2008.

Second Notice

GP15-A3Papanicolaou Technique; Approved Guideline—Third Edition
This guideline addresses procedures for cervical specimen collection, as well as the preparation, fixation, staining, and storage of Papanicolaou slides. The deadline for the completed ballot for GP15-A3 to be received at the CLSI offices is 8 April 2008.

H4-A6Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens—Sixth Edition
This document provides a technique for the collection of diagnostic capillary blood specimens, including recommendations for collection sites and specimen handling and identification. Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens are also included. The deadline for the completed ballot for H4-A6 to be received at the CLSI offices is 8 April 2008.


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 CLSI 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.
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