Verification of Comparability of Patient Results Within One Healthcare System (C54-P) Clinical Evaluation of Immunoassays (I/LA21-A2)
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems (LIS1-A2)
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts (M27-A3)
Quality Control Minimal Inhibitory Concentration (MIC) Limits for Broth Microdilution and MIC Interpretive Breakpoints (M27-S3)
Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals (M31-A3)
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents (M37-A3)

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.  

C54-P—Verification of Comparability of Patient Results Within One Healthcare System
This document provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system. The deadline for the completed ballot for C54-P to be received at the CLSI offices is 31 December 2007.

LIS1-A2—Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
This specification describes the electronic transmission of digital information between clinical laboratory instruments (those that measure one or more parameters from one or multiple samples) and computer systems (those that are configured to accept instrument results for further processing, storage, reporting, or manipulation). The deadline for the completed ballot for LIS1-A2 to be received at the CLSI offices is 3 December 2007.

M27-A3— Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
This standard addresses the selection and preparation of antifungal agents; implementation and interpretation of test procedures; and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections. The deadline for the completed ballot for M27-A3 to be received at the CLSI offices is 10 December 2007.

M27-S3— Quality Control Minimal Inhibitory Concentration (MIC) Limits for Broth Microdilution and MIC Interpretive Breakpoints
This supplemental table provides updated QC ranges and interpretive criteria for broth microdilution testing for CLSI/NCCLS document M27-A2—Reference Methods for Broth Dilution Antifungal Susceptibility Testing of Yeasts. Two charts are laminated for easy posting. The deadline for the completed ballot for M27-S3 to be received at the CLSI offices is 10 December 2007.

M31-A3— Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals
This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use. The deadline for the completed ballot for M31-A3 to be received at the CLSI offices is 10 December 2007.

Second Notice

I/LA21-A2—Clinical Evaluation of Immunoassays
This document addresses the need for clinical evaluation of new immunoassays and new applications of existing assays. As a guide to designing and executing a clinical evaluation, this document will aid developers of “in-house” assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products. The deadline for the completed ballot for I/LA21-A2 to be received at the CLSI offices is 19 November 2007.

M37-A3— Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents
This document addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents. The deadline for the completed ballot for M37-A3 to be received at the CLSI offices is 27 November 2007.

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.

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