Analytical Procedures for the Determination of Lead in Blood and Urine (C40-A); Laboratory Instrument Implementation, Verification, and Maintenance (GP31-P); Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture (H3-A6); Protocol for the Evaluation, Validation, and Implementation of Coagulometers (H57-P); Platelet Function Testing by Aggregometry (H58-P); Verification and Validation of Multiplex Nucleic Acid Assays (MM17-P)

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.  

MM17-P—Verification and Validation of Multiplex Nucleic Acid Assays
This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials. The deadline for the completed ballot for MM17-P to be received at the CLSI offices is 28 September 2007.

Second Notice

C40-A—Analytical Procedures for the Determination of Lead in Blood and Urine; Approved Guideline
This document offers guidance for the measurement of lead in blood and urine, including specimen collection, measurement by GFAAS and ASV, quality assurance, and quality control. The deadline for the completed ballot for C40-A to be received at the CLSI offices is 28 August 2007.

GP31-P—Laboratory Instrument Implementation, Verification, and Maintenance; Proposed Guideline
This guideline provides information about assessing instrument performance and function from the time of instrument purchase to the routine performance of clinical testing. A CLSI-CAP joint project. The deadline for the completed ballot for GP31-P to be received at the CLSI offices is 6 August 2007.

H3-A6—Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard – Sixth Edition
This document provides procedures for the collection of diagnostic specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children. It also includes recommendations on order of draw. The deadline for the completed ballot for H3-A6 to be received at the CLSI offices is 13 August 2007.

H57-P—Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Proposed Guideline
This document provides guidance and procedures to the end -user and manufacturer for the selection, evaluation, validation, and implementation of a laboratory coagulometer. The deadline for the completed ballot for H57-P to be received at the CLSI offices is 28 August 2007.

H58-P—Platelet Function Testing by Aggregometry; Proposed Guideline
This document provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens with the intent to achieve greater uniformity of results. The deadline for the completed ballot for H58-P to be received at the CLSI offices is 28 August 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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