CLSI eNews - 10 March 2005 (Plain Text Version)

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News
Executive Vice President's Message
Integrating a Global Perspective
Press Releases
Standards Status
Notice of Vote and Comment Deadline for Consensus Documents
Recently Approved Documents
Recently Distributed ISO Standards
Focus on Global Terminology
Events and Exhibits
Meeting Calendar
Upcoming Events and Exhibits
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Notice of Vote and Comment Deadline for Consensus Documents

Performance for Precision and Trueness (EP15-A2); Bleeding Time Test (H45-A2); Medical Device Hazards and Recalls (HS11-P); Intestinal Tract Parasites (M28-A2); Genotyping for Infectious Diseases (MM10-P); Collection and Handling of Specimens for Molecular Methods (MM13-P)

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 MM10-P and MM13-P to be received in the Executive Offices is 8 June 2005.

MM10-P—Genotyping for Infectious Diseases: Identification and Characterization; Proposed Guideline
This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting. It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing.

MM13-P—Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Proposed Guideline
This document provides guidance related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type.

-Second Notice-

The deadline for the completed ballots for EP15-A2, H45-A2, and M28-A2 to be received in the Executive Offices is 12 April 2005.

EP15-A2—User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition
This document describes the demonstration of method precision and trueness for clinical laboratory quantitative methods utilizing a protocol designed to be completed within five working days or less.

H45-A2—Performance of the Bleeding Time Test; Approved Guideline—Second Edition
This document contains guidelines for performing the template bleeding time test. A descriptive list of variables that can affect the results of the test is also included.

M28-A2—Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline—Second Edition
This guideline addresses the collection, processing, and examination of intestinal tract specimens for the identification of parasites.

The deadline for the completed ballot for HS11-P to be received in the Executive Offices is 12 May 2005.

HS11-P—A Model for Managing Medical Device Hazards and Recalls; Proposed Guideline
This document provides a framework for healthcare delivery organizations to respond to externally generated notifications of medical device hazards and recalls while focusing on the quality constructs of process control, occurrence management, and process improvement.

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.