Vote and Deadlines
Autoverification of Clinical Laboratory Test Results (AUTO10-P); IT Security of In Vitro Diagnostic Instruments and Software Systems (AUTO11-P); Viral Culture (M41-P); Molecular Diagnostic Methods for Genetic Diseases (MM1-A2); Point-of-Care In Vitro Diagnostic (IVD) Testing (POCT4-A2)

CLSI submits the following for vote as 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.

AUTO10-P—Autoverification of Clinical Laboratory Test Results; Proposed Guideline
This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population. The deadline for the completed ballot for AUTO10-P to be received at the CLSI offices is 18 April 2006.

AUTO11-P—IT Security of In Vitro Diagnostic Instruments and Software Systems; Proposed Standard
This document provides a framework for communication of IT security issues between the IVD system vendor and the healthcare organization. The deadline for the completed ballot for AUTO11-P to be received at the CLSI offices is 18 April 2006.

M41-P—Viral Culture; Proposed Guideline
Guidance for viral culture and identification procedures typically performed in the clinical virology laboratory setting using commercially available cell cultures and reagents. Identifies critical elements that must be addressed in devising a viral culture procedure, including the selection, assessment and maintenance, and verification and quality control of cell cultures; culture medium preparation and quality control; specimen collection and preparation; isolate identification; and result reporting and interpretation. The deadline for the completed ballot for M41-P to be received at the CLSI offices is 1 May 2006.

MM1-A2—Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline—Second Edition
This document provides guidance for the use of molecular biological techniques for clinical detection of heritable mutations associated with genetic disease.  The recommendations in this guideline cover nomenclature for human pedigrees and the designation of mutations; laboratory safety; and “front-end” activities, such as intake information, specimen identification and accessioning, and sample preparation. Other topics addressed are molecular analytical techniques, test validation and characterization, quality assurance, results reporting, and selection of referral laboratories. The guideline also includes definitions of selected terms commonly used in the theory and practice of molecular genetics. The deadline for the completed ballot for MM1-A2 to be received at the CLSI offices is 6 March 2006.

POCT4-A2—Point-of-Care In Vitro Diagnostic (IVD) Testing; Approved Guideline—Second Edition 
This document provides guidance to users of in vitro diagnostic (IVD) devices outside the clinical laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory.  Point-of-care testing (POCT), also known as bedside testing or near-patient testing, is intended to provide more rapid test results than can be achieved in central or satellite laboratory settings. This is important particularly in critical care areas, such as the intensive care unit, emergency rooms, burn units, emergency transport vehicles, and operating rooms, as well as in skilled nursing facilities and hospices. POCT has also been used to expedite treatment decisions and provide convenience for the patient/client. The deadline for the completed ballot for POCT4-A2 to be received at the CLSI offices is 6 March 2006.

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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