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Notice of Vote and Comment Deadline for Consensus Documents
LIS Validation (AUTO8-P); Remote Access (AUTO9-P); Performance for Precision and Trueness (EP15-A2); Bleeding Time Test (H45-A2); Medical Device Hazards and Recalls (HS11-P); Intestinal Tract Parasites (M28-A2)
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 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.
-Second Notice-
The deadline for the completed ballots for AUTO8-P and AUTO9-P to be received in the Executive Offices is 12 April 2005.
AUTO8-P—Protocols to Validate Laboratory Information Systems; Proposed Guideline
This document provides guidance for developing a protocol for validation of the Laboratory Information System (LIS) as well as protocols for assessing the dependability of the LIS when storing, retrieving, and transmitting data.
AUTO9-P—Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Proposed Standard
This document provides a standard communication protocol for instrument system vendors, device manufacturers, and hospital administrators to allow remote connections to laboratory diagnostic devices. The remote connections can be used to monitor instruments’ subsystems; collect diagnostics data for remote system troubleshooting; and collect data for electronic inventory management.
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.
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