Management of Nonconforming Laboratory Events (GP32-P); Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays (H21-A5); One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test (H47-A2)

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.  

GP32-P—Management of Nonconforming Laboratory Events; Proposed Guideline
This guideline provides an outline and the content for developing a program to manage a healthcare service’s nonconforming events that is based on the principles of quality management and patient safety. The deadline for the completed ballot for GP32-P to be received at the CLSI offices is 30 July 2007.

H47-A2—One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition
This document provides guidelines for performing the PT and APTT tests in the clinical laboratory, for reporting results, and for identifying sources of error. The deadline for the completed ballot for H47-A2 to be received at the CLSI offices is 17 July 2007.

Second Notice

H21-A5—Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline – Fifth Edition
This guideline contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and provides general recommendations for performing the tests. The deadline for the completed ballot for H21-A5 to be received at the CLSI offices is 29 June 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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