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CLSI Standards Documents for Public Review

Comment on New and Revised Standards Drafts

Help shape the standards that affect your day-to-day work. To preserve the integrity of standards developed through the CLSI consensus process, we seek input from the public on our in-process draft documents before they are approved for publication. Opening the dialogue to CLSI members and nonmembers alike, we encourage your involvement in shaping our documents to ensure all interested parties are given a voice.

General Information

Requests for documents should be submitted via e-mail to vote@clsi.org or by fax to +1.610.688.0700. Comments related to CLSI draft documents shall be made in our commenting platform and shall be submitted no later than the comment deadline indicated below.

Limited Revision Process

The Limited Revision Process provides an expeditious alternative to the Consensus Document Development Process when the requested document updates meet defined criteria. Limited revisions do not result in changes to the document’s scope, purpose, and/or intended audience. The attached document includes revised (redlined) text, and only the revised text is to be reviewed and commented on. Comments pertaining to other portions of the document (ie, those that were not revised) will be held for the next full revision.

CLSI Standards Documents for Public Review and Comment

QMS18 (Proposed Draft) - Process Management. This guideline describes five requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, assessing process risks, optimizing efficient use of resources, and contributing to patient safety and positive outcomes. This document is available to the public for review and comment for 45 days. (4 May 2022 to 17 June 2022).

PRE04 (Proposed Draft) - Procedures for Handling, Transport, and Processing of Blood Specimens for Common Laboratory Tests. This guideline includes criteria for assessing blood specimen quality and acceptability. This document is available to the public for review and comment for 45 days. (11 May 2022 to 27 June 2022).

EP25 (Proposed Draft) - Evaluation of Stability of In Vitro Diagnostic Reagents. This document provides guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products. This document is available to the public for review and comment for 45 days. (18 May 2022 to 2 July 2022).



The review and comment period provides an opportunity for the public to offer input on CLSI draft consensus documents. At the end of the 45-day review and comment period, the committee that developed the document is required to review and provide responses to all comments received and revise the draft document as appropriate.

Please note CLSI draft documents are available only for the purposes of review and comment and are not to be reproduced or circulated for any other reason. Draft documents have not completed the consensus review process and therefore shall not be used for any clinical purposes or to satisfy regulatory or accreditation requirements. They should not be considered either final or published and may not be quoted or referenced.