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

Documents for Public Review and Comment
EP44-Ed4 (Proposed Draft) - Establishing Reference Intervals. CLSI EP44 provides guidance on the establishment of reference intervals (RI), including collection and testing of samples from a control or reference group, study design, data analysis, and presentation of results. This guideline is intended for new analytes, new or modified applications, and other situations where established RIs are not in place. This document is available to the public for review and comment for 45 days.
H20-Ed3 (Proposed Draft) - Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. CLSI H20 evaluates automated and semiautomated hematology instruments for their capability to perform an acceptable leukocyte (ie, white blood cell [WBC]) differential count. This document is available to the public for review and comment for 45 days.

Documents for Public Review and Comment

EP44-Ed4 (Proposed Draft) - Establishing Reference Intervals. CLSI EP44 provides guidance on the establishment of reference intervals (RI), including collection and testing of samples from a control or reference group, study design, data analysis, and presentation of results. This guideline is intended for new analytes, new or modified applications, and other situations where established RIs are not in place. This document is available to the public for review and comment for 45 days.

H20-Ed3 (Proposed Draft) - Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods. CLSI H20 evaluates automated and semiautomated hematology instruments for their capability to perform an acceptable leukocyte (ie, white blood cell [WBC]) differential count. This document is available to the public for review and comment for 45 days.

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.