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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

EP47 (Proposed Draft) - Evaluation of Reagent Carryover Effects on Test Results. CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments along with establishing the reagent carryover performance claims. This guideline is available to the public for review and comment for 45 days. (19 March to 03 May).

GP40 (Limited Revision Proposed Draft) - Preparations and Testing of Reagent Water in the Medical Laboratory. CLSI GP40 provides guidelines on water purified for medical laboratory use; methods for monitoring water quality and testing for specific contaminants; and water system design considerations. This guideline is available to the public for review and comment for 30 days. (01 April to 01 May).

QMS28 (Proposed Draft) - Laboratory Safety Mangement. CLSI QMS28 includes recommendations for developing, implementing, and maintaining a laboratory safety management program. It covers laboratory maintenance and inspection, personal safety, warning signs and labels, fire prevention, electrical and radiation safety, waste management, and other potential laboratory hazards. This guideline is available to the public for review and comment for 45 days. (15 April to 30 May).

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.