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 or by fax to +1.610.688.0700. Comments related to CLSI draft documents shall be made in writing using the comment table form and shall be submitted no later than the comment deadline indicated below.

CLSI Standards Documents for Public Review and Comment

AUTO15 (Proposed Draft)—Autoverification of Medical Laboratory Results for Specific Disciplines. This guideline includes detailed information for design, testing, validation, implementation, and ongoing support of an autoverification algorithm system for use in the medical laboratory. This draft document is available to the public for review and comment for 60 days (13 December 2018 to 11 February 2019).

EP25 (Proposed Draft)—Evaluation of Stability of In Vitro Diagnostic Products. This guideline provides recommendations for establishing and verifying shelf-life and in-use stability claims for in vitro diagnostic products such as reagent kits, calibrators, and control products. This draft document is available to the public for review and comment for 60 days (27 December 2018 to 25 February 2019).

The review and comment period provides an opportunity for the public to offer input on CLSI draft consensus documents. At the end of the 60-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.