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
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Documents for Public Review and Comment
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AUTO14-Ed1 (Proposed Draft) - Use of Two-Dimensional Bar Coding in Clinical and Anatomic Pathology Laboratories. This standard provides a context and framework for the use of two-dimensional bar codes in clinical and anatomic pathology laboratories. The long-term goal of this standard is to replace linear bar codes currently in use in laboratories because they are known to have unacceptably high error rates that could lead to significant patient safety issues such as misidentified patients and incorrect tests. This document is available to the public for review and comment for 45 days.
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EP31-Ed2 (Proposed Draft) - Verification of Comparability of Patient Results Within One Health Care System. This document provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system. This document is available to the public for review and comment for 45 days.
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EP35-Ed2 (Limited Revision Proposed Draft) - Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures. EP35 provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types, such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type. The recommendations in EP35 apply to both quantitative measurement procedures and qualitative examinations. This document is available to the public for review and comment for 30 days.
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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.