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. (20 June to 1 August.)
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EP21-Ed3 (Proposed Draft) - Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures. This guideline provides developers and end-users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and analytical method are provided to estimate TAE based upon a comparison of results between the candidate method and a comparator method using patient specimens. Each paired difference is compared to a pre-established specification for acceptability, ie, the allowable total error (ATE). Guidance for determining the ATE is provided in CLSI EP46. This document is available to the public for review and comment for 45 days. (11 June to 23 July.)
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EP46-Ed1 (Proposed Draft) - Determining Total Analytical Error Goals for Quantitative Medical Laboratory Test Methods. This document is available to the public for review and comment for 45 days. (11 June to 23 July.)
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MM19-Ed2 (Proposed Draft) - Establishing Molecular Testing in Medical Laboratory Environments. This guideline provides comprehensive recommendations for molecular diagnostic testing, that cover strategic planning, regulatory requirements, implementation, quality management, and special considerations for subspecialties of molecular genetics including infectious diseases, oncology, malignant hematology, and pharmacogenetics. This document is available to the public for review and comment for 45 days. (16 May to 1 July.)
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NBS13-Ed1 (Proposed Draft) - Newborn Screening for Spinal Muscular Atrophy. This document is available to the public for review and comment for 45 days. (30 May to 15 July.)
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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.