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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C65-Ed1 (Proposed Draft) - Biochemical Tumor Marker Testing. This document provides guidance and recommendations for optimal and effective serum tumor marker use. This document is available to the public for review and comment for 45 days. (30 September to 14 November.)
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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. (9 October to 25 November.)
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MM06-Ed3 (Proposed Draft) - Quantitative Molecular Methods for Infectious Diseases. CLSI MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms. It also presents recommendations for quality assurance, proficiency testing, and interpretation of results. This document is available to the public for review and comment for 45 days. (4 September to 22 October.)
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MM14-Ed3 (Limited Revision Proposed Draft) - Proficiency Testing (External Quality Assessment) for Molecular Methods. This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. This document is available to the public for review and comment for 30 days. (30 September to 30 October.)
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NBS06-Ed2 (Proposed Draft) - Newborn Screening for Severe Combined Immunodeficiency and Other Related Severe Immunodeficiencies. CLSI NBS06 discusses the detection of severe combined immunodeficiency (SCID) by population-based newborn screening using dried blood spot specimens to measure T-cell receptor excision circles. The relevance, clinical utility, and feasibility of using κ-deleting recombination excision circles is also discussed. This document is available to the public for review and comment for 45 days. (10 September to 4 November.)
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NBS12-Ed1 (Proposed Draft) - Newborn Screening for Galactosemia. This guideline describes a newborn screening (NBS) system for identifying presymptomatic newborns at increased risk for one or more of the galactosemias, enabling early detection, diagnosis, and the rapid treatment needed to prevent acute morbidity and mortality. This guideline discusses biological and clinical features of classic galactosemia, which is a primary target of most NBS programs, and explains the assays used for screening tests performed on newborn dried blood spot specimens, screening strategies, as well as short-term and long-term follow-up. Different forms of galactosemia that may also be identified by some NBS program approaches are briefly described. This document is available to the public for review and comment for 45 days. (26 August to 21 October.)
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QMS06-Ed4 (Limited Revision Proposed Draft) - Quality Management System: Continual Improvement. This guideline presents continual improvement as an ongoing, systematic effort that is an essential component of a quality management system. A continual improvement program consists of fundamental processes and common supporting elements. This document is available to the public for review and comment for 30 days. (20 September to 21 October.)
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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.