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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

H21 (Proposed Draft) - Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays. This guideline provides procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and general recommendations for performing the tests. This document is available to the public for review and comment for 45 days. (25 August 2022 to 10 October 2022).

NBS10 (Proposed Draft) - Newborn Screening for Congenital Hypothyroidism. This guideline describes a newborn screening system for detecting congenital hypothyroidism (CH). It discusses both first-tier and second-tier screening tests performed on newborn dried blood spot specimens, as well as screening strategies for identifying newborns at increased risk for CH. This document is available to the public for review and comment for 45 days. (09 September 2022 to 24 October 2022).

C40 (Proposed Draft) - Measurement Procedures for the Determination of Lead Concentrations in Blood and Urine. This guideline provides guidance for the measurement of lead in whole blood, including specimen collection procedures, determination of lead by graphite furnace atomic absorption spectrometry, anodic stripping voltammetry (based on disposable screen-printed electrode technologies), and inductively coupled plasma mass spectrometry. It also includes guidelines for quality assurance and quality control, and information on proficiency testing programs and laboratory certification. This document is available to the public for review and comment for 45 days. (12 September 2022 to 27 October 2022).

M64 (Proposed Draft) - Implementation of Taxonomy Changes. This guideline includes recommendations for implementation of nomenclature changes for medically important bacteria and fungi that are identified and reported from clinical specimens, especially when tested for antimicrobial susceptibility. This document is available to the public for review and comment for 45 days. (28 September 2022 to 14 November 2022).

H47 (Proposed Draft) - One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test. This document provides guidelines for performing the PT and APTT tests in the clinical laboratory, for reporting results, and for identifying sources of error. This document is available to the public for review and comment for 30 days. (28 September 2022 to 28 October 2022).

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.