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 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

EP12 (Proposed Draft)Evaluation of Qualitative, Binary Output Examination Performance. This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. This draft document is available to the public for review and comment for 60 days (28 January 2020 to 27 March 2020).

QMS20 (Proposed Draft)The Cost of Quality in Medical Laboratories. This guideline helps laboratories understand, apply, track, and manage the different types of quality costs that affect their processes, services, and financial well-being. This draft document is available to the public for review and comment for 60 days (31 January to 30 March 2020).

NBS09 (Proposed Draft)Newborn Screening for X-Linked Adrenoleukodystrophy. This guideline discusses the detection of X-linked adrenoleukodystrophy (ALD) by population-based newborn screening using dried blood spot specimens to measure C26:0-lysophosphatidylcholine. Males with ALD, who are asymptomatic at birth, may develop adrenal insufficiency and/or cerebral disease in early childhood, and effective therapy requires presymptomatic detection. Genetic counseling is recommended for the families of male and female babies with ALD. This draft document is available to the public for review and comment for 60 days (20 February 2020 to 20 April 2020).

VET02 (Proposed Draft)Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents. This guideline discusses the necessary and recommended data for selecting appropriate breakpoints and quality control ranges for antimicrobial agents for veterinary use. This draft document is available to the public for review and comment for 60 days (17 March 2020 to 15 May 2020).



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.