Comment on New and Revised Standards

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 drafts 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.

DOCUMENTS FOR REVIEW AND COMMENT

C63 (Proposed Draft)Laboratory Support for Pain Management. This guideline includes information for medical laboratories and clinical practices that provide services for pain management. This draft document is available to the public for review and comment for 60 days (26 July to 25 September 2017). 

NBS03 (Proposed Draft)Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns. This guideline describes the recommended protocols for screening preterm, sick, or low birth weight infants for hearing loss, critical congenital heart defects, and diseases detectable through dried blood spot testing. This draft document is available to the public for review and comment for 60 days (2 August to 2 October 2017).

QMS22 (Proposed Draft)Management of Paper-based and Electronic Laboratory Information. This guideline includes recommendations for managing the information generated and entered into a paper-based or electronic recordkeeping system and disseminated electronically or otherwise to end users or other computer systems. This draft document is available to the public for review and comment for 60 days (10 August to 9 October 2017).

MM18 (Proposed Draft)Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing. This guideline includes information on sequencing DNA targets of cultured isolates, provides a quantitative metric for perceiving microbial diversity, and can serve as the basis to identify microorganisms. By establishing interpretive criteria for microorganism identification by targeted DNA sequencing, this guideline provides structure to laboratories that identify microorganisms for medical use. This draft document is available to the public for review and comment for 60 days (16 August to 16 October 2017).

M02 (Proposed Draft)Performance Standards for Antimicrobial Disk Susceptibility Tests. This standard covers the current recommended methods for disk susceptibility testing and criteria for quality control testing. This draft document is available to the public for review and comment for 60 days (18 August to 16 October 2017).

M07 (Proposed Draft)Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. This standard covers reference methods for determining minimal inhibitory concentrations of aerobic bacteria by broth macrodilution, broth microdilution, and agar dilution. This draft document is available to the public for review and comment for 60 days (18 August to 16 October 2017).

M23 (Proposed Draft)Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. This guideline discusses the necessary and recommended data for selecting appropriate breakpoints and quality control ranges for antimicrobial agents. This draft document is available to the public for review and comment for 60 days (30 August to 30 October 2017).



The review and comment period provides an opportunity for the public to offer input on 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.